A major paper by Australian researchers asks a question that should never have needed to be asked: Will more doctors increase or decrease death rates?
But sadly, with the state of health care as it is, this is a very legitimate, even necessary, inquiry.
The report, "Will More Doctors Increase or Decrease Death Rates?", conducted by the Center for Health Program Evaluation in Australia, refers to Australian statistics but I believe the information is relevant to America and other countries as well. The hypothesis? An increase in the doctor supply is associated with an increase in death rates. Read on to find out several potential reasons why this hypothesis may in fact be true.
Health Care and Adverse Events
One possibility of why medical care may increase death rates is the large number of adverse events associated with it. The report mentions a 1995 study in which close to 17 percent of 14,000 hospital admissions were associated with an adverse event. Of those, 51 percent were considered preventable, in close to 14 percent the disability was permanent and in almost 5 percent the patient died.
Dependency on Medical Care
A second possibility, which the researchers call "the dependency hypothesis," is the notion that the more doctors available, the more dependent people are on medical care to maintain their health. They therefore place less importance on lifestyle factors that can have a greater affect on their health.
I believe this is one of the major prevailing thoughts in America and is one of the major reasons why so many people are facing chronic illnesses. It is also one of my primary reasons for establishing this site years ago--to help people realize that they can, and need to, take responsibility for their own health. Doctors are certainly necessary and useful at times, but ultimately the responsibility for your health is your own.
Cognitive Dissonance, or Conflicting Beliefs
Another interesting concept explored in the report is that of cognitive dissonance. Most basically, this is the unsettling state that occurs when a person has conflicting beliefs or opinions.
Cognitive dissonance affects most everyone, but in regard to health care many people understand that certain lifestyle choices are better for their health, yet may not want to make the "right" choices because they are less pleasurable in the present. In order to resolve the conflict of knowing intellectually what the healthy lifestyle choices are while having a desire to live a self-indulgent life, the researchers say people may "adopt an exaggerated confidence in the efficacy of medical care and its ability to offset the harmful effects of self-neglect."
Failure to Inform Patients on Health Truths?
You may have noticed the article listed on the home page titled Doctors Are the Number Three Cause of Death in the U.S. This Journal of the American Medical Association (JAMA) article really reveals the state of the health care system in the United States and if you haven’t read it already I encourage you to do so.
Interestingly, Dr. Starfield, who published the original study mentioned above, said she disagreed with the headline I had come up with. She did not feel that doctors were the third leading cause of death, but thought they were the number one cause of death because of their failure to inform patients about the truth of health. I believe this might be a bit too harsh as even if people understand the health truths they still have freedom of choice and can choose to use sugar, soda and drugs (legal and illegal) to compromise their health and longevity.
Nevertheless, the Australian researchers concluded that their hypothesis that an increase in the doctor supply is associated with an increase in death rates needs to be seriously contemplated.
But why wait for the research to come back? You can take control of your health now by staying informed on the latest health information with the free and trusted preventive health e-newsletter and fortifying your body with the right foods for your metabolic type. This, in addition to taking some time for yourself to reduce stress and get quality sleep, will give you an excellent health start.
Many of you reading this have read or seen this in many places other than my Web site. This article, available on my home page, was widely circulated on the Internet and was one of the reasons why my Web site was initially popular. What you may not realize is that I am the one who made this analysis and popularized it. The original study was published by Dr. Starfield, a full professor of public health at the most prestigious hospital in the United States, Johns Hopkins. Her study never had the headline in it, but instead listed the published research documenting the various causes of deaths that doctors contributed to. I simply added them all up and compared them to cardiovascular diseases and cancer and came up with the above headline, which was widely circulated on the Internet.
Interestingly, when I contacted Dr. Starfield by e-mail she disagreed with the headline I had come up with. She did not feel that doctors were the third leading cause of death, but thought they were the number one cause of death because of their failure to inform their patients about the truth of health. Now this might be a bit too harsh as even if people understand health truth they have freedom of choice and can choose to use sugar, soda and drugs (legal and illegal) to compromise their health and longevity.
However, JAMA actually published a study a year earlier that could support that doctors may be the leading cause of death in the United States.
This finding is more of a speculation though, so below I have provided some other studies to support this assertion.
In 1994, an estimated 2,216,000 (1,721,000 to 2,711,000) hospitalized patients had serious adverse drug reactions (ADRs) and 106,000 (76,000 to 137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. Fatal ADRs accounted for 0.32 percent (95 percent confidence interval (CI), 0.23 percent to 0.41 percent) of hospitalized patients. JAMA April 15, 1998;279(15):1200-5
BMC Nephrol. December 22, 2003
Medication-related problems (MRP) continue to occur at a high rate in ambulatory hemodialysis (HD) patients.
Medication-dosing problems (33.5 percent), adverse drug reactions (20.7 percent), and an indication that was not currently being treated (13.5 percent) were the most common MRP.
5,373 medication orders were reviewed and a MRP was identified every 15.2 medication exposures.
Nurs Times. December 9-15, 2003;99(49):24-5.
In 2002, 16,176 adverse drug reaction reports were received, of which 67 percent related to reactions categorized as 'serious.' Pharm World Sci. December, 2003;25(6):264-8.
Medication administration errors (MAEs) were observed in two departments of a hospital for 20 days.
The medication administration error rate was 14.9 percent. Dose errors were the most frequent (41 percent) errors, followed by wrong time (26 percent) and wrong rate errors. Ten percent of errors were estimated as potentially life-threatening, 26 percent potentially significant and 64 percent potentially minor.
Serious and Fatal Drug Reactions in US Hospitals
Drug-related morbidity and mortality have been estimated to cost more that $136 billion a year in United States. These estimates are higher than the total cost of cardiovascular care or diabetes care in the United States. A major component of these costs is adverse drug reactions (ADE). Am J Med August 1, 2000;109(2):122-30
About 0.05 percent of all hospital admissions were certainly or probably drug-related. Incidence figures based on death certificates only may seriously underestimate the true incidence of fatal adverse drug reactions. Eur J Clin Pharmacol October, 2002;58(7):479-82
In one study of 200 patients, ADRs may have contributed to the deaths of two (one percent) patients. J Clin Pharm Ther October, 2000;25(5):355-61
In a survey of over 28,000 patients, ADRs were considered to be the cause of 3.4 percent of hospital admissions. Of these, 187 ADRs were coded as severe. Gastrointestinal complaints (19 percent) represented the most common events, followed by metabolic and hemorrhagic complications (nine percent). The drugs most frequently responsible for these ADRs were diuretics, calcium channel blockers, nonsteroidal antiinflammatory drugs and digoxin. J Am Geriatr Soc December, 2002;50(12):1962-8
Dr. Mercola's Comment As health reporter Nick Regush said last year:
"There is no way to be nice about this. There is no point in raising false hopes. There is no treatment or vaccine in sight. There is no miracle breakthrough on the horizon.
Medicine, as we know it, is dying. It's entering a terminal phase.
What began as an acute illness reached the chronic stage about a decade ago and progression toward death has been remarkably swift and well beyond anything one could have predicted.
The disease is caused by conflict of interest, tainted research, greed for big bucks, pretentious doctors and scientists, lying, cheating, invasion by the morally bankrupt marketing automatons of the drug industry, derelict politicians and federal and state regulators - all seasoned with huge doses of self-importance and foul odor."
Currently, the United States spends about 1.5 trillion dollars for healthcare, and the projections are that it will double in less than 10 years.
The sad tragedy is that we are spending all of this money on disease management focused on drugs and surgery, and our return on this investment is profoundly poor. More and more people do not have the energy they need to get through the day while millions of others are suffering with painful crippling diseases because they have violated basic health principles.
Often, negative health and lifestyle choices are made because of a lack of knowledge, and it's my passion to increase the public's awareness of the health tragedies facing the nation. I will give you, the consumer, the tools to become a major force for good health and to alleviate disease and suffering.
At Mercola.com, we have been steadily working to introduce innovative software that will accelerate this process, but finishing the manuscript of my book pushed the project back a bit. The beta version will be released shortly and I hope to have the full version out very soon.
The software will help all of us to transform the system together.
This article in the Journal of the American Medical Association (JAMA) is the best article I have ever seen written in the published literature documenting the tragedy of the traditional medical paradigm.
If you want to keep updated on issues like this click here to sign up for my free newsletter.
This information is a followup of the Institute of Medicine report which hit the papers in December of last year, but the data was hard to reference as it was not in peer-reviewed journal. Now it is published in JAMA which is the most widely circulated medical periodical in the world.
The author is Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health and she desribes how the US health care system may contribute to poor health.
ALL THESE ARE DEATHS PER YEAR:
12,000 -- unnecessary surgery 7,000 -- medication errors in hospitals 20,000 -- other errors in hospitals 80,000 -- infections in hospitals 106,000 -- non-error, negative effects of drugs
These total to 225,000 deaths per year from iatrogenic causes!!
What does the word iatrogenic mean? This term is defined as induced in a patient by a physician's activity, manner, or therapy. Used especially of a complication of treatment.
Dr. Starfield offers several warnings in interpreting these numbers:
First, most of the data are derived from studies in hospitalized patients. Second, these estimates are for deaths only and do not include negative effects that are associated with disability or discomfort. Third, the estimates of death due to error are lower than those in the IOM report. If the higher estimates are used, the deaths due to iatrogenic causes would range from 230,000 to 284,000. In any case, 225,000 deaths per year constitutes the third leading cause of death in the United States, after deaths from heart disease and cancer. Even if these figures are overestimated, there is a wide margin between these numbers of deaths and the next leading cause of death (cerebrovascular disease).
Another analysis concluded that between 4% and 18% of consecutive patients experience negative effects in outpatient settings,with:
116 million extra physician visits 77 million extra prescriptions 17 million emergency department visits 8 million hospitalizations 3 million long-term admissions 199,000 additional deaths $77 billion in extra costs
The high cost of the health care system is considered to be a deficit, but seems to be tolerated under the assumption that better health results from more expensive care.
However, evidence from a few studies indicates that as many as 20% to 30% of patients receive inappropriate care.
An estimated 44,000 to 98,000 among them die each year as a result of medical errors.
This might be tolerated if it resulted in better health, but does it? Of 13 countries in a recent comparison, the United States ranks an average of 12th (second from the bottom) for 16 available health indicators. More specifically, the ranking of the US on several indicators was:
13th (last) for low-birth-weight percentages 13th for neonatal mortality and infant mortality overall 11th for postneonatal mortality 13th for years of potential life lost (excluding external causes) 11th for life expectancy at 1 year for females, 12th for males 10th for life expectancy at 15 years for females, 12th for males 10th for life expectancy at 40 years for females, 9th for males 7th for life expectancy at 65 years for females, 7th for males 3rd for life expectancy at 80 years for females, 3rd for males 10th for age-adjusted mortality
The poor performance of the US was recently confirmed by a World Health Organization study, which used different data and ranked the United States as 15th among 25 industrialized countries.
There is a perception that the American public "behaves badly" by smoking, drinking, and perpetrating violence." However the data does not support this assertion.
The proportion of females who smoke ranges from 14% in Japan to 41% in Denmark; in the United States, it is 24% (fifth best). For males, the range is from 26% in Sweden to 61% in Japan; it is 28% in the United States (third best). The US ranks fifth best for alcoholic beverage consumption. The US has relatively low consumption of animal fats (fifth lowest in men aged 55-64 years in 20 industrialized countries) and the third lowest mean cholesterol concentrations among men aged 50 to 70 years among 13 industrialized countries. These estimates of death due to error are lower than those in a recent Institutes of Medicine report, and if the higher estimates are used, the deaths due to iatrogenic causes would range from 230,000 to 284,000.
Even at the lower estimate of 225,000 deaths per year, this constitutes the third leading cause of death in the US, following heart disease and cancer.
Lack of technology is certainly not a contributing factor to the US's low ranking.
Among 29 countries, the United States is second only to Japan in the availability of magnetic resonance imaging units and computed tomography scanners per million population. 17 Japan, however, ranks highest on health, whereas the US ranks among the lowest. It is possible that the high use of technology in Japan is limited to diagnostic technology not matched by high rates of treatment, whereas in the US, high use of diagnostic technology may be linked to more treatment. Supporting this possibility are data showing that the number of employees per bed (full-time equivalents) in the United States is highest among the countries ranked, whereas they are very low in Japan, far lower than can be accounted for by the common practice of having family members rather than hospital staff provide the amenities of hospital care. Journal American Medical Association July 26, 2000;284(4):483-5
DR .MERCOLA'S COMMENT: Folks, this is what they call a "Landmark Article". Only several ones like this are published every year. One of the major reasons it is so huge as that it is published in JAMA which is the largest and one of the most respected medical journals in the entire world.
I did find it most curious that the best wire service in the world, Reuter's, did not pick up this article. I have no idea why they let it slip by.
I would encourage you to bookmark this article and review it several times so you can use the statistics to counter the arguments of your friends and relatives who are so enthralled with the traditional medical paradigm. These statistics prove very clearly that the system is just not working. It is broken and is in desperate need of repair.
I was previously fond of saying that drugs are the fourth leading cause of death in this country. However, this article makes it quite clear that the more powerful number is that doctors are the third leading cause of death in this country killing nearly a quarter million people a year. The only more common causes are cancer and heart disease.
This statistic is likely to be seriously underestimated as much of the coding only describes the cause of organ failure and does not address iatrogenic causes at all.
Japan seems to have benefited from recognizing that technology is wonderful, but just because you diagnose something with it, one should not be committed to undergoing treatment in the traditional paradigm. Their health statistics reflect this aspect of their philosophy as much of their treatment is not treatment at all, but loving care rendered in the home.
Care, not treatment, is the answer. Drugs, surgery and hospitals are rarely the answer to chronic health problems. Facilitating the God-given healing capacity that all of us have is the key. Improving the diet, exercise, and lifestyle are basic.
Effective interventions for the underlying emotional and spiritual wounding behind most chronic illness are also important clues to maximizing health and reducing disease.
Author Affiliation: Department of Health Policy and Management, Johns Hopkins School of Hygiene and Public Health, Baltimore, Md. Corresponding Author and Reprints: Barbara Starfield, MD, MPH, Department of Health Policy and Management, Johns Hopkins School of Hygiene and Public Health, 624 N Broadway, Room 452, Baltimore, MD 21205-1996 (e-mail: firstname.lastname@example.org).
The promise every doctor makes is, “Do no harm.” But doctors and hospitals do make mistakes. And the November 30 shocking report from the Institute of Medicine showed medical mistakes are a common and potentially life-threatening risk. If medical mistakes counted among the leading causes of death in America, they would be eighth.
Surgical gaffes like amputating the wrong foot or a deadly chemotherapy overdose make headlines. But patients may never hear of the more subtle errors, like a delay in diagnosis or testing that costs precious time to fight off disease. Medical mistakes costing lives. Medical mistakes are a stunningly huge problem, says a new report by the Institute of Medicine. It quoted studies estimating that at least 44,000 and perhaps as many as 98,000 hospitalized Americans die every year from errors. To put that into sharper and more alarming perspective, even the lower figure of 44,000 deaths exceeds the number of people who die each year either on the highways, of breast cancer or of AIDS.
It is an intolerable situation, especially when it's taking place in the United States, which leads the world in medical advances. The cause, according to the Institute of Medicine, is not as much recklessness on the part of doctors, nurses and other health providers as it is basic flaws in the way hospitals, clinics and pharmacies operate. That kind of problem is fixable.
As a matter of fact, safeguards have already been implemented to reduce the likelihood of such lethal medical errors. Some hospitals are now using computerized prescriptions to ensure that pharmacists don't misread doctors' scrawled prescriptions. At the urging of anesthesiologists, anesthesia equipment is being standardized. And the Food and Drug Administration is trying to reduce confusion by ensuring that the names of new drugs don't sound too similar to drugs already on the market.
Doctors' notoriously poor handwriting too often leaves pharmacists squinting to decipher a dose C was it 10 milligrams or 10 micrograms? C or even the name of the prescribed drug. Too many drug names sound confusingly alike. Consider the painkiller Celebrex and the anti-seizure drug Cerebyx; or Narcan, which treats morphine overdoses, and Norcuron, which can paralyze breathing muscles.
But far more is needed: a concerted and comprehensive effort to raise the bar on consumer safety in the health care industry, not unlike what has already taken place in other industries. Since many doctors already feel beleaguered by financial constraints imposed on their care, insurers and health maintenance organizations must also bear the burden of improving safety.
At a minimum, the Institute of Medicine wants to reduce medical errors by half within five years. Considering the number of people who die each year in hospitals - where they presumably go to get better - even that goal may be too conservative.
Keeping Up with Changes
Health care is a decade behind other high-risk industries in improving safety, the report said. It pointed to the transportation industry as a model: Just as engineers design cars so they cannot start in reverse, and airlines limit pilots’ flying time to keep them rested, so can health care be improved. Some fixes already are under way: Some hospitals have computerized prescriptions. The Food and Drug Administration is hunting ways to catch sound-a-like drugs.
Anesthesiologists persuaded many manufacturers to standardize equipment and thus decreased technology-caused errors. Many doctors now literally mark the spot of surgical incisions before patients are put to sleep, so everyone agrees on what will be cut.
Changes Coming from Congress
The Institute of Medicine is part of the National Academy of Sciences, a private organization chartered by Congress to advise the government on scientific matters. Congress just passed legislation ordering the Agency for Health Care Policy and Research to hunt strategies to reduce medical mistakes. The bill will even change the name to the Agency for Healthcare Research and Quality to reflect the emphasis. President Clinton is expected to sign the bill soon. But the Institute of Medicine said reducing medical mistakes requires a bigger commitment.
It recommended that Congress should establish a federal Center for Patient Safety. It would require $35 million to start and should eventually spend $100 million a year in safety research.
The report said the total cost of medical mistakes, lost income and production, cost of disability and health care, totals $17 to 29 billion a year.
And that’s not mentioning the human toll. The government should require that hospitals, and eventually other health organizations, report all serious mistakes to state agencies so experts can detect patterns of problems and take action. About 20 states now require error reporting.
But how much and what penalties they impose varies widely. State licensing boards and medical accreditors should periodically re-examine health practitioners for competence, stressing safety practices. Standardized medical equipment and treatment guidelines can help doctors keep up. Change the “culture of secrecy” that surrounds medical mistakes, encouraging doctors to discuss errors as well as near misses so problems are fixed.
But is there something you can do, even from your sickbed, to protect yourself?
Become an Expert
First, know what ails you. Ask your doctor all about it. Research it on the Internet, for instance. Patients should feel entitled to inquire about their care no matter how sick they are. Second, know about your drugs. The study shows more than 7,000 die each year because of medication errors.
Kohn L, ed, Corrigan J, ed, Donaldson M, ed. To Err Is Human: Building a Safer Health System.
Washington, DC: National Academy Press; 1999
Death by Medicine, Part I By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD
A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine frequently causes more harm than good. The number of people having in-hospital, adverse drug reactions (ADR) to prescribed medicine is 2.2 million.1 Dr. Richard Besser, of the CDC, in 1995, said the number of unnecessary antibiotics prescribed annually for viral infections was 20 million. Dr. Besser, in 2003, now refers to tens of millions of unnecessary antibiotics.2, 2a
The number of unnecessary medical and surgical procedures performed annually is 7.5 million.3 The number of people exposed to unnecessary hospitalization annually is 8.9 million.4 The total number of iatrogenic deaths shown in the following table is 783,936. It is evident that the American medical system is the leading cause of death and injury in the United States. The 2001 heart disease annual death rate is 699,697; the annual cancer death rate, 553,251.5
TABLES AND FIGURES (see Section on Statistical Tables and Figures, below, for exposition)
ANNUAL PHYSICAL AND ECONOMIC COST OF MEDICAL INTERVENTION
We could have an even higher death rate by using Dr. Lucien Leape?s 1997 medical and drug error rate of 3 million. 14 Multiplied by the fatality rate of 14% (that Leape used in 199416 we arrive at an annual death rate of 420,000 for drug errors and medical errors combined. If we put this number in place of Lazorou?s 106,000 drug errors and the Institute of Medicine?s (IOM) 98,000 medical errors, we could add another 216,000 deaths making a total of 999,936 deaths annually.
Unnecessary Events People Affected Iatrogenic Events Hospitalization 8.9 million 4 1.78 million16 Procedures 7.5 million 3 1.3 million40 TOTAL 16.4 million 3.08 million
The enumerating of unnecessary medical events is very important in our analysis. Any medical procedure that is invasive and not necessary must be considered as part of the larger iatrogenic picture. Unfortunately, cause and effect go unmonitored. The figures on unnecessary events represent people (?patients?) who are thrust into a dangerous healthcare system. They are helpless victims. Each one of these 16.4 million lives is being affected in a way that could have a fatal consequence. Simply entering a hospital could result in the following:
In 16.4 million people, 2.1% chance of a serious adverse drug reaction,1 (186,000)
In 16.4 million people, 5-6% chance of acquiring a nosocomial infection,9 (489,500)
In16.4 million people, 4-36% chance of having an iatrogenic injury in hospital (medical error and adverse drug reactions),16 (1.78 million)
In 16.4 million people, 17% chance of a procedure error,40 (1.3 million)
All the statistics above represent a one-year time span. Imagine the numbers over a ten-year period. Working with the most conservative figures from our statistics we project the following 10-year death rates.
TEN-YEAR DEATH RATES FOR MEDICAL INTERVENTION
Condition 10-Year Deaths Author Adverse Drug Reaction 1.06 million (1) Medical error 0.98 million (6) Bedsores 1.15 million (7,8) Nosocomial Infection 0.88 million (9,10) Malnutrition 1.09 million (11) Outpatients 1.99 million (12, 112) Unnecessary Procedures 371,360 (3,13) Surgery-related 320,000 (85) TOTAL 7,841,360 (7.8 million)
Our projected statistic of 7.8 million iatrogenic deaths is more than all the casualties from wars that America has fought in its entire history.
Our projected figures for unnecessary medical events occurring over a 10-year period are also dramatic.
TEN-YEAR STATISTICS FOR UNNECESSARY INTERVENTION
Unnecessary Events 10-year Number Iatrogenic Events Hospitalization 89 million 4 17 million Procedures 75 million 3 15 million TOTAL 164 million
These projected figures show that a total of 164 million people, approximately 56% of the population of the United States, have been treated unnecessarily by the medical industry ? in other words, nearly 50,000 people per day.
INTRODUCTION Never before have the complete statistics on the multiple causes of iatrogenesis been combined in one paper. Medical science amasses tens of thousands of papers annually--each one a tiny fragment of the whole picture. To look at only one piece and try to understand the benefits and risks is to stand one inch away from an elephant and describe everything about it. You have to pull back to reveal the complete picture, such as we have done here. Each specialty, each division of medicine, keeps their own records and data on morbidity and mortality like pieces of a puzzle. But the numbers and statistics were always hiding in plain sight. We have now completed the painstaking work of reviewing thousands and thousands of studies. Finally putting the puzzle together we came up with some disturbing answers.
Is American Medicine Working?
At 14 percent of the Gross National Product, health care spending reached $1.6 trillion in 2003.15 Considering this enormous expenditure, we should have the best medicine in the world. We should be reversing disease, preventing disease, and doing minimal harm. However, careful and objective review shows the opposite. Because of the extraordinary narrow context of medical technology through which contemporary medicine examines the human condition, we are completely missing the full picture.
Medicine is not taking into consideration the following monumentally important aspects of a healthy human organism: (a) stress and how it adversely affects the immune system and life processes; (b) insufficient exercise; (c) excessive caloric intake; (d) highly-processed and denatured foods grown in denatured and chemically-damaged soil; and (e) exposure to tens of thousands of environmental toxins. Instead of minimizing these disease-causing factors, we actually cause more illness through medical technology, diagnostic testing, overuse of medical and surgical procedures, and overuse of pharmaceutical drugs. The huge disservice of this therapeutic strategy is the result of little effort or money being appropriated for preventing disease.
Under-reporting of Iatrogenic Events
As few as 5 percent and only up to 20 percent of iatrogenic acts are ever reported.16,24,25,33,34 This implies that if medical errors were completely and accurately reported, we would have a much higher annual iatrogenic death rate than 783,936. Dr. Leape, in 1994, said his figure of 180,000 medical mistakes annually was equivalent to three jumbo-jet crashes every two days.16 Our report shows that six jumbo jets are falling out of the sky each and every day.
Correcting a Compromised System
What we must deduce from this report is that medicine is in need of complete and total reform: from the curriculum in medical schools to protecting patients from excessive medical intervention. It is quite obvious that we can’t change anything if we are not honest about what needs to be changed. This report simply shows the degree to which change is required.
We are fully aware that what stands in the way of change are powerful pharmaceutical companies, medical technology companies, and special interest groups with enormous vested interests in the business of medicine. They fund medical research, support medical schools and hospitals, and advertise in medical journals. With deep pockets they entice scientists and academics to support their efforts. Such funding can sway the balance of opinion from professional caution to uncritical acceptance of a new therapy or drug.
You only have to look at the number of invested people on hospital, medical, and government health advisory boards to see conflict of interest. The public is mostly unaware of these interlocking interests. For example, a 2003 study found that nearly half of medical school faculty, who serve on Institutional Review Boards (IRB) to advise on clinical trial research, also serve as consultants to the pharmaceutical industry.17 The authors were concerned that such representation could cause potential conflicts of interest.
A news release by Dr. Erik Campbell, the lead author, said, "Our previous research with faculty has shown us that ties to industry can affect scientific behavior, leading to such things as trade secrecy and delays in publishing research. It's possible that similar relationships with companies could affect IRB members' activities and attitudes."18
Medical Ethics and Conflict of Interest in Scientific Medicine
Jonathan Quick, director of Essential Drugs and Medicines Policy for the World Health Organization (WHO) wrote in a recent WHO Bulletin: "If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken."19
Former editor of the New England Journal of Medicine (NEJM), Dr. Marcia Angell, struggled to bring the attention of the world to the problem of commercializing scientific research in her outgoing editorial titled "Is Academic Medicine for Sale?"20 Angell called for stronger restrictions on pharmaceutical stock ownership and other financial incentives for researchers. She said that growing conflicts of interest are tainting science.
She warned that, "When the boundaries between industry and academic medicine become as blurred as they are now, the business goals of industry influence the mission of medical schools in multiple ways." She did not discount the benefits of research but said a Faustian bargain now existed between medical schools and the pharmaceutical industry.
Angell left the NEMJ in June 2000. Two years later, in June 2002, the NEJM announced that it would now accept biased journalists (those who accept money from drug companies) because it is too difficult to find ones who have no ties. Another former editor of the journal, Dr. Jerome Kassirer, said that was just not the case, that there are plenty of researchers who don’t work for drug companies.21 The ABC report said that one measurable tie between pharmaceutical companies and doctors amounts to over $2 billion a year spent for over 314,000 events that doctors attend.
The ABC report also noted that a survey of clinical trials revealed that when a drug company funds a study, there is a 90 percent chance that the drug will be perceived as effective whereas a non-drug company-funded study will show favorable results 50 percent of the time. It appears that money can’t buy you love but it can buy you any "scientific" result you want. The only safeguard to reporting these studies was if the journal writers remained unbiased. That is no longer the case.
Cynthia Crossen, writer for the Wall Street Journal in 1996, published Tainted Truth: The Manipulation of Fact in America, a book about the widespread practice of lying with statistics.22 Commenting on the state of scientific research she said that, "The road to hell was paved with the flood of corporate research dollars that eagerly filled gaps left by slashed government research funding." Her data on financial involvement showed that in l981 the drug industry "gave" $292 million to colleges and universities for research. In l991 it "gave" $2.1 billion.
THE FIRST IATROGENIC STUDY
Dr. Lucian L. Leape opened medicine’s Pandora’s box in his 1994 JAMA paper, "Error in Medicine".16 He began the paper by reminiscing about Florence Nightingale’s maxim--"first do no harm." But he found evidence of the opposite happening in medicine. He found that Schimmel reported in 1964 that 20 percent of hospital patients suffered iatrogenic injury, with a 20 percent fatality rate. Steel in 1981 reported that 36 percent of hospitalized patients experienced iatrogenesis with a 25 percent fatality rate and adverse drug reactions were involved in 50 percent of the injuries. Bedell in 1991 reported that 64 percent of acute heart attacks in one hospital were preventable and were mostly due to adverse drug reactions.
However, Leape focused on his and Brennan’s "Harvard Medical Practice Study" published in 1991.16a They found that in 1984, in New York State, there was a 4 percent iatrogenic injury rate for patients with a 14 percent fatality rate. From the 98,609 patients injured and the 14 percent fatality rate, he estimated that in the whole of the U.S. 180,000 people die each year, partly as a result of iatrogenic injury. Leape compared these deaths to the equivalent of three jumbo-jet crashes every two days.
Why Leape chose to use the much lower figure of four percent injury for his analysis remains in question. Perhaps he wanted to tread lightly. If Leape had, instead, calculated the average rate among the three studies he cites (36 percent, 20 percent, and 4 percent), he would have come up with a 20 percent medical error rate. The number of fatalities that he could have presented, using an average rate of injury and his 14 percent fatality, is an annual 1,189,576 iatrogenic deaths, or over ten jumbo jets crashing every day.
Leape acknowledged that the literature on medical error is sparse and we are only seeing the tip of the iceberg. He said that when errors are specifically sought out, reported rates are "distressingly high". He cited several autopsy studies with rates as high as 35 percent to 40 percent of missed diagnoses causing death. He also commented that an intensive care unit reported an average of 1.7 errors per day per patient, and 29 percent of those errors were potentially serious or fatal. We wonder: what is the effect on someone who daily gets the wrong medication, the wrong dose, the wrong procedure; how do we measure the accumulated burden of injury; and when the patient finally succumbs after the tenth error that week, what is entered on the death certificate?
Leape calculated the rate of error in the intensive care unit. First, he found that each patient had an average of 178 "activities" (staff/procedure/medical interactions) a day, of which 1.7 were errors, which means a 1 percent failure rate. To some this may not seem like much, but putting this into perspective, Leape cited industry standards where in aviation a 0.1 percent failure rate would mean 2 unsafe plane landings per day at O’Hare airport; in the U.S. Mail, 16,000 pieces of lost mail every hour; or in banking, 32,000 bank checks deducted from the wrong bank account every hour.
Analyzing why there is so much medical error Leape acknowledged the lack of reporting. Unlike a jumbo-jet crash, which gets instant media coverage, hospital errors are spread out over the country in thousands of different locations. They are also perceived as isolated and unusual events. However, the most important reason that medical error is unrecognized and growing, according to Leape, was, and still is, that doctors and nurses are unequipped to deal with human error, due to the culture of medical training and practice.
Doctors are taught that mistakes are unacceptable. Medical mistakes are therefore viewed as a failure of character and any error equals negligence. We can see how a great deal of sweeping under the rug takes place since nobody is taught what to do when medical error does occur. Leape cited McIntyre and Popper who said the "infallibility model" of medicine leads to intellectual dishonesty with a need to cover up mistakes rather than admit them. There are no Grand Rounds on medical errors, no sharing of failures among doctors and no one to support them emotionally when their error harms a patient.
Leape hoped his paper would encourage medicine "to fundamentally change the way they think about errors and why they occur". It’s been almost a decade since this groundbreaking work, but the mistakes continue to soar.
One year later, in 1995, a report in JAMA said that, "Over a million patients are injured in U.S. hospitals each year, and approximately 280,000 die annually as a result of these injuries. Therefore, the iatrogenic death rate dwarfs the annual automobile accident mortality rate of 45,000 and accounts for more deaths than all other accidents combined."23
At a press conference in 1997 Dr. Leape released a nationwide poll on patient iatrogenesis conducted by the National Patient Safety Foundation (NPSF), which is sponsored by the American Medical Association. The survey found that more than 100 million Americans have been impacted directly and indirectly by a medical mistake. Forty-two percent were directly affected and a total of 84 percent personally knew of someone who had experienced a medical mistake.14 Dr. Leape is a founding member of the NPSF.
Dr. Leape at this press conference also updated his 1994 statistics saying that medical errors in inpatient hospital settings nationwide, as of 1997, could be as high as three million and could cost as much as $200 billion. Leape used a 14 percent fatality rate to determine a medical error death rate of 180,000 in 1994.16 In 1997, using Leape’s base number of three million errors, the annual deaths could be as much as 420,000 for inpatients alone. This does not include nursing home deaths, or people in the outpatient community dying of drug side effects or as the result of medical procedures.
ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED
Leape, in 1994, said that he was well aware that medical errors were not being reported.16 According to a study in two obstetrical units in the U.K., only about one quarter of the adverse incidents on the units are ever reported for reasons of protecting staff or preserving reputations, or fear of reprisals, including law suits.24 An analysis by Wald and Shojania found that only 1.5 percent of all adverse events result in an incident report, and only 6 percent of adverse drug events are identified properly.
The authors learned that the American College of Surgeons gives a very broad guess that surgical incident reports routinely capture only 5-30 percent of adverse events. In one surgical study only 20 percent of surgical complications resulted in discussion at Morbidity and Mortality Rounds.25 From these studies it appears that all the statistics that are gathered may be substantially underestimating the number of adverse drug and medical therapy incidents. It also underscores the fact that our mortality statistics are actually conservative figures.
An article in Psychiatric Times outlines the stakes involved with reporting medical errors.26 They found that the public is fearful of suffering a fatal medical error, and doctors are afraid they will be sued if they report an error. This brings up the obvious question: who is reporting medical errors? Usually it is the patient or the patient’s surviving family. If no one notices the error, it is never reported. Janet Heinrich, an associate director at the U.S.
General Accounting Office responsible for health financing and public health issues, testifying before a House subcommittee about medical errors, said that, "The full magnitude of their threat to the American public is unknown." She added, "Gathering valid and useful information about adverse events is extremely difficult." She acknowledged that the fear of being blamed, and the potential for legal liability, played key roles in the under-reporting of errors. The Psychiatric Times noted that the American Medical Association is strongly opposed to mandatory reporting of medical errors.26 If doctors aren’t reporting, what about nurses? In a survey of nurses, they also did not report medical mistakes for fear of retaliation.27
Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA.28 The reasons range from not knowing such a reporting system exists to fear of being sued because they prescribed a drug that caused harm. 29 However, it is this tremendously flawed system of voluntary reporting from doctors that we depend on to know whether a drug or a medical intervention is harmful.
Pharmacology texts will also tell doctors how hard it is to separate drug side effects from disease symptoms. Treatment failure is most often attributed to the disease and not the drug or the doctor. Doctors are warned, "Probably nowhere else in professional life are mistakes so easily hidden, even from ourselves."30 It may be hard to accept, but not difficult to understand, why only one in twenty side effects is reported to either hospital administrators or the FDA.31,31a
If hospitals admitted to the actual number of errors and mistakes, which is about 20 times what is reported, they would come under intense scrutiny.32 Jerry Phillips, associate director of the Office of Post Marketing Drug Risk Assessment at the FDA, confirms this number. "In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only five percent of the actual reactions that occur."33 Dr. Jay Cohen, who has extensively researched adverse drug reactions, comments that because only five percent of adverse drug reactions are being reported, there are, in reality, five million medication reactions each year.34
It remains that whatever figure you choose to believe about the side effects from drugs, all the experts agree that you have to multiply that by 20 to get a more accurate estimate of what is really occurring in the burgeoning "field" of iatrogenic medicine.
A 2003 survey is all the more distressing because there seems to be no improvement in error-reporting even with all the attention on this topic. Dr. Dorothea Wild surveyed medical residents at a community hospital in Connecticut. She found that only half of the residents were aware that the hospital had a medical error-reporting system, and the vast majority didn’t use it at all. Dr. Wild says this does not bode well for the future. If doctors don’t learn error-reporting in their training, they will never use it. And she adds that error reporting is the first step in finding out where the gaps in the medical system are and fixing them. That first baby step has not even begun.35
PUBLIC SUGGESTIONS ON IATROGENESIS
In a telephone survey, 1,207 adults were asked to indicate how effective they thought the following would be in reducing preventable medical errors that resulted in serious harm:36
giving doctors more time to spend with patients: very effective 78 percent requiring hospitals to develop systems to avoid medical errors: very effective 74 percent better training of health professionals: very effective 73 percent using only doctors specially trained in intensive care medicine on intensive care units: very effective 73 percent requiring hospitals to report all serious medical errors to a state agency: very effective 71 percent increasing the number of hospital nurses: very effective 69 percent reducing the work hours of doctors-in-training to avoid fatigue: very effective 66 percent encouraging hospitals to voluntarily report serious medical errors to a state agency: very effective 62 percent
Drugs comprise the major treatment modality of scientific medicine. With the discovery of the "Germ Theory" medical scientists convinced the public that infectious organisms were the cause of illness. Finding the "cure" for these infections proved much harder than anyone imagined. From the beginning, chemical drugs promised much more than they delivered. But far beyond not working, the drugs also caused incalculable side effects. The drugs themselves, even when properly prescribed, have side effects that can be fatal, as Lazarou’s study1 shows. But human error can make the situation even worse.
A survey of a 1992 national pharmacy database found a total of 429,827 medication errors from 1,081 hospitals. Medication errors occurred in 5.22 percent of patients admitted to these hospitals each year. The authors concluded that a minimum of 90,895 patients annually were harmed by medication errors in the country as a whole.37
A 2002 study shows that 20 percent of hospital medications for patients had dosage mistakes. Nearly 40 percent of these errors were considered potentially harmful to the patient. In a typical 300-patient hospital the number of errors per day were 40.38
Problems involving patients’ medications were even higher the following year. The error rate intercepted by pharmacists in this study was 24 percent, making the potential minimum number of patients harmed by prescription drugs 417,908.39
Recent Adverse Drug Reactions
More recent studies on adverse drug reactions show that the figures from 1994 (published in Lazarou’s 1998 JAMA article) may be increasing. A 2003 study followed 400 patients after discharge from a tertiary care hospital (hospital care that requires highly specialized skills, technology or support services). Seventy-six patients (19 percent) had adverse events. Adverse drug events were the most common at 66 percent. The next most common events were procedure-related injuries at 17 percent.40
In a NEJM study an alarming one-in-four patients suffered observable side effects from the more than 3.34 billion prescription drugs filled in 2002.41 One of the doctors who produced the study was interviewed by Reuters and commented that, "With these 10-minute appointments, it's hard for the doctor to get into whether the symptoms are bothering the patients."42 William Tierney, who editorialized on the NEJM study, said " ... given the increasing number of powerful drugs available to care for the aging population, the problem will only get worse."
The drugs with the worst record of side effects were the SSRIs, the NSAIDs, and calcium-channel blockers. Reuters also reported that prior research has suggested that nearly five percent of hospital admissions--over 1 million per year--are the result of drug side effects. But most of the cases are not documented as such. The study found one of the reasons for this failure: in nearly two-thirds of the cases, doctors couldn’t diagnose drug side effects or the side effects persisted because the doctor failed to heed the warning signs.
Medicating Our Feelings
We only need to look at the side effects of antidepressant drugs, which give hope to a depressed population. Patients seeking a more joyful existence and relief from worry, stress and anxiety, fall victim to the messages blatantly displayed on TV and billboards. Often, instead of relief, they also fall victim to a myriad of iatrogenic side effects of antidepressant medication.
Also, a whole generation of antidepressant users has resulted from young people growing up on Ritalin. Medicating youth and modifying their emotions must have some impact on how they learn to deal with their feelings. They learn to equate coping with drugs and not their inner resources. As adults, these medicated youth reach for alcohol, drugs, or even street drugs, to cope. According to the Journal of the American Medical Association, "Ritalin acts much like cocaine."43 Today’s marketing of mood-modifying drugs, such as Prozac or Zoloft, makes them not only socially acceptable but almost a necessity in today’s stressful world.
In order to reach the widest audience possible, drug companies are no longer just targeting medical doctors with their message about antidepressants. By 1995 drug companies had tripled the amount of money allotted to direct advertising of prescription drugs to consumers. The majority of the money is spent on seductive television ads. From 1996 to 2000, spending rose from $791 million to nearly $2.5 billion.44 Even though $2.5 billion may seem like a lot of money, the authors comment that it only represents 15 percent of the total pharmaceutical advertising budget.
According to medical experts "there is no solid evidence on the appropriateness of prescribing that results from consumers requesting an advertised drug." However, the drug companies maintain that direct-to-consumer advertising is educational. Dr. Sidney M. Wolfe, of the Public Citizen Health Research Group in Washington, D.C., argues that the public is often misinformed about these ads.45 People want what they see on television and are told to go to their doctor for a prescription.
Doctors in private practice either acquiesce to their patients’ demands for these drugs or spend valuable clinic time trying to talk patients out of unnecessary drugs. Dr. Wolfe remarks that one important study found that people mistakenly believe that the "FDA reviews all ads before they are released and allows only the safest and most effective drugs to be promoted directly to the public."46
How Do We Know Drugs Are Safe?
Another aspect of scientific medicine that the public takes for granted is the testing of new drugs. Unlike the class of people that take drugs who are ill and need medication, in general, drugs are tested on individuals who are fairly healthy and not on other medications that can interfere with findings. But when they are declared "safe" and enter the drug prescription books, they are naturally going to be used by people on a variety of other medications and who also have a lot of other health problems.
Then, a new Phase of drug testing called Post-Approval comes into play, which is the documentation of side effects once drugs hit the market. In one very telling report, the General Accounting Office (an agency of the U.S. Government) "found that of the 198 drugs approved by the FDA between 1976 and 1985 ... 102 (or 51.5 percent) had serious post-approval risks ... the serious post-approval risks (included) heart failure, myocardial infarction, anaphylaxis, respiratory depression and arrest, seizures, kidney and liver failure, severe blood disorders, birth defects and fetal toxicity, and blindness."47
The investigative show NBC’s "Dateline" wondered if your doctor is moonlighting as a drug rep. After a year-long investigation they reported that because doctors can legally prescribe any drug to any patient for any condition, drug companies heavily promote "off-label" and frequently inappropriate and non-tested uses of these medications in spite of the fact that these drugs are only approved for specific indications they have been tested for.48
The leading causes of adverse drug reactions are antibiotics (17 percent), cardiovascular drugs (17 percent), chemotherapy (15 percent), and analgesics and anti-inflammatory agents (15 percent).49
Specific Drug Iatrogenesis: Antibiotics
Dr. Egger, in a recent editorial, wrote that after 50 years of increasing use of antibiotics, 30 million pounds of antibiotics are used in America per year.50 Twenty-five million pounds of this total are used in animal husbandry. The vast majority of this amount, 23 million pounds, is used to try to prevent disease, the stress of shipping, and to promote growth. Only 2 million pounds are given for specific animal infections. Dr. Egger reminds us that low concentrations of antibiotics are measurable in many of our foods, rivers, and streams around the world. Much of this is seeping into bodies of water from animal farms.
Egger says overuse of antibiotics results in food-borne infections resistant to antibiotics. Salmonella is found in 20 percent of ground meat but constant exposure of cattle to antibiotics has made 84 percent of salmonella resistant to at least one anti-salmonella antibiotic. Diseased animal food accounts for 80 percent of salmonellosis in humans, or 1.4 million cases per year.
The conventional approach to dealing with this epidemic is to radiate food to try to kill all organisms but keep using the antibiotics that cause the original problem. Approximately 20 percent of chickens are contaminated with Campylobacter jejuni causing 2.4 million human cases of illness annually. Fifty-four percent of these organisms are resistant to at least one anti-campylobacter antimicrobial.
A ban on growth-promoting antibiotics in Denmark began in 1999, which led to a decrease from 453,200 pounds to 195,800 pounds within a year. Another report from Scandinavia found that taking away antibiotic growth promoters had no or minimal effect on food production costs. Egger further warns that in America the current crowded, unsanitary methods of animal farming support constant stress and infection, and are geared toward high antibiotic use. He says these conditions would have to be changed along with cutting back on antibiotic use.
In America, over 3 million pounds of antibiotics are used every year on humans. With a population of 284 million Americans, this amount is enough to give every man, woman and child 10 teaspoons of pure antibiotics per year. Egger says that exposure to a steady stream of antibiotics has altered pathogens such as Streptococcus pneumoniae, Staplococcus aureus, and entercocci, to name a few.
Almost half of patients with upper respiratory tract infections in the United States still receive antibiotics from their doctor.51 According to the CDC, 90 percent of upper respiratory infections are viral and should not be treated with antibiotics. In Germany the prevalence for systemic antibiotic use in children aged 0 to 6 years was 42.9 percent.52
Data taken from nine U.S. health plans between 1996 and 2000 on antibiotic use in 25,000 children found that rates of antibiotic use decreased. Antibiotic use in children, aged 3 months to under 3 years, decreased 24 percent, from 2.46 to 1.89 antibiotic prescriptions per/patient per/year. For children, 3 years to under 6 years, there was a 25 percent reduction from 1.47 to 1.09 antibiotic prescriptions per/patient per/year. And for children aged 6 to under 18 years, there was a 16 percent reduction from 0.85 to 0.69 antibiotic prescriptions per/ patient /per year.53 Although there was a reduction in antibiotic use, the data indicate that on average every child in America receives 1.22 antibiotic prescriptions annually.
Group A beta-hemolytic streptococci is the only common cause of sore throat that requires antibiotics, penicillin and erythromycin being the only recommended treatment. However, 90 percent of sore throats are viral. The authors of this study estimated there were 6.7 million adult annual visits for sore throat between 1989 and 1999 in the United States. Antibiotics were used in 73 percent of visits. Furthermore, patients treated with antibiotics were given non-recommended broad-spectrum antibiotics in 68 percent of visits.
The authors noted, that from 1989 to 1999, there was a significant increase in the newer and more expensive broad-spectrum antibiotics and a decrease in use of penicillin and erythromycin, which are the recommended antibiotics.54 If antibiotics were given in 73 percent of visits and should have only been given in 10 percent, this represents 63 percent, or a total of 4.2 million visits for sore throat that ended in unnecessary antibiotic prescriptions between1989 and 1999. In 1995, Dr. Besser and the CDC cited 2003 cited much higher figures of 20 million unnecessary antibiotic prescriptions per year for viral infections.2 Neither of these figures takes into account the number of unnecessary antibiotics used for non-fatal conditions such as acne, intestinal infection, skin infections, ear infections, etc.
The Problem with Antibiotics: They are Anti-Life
On September 17, 2003 the CDC relaunched a program, started in 1995, called "Get Smart: Know When Antibiotics Work."55 This is a $1.6 million campaign to educate patients about the overuse and inappropriate use of antibiotics. Most people involved with alternative medicine have known about the dangers of overuse of antibiotics for decades. Finally the government is focusing on the problem, yet they are only putting a miniscule amount of money into an iatrogenic epidemic that is costing billions of dollars and thousands of lives.
The CDC warns that 90 percent of upper respiratory infections, including children’s ear infections, are viral, and antibiotics don’t treat viral infection. More than 40 percent of about 50 million prescriptions for antibiotics each year in physicians' offices were inappropriate.2 And using antibiotics, when not needed, can lead to the development of deadly strains of bacteria that are resistant to drugs and cause more than 88,000 deaths due to hospital-acquired infections.9
However, the CDC seems to be blaming patients for misusing antibiotics even though they are only available on prescription from a doctor who should know how to prescribe properly. Dr. Richard Besser, head of "Get Smart," says "Programs that have just targeted physicians have not worked. Direct-to-consumer advertising of drugs is to blame in some cases." Dr. Besser says the program "teaches patients and the general public that antibiotics are precious resources that must be used correctly if we want to have them around when we need them. Hopefully, as a result of this campaign, patients will feel more comfortable asking their doctors for the best care for their illnesses, rather than asking for antibiotics."56
And what does the "best care" constitute? The CDC does not elaborate and patently avoids the latest research on the dozens of nutraceuticals scientifically proven to treat viral infections and boost the immune system. Will their doctors recommend vitamin C, echinacea, elderberry, vitamin A, zinc, or homeopathic oscillococcinum? No, they won’t. The archaic solutions offered by the CDC include a radio ad, "Just Say No--Snort, sniffle, sneeze--No antibiotics please." Their commonsense recommendations, that most people do anyway, include resting, drinking plenty of fluids, and using a humidifier.
The pharmaceutical industry claims they are all for limiting the use of antibiotics. In order to make sure that happens, the drug company Bayer is sponsoring a program called, "Operation Clean Hands," through an organization called LIBRA.57 The CDC is also involved with trying to minimize antibiotic resistance, but nowhere in their publications is there any reference to the role of nutraceuticals in boosting the immune system nor to the thousands of journal articles that support this approach.
This recalcitrant tunnel vision and refusal to use available non-drug alternatives is absolutely inappropriate when the CDC is desperately trying to curb the nightmare of overuse of antibiotics. The CDC should also be called to task because it is only focusing on the overuse of antibiotics. There are similar nightmares for every class of drug being prescribed today.
Drugs Pollute Our Water Supply
We have reached the point of saturation with prescription drugs. We have arrived at the point where every body of water tested contains measurable drug residues. We are inundated with drugs. The tons of antibiotics used in animal farming, which run off into the water table and surrounding bodies of water, are conferring antibiotic resistance to germs in sewage, and these germs are also found in our water supply.
Flushed down our toilets are tons of drugs and drug metabolites that also find their way into our water supply. We have no idea what the long-term consequences of ingesting a mixture of drugs and drug-breakdown products will do to our health. It’s another level of iatrogenic disease that we are unable to completely measure.58-67
Specific Drug Iatrogenesis: NSAIDs
It’s not just America that is plagued with iatrogenesis. A survey of 1,072 French general practitioners (GPs) tested their basic pharmacological knowledge and practice in prescribing NSAIDs. Non-steroidal anti-inflammatory drugs (NSAIDs) rank first among commonly prescribed drugs for serious adverse reactions. The results of the study suggested that GPs don’t have adequate knowledge of these drugs and are unable to effectively manage adverse reactions.68
A cross-sectional survey of 125 patients attending specialty pain clinics in South London found that possible iatrogenic factors such as "over-investigation, inappropriate information, and advice given to patients as well as misdiagnosis, over-treatment, and inappropriate prescription of medication were common."69
Specific Drug Iatrogenesis: Cancer Chemotherapy
In 1989, a German biostatistician, Ulrich Abel PhD, after publishing dozens of papers on cancer chemotherapy, wrote a monograph "Chemotherapy of Advanced Epithelial Cancer." It was later published in a shorter form in a peer-reviewed medical journal.70 Dr. Abel presented a comprehensive analysis of clinical trials and publications representing over 3,000 articles examining the value of cytotoxic chemotherapy on advanced epithelial cancer. Epithelial cancer is the type of cancer we are most familiar with. It arises from epithelium found in the lining of body organs such as breast, prostate, lung, stomach, or bowel.
From these sites cancer usually infiltrates into adjacent tissue and spreads to bone, liver, lung, or the brain. With his exhaustive review Dr. Abel concludes that there is no direct evidence that chemotherapy prolongs survival in patients with advanced carcinoma. He said that in small-cell lung cancer and perhaps ovarian cancer the therapeutic benefit is only slight. Dr. Abel goes on to say, "Many oncologists take it for granted that response to therapy prolongs survival, an opinion which is based on a fallacy and which is not supported by clinical studies."
Over a decade after Dr. Abel’s exhaustive review of chemotherapy, there seems no decrease in its use for advanced carcinoma. For example, when conventional chemotherapy and radiation has not worked to prevent metastases in breast cancer, high-dose chemotherapy (HDC) along with stem-cell transplant (SCT) is the treatment of choice. However, in March 2000, results from the largest multi-center randomized controlled trial conducted thus far showed that, compared to a prolonged course of monthly conventional-dose chemotherapy, HDC and SCT were of no benefit.71 There was even a slightly lower survival rate for the HDC/SCT group. And the authors noted that serious adverse effects occurred more often in the HDC group than the standard-dose group. There was one treatment-related death (within 100 days of therapy) in the HDC group, but none in the conventional chemotherapy group. The women in this trial were highly selected as having the best chance to respond.
There is also no all-encompassing follow-up study like Dr. Abel’s that tells us if there is any improvement in cancer-survival statistics since 1989. In fact, we need to research whether chemotherapy itself is responsible for secondary cancers instead of progression of the original disease. We continue to question why well-researched alternative cancer treatments aren’t used.
Drug Companies Fined
Periodically, a drug manufacturer is fined by the FDA when the abuses are too glaring and impossible to cover up. The May 2002 Washington Post reported that the maker of Claritin, Schering-Plough Corp., was to pay a $500 million fine to the FDA for quality-control problems at four of its factories.72 The FDA tabulated infractions that included 90 percent, or 125 of the drugs they made since 1998. Besides the fine, the company had to stop manufacturing 73 drugs or suffer another $175 million fine. PR statements by the company told another story. The company assured consumers that they should still feel confident in its products.
Such a large settlement serves as a warning to the drug industry about maintaining strict manufacturing practices and has given the FDA more clout in dealing with drug company compliance. According to the Washington Post article, a federal appeals court ruled in 1999 that the FDA could seize the profits of companies that violate "good manufacturing practices." Since that time Abbott Laboratories Inc. paid $100 million for failing to meet quality standards in the production of medical test kits, and Wyeth Laboratories Inc. paid $30 million in 2000 to settle accusations of poor manufacturing practices.
The indictment against Schering-Plough came after the Public Citizen Health Research Group, lead by Dr. Sidney Wolfe, called for a criminal investigation of Schering-Plough, charging that the company distributed albuterol asthma inhalers even though it knew the units were missing the active ingredient.
UNNECESSARY SURGICAL PROCEDURES
Summary: 1974: 2.4 million unnecessary surgeries performed annually resulting in 11,900 deaths at an annual cost of $3.9 billion.73,74
2001: 7.5 million unnecessary surgical procedures resulting in 37,136 deaths at a cost of $122 billion (using 1974 dollars).3
It’s very difficult to obtain accurate statistics when studying unnecessary surgery. Dr. Leape in 1989 wrote that perhaps 30 percent of controversial surgeries are unnecessary. Controversial surgeries include Cesarean section, tonsillectomy, appendectomy, hysterectomy, gastrectomy for obesity, breast implants, and elective breast implants.74
Almost 30 years ago, in 1974, the Congressional Committee on Interstate and Foreign Commerce held hearings on unnecessary surgery. They found that 17.6 percent of recommendations for surgery were not confirmed by a second opinion. The House Subcommittee on Oversight and Investigations extrapolated these figures and estimated that, on a nationwide basis, there were 2.4 million unnecessary surgeries performed annually, resulting in 11,900 deaths at an annual cost of $3.9 billion.73
In 2001, the top 50 medical and surgical procedures totaled approximately 41.8 million. These figures were taken from the Healthcare Cost and Utilization Project within the Agency for Healthcare Research and Quality.13 Using 17.6 percent from the 1974 U.S. Congressional House Subcommittee Oversight Investigation as the percentage of unnecessary surgical procedures, and extrapolating from the death rate in 1974, we come up with an unnecessary procedure number of 7.5 million (7,489,718) and a death rate of 37,136, at a cost of $122 billion (using 1974 dollars).
Researchers performed a very similar analysis, using the 1974 ‘unnecessary surgery percentage’ of 17.6, on back surgery. In 1995, researchers testifying before the Department of Veterans Affairs estimated that of 250,000 back surgeries in the U.S. at a hospital cost of $11,000 per patient, the total number of unnecessary back surgeries each year in the U.S. could approach 44,000, costing as much as $484 million.75
The unnecessary surgery figures are escalating just as prescription drugs driven by television advertising. Media-driven surgery such as gastric bypass for obesity "modeled" by Hollywood personalities seduces obese people to think this route is safe and sexy. There is even a problem of surgery being advertised on the Internet.76 A study in Spain declares that between 20 percent and 25 percent of total surgical practice represents unnecessary operations.77
According to data from the National Center for Health Statistics from 1979 to 1984, there was a nine percent increase in the total number of surgical procedures, and the number of surgeons grew by 20 percent. The author notes that there has not been a parallel increase in the number of surgeries despite a recent large increase in the number of surgeons. There was concern that there would be too many surgeons to share a small surgical caseload.78
The previous author spoke too soon--there was no cause to worry about a small surgical caseload. By 1994, there was an increase of 38 percent for a total of 7,929,000 cases for the top ten surgical procedures. In 1983, surgical cases totaled 5,731,000. In 1994, cataract surgery was number one with over two million operations, and second was Cesarean section (858,000 procedures). Inguinal hernia operations were third (689,000 procedures), and knee arthroscopy, in seventh place, grew 153 percent (632,000 procedures) while prostate surgery declined 29 percent (229,000 procedures).79
The list of iatrogenic diseases from surgery is as long as the list of procedures themselves. In one study epidural catheters were inserted to deliver anesthetic into the epidural space around the spinal nerves to block them for lower Cesarean section, abdominal surgery, or prostate surgery. In some cases, non-sterile technique, during catheter insertion, resulted in serious infections, even leading to limb paralysis.80
In one review of the literature, the authors demonstrated "a significant rate of overutilization of coronary angiography, coronary artery surgery, cardiac pacemaker insertion, upper gastrointestinal endoscopies, carotid endarterectomies, back surgery, and pain-relieving procedures."81
A 1987 JAMA study found the following significant levels of inappropriate surgery: 17 percent of cases for coronary angiography, 32 percent for carotid endarterectomy, and 17 percent for upper gastrointestinal tract endoscopy.82 Using the Healthcare Cost and Utilization Project (HCUP) statistics provided by the government for 2001, the number of people getting upper gastrointestinal endoscopy, which usually entails biopsy, was 697,675; the number getting endarterectomy was 142,401; and the number having coronary angiography was 719,949.13 Therefore, according to the JAMA study 17 percent, or 118,604 people had an unnecessary endoscopy procedure. Endarterectomy occurred in 142,401 patients; potentially 32 percent or 45,568 did not need this procedure. And 17 percent of 719,949, or 122,391 people receiving coronary angiography were subjected to this highly invasive procedure unnecessarily. These are all forms of medical iatrogenesis.
Death by Medicine, Part II
We have added, cumulatively, figures from 13 references of annual iatrogenic deaths. However, there is invariably some degree of overlap and double counting that can occur in gathering non-finite statistics.
Death numbers don't come with names and birth dates to prevent duplication On the other hand, there are many missing statistics. As we will show, only about 5 to 20% of iatrogenic incidents are even recorded.16,24,25,33,34 And, our outpatient iatrogenic statistics112 only include drug-related events and not surgical cases, diagnostic errors, or therapeutic mishaps.
We have also been conservative in our inclusion of statistics that were not reported in peer review journals or by government institutions. For example, on July 23, 2002, The Chicago Tribune analyzed records from patient databases, court cases, 5,810 hospitals, as well as 75 federal and state agencies and found 103,000 cases of death due to hospital infections, 75% of which were preventable.152 We do not include this figure but report the lower Weinstein figure of 88,000.9 Another figure that we withheld, for lack of proper peer review was The National Committee for Quality Assurance, September 2003 report which found that at least 57,000 people die annually from lack of proper care for commons diseases such as high blood pressure, diabetes, or heart disease.153
Overlapping of statistics in Death by Medicine may occur with the Institute of Medicine (IOM) paper that designates "medical error" as including drugs, surgery, and unnecessary procedures.6 Since we have also included other statistics on adverse drug reactions, surgery and, unnecessary procedures, perhaps a much as 50% of the IOM number could be redundant. However, even taking away half the 98,000 IOM number still leaves us with iatrogenic events as the number one killer at 738,000 annual deaths.
MEDICAL AND SURGICAL PROCEDURES
It is instructive to know the mortality rate associated with different medical and surgical procedures. Even though we must sign release forms when we undergo any procedure, many of us are in denial about the true risks involved. We seem to hold a collective impression that since medical and surgical procedures are so commonplace, they are both necessary and safe. Unfortunately, partaking in allopathic medicine itself is one of the highest causes of death as well as the most expensive way to die.
Shouldn’t the daily death rate of iatrogenesis in hospitals, out of hospitals, in nursing homes, and psychiatric residences be reported like the pollen count or the smog index? Let’s stop hiding the truth from ourselves. It’s only when we focus on the problem and ask the right questions that we can hope to find solutions.
Perhaps the words "health care" give us the illusion that medicine is about health. Allopathic medicine is not a purveyor of healthcare but of disease-care. Studying the mortality figures in the Healthcare Cost and Utilization Project (HCUP) within the U.S. government’s Agency for Healthcare Research and Quality, we found many points of interest.13 The HCUP computer program that calculates the annual mortality statistics for all U.S. hospital discharges is only as good as the codes that are put into the system.
In an e-mail correspondence with HCUP, we were told that the mortality rates that were indicated in tables and charts for each procedure were not necessarily due to the procedure but only indicated that someone who received that procedure died either from their original disease or from the procedure.
Therefore there is no way of knowing exactly how many people died from a particular procedure. There are also no codes for adverse drug side effects, none for surgical mishap, and none for medical error. Until there are codes for medical error, statistics of those people who are dying from various types of medical error will be buried in the general statistics. There is a code for "poisoning & toxic effects of drugs" and a code for "complications of treatment."
However, the mortality figures registered in these categories are very low and don’t compare with what we know from studies such as the JAMA 1998 study1 that said there were an average of 106,000 prescription medication deaths per year.
WHY AREN’T MEDICAL AND SURGICAL PROCEDURES STUDIED?
In 1978, the U.S. Office of Technology Assessment (OTA) reported that, "Only 10 percent to 20 percent of all procedures currently used in medical practice have been shown to be efficacious by controlled trial."83 In 1995, the OTA compared medical technology in eight countries (Australia, Canada, France, Germany, Netherlands, Sweden, United Kingdom, and the United States) and again noted that few medical procedures in the United States had been subjected to clinical trial. It also reported that infant mortality was high and life expectancy was low compared to other developed countries.84
Although almost 10 years old, much of what was said in this report holds true today. The report lays the blame for the high cost of medicine squarely at the feet of the medical free-enterprise system and the fact that there is no national health care policy. It describes the failure of government attempts to control health care costs due to market incentive and profit motive in the financing and organization of health care including private insurance, hospital system, physician services, and drug and medical device industries.
Whereas we may want to expand health-care, expansion of disease-care is the goal of free enterprise. "Health Care Technology and Its Assessment in Eight Countries" is also the last report prepared by the OTA, which was shut down in 1995. It’s also, perhaps, the last honest, in-depth look at modern medicine. Because of the importance of this 60-page report, we enclose a summary in the Appendix.
SURGICAL ERRORS FINALLY REPORTED
Just hours before completion of this paper, statistics on surgical-related deaths became available. An October 8, 2003 JAMA study from the U.S. government’s Agency for Healthcare Research and Quality (AHRQ) documented 32,000 mostly surgery-related deaths costing $9 billion and accounting for 2.4 million extra days in the hospital in 2000.85 In a press release accompanying the JAMA study, the AHRQ director, Carolyn M. Clancy, M.D., admitted, "This study gives us the first direct evidence that medical injuries pose a real threat to the American public and increase the costs of health care." 86
Hospital administrative data from 20 percent of the nation’s hospitals were analyzed for eighteen different surgical complications including postoperative infections, foreign objects left in wounds, surgical wounds reopening, and post-operative bleeding. In the same press release the study’s authors said that, "The findings greatly underestimate the problem, since many other complications happen that are not listed in hospital administrative data." They also felt that, "The message here is that medical injuries can have a devastating impact on the health care system. We need more research to identify why these injuries occur and find ways to prevent them from happening."
One of the authors, Dr. Zhan said that improved medical practices, including an emphasis on better hand-washing, might help reduce the morbidity and mortality rates. An accompanying JAMA editorial by health-risk researcher Dr. Saul Weingart of Harvard’s Beth Israel Deaconess Medical Center said, "Given their staggering magnitude, these estimates are clearly sobering."87
When X-rays were discovered, no one knew the long-term effects of ionizing radiation. In the 1950s monthly fluoroscopic exams at the doctor’s office were routine. You could even walk into most shoe stores and see your foot bones; looking at bones was an amusing novelty. We still don’t know the ultimate outcome of our initial escapade with X-rays.
It was common practice to use X-rays in pregnant women to measure the size of the pelvis, and make a diagnosis of twins. Finally, a study of 700,000 children born between 1947 and 1964 was conducted in 37 major maternity hospitals. The children of mothers who had received pelvic X-rays during pregnancy were compared with the children of mothers who had not been X-rayed. Cancer mortality was 40 percent higher among the children with X-rayed mothers.88
In present-day medicine, coronary angiography combines an invasive surgical procedure of snaking a tube through a blood vessel in the groin up to the heart. To get any useful information during the angiography procedure X-rays are taken almost continuously with minimum dosage ranges between 460 and 1,580 mrem. The minimum radiation from a routine chest X-ray is 2 mrem. X-ray radiation accumulates in the body and it is well-known that ionizing radiation used in X-ray procedures causes gene mutation. We can only obtain guesstimates as to its impact on health from this high level of radiation. Experts manage to obscure the real effects in statistical jargon such as, "The risk for lifetime fatal cancer due to radiation exposure is estimated to be four in 1 million per 1,000 mrem."89
However, Dr. John Gofman, who has been studying the effects of radiation on human health for 45 years, is prepared to tell us exactly what diagnostic X-rays are doing to our health. Dr. Gofman has a PhD in nuclear and physical chemistry and is a medical doctor. He worked on the Manhattan nuclear project, discovered uranium-2323, was the first person to isolate plutonium, and since 1960, he’s been studying the effects of radiation on human health.
With five scientifically documented books totaling over 2,800 pages, Dr. Gofman provides strong evidence that medical technology, specifically X-rays, CT scans, mammography, and fluoroscopy, are a contributing factor to 75 percent of new cancers.
His 699-page report, updated in 2000, "Radiation from Medical Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response Studies with Physicians per 100,000 Population to here"90 shows that as the number of physicians increases in a geographical area with an increase in the number of X-ray diagnostic tests, there is an associated increase in the rate of cancer and ischemic heart disease. Dr. Gofman elaborates that it’s not X-rays alone that cause the damage but a combination of health risk factors including: poor diet, smoking, abortions, and the use of birth control pills. Dr. Gofman predicts that 100 million premature deaths over the next decade will be the result of ionizing radiation.
In his book, "Preventing Breast Cancer," Dr. Gofman says that breast cancer is the leading cause of death among American women between the ages of 44 and 55. Because breast tissue is highly radiation-sensitive, mammograms can cause cancer. The danger can be heightened by a woman’s genetic makeup, preexisting benign breast disease, artificial menopause, obesity, and hormonal imbalance.91
Even X-rays for back pain can lead someone into crippling surgery. Dr. Sarno, a well-known New York orthopedic surgeon, found that X-rays don’t always tell the truth. In his books he cites studies on normal people without a trace of back pain that have spinal abnormalities on X-ray. Other studies have shown that some people with back pain have normal spines on X-ray. So, Dr. Sarno says there is not necessarily any association between back pain and spinal X-ray abnormality.92 However, if a person happens to have back pain and an incidental abnormality on X-ray, they may be treated surgically, sometimes with no change in back pain, or worsening of back pain, or even permanent disability.
In addition, doctors often order X-rays as protection against malpractice claims to give the impression that they are leaving no stone unturned. It appears that doctors are putting their own fears before the interests of their patients.
8.9 million (8,925,033) people were hospitalized unnecessarily in 2001.4
In a study of inappropriate hospitalization 1,132 medical records were reviewed by two doctors. Twenty-three percent of all admissions were inappropriate and an additional 17 percent could have been handled in ambulatory out-patient clinics. Thirty-four percent of all hospital days were also inappropriate and could have been avoided.93 The rate of inappropriate admissions in 1990 was 23.5 percent.94 In 1999, another study confirmed the figure of 24 percent inappropriate admissions indicating a consistent pattern from 1986 to 1999,95 showing steady reporting of approximately 24 percent inappropriate admissions each year.
Putting these figures into present-day terms using the HCUP database, the total number of patient discharges from hospitals in the U.S. in 2001 was 37,187,641.13 The above data indicate that 24 percent of those hospitalizations need never have occurred. It further means that 8,925,033 people were exposed to unnecessary medical intervention in hospitals and therefore represent almost 9 million potential iatrogenic episodes.4
WOMEN’S EXPERIENCE IN MEDICINE
Briefly, we will look at the medical iatrogenesis of women in particular. Dr. Martin Charcot (1825-1893) was world-renowned, the most celebrated doctor of his time. He practiced in the Paris hospital La Salpetriere. He became an expert in hysteria diagnosing an average of 10 hysterical women each day, transforming them into ... "iatrogenic monsters," turning simple ‘neurosis’ into hysteria.96 The number of women diagnosed with hysteria and hospitalized rose from one percent in 1841 to 17 percent in 1883.
Hysteria is derived from the Latin "hystera," meaning uterus. Dr. Adriane Fugh-Berman stated very clearly in her paper that there is a tradition in U.S. medicine of excessive medical and surgical interventions on women. Only 100 years ago male doctors decided that female psychological imbalance originated in the uterus. When surgery to remove the uterus was perfected it became the "cure" for mental instability, effecting a physical and psychological castration. Dr. Fugh-Berman noted that U.S. doctors eventually disabused themselves of that notion but have continued to treat women very differently than they treat men.97 She cites the following:
Thousands of prophylactic mastectomies are performed annually. One-third of U.S. women have had a hysterectomy before menopause. Women are prescribed drugs more frequently than are men. Women are given potent drugs for disease prevention, which results in disease substitution due to side effects. Fetal monitoring is unsupported by studies and not recommended by the CDC.98 It confines women to a hospital bed and may result in higher incidence of cesarean section.99 Normal processes such as menopause and childbirth have been heavily medicalized. Synthetic hormone replacement therapy (HRT) does not prevent heart disease or dementia. It does increase the risk of breast cancer, heart disease, stroke, and gall bladder attack.100
We would add that as many as one-third of postmenopausal women use HRT.101,102 These numbers are important in light of the much-publicized Women’s Health Initiative Study, which was forced to stop before its completion because of a higher death rate in the synthetic estrogen-progestin (HRT) group.103
In 1983, 809,000 cesarean sections (21 percent of live births) were performed, making it the most common obstetric and gynecologic (OB/GYN) surgical procedure. The second most common OB/GYN operation was hysterectomy (673,000), and diagnostic dilation and curettage of the uterus (632,000) was third. In 1983, OB/GYN operations represented 23 percent of all surgery completed in this country.104
In 2001, Cesarean section is still the most common OB/GYN surgical procedure. Approximately 4 million births occur annually, with a 24 percent C-Section rate, i.e., 960,000 operations. In the Netherlands only eight percent of babies are delivered by Cesarean section. Assuming human babies are similar in the United States and in the Netherlands, we are performing 640,000 unnecessary C-Sections in the United States with its three to four times higher mortality and 20 times greater morbidity than vaginal delivery.105
The cesarean section rate was only 4.5 percent in the United States in 1965. By 1986 it had climbed to 24.1 percent. The author states that obviously an "uncontrolled pandemic of medically unnecessary cesarean births is occurring."106 VanHam reported a cesarean section postpartum hemorrhage rate of seven percent, a hematoma formation rate of 3.5 percent, a urinary tract infection rate of three percent, and a combined postoperative morbidity rate of 35.7 percent in a high-risk population undergoing cesarean section.107
NEVER ENOUGH STUDIES
Scientists used the excuse that there were never enough studies revealing the dangers of DDT and other dangerous pesticides to ban them. They also used this excuse around the issue of tobacco, claiming that more studies were needed before they could be certain that tobacco really caused lung cancer. Even the American Medical Association (AMA) was complicit in suppressing results of tobacco research. In 1964, the Surgeon General's report condemned smoking, however the AMA refused to endorse it. What was their reason? They needed more research. Actually what they really wanted was more money and they got it from a consortium of tobacco companies who paid the AMA $18 million over the next nine years, during which the AMA said nothing about the dangers of smoking.108
The Journal of the American Medical Association (JAMA), "after careful consideration of the extent to which cigarettes were used by physicians in practice," began accepting tobacco advertisements and money in 1933. State journals such as the New York State Journal of Medicine also began to run Chesterfield ads claiming that cigarettes are, "Just as pure as the water you drink ... and practically untouched by human hands."
In 1948, JAMA argued "more can be said in behalf of smoking as a form of escape from tension than against it ... there does not seem to be any preponderance of evidence that would indicate the abolition of the use of tobacco as a substance contrary to the public health."109 Today, scientists continue to use the excuse that they need more studies before they will lend their support to restrict the inordinate use of drugs.
OVERVIEW OF STATISTICAL TABLES AND FIGURES
Adverse Drug Reactions
The Lazarou study1 was based on statistical analysis of 33 million U.S. hospital admissions in 1994. Hospital records for prescribed medications were analyzed. The number of serious injuries due to prescribed drugs was 2.2 million; 2.1 percent of in-patients experienced a serious adverse drug reaction; 4.7 percent of all hospital admissions were due to a serious adverse drug reaction; and fatal adverse drug reactions occurred in 0.19 percent of in-patients and 0.13 percent of admissions. The authors concluded that a projected 106,000 deaths occur annually due to adverse drug reactions.
We used a cost analysis from a 2000 study in which the increase in hospitalization costs per patient suffering an adverse drug reaction was $5,483. Therefore, costs for the Lazarou study’s 2.2 million patients with serious drug reactions amounted $12 billion.1,49
Serious adverse drug reactions commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.110
Over 1 million people develop bedsores in U.S. hospitals every year. It’s a tremendous burden to patients and family, and a $55 billion dollar health care burden.7 Bedsores are preventable with proper nursing care. It is true that 50 percent of those affected are in a vulnerable age group of over 70. In the elderly bedsores carry a four-fold increase in the rate of death.
The mortality rate in hospitals for patients with bedsores is between 23 percent and 37 percent.8 Even if we just take the 50 percent of people over 70 with bedsores and the lowest mortality at 23 percent, that gives us a death rate due to bedsores of 115,000. Critics will say that it was the disease or advanced age that killed the patient, not the bedsore, but our argument is that an early death, by denying proper care, deserves to be counted. It is only after counting these unnecessary deaths that we can then turn our attention to fixing the problem.
Malnutrition in Nursing Homes
The General Accounting Office (GAO), a special investigative branch of Congress, gave citations to 20 percent of the nation's 17,000 nursing homes for violations between July 2000 and January 2002. Many violations involved serious physical injury and death.111
A report from the Coalition for Nursing Home Reform states that at least one-third of the nation’s 1.6 million nursing home residents may suffer from malnutrition and dehydration, which hastens their death. The report calls for adequate nursing staff to help feed patients who aren’t able to manage a food tray by themselves.11 It is difficult to place a mortality rate on malnutrition and dehydration. This Coalition report states that malnourished residents, compared with well-nourished hospitalized nursing home residents, have a five-fold increase in mortality when they are admitted to hospital. So, if we take one-third of the 1.6 million nursing home residents who are malnourished and multiply that by a mortality rate of 20 percent,8,14 we find 108,800 premature deaths due to malnutrition in nursing homes.
The rate of nosocomial infections per 1,000 patient days has increased 36 percent - from 7.2 in 1975 to 9.8 in 1995. Reports from more than 270 U.S. hospitals showed that the nosocomial infection rate itself had remained stable over the previous 20 years with approximately five to six hospital-acquired infections occurring per 100 admissions, which is a rate of 5-6 percent. However, because of progressively shorter inpatient stays and the increasing number of admissions, the actual number of infections increased.
It is estimated that in 1995, nosocomial infections cost $4.5 billion and contributed to more than 88,000 deaths - one death every 6 minutes.9 The 2003 incidence of nosocomial mortality is quite probably higher than in 1995 because of the tremendous increase in antibiotic-resistant organisms. Morbidity and Mortality Report found that nosocomial infections cost $5 billion annually in 1999.10 This is a $0.5 billion increase in four years. The present cost of nosocomial infections might now be in the order of $5.5 billion.
Dr. Barbara Starfield in a 2000 JAMA paper presents us with well-documented facts that are both shocking and unassailable.12
The U.S. ranks twelfth out of 13 countries in a total of 16 health indicators. Japan, Sweden, and Canada were first, second, and third. More than 40 million people have no health insurance. 20 percent to 30 percent of patients receive contraindicated care. Dr. Starfield warns that one cause of medical mistakes is the overuse of technology, which may create a "cascade effect" leading to more treatment. She urges the use of ICD (International Classification of Diseases) codes that have designations called: "Drugs, Medicinal, and Biological Substances Causing Adverse Effects in Therapeutic Use" and "Complications of Surgical and Medical Care" to help doctors quantify and recognize the magnitude of the medical error problem. Starfield says that, at present, deaths actually due to medical error are likely to be coded according to some other cause of death.
She concludes that against the backdrop of our abysmal health report card compared to the rest of the Westernized countries, we should recognize that the harmful effects of health care interventions account for a substantial proportion of our excess deaths.
Starfield cites Weingart’s 2000 article, "Epidemiology of Medical Error" on outpatient iatrogenesis. And Weingart, in turn, cites several authors and provides statistics showing that between 4 percent to 18 percent of consecutive patients in outpatient settings suffer an iatrogenic event leading to:112
116 million extra physician visits 77 million extra prescriptions 17 million emergency department visits 8 million hospitalizations 3 million long-term admissions 199,000 additional deaths $77 billion in extra costs
There are 12,000 deaths per year from unnecessary surgeries. However, results from the few studies that have measured unnecessary surgery directly indicate that for some highly controversial operations, the fraction that are unwarranted could be as high as 30 percent.74
IT’S A GLOBAL ISSUE
A survey published in the Journal of Health Affairs pointed out that between 18 percent and 28 percent of people who were recently ill had suffered from a medical or drug error in the previous two years. The study surveyed 750 recently-ill adults in five different countries. The breakdown by country showed 18 percent of those in Britain, 25 percent in Canada, 23 percent in Australia, 23 percent in New Zealand, and the highest number was in the U.S. at 28 percent.113
A recent finding by the Institute of Medicine is that the 41 million Americans without health insurance have consistently worse clinical outcomes than those who are insured, and are at increased risk for dying prematurely.114
When doctors bill for services they do not render, advise unnecessary tests, or screen everyone for a rare condition, they are committing insurance fraud. The U.S. General Accounting Office (GAO) gave a 1998 figure of $12 billion lost to fraudulent or unnecessary claims, and reclaimed $480 million in judgments in that year. In 2001, the federal government won or negotiated more than $1.7 billion in judgments, settlements, and administrative impositions in health care fraud cases and proceedings.115
WAREHOUSING OUR ELDERS
It is only fitting that we end this report with acknowledgement of our elders. The moral and ethical fiber of society can be judged by the way it treats its weakest and most vulnerable members. Some cultures honor and respect the wisdom of their elders, keeping them at home--the better to continue participation in their community. However, American nursing homes, where millions of our elders die, represent the pinnacle of social isolation and medical abuse.
Important Statistics about Nursing Homes
1. In America, at any one time, approximately 1.6 million elderly are confined to nursing homes. By 2050 that number could be 6.6 million.11,116
2. A total of 20 percent of all deaths from all causes occur in nursing homes.117
3. Hip fractures are the single greatest reason for nursing home admissions.118 Nursing homes represent a reservoir for drug-resistant organisms due to overuse of antibiotics.119
Congressman Waxman reminded us that "as a society we will be judged by how we treat the elderly" when he presented a report that he sponsored, "Abuse of Residents is a Major Problem in U.S. Nursing Homes," on July 30, 2001. The report uncovered that one-third--5,283 of the nations’ 17,000 nursing homes--were cited for an abuse violation in the two-year period studied, January 1999 to January 2001.116 Waxman stated that "the people who cared for us, deserve better." He also made it very clear that this was only the tip of the iceberg and there is much more abuse occurring that we don’t know about or ignore.116a
The major findings of "Abuse of Residents is a Major Problem in U.S. Nursing Homes," were:
Over 30 percent of nursing homes in the United States were cited for abuses, totaling more than 9,000 abuse violations. 10 percent of nursing homes had violations that caused actual physical harm to residents, or worse. Over 40 percent, or 3,800, abuse violations were only discovered after a formal complaint was filed, usually by concerned family members. Many verbal abuse violations were found. Occasions of sexual abuse. Incidents of physical abuse causing numerous injuries such as fractured femur, hip, elbow, wrist, and other injuries.
Dangerously understaffed nursing homes lead to neglect, abuse, overuse of medications, and physical restraints. An exhaustive study of nurse-to-patient ratios in nursing homes was mandated by Congress in 1990. The study was finally begun in 1998 and took four years to complete.120 Commenting on the study, a spokesperson for The National Citizens’ Coalition for Nursing Home Reform said, "They compiled two reports of three volumes each thoroughly documenting the number of hours of care residents must receive from nurses and nursing assistants to avoid painful, even dangerous, conditions such as bedsores and infections. Yet it took the Department of Health and Human Services and Secretary Tommy Thompson only four months to dismiss the report as ‘insufficient.’"121
Bedsores occur three times more commonly in nursing homes than in acute care or veterans’ hospitals.122 But we know that bedsores can be prevented with proper nursing care. It shouldn’t take four years for someone to find out that proper care of bedsores requires proper staffing. In spite of such urgent need in nursing homes where additional staff could solve so many problems, we hear the familiar refrain "not enough research"--one that merely buys time for those in charge and relegates another smoldering crisis to the back burner.
Since many nursing home patients suffer from chronic debilitating conditions, their assumed cause of death is often unquestioned by physicians. Some studies show that as many as 50 percent of deaths due to restraints, falls, suicide, homicide, and choking in nursing homes may be covered up.123,124 It is quite possible that many nursing home deaths are attributed, instead, to heart disease, which, until our report, was the number one cause of death. In fact, researchers have found that heart disease may be over-represented in the general population as a cause of death on death certificates by 7.9 percent to 24.3 percent. In the elderly the over-reporting of heart disease as a cause of death is as much as two-fold.125
When elucidating iatrogenesis in nursing homes, some critics have asked, "To what extent did these elderly people already have life-threatening diseases that led to their premature deaths anyway?" Our response is that if a loved one dies one day, one week, one year, a decade, or two decades prematurely, thanks to some medical misadventure, that is still a premature, iatrogenic death. In a legalistic sense perhaps more weight is placed on the loss of many potential years compared to an additional few weeks, but this attitude is not justified in an ethical or moral sense.
The fact that there are very few statistics on malnutrition in acute-care hospitals and nursing homes shows the lack of concern in this area. A survey of the literature turns up very few American studies. Those that do appear are foreign studies in Italy, Spain, and Brazil. However, there is one very revealing American study conducted over a 14-month period that evaluated 837 patients in a 100-bed sub-acute-care hospital for their nutritional status. Only eight percent of the patients were found to be well nourished.
Almost one-third (29 percent) were malnourished and almost two-thirds (63 percent) were at risk of malnutrition. The consequences of this state of deficiency were that 25 percent of the malnourished patients required readmission to an acute-care hospital compared to 11 percent of the well-nourished patients. The authors concluded that malnutrition reached epidemic proportions in patients admitted to this sub-acute-care facility.126
Many studies conclude that physical restraints are an underreported and preventable cause of death. Whereas administrators say they must use restraints to prevent falls, in fact, they cause more injury and death because people naturally fight against such imprisonment. Studies show that compared to no restraints, the use of restraints carries a higher mortality rate and economic burden.127-129 Studies found that physical restraints, including bedrails, are the cause of at least one in every 1,000 nursing-home deaths.130-132
However, deaths caused by malnutrition, dehydration, and physical restraints are rarely recorded on death certificates. Several studies reveal that nearly half of the listed causes of death on death certificates for older persons with chronic or multi-system disease are inaccurate.133 Even though 1-in-5 people die in nursing homes, the autopsy rate is only 0.8 percent.134 Thus, we have no way of knowing the true causes of death.
The CDC may be focused on reducing the number of prescriptions for children but a 2003 study finds over-medication of our elderly population. Dr. Robert Epstein, chief medical officer of Medco Health Solutions Inc. (a unit of Merck & Co.), conducted the study on drug trends.135 He found that seniors are going to multiple physicians and getting multiple prescriptions and using multiple pharmacies. Medco oversees drug-benefit plans for more than 60 million Americans, including 6.3 million senior citizens who received more than 160 million prescriptions. According to the study, the average senior receives 25 prescriptions annually.
In those 6.3 million seniors, a total of 7.9 million medication alerts were triggered: less than one-half that number, 3.4 million, were detected in 1999. About 2.2 million of those alerts indicated excessive dosages unsuitable for senior citizens, and about 2.4 million alerts indicated clinically inappropriate drugs for the elderly. Reuters interviewed Kasey Thompson, director of the Center on Patient Safety at the American Society of Health System Pharmacists, who said, "There are serious and systemic problems with poor continuity of care in the United States." He says this study shows "the tip of the iceberg" of a national problem.
According to Drug Benefit Trends, the average number of prescriptions dispensed per non-Medicare HMO member per year rose 5.6 percent from 1999 to 2000--from 7.1 to 7.5 prescriptions. The average number dispensed for Medicare members increased 5.5 percent--from 18.1 to 19.1 prescriptions.136 The number of prescriptions in 2000 was 2.98 billion, with an average per person prescription amount of 10.4 annually.137
In a study of 818 residents of residential care facilities for the elderly, 94 percent were receiving at least one medication at the time of the interview. The average intake of medications was five per resident; the authors noted that many of these drugs were given without a documented diagnosis justifying their use.138
Unfortunately, seniors, and groups like the American Association for Retired Persons (AARP), appear to be dependent on prescription drugs and are demanding that coverage for drugs be a basic right.139 They have accepted the overriding assumption from allopathic medicine that aging and dying in America must be accompanied by drugs in nursing homes and eventual hospitalization with tubes coming out of every orifice.
Instead of choosing between drugs and a diet-lifestyle change, seniors are given the choiceless option of either high-cost patented drugs or low-cost generic drugs. Drug companies are attempting to keep the most expensive drugs on the shelves and to suppress access to generic drugs, in spite of stiff fines of hundreds of millions of dollars from the government.140,141 In 2001 some of the world's biggest drug companies, including Roche, were fined a record £523 million ($871 million) for conspiring to increase the price of vitamins.142
We would urge AARP, especially, to become more involved in prevention of disease and not to rely so heavily on drugs. At present, the AARP recommendations for diet and nutrition assume that seniors are getting all the nutrition they need in an average diet. At most, they suggest extra calcium and a multiple vitamin/mineral supplement.143 This is not enough, and in our next report we will show how to live a healthier life without unnecessary medical intervention.
We would like to send the same message to the Hemlock Society, which offers euthanasia options to chronically ill people, especially those in severe pain. What if some of these chronic diseases are really lifestyle diseases caused by deficiency of essential nutrients, lack of care, inappropriate medication, or lack of love? This question is extremely important to consider when you are depressed or in pain. We must look to healing those conditions before offering up our lives.
Let’s also look at the irony of under use of proper pain medication for patients that really need it. For example, in one particular study pain management was evaluated in a group of 13,625 cancer patients, aged 65 or over, living in nursing homes. Overall, almost 30 percent, or 4,003 patients, reported pain. However, more than 25 percent received absolutely no pain relief medication; 16 percent received a World Health Organization (WHO) level-one drug (mild analgesic); 32 percent a WHO level-two drug (moderate analgesic); and only 26 percent received adequate pain relieving morphine. The authors concluded that older patients and minority patients were more likely to have their pain untreated.144
The time has come to set a standard for caring for the vulnerable among us--a standard that goes beyond making sure they are housed and fed, and not openly abused. We must stop looking the other way and we, as a society, must take responsibility for the way in which we deal with those who are unable to care for themselves.
WHAT REMAINS TO BE UNCOVERED
Our ongoing research will continue to quantify the morbidity, mortality, and financial loss due to: X-ray exposures: mammography, fluoroscopy, CT scans. Overuse of antibiotics in all conditions. Drugs that are carcinogenic: hormone replacement therapy (*see below), immunosuppressive drugs, prescription drugs. Cancer chemotherapy: If it doesn’t extend life, is it shortening life?70 Surgery and unnecessary surgery: Cesarean section, radical mastectomy, preventive mastectomy, radical hysterectomy, prostatectomy, cholecystectomies, cosmetic surgery, arthroscopy, etc. Discredited medical procedures and therapies. Unproven medical therapies. Outpatient surgery. Doctors themselves: when doctors go on strike, it appears the mortality rate goes down.
*Part of our ongoing research will be to quantify the mortality and morbidity caused by hormone replacement therapy (HRT) since the mid-1940s. In December 2000, a government scientific advisory panel recommended that synthetic estrogen be added to the nation's list of cancer-causing agents. HRT, either synthetic estrogen alone or combined with synthetic progesterone, is used by an estimated 13.5 million to 16 million women in the United States.145
The aborted Women’s Health Initiative Study (WHI) of 2002 showed that women taking synthetic estrogen combined with synthetic progesterone have a higher incidence of ovarian cancer, breast cancer, stroke, and heart disease and little evidence of osteoporosis reduction or prevention of dementia. WHI researchers, who usually never give recommendations, other than demanding more studies, are advising doctors to be very cautious about prescribing HRT to their patients.100,146-150
Results of the "Million Women Study" on HRT and breast cancer in the U.K were published in the Lancet, August 2003. Lead author, Professor Valerie Beral, director of the Cancer Research UK Epidemiology Unit, is very open about the damage HRT has caused. She said, "We estimate that over the past decade, use of HRT by UK women aged 50 to 64 has resulted in an extra 20,000 breast cancers, oestrogen-progestagen (combination) therapy accounting for 15,000 of these."151 However, we were not able to find the statistics on breast cancer, stroke, uterine cancer, or heart disease due to HRT used by American women. The population of America is roughly six times that of the U.K. Therefore, it is possible that 120,000 cases of breast cancer have been caused by HRT in the past decade.
When the number one killer in a society is the health care system, then that system has no excuse except to address its own urgent shortcomings. It’s a failed system in need of immediate attention. What we have outlined in this paper are insupportable aspects of our contemporary medical system that need to be changed--beginning at its very foundations.
Death by Medicine - Appendix
OFFICE OF TECHNOLOGY ASSESSMENT (OTA) Health Care Technology and Its Assessment in Eight Countries, 1995.
General Facts 1. In 1990 life expectancy in the U.S. was 71.8 years for men and 78.8 for women, among the lowest of the developed countries.
2. The 1990 infant mortality rate was 9.2 per 1,000 live births. This was in the bottom half of the distribution among all developed countries. (OTA comments on the frustration of poor statistics and high healthcare spending.)
3. Health status is correlated with socioeconomic status.
4. Healthcare is not universal.
5. Healthcare is based on the free market system with no fixed budget or limitations on expansion.
6. Healthcare accounts for 14% of the U.S. GNP, which was over $800 billion in 1993.
7. The federal government does no central planning. It is the major purchaser of health care for older people and some poor people.
8. Americans have a lower level of satisfaction with their healthcare system than people in other developed countries.
9. U.S. medicine specializes in expensive medical technology. Some major U.S. cities have more MRI scanners than most countries.
10. Huge public and private investment in medical research and pharmaceutical development drives this "technological arms race."
11. Any efforts to restrain technological developments in healthcare are opposed by policy makers concerned about negative impacts on medical-technology industries.
12. In 1990 there were: 5,480 acute-care hospitals, 880 specialty hospitals (psychiatric, long-term care, rehab) and 340 federal hospitals (military, vets and Native Americans) providing 2.7 hospitals per 100,000 population.
13. In 1990 the average length of stay for an annual 33 million admissions was 9.2 days. Bed occupancy rate was 66%. Lengths of stay were shorter and admission rates lower than other countries.
14. In 1990 there were 615,000 physicians, 2.4 per 1,000; 33% were primary care (family medicine, internal medicine, and pediatrics) and 67% were specialists.
15. In 1991 government-run healthcare spending was $81 billion.
16. Total healthcare spending was $752 billion in 1991, an increase from $70 billion in 1950. Spending grew five-fold per capita.
17. Reasons for increased healthcare spending:
a. The high cost of defensive medicine, with an escalation in services solely to avoid malpractice litigation.
b. U.S. healthcare based on defensive medicine costs nearly $45 billion per year, or about 5% of total healthcare spending, according to one source.
c. The availability and use of new medical technologies have contributed the most to increased healthcare spending, argue many analysts. OTA admits that these costs are impossible to quantify.
18. The reasons government attempts to control healthcare costs have failed:
a. Market incentive and profit-motive involvement in the financing and organization of healthcare including private insurance, hospital system, physician services, and drug and medical device industries.
b. Expansion is the goal of free enterprise.
Health-Related Research and Development
19. The U.S. spends more than any other country on R & D.
20. $9.2 billion was spent in 1989 by the federal government; U.S. industries spent an additional $9.4 billion.
21. There was a 50% rise in total national R & D expenditures between 1983 and 1992.
22. NIH receives about half of the government funding.
23. NIH spent more on basic research ($4.1 billion in 1989) than for clinical trials of medical treatments on humans ($519 million in 1989).
24. Most of the trials evaluate new cancer treatment protocols and new treatments for complications of AIDS and do not study existing treatments, even though the effectiveness of many of them is unknown and questioned.
25. The NIH in 1990 had just begun to do meta-analysis and cost-effectiveness analysis.
Pharmaceutical and Medical Device Industry
26. About two-thirds of the industry's $9.4 billion budget went to drug research; the remaining one-third was spent by device manufacturers.
27. In addition to R & D, the medical industry spent 24% of total sales on promoting their products and only 15% of total sales on development.
28. Total marketing expenses in 1990 were over $5 billion.
29. Many products provide no benefit over existing products.
30. Public and private healthcare consumers buy these products.
31. If healthcare spending is perceived as a problem, a highly profitable drug industry exacerbates the problem.
Controlling Health Care Technology
32. The FDA ensures the safety and efficacy of drugs, biologics, and medical devices.
33. The FDA does not consider costs of therapy.
34. The FDA does not consider the effectiveness of a therapy.
35. The FDA does not compare a product to currently marketed products
36. The FDA does not consider non-drug alternatives for a given clinical problem.
37. Drug development costs $200 million to bring a new drug to market. AIDS-drug interest groups forced new regulations that speed up the approval process.
38. Such drugs should be subject to greater post-marketing surveillance requirements. But as of 1995 these provisions had not yet come into play.
39. Many argue that reductions in the pre-approval testing of drugs opens the possibility of significant undiscovered toxicities.
Health Care Technology Assessment
40. Failure to evaluate technology was a focus of a 1978 report from OTA with examples of many common medical practices supported by limited published data. (10-20%)
41. In 1978 congress created the National Center for Health Care Technology (NCHCT) to advise Medicare and Medicaid.
42. With an annual budget of $4 million NCHCT published three broad assessments of high-priority technologies and made about 75 coverage recommendations to Medicare.
43. NCHCT was put out of business by Congress in 1981-a political casualty. The medical profession opposed it from the beginning. The AMA testified before Congress in 1981 that "clinical policy analysis and judgments are better made-and are being responsibly made-within the medical profession. Assessing risks and costs, as well as benefits, has been central to the exercise of good medical judgment for decades."
44. The medical device lobby also opposed government oversight by NCHCT.
Examples of Lack of Proper Management of HealthCare
1. Treatments for Coronary Artery Disease
45. Since the early 1970's the number of coronary artery-bypass surgeries (CABGS) has risen rapidly without government regulation and without clinical trials.
46. Angioplasty for single vessel disease was introduced in 1978. The first published trial of angioplasty versus medical treatment was in 1992.
47. Angioplasty did not cut down on the number of CABGS as was promoted.
48. Both procedures increase in number every year as the patient population grows older and sicker.
49. Rates of use are higher in white patients, in private insurance patients, and there is great variation in different geographic regions. Such facts imply that use of these procedures is based on non-clinical factors.
50. At the time of this report, 1995, the NIH consensus program had not assessed CABGS since 1980 and had never assessed angioplasty.
51. RAND researchers evaluated CABGS in New York in 1990. They reviewed 1,300 procedures and found 2% were inappropriate, 90% appropriate, and 7% uncertain. For 1,300 angioplasties, 4% were inappropriate and 38% uncertain. Using RAND methodologies a panel of British physicians rated twice as many procedures "inappropriate" as did a U.S. panel rating the same clinical cases. The New York numbers are in question because New York State limits the number of surgery centers, and the per-capita supply of cardiac surgeons in New York is about one-half the national average.
52. The estimated five-year cost is $33,000 for angioplasty and $40,000 for CABGS. So, angioplasty did not lower costs. This was because of high failure rates of angioplasty.
2. Computed Tomography CT
53. The first CT scanner in the U.S. was installed at the Mayo Clinic in 1973. In 1992 the number of operational CT scanners was 6,060. By comparison, in 1993 there were 216 CT units in Canada.
54. There is little information available on how CT scan improves or affects patient outcome.
55. In some institutions up to 90% of scans performed were negative.
56. Approval by the FDA was not required for CT scanners. No evidence of safety or efficacy was required.
57. The first MRI was introduced in 1978 in Great Britain; the first U.S. scanner in 1980. By 1988 there were 1,230 units; by 1992 between 2,800 and 3,000.
58. A definitive review published in 1994 found less than 30 studies out of 5,000 that were prospective comparisons of diagnostic accuracy or therapeutic choice.
59. American College of Physicians assessed MRI studies and rated 13 out of 17 trials as "weak" - meaning the absence of any studies on therapeutic impact or patient outcomes.
60. The OAT concludes that, "It is evident that hospitals, physician-entrepreneurs, and medical device manufacturers have approached MRI and CT as commodities with high-profit potential, and decision-making on the acquisition and use of these procedures has been highly influenced by this approach. Clinical evaluation, appropriate patient selection, and matching supply to legitimate demand might be viewed as secondary forces."
4. Laparoscopic Surgery
61. Laparoscopic cholecystectomy was introduced at a professional surgical society meeting in late 1989. In 1992, five years after introduction, 85% of all cholecystectomies were performed laparoscopically.
62. There was an associated increase of 30% in the number of cholecystectomies performed.
63. Because of the increased volume of gall bladder operations, the total costs increased 11.4% between 1988 and 1992, in spite of a 25.1% drop in the average cost per surgery.
64. The mortality rate for gall bladder surgeries also did not decline as a result of the lower risk because so many more were performed.
65. When studies were finally done on completed cases, the results showed that laparoscopic cholecystectomy was associated with reduced in-patient duration, decreased pain, and shorter period of restricted activity. But there were increased rates of bile duct and major vessel injuries and a suggestion that these rates were worse for people with acute cholecystitis. There were still no clinical trials to clarify this issue.
66. Patient demand, fueled by substantial media attention, was a major force in promoting rapid adoption.
67. The video, which introduced the procedure in 1989, was produced by the major manufacturer of laparoscopic equipment.
68. Doctors were given two-day training seminars before performing the surgery on patients. Infant Mortality
69. In 1990 the U.S. ranked twenty-fourth in infant mortality out of 38 developed countries with a rate of 9.2 deaths per 1,000 live births.
70. U.S. black infant mortality is 18.6 per 1,000 live births and 8.8 for whites.
Screening for Breast Cancer
71. There has always been a debate over mammography screening in women under 50.
72. In 1992 the Canadian National Breast Cancer Study of 50,000 women showed that mammography had no effect on mortality for younger women, aged 40-50.
73. The National Cancer Institute (NCI) refused to change its recommendations on mammography.
74. The American Cancer Society decided to wait for more studies on mammography.
75. Then, in December 1993 NCI announced that women over 50 should have routine screening every one to two years but younger women would have no benefit from having mammography.
76. The OTA concluded that, "There are no mechanisms in place to limit dissemination of technologies regardless of their clinical value."
In the 1960s the results of a large randomized controlled study by the University Group Diabetes Program showed that tolbutamide, virtually the only blood sugar lowering agent available at the time in pill form, was associated with a significant increase in mortality in patients who developed myocardial infarction.
The obvious response from the medical profession should have been gratitude: here was an important way to improve the safety of clinical practice. But in fact the response was doubt, outrage, even legal proceedings against the investigators; the controversy went on for years.
An important clue surfaced at the annual meeting of the American Diabetes Association soon after the study was published. During the discussion a practitioner stood up and said he simply could not, and would not, accept the findings, because admitting to his patients that he had been using an unsafe treatment would shame him in their eyes. Other examples of such reactions to improvement efforts are not hard to find.
Indeed, it is arguable that shame is the universal dark side of improvement.
After all, improvement means that, however good your performance has been, it is not as good as it could be. As such, the experience of shame helps to explain why improvement, which ought to be a "no brainer", is generally such a slow and difficult process.
What is it about shame that makes it so hard to deal with? Along with embarrassment and guilt, shame is one of the emotions that motivate moral behavior. Current thinking suggests that shame is so devastating because it goes right to the core of a person's identity, making them feel exposed, inferior, degraded; it leads to avoidance, to silence.
The enormous power of shame is apparent in the adoption of shaming by many human rights organizations as their principal lever for social change; on the flip side lies the obvious social corrosiveness of "shameless" behavior.
Despite its potential importance in medical life, shame has received little attention in the medical literature: a search on the term shame in Medline in November 2001 yielded only 947 references out of the millions indexed. In a sense, shame is the "elephant in the room": something so big and disturbing that we don't even see it, despite the fact that we keep bumping into it.
An important exception to this blindness to medical shame is a paper published in 1987 by the psychiatrist Aaron Lazare which reminded us that patients commonly see their diseases as defects, inadequacies, or shortcomings, and that visits to doctors' surgeries and hospitals involve potentially humiliating physical and psychological exposure.
Patients respond by avoiding the healthcare system, withholding information, complaining, and suing. Doctors too can feel shamed in medical encounters, which Lazare suggests contributes to dissatisfaction with clinical practice.
Indeed, much of the extreme distress of doctors who are sued for malpractice appears to be attributable to the shame rather than to the financial losses. Also, who can doubt that a major concern underlying the controversy currently raging over mandatory reporting of medical errors is the fear of being shamed?
Doctors may, in fact, be particularly vulnerable to shame, since they are self-selected for perfectionism when they choose to enter the profession.
Moreover, the use of shaming as punishment for shortcomings and "moral errors" committed by medical students and trainees such as lack of sufficient dedication, hard work, and a proper reverence for role obligations probably contributes further to the extreme sensitivity of doctors to shaming.
What are the lessons here for those working to improve the quality and safety of medical care?
Firstly, we should recognize that shame is a powerful force in slowing or preventing improvement and that unless it is confronted and dealt with progress in improvement will be slow. Secondly, we should also recognize that shame is a fundamental human emotion and not about to go away. Once these ideas are understood, the work of mitigating and managing shame can flourish.
This work has, of course, been under way for some time. The move away from "cutting off the tail of the performance curve" that is, getting rid of bad apples towards "shifting the whole curve" as the basic strategy in quality improvement and the recognition that medical error results as much from malfunctioning systems as from incompetent practitioners are important developments in this regard.
They have helped to minimize challenges to the integrity of healthcare workers and support the transformation of medicine from a culture of blame to a culture of safety.
But quality improvement has another powerful tool for managing shame. Bringing issues of quality and safety out of the shadows can, by itself, remove some of the sting associated with improvement. After all, how shameful can these issues be if they are being widely shared and openly discussed?
Here is where reports by public bodies and journals like Quality and Safety in Health Care come in. More specifically, such a journal supports three major elements autonomy, mastery, and connectedness that motivate people to learn and improve, bolstering their competence and their sense of self worth, and thus serving as antidotes to shame.
British Medical Journal 2002;324:623-624 March 16, 2002
Dr. Mercola's Comment: I believe this is a central issue to the transformation of the medical paradigm.
It never occurred to me that shame could be a strongly motivating influence preventing many physicians from changing their previous practice habits.
Shifting them would imply that they were wrong in the past and that is something that most physicians seem to have a great deal of problems with and the shaming seems central to the cause.
Fortunately, EFT would be a wonderful tool to heal this wound. The practical challenge, of course, will be to arrange for the physicians to receive this treatment so they can progress forward with truthful information that will really serve their patients well.
We don't often think of vaccines as causing death when we submit to their use. We assume that vaccines are tested for safety and effectiveness, and they are ... but the testing is on animals. Vaccines cannot be proven safe until they are given to humans .. the first time.
Then they are an experiment and the person taking them becomes a human "guinea pig". Vaccines are designed to cause the very disease they are to prevent and a truly safe vaccine is one that is not effective.
The delicate balance between safety and effectiveness (disease and death) is our risk factor when we take a vaccination. Although many cases of SIDS (sudden infant death syndrome) have been linked to vaccines (See citations), the SIDS relationship to vaccines is often hotly debated. Also children die at a rate eight times faster than normal after a DPT shot. Perhaps that is what James R Shannon of NIH, meant when he said "No vaccination can be proven safe before it is given to children."
There are many causes of death in infants today, yet vaccines remain the most widely "unpublicized" cause of death today in children. The rates of SIDS deaths in young children parallel the timing for vaccinations precisely at 2 - 4- and 6 - months intervals. Yet, the causation of those SIDS deaths is listed as "uncertain" and most definitely SIDS death on a coroner's report would never be associated with the vaccine given a few day (or hours) before death. Children have a lot against them since their mothers are not passing on immunity to them in the breast milk (because they were vaccinated and no longer make antibodies). So childhood and infant deaths will go up, not down because of vaccinations. Statistics don't lie, but can surely be manipulated to give false opinions. Vaccines Prevent Health and unfortunately, they sometimes cause death!
New Stem Cell "Breakthrough" Actually Results in Growth of Cancer Cells by David Gutierrez
(NewsTarget) A new technique for producing stem cells that has been hailed as "breakthrough" actually produces stem cells that cause cancer in organisms that grow from them.
Two different teams of scientists announced a new technique for developing stem cells in the same month. In an article published in the online edition of the journal Cell, Dr. Shinya Yamanaka and colleagues said that they had transformed human skin cells into stem cells by using a virus to inject the skin cells with four specific genes.
Yamanaka and his colleagues at Kyoto University in Japan had formerly turned mouse skin cells into stem cells through a similar technique. Yamanaka is now setting up a lab at the Gladstone Institute of Cardiovascular Disease, which is associated with the University of California at San Francisco.
At roughly the same time, a team of researchers from the University of Wisconsin at Madison announced in the online edition of the journal Science that they had turned human skin cells into stem cells through the same technique, but using a different four genes.
Stem cells are cells that retain the ability to transform into any other kind of cell. This ability has made them the focus of a great deal of research, out of hopes that they can be used to regenerate destroyed tissue for victims of severe injury or degenerative diseases. Because many stem cells are derived from destroyed human embryos, however, much stem cell research has been dogged by controversy from anti-abortion activists, as well as women's rights advocates who object to the invasive procedure required to harvest live eggs for the process.
While less controversial, the stem cells produced by the new technique appear to be carcinogenic. When Yamanaka's team implanted the cells into mouse embryos, those embryos developed as expected -- with the DNA of the original stem cell, not of the embryo. But mice cloned in this fashion eventually developed neck tumors.
"It seems that everyone in the mainstream media is so excited about this new stem cell technique that they forgot to notice the fact that it leads to the growth of cancer tumors," said consumer health advocate Mike Adams.
About 100 billion people have died since humans first walked the earth. The practice of burying the dead may date back 350,000 years.
This fascinating article in Discover takes a look at some information about death you might not have been aware of, including the fact that no American has died of old age since 1951 (when the government eliminated that classification on death certificates).
One fact of particular interest to readers of this newsletter is that 80 percent of people in the United States die in a hospital.
Discover September 2006; 27(9)
Dr. Mercola's Comment: If you have been reading this newsletter for any length of time you know that merely the routine activity of conventional medicine can be enough to harm or kill you if you're not careful, so I'm not terribly surprised by the statistic revealing that 80 percent of Americans die in a hospital.
Here are a couple more pertinent medical-related factoids from the article:
Vultures in India are dying due to residues of the anti-inflammatory drug diclofenac (better known as Voltaren) that they ingest when they eat dead cattle carcasses. More New York City residents die from suicide than are murdered. Here are a few more facts, not from the article:
Death rate actually decreases when doctors go on strike, and deaths blamed on mistakes made with prescription drugs sold at pharmacies spike at the beginning of each month. Meanwhile, wild variations in health care quality lead to:
42,000-79,000 avoidable deaths 66.5 million avoidable sick days $1.8 billion in additional medical care costs
The sad tragedy is that the conventional medical paradigm is fatally flawed. The United States is spending $2 trillion every year for a system that is based on disease management focused on drugs and surgery that fail to address the underlying cause of disease.
Additionally, clever manipulation of the official government death rates conceals the fact that the conventional medical system, not heart disease or cancer, is the leading cause of death in this country. Yet, in all fairness, physicians themselves are not the primary reason, as they are under the pernicious influence of the multi-billion-dollar marketing umbrella of the drug companies.
Our return on the massive investment in health care is profoundly poor. The bottom line is that the system is crumbling before our eyes. The very economic stability of the United States is threatened by this abuse. The good news is that the expense and misery can be powerful motivating factors to change.
If you want to take a giant step toward better health for you and your family, and avoid becoming another death statistic, please stay tuned as I am currently testing the new version of Mercola.com that will allow you to actively participate in developing the largest collection of health truth this world has ever known.
I have had a team of programmers working for many months to create a brand new Web 2.0 site that is based on the wildly popular Digg.com, which did not exist until December 2004 and now is in the top 25 Web sites in the world.
We are actually alpha testing the program now and hope to have it available soon. Once completed it may be one of the single most important catalysts for the transformation of the health care system.
Flip-Flop Science: Does Anyone Really Know What Makes You Healthy? The nature of medical wisdom, with the here-today-gone-tomorrow nature of its recommendations, is controversial to say the least. Many explanations have been offered to make sense of why recommendations that are made with confidence this year are later refuted and reversed.
One of the simplest explanations is that this is the natural rhythm of science. An observation leads to a hypothesis. The hypothesis is then tested, and usually fails, which is always the most likely outcome in any scientific endeavor.
Why is that so?
Quite simply because there are an infinite number of wrong hypotheses for every right one. Therefore, the odds are always against any particular hypothesis being true, no matter how obvious or vitally important it might seem in the beginning.
The seesaw effect is often caused by the interplay between observational studies and clinical trials.
The catch with observational studies is that they cannot conclude that one event causes the other. They can only provide hypothesis-generating evidence, which in a court of law would amount to circumstantial evidence. Observational studies are then often followed up with randomized-controlled clinical trials, essentially an experiment, which typically results in the flip-flop rhythm of medical wisdom, when the experiment doesn’t show the same result.
According to a 1994 editorial by Jerome Kassirer and Marcia Angell, two editors from The New England Journal of Medicine, “The problem is not in the research but in the way it is interpreted for the public.” Each study is just a piece of the puzzle and so the media needs to do a better job of communicating the many limitations and caveats involved, perhaps most importantly the fact that “an association between two events is not the same as a cause and effect.”
New York Times September 16, 2007
Dr. Mercola's Comments: So, what is the best way for you to respond to all the constant stream of new research findings?
As proposed in this article, your prudent approach would probably be to remain skeptical, especially in the beginning stages, as oftentimes the very first scientific claim is most likely to be wrong. Even though it’s usually the first report that gets the most media coverage.
Remember that nearly always, the institution funding the study is some corporation that could care less about your health, or the study is done by researchers who are so firmly entrenched in the established paradigm that they discount and excuse away anything that conflicts with their belief system.
Sad but true. This inherent bias has been responsible for untold unnecessary grief and suffering.
The exception to this rule is when reports show unexpected harm, which is often the case in follow-up studies of pharmaceutical drugs. If you are exposing yourself to a particular pill or fad diet, for example, with the goal of promoting good health, but it later turns out to be associated with an increased risk of health problems, rather than a decreased risk, then that’s obviously a bad sign that warrants your consideration. Of course, conventional medical science does have its place. If you’re in a car accident, your nearest trauma center is a blessing that can save your life. However, to believe that you can create good health through taking drugs to solve your health care challenges is a very dangerous pipe dream. It simply won’t happen.
What DOES Make You Healthy?
There are certain basic tenets of optimal health (and healthy weight) that have always remained permanent truths, regardless of what marvels modern science comes up with next:
Eat a healthy diet that’s right for your nutritional type (paying very careful attention to keeping your insulin levels down) Drink plenty of clean water Manage your stress Exercise Sunlight Limit toxin exposure Consume healthy fat Eat plenty of raw food Optimize insulin and leptin levels Get plenty of sleep Remember, leading a common sense, healthy lifestyle is your best bet to produce a healthy body and mind, and increase your longevity.
Unfortunately, the pharmaceutical industry, the food industry, and even government itself sure won't make it easy for you to avoid the garbage that ruins your health.
My previous articles, How Drug Companies Deceive You and How the Food Industry is Deceiving You are just a couple of examples of how you are kept in the dark about common sense health issues.
The drug industry spends about $15 billion a year manipulating and distorting your perceptions about the proper solutions for your health challenges. And, the food industry spends TWICE that much to brainwash you and your children to choose highly processed convenience foods that will accelerate your path toward death and disease -- and your need to use drugs to control your symptoms. It’s a vicious cycle of deceit and misinformation.
Fortunately, you can still take self-responsibility, educate yourself, and make better, healthier choices.
By adhering to the basic tenets of optimal health – the basics of a healthy lifestyle, not just a temporary fix for a particular ailment -- you are building a healthy mind and body, and thereby safeguarding yourself against a multitude of health problems and serious diseases.
According to the Journal of the American Medical Association (JAMA), "Adverse drug reactions are the fourth leading cause of death in America. Reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined."
Annually, drug companies spend billions on TV commercials and print media. They spend over $12 billion a year handing out drug samples and employing sales forces to influence doctors to promote specifically branded drugs. The drug industry employs over 1,200 lobbyists, including 40 former members of Congress. Drug companies have spent close to a billion dollars since 1998 on lobbying. In 2004, drug companies and their officials contributed at least $17 million to federal election campaigns.
To get a full diagnosis of this provocative story, highly acclaimed health guru Gary Null sent his lead investigator and director of operations, Manette Loudon, to Washington, D.C. to interview Food and Drug Administration (FDA) employee and Vioxx whistleblower Dr. David Graham. What you are about to read may leave you questioning the safety of all drugs, but it is a story that must be told. Unless Congress steps up to the plate and changes policy at the FDA, millions more will become unwitting victims of adverse drug reactions from unsafe drugs.
Loudon: Dr. Graham, it's truly a pleasure to have the opportunity to interview you. Let me begin by asking you how long you've been with the FDA and what your current position is?
Dr. David Graham: I've been with the FDA for 20 years. I'm currently the Associate Director for Science and Medicine in the Office of Drug Safety. That's my official job. But when I'm here today I'm speaking in my private capacity on my own time, and I do not represent the FDA.
We can be pretty certain that the FDA would not agree with most of what I have to say. So with those disclaimers, you know everything is OK.
Loudon: On November 23, 2004 (during the) PBS Online News Hour Program, you were quoted as making the following statement: "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx. Simply put, FDA and the Center for Drug Evaluation Research (CDER) are broken." Since you've made that statement, has anything changed within the FDA to fix what's broken and, if not, how serious is the problem that we're dealing with here?
Dr. Graham: Since November, when I appeared before the Senate Finance Committee and announced to the world that the FDA was incapable of protecting America from unsafe drugs or from another Vioxx, very little has changed on the surface and substantively nothing has changed.
The structural problems that exist within the FDA, where the people who approve the drugs are also the ones who oversee the post marketing regulation of the drug, remain unchanged. The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur. America is just as at risk now as it was in November, as it was two years ago, and as it was five years ago.
Loudon: In that same PBS program, you were also quoted saying, "The organizational structure within the CDER is currently geared towards the review and approval of new drugs. When a serious safety issue arises at post marketing, the immediate reaction is almost always one of denial, rejection and heat. They approved the drugs, so there can't possibly be anything wrong with it. This is an inherent conflict of interest."
Based on what you're saying it appears that the FDA is responsible for protecting the interests of pharmaceutical companies and not the American people. Do you believe the FDA can protect the public from dangerous drugs?
Dr. Graham: As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured.
Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about 5 percent. The "gorilla in the living room" is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug. So you have that conflict as well.
Loudon: When did that go into effect?
Dr. Graham: The Prescription Drug User Fee Act came into play in 1992. It was passed by Congress as a way of providing the FDA with more funds so that it could hire more physicians and other scientists to review drug applications so that drugs would be approved more quickly.
For industry, every day a drug is held up from being marketed, represents a loss of 1 million to 2 million dollars of profit. The incentive is to review and approve the drugs as quickly as possible, and not stand in the way of profit-making. The FDA cooperates with that mandate.
Loudon: And what about those new drugs? Are they any better than what already exists on the market?
Dr. Graham: It's a myth that is promulgated not only by industry but also by the FDA itself. It's a misperception that our lawmakers in Congress have as well and they've been fed this line by industry.
Industry is saying there are all these lifesaving drugs that the FDA is slow to approve and people are dying in the streets because of it. The fact is that probably about two-thirds to three-quarters of the drugs that the FDA reviews are already on the market and are being reviewed for another indication.
So, for example, if I've got a drug that can treat bronchitis and now it's going to be used to treat a urinary tract infection, well, that's a new indication. But it's the same drug and we already know about the safety of the drug. There is nothing life-saving there. There is nothing new. There is nothing innovative.
A very small proportion of drugs represent a new drug that hasn't been marketed before. Most of those drugs are no better than the ones that exist. If you want to talk about breakthrough drugs -- the ones that really make a difference in patients' lives and represent a revolution in pharmacology -- we're talking about maybe one or two drugs a year. Most of them aren't breakthroughs and most of them aren't life-saving, but they get treated as if they were.
Loudon: Are you at liberty to discuss some of the problems your colleagues are finding with other drugs and if so, how widespread is the problem?
Dr. Graham: I'm really not at liberty to talk about things that pertain to my official duties at the FDA. I can talk in my private capacity, but I can't talk about material that would be confidential.
What I can say is that there are a number of other scientists within the FDA who have also worked with drugs that they know are not safe, even though the FDA has approved or allowed them to remain on the market. They face some of the same difficulties that I do. The difference is that either the problem isn't as serious in terms of the numbers of people that were injured or that it's a fatal reaction -- they're not willing to expose themselves to retaliation by the FDA -- and retaliation would surely follow.
Crusador would like to thank Manette Loudon and Pam Klebs for their help in putting this interview with Dr. David Graham together.
Secrets of the FDA Revealed by Top Insider Doctor: Part 2
According to the Journal of the American Medical Association (JAMA), "Adverse drug reactions are the fourth leading cause of death in America. Reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined."
Annually, drug companies spend billions on TV commercials and print media. They spend over $12 billion a year handing out drug samples and employing sales forces to influence doctors to promote specifically branded drugs. The drug industry employs over 1,200 lobbyists, including 40 former members of Congress. Drug companies have spent close to a billion dollars since 1998 on lobbying. In 2004, drug companies and their officials contributed at least $17 million to federal election campaigns.
To get a full diagnosis of this provocative story, highly acclaimed health guru Gary Null sent his lead investigator and director of operations, Manette Loudon, to Washington, D.C. to interview FDA employee and Vioxx whistleblower Dr. David Graham. What you are about to read may leave you questioning the safety of all drugs, but it is a story that must be told. Unless Congress steps up to the plate and changes policy at the FDA, millions more will become unwitting victims of adverse drug reactions from unsafe drugs.
Loudon: Do you think we should have any confidence in the FDA and, if so, can you elaborate on what they do that you feel benefits the American people?
Dr. Graham: In terms of confidence in what the FDA does, there are two things that the FDA determines when it looks at a drug: It determines whether or not a drug is safe and it determines whether or not it's effective.
Regarding the determination of drug effectiveness, I think the FDA does a pretty good job. If the FDA says that the drug will have a particular effect, probably for many of the patients who take the drug it will actually have that effect. If the FDA says a given drug will lower blood pressure and you're somebody who has high blood pressure, there's a good chance that the drug will have an effect that lowers your blood pressure. That has to do with the rigor with which they force the drug companies to establish that the drug actually has an effect.
On the safety side, I think that the American public can't be very confident. They can have some confidence because it turns out that most drugs are remarkably safe.
But, when there are unsafe drugs, the FDA is very likely to err on the side of industry. Rarely will they keep a drug from being marketed or pull a drug off the market. A lot of this has to do with the standards that the FDA uses for safety. When they look at efficacy, they assume that the drug doesn't work and the company has to prove that the drug does work.
When they look at safety it's entirely the opposite. The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe. Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe?
There's no incentive for the companies to do things right. The clinical trials that are done are too small, and as a result it's very unusual to find a serious safety problem in these clinical trials. Safety flaws are discovered after the drug gets on the market.
Loudon: I read somewhere that a drug only has to be better than a sugar pill
Dr. Graham: Right. The standard that the FDA uses to approve a drug is primarily "does the drug work?" That's what they call efficacy.
Most often, they'll compare the drug against something called a placebo or a sugar pill. It's basically something that doesn't have a medical effect. The assumption is that the drug will be no different than the sugar pill. The FDA puts the onus on the drug company to conduct a clinical trial to show that the drug is different from a sugar pill. The way the FDA's approval standards are, the drug does not necessarily have to have a very great effect in order to be approved. The drug might lower your blood pressure by just a few millimeters of mercury, but the FDA will say we can approve it because it does lower your blood pressure.
Now, would that be a benefit or are there other drugs out there -- many other drugs -- that patients could take instead that would lower their blood pressure by 10 or 15 or 20 millimeters? The FDA doesn't really care about that.
What happens is the drug gets marketed. You've got two drugs that are out there -- one drug that effectively lowers your blood pressure a substantial degree and another drug that barely lowers your blood pressure at all. The company that has that second drug markets it like it's this breakthrough medicine. It lowers your blood pressure and they have all these glitzy ads, direct-to-consumer advertising. Lots of patients and lots of doctors will use that medication.
What happens in the process is these patients are actually in a sense being denied a more effective treatment because the FDA doesn't require that drugs that come on to market be at least equivalent to, or better than, the drugs that are already there.
All they have to do is be better than a sugar pill.
Loudon: When you consider the financial impact your whistle blowing has had on the pharmaceutical industry do you have any fears that your life may be in jeopardy?
Dr. Graham: I have tried not to think about that. In the work that I've done, I've never really thought about what the financial impact would be on any particular company. I put that out of my mind because my primary concern is whether or not the drug is safe. If it's not safe, how unsafe is it and how many people are being hurt by it?
In terms of when I identify an unsafe drug, to me it doesn't really matter what drug company it is. I've helped to get 10 different drugs off the market, and they're from 10 different drug companies. It's not a vendetta against any particular drug company. I have to hope that the drug companies don't take it personally. I'm just a scientist doing my job, and I have to leave the rest to God to protect me.
Loudon: Has anyone tried to silence you and stop you from becoming a whistleblower?
Dr. Graham: Prior to my Senate testimony in mid-November of 2004, there was an orchestrated campaign by senior level FDA managers to intimidate me so that I would not testify before Congress.
This intimidation took several forms. One attack came from our acting center director who contacted the editor of the Lancet, the prestigious medical journal in the United Kingdom, and intimated to the editor that I had committed scientific misconduct and that they shouldn't publish a paper that I had written showing that Vioxx increases the risks of heart attack. This high-level FDA official never talked to me about this allegation. He just went directly to the Lancet.
The second attack was from other high level FDA officials who contacted Sen. (Charles) Grassley's (R-Iowa) office and attempted to prevent Sen. Grassley and his staff from supporting me and calling me as a witness. They knew that if they could disarm Sen. Grassley that would neutralize me.
The third attack came from senior FDA officials who contacted Tom Devine, my attorney at the Government Accountability Project, and attempted to convince him that he should not represent me because I was guilty of scientific misconduct; I was a bully; a demigod; and a terrible person that couldn't be trusted.
These people were posing as whistleblowers themselves ratting on another whistleblower. Some of these senior level FDA officials were in my supervisory chain and are people I work for. They were involved in a coordinated attempt to discredit me and to smear my name and to prevent me from giving testimony.
There's one other thing that happened the week before I testified. The Acting Commissioner of the FDA invited me to his office and offered me a job in the commissioner's office to oversee the revitalization of drug safety for the FDA if I would just leave the Office of Drug Safety and come to the Commissioner's Office. Obviously, he had been tipped off by people in the Senate Finance Committee who are sympathetic to the FDA's status quo that I was going to be called as a witness.
To preempt that, he offers me this job, which basically would have been exile to a fancy title with no real ability to have an impact. This was a conspiracy and it was coordinated and there was collaboration among senior level FDA officials.
What a mess!
Crusador would like to thank Manette Loudon and Pam Klebs for their help in putting this interview with Dr. David Graham together.
Dr. Mercola's Comment: Dr. David Graham has also helped write new legislation called the Grassley Dodd Bill that is currently held up in committee. It is a radical bill that should help transform the FDA back to its roots and really protect the public safety. It would set up a new independent Center inside the Food and Drug Administration (FDA) to review drugs and biological products once they are on the market.
The bill addresses the fact that the Office of New Drugs carries too much sway over the FDA's drug-safety apparatus. Today, drug makers have the ability to negotiate with the FDA officials who approved their drugs to begin with when the FDA considers corrective action. By creating a Center for post-market review, this legislation puts you, the American consumers, where you belong at the FDA, and that's front and center.
Dr. Mercola's Comment: Dr. David Graham has also helped write new legislation called the Grassley Dodd Bill that is currently held up in committee. It is a radical bill that should help transform the FDA back to its roots and really protect the public safety. It would set up a new independent Center inside the Food and Drug Administration (FDA) to review drugs and biological products once they are on the market.
The bill addresses the fact that office of new drugs carries too much sway over the FDA's drug-safety apparatus. Today drug makers have the ability to negotiate with the FDA officials who approved their drugs to begin with when the FDA considers corrective action By creating a Center for post-market review, this legislation puts you, the American consumers where you belong at the FDA, and that's front and center.
I don't ask you to write your congressman frequently, but this one is worth it. You can help save some lives by helping to increase pressure to change the way the FDA is run. The drug companies do NOT want this bill passed and they have the largest lobby in Congress so we really need all the help we can,
You can find out how to contact your Congressman by going to the following URL:
http://www.house.gov/writerep/ All you need to do is write a simple short note telling them how you feel the FDA is critically broken and you believe that the new proposed legislation would really help improve that.
If you want to review the entire bill it is up on the site.
From approving harmful drugs to letting the pharmaceutical industry get away with murder, the Food and Drug Administration (FDA) seems to be continually failing to get it right. And while the agency may be trying to move in a positive direction, the attempts seem short-lived.
According to Dr. David Graham and Senate Finance Committee Chairman Charles E. Grassley, the FDA's new Drug Safety Oversight Board will not increase the ability of the agency to remove unsafe prescription drugs from the market and could actually hinder efforts to make medications safer.
The Dynamic Duo
Graham -- who in November 2004 criticized the FDA's ability to protect the public from harmful drugs -- blasted the structure of the membership of the board, noting the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself."
And in a letter to acting Commissioner Lester M. Crawford, Grassley stated that the makeup of the board led him to conclude that, "What we have here is nothing more than the status quo."
The 15-member board largely consists of FDA managers with some input of the National Institutes of Health and the Department of Veterans Affairs. The qualms Graham and Grassley have with the current board arrangement is that 11 of the 15 voting positions of the board are filled by senior FDA managers for the agency's Center for Drug Evaluation and Research -- the very same office responsible for reviewing and approving new drugs.
Additional concerns include:
Most of the safety board's deliberations will be kept private. A two-thirds majority vote is required to recommend the FDA take action on anything. Need for a Change
Both Graham's and Grassley's disapprovals show that Congress may not be satisfied with the FDA's actions and may press for a change on pending legislation to create a more independent drug office.
In fact, Congress is already considering bills that would more aggressively address drug safety: A bipartisan effort led by Grassley and Sen. Christopher Dodd introduced a bill that would create a board with far fewer ties to the FDA; however, opponents argue the bill will focus far too much on the risks of a drug, and not its benefits.
Medical News Today June 13, 2005
Dr. Mercola's Comment: While we were lead to believe that things were finally changing for the better, it appears the FDA's propensity to continue protecting the hand that feeds it and putting its own agenda ahead of your health is still alive and kicking.
I certainly agree with Dr. David Graham's contention that current drug safety standards in the country are even worse than they were in 2004.
What the FDA is apparently getting away with is somewhat surprising. My guess is that it is a direct reflection of the drug industry control of Congress. They clearly have the strongest political lobby, and that can wield quite a bit of power and influence.
The drug companies financially support the FDA in the form of user fees for drug approval and significantly influence American political leaders that are responsible for FDA policies and funding. From 1998 to 2005, drug and chemical corporations spent $758 million on lobbying politicians. The goal of corporate lobbying is to influence what food and drug products can be marketed and how they are labeled.
In the 2004 elections alone, nearly $1 million was contributed to President Bush, $500,000 to his opponent John Kerry, and over $100,000 was contributed to approximately 18 members of Congress. The drug and chemical industries employ over 1,200 full-time lobbyists, including 40 former members of Congress. The drug and chemical corporate lobbyists are extremely successful at what they do, which puts the FDA at the mercy of the very same chemical industry that they aim to regulate.
This seems to be the only logical explanation for this type of behavior.
Ten of the 32 Food and Drug Administration (FDA) drug advisers whose total votes favored the controversial painkillers Celebrex, Bextra and Vioxx had financial ties to the industry. According to public records and disclosures in medical journals, the 10 advisors had recently consulted with the drugs’ makers.
Although most (8) of the 10 members said their ties did not influence their votes, had they not voted the advisory committee results would have been as follows: 12 to 8 to withdraw Bextra from the market 14 to 8 to keep Vioxx off the market
However, the advisors with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 to bring Vioxx back to the market. Their votes did not significantly influence the decision to keep Celebrex on the market.
It’s commonly known that researchers who work with industry serve on FDA advisory panels; the agency says it works to balance expertise with potential conflicts of interest. However, the FDA often keeps such ties secret from the public and experts say studies have shown that money does influence scientific judgments.
The 10 advisors had worked in some capacity for Merck, Voixx’s maker, Pfizer, which makes Celebrex and Bextra, or Novartis, which is applying to sell Prexige, a similar drug.
Three votes were taken for each drug. Out of the 30 votes cast by the 10 advisers in question, 28 voted to continue marketing all three drugs. Comparatively, out of the 66 votes cast by the remaining 22 members of the panel, only 37 voted in favor of the drugs.
The FDA said that the committee members were “screened for conflicts of interest according to the same strict ethics guidelines FDA applies to all its advisory committees.''
Merck, which pulled Vioxx from the market in the biggest drug recall to date, has not determined whether they will reintroduce the drug.
San Francisco Chronicle February 25, 2005 Bloomberg February 26, 2005
Dr. Mercola's Comment: Last week, in the lead story in the February 23 newsletter I pointed out that there just had to be a massive conflict of interest for Vioxx to be reintroduced to the market after killing 55,000 people. Here is my quote from that article:
At this time I have no details on the physicians who were on this "expert" FDA advisory panel, but I would not be surprised to find out that there is massive conflict of interest involved. Please don't be shocked, but massive conflict of interest is a regular event with the FDA.
It was blatantly obvious that these drugs wouldn’t have been voted for favorably if financial ties weren’t involved. There was no other way that Vioxx could have been approved and be allowed to kill even more people. Makes absolutely no sense unless you factor in corporate greed--pure, unadulterated corporate greed that places money ahead of human life, pain and suffering.
If this doesn't wake you up to just how EVIL the drug companies are then I simply don't know what will. This is one of the biggest stories since I started this newsletter in 1997, yet the media has not given it the attention it truly deserves and before you know it, the story will be buried and away from the consciousness of most Americans. For most Americans the virtually meaningless Academy Awards dwarfs the importance of this story.
Thank God for the New York Times. Without question, they are one of the best, if not the best, investigative papers in the world. They’re the ones who made the request to have the FDA “expert” advisory panel’s industry ties analyzed.
To add insult to injury, the day after the NY Times story the FDA had the audacity to state that they had done their due diligence and screened the members of the "expert" advisory panel for conflict of interest so they would give an unbiased vote in the decision of whether or not Vioxx should be put back on the market.
Well, they did indeed screen EVERY panel member for any potential conflict of interest. That would lead the public to believe they were doing their job. BUT, guess what happened if they found a potential conflict of interest? They gave the doctor a waiver so they could participate in the "expert" panel.
Folks, it just doesn't get any more blatant than this. We have got to put an end to this nonsense and start the process to have responsible leadership at the FDA. If this appaling behavior disgusts you as much as it does me then I encourage you to forward the story to your friends and relatives, especially if they are convinced the FDA is their friend and protects them. Nothing could be further from the truth. The media isn’t doing their job so we need public support to expose the FDA’s crimes.
Fortunately there are some amazing individuals at the FDA. Dr. David Graham is the associate director of the Office of Drug Safety for the FDA. He is a graduate of the John Hopkins University School of Medicine and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. Earlier this week I was able to find a link to his entire testimony to Congress in November 2004. This is the testimony in which he blew the whistle on the Vioxx.
This event would be partially mitigated if the drugs in question were absolutely necessary and the only option for this problem, but the fact is there are many natural effective alternatives to these medications.:
Normalize your daily ratio of omega-3 and omega-6 fats by taking a high-quality fish or cod liver oil.
Reduce (with the idea of soon eliminating) grains and sugars from your diet.
Optimize your diet according to your body's unique metabolic type.
Consider herbal alternatives I've outlined in a recent article.
It has been discovered that nonsteroidal anti-inflammatory drugs, or NSAIDS, such as Cox-2 inhibitors Vioxx, Bextra and Celebrex, lead to an increased risk of cardiovascular problems. However, it turns out that these prescription drugs are not the only painkillers that should be avoided: The FDA has urged the public to limit the use of over-the-counter pain medications and to use them in strict accordance with the label directions.
Over-The-Counter Pain Relievers to be Wary Of: Aleve Aspirin Ibuprofen Aleve (made by Bayer) is the first non-prescription NSAID to be added to the list of painkillers associated with heart attacks and strokes. In fact, Aleve is so detrimental to one's health that those who have been taking the drug for nearly three years have been advised to stop using it, while those who opt to continue taking it should take no more than two pills a day for no longer than 10 days (unless otherwise advised by a doctor).
People taking the prescription version of Aleve, Naprosyn, are also being directed to take the drug with extreme caution.
Further, a study administered to discover whether Aleve or Celebrex could prevent Alzheimer's disease showed that those taking Aleve had an estimated 50 percent higher risk of heart attacks and strokes than those taking a placebo.
USA Today December 23, 2004
USA Today December 20, 2004
Dr. Mercola's Comment: Folks they are dropping like flies. The leading NSAID in the world, Vioxx, led the cascade in late September; Vioxx was the beginning of the end of conventional medicine. (Merck will lose $50 billion.) A few weeks later the second COX-2 inhibitor, Bextra, bit the dust. Then the third and final cox-2 inhibitor, Celebrex, got hit. Pfizer is the number one drug company in the world and their stock dropped $25 billion over the weekend.
Now, it appears that all NSAIDs may be problematic, not just the COX-2 inhibitors. The NIH told us that the popular over-the-counter pain reliever, Aleve, has been linked to an increased risk of heart attack and stroke. The director of the FDA's drugs division, said consumers should take Aleve only as directed on its label: No more than two pills a day. Aleve is the first OTC drug to enter the NSAID mess, but it is still available as prescription strength.
So the warning is about the OTC drug that only has 200 mg of naproxen. But guess what? The prescription product has more than twice the dose of the OTC brand and has 500 mg. The recommended dose is up to 1500 mg. This is nearly FOUR TIMES the dose the FDA now advises consumers not to exceed.
Do you want to hear what deputy director of the FDA's Office of New Drugs said about Aleve? Well, here you go:
"This is a very confusing situation...there is little data about the long-term effects of naproxen or any other related pain reliever."
The FDA has finally admitted that the entire class of drugs known as NSAIDs is expected to fall as a result of this new information. So that means that if you are taking Advil or any other NSAID, you will want to consider finding a healthier option ASAP, as the drug you are taking could actually take your life.
So what can you do to treat pain in a way that not only addresses its cause but also makes you healthier?
There are two steps that will help the vast majority of people with pain. That is to start a high quality fish oil (cod liver oil) at this time of year and to avoid sugar. Omega-3 fats are precursors to mediators of inflammation called prostaglandins. In fact, that is how Vioxx and other NSAIDs work -- they manipulate prostaglandins. However, when you do it in an unnatural drug way, there is frequently another price to pay, like side effects, which can lead to death. Further, when you use natural methods like omega-3 fats and stopping sugar, the side effects are good health.
Sugar and grain avoidance for most people will lower insulin levels. Elevated insulin levels are one of the most important reasons why inflammatory prostaglandins are produced. That is why stopping sugar and sweets are so essential to controlling arthritis pain and other types of chronic degenerative illness.
Most people were using Vioxx for osteoarthritis and other types of pain. But for those that were using it for the less common rheumatoid arthritis, it is important to know that optimizing vitamin D is one of the most important physical measures one can take to treat RA. Sun exposure is clearly the best way to achieve this however at this time of year the only alternative to a month's vacation in the Caribbean that most of us can't do is to consume healthy vitamin D from cod liver oil. Cod liver oil is clearly the safest form of vitamin D supplementation as contains vitamin A, which can balance against absorbing too much vitamin D.
Metabolic typing is another tool that I have seen work in thousands of patients to reduce their pain -- if you are not yet aware of your metabolic type and how this can profoundly improve your health and help reduce pain, I strongly recommend you consider my bestselling book, TOTAL HEALTH Program, which will help you understand your metabolic type and all the right micronutrients for your particular biochemistry (plus it contains over 150 new recipes in Part 2!)
Also, eating according to your metabolic type is absolutely amazing, especially when combined with an effective energy psychology tool like Emotional Freedom Technique (EFT) that can address previous emotional traumas that cause bioelectrical short circuiting predisposing one to immune dysfunction.
The recent events regarding the complications linked to using painkillers only secures my opinion that we are entering the beginning of the end of conventional medicine.
Folks, believe me when I say that these occurrences are merely the tip of the iceberg. With BOTH prescription and over-the-counter medications being named "dangerous," as well as the underlying deceit and greed associated with the medical profession, the entire conventional system is on a rapid decline.
The following excerpts are taken from an essay written by Dr. Robert E. Willner, who has practiced medicine for 40 years and refers to himself as an insider of traditional medicine.
The foundation of the medical profession lies in the hands of the pharmaceutical industry and remains a profession riddled with conflicts of interest. Too often, true disease prevention is referred to as too time consuming or as a barrier to economic profits. Traditional doctors engage in a simple and profitable practice. They first spend a limited amount of time with their patients, charge them an exorbitant fee, then fill out a script for a prescription without looking into the possible side effects of the medication.
Don't Hesitate to Question Your Doctor
Rather than simply accepting your doctor's opinion regarding a treatment or diagnosis, ask him or her the source of information they are basing their opinions on.
Inquire about natural and alternative therapies. Most doctors are open to new ideas, however are oblivious to the fact that a barrier has been put up around them based on what they've been exposed to for years in the traditional medical industry.
The power of the AMA has clearly left an impression upon the practice of modern medicine today. Not only has it stifled the doors to creativity but has also created a conformist way of thinking among doctors.
A huge force behind the narrow-minded thinking of doctors has been the pharmaceutical industry, which has brought success to doctors a miniscule less than 10 percent of the diseases they attempt to treat. Pharmaceutical industries have their hands in many influential areas such as research grants, contracts and advertising support for thousands of published medical journals, which are used as reference guides.
As long as the medical industry remains under the grip of the pharmaceutical industry, the public will continue to be denied other treatment options for their health care and disease treatment.
Positive Strides in the Medical Industry
One area that modern medicine has shown signs of progress in is the diagnosis and treatment of individuals needing crisis care. Advancements in surgical procedures have not only saved many lives but also have brought back a decent quality of life to millions. Unfortunately, these great technological advancements in many cases have been abused due to greed and profit.
While traditional doctors have made some great achievements in the area of crisis care, it is important to keep in mind that this type of care represents an extremely small area in comparison to all of the other health issues and diseases it has to face.
Molocure July 2004
Dr. Mercola's Comment: One of the important points to remember here is that you can play a vital role in making your health care safe and not fall victim to the greedy pharmaceutical industries by becoming:
Active Involved Informed You need to see yourself as the center of the health care team. You need to ask questions, and if you can't then you need to have loved ones or other advocates speak on your behalf.
Keeping up to date on the latest manipulations of the drug industry is key to taking control of your health. It is my vision through Mercola.com to expose the existing medical paradigm's techniques, habits, and messages that have put, and increasingly are putting, your health and the health of the American public in grave danger.
I invite you to delve into the site for all its useful information, sign up for my twice-weekly newsletter, and, most of all, join me in this quest to transform the medical paradigm to one where all medical professionals are truly committed to their patients' health and well-being at the deepest levels
Much of the problem would be avoided if you find a physician who uses drugs only as a last resort and who has a firm understanding of the natural medical principles advocated on this site.
As far as professional groups go, chiropractors and naturopaths are the two groups that are generally light years ahead of the traditional medical profession. However, you need to be very careful in selecting any health care provider as ultimately they are individuals and may not be able to provide the top-quality care you require.
A helpful strategy is to ask people in several good health food stores who they would recommend. Normally, health food stores are networked in with the top local health care providers. Be careful to ask a number of different individuals though, as you are seeking a consensus here.
If you live in the United States and need medical care or treatment for a disease you can follow one of two paths to better health--conventional or alternative. In making this decision it is important to know the differences between the two practices.
A Comparison of Conventional to Alternative Medicine
Conventional (Disease-based Model)
Offers the best medicine in surgeries or trauma care
Treatment of immune health-related conditions routinely consists of prescribing drugs or recommending medical procedures, which are often invasive
Targets treating symptoms, not the underlying causes
Treats the human body in parts, not as a whole
Medical schools are set up by organ specific departments that don't share any kind of relationship with one another
The shaping of conventional medical doctors is based upon using "rescue medicine," not finding treatment and prevention alternatives for illnesses Alternative Medicine (Prevention-based Model) Approaches medical treatment by placing its focus primarily on proactive measures Treats the condition, not the symptoms More cost effective Treatment targets the whole body
The growing number of people turning to alternative therapies is growing stronger and is becoming more and more the chosen form of medical treatment among Americans.
Just consider these statistics: One out of every three Americans uses some kind of alternative medicine
Between 1990 and 1997 there was a 47 percent increase in visits to alternative practitioners, from 427 million to 629 million, bypassing the estimated total number of visits made to all conventional primary care doctors in 1997
As these statistics reveal the rapidly increasing number of people choosing alternative therapies as a form of treatment, the debated question among the health care industry is, "Why don't more conventional doctors recommend alternative medicine?"
The driving force behind the continuing growth of conventional medicine has been the pharmaceutical industry, embraced by both doctors and pharmacists, who calculate their worth through treating disease by prescribing medications. For example, if a patient is diagnosed with breast cancer, the protocol for the doctor is to prescribe tamoxifen. If a patient is diagnosed with schizophrenia, clozaril is prescribed.
Medical Schools Receive Funding From Drug Companies
Most medical schools receive a huge chunk of funding from the pharmaceutical industry that has a vested interest in marketing their medicines. Evidence of this could be seen in Pfizer Inc, a company that develops produces and markets the leading prescription medications for humans and offers several scholarships and grants to American Medical Schools.
The Mass Media Favors Drug Advertising
Just as pharmaceutical companies are all about making profits, so is the mass media and this is clearly exposed in the high numbers of drug commercials consumers are exposed to every day. Drug ads equal profits for the media.
The number of mass media commercials has exploded over the past few years. In 1999, drug companies spent $1.8 billion on direct-to-consumer advertisements for prescription drugs. Even more disturbing, it was discovered that around 10 percent of the people who watched the commercials inquired to their doctor about the specific drugs.
Even the American Medical Association maintains a relationship with the pharmaceutical industry. If you go to their homepage you will find a sizable advertisement for the statin, Crestor.
The scale for funding of medical research is disproportionately tipped to favor conventional medicine over alternative medicine. An example of this could be seen in the 0.08 percent of the British National Health Service research budget set aside for alternative research. Also, out of $12 billion allocated every year by Congress to the National Institutes of Health, a mere $5.4 million goes to the Office of Alternative Medicine to investigate the claims of approximately 50 therapies.
The lack of alternative medicine research funding results in three critical consequences:
The prevention of relevant research projects
It negatively affects the creation of a research infrastructure similar to the one of conventional medicine
Deters well-trained career scientists from entering into the field
One of the biggest complaints the conventional medical industry has against alternative medicine is the lack of scientific research to support their practices.
Ironically, much of the research on conventional medicine has raised many speculations over validity issues. An example of this is the hundreds of articles published in top medical journals claimed to be written by academic researchers that are actually written by ghostwriters working for agencies, which receive large amounts of money from pharmaceutical companies to market their products. These are the very journals medical professionals rely on when determining treatment options.
Over 60 percent of clinical studies that involve human participants get financial backing from drug companies, not from the federal government. Studies also show that it is often common for companies to hold off on the publication of data that reveal their drugs are ineffective.
The conventional medical model is fatally flawed and is largely profit-driven by the pharmaceutical industry that influences the media through drug advertisements. Evidence that the American public is becoming discouraged with conventional medicine has become obvious in the growing numbers turning to alternative treatments for answers.
On the other hand, convincing doctors and the media the value of alternative medicine might be a long way off considering their tight ties with drug companies. Profit-hungry drug companies won't be making the shift to change the attitude of conventional doctors any time soon. There is too much money at stake for them to lose. That leaves it up to us to take control over our own health and make the changes.
The pharmaceutical industry often uses "front groups" to promote its agenda under the veil of other interests. According to AARP, a U.S. seniors group with about 35 million members aged over 50, United Seniors Association, Seniors Coalition and 60 Plus Association are three such front groups, which claim to represent older Americans but actually push industry favoring messages.
Although all three organizations claim to be nonpartisan, they tend to support only one political party. According to one political scientist, the drug industry spends the most of any industry on political advertising--they invested more than $30 million in the 2002 elections alone, with more than one-third of its television ads bearing the name of United Seniors Association.
These organizations have all received significant contributions from the drug industry, as shown by an examination of tax records, and have been involved in pro-industry campaigning, including multimillion-dollar television advertisements during the November 2002 congressional elections.
According to AARP, the 60 Plus Association is also accused of "astro-turfing," or creating a false grass roots campaign to defeat proposed prescription drug laws.
AARP is currently lobbying for a national pharmaceutical plan to help older people pay for prescription drugs. Proposals for a new plan are politically split with Democrats favoring a government-run approach and Republicans favoring a more privatized market-based plan that is also promoted by the pharmaceutical industry.
AARP is considering a proposal for new laws requiring that sponsors’ names be released in any political advertising, as often sponsors names remain hidden.
AARP Online Bulletin February, 2003
Dr. Mercola's Comment Since the mid-1990s, pharmaceutical companies have tripled the amount of money they spend on advertising prescription drugs directly to consumers.
Is it any surprise that they have resorted to even more deceptive practices? Not from my perspective. If you understand marketing you will instantly recognize that an endorsement from an "impartial" third party is far more powerful than the magazine and television ads.
The drug companies are well aware of this strategy, as they have been using it for many decades with physicians. They sponsor studies that are published in respectable medical journals that "prove" their drug is a "logical" or "scientific" solution for the diseases in the studies.
It is rare that a physician realizes they are being deceived, as it is uncommon for the average physician to critically analyze the funding sources for the study.
Drug companies may spend over $3 billion a year to advertise their drugs to consumers.
That may seem like a bunch of money, but it is peanuts compared to their return.
Americans may spend over $500 billion on drugs this year and that does not even include the $100 billion that President Bush is trying to get approved for the Medicare drug benefit program.
Does anyone out there really believe that American are getting half a trillion dollars of benefits from these drugs?
Drug companies are not stupid. They have been able to change the rules so they can now market directly to consumers.
With this type of marketing, it is no wonder that two-thirds of doctor visits result in a drug being prescribed.
This is one of the main reasons why spending for prescription drugs is the fastest growing category of health care expenditures.
It is also one of the major factors contributing to the reason why physicians are the third-leading cause of death in the United States. Most physicians rely on using drugs as Band-Aids rather than seeking the cause of the problem.
Fortunately, you do not have to capitulate. This newsletter, and many other fabulous resources that are now available, will help enable you to take control over your own health. One of the most important areas of course is selection of foods that will promote health.
If you haven't already reviewed the nutrition plan, I encourage you to do so as it is one of the foundational pillars of healing.
The other major route to taking control of your own health is to address the root cause of your illness, and in my experience well over 50 percent of the time this will involve addressing the underlying stress in your life. I have found that EFT is one of the most effective solutions for stress.
If you haven’t already downloaded the free EFT report you will want to consider doing so. It has enormous potential to help you start along the course of transforming your life toward health and healing.
Natural medicine has come under attack as pharmaceutical company lobbyists push lawmakers to deprive Americans of the benefits of dietary supplements. Drug-front groups have implemented slanderous campaigns in attempts to undermine the value of natural health lifestyles.
These attacks to natural medicine prompted an independent review of government-approved medicine, which revealed that conventional medicine was the leading cause of death in the United States. This review of government health statistics showed that in most cases, American medicine does more harm than good. Compelling evidence from this study unveiled astounding statistics on the 783,936 deaths per year that have resulted from conventional medicine.
The purpose of this article was to memorialize the failure of the American medical system by exposing the horrifying statistics of the inadequacies of today’s health care system with the goal of beginning some meaningful reform.
Highlights from the findings in the review:
U.S. health care spending has reached $1.6 trillion in 2003, which represents 14 percent of the nation’s gross national product.
In a 1992 survey, a national pharmacy database found a total of 429,827 medication errors from 1,081 hospitals.
In 1974, 2.4 million unnecessary surgeries were performed that resulted in 11,900 deaths compared to the year 2001, where 7.5 million unnecessary surgeries were performed resulting in 37,136 deaths.
A 1998 study reported an estimated 106,000 deaths from prescription medications per year.
Nearly 9 million people were unnecessarily hospitalized in 2001.
Here are additional reasons why the traditional paradigm is flawed:
Studies have found that the 41 million Americans without health insurance have an increased risk for dying prematurely and not receiving appropriate medical care.
20 percent of all causes of death occur in nursing homes.
More than 30 percent of nursing homes in the United States were cited for abuses, exceeding over 9,000 violations.
A study of a 100-bed sub-acute care hospital revealed that only 8 percent of the patients were well nourished, 29 percent were malnourished and 63 percent were at risk of malnutrition.
Life Extension Institute March 2004
Dr. Mercola's Comment: This definitive review of the conventional health care system is a must-read because it describes in detail the failure of the traditional paradigm and provides us with shocking statistics on the thousands and thousands of deaths that resulted from unnecessary or incorrect medical treatments.
The only problem I have with this article is that the formatting is really terrible and makes it difficult to follow. The Web site uses a type of frame and you need to use the light blue bar on the immediate right of the text to scroll down and reach the next page. However, despite the formatting issue, I highly recommend reading this article.
This article acts as yet another huge wake-up call by providing further substantial evidence that the health care system is in desperate need of drastic reform. Too many lives are being lost at the hands of conventional medicine.
The findings in this review also further reinforce my vision and passion, which is to transform the medicine and surgery-bombarded medical paradigm to one that focuses on treatment and prevention of the underlying causes.
I view this review as a very positive step toward fulfilling my vision because it specifically outlines the blatant mistakes and failures of the traditional system.
The statistics from this review gives people even more reasons to explore alternative and less evasive approaches to health care--such as educating yourself with the information in my Total Health Program--to find out what is truly going on.
The increasing number of people visiting my Web site have access to a constantly expanding database that they can use as a tool to educate themselves on how to facilitate their own healing.
If you haven’t done so already, I encourage you to look at my site and subscribe to my twice-weekly newsletter, but most of all join me in my quest to transform the medical paradigm to one that is sincerely dedicated to listening to the patients’ concerns and expressing commitment to their health and well-being at the deepest levels.
Blunders By Doctors Kill 40,000 people a Year In Britain By Lois Rogers
MEDICAL error is the third most frequent cause of death in Britain after cancer and heart disease, killing up to 40,000 people a year - about four times more than die from all other types of accident. Provisional research figures on hospital mistakes show that a further 280,000 people suffer from non-fatal drug-prescribing errors, overdoses and infections. The victims spend an average of six extra days recovering in hospital, at an annual cost of £730m in England alone.
A pilot study investigating the issue - the first attempt to measure the problem in Britain - shows that one in 14 patients suffers some kind of adverse event such as diagnostic error, operation mistake or drug reaction. Charles Vincent, head of the clinical risk unit at University College London, who is leading the study, has pioneered efforts to examine the extent of clinical errors in Britain. His team has so far concentrated on two London hospitals. The first data from one hospital showed that 32 out of 480 patients in four different departments were victims of hospital mistakes.
Vincent's estimate of 40,000 deaths comes from studies showing that 3-4% of patients in the developed world suffer some kind of harm in hospital. For 70% of them the resulting disability is short-lived, but 14% subsequently die. "It is a substantial problem," Vincent said. "There is a need to find out the true extent of error, what kind of things are going wrong and the cost." He believes the death rate may be even higher than indicated by the preliminary figures.
Britain's death rate is comparable to that in America, where recommendations in a report produced by the Kellogg Foundation three weeks ago are likely to result in the creation of a new federal agency to protect patients from medical error
The report drew on studies that examined the records of 30,195 patients and found a 3.7% error rate. Of those injured, 14% died. Researchers concluded that 70% of the errors - and 155,000 deaths - were avoidable.
Department of Health officials are now examining a proposal for a £1.2m three-year national study of 20 hospitals and 10,000 medical records to establish exactly how these avoidable deaths occur and how to prevent them.
COMMENT: An appropriate follow-up to the article two weeks ago documenting the 100,000 annual deaths in our own country due to medical mistakes.
British Journal Finds "One in Ten Harmed in Hospital"
Almost 70,000 British patients a year die partly as a result of "adverse events" they suffer during hospital stays, says a shocking report. One in ten of all patients admitted to hospital is harmed by complications, half caused by medical mistakes of some kind. The cost of the extra days in hospital needed is running to at least 1.5 billion dollars a year, said the research team from University College London.
A leading doctor said that the profession was failing to "learn from its mistakes".
The study looked at more than 1,000 medical and nursing records at two hospitals in London, then expanded these results to produce national predictions.
Researchers found that almost 11% of patients had suffered some sort of adverse event - some more than one.
In approximately 50%, the researchers judged that hospital staff should have prevented them happening.
Contributing to death
A third of the events led to "moderate or greater impairment" - in 19% of cases, the decline in their health as a result was permanent, and in 6%, the adverse event contributed to death.
The main causes of adverse events relate to operative errors, drugs, medical procedures and diagnosis. Each of these is amenable to prevention.
However, he also admitted that mistakes were inevitable because there were too few medical staff, who were forced to work too quickly to cope with intense demand.
An earlier Australian study estimated that adverse events accounted for 8% of hospital bed days and cost the Australian healthcare system $4.7 billion a year.
The researchers found that 10.8% of patients admitted to hospital experience an adverse event, with an overall 11.7% rate of adverse events when multiple adverse events are included.
About half of these events were judged preventable. A third of adverse events led to moderate or greater disability or death. Some adverse events are serious and are traumatic for both staff and patients. Others are frequent, minor events that go unnoticed in routine clinical care and yet together have massive economic consequences.
This study is primarily a pilot and has certain limitations. The study was small and based on only two hospitals.
In addition, the case mix does not accurately reflect hospital practice. The specialties included in the review could have higher rates of adverse events than other specialties.
Although we cannot extrapolate with any precision, our findings strongly suggest that adverse events are a serious problem in the NHS, as they are in the United States and Australia. We estimate that around 5% of the 8.5 million patients admitted to hospitals in England and Wales each year experience preventable adverse events, leading to an additional three million bed days.
About half of the adverse events were preventable with current standards of care
British Medical Journal March 4, 2001 517; 548; 562
Dr. Mercola's Comment: The traditional paradigm is falling apart all over the world. YOU can play a part in changing this situation. Please read my editorial in the 200th issue.
Deaths in England Due to Medical Errors up 500% By Sarah Lyall
About 1,200 people died in public hospitals in Britain last year because of mistakes in prescribing and administering medicine, according to a report published by a government watchdog group.
Outlined in a report by the Audit Commission, the errors included administering the wrong medicine - in one case, a breast cancer patient was given the sleeping drug Temazepam instead of the cancer drug Tamoxifen - to giving out the wrong dosage of the right drug, to unknowingly prescribing a drug that caused a fatal reaction.
The death toll was five times higher than that in 1990, according to the report.
In addition, the thousands of patients who survive medicine-related mistakes each year invariably become sicker, requiring more treatment that create an extra expense for the National Health Service, the report said.
"The health service is probably spending $725 million a year making better people who experienced an adverse incident or errors, and that does not include the human cost to patients," said Nick Mapstone, an author of the report.
Mr. Mapstone said that many of the most common errors are avoidable and could be rectified if the health service introduced computerized patient record and prescription systems.
As it is now, patients' notes are often illegible, incomplete or missing altogether, the report said, making it impossible for doctors and nurses to have accurate information.
The government has promised to introduce computerized prescriptions - which could include a standard national system for coding medicines and the use of bar codes to support development of electronic prescribing systems - by 2005, but Mr. Mapstone said he did not think it would meet the deadline.
Addressing the issues raised by the report, Dr. Trevor Pickersgill, a spokesman for the junior doctors' committee of the British Medical Association, said that understaffing in hospitals and the increasing complexity of modern drug therapy have created a culture "where mistakes unfortunately do happen."
"The number of drugs is increasing, the effectiveness - and therefore often the toxicity - of drugs is increasing, the number of people on multiple medications is increasing, and that increases the risk of interaction," Dr. Pickersgill told the BBC.
"We must also remember that one in six pharmacy posts in hospitals are unfilled, and new doctors who are doing the work on the wards are overworked as well," he said.
A number of highly publicized cases of drug-related error in recent months has brought home the problem. In one case, a cancer patient was prescribed and administered a drug at 1,000 times the recommended dose, according to the report.
In another case, at Queen's Medical Center in Nottingham, a teenager, who was a cancer patient in remission, fell into a coma and died after an anticancer drug was mistakenly injected into his spine.
"The recent events at Queen's Medical Center illustrate how day-to- day pressures can lead to acknowledged best practice being ignored," the report said.
Jackie Glatter, a spokeswoman for the Consumers' Association, which lobbies for patients' rights, said: "The report shows there is a strong need for detailed and clear patient information about treatments and medicines - not just in hospitals, but also when people are taking medicine at home."
New York Times December 20, 2001
Dr. Mercola's Comment: No surprise here. But despite the fact that these errors have been known for some time, we are still not observing any significant progress in improving them.
As the article above states, the error rate is actually worsening, not mildly worsening mind you, but dramatically worsening.
The rate has gone up 500% over the past ten years.
One would think that modern technology, similar to that used in the airline industry, could be implemented to reduce these mistakes.
Some day that may occur.
But should you wait until that day?
Wouldn't it seem far wiser to follow simple and practical steps to activate the ability to heal and recover from your disease automatically that God gave each and every one of us?
The eating plan is the first step. Many people feel that this is too much of a challenge for them. If you are one of these people, you don't have to worry as you can use EFT to help remove the addictive cravings that cause you to limit your ability to successfully implement the program.
Even Doctors Have No Faith in Conventional Medicine
Physicians are less likely than the general public to have a regular primary care provider and to have regular check-ups, according to a new study entitled "Physician, Heal Thyself?".
Researchers from Yale University School of Medicine in New Haven, Connecticut studied 915 doctors (mostly men) who graduated from Johns Hopkins School of Medicine between 1948 and 1964
They found that more than one-third had no regular source of medical care. These doctors were less likely than other physicians to receive "preventive" care such as flu shots and routine cancer screening. The authors stress that this trend is concerning, since doctors' own health habits may influence their recommendations to patients.
The doctors most likely to have a regular care provider were: Psychiatrists Pediatricians
The doctors least likely to have a regular care provider were: Internists Surgeons Pathologists
Doctors' attitudes toward the power of medicine played an important role as well.
Those who said they strongly believe doctors and other health professionals influence their health were more likely to have a regular care provider.
Those who firmly believed they had their health in their own hands, as well as those who left it up to "chance," were less likely to regularly see a doctor.
Among doctors who did not have regular doctors: 55 percent had been screened for colorectal cancer 44 percent for breast cancer 62 percent for prostate cancer 59 percent had received flu vaccines
The percentage of doctors lacking a regular medical care provider is far higher than that found in the general population, the report indicates. Research shows that about 15% of Americans have no regular care provider, compared with 34% in this study.
Archives of Internal Medicine, November 27, 2000; 160: 3209-3214
Dr. Mercola's Comment: Here we have evidence that even doctors themselves are unconvinced of the benefits of conventional medicine. Surely if they saw its positive effects day after day, they would not hesitate to receive the same care themselves.
Many who receive this newsletter are health care professionals and would benefit from carefully reflecting on this information. In addition to the point made above, most people do not realize that symptoms of disease do not typically occur until one is 80% of the way towards the full-blown expression of the illness.
In the case of heart disease, this could be 100% as the most common symptom of heart disease is NOT chest pain, but sudden death. In other words there are no symptoms at all and then the next moment you are dead. This is a dramatic example as heart disease is commonly cited as the number one killer in this country (I actually believe it is negligence from traditional medicine and the reliance on the pharmacological paradigm).
But aside from preventing sudden death, life could be far more enjoyable when you are experiencing optimal health. However, I do believe it is wise for physicians to avoid seeing traditional physicians, as that paradigm is responsible for many of the deaths in this country.
Seeking care from a natural medicine clinician would clearly be the preferred option. Earlier this year I made a commitment to receive care from several doctors and every week I normally see one or two doctors to fine tune my health and the results have been remarkable.
One of the doctors I see uses primarily TBM (Total Body Modification) and the other uses cranial Osteopathy. Prior to this I had no symptoms at all that disrupted my life and I could run rings around most people with all the energy I had. I did not think I could be much healthier, but I was wrong and I am very glad that I made that commitment.
I would encourage all of you to seek your health care from someone who is currently receiving care from another professional themselves. If they are not, you might want to consider switching your physician. None of us can stay optimally healthy by ourselves.
Doctors Need More Nutrition Training Nutrition experts say American physicians are undertrained when it comes to issues of nutrition and health. The authority whom patients most wish to consult for information on health -- their physician -- remains insufficiently informed about the role of diet in the prevention and treatment of disease,"concludes a recently convened panel of US nutrition experts known as the Intersociety Professional Nutrition Education Consortium. Its prime directive is to raise the level of nutrition education at US medical schools."
The report's authors point out that less than 6% of medical school graduates now receive adequate nutrition training. Despite the fact that the US Congress in 1990 mandated better nutrition education in all US medical schools, it remains inadequate.
American Journal of Clinical Nutrition 1998;68.
COMMENT: Health is a complex integration of physical, emotional and spiritual elements. It is clear that nutrition is the foundation of physical health. I believe it is a sad tragedy that most physicians are so uninformed about the basics of how to stay healthy and about the more critical concern for integrating a spiritual foundation that will support them and their patients. It is even worse than this article suggests as this journal is a traditional nutritional journal that is relatively unaware of most of the innovative nutritional therapies.
Doctors Fast to Interrupt Patients' Concerns When it comes to a doctor's visit, the patient has an average of 23 seconds to state their concerns before a physician interrupts. Overall, only 28% of doctors know their patient's full spectrum of concerns before they begin to focus on one particular concern, and once the conversation is focused, the likelihood of returning to other concerns is only 8%. Physicians commonly redirect and focus clinical interviews before giving patients the opportunity to complete their statement of concerns. The problem is that the conversation rarely veers back to other concerns the patient might have, often leaving patients with the feeling they may not have discussed all their problems or even the most important one.
If the physician doesn't actively ask if all the points have been covered, patients tend to have more "doorknob" questions -- that is, they bring up an important problem just as they are leaving the office. The good news is that patients need only slightly more than 23 seconds to state their problems. Most people have 2 to 3 things they want to discuss with their doctor, and if given the chance, raise those issues in an average of 32 seconds. Our findings show that if those concerns are clarified at the beginning, you are less likely to have late-arising concerns, therefore the visits are more efficient and on average, the agenda setting portion of the interview takes about half a minute.
The best thing (for patients to do) is to prepare before the office visit, write down their concerns, so that when they get in to see the doctor they are able to verbalize very clearly and at the beginning what their concerns are. The researchers found that 75% of physicians elicited patient concerns, that is, they asked questions such as "How can I help you?" or "What brings you here today?" When a physician did not ask such questions, 35% of patients had late-arising questions, compared with 15% of cases in which the doctor did ask such questions. It's infrequent that the doctor asks if there are other concerns before they -- in my opinion -- prematurely start to delve into the first concern stated. So by keeping the agenda open a little longer and saying what else do we need to address today, it allows the doctor and the patients to plan the office visit to be more efficient and effective.
The Journal of the American Medical Association January 20, 1999;281:283-287.
COMMENT: This newsletter is unusual in that nearly one third of the readers are physicians. I believe that this is a valuable piece of research for both patients and physicians alike. I know that it really helped reinforce the importance of setting the agenda at the beginning of the visit. I am grateful to the authors for providing insights to improve patient visits.
The Frightening Road Ahead for Prescription Drugs and the Implications for 'Real' Alternative Health By Nicholas Regush
Here are some of the people who need a refresher course in the history of prescription drugs:
Federal politicians who have been pushing the Food And Drug Administration to speed up their review of drugs. FDA bureaucrats who speed up review of "me-too" drugs to placate the drug industry. (The "me-too" drugs are essentially those that are very similar to existing drugs.) Drug company marketeers who hype the value of new drugs. Doctors who get caught up in sales pitches and do not take the time to do basic research that would indicate the marginal value ( if any added benefits) of most new drugs. Business leaders and doctors on the "alternative" medical front that are helping to grind the FDA into the ground by arguing that the agency is stopping BREAKTHROUGH drugs from being used in the U.S. Patients who are rallied by the drug industry to pressure the FDA to approve questionable drugs. Anyone who believes that the FDA is stopping tons of terrific new life-saving drugs from getting on the market has no idea what he or she is talking about and badly needs a history lesson, not to mention a few tips on how to conduct some basic inquiries.
This notion that there are all these extraordinary drugs in the medical pipeline is pure propaganda - whether it's coming from drug company low lifes or the other low lifes - the shameless hucksters of what I like to call the "quasi-alternative" health movement.
There has been so much evidence gathered for years to prove this point - that the vast majority of drugs approved by the FDA have little or nothing to do with saving lives or even improving lives beyond what is already available on the shelves - that it is amazing that the propagandists still have some influence in the U.S. Congress.
On the "conventional" front, the FDA gets new drug applications for so-called life-saving drugs once in a Blue Moon. The rest of the NDAs are for me-too's or drugs of questionable and marginal value.
On what I like to call the "real alternative" front, the real progress that is being made in health care comes from those health professionals who are attempting to provide a level of care that takes the entire being into account - and often this does not require drug therapy of any kind.
Proper nutrition, for one thing, will go a long way in helping someone become healthier.
If conventional drugs are deemed necessary, there are more than enough on the shelves that have been around long enough to determine the side-effects patterns, to help a patient.
What all the people referred to above have succumbed to is a mantra that keeps repeating how valuable chemicals are in making people well. Yes, there are certainly important drugs out there, but probably not more than 100 of them are really needed. The rest are candy for someone's bank account.
Not only is drug prescription out-of-control, but with an FDA that has been reduced to an arm of the drug industry, there will be many more drugs out there before long - and many of them will be needlessly harming people who have simply become market-targets for the most prosperous business in the world.
The new vision of health that is slowly emerging looks at the entire body as a dynamic entity, one that requires a wide range of sustenance, including good nutrition, clean air, unpolluted water and a far more equitable society that doesn't ravage the mind with endless pressures about success and consumption.
Unfortunately, before this real alternative model of medicine takes hold, huge numbers of people will die needlessly because of toxic insults produced by drugs. And many of those who die will not have had the opportunity to test out other modes of less toxic treatment.
My take on conventional medicine has always been that it has become so drug-driven that any therapy now becomes a crapshoot.
My take on alternative medicine is that there are essentially two forms of it:
one is close to the conventional-toxic model (the "quasi-alternative") and insists on all these extraordinary new drug and drug-like remedies out there that will prevent illness and cure disease; the other (the "real alternative") is a more intelligent approach to the body in its efforts to understand how an individual UNIQUELY responds to all the inputs in his or her environment. In some ways, the drug charlatans on the conventional side have a lot in common with their remedy-pushing brothers and sisters on the quasi alternative side. What is unfortunate is that some of what is referred to as "alternative medicine" is not alternative at all; it is merely more of the same bad research, market-targeting and money grubbing.
Also, unfortunately, the money grubbers on the quasi alternative side are helping to do great damage to the FDA by questioning the need for its existence. Well, folks, take the FDA away and you'll see a drug free-for-all the likes of which has never been seen on this planet.
I'm well aware of the fact that the FDA prosecutes many doctors who are probably in the alternative camp who I find admirable. These are doctors who try to help the patient heal the entire body, rather than foolishly carving it up into bits and pieces like chopped meat.
However, these prosecutions will only escalate now that the FDA is about to expand its program - namely to get drugs passed more quickly through its review pipeline.
With almost no public debate, the agency agreed with the drug industry to let them foot even more of the review bill. Not only does this make the FDA far more dependent on the drug industry, and not only will the FDA likely approve many more drugs that will harm or kill people, but the agency will also likely go on a rampage against many health practitioners that are trying to escape the conventional mode of medicine by offering new therapies, including many involving nutrition.
Rather than work closely with those types of doctors to determine if there is a place where some compromise can be reached, the FDA will now more than likely play Big Brother more than ever.
The FDA, I suspect, will also take a real bead on nutritional supplements - far more than ever - because of pressures from the drug industry to allow only prescription sales for many of those products, and sales that will likely end up going to the conventional drug industry. Well, what did you expect?
The doctors in the real alternative movement who apply holistic principles will have their drug and remedy peddling "friends" in the quasi- alternative movement to thank, in part, for that new direction, as a direct result of all the lobbying that has been done to get drugs through the FDA much more quickly. And that has turned out to require drug industry support. Reciprocity will be the name of the game here! What great irony!
Few, I'm sure, in this drug peddling bunch have much of a notion about what Thalidomide, the Dalkon Shield and Breast Implants did to people. Few will even remember that in recent years the FDA had to yank 9 damaging drugs from the market.
This culture is fast becoming a war zone between those on the "drug" side and those on the "holistic" side.
Where do you stand? Have you got it straight yet?
RedFlagsWeekly.Com May 27, 2002 The mission of RedFlagsWeekly.com is to probe medical, scientific, environmental, artistic and political issues in a manner that one rarely encounters in mainstream news reports. Corporate bottom lines and inadequate training in specialty journalism often provide the reading, viewing and listening public with narrow and simplistic information.
Most New Drugs Are Me-Too Medications
Nearly two-thirds of prescription drugs approved in the 1990s were modified versions of existing drugs or products containing the same active ingredients as those already on the market, according to a new study by the National Institute for Health Care Management (NIHCM) Foundation.
Only 15% of new drug approvals were for medications that contain new active ingredients and provide significant improvement over existing drug therapies, the study found.
The findings strike at the heart of the pharmaceutical industry's claim that changes to Hatch-Waxman, the 1984 US patent protection law, would harm patients by stifling drug innovation. It is because of these protections, the foundation argues, that drug companies seek to extend their market exclusivity by introducing altered versions of older medications.
It's very hard to come up with very innovative drugs. So when drugmakers get a successful product, they need to protect it by modifying it in some way.
Intellectual property protections are intended to foster real innovation, "but what we've done is created a great deal of incentive to tweak the product. What we see here is that the drug companies are protecting their brand franchise.
The NIHCM Foundation study is based on US Food and Drug Administration (FDA) statistics on new drug applications (NDAs) approved from 1989 to 2000. It incorporates the agency's own system of classifying those applications based on a drug's level of innovation.
Of the 1,035 drugs approved by the FDA over the 12-year period, only one-third (361) were new molecular entities, which treat diseases in novel ways, the investigators found. Less than half (153) of those were given "priority" status, which is reserved for drugs the agency believes could provide significant clinical improvement over existing medications. Of the 674 drugs that didn't contain a new chemical entity, only 91 were given priority status.
Among the highly innovative drugs that were approved were Pfizer Inc.'s Lipitor (atorvastatin) for high cholesterol and Viagra (sildenafil) for erectile dysfunction, as well as Merck & Co.'s Fosamax (alendronate sodium) for osteoporosis; and GlaxoSmithKline's Avandia (rosiglitazone) for type 2 diabetes.
But a total of 674 drugs, or 65% of FDA-approved medications, contained active ingredients that were already available in marketed products. Of these, 558 drugs differed from the marketed products in that they were combined with another active ingredient, offered in a different dosage form or delivered through a different route of administration.
A product traditionally available in oral form, for example, might have been reformulated to be delivered via a transdermal patch.
Retail spending on prescription drugs doubled from $64.6 billion in 1995 to $132 billion in 2000.
Of the $67.4 billion increase, $44 billion is the result of increased spending on drugs approved between 1995 and 2000. Priority drugs with new chemical ingredients accounted for 33% of the increase in spending. "Standard-rated" drugs, which don't qualify for expedited FDA review, accounted for 67% of the increase.
New drugs of all types were priced much higher than the older drugs they replaced, the study notes. New priority-rated drugs commanded the highest prices. In 2000, the average price per prescription for the most innovative class of drugs was $91.20, versus an average price of $37.20 for older drugs, approved before 1995.
At $65.07 per prescription, incrementally modified drugs designated for standard review, while not as expensive as some other classes, still cost 75% more than older drugs in 2000, the researchers found. This suggests that brand manufacturers can maintain relatively high prices for aging products by making incremental changes to them.
The point is that a lot more money is going into prescription drugs, but it isn't producing many more innovative medicines. Increased spending may help to support research and development, "but what it also definitely does is support a lot of line extensions" to help preserve blockbuster products.
National Institute for Health Care Management (NIHCM) Foundation May 28, 2002
Dr. Mercola's Comment: This report, although published recently, does not have the more current statistics which show $175 billion was spent on drugs in 2001, up from the $132 billion in 2000. This easily translates to $200 billion dollars for drugs in 2002.
It is a sad, but not totally unexpected tragedy, that the country's drug use is being extended to our children. Americans had more than 3 billion prescriptions filled last year.
On average that is one prescription, every single month, for each man woman and child in the US.
As the late Illinois Senator, Everett Dirksen was fond of saying when he was referring to the Defense Department budget, "a billion dollars here, a billion dollars there and before you know it, you are talking real money".
Well we are talking a lot more than a few billion dollars. How about something like a nearly 200 billion dollars for drugs spent last year.
The sad tragedy is that we are spending all of this money on disease management focused on drugs and our return on this investment is profoundly poor.
Clearly there is something seriously wrong here.
For further comment on this article please see Nicholas Regush's analysis.
FDA is "Virtually Incapable of Protecting You From Unsafe Drugs"
Most people are familiar with the scrupulous claims against the FDA's inability to protect Americans from unsafe drugs. It has been an issue flooding the headlines of newspapers and the nightly news for the past few months.
Accusations against the FDA started when Merck was pulled Vioxx from the market in 2004. Apparently the FDA had been aware of the drug's adverse side effects as early as 1999. Since Vioxx's removal, other drugs have been placed under the microscope and the agency's credibility has been questioned. One FDA drug safety reviewer, Dr. David Graham, told a Congressional panel that federal drug regulators were "virtually incapable of protecting America."
Previously "Approved" Drugs in Question
Crestor (cholesterol-lowering drug): Causes acute kidney failure Bextra (painkiller): Increases risk of heart attack in those undergoing cardiac surgery and may also cause a fatal skin reaction Meridia (weight-loss pill): Causes substantial increases in blood pressure and has been associated with 124 reports of serious cardiovascular problems Serevent (asthma medication): Increases risk of asthma-related deaths and life-threatening episodes Accutane (acne drug): Causes birth defects The director of the FDA's Center for Drug Evaluation and Research opposed Graham's accusations; arguing Graham's findings and numbers "constitute junk science" and were nonetheless "irresponsible." The director continued on by stating that all of the agency's decisions and drugs are not only safe but also effective.
New York Times November 19, 2004
Dr. Mercola's Comment: As it so vividly obvious, conventional medicine is entering a terminal phase. That is why it is so important to take a stance now.
For the past few months I have been seeing seven new patients every day that see me from all over the country. Many have very serious diseases and are on multiple medications. In nearly every case we are able to develop a plan to help wean them off of all their medications and become symptom free.
This is not an ad for my clinic, as there are many outstanding natural medicine clinicians that can provide similar services. The point is to get you off these dangerous medications before they kill you and seek competent professional help if you require that. The Vioxx scandal is a perfect example. Tens of thousands of people needlessly died so that Merck could make a few billion extra dollars.
Conventional healthcare slowly but surely progressed into a nasty disease; which now is at a rapid progression towards death. This "disease" is caused by:
Rampant conflict of interest Tainted research and greed Lying and cheating by the morally bankrupt drug industry Inept federal and state regulators Unfortunately, one of the most prominent article on this site is "Doctors are the Third Leading Cause of Death." Well that article was written in 2000 and (based on a variety of newer references) doctors are in fact the LEADING cause of death in this country. Not heart disease, not cancer -- doctors.
In all fairness, doctors themselves are not to blame for all of this. The entire modern health care system, however, is to blame for allowing, even promoting, so many unnecessary procedures, DRUGS and mishaps. This illustrates precisely why the system is so desperately in need of change, and why facilitating this change is, and will continue to be, such a substantial portion of my vision.
You can eliminate your "need" for drugs with these two factors -- monitor the foods you put into your body and address your emotional well being. These factors have absolutely everything to do with building your immune system and avoiding unnecessary pharmaceuticals.
This is no "quick fix," but rather is a lifestyle change that will be well worth the effort. To fully understand the details of these factors, I highly recommend getting my Total Health Program, as this book will allow you to realize the action needed to set you free from the "pill-taking" life and give you ultimate control of your health.
Alternative Medicine Still Scares Pediatricians
Most pediatricians are aware their patients subscribe to some type of complementary or alternative therapies (CAM) to help with their health conditions, yet they still choose not to discuss these types of therapies with their patients.
Some of the resistance expressed by pediatricians for CAM treatment options stem from a lack of knowledge about the therapies and possible side effects. A study shows less than 5 percent of pediatricians maintained a working knowledge of CAM therapies. Also, only a select few were familiar with alternative therapies such as dietary supplements or massage therapies.
Patients, on the other hand, have expressed curiosity and interest in CAM therapies and often ask about them during routine doctor visits. This was apparent in a study that showed a whopping 87 percent of patients had brought forth questions to their pediatricians about CAM therapies in the past three months.
Interestingly enough, a survey revealed that 34 percent of pediatricians admitted to either using a form of CAD therapy for themselves or had a family member who used these therapies in the past year.
EurekAlert November 16, 2004
Dr. Mercola's Comment: Lately, there are news stories popping up every week taking the media by storm that reflect the growing disenchantment patients and medical experts are having with conventional medicine. Some of these stories reached huge proportions such as the Vioxx scandal, which attracted a great deal of attention.
And there are some that don't command the attention they should -- which is why you should subscribe to my free twice-weekly eHealthy News You Can Use newsletter. As a subscriber you will be provided with comprehensive, clear and researched guidance on the best nutrition, medical, emotional therapy and lifestyle choices to improve and maintain total health.
Emphasizing alternative therapies that treat the root cause of disease rather than the symptoms is at the heart of my vision to transform the existing medical paradigm from one addicted to needless pharmaceuticals and surgeries.
Traditional Medicine Starts To Examine Alternative Therapies by Judy Gerstel
We're on the brink of going back to the future in medicine.
Stem cells, genes and transplants are getting the headlines, but the bigger story may be that medicine is advancing beyond the biomedical model and embracing medical pluralism.
The overwhelming trend is the integration of orthodox medicine, defined by its pharmaceuticals and invasive techniques, with other ancient, old-fashioned and unconventional healing practices.
The future of medicine, it seems, is not only in the high-tech laboratory and the surgical suite but also on the NST and massage tables, at the herbalists and the health food store, behind the therapist's closed door, but most especially in the cerebral hemisphere ã the mind.
This week's edition of Annals Of Internal Medicine, the August journal of the conservative American College of Physicians-American Society of Internal Medicine, kicks off an unprecedented series on complementary and alternative medicine.
And they take the subject seriously, referring to "postmodern medical diversity." It's probably the first time that Haitian "vodun", hair analysis, crystals, magnets and charismatic healing have all been mentioned without derision in the pages of Annals.
Authored by David Eisenberg, MD, and Ted Kaptchuk, OMD (Doctor of Oriental Medicine) of Harvard Medical School and its division of complementary and integrative medical therapies, the series considers everything from acupuncture to iridology to chicken soup to Reiki to vitamins to "ethno-medicine."
"The alternative medicine `boom' is not new," Kaptchuk says. "What's new is that orthodox medicine has abandoned the crusade against alternative medicine and is trying to accommodate widespread patient belief and acceptance of these practices."
MDs are unlikely to suddenly start recommending copper bracelets to combat arthritis or stopping a nosebleed by placing a a red string around the neck, but they are acknowledging that a patient's belief in healing properties may be just as powerful in many medical situations as the interventions of the physician.
In this week's issue of the journal Science, there's stunning testimony from University of British Columbia researchers about how the mind can heal the body. Their study suggests that the placebo effect in Parkinson's disease produces the same neurological outcome as active drugs used to treat Parkinson's: an increase in dopamine release by neurons impaired by the disease.
The placebo effect occurs when individuals take an inactive substance, rather than an active drug, and experience beneficial effects only because they believe they're receiving beneficial treatment.
"The magnitude of the placebo effect was surprising," admits UBC researcher Ral de la Fuente-Ferny¥ndez. "The greater the expectation, the greater the effect of the mind's healing power."
He adds, "This paper shows that there must be a bridge between traditional medicine and natural medicine."
In studies of the impact of psychological therapies on longevity in patients with metastatic cancers, Ontario Cancer Institute senior scientist Alastair Cunningham found an association between intense spiritual work and longer survival.
"The psychological dimension offers promise for the treatment of many physical diseases," writes Cunningham in the forthcoming issue of Advances In Mind-Body Medicine, an innovative, peer-reviewed scholarly journal published in the U.S.
"Modern medicine is conservative," says Cunningham. "My approach is to try to play on the medical playing field and give evidence."
Scientific, evidence-based proof of the placebo effect and the psychological dimension is only one reason for the dramatic shift right now toward inclusiveness and away from the historical antagonism to alternative practices by the medical establishment, say the Annals authors.
"People generally adopt multiple healing practices, even when biomedicine is generally available," note the Annals authors.
This sheer force of numbers comes at the same time as a trend toward consumer-oriented medicine and away from "doctor knows best."
More and more, the increasingly sophisticated patient is an educated partner in medical decisions. Knowledgeable health consumers are letting the medical profession know they want inclusive medicine.
The medical profession is responding for two reasons. First, there's money to be made from patients, since most alternative services must be paid for privately.
But with the US leading the way, there's also more funding for alternative and complementary medicine. American researchers vie for grants from the prestigious National Institutes of Health's Office of Alternative Medicine. And insurance providers such as HMOs in the US are beginning to realize that alternative practices can be just as effective and a lot cheaper than expensive high-tech interventions.
But what may appear to be new and cutting-edge is only a change in perception and attitude by orthodox medicine, maintains Harvard's Kaptchuk, co-author of the Annals article.
"I'm so bored with people being hypocritical and pretending that all this is new, rather than saying that they've changed standards," he says. "That's a kind of distortion, not looking at the reality of the phenomena. It's the response that's different. What is new is that conventional medicine has to redefine its relationship to this phenomena."
Kaptchuk claims that orthodox medicine's nascent inclusiveness of complementary and alternative medicine is "a breathless attempt to co-opt it."
"It's market-driven," he says, with distaste. His cynicism is understandable.
"In 1970 I was arrested in Cambridge (Mass.) for practicing medicine without a license," Kaptchuk says. "Now I'm a professor at Harvard Medical School."
The Star.com August 10, 2001
Dr. Mercola's Comment: First it was Dr. Eisenberg's article in NEJM eight years ago (328:246-252, Jan 28, 1993) that started the whole process. Then three years ago JAMA devoted an entire issue to alternative therapies.
Now the journal of the highly conservative and ultra traditional US Internists (Annals of Internal Medicine) publishes an update of Dr. Eisenberg's article in its August 2001 issue.
More Than One-Third of U.S. Uses Natural Medicine
The government has suggested that more and more people are turning to meditation, herbs, yoga and other forms of alternative medicine because of lack of results with conventional care. One of the largest U.S. studies conducted on alternative medicine found that over one-third of American adults practiced some type of non-conventional medicine in 2002. The report was based on information from 31,044 interviews with adults aged 18 and older.
Researchers believed the results of the study pointed to the fact that more people are using alternative medicine. Also, it was apparent that an increasing number of people have turned to natural products like herbs or enzymes to help with chronic or recurring pain.
Experts suggested that people should not neglect conventional medicine in those instances where it has been proven to help certain conditions and also recommended consulting a doctor before practicing alternative medicine. Experts were concerned about the number of people turning to alternative medicine because they felt they were no longer able to afford the costs of conventional care.
Experts cautioned people who assumed that just because a product was natural that it was automatically safe to use. An example they cited was the 6.6 percent of people in the study found to use the supplement kava kava, which has been linked to liver disease.
Significant findings from the study include:
62 percent of the participants used some form complementary and alternative medicine over the past year for a specific medical condition, broken down as follows:
Prayer for own health, 43 percent Prayer by others for the respondent's health, 24 percent Natural products (such as herbs, other botanicals, and enzymes), 19 percent Deep breathing exercises, 12 percent Participation in prayer group for own health, 10 percent Meditation, 8 percent Chiropractic care, 8 percent Yoga, 5 percent Massage, 5 percent Diet-based therapies, 4 percent
45 percent turned to some kind of prayer to help them heal in the past 12 months
There was a higher tendency for women to use complementary and alternative medicine than men
28 percent of the participants felt that conventional treatment would not help them
Based on the findings of this report, there appears to be a greater percentage of people turning to complementary and alternative medicine for their health needs.
Center for Disease Control National Center for Health Statistics May 27, 2004 (20-page Full-Text PDF Report)
Dr. Mercola's Comment: It’s great news that these numbers appear to be increasing, but you can see that we still have a long way to go though as only 4 percent, or one in 25, are using nutrition to address their health.
Fortunately, chiropractic is up to 8 percent, or double those who use nutrition. Recently, I spoke to all the students at Parker Chiropractic College, which is one of the finest chiropractic colleges in the country. I had lunch with their incredible president, Fabrizzio Mancinni, and he has a great perspective on this low number and views it from a positive angle--he thinks that means there is much more of an opportunity.
Similarly, I believe that over 95 percent of the U.S. population is in desperate need of sound nutritional therapy.
The public’s loss of faith in conventional medicine doesn’t come as a surprise to me, as I wrote in a past newsletter article that even doctors weren’t comfortable with the benefits from conventional medicine.
Currently, the United States spends about $1.5 trillion for health care, and the projections are that it will double in less than 10 years. These are devastating statistics particularly considering the growing number of people who feel that conventional medicine isn’t helping them.
The other sad tragedy is that we are spending all of this money on disease management focused on drugs and surgery, and our return on this investment is profoundly poor. More and more people do not have the energy they need to get through the day while millions of others are suffering with painful crippling diseases because they have violated basic health principles.
Often, negative health and lifestyle choices are made because of a lack of knowledge, and it's my vision to increase the public's awareness of the health tragedies facing the nation. Through this Web site and free e-newsletter I will give you, the consumer, the tools to become a major force for good health and to alleviate disease and suffering.
$30 Billion Vioxx Recall -- The Dangers, Powerful Lessons & Safe Alternatives that Everyone Must Know
In a move that surprised and shook up many people - from patients to stock analysts -- Merck & Co. announced the withdrawal of the popular anti-inflammatory drug Vioxx from the market late last week due to a study that shows patients taking the drug face twice the risk of heart attack compared to those taking a placebo, especially those who had been taking the drug longer than 18 months.
Still, the Vioxx example raises concerns about FDA's review process along with how long it took Merck to remove the drug from the market. Vioxx is the first prescription drug to be pulled from pharmacy shelves in three years for safety concerns. A FDA spokeswoman says the agency has been pressured from all sides - medicine, industry and consumers - to approve new drugs more quickly or slowly depending on the demand or risk.
Another major concern: A Wake Forest professor who has researched clinical trials for three decades points out more than half of all drugs introduced in the market have a new side effect after their approval with the current system. In a related issue, medical experts are finding older, proven pharmaceuticals have become far more deadly when combined with newer drugs.
These issues point to a gap in FDA regulations to fail to assess the safety of pharmaceuticals after their approval. Although the federal agency received some 2,400 agreements these after-the-fact studies, less than 900 were actually conducted, according to a 2002 FDA report.
Some believe longer clinical trials could be the solution to the problem. For example, the increased risk of heart attacks and strokes among Vioxx users didn't happen until they took the drug for 18 months. In fact, the Center for Drug Evaluations and Research says FDA will move in that direction for comparable drugs those that may be approved down the road.
The news also hit Merck hard on the Dow Jones Industrial Exchange. Shares of Merck & Co. lost more than a quarter of their value last Thursday after the company pulled Vioxx from the market, plunging 26.8 percent to close at $33. Stock prices have bounced back a dollar about $33.50 a share as of late yesterday.
In the meantime, a tidal wave of lawsuits have hit the courts in the United States, Canada and as far away as Israel. One lawsuit filed in Cook County Circuit Court alleges Merck knew about Vioxx's harmful side effects at least since the drug had been formally approved. Merck, argued one attorney, "intentionally tried to downplay the risks" until the evidence "was so overwhelming they had no choice."
The lawsuit could do serious harm to the company: Vioxx currently has 2 million users worldwide and some 84 million people have taken the drug since its approval by the FDA in 1999.
In reaction to the withdrawal of Vioxx, Pfizer Inc. has informing wholesalers, pharmacy chains, pharmacy benefit managers and other managed care organizations that they will manufacture enough Celebrex, their Cox-2 inhibitor, to meet the patient demand. The company also cited three long-term studies of Celebrex that showed the drug does not have any significant safety issues.
Wired October 3, 2004 Senior Journal.com September 30, 2004
Dr. Mercola's Comment: According to the FDA, this is one of the largest drug recalls ever. However this is no surprise. Long time readers of this article might be aware that FIVE years ago I posted warnings about Vioxx, BEFORE it was even on the market. I don't know how much more of a warning I could have posted. You did not have to be one of the nearly 100 million worldwide who took this drug if you had read the multiple warnings (see below) that I have issued in this newsletter.
Folks, that is what you get when you subscribe to the "eHealthy News You Can Use" newsletter -- and that is what your family and friends will get if you email this story to them and recommend that they subscribe to this free e-newsletter: information that is YEARS ahead of its time that can literally save your life. When I posted my original warning on Vioxx five years ago, I received the "doubting" emails I still get to this day with the information I post: things like, "but they wouldn't be allowed to sell it if it wasn't safe" or I "don't know what I am talking about because the FDA did or is about to approve it!" And other such naivete (and some name-calling I won't post here).
Well, I am not referring you to the warning on Vioxx I posted five years ago just to say I was right again ... I am referring you to demonstrate that the cautions, insight and guidance you'll find in this newsletter are based on fact and honest clinical insight -- fact and insight not tainted by greed and corruption that dominates the contemporary healthcare industry.
As long-time readers know, this is just one of many quite valid warnings that I have issued to alert you to the dangers that the drug model has for your health. So if you have friends and relatives that you value please forward this article to them and encourage them to subscribe to this free newsletter so they don't have to wait till drug companies decide to be responsible and take their drugs off the market before further people are seriously injured or killed.
I am very glad that Merck did the responsible thing and took Vioxx off the market, even though doing so meant losing nearly $30 billion dollars. That may seem like a lot of money but is only twice what drug companies pay to market their drugs to doctors every year. Merck sold billions of dollars of Vioxx for one reason though. People are in pain and Vioxx worked. It just had very serious side effects, like death. Folks don't think Celebrex is much better, just because it isn't off the market yet, doesn't mean that it is loaded with the same type of side effects. They just haven't done the studies yet that from a legal perspective, would force them to take this drug off the market.
The market for analgesics is over TEN BILLION dollars per year. That is one big number. That is why these are important drugs to watch. It is important to remember that anytime you are dealing with numbers that large there will inevitably be corruption, greed and negative influences that are a part of the story if drugs are involved.
So what can you do to treat pain in a way that not only addresses its cause but makes you healthier?
There are two steps that will help the vast majority of people with pain. That is to start a high quality fish oil (cod liver oil) at this time of year and to stop sugar. Omega-3 fats are precursors to mediators of inflammation called prostaglandins. In fact that is how Vioxx and other NSAIDs work. They manipulate prostaglandins. However, when you do it in an unnatural drug way, there is frequently another price to pay like side effects that can lead to death. When you use natural methods like omega-3 fats and stopping sugar, the side effects are good health.
Sugar and grain avoidance for most people will lower insulin levels. Elevated insulin levels are one of the most important reasons why inflammatory prostaglandins are produced. That is why stopping sugar and sweets are so essential to controlling arthritis pain and other types of chronic degenerative illness.
Most people were using Vioxx for osteoarthritis and other types of pain. But for those that were using it for the less common rheumatoid arthritis, it is important to know that optimizing vitamin D is one of the most important physical measures one can take to treat RA. Sun exposure is clearly the best way to achieve this however at this time of year the only alternative to months vacation in the Caribbean that most of us can't do is to consume healthy vitamin D that is in cod liver oil. Cod liver oil is clearly the safest form of vitamin D supplementation as it also has vitamin A and this can balance against absorbing too much vitamin D.
Metabolic typing is another tool that I have seen works in thousands of patients to reduce their pain -- if you are not yet aware of your metabolic type and how this can profoundly improve your health and help reduce pain, I strongly recommend you consider my bestselling Total Health book, which is centered around the topic (and provides strategies for avoiding sugars and grains). Eating according to your metabolic type is absolutely amazing , especially when combined with an effective energy psychology tool like EFT that can address previous emotional traumas that cause bioelectrical short circuiting predisposing one to immune dysfunction.
Vioxx Increases Heart Attacks 50 Percent: FDA Study
A study has shown that patients who take the arthritis drug Vioxx stood 50 percent higher risk of having a heart attack or experiencing a fatal cardiac episode than those taking Celebrex, another popular arthritis drug.
The patients in the higher risk bracket for suffering a heart attack or sudden cardiac death were those who took the highest recommended daily dosage of Vioxx, compared to those taking standard painkillers. Based on these results, researchers cautioned people against taking high dosages of Vioxx.
These findings raised concerns of researchers particularly because sudden cardiac death is considered the leading cause of death in the United States.
Despite the consistent support of those defending the safety of Vioxx, sales have remained stagnant for the past few years. The risk of heart attack and cardiac death occurs when patients continue to take the higher dose of the drug beyond the approved treatment period of five days.
Yahoo News August 25, 2004
Dr. Mercola's Comment: If you've forgotten, the market for pain relievers is about $10 BILLION per year. Anytime you deal with numbers that large there will inevitably be corruption, greed and negative influences.
Why take the risk of serious side effects from anti-inflammatories when you can create your own anti-inflammatory?
Simply changing the ratio of omega-6 to omega-3 fats in your diet could do this. Folks, this is non-controversial and there are dozens and dozens of studies which clearly demonstrate this. Even traditional medicine has firmly embraced these concepts.
I review many controversial topics, but there is no disagreement on this one, virtually everyone acknowledges that omega-3 fats play a crucial role in arthritis. If you need guidelines on how to use them please review my comments on Dr. Connor's excellent article.
The pain in many conditions can be quite severe. Fortunately, there are simple basic solutions for over 95 percent of the conditions that you would be taking these drugs for.
The most basic course of action is to follow the eating plan.
For severe rheumatoid arthritis, I have found my revision of Dr. Brown's protocol useful in producing remission in more than 3,000 patients with RA I have cared for over the past several years.
How Vioxx and Celebrex Increase Your Risk of Heart Attack
Research in mice suggests that a newer class of painkilling drugs called COX-2 inhibitors could trigger a chain of events potentially harmful to the cardiovascular system.
Researchers speculate, though, that their findings might explain the outcome of a recent major trial in which patients taking a COX-2 inhibitor -- the arthritis drug Vioxx -- had higher rates of heart attack and other cardiovascular complications compared with patients on naproxen.
Naproxen, used in painkillers such as Aleve, belongs to a group of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs), which includes many familiar painkillers such as aspirin and ibuprofen. Aspirin is also well known for its heart-healthy blood-thinning effects.
COX-2 inhibitors -- which besides Vioxx include the arthritis drugs Celebrex, among others -- are a newer type of NSAID shown to be easier on the stomach. Unlike older forms such as aspirin, they work by selectively blocking the COX-2 enzyme. Traditional NSAIDs inhibit both the COX-2 and COX-1 enzymes, and this is believed to underlie the gastrointestinal side effects that can come with the drugs.
But the new mouse research suggests that the selectivity of COX-2 inhibitors could create an imbalance that promotes blood clotting and blood vessel constriction.
COX-1 makes thromboxane A2, which promotes blood vessel constriction and "stickiness" in blood cells called platelets. COX-2 is the major source of prostacyclin, which helps prevent platelets from clumping and promotes blood vessel dilation.
The researchers hypothesized that the heart-healthy ways of prostacyclin might counter the ill cardiovascular effects of thromboxane A2 in the body -- meaning that blocking only COX-2, and therefore prostacyclin, could allow thromboxane A2 to go about its business unchecked.
The researchers found that mice without a PGI2 receptor -- which mimics the clinical effect of taking COX-2 inhibitors -- had an enhanced vascular response to injury and showed increased thromboxane A2 formation and platelet activation. This exaggerated response was canceled out in mice lacking both thromboxane A2 and PGI2 receptors
Recently Merck & Co. Inc., the maker of Vioxx, announced that the arthritis drug's labeling would be changed to state that it carries higher cardiovascular risks than naproxen -- a move required by the US Food and Drug Administration following the Vioxx-naproxen trial.
However, that labeling also highlights data from two other studies showing that Vioxx users had a lower rate of cardiovascular problems compared with study participants taking an inactive placebo, although the difference was not statistically significant.
Science April 19, 2002;296:539-541
Dr. Mercola's Comment: Folks, I announced this warning in January 1999, over three years ago when it was first published by the National Academy of Sciences. That is one of the benefits you receive by reading this newsletter. You will find out the medical facts that will be making headlines in the future.
The market for analgesics is about TEN BILLION dollars per year. That is one big number. That is why these are important drugs to watch. It is important to remember that anytime you are dealing with numbers that large there will inevitably be corruption, greed and negative influences that are a part of the story if drugs are involved.
Originally, these drugs were thought to decrease the risk of ulcers. However, an FDA Advisory Panel has since found that these drugs do NOT decrease one's risk of developing ulcers.
They also appear to be associated with an increase in damage to the kidneys.
Now we find more evidence that, as I said in 1999, these drugs also increase one's risk of heart disease. I do want to put the increased heart attack risk in its proper perspective. Although they appear to double the risk of heart disease, the overall risk is still quite low.
The drugs can likely still be used as a temporary measure while one is working on the cause of the problem. If one is following the proper eating plan, it is likely that the small increase in heart disease will not occur due to the other changes that occur in one's biochemistry due to eating properly. This is primarily related to normalization of insulin levels that corrects thousands of chemical pathways that would affect heart disease risk.
Additionaly, it is important to recognize that my revised eating plan has a strong emphasis on omega-3 fats which influence the good prostaglandins in your body. Prostaglandins are chemicals that you body makes and can either promote or prevent inflammation.
In fact that is how Vioxx and Celebrex and all the other anti-inflammatories like aspirin work. They impair the prostaglandin pathways.
You can create your own anti-inflammatory just by changing the ratio of omega-6 to omega-3 fats in your diet. Folks this is non-controversial and there are dozens and dozens of studies which clearly demonstrate this. Even traditional medicine has firmly embraced these concepts.
I review many controversial topics, but there is no disagreement on this one, virturally everyone acknowledges that omega-3 fats play a crucial role in arthritis. If you need guidelines on how to use them please review my comments on Dr. Connor's excellent article.
However, this story does demonstrate the dangers of using these drug band-aids as a permanent "fix" for the problem. They may actually seem to work, but they work at a huge price, both economically and physically. Does one really want to trade joint pain for a heart attack?
Having stated that, the pain in many conditions can be quite severe. Fortunately there are simple basic solutions for over 95% of the conditions that you would be taking these drugs for.
The first step, of course, is to follow the eating plan.
Next would be NST which works incredibly well for both osteoarthritis (DJD) and rheumatoid arthritis (RA).
For severe rheumatoid arthritis I have found my revision of Dr. Brown's protocol useful in producing remission in over 2,000 patients with RA that I have cared for in the last 13 years.
Related Articles: Celebrex and Vioxx Increase Heart Disease Risk Common Anti-Inflammatory Can Cause Non-Bacterial Meningitis Drug Company Lies About Celebrex in JAMA COX-2 Drugs May Damage Kidneys Celebrex Not Shown to Lower Ulcer Risk
Arthritis Drug Linked to Heart Failure
A study showed the popular arthritis drug Vioxx might place those who take it at risk of developing congestive heart failure.
According to research, patients who were prescribed Vioxx increased their chances of being treated for heart failure by 80 percent. Some of the other problems associated with anti-inflammatory drugs include higher risks of heart attacks and kidney damage.
Based on these findings, doctors were cautioned to closely monitor patient's blood pressure because of the likelihood that it could initiate heart failure.
Doctors stated that patients with healthy hearts didn't need to worry about the drugs because it was discovered that the drugs weren't harmful to those who had normal hearts to begin with.
Participants of the study included 45,000 elderly people living in Ontario, Canada. One of the groups took Vioxx, Celebrex or some other type of pain reliever. The other group didn't take any drugs. Both groups were observed for one year.
Results of the Study
The group that took Vioxx had an 80 percent increased tendency for developing heart failure. The group that took pain relievers such as ibuprofen showed a 40 percent increased risk of heart failure. Celebrex was the only pain reliever that showed results similar to those who didn't take any drugs. Vioxx and Celebrex, both medications that require a prescription, work by inhibiting the chemical that triggers pain and inflammation in the joints.
In October 1999, Vioxx was approved for sale in Canada for treatment of osteoarthritis. Statistics showed that approximately one out of every five residents who live in Ontario and are over the age of 65 take medication for arthritis.
Even though the risks haven't been proven as definite, experts stated that due to the high number of people who are on some form of arthritis medication that it should be taken with caution.
Toronto Star May 28, 2004
Dr. Mercola's Comment: As I wrote in a past article, at least one-quarter of Americans have arthritis or a related disease. The good news is that there are alternatives to anti-inflammatory drugs for arthritis and you can learn about some of them now.
The market for pain relievers is about $10 BILLION per year. That is one big number. That is why these are important drugs to watch. It is important to remember that anytime you are dealing with numbers that large there will inevitably be corruption, greed and negative influences that are a part of the story if drugs are involved.
You can create your own anti-inflammatory just by changing the ratio of omega-6 to omega-3 fats in your diet.
This is non-controversial and there are dozens and dozens of studies, which clearly demonstrate this. Even traditional medicine has firmly embraced these concepts.
Plus, there are alternatives to drugs for arthritis. For a drug-free, effective and rapid solution to most cases of arthritis, specifically rheumatoid arthritis, I highly encourage you to carefully read through the Physicians' Protocol for Using Antibiotics in Rheumatic Disease.
There are some general principles that seem to hold true for all people and these include:
Eliminating sugar and grains Having unprocessed, high-quality foods, organic if possible, right for your metabolic type Eating your food as close to raw as possible Having omega-3 fish oil Also, most people with RA seem to have some sort of precipitating emotional trauma. The emotional trauma weakens the immune system, which is what allows the infection to get in. EFT is a useful technique that has resulted in profound improvements in patients with RA.
Related Articles: Treating Rheumatoid Arthritis With Tumour Necrosis Factor Doesn't Make Sense Writing (Journaling) About Stress Helps Asthma, Arthritis Olive Oil, Cooked Vegetables May Reduce Arthritis Risk Arthritis Drug May be Causing Serious Blood Reactions Do Arthritis, MS or Other Conditions Make Exercise Difficult? Here's What Can Help Illegal Methods Used for Marketing Arthritis Drug
Whistle Blower is My New Hero
Dr. David Graham, associate director in the FDA's Office of Drug Safety, called the FDA's approval of arthritis drug Vioxx, "The single greatest drug safety catastrophe in the history of this country or the history of this world." Graham went on to cite the following statistic: A staggering 88,000 to 139,000 Americans suffered heart attacks and strokes as a result of taking Vioxx. In addition to Vioxx, Graham named five other drugs that are putting the lives of the public at risk. The five drugs in question are:
Meridia Crestor Accutane Serevent Bextra
Graham stated that the FDA's inability to protect Americans from another case similar to the Vioxx case was clear evidence that massive changes need to be implemented for the future protection of the public.
One of the regulatory changes Graham proposed was granting the Office of Drug Safety independent regulatory authority. Presently, safety officers are faced with a conflict of interest in the event they have to convince the Office of New Drugs that a drug is causing side effects. The conflict arises because the very group that approved the drug in the first place is also responsible for taking regulatory action against any post-marketing activities.
Tom Devine, Graham's lawyer, stated that Graham would be exiled from his duties of reviewing drugs and placed in the office of the commissioner. Devine described this position as "filling space under the scrutinizing watch of a babysitter."
USA Today November 25, 2004
British Medical Journal November 27, 2004
Dr. Mercola's Comment: Dr. David Graham is one of my new heroes. He is the person who blew the whistle on the FDA when he testified before Congress about Vioxx late in November.
So what does Dr. Graham get for blowing the whistle?
He's going to be exiled from his work reviewing drugs and put to work in the office of the commissioner. The irony here is unmistakable. First, the FDA is quietly let off the hook after approving a drug responsible for causing almost 139,000 deaths, and then the person who speaks out against this is stripped of his job responsibilities.
I look up to Dr. Graham not only for his honest testimony and concern for public safety, but for the integrity of his character. His background information includes father to six children, assistant scoutmaster and a wiry long-distance runner turned backpacker who, when flummoxed, begins sentences with an "Oh, golly." He is no slacker, as he was educated at one of the leading medical schools in the world, Johns Hopkins University School of Medicine. He also attended Yale and the University of Pennsylvania.
This is a man of conviction, and he will likely be one of the single leading forces making a dent in this fatally flawed paradigm. Perhaps I am biased because he is a fellow runner, but I LOVE this guy and hope I will be able to meet him some day.
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40 Million Arthritics Pay $100 Billion Every Year in U.S.
Research has been found that arthritis and other rheumatic conditions (AORC) are the primary cause of disability in the United States, with direct and indirect costs reaching over $116 billion--approximately 1.4 percent of the U.S. gross domestic product.
More than 38 million U.S. adults suffer from arthritis or other rheumatic conditions. Direct costs attributable to AORC were estimated at $51.1 billion, while outpatient, inpatient, prescription drug, and residual direct costs totaled $22.0 billion, $14.7 billion, $4.1 billion, and $6.5 billion, respectively.
The report highlights the need for state and local public health officials to create more self-management programs so that patients can achieve a higher quality of life while overall costs to the United States would be reduced.
Centers for Disease Control November 20, 2003
Dr. Mercola's Comment: It’s most unfortunate that Americans are spending billions of dollars on drugs and surgeries to treat these conditions when the bottom line is that drugs and surgery are both terrible options for most of these patients as they in no way, shape or form solve the problem. If the problem is caught prior to permanent irreversible joint damage, neither therapy is needed.
Although I don't agree with most traditional medical approaches, at least most specialists occasionally provide authentically useful care. ER docs are great examples of course. However, I have never seen the need for rheumatologists, and I never refer any patients to them.
Since 1989 I have treated over 3,000 patients with RA and most have done quite well. In the early days I used antibiotics to treat what Dr. Brown believed to be an underlying mycoplasma infection. More recently, I have used a variety of natural therapies to help the person's body resolve the infection.
Interestingly, the recommended diet may be completely different for each person. Recently, I saw two severely crippled patients with RA who were on multiple pain meds, anti-inflammatories, prednisone, methotrexate and interferon.
They both received extensive emotional therapy and an individualized diet based on metabolic typing. Interestingly, one patient received a near vegetarian diet, and the other was told to eat plenty of fat and meat and very few vegetables.
At their two-month follow-up appointments, they both were off of nearly all their meds and were pain free. It was remarkable and convinced me that I had reached a new threshold in the plan for RA, as now most do not even need the antibiotics that I have used for the past 14 years.
So this study is ridiculous as neither drugs nor surgery are needed to preserve hand function. The only thing that is needed is to address the underlying cause of disease. If you know any patients with RA who are struggling with this devastating disease and they are seeking a real solution you would serve them well by contacting our office.
Danger: Regular Aspirin or Tylenol Can Hurt Your Kidneys as Evidenced By Professional Athletes By Mike Wise
When an N.B.A. trainer recently doled out a weeklong dose of an anti-inflammatory medicine called Vioxx to an ailing player, the player shot him an incredulous glance. "I'm not taking these anymore, especially after what happened to 'Zo," said the player, according to the trainer. "Give me something else."
Since Alonzo Mourning, the Miami Heat's All-Star center, was found to have a kidney disorder more than a year ago - the same disease that caused the San Antonio swingman Sean Elliott to undergo a kidney transplant and eventually forced him to retire - many players in the National Basketball Association have grown acutely concerned about the use of anti-inflammatory drugs.
Medical experts say that use of the medication does not cause the kidney disease, which is called focal segmental sclerosis. But many doctors say that prolonged use at excessive levels of anti-inflammatory drugs, from over-the-counter medicine like ibuprofen and aspirin to prescription drugs like Vioxx and Indocin, may lead to other kinds of kidney problems.
Shaquille O'Neal, worried that his use of the anti-inflammatory drug Naprosyn over the years could lead to the disease Mourning has, refused to take the drug for most of last season.
Rick Fox, O'Neal's teammate on the Los Angeles Lakers, launched an awareness campaign on his Web site to alert players to the potential risk of taking anti-inflammatory medication; Fox asked whether players were essentially risking the health of their kidneys to compete for championship rings.
The appeal of the medicine is clear: it helps alleviate the aches and bruises that are a daily burden for elite athletes. The medication, known as nonsteroidal anti-inflammatory drugs, can ease the soreness of things like back pain and arthritic knees. It helps players withstand the rigors of their long seasons, of playing as many as five games in a week.
Pro basketball players, like athletes in professional football, baseball and hockey, have long felt pressure to play in pain, to distinguish between serious injuries that require them to sit out and minor injuries that can be overcome, often with medication.
"I think the whole N.B.A. takes these," said Dr. Gerald Appel, the director of the nephrology division at Columbia Presbyterian Medical Center in Manhattan and has been treating Mourning. "I know the whole N.F.L. does."
Pro athletes more commonly use nonsteroidal anti-inflammatory drugs. Since Mourning's condition was diagnosed in October 2000, many players have had to be convinced by their team and personal doctors that taking anti-inflammatory drugs for a short time will not harm their kidneys; players also needed reassurance that they were not predisposed to coming down with Mourning's disease, which studies have shown is contracted disproportionately by African-Americans.
"You literally have to sit down and tell a guy that if he's on it for a week, nothing will happen," said a veteran N.B.A. trainer, who spoke on condition of anonymity. "'Zo's condition has had a widespread effect in that way."
Fear Leads to Precaution
Many doctors say that if someone uses anti-inflammatory medicines in excessive amounts over long periods of time - as some N.B.A. players apparently have, taking three or four times the recommended dose - it can affect kidney function.
Despite medical opinion, some N.B.A. players continue to fear that Mourning's disease was caused by the medication. O'Neal underwent a kidney test earlier this month to check for any sign of the disease. When O'Neal is in excruciating pain, he now takes three Indocin pills for a short period of time.
"My body got used to Naprosyn and Orudis," he said of two anti-inflammatory drugs. "I used to pop that stuff like Tic Tacs, but I'm a lot more careful now."
Fox, O'Neal's teammate on the Lakers, was so disturbed by what happened to Mourning and Elliott that he began speaking out about N.B.A. players abusing anti-inflammatory medication. On his Web page, Fox said he used to walk around the locker room doling out medication to anyone who wanted it.
"I would literally shake up a big Advil bottle and deal it out," he said in an interview.
"Pain is something we've always dealt with," Fox said. "No one sees the behind-the- scenes things we do that go into getting our bodies ready to play every night. Alonzo and Sean played a lot of games. To stay on the floor at some point and time, they have had to take something.
"But the bottom line is, how far are we going to go? If you ask Alonzo and Sean, they probably wouldn't find it funny that I was walking around the locker room with an Advil bottle. Here they are dealing with situations in which, possibly, their decisions may have come back to haunt them."
Mourning said he still believed that long-term use of anti-inflammatories over his 12-year career contributed to his disease. "When I was first diagnosed, they said that some of the possible causes may have to do with all the anti-inflammatories I took early in my career," he said in a recent interview.
"Modern medicine, yeah, it's effective," Mourning said. "But if you're playing the game at a high level, a lot of athletes have a tendency to sometimes kind of abuse their bodies with that medicine in order to be effective.
"I'm not saying that was the case for me, but I do know, based on the conversations with my doctors, they feel that some of that has contributed to it. So I'm definitely left with that. The damage has been done. I just got to learn how to deal with it and make the proper adjustments."
In one of the more remarkable stories of this season, Mourning has overcome many of the problems with stamina and fatigue associated with his disease to lead the Heat's recent resurgence. The Heat lost last night in Utah, 101-89, but Miami had won seven of its previous eight games.
Mourning, who is 33 and missed 69 games last season because of the disease, has done this without being able to take anti-inflammatory medication. "I can't even take Advil anymore," Mourning said. "Anything that has ibuprofen or any anti-inflammatory agent in it, I can't take. It affects your kidneys."
Appel agreed that anti-inflammatory drugs would affect Mourning's health, "in the sense that it decreases his kidney function in his current state."
"But there's no evidence to suggest his condition was caused by the medication," Appel said. "The vast majority of these cases are idiopathic; we don't know what the cause is."
Dr. Gerald Chodak, a clinical professor of urology at the University of Chicago. said "Decreased kidney function is a known side effect with almost every anti-inflammatory you can think of."
How High a Price?
Elliott, a former All-Star with the Spurs, received a kidney from his brother Noel after the 1998-99 season. Elliott returned to play near the end of the next season, but he retired after last season.
To compete, Mourning needs to take eight pills a day to deal with focal segmental sclerosis, in which a portion of the nearly one million filters in each kidney begin to scar, recede and leak proteins into the urine. The regimen includes an immune suppressant, blood-pressure medication and a drug to reduce his cholesterol.
"Because of my condition, I'm slightly anemic," Mourning said. "My concern is this: not having to get to the stage of transplantation or dialysis. If I am playing, is it a deterrent toward me healing? They have reassured me that the stress I'm putting on my body on a basketball court does not affect my kidney disorder."
Appel said that Mourning's comeback should give hope to people suffering from kidney disorders and reassurance to N.B.A. players. "If Alonzo had stayed away from basketball and retired and went on to a transplant, I think the fear level would have been much greater," Appel said. "The fact that he did come back and we could treat this disease gives us great hope."
New York Times January 29, 2002
Dr. Mercola's Comment: About 15% of the people on dialysis today are there as a result of the damage that Tylenol and/or aspirin did to their kidneys.
Twenty percent of those with heart failure are due to them taking NSAIDs.
These drugs may also be associated with diverticular disease of the colon.
Pain is a wonderful guide that is given to us to provide with some feedback so we can take action to correct the problem before it gives us further problems.
To mask the pain with these drugs makes about as much sense as driving down the road and having the oil light come up on your dashboard and choosing to put some duct tape over the dashboard so the annoying red light is removed.
The light is there for a reason, to warn you of the damage that is imminent unless you take some immediate proactive action.
Fortunately you can use the energy psychology tool Emotional Freedom Technique (EFT) to resolve most of the pains that one encounters.
Those with chronic arthritis like rheumatoid arthritis seem also to benefit from my rheumatoid arthritis protocol.
Amazing Recovery From Dermatomyositis, a Rheumatoid-Arthritis-Like Disease
Dr. Mercola's Comment: Dr. Thomas Brown passed away 14 years ago. He developed an innovative alternative to the traditional approach to the treatment of rheumatoid arthritis (RA) more than 50 years ago. He believed that RA was due to an infection with an organism called mycoplasma and used antibiotics as an alternative to treatment with the miracle drug of his time, prednisone.
He was able to help more than 10,000 patients recover from RA during his career (http://www.mercola.com/2000/aug/27/rheumatoid_arthritis.htm). I have revised his protocol with diet, Emotional Freedom Technique (EFT -- http://www.mercola.com/forms/eftcourse.htm) and NST strategies and have helped nearly 3,000 patients recover from RA. However, I have always been seeking to avoid using the antibiotics to treat this problem. Although the antibiotics frequently worked and the six-month period of worsening that was part of Dr. Brown's protocol was virtually eliminated, I always felt like I had failed because I had to resort to the use of antibiotics.
Well, this year seems to mark the transition in my version of the antibiotic protocol. The major change seems to be the use of Metabolic Typing. Since we have integrated Metabolic Typing with full use of EFT to address the stressors that seem to be universally present in RA, we have been able to cause RA to routinely go into remission without the use of antibiotics.
To say I am excited is a serious understatement.
The following story very clearly illustrates that there is no one perfect diet for a disease. The following woman was on potent immune crippling drugs and was so devastated by dermatomyositis, a disease with many similarities to RA, that she could hardly pick up her newborn son or a gallon of milk and could not climb stairs.
She received specific diet recommendations based on her Metabolic Type. It is very easy to understand how a physician treating only one such patient would come to the conclusion that the diet that person was on was the "cure" for RA, when in fact nothing could be further from the truth. Another person with the same disease could quite possibly need an entirely different diet to receive any benefits, that is how powerful Metabolic Typing can be.
If you are not yet familiar with metabolic typing and you don't know your metabolic type, I strongly encourage you to check out the Total Health Program. It provides my entire dietary program of which metabolic typing is a central component; there is a general test and the full means to understand your metabolic type in the book, including both the types of foods and specific proportions of micronutrients (carbs, fats, proteins) that are ideal for you in particular. (Part Two then provides over 150 healthy and delicious recipes with easy instructions on how to tailor each to your metabolic type.)
There are some general principles that seem to hold true for all Metabolic Types and these include:
Eliminating sugar and grains Having unprocessed, high-quality foods, organic if possible Eating your food as close to raw as possible Having omega-3 fish oil I am overjoyed beyond belief that after 14 years of treating RA I can finally offer a drug-free, effective and rapid solution for most of those with RA with the aid of Metabolic Typing. However, it is clear that a perfect diet alone will rarely cause the RA to go into remission.
This is because RA is an autoimmune illness. It does indeed appear to be caused by an infection, as Dr. Brown speculated. But the central issue is why did the person acquire the infection in the first place? It is my experience that this infection is usually acquired when a person has a stressful event that causes a disruption in their bioelectrical circuits, which causes an impairment in their immune system. This impairment predisposes them to developing the initial infection and also contributes to their relative inability to effectively defeat the infection.
The antibiotics clearly seem to help most people fight the infection, but, as I mention above, there are better ways that address the underlying foundational cause of the illness.
I am quite convinced that energy techniques are required to resolve this energetic disruption. Prayer can certainly be one of them. However, in my experience, most have not utilized prayer in a way that rallies their body's resources to resolve the problem.
In my experience, energy psychology techniques are very helpful in this area and can be easily integrated with prayer. I happen to use EFT in my practice and you can download my free 25-page report to find out more about this technique
However, the emotional trauma that causes RA is nearly universally quite severe and is best treated by a professional. Trying to treat this trauma by yourself is somewhat similar to a general surgeon trying to perform an appendectomy on him or herself. Although it is possible, it is not generally recommended (Interesting aside: I read an article in JAMA about 10 years ago in which a surgeon in the late 1800s actually did this. Unfortunately, he died from complications.).
Dr. Partirica Carrington has actually compiled some guidelines on how you can find an EFT practitioner.
The following story was contributed by Suzanne Delich of Dyer, IN:
Imagine not having the strength or energy to care for your newborn. In December 1999 I was so sick that I could barely pick up my 15-pound baby boy or a gallon of milk without a struggle. Getting off the floor by myself was an impossibility. I couldn't even climb stairs due to the weakness in my legs. I had a red itchy rash all over my face, including my eyelids, front and back of my neck, my chest, my knuckles, and on my right knee that resembled a second-degree burn.
My sleep was so restless, due to the itchiness of the rash, that I was tired constantly. In the morning I woke to find dried blood on my face where I scratched all night long. I spent most days napping alongside of my child and immediately went to bed once my husband returned from work. I was so spacey that I couldn't think straight.
I began my healing journey in January 2000. My first stop was to my general practitioner. He looked at me and advised me that I had post-partum depression and told me to go home and exercise. Within a week I was back in his office and requested a test for Lupus. The tests came back positive for a mixed connective tissue disease. I was given little hope and referred to a rheumatologist.
My next stop was to a rheumatologist. Wow, did I feel awkward sitting in his waiting room, I was the only patient under 60. Extensive testing showed that I had dermatomyositis, an autoimmune disease that causes muscle myopathy, wasting away of muscle, extreme fatigue, and very itchy skin rashes. His prognosis was very grim. He told me I had a life-threatening illness and gave me his home telephone number to call in case I started experiencing problems breathing. His course of treatment included high doses of Prednisone and Fosamax, to build up the bone density that I would be losing by taking the Prednisone. At that point I felt trapped between a rock and a hard place. What could I do? I needed to get better so I could care for my child. So I decided to go along with his recommendations. Well, his treatment worked for awhile, but as soon as I weaned off of the Prednisone, my muscle weakness and rash came back worse than ever.
The whole time I was under his care, I started looking into other treatment options. That's when I came across a rheumatic support group online (Rheumatic.org). They promoted the benefits of the antibiotic minocin to heal rheumatic diseases, including dermatomyositis. Every day I was flooded with e-mails, some of which mentioned a holistic doctor who uses natural healing modalities to treat chronic disease. Everyone was talking about Dr. Joseph Mercola of The Optimal Wellness Center. Through corresponding with group members, and visiting mercola.com, I discovered that Dr. Mercola prescribes minocin to treat rheumatoid arthritis and other autoimmune diseases. Dr. Mercola's Web site is so informative that I decided to subscribe to his free twice-weekly newsletter.
Little did I know that my next rheumy visit would be one of my last. I asked him to put me on minocin and he refused. Instead, he tried to persuade me to start incorporating methotrexate into my treatment regime. Knowing the devastating side effects of the drug I flat out refused and went home to schedule my next appointment with Dr. Mercola. I knew that it was time to find a doctor who wanted to help heal my body, not further destroy what was left of it.
In June 2001 I had my first consultation with Dr. Mercola. During this time he told me that he'd have me back on my feet within eight to 12 months. He even said it with a smile on his face and hope in his voice. That was the first time anyone gave me hope. That was the day my true healing journey began. His course of treatment included eliminating grains, sugar, and dairy from my diet and adding lots and lots of fresh organic veggies, in the form of fresh juice, cod liver oil, and healthy sources of protein into my diet. Additionally, he told me that I would be working with his therapist Jody to help me deal with emotional issues, meeting with Jordan who would examine my blood under a microscope, and discussing my diet with Jim the nutritionist.
I left the office that day with a renewed sense of hope for the future. I felt such peace and joy.
The next day I woke up confused and scared. How was I going to make such enormous lifestyle changes? Could I rise to the challenge? I pondered this for awhile; then decided to get to work. I cleared my cupboards and refrigerator of all unhealthy food and then went to the store to purchase some veggies. I came home and decided to prepare my first batch of veggie juice. It didn't taste like V-8, but it wasn't bad. Initially, I juiced inorganic veggies, soaked in vinegar to remove impurities, in my Hamilton Beach juicer. As I became more committed to juicing, I decided to buy organic produce and an Omega 8001 juicer. Juicing became much easier and less time consuming when I started using my new juicer.
Juicing has been crucial to my healing. It is full of vitamins and antioxidants to promote a healthy immune system and it helps to flush out toxins from the body. I not only juice for myself but for my whole family. My 3-year-old just loves "green juice," as he calls it. I normally juice celery, lettuce, spinach, chard or collard greens, cucumber, and garlic. I add a few carrots and/or beets to my family's juice, but refrain from adding them to mine due to the sugar content.
Following the diet was a real challenge in the beginning. The first three months were the worst. I refused to socialize outside of the home because I couldn't control my food selection. This evoked a lot of anger and depression in me because I felt so isolated. In order to deal with this, I began incorporating EFT into my healing regimen. As I became more comfortable with the program things got much better. It is now a normal part of my life.
However, whenever I become angry, depressed, or tempted to indulge in unhealthy fare, I sit down and start to tap along the EFT meridian points. EFT is a great tool; I'm so glad Jordan took the time to teach me how to use it. EFT has helped me to deal with my emotions and food cravings so I could continue to follow the program. It's a great way to eliminate negative emotions/thoughts that lead to unhealthy behavior. My husband even uses it.
In addition to EFT, I routinely use prayer and the support of my family to deal with my emotions. Fortunately, I was blessed with a wonderful husband and son. On a monthly basis, I see Jody at the wellness center. She has been instrumental in helping me to resolve negative emotions and replace them with positive ones. I don't think I could have followed such a rigorous program without help.
Another strategy I use to reach optimal wellness is to incorporate more raw foods into my diet. I add raw, organic cage-free eggs, chorella and/or spirulina to my veggie juice. I enjoy eating raw broccoli, spinach, swiss chard, tomatoes, nuts and seeds. My favorite snack is an organic Gala apple with a handful of walnuts alongside. My goal is to eventually eat 80 percent raw, since I know that cooking destroys many of the healthful benefits of food. I do eat some cooked meat, including beef, chicken, tilapia and sardines. When possible I try to purchase organic.
Real improvement started to manifest within three months of starting the program. My rash started to fade, the brain fog lifted, and I became less fatigued. I attribute this to the elimination of grains--especially wheat--and sugar, the incorporation of juice and cod liver oil into my diet, and the use of minocin to treat the dermatomyositis. Without a doubt the juicing was the most beneficial change I have made. Right after drinking a glass of juice, I feel more energetic and less fatigued. It's like drinking a triple espresso without the negative side effects of coffee.
It's now July 2003 and I am the model of good health. I no longer take the minocin and rely on my diet and a few supplements to maintain my health. All of my strength has returned, I'm full of energy, my rash is almost gone, and I am enjoying life again. I routinely juice, continue to follow the diet, exercise constantly, and practice stress management. I've never been happier. I no longer worry about being physically unable to care for my son. I feel so good that my husband and I are considering having another child. We are having a great summer.
I am so comfortable with the diet I couldn't imagine doing things differently. Occasionally, I deviate from the diet, and my body lets me know. I never want to be as sick as I was in December 1999. That realization, along with the smile on my son's beautiful face, keeps me from deviating too much. My husband and my son inspire me to do my very best.
Spirituality Linked to Better Health in Arthritis
A high level of spirituality appears to be associated with better health among individuals with rheumatoid arthritis and could also help them cope with their illness more effectively.
Spirituality may be a type of psychological resource that allows individuals to adjust better to living with a chronic illness.
Investigators studied 77 people, all of whom had rheumatoid arthritis for more than 2 years. The female study participants reported an average of 12 swollen and tender joints while the males had 7 swollen and tender joints, on average. One in four study participants reported clinically significant levels of depressive symptoms.
In general, people with a high level of spirituality -- who were also more likely to attend church, pray and read the Bible -- rated themselves as healthier and less disabled than their less spiritual peers, and also reported having more positive thoughts.
Greater spirituality was also associated with more overall adaptive coping, meaning that in the face of a serious challenge -- like having a chronic illness -- folks who are higher in spirituality 'rise to the challenge' more easily.
The more spiritual individuals were also less passive, showed greater restraint, had more faith in others and drew strength from others more than did their less spiritual peers. The findings held true even after the researchers took the participants' level of disease activity, age, education, fatigue and ability to function independently into account.
Several factors could explain the link between spirituality and well-being.
People's perceptions of themselves and how they are doing play a major role in their happiness.
If you perceive having a chronic illness as having meaning and providing an opportunity to learn and grow as a person, it may be much easier to reformulate life priorities and adapt to living with an illness.
Also, having a spiritual meaning gives a sense of connectedness to others. Social support is a well-known buffer against stress and emotional problems.
The researcher pointed out that relatively little work has been done on spirituality, per se, and most that is available has failed to distinguish between spirituality and religiousness.
Researchers distinguish between the two by describing spirituality as a belief in a power outside oneself and one's own existence" and religiousness as the outward practice of a particular spiritual understanding.
More scientific work in this area is clearly needed to help us understand how spirituality may facilitate adjustment to living with chronic illness.
Annual Association of Rheumatology Health Professionals January 2002
Dr. Mercola's Comment: The results of this study are not surprising since I have posted on the relationship between spirituality and rheumatoid arthritis previously.
Patients who used religion or spirituality to cope with the chronic pain of rheumatoid arthritis reduced their pain and boosted their sense of well-being.
Religion appears to promote health, and therefore physicians should consider attending to their patients' spiritual beliefs.
Over 94 percent of the American public believes in a God or a "higher power," and most claim that religion is "fairly" or "very" important in their lives.
However, American physicians tend to be less likely than their patients to believe in God--only 64 percent compared to 91 percent, respectively, one survey found.
Of previous reviews examining the effects of religious commitment on health care outcomes:
75 percent showed a positive benefit 17 percent had mixed or no effect 7 percent showed a negative effect It really seems medical malpractice to not incorporate a spiritual dimension into the practice of medicine. However, I am clearly not referring to doctors proselytizing to patients about their own spiritual beliefs.
I have also found journaling for 10 minutes every day to be very helpful, especially if you either burn the paper afterward or do not save the file on if you are typing.
Knowing that no one will ever see what is written really allows you to be freer with what you are writing down. The trick here is to not stop typing or writing at all during the 10 minutes and to just write continuously. It is a very powerful form of prayer and is particularly helpful for improving health or recovering from traumas.
If you are interested in the strong connection between spiritual health and physical health, you may want to check out the Web site of The National Institute for Healthcare Research, a privately funded, nonprofit organization, which is dedicated to advancing the understanding of the connection between spirituality and health.
Recently, I have begun to use the Emotional Freedom Technique (EFT -- http://www.mercola.com/forms/eftcourse.htm) as a tool to facilitate crossing through the barriers that many people have from past emotional traumas, which has resulted in their disconnection from their relationship with God due to anger or bitterness.
You might want to consider purchasing my EFT workshops on video or DVD, which will provide you with a basic foundation in EFT. The videos are risk free. They have a full one-year money-back guarantee. If you are not absolutely satisfied that the techniques you learn from viewing the workshops are not worth it, you can return the video or DVD for a full refund.
Physicians' Protocol For Using Antibiotics in Rheumatic Disease The following is a modified version of Dr. Brown's protocol.
Rheumatoid arthritis affects about 1 percent of our population and at least two million Americans have definite or classical rheumatoid arthritis. It is a much more devastating illness than previously appreciated. Most patients with rheumatoid arthritis have a progressive disability. More than 50% of patients who were working at the start of their disease are disabled after five years of rheumatoid arthritis. The annual cost of this disease in the U.S. is estimated to be over $1 billion.
There is also an increased mortality rate. The five-year survival rate of patients with more than thirty joints involved is approximately 50%. This is similar to severe coronary artery disease or stage IV Hodgkin's disease. Thirty years ago, one researcher concluded that there was an average loss of eighteen years of life in patients who developed rheumatoid arthritis before the age of 50.
Most authorities believe that remissions rarely occur. Some experts feel that the term "remission-inducing" should not be used to describe ANY current rheumatoid arthritis treatment. A review of contemporary treatment methods shows that medical science has not been able to significantly improve the long-term outcome of this disease.
My Experience with the Dr. Brown's Protocol
I first became aware of Doctor Brown's protocol in 1989 when I saw him on 20/20 on ABC. This was shortly after the introduction of his first edition of The Road Back.The newest version is The New Arthritis Breakthrough that is written by Henry Scammel. Unfortunately, Dr. Brown died from prostate cancer shortly after the 20/20 program so I never had a chance to meet him. By the year 2000, I will have treated over 1,500 patients with rheumatic illnesses, including SLE, scleroderma, polymyositis and dermatomyositis.
My application of Dr. Brown's protocol has changed significantly since I first started implementing it. Initially, I followed Dr. Brown's work rigidly with very little modification other than shifting the tetracycline choice to Minocin. I believe I was one of the first people who recommended the shift to Minocin, which seems to have been widely adopted at this time.
In the early 90s, I started to integrate the nutritional model into the program and noticed a significant improvement in the treatment response. I cannot emphasize strongly enough the importance of this aspect of the program. It is absolutely an essential component of the revised Dr. Brown protocol. One may achieve remission without it, but the chances are much improved with its implementation. The additional benefit of the dietary changes is that they severely reduce the risk of the two to six month worsening of symptoms that Dr. Brown described in his book.
In the late 80s, the common retort from other physicians was that there was "no scientific proof" that this treatment works. Well, that is certainly not true today. If one peeks ahead at the bibliography, one will find over 200 references in the peer-reviewed medical literature that supports the application of Minocin in the use of rheumatic illnesses.
The definitive scientific support for minocycline in the treatment of rheumatoid arthritis came with the MIRA trial in the United States. This was a double blind randomized placebo controlled trial done at six university centers involving 200 patients for nearly one year. The dosage they used (100 mg twice daily) was much higher and likely less effective than what most clinicians currently use.
They also did not employ any additional antibiotics or nutritional regimens, yet 55% of the patients improved. This study finally provided the "proof" that many traditional clinicians demanded before seriously considering this treatment as an alternative regimen for rheumatoid arthritis.
Dr. Thomas Brown's effort to treat the chronic mycoplasma infections believed to cause rheumatoid arthritis is the basis for this therapy. Dr. Brown believed that most rheumatic illnesses respond to this treatment. He and others used this therapy for SLE, ankylosing spondylitis, scleroderma, dermatomyositis and polymyositis.
Dr. Osler was also a preeminent figure of his time (1849- 1919). Many regard him as the consummate physician of modern times. An excerpt from a commentary on Dr. William Osler provides a useful perspective on application of alternative medical paradigms:
Osler would be receptive to the cautious exploration of nontraditional methods of treatment, particularly in situations in which our present science has little to offer. From his reading of medical history, he would know that many pharmacologic agents were originally derived from folk medicine. He would also remember that in the 19th century physicians no less intelligent than those in our own day initially ridiculed the unconventional practices of Semmelweis and Lister.
Osler would caution us against the arrogance of believing that only our current medical practices can benefit the patient. He would realize that new scientific insights might emerge from as yet unproved beliefs. Although he would fight vigorously to protect the public against frauds and charlatans, he would encourage critical study of whatever therapeutic approaches were reliably reported to be beneficial to patients.
Revised Antibiotic-Free Approach
Although the antibiotics frequently worked and the six-month period of worsening that was part of Dr. Brown's protocol was virtually eliminated, I always felt like I had failed because I had to resort to the use of antibiotics.
This has now changed, as I have been able to implement a major change in my revision of the protocol that allows for a completely drug-free treatment of RA. The major change seems to be the use of Metabolic Typing, along with energy techniques. Since we have integrated Metabolic Typing with full use of EFT to address the stressors that seem to be universally present in RA, we have been able to cause RA to routinely go into remission without the use of antibiotics.
To say I am excited is a serious understatement.
Metabolic Typing allows each patient to get a unique diet that is right for their body. It is very easy to understand how a physician who successfully treats one patient with a particular diet would come to the conclusion that the diet that person was on was the "cure" for RA, when in fact nothing could be further from the truth. Another person with the same disease could quite possibly need an entirely different diet to receive any benefits, that is how powerful Metabolic Typing can be.
If you haven't yet read the book The Metabolic Typing Diet, I would strongly encourage you to do so as it reviews these topics extensively (it is definitely a book that belongs on the shelf of anyone with any interest in nutrition).
There are some general principles that seem to hold true for all Metabolic Types and these include:
Eliminating sugar and grains (you can read more about this below) Having unprocessed, high-quality foods, organic if possible Eating your food as close to raw as possible Having omega-3 fish oil I am overjoyed beyond belief that after 14 years of treating RA I can finally offer a drug-free, effective and rapid solution for most of those with RA with the aid of Metabolic Typing. However, it is clear that a perfect diet alone will rarely cause the RA to go into remission.
This is because RA is an autoimmune illness. It does indeed appear to be caused by an infection, as Dr. Brown speculated. But the central issue is why did the person acquire the infection in the first place? It is my experience that this infection is usually acquired when a person has a stressful event that causes a disruption in their bioelectrical circuits, which causes an impairment in their immune system. This impairment predisposes them to developing the initial infection and also contributes to their relative inability to effectively defeat the infection.
The antibiotics clearly seem to help most people fight the infection, but, as I mention above, there are better ways that address the underlying foundational cause of the illness.
I am quite convinced that energy techniques are required to resolve this energetic disruption. Prayer can certainly be one of them. However, in my experience, most have not utilized prayer in a way that rallies their body's resources to resolve the problem.
In my experience, energy psychology techniques are very helpful in this area and can be easily integrated with prayer. I happen to use EFT in my practice and you can download my free 25-page report to find out more about this technique
However, the emotional trauma that causes RA is nearly universally quite severe and is best treated by a professional. Trying to treat this trauma by yourself is somewhat similar to a general surgeon trying to perform an appendectomy on him or herself. Although it is possible, it is not generally recommended (Interesting aside: I read an article in JAMA about 10 years ago in which a surgeon in the late 1800s actually did this. Unfortunately, he died from complications.).
Dr. Partirica Carrington has actually compiled some guidelines on how you can find an EFT practitioner.
In the following sections I have included information about the antibiotic therapy for RA for anyone who is interested. However, I now recommend my drug-free approach for anyone fighting this illness.
Limiting sugar is a critical element of the treatment program. Sugar has multiple significant negative influences on a person's biochemistry. Its major mode of action is through elevation of insulin levels. However, it has a similarly severe impairment of intestinal microflora. Patients who are unable to decrease their sugar intake are far less likely improve.
One of the major benefits of implementing the dietary changes is that one does not seem to develop worsening of symptoms the first three to six months that is described in Dr. Brown's book. Most of my patients tend to not worsen once they start the antibiotics. I believe this is due to the beneficial effects that the diet has on the immune response.
Antibiotic Therapy With Minocin
There are three different tetracyclines available: simple tetracycline, doxycycline, or Minocin (minocycline). Minocin has a distinct and clear advantage over tetracycline and doxycycline in three important areas.
Extended spectrum of activity Greater tissue penetrability Higher and more sustained serum levels
Bacterial cell membranes contain a lipid layer. One mechanism of building up a resistance to an antibiotic is to produce a thicker lipid layer. This layer makes it difficult for an antibiotic to penetrate. Minocin's chemical structure makes it the most lipid soluble of all the tetracyclines.
This difference can clearly be demonstrated when one compares the drugs in the treatment of two common clinical conditions. Minocin gives consistently superior clinical results in the treatment of chronic prostatitis. In other studies, Minocin was used to improve between 75-85% of patients whose acne had become resistant to tetracycline. Strep is also believed to be a contributing cause to many patients with rheumatoid arthritis. Minocin has shown significant activity against treatment of this organism.
There are several important factors to consider when using Minocin. Unlike the other tetracyclines, it tends not to cause yeast infections. Some infectious disease experts even believe that it even has a mild anti-yeast activity. Women can be on this medication for several years and not have any vaginal yeast infections. Nevertheless, it would be prudent to have patients on prophylactic oral Lactobacillus acidophilus and bifidus preparations. This will help to replace the normal intestinal flora that is killed with the Minocin.
Another advantage of Minocin is that it tends not to sensitize patients to the sun. This minimizes the risk of sunburn and increased risk of skin cancer. However, one must incorporate several precautions with the use of Minocin. Like other tetracyclines, food impairs its absorption. However, the absorption is much less impaired than with other tetracyclines. This is fortunate because some patients cannot tolerate
Minocin on an empty stomach. They must take it with a meal to avoid GI side effects. If they need to take it with a meal, they will still absorb 85% of the medication, whereas tetracycline is only 50% absorbed. In June of 1990, a pelletized version of Minocin became available. This improved absorption when taken with meals. This form is only available in the non-generic Lederle brand and is a more than reasonable justification to not substitute for the generic version. Clinical experience has shown that many patients will relapse when they switch from the brand name to the generic. In February 2006 Wyeth sold manufacturing rights of Minocin to Triax Pharmaceuticals (866-488-7429).
Clinically it has been documented that it is important to take Lederle brand Minocin. Most all generic minocycline is clearly not as effective. A large percentage of patients will not respond at all or not do as well with generic non-Lederle minocycline.
Traditionally it was recommended to only receive the brand name Lederle Minocin. However, there is one generic brand that is acceptable and that is the brand made by Lederle. The only difference between Lederle generic Minocin and brand name Minocin is the label and the price.
The problem is finding the Lederle brand generic. Some of my patients have been able to find it at Wal Mart. Since Wal Mart is one of the largest drug chains in the US, this should make the treatment more widely available for a reduced charge.
Many patients are on NSAID's which contribute to microulcerations of the stomach which cause chronic blood loss. It is certainly possible they can develop a peptic ulceration contributing to their blood loss. In either event, patients frequently receive iron supplements to correct their blood counts.
IT IS IMPERATIVE THAT MINOCIN NOT BE GIVEN WITH IRON. Over 85% of the dose will bind to the iron and pass through the colon unabsorbed. If iron is taken, it should be at least one hour before the minocin or two hours after. One recent uncommon complication of Minocin is a cell-mediated hypersensitivity pneumonitis.
Most patients can start on Minocin 100 mg. every Monday, Wednesday, and Friday evening. Doxycycline can be substituted for patients who cannot afford the more expensive Minocin. It is important to not give either medication daily, as this does not seem to provide as great a clinical benefit.
Tetracycline type drugs can cause a permanent yellow- grayish brown discoloration of the teeth. This can occur in the last half of pregnancy and in children up to eight years old. One should not routinely use tetracycline in children. If patients have severe disease, one can consider increasing the dose to as high as 200 mg three times a week. Aside from the cost of this approach, several problems result may result from the higher doses. Minocin can cause quite severe nausea and vertigo. Taking the dose at night does tend to decrease this problem considerably.
However, if one takes the dose at bedtime, one must tell the patient to swallow the medication with TWO glasses of water. This is to insure that the capsule doesn't get stuck in the throat. If that occurs, a severe chemical esophagitis can result which can send the patient to the emergency room.
For those physicians who elect to use tetracycline or doxycycline for cost or sensitivity reasons, several methods may help lessen the inevitable secondary yeast overgrowth. Lactobacillus acidophilus will help maintain normal bowel flora and decrease the risk of fungal overgrowth.
Aggressive avoidance of all sugars, especially those found in non-diet sodas will also decrease the substrate for the yeast's growth. Macrolide antibiotics like Biaxin or Zithromax may be used if tetracyclines are contraindicated. They would also be used in the three pills a week regimen.
The other drug used to treat rheumatoid arthritis is clindamycin. Dr. Brown's book discusses the uses of intravenous clindamycin. It is important to use the IV form of treatment if the disease is severe. Nearly all scleroderma patients should take an aggressive stance and use IV treatment. Scleroderma is a particularly dangerous form of rheumatic illness that should receive aggressive intervention.
A major problem with the IV form is the cost. The price ranges from $100 to $300 per dose if administered by a home health care agency. However, if purchased directly from Upjohn, significant savings will be appreciated.
For patients with milder illness, the oral form is preferable. If the patient has a mild rheumatic illness (the minority of cases), it is even possible to exclude this from their regimen. Initial starting doses for an adult would be a 1200 mg dose once a week.
Patients do not seem to tolerate this medication as well as Minocin. The major complaint seems to be a bitter metallic type taste, which lasts about 24 hours after the dose. Taking the dose after dinner does seem to help modify this complaint somewhat. If this is a problem, one can lower the dose and gradually increase the dose over a few weeks.
Concern about the development of C. difficile pseudomembranous enterocolitis as a result of the clindamycin is appropriate. This complication is quite rare at this dosage regimen, but it certainly can occur. It is important to warn all patients about the possibility of developing a severe uncontrollable diarrhea. Administration of the acidophilus seems to limit this complication by promoting the growth of the healthy gut flora.
If one encounters a resistant form of rheumatic illness, intravenous administration should be considered. Generally, weekly doses of 900 mg are administered until clinical improvement is observed. This generally occurs within the first ten doses. At that time, the regimen can be decreased to every two weeks with the oral form substituted on the weeks where the IV is not taken.
What To Do If Severe Patients Fail To Respond
The most frequent reason for failure to respond to the protocol is lack of adherence to the dietary guidelines. Most patients will be eating too many grains and sugars, which disturb insulin physiology. It is important that patients adhere as strictly as possible to the guidelines.A small minority, generally under 15%, of patients will fail to respond to the protocol described above despite rigid adherence to the diet.These individuals should already be on the IV Clindamycin.
It appears that the hyaluronic acid, which is a potentiating agent commonly used in the treatment of cancer may be quite useful. It seems that hyaluronic acid has very little to no direct toxicity but works in a highly synergistic fashion when administered directly in the IV bag with the Clindamycin.
Hyaluronic acid is also used in orthopedic procedures. The dose is generally from 2 to 10 cc into the IV bag. Hyaluronic acid is not inexpensive as the cost may range up to $10 per cc.One does need to exert some caution with its use as it may precipitate a significant Herxheimer flare reaction.
Patients will frequently have emotional traumas that worsen their illness. Severe emotional traumas can seriously impair the immune response to this treatment.
Physicians' Protocol For Using Antibiotics in Rheumatic Disease
The first non-aspirin NSAID, indomethacin was introduced in 1963. Now more than 30 are available. Relafen is one of the better alternatives as it seems to cause less of an intestinal dysbiosis. If cost is a concern, generic ibuprofen can be used. Unfortunately, recent studies suggest this drug is more damaging to the kidneys. One must be especially careful to monitor renal function studies periodically. It is important for the patient to understand and accept the risks associated with these more toxic drugs.
Unfortunately, these drugs are not benign. Every year, they do enough damage to the GI tract to kill 2,000 to 4,000 patients with rheumatoid arthritis alone. That is ten patients EVERY DAY. At any given time patients receiving NSAID therapy have gastric ulcers in the range of 10-20%. Duodenal ulcers are lower at 2- 5%. Patients on NSAIDs are at approximately three times greater relative risk for developing serious gastrointestinal side effects than are non-users.
Approximately 1.2% of patients taking NSAIDs are hospitalized for upper GI problems per year of exposure. One study of patients taking NSAIDs showed that a life-threatening complication was the first sign of ulcer in more than half of the subjects.
Researchers found that the drugs suppress production of prostacyclin, which is needed to dilate blood vessels and inhibit clotting. Earlier studies had found that mice genetically engineered to be unable to use prostacyclin properly were prone to clotting disorders.
Anyone who is at increased risk of cardiovascular disease should steer clear of these two new medications. Ulcer complications are certainly potentially life-threatening,but, heart attacks are a much more common and likely risk, especially in older individuals.
Risk factor analysis helps to discriminate those that are at increased danger of developing these complications. Those associated with a higher frequency of adverse events are:
Old age Peptic ulcer history Alcohol dependency Cigarette smoking Concurrent prednisone or corticosteroid use Disability High dose of the NSAID NSAID known to be more toxic
Studies clearly show that the non-acetylated salicylates are the safest NSAIDs. Celebrex and Vioxx likely cause the least risk for peptic ulcer. But as mentioned, they pose an increased risk for heart disease. Factoring these newer medications out would leave the following less toxic NSAIDs: Relafen, Daypro, Voltaren, Motrin, and Naprosyn. Meclomen, Indocin, Orudis, and Tolectin are among the most toxic or likely to cause complications.
They are much more dangerous than the antibiotics or non-acetylated salicylates. One should run an SMA at least once a year on patients who are on these medications. One must monitor the serum potassium levels if the patient is on an ACE inhibitor as these medications can cause hyperkalemia. One should also monitor their kidney function. The SMA will also show any liver impairment that the drugs might cause.
These medications can also impair prostaglandin metabolism and cause papillary necrosis and chronic interstitial nephritis. The kidney needs vasodilatory prostaglandins (PGE2 and prostacycline) to counterbalance the effects of potent vasoconstrictor hormones such as angiotensin II and catecholamines. NSAIDs decrease prostaglandin synthesis by inhibiting cyclooxygenase, leading to unopposed constriction of the renal arterioles supplying the kidney.
One might consider the use of non-acetylated salicylates such as salsalate, sodium salicylate and magnesium salicylate (i.e., Salflex, Disalcid, or Trilisate). They are the drugs of choice if there is renal insufficiency. They have minimal interference with anticyclooxygenase and other prostaglandins.
Additionally, they will not impair platelet inhibition of those patients who are on every other day aspirin to decrease their risk for stroke or heart disease. Unlike aspirin, they do not increase the formation of products of lipoxygenase-mediated metabolism of arachidonic acid. For this reason, they may be less likely to precipitate hypersensitivity reactions. These drugs have been safely used in patients with reversible obstructive airway disease and a history of aspirin sensitivity.
They also are much gentler on the stomach then the other NSAIDs and are the drug of choice if the patient has problems with peptic ulcer disease. Unfortunately, all these benefits are balanced by the fact they may not be as effective as the other agents and are less convenient to take. One needs to push them to 1.5-2 grams bid and tinnitus is a frequent complication.
One should warn patients of this complication and explain that if tinnitus does develop they need to stop the drugs for a day and restart with a dose that is half a pill per day lower. They repeat this until they find a dose that relieves their pain and doesn't give them any ringing.
One can give patients with severe disease a prescription for prednisone 5 mg. They can take one of them a day if they develop a severe flare-up as a result of going on the antibiotics. They can use an additional tablet at night if they are in really severe flare.
Explain to all patients that the prednisone is very dangerous and every dose they take decreases their bone density. However, it is a trade-off. Since they will only be on it for a matter of months, its use may be justifiable. This is the first medicine they should try to stop as soon as their symptoms permit.
Blood levels of cortisol peak between 3 and 9am. It would, therefore, be safest to administer the prednisone in the morning. This will minimize the suppression on the hypothalamic-pituitary-adrenal axis. Patients often ask the dangers of these medications. The most significant one is osteoporosis.
Other side effects that usually occur at higher doses include adrenal insufficiency, atherosclerosis acceleration, cataract formation, Cushing's syndrome, diabetes, ulcers, herpes simplex and tuberculosis reactivation, insomnia, hypertension, myopathy and renal stones.
One also needs to be concerned about the increased risk of peptic ulcer disease when using this medicine with conventional non-steroidal anti-inflammatories. Persons receiving both of these medicines may have a 15 times greater risk of developing an ulcer.
If a patient is already on prednisone, it is helpful to give them a prescription for 1 mg tablets so they can wean themselves off of the prednisone as soon as possible. Usually one lowers the dose by about 1 mg per week. If a relapse of the symptoms occurs, than further reduction of the prednisone is not indicated.
The following criteria can help establish remission: *A decrease in duration of morning stiffness to no more than 15 minutes
No pain at rest Little or no pain or tenderness on motion Absence of joint swelling A normal energy level A decrease in the ESR to no more than 30 A normalization of the patient's CBC. Generally the HGB, HCT, & MCV will increase to normal and their "pseudo"-iron deficiency will disappear ANA, RF, & ASO titers returning to normal
The natural course of rheumatoid arthritis is quite remarkable. Less than 1% of patients who are rheumatoid factor seropositive have a spontaneous remission. Some disability occurs in 50-70% of patients within five years after onset of the disease. Half of the patients will stop working within 10 years. This devastating natural prognosis is what makes the antibiotic therapy so exciting.
Approximately one third of patients have been lost to follow-up for whatever reason and have not continued with treatment. The remaining patients seem to have a 60-90% likelihood of improvement on this treatment regimen. That is quite a stark contrast to the numbers quoted above.
There are many variables associated with an increased chance of remission or improvement. The younger the patient is the better they seem to do. The more closely they follow the diet, the less likely they are to have a severe flare-up and the more likely they are to improve. Smoking seems to be negatively associated with improvement. The longer the patient has had the illness and the more severe the illness the more difficult it seems to treat.
If patients discontinue their medications before all of the above criteria are met, there is a greater risk that the disease will recur. If the patient meets the above criteria, one can have them to try to stop their anti-inflammatory medication once they start to experience these improvements. If the improvements are stable for six months, then discontinue the clindamycin. If the improvements are maintained for the next six months, one can then discontinue their Minocin and monitor for recurrences. If symptoms should recur, it would be wise to restart the previous antibiotic regimen.
Overall, nearly 80% of the patients do remarkably better with this program. Approximately 5% of the patients continued to worsen and required conventional agents, like methotrexate, to relieve their symptoms. Approximately 15% of the patients who started the treatment dropped out of the program and were lost to follow-up. The longer and more severe the illness, the longer it takes to cure. Smokers tend not to do as well with this program. Age and competency of the person's immune system are also likely important factors.
Dr. Brown successfully treated over 10,000 patients with this protocol. He found that significant benefits from the treatment require on the average one to two years. I have treated nearly over 1,500 patients and find that the dietary modification I advocate accelerates the response rate to several months. The length of therapy can vary widely.
In severe cases, it may take up to thirty months for the patients to gain sustained improvement. One requires patience because remissions may take up to 3 to 5 years. Dr. Brown's pioneering approach represents a safer less toxic alternative to many conventional regimens and results of the NIH trial have finally scientifically validated this treatment.
Preliminary Laboratory Evaluation For Non-Rheumatologists
It is important to evaluate patients to determine if indeed they have rheumatoid arthritis. Most patients will have received evaluations and treatment by one or more board certified rheumatologists. If this is the case, the diagnosis is rarely in question and one only needs to establish some baseline laboratory data.
However, patients will frequently come in without having any appropriate workup done by a physician. Arthritic pain can be an early manifestation of 20-30 different clinical problems. These include not only rheumatic disease, but also metabolic, infectious and malignant disorders. These patients will require a more extensive laboratory analysis.
Rheumatoid arthritis is a clinical diagnosis for which there is not a single test or group of laboratory tests which can be considered confirmatory. When a patient hasn't been properly diagnosed, then one needs to establish the diagnosis with the standard Rheumatism Association's criteria found in the table at the end of the article.
One must also make certain that the first four symptoms listed in the table are present for six or more weeks. These criteria have a 91-94% sensitivity and 89% specificity for the diagnosis of rheumatoid arthritis. However, these criteria were designed for classification and not for diagnosis. One must make the diagnosis on clinical grounds. It is important to note that many patients with negative serologic tests can have a strong clinical picture for rheumatoid arthritis.
The metacarpophalangeal joints, proximal interphalangeal and wrists joints are the first joints to become symptomatic. In a way, the hands are the calling card of rheumatoid arthritis. If the patient completely lacks hand and wrist involvement, even by history, the diagnosis of rheumatoid arthritis is doubtful. Rheumatoid arthritis rarely affects the hips and ankles early in its course.
Fatigue may be present before the joint symptoms begin. Morning stiffness is a sensitive indicator of rheumatoid arthritis. An increase in fluid in and around the joint probably causes the stiffness. The joints are warm, but the skin is rarely red. When the joints develop effusions, the patients holds them flexed at 5 to 20 degrees as it is too painful to extend them fully.
The general initial laboratory evaluation should include a baseline ESR, CBC, SMA, U/A, and an ASO titer. One can also draw RF and ANA titers to further objectively document improvement with the therapy. However, they seldom add much to the assessment.
Follow-up visits can be every two months for patients who live within 50 miles, and every three to four months for those who live farther away. An ESR at every visit is an inexpensive and reliable objective parameter of the extent of the disease. However, one should run this test within several hours of the blood draw. Otherwise, one cannot obtain reliable and reproducible results. This is nearly impossible with most clinical labs that pick up your specimen at the office.
Inexpensive disposable ESR kits are a practical alternative to the commercial or hospital labs. One can then run them in the office, usually within one hour of the blood draw. One must be careful to not run the test on the same countertop as your centrifuge. This may cause a falsely elevated ESR due to the agitation of the ESR measuring tube.
Many patients with rheumatoid arthritis have a hypochromic, microcytic CBC. This is probably due to the inflammation in the rheumatoid arthritis impairing optimal bone marrow utilization of iron. This type of anemia does NOT respond to iron. Patients who take iron can actually worsen if they don't need it as the iron serves as a potent oxidant stress. Ferritin levels are generally the most reliable indicator of total iron body stores. Unfortunately it is also an acute phase reactant protein and will be elevated anytime the ESR is elevated. This makes ferritin an unreliable test in patients with rheumatoid arthritis.
One needs to be very sensitive to this clinical problem when treating patients with rheumatoid arthritis. It is frequently a complicating condition. Many times, patients will confuse the pain from it with a flare-up of their arthritis. One needs to aggressively treat this problem. If this problem is ignored, the likelihood of successfully treating the arthritis is significantly diminished.
Fibromyalgia is a very common problem. Some experts believe that 5% of people are affected with it. Over 12% of the patients at the Mayo Clinic's Department of Physical Medicine and Rehabilitation have this problem. It is the third most common diagnosis by rheumatologists in the outpatient setting. Fibromyalgia affects women five times as frequently as men.
Physicians' Protocol For Using Antibiotics in Rheumatic Disease
Signs And Symptoms of Fibromyalgia
One of the main features of fibromyalgia is the morning stiffness, fatigue, and multiple areas of tenderness in typical locations. Most patients with fibromyalgia complain of pain over many areas of the body, with an average of six to nine locations. Although the pain is frequently described as being all over, it is most prominent in the neck, shoulders, elbows, hips, knees, and back.
Tender points are generally symmetrical and on both sides of the body. The areas of tenderness are usually small (less than an inch in diameter) and deep within the muscle. They are often located in sites that are slightly tender in normal people.
Patients with fibromyalgia, however, differ in having increased tenderness at these sites than normal persons. Firm palpation with the thumb (just past the point where the nail turns white) over the outside elbow will typically cause a vague sensation of discomfort. Patients with fibromyalgia will experience much more pain and will often withdraw the arm involuntarily.
More than 70% of patients describe their pain as profound aching and stiffness of the muscles. Often it is relatively constant from moment to moment, but certain positions or movements may momentarily worsen the pain. Other terms used to describe the pain are dull and numb.
Sharp or intermittent pain is relatively uncommon. Patients with fibromyalgia often complain that sudden loud noises worsen their pain. The generalized stiffness of fibromyalgia does not diminish with activity, unlike the stiffness of rheumatoid arthritis, which lessens as the day progresses.
Despite the lack of abnormal lab tests, patients can suffer considerable discomfort. The fatigue is often severe enough to impair activities of work and recreation. Patients commonly experience fatigue on arising and complain of being more fatigued when they wake up then when they went to bed. Over 90% of patients believe the pain, stiffness, and fatigue are made worse by cold, damp weather. Overexertion, anxiety and stress are also factors. Many people find that localized heat, such as hot baths, showers, or heating pads, give them some relief. There is also a tendency for pain to improve in the summer with mild activity or with rest.
Some patients will date the onset of their symptoms to some initiating event. This is often an injury, such as a fall, a motor vehicle accident, or a vocational or sports injury. Others find that their symptoms began with a stressful or emotional event, such as a death in the family, a divorce, a job loss, or similar occurrence.
Patients with fibromyalgia have pain in at least 11 of the following 18 tender point sites (one on each side of the body):
Base of the skull where the suboccipital muscle inserts. Back of the low neck (anterior intertransverse spaces of C5-C7). Midpoint of the upper shoulders (trapezius). On the back in the middle of the scapula. On the chest where the second rib attaches to the breastbone (sternum). One inch below the outside of each elbow (lateral epicondyle). Upper outer quadrant of buttocks. Just behind the swelling on the upper leg bone below the hip (trochanteric prominence). The inside of both knees (medial fat pads proximal to the joint line).
Treatment Of Fibromyalgia
There is a persuasive body of emerging evidence that indicates that patients with fibromyalgia are physically unfit in terms of sustained endurance. Some studies show that cardiovascular fitness training programs can decrease fibromyalgia pain by 75%. Sleep is critical to the improvement. Many times, improved fitness will correct the sleep disturbance.
My favorite, and most profoundly beneficial treatment for fibromyalgia is NST.
Allergies, especially to mold, seem to be another common cause of fibromyalgia. There are some simple interventions using techniques called Total Body Modification (TBM) 800-243-4826.
Exercise For Rheumatoid Arthritis
It is very important to exercise or increase muscle tone of the non-weight bearing joints. Experts tell us that disuse results in muscle atrophy and weakness. Additionally, immobility may result in joint contractures and loss of range of motion (ROM). Active ROM exercises are preferred to passive.
There is some evidence that passive ROM exercises increase the number of WBCs in the joint. If the joints are stiff, one should stretch and apply heat before exercising. If the joints are swollen, application of ten minutes of ice before exercise would be helpful.
The inflamed joint is very vulnerable to damage from improper exercise, so one must be cautious. People with arthritis must strike a delicate balance between rest and activity. They must avoid activities that aggravate joint pain. Patients should avoid any exercise that strains a significantly unstable joint.
A good rule of thumb is that if the pain lasts longer than one hour after stopping exercise, the patient should slow down or choose another form of exercise. Assistive devices are also helpful to decrease the pressure on affected joints. Many patients need to be urged to take advantage of these. The Arthritis Foundation has a book, Guide to Independent Living, which instructs patients about how to obtain them.
Of course, it is important to maintain good cardiovascular fitness. Walking with appropriate supportive shoes is also another important consideration.
The Infectious Cause Of Rheumatoid Arthritis
It is quite clear that autoimmunity plays a major role in the progression of rheumatoid arthritis. Most rheumatology investigators believe that an infectious agent causes rheumatoid arthritis. There is little agreement as to the involved organism. Investigators have proposed the following infectious agents: Human T-cell lymphotropic virus Type I, rubella virus, cytomegalovirus, herpesvirus, and mycoplasma. This review will focus on the evidence supporting the hypothesis that mycoplasma is a common etiologic agent of rheumatoid arthritis.
Mycoplasmas are the smallest self-replicating prokaryotes. They differ from classical bacteria by lacking rigid cell wall structures and are the smallest known organisms capable of extracellular existence. They are considered to be parasites of humans, animals, and plants.
In 1939, Dr. Sabin, the discoverer of the polio vaccine, first reported a chronic arthritis in mice caused by a mycoplasma. He suggested this agent might cause that human rheumatoid arthritis. Dr. Thomas Brown was a rheumatologist who worked with Dr. Sabin at the Rockefeller Institute. Dr. Brown trained at John Hopkins Hospital and then served as chief of medicine at George Washington Medical School before serving as chairman of the Arthritis Institute in Arlington, Virginia. He was a strong advocate of the mycoplasma infectious theory for over fifty years of his life.
Culturing Mycoplasmas From Joints
Mycoplasmas have limited biosynthetic capabilities and are very difficult to culture and grow from synovial tissues. They require complex growth media or a close parasitic relation with animal cells. This contributed to many investigators failure to isolate them from arthritic tissue. In reactive arthritis immune complexes rather than viable organisms localize in the joints. The infectious agent is actually present at another site. Some investigators believe that the organism binding in the immune complex contributes to the difficulty in obtaining positive mycoplasma cultures.
Despite this difficulty some researchers have successfully isolated mycoplasma from synovial tissues of patients with rheumatoid arthritis. A British group used a leucocyte-migration inhibition test and found two-thirds of their rheumatoid arthritis patients to be infected with Mycoplasma fermentens. These results are impressive since they did not include more prevalent Mycoplasma strains like M salivarium, M ovale, M hominis, and M pneumonia.
One Finnish investigator reported a 100% incidence of isolation of mycoplasma from 27 rheumatoid synovia using a modified culture technique. None of the non- rheumatoid tissue yielded any mycoplasmas. The same investigator used an indirect hemagglutination technique and reported mycoplasma antibodies in 53% of patients with definite rheumatoid arthritis. Using similar techniques other investigators have cultured mycoplasma in 80- 100% of their rheumatoid arthritis test population.
Rheumatoid arthritis follows some mycoplasma respiratory infections. One study of over 1000 patients was able to identify arthritis in nearly 1% of the patients. These infections can be associated with a positive rheumatoid factor. This provides additional support for mycoplasma as an etiologic agent for rheumatoid arthritis. Human genital mycoplasma infections have also caused septic arthritis.
Harvard investigators were able to culture mycoplasma or a similar organism, ureaplasma urealyticum, from 63% of female patients with SLE and only 4% of patients with CFS. The researchers chose CFS as these patients shared similar symptoms as those with SLE, such as fatigue, arthralgias, and myalgias.
Animal Evidence for The Protocol
The full spectrum of human rheumatoid arthritis immune responses (lymphokine production, altered lymphocyte reactivity, immune complex deposition, cell-mediated immunity and development of autoimmune reactions) occurs in mycoplasma induced animal arthritis. Investigators have implicated at least 31 different mycoplasma species. Mycoplasma can produce experimental arthritis in animals from three days to months later. The time seems to depend on the dose given and the virulence of the organism.
There is a close degree of similarity between these infections and those of human rheumatoid arthritis. Mycoplasmas cause arthritis in animals by several mechanisms. They either directly multiply within the joint or initiate an intense local immune response. Mycoplasma produces a chronic arthritis in animals that is remarkably similar to rheumatoid arthritis in humans. Arthritogenic mycoplasmas cause joint inflammation in animals by many mechanisms. They induce nonspecific lymphocyte cytotoxicity and antilymphocyte antibodies as well as rheumatoid factor. Mycoplasma clearly causes chronic arthritis in mice, rats, fowl, swine, sheep, goats, cattle and rabbits. The arthritis appears to be the direct result of joint infection with culturable mycoplasma organisms.
Gorillas have tissue reactions closer to man than any other animal. Investigators have shown that mycoplasma can precipitate a rheumatic illness in gorillas. One study demonstrated mycoplasma antigens occur in immune complexes in great apes. The human and gorilla IgG are very similar and express nearly identical rheumatoid factors (IgM anti-IgG antibodies). The study showed that when mycoplasma binds to IgG it can cause a conformational change. This conformational change results in an anti-IgG antibody, which can then stimulate an autoimmune response.
The Science of Why Minocycline Is Used
If mycoplasma were a causative factor in rheumatoid arthritis, one would expect tetracycline type drugs to provide some sort of improvement in the disease. Collagenase activity increases in rheumatoid arthritis and probably has a role in its cause. Investigators demonstrated that tetracycline and minocycline inhibit leukocyte, macrophage, and synovial collagenase.
There are several other aspects of tetracyclines that may play a role in rheumatoid arthritis. Investigators have shown minocycline and tetracycline to retard excessive connective tissue breakdown and bone resorption while doxycycline inhibits digestion of human cartilage. It is also possible that tetracycline treatment improves rheumatic illness by reducing delayed-type hypersensitivity response. Minocycline and doxycycline both inhibit phosolipases which are considered proinflammatory and capable of inducing synovitis.
Minocycline is a more potent antibiotic than tetracycline and penetrates tissues better. These characteristics shifted the treatment of rheumatic illness away from tetracycline to minocycline. Minocycline may benefit rheumatoid arthritis patients through its immunomodulating and immunosuppressive properties. In vitro studies demonstrated a decreased neutrophil production of reactive oxygen intermediates along with diminished neutrophil chemotaxis and phagocytosis.
Investigators showed that minocycline reduced the incidence of severity of synovitis in animal models of arthritis. The improvement was independent of minocycline's effect on collagenase. Minocycline has also been shown to increase intracellular calcium concentrations that inhibit T-cells.
Individuals with the Class II major histocompatibility complex (MHC) DR4 allele seem to be predisposed to developing rheumatoid arthritis. The infectious agent probably interacts with this specific antigen in some way to precipitate rheumatoid arthritis. There is strong support for the role of T cells in this interaction.
Minocycline may suppress rheumatoid arthritis by altering T cell calcium flux and the expression of T cell derived from collagen binding protein. Minocycline produced a suppression of the delayed hypersensitivity in patients with Reiter's syndrome. Investigators also successfully used minocycline to treat the arthritis and early morning stiffness of Reiter's syndrome.
In 1970 investigators at Boston University conducted a small, randomized placebo-controlled trial to determine if tetracycline would treat rheumatoid arthritis. They used 250 mg of tetracycline a day. Their study showed no improvement after one year of tetracycline treatment. Several factors could explain their inability to demonstrate any benefits.
Their study used only 27 patients for a one-year trial, and only 12 received tetracycline. Noncompliance could have been a factor. Additionally, none of the patients had severe arthritis. Patients were excluded from the trial if they were on any anti-remittive therapy.
Finnish investigators used lymecycline to treat the reactive arthritis in Chlamydia trachomatous infections. The study compared the effect of the medication in patients with two other reactive arthritis infections Yersinia and Campylobacter.
Lymecyline produced a shorter course of illness in the Chlamydia induced arthritis patients, but did not affect the other enteric infections-associated reactive arthritis. The investigators later published findings that suggested lymecycline achieved its effect through non-antimicrobial actions. They speculated it worked by preventing the oxidative activation of collagenase.
Breedveld published the first trial of minocycline for the treatment of animal and human rheumatoid arthritis. In the first published human trial, Breedveld treated ten patients in an open study for 16 weeks. He used a very high dose of 400 mg per day. Most patients had vestibular side effects resulting from this dose.
However, all patients showed benefit from the treatment. All variables of efficacy were significantly improved at the end of the trial. Breedveld concluded an expansion of his initial study and observed similar impressive results. This was a 26-week double-blind placebo-controlled randomized trial with minocycline for 80 patients. They were given 200 mg twice a day. The Ritchie articular index and the number of swollen joints significantly improved (p < 0.05) more in the minocyline group than in the placebo group.
Investigators in Israel studied 18 patients with severe rheumatoid arthritis for 48 weeks. These patients had failed two other DMARD. They were taken off all DMARD agents and given minocycline 100 mg twice a day. Six patients did not complete the study, three withdrew because of lack of improvement, and three had side effects of vertigo or leukopenia. All patients completing the study improved. Three had complete remission, three had substantial improvement of greater than 50% and six had moderate improvement of 25% in the number of active joints and morning stiffness.
Criteria For Classification Of Rheumatoid Arthritis
Morning Stiffness - Morning stiffness in and around joints lasting at least one hour before maximal improvement is noted.
Arthritis of three or more joint areas - At least three joint areas have simultaneously had soft-tissue swelling or fluid (not bony overgrowth) observed by a physician. There are 14 possible joints: right or left PIP, MCP, wrist, elbow, knee, ankle, and MTP joints.
Arthritis of hand joints - At least one joint area swollen as above in a wrist, MCP, or PIP joint
Symmetric arthritis - Simultaneous involvement of the same joint areas (as in criterion 2) on both sides of the body (bilateral involvement of PIPs, MCPs, or MTPs) is acceptable without absolute symmetry. Lack of symmetry is not sufficient to rule out the diagnosis of rheumatoid arthritis.
Rheumatoid Nodules - Subcutaneous nodules over bony prominences, or extensor surfaces, or in juxta-articular regions, observed by a physician. Only about 25% of patients with rheumatoid arthritis develop nodules, and usually as a later manifestation.
Serum Rheumatoid Factor - Demonstration of abnormal amounts of serum rheumatoid factor by any method that has been positive in less than 5% of normal control subjects. This test is positive only 30-40% of the time in the early months of rheumatoid arthritis.
Radiological changes typical of rheumatoid arthritis on PA hand and wrist X-rays, which must include erosions or unequivocal bony decalcification localized to or most marked adjacent to the involved joints (osteoarthritic changes alone do not count).
Note: Patients must satisfy at least four of the seven criteria listed. Any of criteria 1-4 must have been present for at least 6 weeks. Patients with two clinical diagnoses are not excluded. Designations as classic, definite, or probable rheumatoid arthritis is not to be made.
Presented at the 32nd International Congress of the Great Lakes College of Clinical Medicine. Baltimore, Maryland, September 25, 1999
Dr. Joseph M. Mercola
60 Minutes Features Story on a Single Death From Naturopathic Doctor as Coverage on the 55,000 Vioxx Deaths Fades From the Headlines
Dr. Mercola's Comment: On Wednesday, Jan. 12, 2005, the TV show, 60 Minutes, did a story on Dr. Jim Shortt, a physician from North Carolina, who is accused of murdering a patient because he intravenously infused hydrogen peroxide as a treatment. Allegedly, the hydrogen peroxide produced bubbles in the patient's bloodstream that eventually caused multiple organ failure and cardiac arrest.
Using IV oxidative medicine is not something I have done before as the simple, less aggressive approaches of diet optimization, exercise programs and emotional work have been so useful for most of my patients. However, I suspect this therapy, properly applied, could be beneficial to many, and it is sad to see it being vulcanized in the popular press.
The mass media focus on Dr. Shortt has sparked a lot of controversy, confusion and debate. A friend of mine and respected colleague, Robert Jay Rowen, MD, who is president of the International Oxidation Medicine Association, asked me if I would therefore publish his insights below to help clear the air, which I urge everyone to read.
The press is concerned about one death that, upon further examination, as you will note below, might not even be related to the treatment. I certainly don't want to minimize anyone's death, but more than 55,000 people died from taking Vioxx and we are not seeing in excess of 50,000 times the press on this issue.
In fact, we are not seeing much coverage of the Vioxx horror at all from the mass media relative to that drug disaster. Shouldn't a situation responsible for so many deaths be dominating our national headlines still, as the tsunami disaster has been?
Shouldn't responsible journalists like those at 60 Minutes and all the other major TV news programs be relentlessly probing Merck and the FDA to find out all the responsible parties for the Vioxx disaster and ensure justice is served?
Why would they possibly run a "scare" story on a single physician who may or may not have been responsible for a single person's tragic death when more than 55,000 deaths have occurred due to some very serious issues with the drug companies and the FDA? Shouldn't the network news magazines, with the amount of people they reach, be diligently focused on making sure people are very wary of taking pharmaceuticals, even if they are "FDA approved," since the single FDA-approved drug Vioxx has killed more than 55,000?
Well, they should be. But then, we have to ask where the priorities of some in the mass media might really reside. We have to remember that the drug companies, including Merck, collectively "contribute" more than $3 billion a year on consumer advertising of their pharmaceuticals, most of it to the major television networks.
If only Dr. Shortt had the foresight to contribute $3 billion in advertising with the mass media, I'm quite convinced the story on him would never have aired.
By Robert Jay Rowen, MD President, International Oxidative Medicine Association
You may have heard about Dr. Jim Shortt in South Carolina. He's accused of murdering one his patients, Mrs. Katherine Bibeau, by giving her intravenous hydrogen peroxide. Maybe you read the story in your local paper or saw the hatchet job CBS did on 60 Minutes.
In charging Dr. Shortt with murder, the coroner and pathologist claim this woman died as a result of bubbles in her bloodstream. They allege these bubbles were caused by the hydrogen peroxide infusion Dr. Shortt gave his patient. But this is absolutely impossible. Let me tell you why.
Why Peroxide Therapy Is Safe
Hydrogen peroxide therapy uses the same stuff you pour on your cuts, but at much lower concentrations. The doctor takes a half-teaspoon of peroxide and dilutes it in 81/2 ounces of sugar water. That means, the peroxide Mrs. Bibeau received was just 1/100th as strong as the stuff you put on cuts.
When you put hydrogen peroxide on a cut, you get bubbles. Those bubbles are simply the hydrogen peroxide releasing oxygen.
When the peroxide enters the bloodstream, it releases oxygen there too. The roughly half-teaspoon of peroxide the doctor uses will release about 25 cc of oxygen. And since it is administered through an IV, it doesn't go in all at once but over the course of two hours.
Is that enough to have killed this woman? Look at what the mainstream medical literature says. According to one physiology textbook, it takes 50 cc of air to cause damage to the body. That damage can include a sudden drop in blood pressure or changes to the heartbeat. But that 50 cc of air would have to be administered instantly in order to cause this kind of damage. In order to kill someone, however, the medical literature says it takes 300 cc of air administered instantly. (J Vasc Interv Radiol, 2001; 12:1291-1295)
At most, Mrs. Bibeau received only 25 cc of oxygen. So even if Dr. Shortt had administered it instantly, it still would have been less than 10 percent of the amount needed to kill her.
And even if she had been given 10 times as much peroxide, it still wouldn't have killed her. Why? Because there's a huge difference between oxygen and air. Air is composed mostly of nitrogen, which remains in the blood for long periods of time and can do great harm (think of the bends in scuba divers.) Oxygen, on the other hand, is rapidly consumed, easy to absorb, and vital for good health.
Your Body Burns Oxygen Instantly
The pathologist claims that he found bubbles in Mrs. Bibeau's bloodstream. Yet she died four days after her hydrogen peroxide treatment. Could those bubbles possibly come from the hydrogen peroxide therapy? Of course not! Any pre-med student will tell you oxygen is consumed so quickly, it's impossible any bubbles would have lasted all that time. Even if she were given gallons of oxygen fast enough to kill her instantly, her body would have continued absorbing it, even after death. You see, cells remain active and continue using oxygen long after the heart stops.
But only 25 cc of oxygen, four days before and given during a two-hour IV? Your body burns that much oxygen in mere seconds! Oxygen in these amounts simply can't kill someone. And doctors who administer hydrogen peroxide therapy have known this for decades.
Wrong, Wrong, Wrong!
Hydrogen peroxide is not the monster therapy the so-called authorities are making it out to be. The medical examiner is wrong. The coroner is wrong. 60 Minutes is wrong.
There are no medical reports anywhere that indicate properly administered hydrogen peroxide could cause any of the skin markings, lab abnormalities and/or clotting in Mrs. Bibeau when she arrived at the ER. On the contrary, hundreds of reputable doctors (including me) have given millions of peroxide treatments over many, many years. And thousands of grateful patients credit this amazing therapy with saving their lives!
Hydrogen peroxide has been reported as effective for many treatments, including the following:
Asthma Yeast infections Lupus and autoimmune diseases Chronic lung diseases Legionnaire's disease Crohn's disease Peer review medical journals have reported absolutely stunning effects in human heart and circulation disease including arterial plaque removal, wound healing, pneumonia increased oxygenation and as an adjunctive treatment for cancer. And I've personally witnessed dramatic improvements in people with cardiovascular disease, cancer, multiple sclerosis and certain types of arthritis.
And in all of those cases and patient histories, there has never been any proof that properly administered hydrogen peroxide causes any harm.
So What Killed Mrs. Bibeau?
Well, here's something interesting. The coroner's report said she was taking the drugs Tegretol and Copaxone. Look these drugs up in the Physician's Desk Reference. You'll find that they cause a variety of side affects including echymosis (bruising), infection, bleeding, metorrhagia, thrombosis, clotting problems, liver damage and infections. These are the exact symptoms found in Mrs. Bibeau when she arrived at the hospital.
Peroxide has caused no significant harm in the millions of infusions worldwide given by doctors over a span of decades. Contrast that to a minimum of 140,000 deaths caused by drugs prescribed by doctors every year. That fact alone should force the pathologist to look first at the drugs as a primary cause of this woman's death, not peroxide.
So why is the system putting a spin on this death and covering up the real cause? Well, it wouldn't be the first time that an effective alternative therapy and doctor was railroaded. It's too easy for the pathologist, the coroner, and the mainstream media to attack what they don't understand.
Drugs are good, so peroxide must be bad, right? I hope you now know better!
What You Can Do
Please help spread the truth! Share this article with everyone you can. Send them to our Web site.
If you're a South Carolina citizen, you must write your state-elected officials and demand an independent investigation into the coroner's report. Demand that the death certificate reflect the real cause. You can find your state senator's information here. Locate your state representative's information at this site.
If you're not a South Carolina resident, you can still help. Please consider a contribution to Dr. Shortt's legal defense fund. Send your donation to Free Choice Legal Defense Fund, c/o Transfer Point, 1073 Statler Rd., Columbia, S.C. 29210. Any funds left over will be used to secure protection for oxidation therapies and/or press for more medical freedom laws in still unprotected states.
An innocent man's freedom is at stake. And a life-saving therapy is under attack. Please help!
(I also urge you to read more about the Associated Press story on Dr. Shortt and the hatchet job CBS did on 60 Minutes.)
No More Celebrex Ads: FDA Orders Them Off the Air
Ads for Pfizer's arthritis drug Celebrex are not only misleading and not supported by evidence, but also they overstate the drug's benefits while understating its risks, according to the Food and Drug Administration (FDA).
This finding prompted the FDA to call for "an immediate halt" to all ads (TV, print, infomercials and direct-mail) for Celebrex, which was also found in December 2004 to increase the risk of heart attacks. The government called the ads' claims, which also included claims made for related drug Bextra, "serious violations of federal law."
The FDA is considering ordering warning labels or a market withdrawal for Celebrex due to the heart risk findings. Vioxx, a related drug made by Merck & Co., was pulled from the market in the fall of 2004 due to findings that it increased risks of heart problems and stroke.
Though Pfizer, which spent over $70 million advertising Celebrex to Americans in the first nine months of 2004 alone, voluntarily pulled its ads in December 2004, they say they plan to continue marketing the drug to doctors. Sales from Celebrex and Bextra were projected to reach more than $4 billion in 2004--nearly 10 percent of Pfizer's revenue.
Five ads for Celebrex and/or Bextra were found to be in violation of federal law. Violations included:
Omitted facts, including information about risks Wrong claims of superiority Unsubstantiated claims about the drugs' effectiveness The FDA mentioned specific ads in a letter to Pfizer, which included:
A woman playing guitar with a voiceover saying, "With Celebrex, I play the long version." The FDA said this makes a claim about the drug's benefits without explaining side effects. A 27-minute infomercial that promises dramatic effects and pain-free relief, yet doesn't include information about the drug's safety or risks. Seattle Post-Intelligencer January 13, 2005
Dr. Mercola's Comment: The FDA recently "slapped" AstraZeneca's hands for false and misleading advertising of its controversial statin Crestor. Now, it looks like it's Pfizer's turn.
The "new math" the mega-billion drug companies use to make profits explains why Pfizer would be reluctant to stop marketing Celebrex to doctors. Even though Pfizer spent $70 million domestically advertising Celebrex to consumers during the first nine of months of 2004, the combined sales of Celebrex and Bextra alone will likely make up 10 percent of the company's 2004 revenues.
The drug companies stand to lose billions of dollars--Merck & Co. already lost $30 billion over Vioxx. But you stand to lose much more than that--your own health--if you continue to rely on these risky pills to cover up your symptoms.
The truth is, probably the most important way to reduce inflammation, and then chronic pain, is to eliminate sugar from your diet (and for most of us this also includes all grains). Just this simple strategy may provide you with absolutely amazing relief.
Another option? By merely changing the ratio of omega-3 to omega-6 fats--essential to human health--you already have a natural alternative to taking drugs at your fingertips. In short, you need to increase omega-3 found in fish and cod liver oils while decreasing omega-6 from nearly all vegetable seed and nut oils.
One reason for this is that the omega-3 fats EPA and DHA found in fish oil have been found, by many animal and clinical studies, to have anti-inflammatory properties that reduce joint inflammation and promote joint lubrication.
Those of you who read the newsletter regularly know that I'm a fan of Carlson's brand fish oil and cod liver oil as I have seen clear and often substantial improvements in my patients who use it. It has shown particularly positive benefits in those with rheumatoid arthritis.
You can find the Carlson's fish oil/cod liver oil at your local health food store or, for your convenience, in my Recommended Products section; Your local health food store may also be very helpful in recommending any other trustworthy mercury free brands.
Meanwhile, I strongly urge you to read my recent article about the seven ways to protect your heart using anti-inflammatory alternatives for some other tips you can start trying out today.
Related Articles: Drug Company Lies About Celebrex in JAMA How Vioxx and Celebrex Increase Your Risk of Heart Attack Celebrex and Vioxx Increase Heart Disease Risk Celebrex Not Shown to Lower Ulcer Risk Further Evidence That Celebrex Is Not All It Is Cracked Up to Be In Light of Vioxx, Bextra Getting A Closer Look
After one popular pain-killing drug, Merck's Vioxx, was pulled from the market and two others, Pfizer's Bextra and Celebrex, had their safety severely questioned, many Americans are opting to leave their anti-inflammatory drugs on the shelf -- and understandably so.
These drugs are in a class of painkillers known as cox-2 inhibitors, which are part of a larger class known as nonsteroidal anti-inflammatory drugs (NSAIDS), and are often used to treat arthritis and other pain. Let's take a quick look at these drugs' disturbing past:
Vioxx was pulled from the market in September 2004 after a study showed that patients taking the drug faced twice the risk of heart attack
Bextra was found to double the risk for heart attack and stroke
The National Institutes of Health announced, also in December 2004, that over-the-counter pain reliever Aleve has been linked to an increased risk of heart attack and stroke
In light of all of these significant warning signs, increasing numbers of patients, particularly those with arthritis, are seeking pain relief through alternative methods -- and they're in luck. Probably the most important way is to reduce inflammation is to eliminate sugar from your diet and for most of us that also includes all grains. Just this simple strategy may provide amazing relief.
If eliminating sugar and grains doesn't provide you with the relief you seen then the following herbal solutions provide the benefits of painkilling drugs without raising your risk of serious health problems like heart attacks and stroke.
You should work with your own knowledgeable health care professional, someone who understands natural medicine, to develop the best combination of herbal alternatives for you.
Ginger: This herb is anti-inflammatory and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice. Powder capsules are also available, but I recommend using the fresh root.
Boswellia: Also known as boswellin or "Indian frankincense," this herb contains specific active anti-inflammatory ingredients, referred to as boswellic acids that animal studies have shown significantly reduce inflammation. This is one of my personal favorites as I have seen it work well with many of my rheumatoid arthritis patients
And in another study of 175 patients with rheumatic disorders such as rheumatoid arthritis, 122 participants had reduced stiffness and inflammation just two to four weeks after starting on boswellia.
Fish Oils: The omega-3 fats EPA and DHA found in fish oil have been found, by many animal and clinical studies, to have anti-inflammatory properties that reduce joint inflammation and promote joint lubrication.
Animal based omega-3 fats are absolutely essential for any comprehensive anti-inflammatory program. They form the precursors to the molecules that actually produce or inhibit inflammation in your body (prostaglandins). That is why it is essential to make sure you are getting enough. It is also vital to understand that you need to reduce omega-6 fats like vegetable oils seeds and nuts, as it is actually the ratio of omega 6:3 fats that determines how much inflammation is present. You could theoretically consume enough omega-3 fish oils to work but then ruin the effect by consuming too many omega-6 fats.
Those of you who read the newsletter regularly know that I'm a fan of Carlson's brand fish oil and cod liver oil as I have seen clear and often substantial improvements in my patients who use it. It has shown particularly positive benefits in those with rheumatoid arthritis.
You can find the Carlson's fish oil/cod liver oil in my Recommended Products section; your local health food store may also carry Carlson's, and usually they are very helpful in recommending any other trustworthy brands.
Bromelain: This enzyme, found in pineapples, is a natural anti-inflammatory. It can be taken in supplement form, but eating fresh pineapple may also be helpful.
Cetyl Myristoleate (CMO): This oil, found in fish and dairy butter, acts as a "joint lubricant" and an anti-inflammatory. The delicious raw butter we carry from organic pastures contains "Wulzen anti-stiffness factor." This factor has been found to be highly effective in reversing arthritis and protects against calcification of joints. I have also used this for myself to relieve ganglion cysts and a mild annoying carpal tunnel syndrome that pops up when I type too much on non-ergonomic keyboards. I used a topical preparation for this.
In one study of 106 people with various types of arthritis who did not respond to NSAIDs, 63.5 percent of those who took CMO orally and applied the cream topically (it's available both in oral supplement and cream forms) improved, compared to only 14.5 percent of those taking a placebo.
Evening Primrose, Black Currant and Borage Oils: These contain the essential fatty acid gamma linolenic acid (GLA), which is useful for treating arthritic pain. These are the exception to omega-6 fats that are necessary to have in your diet. It is reasonable for many to take these as a supplement, particularly if you struggle with dry skin in the winter, as this is a strong indicator that you are deficient in these fats
In one study of 37 rheumatoid arthritis patients, those who received 1.4 grams of GLA per day reduced the number of tender joints by 36 percent, the tenderness of the joints by 45 percent, the number of swollen joints by 28 percent, and the degree of joint swelling by 41 percent. The placebo group showed no significant improvements.
I personally prefer the use of GLA supplements from evening primrose oil but borage oil contains a higher concentration of GLA, which means you need fewer capsules, and it tends to be less expensive.
Cayenne Cream: Also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting the body's supply of substance P, a chemical component of nerve cells that transmits pain signals to the brain.
Related Articles (on www.mercola.com): Finally -- FDA Admits That ALL Anti-Inflammatories May Kill You
Vioxx and Celebrex (Cox-2 Inhibitors) May Affect Kidneys
How Vioxx and Celebrex Increase Your Risk of Heart Attack
Warning: Taking Bextra May Harm Your Health
In Light of Vioxx, Bextra Getting A Closer Look
Two Tried-and-True Tips for Pain Relief
Evil Marketing Geniuses
A generic version of the cholesterol-lowering statin drug Zocor has received tentative approval, with final approval expected in late June 2006.
As a result, the drug's manufacturer, Teva Pharmaceutical Industries, is expected to gain significant profits, and has been given a "buy" rating by Standard & Poor's Equity research.
Generic Zocor will likely cost 35 cents or less a day, compared to brand-name cholesterol drugs like Pfizer's Lipitor, which sells for $2 or more a day.
Statin drugs are among the nation's best-selling medications, bringing in $16 billion in 2005. Part of the reason behind the growing popularity of statin drugs may be due to changes in the National Cholesterol Education Program committee guidelines for treating cholesterol back in 1993, and again in 2004.
The changes lowered the LDL cholesterol levels that were advised to be treated with drug therapy -- thereby significantly increasing the statin market.
Forbes.com May 26, 2006
Dr. Mercola's Comment: The health care field has evolved into a facade for the business of selling drugs. The pharmaceutical industry spends more than $4 billion a year to market drugs to consumers in the United States and more than $16 billion to market them to U.S. physicians. Moreover, they have come up with some of the most effective and creative marketing schemes in history.
You probably didn't know that top U.S. drug makers spend 2.5 times as much on marketing and administration as they do on research, and at least a third of the drugs marketed by industry leaders were discovered by universities or small biotech companies.
YET drug companies justify their extremely high prices by saying they need this money to cover their high R&D costs.
Hogwash. They need to charge high prices to increase their profits, period. After all, they need to maintain their status as one of the most profitable industries on the planet.
One particularly pernicious marketing strategy they use is to create an illness where none existed before so they can offer you an expensive solution. Does this sound too incredible to be true?
To be sure, let's examine the cholesterol issue. In 2001 Dr. Antonio M. Gotto, Jr., dean of Cornell University Medical College, spoke at a press conference at the XII International Symposium on Atherosclerosis. He predicted more than half the population of the United States could one day be taking daily doses of cholesterol-lowering statin drugs.
As if to make Dr. Gotto's prediction true, later in 2001 the drug companies were able to manipulate the National Cholesterol Education Program committee to change the 1993 guidelines for treating those with cholesterol.
They modified the recommendations to include anyone with an LDL (bad cholesterol) level from 130 to 100 to be a candidate for drug therapy. This one change increased their potential market in the United States alone by more than 36 million people. This tripled the number of people that were eligible for cholesterol-lowering medications.
Then, in 2004, the same federal committee reduced the level even further to 70. It is difficult to obtain estimates, but it is likely that this added tens of millions of potential new candidates for their expensive solution.
What is their solution? Using drugs that in no way, shape or form treat the problem and are required to be taken indefinitely. Lipitor alone generates more than $10 billion a year in annual sales.
Drug Industry Lies About New Drug Research and Development
The pharmaceutical industry spends about one-fifth of what it says it spends on the research and development (R&D) of new drugs, destroying the chief argument it uses against making prescription drugs affordable to middle and low-income seniors, a Public Citizen investigation has found.
A Public Citizen report reveals how major U.S. drug companies and their Washington lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), have carried out a misleading campaign to scare policymakers and the public.
PhRMA's central claim is that the industry needs extraordinary profits to fund "risky" and innovative research and development to discover new drugs. In fact, taxpayers are footing a significant portion of the R&D bill, which is much lower than the companies claim.
This R&D scare card is built on myths and falsehoods that are maintained by the drug industry to block Medicare drug coverage and measures that would rein in skyrocketing drug costs.
Public Citizen based the study on an extensive review of government and industry data and a report obtained through the Freedom of Information Act from the National Institutes of Health (NIH). Among the report's key findings:
The actual after-tax cash outlay - what drug companies really spend on R&D for each new drug (including failures) - is approximately $110 million (in year 2000 dollars.) This is in marked contrast with the $500 million figure PhRMA frequently touts.
The NIH document shows how crucial taxpayer-funded research is to the development of top-selling drugs. According to the NIH, U.S. taxpayer-funded scientists conducted at least 55 percent of the research projects that led to the discovery and development of the five top-selling drugs in 1995.
Public Citizen found that, at most, about 22 percent of the new drugs brought to market in the past two decades were innovative drugs that represented important therapeutic advances. Most new drugs were "me-too" or copycat drugs that have little or no therapeutic gain over existing drugs, undercutting the industry's claim that R&D expenses are used to discover new treatments for serious and life-threatening illnesses.
A second report issued today by Public Citizen, The Other Drug War: Big Pharma's 625 Washington Lobbyists, examines how the U.S. drug industry spent an unprecedented $262 million on political influence in the 1999-2000 election cycle. That includes $177 million on lobbying, $65 million on issue ads and $20 million on campaign contributions. The report shows that:
The drug industry hired 625 different lobbyists last year - or more than one lobbyist for every member of Congress - to coax, cajole and coerce lawmakers.
The one-year bill for this team of lobbyists was $92.3 million, a $7.2 million increase over what the industry spent for lobbyists in 1999. Drug companies took advantage of the revolving door between Congress, the executive branch and the industry itself.
Of the 625 lobbyists employed in 2000, more than half were either former members of Congress (21) or worked in Congress or other federal agencies (295).
The industry's $20 million in campaign contributions and millions more in issue ads attacking candidates opposed by the industry aided its army of lobbyists in gaining access to congressional representatives.
The drug industry is stealing from us twice:
First it claims that it needs huge profits to develop new drugs, even while drug companies get hefty taxpayer subsidies.
Second, the companies gouge taxpayers while spending millions from their profits to buy access to lawmakers and defeat pro-consumer prescription drug legislation.
Rep. Pete Stark (D-Calif.), the ranking Democrat on the House Ways and Means Health Subcommittee, added, "Not surprisingly, pharmaceutical companies have been deceiving Congress and the American public for years.
Worried that a benefit would lead to discounted prices in the lucrative senior citizen market, the industry spent a record $262 million on political influence in the 1999-2000 election cycle.
The report, The Other Drug War: Big Pharma's 625 Washington Lobbyists, documents how the U.S. drug industry spent $177 million on lobbying, $65 million on issue ads and $20 million on campaign contributions - more than any other industry in 1999-2000.
"The drug industry is one of the more hypocritical industries around," said Frank Clemente, director of Public Citizen's Congress Watch. "It claims to be working for consumers when in fact it uses profits from sales to buy access to lawmakers and defeat pro-consumer prescription drug legislation." Among the report's highlights:
Public Citizen's Congress Watch July 23, 2001
For the full-text reports from Public Citizen, click on the links below:
Rx R&D Myths: The Case Against The Drug Industry?s R&D "Scare Card"
The Other Drug War: Big Pharma's 625 Washington Lobbyists
The World's Weirdest Deaths
Do You Fear Death and Disease? Disease, and inevitably, death, is a reality that preoccupies many of us, at least in terms of trying to put it off for as long as possible. The good news is, if you make the right lifestyle choices, you may not have to worry about facing either for a very long time, barring accidents like getting in the way of a spinning helicopter blade, or engaging in self destructive behavior.
This site is loaded with thousands of pages that can educate you about simple inexpensive lifestyle choices that will allow you to avoid dangerous medications so you can live as long as you were designed to with as much function, energy and vitality as you can possibly achieve.
Whether you believe that you are a victim of your gene pool, or master of your own life; whether you believe this existence is only a transition to the next level, or that once you die there is “nothing,” doesn't change the inevitable outcome of course, but it does change your frames of reference when contemplating disease and death.
The Time to Change Your Frame of Reference is NOW
One of the primary reasons behind the enduring rift between conventional medical science and natural healing techniques is the contrasting nature of their basic philosophies about what disease is.
Conventional medicine tends to view organisms as machines, made of various parts that are either functioning properly or have somehow failed.
Most who practice natural medicine, however, strongly believe that there is a vitalizing force that activates your body. Some refer to this as your soul, psyche, spirit, or life force. This pervasive divine intelligence guides every cell in your body toward health and healing, as long as you cooperate.
Your body was designed to move toward health, not toward disease.
Unfortunately, contemporary society throws many barriers in your way with its pervasive fraud, deception and toxic influences.
Several doctors and scientists, including Bruce Lipton, PhD., Dr. Geerd Hamer, and Dr. David Holt, are finally bringing these concepts out into the open, with plenty of scientific proof to back their claims; that you are not a victim of your genes or of nefarious “bugs.” That your mind in fact controls your genetic expression, which means you are in the driver’s seat; you are your own creator, and your ability to heal is ever present, provided your body’s natural functions are not thwarted by toxic substances, such as synthetic pharmaceutical drugs.
Did you know that the death rate actually decreases when doctors go on strike? How could that be? How could you heal better without medical intervention?
Well, according to Dr. Geerd Hamer’s German New Medicine, the signs and symptoms that conventional medicine views as “disease,” are in fact signs of a HEALING CRISIS; once it’s over, you’re well on your way to be fully cured and good as new. Unfortunately, conventional medicine views this healing cycle as something to be eradicated, and put you on invasive treatments, which either delays or stops your natural healing altogether…
The Art of Healing; “Allowing Health,” Not “Fighting Disease”
With that in mind, is it any wonder that up to 80 percent of people actually end up dying in a hospital? And, if you read Dr. Gary Null's excellent piece "Death by Medicine" you will discover that adverse reactions from prescription drugs are responsible for nearly three-quarters of a million avoidable deaths EVERY YEAR in the United States alone.
We no longer die of old age. We die from inappropriate medical interventions that derail our bodies’ natural healing capacity.
All the more reason to seek out better, safer solutions to treat your health problems rather than relying on dangerous over-the-counter or prescription medications. Nearly the entire modern health care system is responsible for allowing countless unnecessary drugs to be prescribed, which leads directly to these prescription drug fatalities.
The fact is, prescription and over-the-counter drugs, designed to “fight disease,” kill more people every year than the combined deaths of all those who die from the use of every illegal drug in existence. So although a distinction is made between legal prescription drugs and illegal drugs used for recreational purposes there really isn't much difference is there?
What many people do not realize is that it is possible to maintain total health by avoiding unnecessary drugs and by gaining a comprehensive, clear and researched understanding of good nutrition and proper lifestyle choices, and by allowing healing, including the healing crisis, to take place without panicking.
Because it’s not a matter of IF you’re going to die. It’s a matter of HOW. For me, dying quietly and painlessly in old age would be a “good death,” far preferred over dying from toxic poisoning, due to corporate and governmental greed and immorality.
Jack Daniel's much needed Anger Management In 1911, Jack Daniel, founder of the famous Tennessee whiskey distillery, died of blood poisoning due to a toe injury he received after kicking his safe in anger when he could not remember its combination code.
Decapitated by his car's drive chain, but it was worth it! In 1927, British racing driver J.G. Parry-Thomas was decapitated by his car's drive chain when it snapped. He was attempting to break his own Land speed record. Incredibly enough, despite being killed in the attempt, he succeeded in setting a new record of 171 mph.
He swallowed a toothpick at a party In 1941, writer Sherwood Anderson, swallowed a toothpick at a party and then died of peritonitis.
Four weeks without water in the Libyan Desert In 1943, Lady be Good, a USAAF B-24 bomber, lost its way and crash landed in the Libyan Desert. The Mummified remains of its crew, who struggled for a week without water, were not found until 1960.
The jockey died but the horse kept going ... and WON! In 1953, jockey Frank Hayes suffered a heart attack during a horse race. The horse, Sweet Kiss, went on to finish first, making Hayes the only deceased jockey to win a race.
The right song for his last performance In 1960, famed baritone Leonard Warren collapsed on the stage of the New York Metropolitan Opera of a massive stroke during a performance of "La forza del destino" (The force of destiny).
"Are we boring you, Mr. Rodale?" In 1971, Jerome Irving Rodale, an American pioneer of organic farming, died of a heart attack while being interviewed on the *** Cavett Show. When he appeared to fall asleep, Cavett quipped "Are we boring you, Mr. Rodale?" The show was never broadcast.
Assassinated with an umbrella In 1978, Bulgarian dissident Georgi Markov was assassinated by poisoning in London by an unknown assailant who shot him in the leg with a specially modified umbrella that fired a metal pellet full of ricin poison.
Decapitated by a helicopter blade In 1982, actor Vic Morrow was decapitated by helicopter blade during filming of "Twilight Zone: The Movie" and was killed instantly, along with child actors Myca Dinh Le and Renee Shin-Yi Chen.
A foil pierced his eyeball and entered his brain Also in 1982, Olympic champion fencer Vladimir Smirnov died nine days after his opponent's foil snapped during a match, pierced his eyeball and entered his brain.
Wasn't that just part of the act? In 1983, British magician Tommy Cooper died on stage at Her Majesty's Theatre during a live television routine. Most of the audience and viewers believed it was part of his act.
Brandon Lee and the magic bullet In 1993, Brandon Lee, the son of Bruce Lee, was shot and killed by a prop .44 Magnum while filming the movie The Crow. The scene involved the firing of a full-powder blank (full charge of gunpowder, but no bullet) at Brandon's character. However, unknown to the film crew, a bullet was already lodged in the barrel.
As you said: "Too bad you can only live so long" In 1996, Richard Versalle suffered a heart attack onstage at the New York Metropolitan Opera after delivering the line "Too bad you can only live so long" during a performance of The Makropulos Case.
Too much Viagra killed the dictator In 1998, Nigerian dictator Sani Abacha died at his residence in Abuja of a heart attack, rumored to have been caused by the ingestion of large quantities of the drug Viagra.
Prince of Nepal didn't like his Royal Family
In 2001, on June 1, Crown Prince Dipendra of Nepal, enraged from a dispute over his marriage arrangements (and possibly intoxicated), went on a rampage at dinner and massacred nearly the entire Royal Family, including his father the king. But in accordance with custom and tradition, Dipendra, then in a coma due to wounds sustained either from palace guards or a botched suicide attempt, became king for three days before dying on June 4.
Nasty weather for this environmentalist In 2003, American environmentalist Timothy Treadwell, self-proclaimed "eco-warrior" that had lived in the wilderness among bears for thirteen summers in a remote portion of Alaska, was killed and partially consumed along with his girlfriend Amie Huguenard after they had been slated to leave due to the impending harsh winter in Alaska. A critically-acclaimed documentary about the incident, Grizzly Man, was released in 2005.
Cholesterol-Lowering Drugs: What Are Drugmakers Hiding?
Nearly two years after a clinical trial of the cholesterol-lowering drugs Zetia and Vytorin was finished, the results have still not been released by the drugs’ makers (Merck and Schering-Plough).
Yet, close to 800,000 prescriptions for the drugs are written each week in the United States, bringing in close to $4 billion for the year.
The companies have responded to cardiologists’ concerns over the lack of safety data for the drugs by promising to publish only a portion of the results in March, a move that critics are calling highly unusual.
Currently, no one knows whether Zetia and Vytorin are as effective as other cholesterol-lowering medications called statins. If they turn out to be less so, patients may be unnecessarily at risk of heart attacks.
Zetia was approved by the U.S. Food and Drug Administration in 2002 because it was found to lower LDL cholesterol by 15 to 20 percent. Vytorin combines Zetia with Merck’s statin drug, Zocor.
Together, the drugs have acquired close to 20 percent of the U.S. market for cholesterol-lowering drugs.
However, because Zetia and Vytorin work differently than standard statin drugs, cardiologists have expressed concerns that they may not protect the cardiovascular system as much as using a statin does.
Drugmakers Changed the Trial’s Endpoint
Along with announcing that they will only be releasing part of the clinical trial’s results, Merck and Schering-Plough said they had changed the trial’s endpoint, or the final result the study was supposed to measure.
Typically, the trial’s endpoint is supposed to remain constant because otherwise the study’s authors could change their goals to conform to the data they received.
The delay in publishing the study’s results raise further questions as to whether the drug industry is improving their disclosure of clinical trials.
Two years ago drugmakers promised to disclose study results publicly, however they face few penalties for failing to do so.
Sources: New York Times November 21, 2007
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Dr. Mercola's Comments: It is a common trick of the drug cartel to overwhelmingly make public only the positive results to their clinical trials. And if it doesn’t look like you’re going to get any positives, well then you just change what you were looking for (which could easily be the purpose behind Merck and Schering-Plough’s decision to change their trials endpoint).
But the thing that gets me the most riled up is the blatant fact that millions of Americans have been taking these drugs, and paying for the privilege, without any solid evidence whether they’re truly effective (let alone what the real risks are).
The cardiologists referred to in the New York Times article are right to express concern over prescribing drugs that may or may not work. But they missed the boat in comparing these newer cholesterol-lowering drugs to their “gold standard,” the statins. In reality, neither drug is the answer.
PLEASE Understand -- Drugs are Not Your Answer to High Cholesterol
It may surprise you to learn that cholesterol is not the major culprit in heart disease or any disease. It may surprise you even more to learn that the guidelines that dictate what number your cholesterol levels should be to keep you “healthy” are fraught with conflict of interest -- and have never been proven to be good for you.
It is VERY rare for anyone to need cholesterol-lowering drugs. Among the more than 20,000 patients who have come to my clinic, only four or five of them truly needed these drugs, as they had genetic challenges that required it. If you or someone you know is taking them, odds are very high, greater than 100 to 1, that you or they don't need it.
This is true whether the drugs are statins or the newer Zetia and Vytorin.
You should know that among the many dangers of statins drugs is an increased risk of heart disease. This is because patients taking statins become depleted in Coenzyme Q10 (CoQ10), which leads to fatigue, muscle weakness, soreness and, ironically, heart failure.
The FDA has had a petition to label statin packages with a warning about statin-induced CoQ10 depletion for years, but nothing has been done about it. Some of the other risks of statin drugs include:
Weakness Muscle aches An increase in cancer risk Immune system suppression Serious degenerative muscle tissue condition (rhabdomyolysis)
Potential increase in liver enzymes so patients must be monitored for normal liver function What can you do to protect your heart and keep your cholesterol levels where they naturally should be, without exposing yourself to these outlandish risks?
Reduce, with the plan of eliminating, grains and sugars in your daily diet. Eat the right foods for your nutritional type.
Get the right amount of exercise. For the vast majority of people, it really is as simple as that.
Common Cholesterol Drug Lowers Cholesterol but Not Death Rate
Numerous studies have shown that statins, drugs to lower cholesterol, can reduce rates of heart disease and prevent heart disease by lowering cholesterol levels, however a new study involving the statin pravastatin, known as Pravachol, proved otherwise.
In the study, which compared the effects of pravastatin versus the usual care recommended by physicians on cholesterol levels of over 10,000 people, found that the drug did not reduce the risk of death or heart disease in those with moderately high cholesterol and high blood pressure. Though statins have been the subject of many clinical trials, groups of people, such as women and certain racial groups, and individuals such as those with well-controlled hypertension and diabetes, were not adequately represented. The new study used a wide range of people -- made up of almost half women, 38 percent black, 35 percent with a history of diabetes, and 55 percent aged 65 years or older -- to assess the drug’s effects.
Results showed that pravastatin did indeed lower cholesterol, with a decrease of 17 percent in total cholesterol levels among those taking statin, compared with eight percent in the usual care group after four years of the study. Levels of LDL, bad cholesterol, had also dropped -- 28 percent among those taking pravastatin and 11 percent in the usual care group.
However, while lowered LDL cholesterol has been shown to reduce the risk of stroke and heart attack, study participants who took pravastatin and those who received usual care showed the same rates of death and heart disease.
JAMA December 18, 2002;288:1998-3007,3042-3044
Dr. Mercola's Comment This raises the question of whether statin drugs even work to lower the risk of heart disease. I haven’t examined this issue for some time, but this study provides an opportunity to review the basics and provide some practical alternatives.
First, it is important to remember history. Less than 18 months ago Baycol, a statin drug, was removed from the market because dozens of deaths had been associated with its use, causing nearly 750,000 people to stop taking the drug.
If you were to believe the "experts," half of Americans should be placed on these statin drugs.
However, nothing could be further from the truth. As the study above suggests, when you treat the symptoms of high cholesterol with a drug you are in no way, shape or from treating the cause. So it should come as no surprise that they do not work to lower the overall death rate.
However, there are some simple things one can do to normalize cholesterol levels.
The first is to normalize your insulin levels by eliminating sugar and grains. This works for most people unless they have a genetic defect called familial hypercholsterolemia.
Secondly you can take a high-quality fish oil that is chock full of beneficial omega-3 fatty acids. It is important to find a fish oil that is independently tested by a lab and found to conform to purity guidelines. This will ensure that the oil is free of mercury and other toxins. One such brand, which I have found to be of superior quality, is Carlson’s fish and cod liver oil, and I now offer this exceptional fish oil/cod liver oil to you in my "Recommended Products" section.
Additionally, if you are a man, or a woman who is in menopause, you should check your iron levels as elevated levels of iron can cause major oxidative damage in the blood vessels, heart and other organs. Excess iron is also one of the major contributing factors of cancer risk.
Regular exercise is another important tool that may reduce your risk of heart disease.
The Baycol Recall: How Safe Is Your Statin?
Women Can Have Too Much Iron
Iron Can Have Devastating Effects on Your Health
Exercise Could Wipe Out Effect of Stress on Heart
The Truth About Cholesterol-Lowering Drugs (Statins), Cholesterol and Health Do you or someone you love take statin drugs? Are you considering them? If so, please keep reading ?
With at least 12 million Americans taking cholesterol-lowering drugs, mostly statins, and experts' recommendations that another 23 million should be taking them, it's important to remain educated on this issue, the primary one being that they're linked to many, many dangerous side effects.
Statins currently available on the U.S. market include:
Lipitor (atorvastatin) - Pfizer Zocor (simvastatin) - Merck Pravachol (pravastatin) - Bristol-Myers Squibb Lescol (fluvastatin) - Novartis Mevacor (lovastatin) - Merck Crestor (rosuvastatin) - AstraZeneca Click on the individual drug names above to view their prescribing information, commonly known as the "package inserts."
Cholesterol is NOT the Cause of Heart Disease
Yes, this is a startling statement but it is true. Learn why from one of the leading alternative physicians in the country. If you believe you have cholesterol problems this is a MUST READ article for you.
Crestor and Other Statins: Are They Really Worth the Risk? The statin Crestor is being promoted as the "best" statin drug on the market, but are any of these cholesterol-lowering drugs worth the serious risks they pose? And, is lowering cholesterol really the best way to prevent heart disease in the first place?
Will Statins Become OTC Drugs in the U.S.? Merck's attempt to sell their cholesterol-lowering drug Mevacor over the counter has some experts worried. Find out why this attempt has been called "a very bad idea."
More Insane Uses for Statin Drugs Do you have statins in your medicine cabinet? Find out which statins were removed from pharmacy shelves because of dangerous side effects.
The Truth About Crestor: Is Crestor Dangerous And, if so, Why? The intensive marketing of the super-strong cholesterol-lowering statin drug is setting off warning bells among many doctors and patients. Is Crestor putting you at risk?
The Dangers of Statin Drugs: What You Haven't Been Told About Cholesterol-Lowering Medication If you're one of the millions of Americans currently taking statin drugs, don't miss this important and revealing article. Find out what you haven't been told about statin drugs to lower cholesterol that could dramatically affect your health today and in the future.
Statins, Calcium a Deadly Mix Even if cholesterol levels are under control with taking statins, you still might be at risk of having a heart attack. Find out how calcium build-up in the coronary arteries is counteracting the benefits of statins.
Cholesterol Lowering Drugs to Go Over the Counter Some of the world's biggest drug companies have been busy trying to convince regulators to allow cholesterol-lowering statin drugs to be sold over the counter. See how the United States could be next in line after Britain in making the move to selling cholesterol-lowering drugs over the counter.
Will Cholesterol Drugs go Over the Counter Soon? Dangerous statin drugs, used by millions of Americans to lower cholesterol, may soon be available over the counter. Find out why these drugs are not a good way to normalize your cholesterol.
Safety Concerns Surround the Latest Statin, Crestor Some experts are concerned by this drug's potential serious side effects. Find out how to lower your cholesterol naturally and avoid dangerous statin drugs.
Cholesterol Drugs Actually Cause Heart Disease Cholesterol drugs are prescribed for millions of people even though they lead to a life-threatening deficiency of CoQ10, which can actually cause heart failure.
'Experts' Recommend Higher Doses of Cholesterol Drugs 'Experts' say using high doses of cholesterol drugs can reduce the risk of heart attack, bypass surgery and chest pains. Find out how this could affect your physical and financial status.
The Cure for High Cholesterol--Hint it is NOT a Drug Avoid using statin drugs to lower cholesterol levels with these natural solutions and reap great health as a side effect. If you or someone you know has high cholesterol this is a must read.
New Cholesterol Guidelines Issued New federal guidelines have changed the "normal" range for cholesterol so now even more people will be put on cholesterol-lowering drugs.
New Cholesterol Guidelines for Converting Healthy People into Patients Instead of preventing cardiovascular disease, the new guidelines may transform healthy individuals into unhappy hypochondriacs obsessed with the chemical composition of their food and their blood, destroy the joy of eating, and divert health care money from the sick and the poor to the rich and the healthy.
Cholesterol Guidelines Fraught With Massive Conflict of Interest Eight of the nine influential doctors responsible for forming new cholesterol guidelines may be blinded by dollar signs. It seems they have been making money from drug companies by urging patients to take their drugs.
Lunatic Recommendations For Statin Drug Use "Experts" from the American College of Physicians recommended that most diabetics should be taking cholesterol-lowering medication to reduce their risk of having a heart attack--even if their cholesterol levels fell in the normal range.
More Reasons to Avoid Statin Drugs / Does Lipitor Raise Lp(a)? Lipoprotein (a) is one of the strongest indicators for heart disease, yet very few doctors check their patients' Lp(a) levels. What's worse is that when they do, they often prescribe statin drugs as a solution to elevated levels.
Common Cholesterol Drug Lowers Cholesterol but Not Death Rate In one of the largest cholesterol-drug trials ever conducted, statins did not lower death rates. Find out what you can do to lower your risk of heart disease, the number one killer in the United States.
Cholesterol-Lowering Drugs are Less Effective in Reality than in Trials Cholesterol levels dropped one-third less than expected among statin users. People must take the pills in order for them to be effective and many forget or choose not to.
Cholesterol Drugs: How Expensive is Too Expensive? It may be too expensive to treat every person who has high cholesterol with cholesterol-lowering statin drugs. Better alternatives reviewed.
Cholesterol Lowering Drugs Suppress Immune System Statins, have been found to suppress the immune system. In an interesting twist on the findings of this adverse effect, however, it is being hailed as a benefit. The researchers have focused on the fact that the drugs may be useful for treating transplant patients. However, how this immune suppression could affect the vast majority of patients taking the drugs is not discussed.
Low Cholesterol Causes Aggressive Behavior Despite the fact that most people are worried about having cholesterol levels that are too high, yet another study has found that low cholesterol is actually associated with adverse behavioral effects such as aggression and depression.
Low Cholesterol Linked to Depression Results of a study conducted by Dutch researchers provide additional evidence for a link between low cholesterol levels and an increased risk of depression in men.
HALF the population will be taking Statins A prominent medical authority announced his prediction that 50 percent of the entire U.S. population could be taking statin medication.
Low Cholesterol Linked to Stroke Risk If your cholesterol levels are too low, it may increase your risk of stroke.
Low Cholesterol Linked to Violence Lowering cholesterol could trigger changes in brain chemistry that encourage violent behavior.
The Baycol Statin Recall and Safety Issue:
In August 2001, Bayer AG, the maker of Baycol (cerivastatin), a popular cholesterol-lowering drug used by about 700,000 Americans, pulled the medicine off the market after 31 people died from severe muscle breakdown, a well-recognized side effect of cholesterol-lowering drugs. Related articles follow:
Statins: Is the Danger in the Dose? Here is the hard data on Baycol-associated adverse reactions. If you or someone you know is taking one of the statin cholesterol-lowering drugs, this is a "must-read" article by Jay Cohen, MD to help you understand the potential dangers that this exposes you to.
Baycol Pulled From Market as Numerous Deaths Linked to It Baycol, a cholestrol-lowering drug (statin), has been voluntarily pulled off the market because of numerous deaths associated with its use.
The Baycol Recall: How Safe is Your Statin? With the recall of Baycol, patients are now searching out a new drug to take its place, but are other statins really safe? Here are some precautions necessary for anyone taking Baycol or any statin.
Baycol: Another Fluoride Drug Bites the Dust Baycol is just one of many fluoride drugs to be pulled from the market due to health hazards posed. Read about this and some of the others in this informative article written by Andreas Schuld and Wendy Small.
BMJ: Bayer faces potential fine over cholesterol lowering drug Bayer might have to pay a fine to the German government of about $23,400 for withholding from the German authorities information on the drug's potentially fatal interaction with another drug.
Lipitor Tied to Liver, Kidney Injury, as Well as Muscle Damage It seems that Baycol is not alone among cholesterol lowering drugs in posing serious dangers to the public. A number of legal actions are also being pursued against Pfizer Inc., the manufacturer of the Lipitor.
Excerpts from Public Citizen's Health Research Group's Petition to Require a Box Warning on All HMG-CoA Reductase Inhibitors ("Statins"):
" ... Public Citizen, representing 135,000 consumers nationwide, hereby petitions the FDA pursuant to the Federal Food, Drug and Cosmetic Act 21, U.S.C. Section 355(e)(3), and C.F.R. 10.30, to add a black box warning and additional consistent bolded warnings about this serious problem to the label of all statins marketed in the United States."
"Doctors and the public must be warned to immediately discontinue use of statin drugs at the onset of muscle pain, muscle tenderness, muscle weakness or tiredness."
"Prompt cessation of the use of statins at the first sign of muscle pain, muscle tenderness, muscle weakness or tiredness and prompt evaluation by a physician including a blood test for creatine phosphokinase (a measure of muscle destruction) may avoid the progression to more extensive muscle damage, rhabdomyolysis and death."
"Rhabdomyolysis has been reported with all statins currently marketed in the United States."
About the Experts
Joseph Mercola, DO Medical Director of the Optimal Wellness Center and www.mercola.com. Read about my complete background information.
Uffe Ravnskov, MD Born 1934 in Copenhagen, Denmark Graduated 1961 from the University of Copenhagen with an M.D. 1961-1967: Various appointments at surgical, roentgenological, neurological, pediatric and medical departments in Denmark and Sweden. 1968-1979: Various appointments at the Department of Nephrology, and the Department of Clinical Chemistry, University Hospital, Lund, Sweden. 1975-79: As an assistant professor at the Department of Nephrology. 1973: PhD at the University of Lund. 1979-2000: A private practitioner. Since 1979 an independent researcher. A specialist in internal medicine and nephrology. Honored by the Skrabanek Award 1998.
Uffe Ravnskov is the author of The Cholesterol Myths.
For more information about him, see Dr. Ravnskov's Web site.
Jay Cohen, M.D., is an associate professor of Family and Preventative Medicine and of Psychiatry at the University of California in San Diego. He is the author of two books and has numerous papers published in peer-reviewed journals. His book, Over Dose: The Case Against the Drug Companies, is an outstanding read.
Introduction Good morning. My name is David Graham, and I am pleased to come before you today to speak about Vioxx, heart attacks and the FDA. By way of introduction, I graduated from the Johns Hopkins University School of Medicine, and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. After this, I completed a three-year fellowship in pharmacoepidemiology and a Masters in Public Health at Johns Hopkins, with a concentration in epidemiology and biostatistics. Over my 20 year career in the field, all of it at FDA, I have served in a variety of capacities. I am currently the Associate Director for Science and Medicine in FDA’s Office of Drug Safety.
During my career, I believe I have made a real difference for the cause of patient safety. My research and efforts within FDA led to the withdrawal from the US market of Omniflox, an antibiotic that caused hemolytic anemia; Rezulin, a diabetes drug that caused acute liver failure; Fen-Phen and Redux, weight loss drugs that caused heart valve injury; and PPA (phenylpropanolamine), an over-the-counter decongestant and weight loss product that caused hemorrhagic stroke in young women. My research also led to the withdrawal from outpatient use of Trovan, an antibiotic that caused acute liver failure and death.
I also contributed to the team effort that led to the withdrawal of Lotronex, a drug for irritable bowel syndrome that causes ischemic colitis; Baycol, a cholesterol-lowering drug that caused severe muscle injury, kidney failure and death; Seldane, an antihistamine that caused heart arrhythmias and death; and Propulsid, a drug for night-time heartburn that caused heart arrythmias and death. I have done extensive work concerning the issue of pregnancy exposure to Accutane, a drug that is used to treat acne but can cause birth defects in some children who are exposed in-utero if their mothers take the drug during the first trimester. During my career, I have recommended the market withdrawal of 12 drugs.
Only 2 of these remain on the market today-Accutane and Arava, a drug for the treatment of rheumatoid arthritis that I and a co-worker believe causes an unacceptably high risk of acute liver failure and death.
Vioxx and Heart Attacks
Let me begin by describing what we found in our study, what others have found, and what this means for the American people. Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx. The labeling at approval said nothing about heart attack risks. In November 2000, another Merck clinical trial named VIGOR found a 5-fold increase in heart attack risk with high-dose Vioxx. The company said the drug was safe and that the comparison drug naproxen, was protective.
In 2002, a large epidemiologic study reported a 2-fold increase in heart attack risk with high-dose Vioxx and another study reported that naproxen did not affect heart attack risk. About 18 months after the VIGOR results were published, FDA made a labeling change about heart attack risk with high-dose Vioxx, but did not place this in the “Warnings” section. Also, it did not ban the high-dose formulation and its use. I believe such a ban should have been implemented. Of note, FDA’s label change had absolutely no effect on how often high-dose Vioxx was prescribed, so what good did it achieve?
In March of 2004, another epidemiologic study reported that both high-dose and low-dose Vioxx increased the risk of heart attacks compared to Vioxx’s leading competitor, Celebrex. Our study, first reported in late August of this year found that Vioxx increased the risk of heart attack and sudden death by 3.7 fold for high-dose and 1.5 fold for low-dose, compared to Celebrex. A study report describing this work was put on the FDA website on election day.
Among many things, this report estimated that nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx. I emphasize to the Committee that this is an extremely conservative estimate. FDA always claims that randomized clinical trials provide the best data. If you apply the risk-levels seen in the 2 Merck tria ls, VIGOR and APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died. For the survivors, their lives were changed forever.
It’s important to note that this range does not depend at all on the data from our Kaiser-FDA study. Indeed, Dr. Eric Topol at the Cleveland Clinic recently estimated up to 160,000 cases of heart attacks and strokes due to Vioxx, in an article published in the New England Journal of Medicine. This article lays out clearly the public health significance of what we’re talking about today.
Placing 100,000 Vioxx Deaths in Perspective
So, how many people is 100,000? The attached Tables 1 and 2 show the estimated percentage of the population in your home State and in selected cities from your State that would have been affected had all 100,000 excess cases of heart attack and sudden cardiac death due to Vioxx occurred only in your State or city. This is to help you understand how many lives we’re talking about. We’re not just talking numbers.
For example, if we were talking about Florida or Pennsylvania, 1% of the entire State population would have been affected. For Iowa, it would be 5%, for Maine, 10% and for Wyoming, 27%. If we look at selected cities, I’m sorry to say, Senator Grassley, but 67% of the citizens of Des Moines would be affected, and what’s worse, the entire population of every other city in the State of Iowa.
But there is another way to put this range of excess cases into perspective. Imagine that instead of a serious side-effect of a widely used prescription drug, we were talking about jetliners. Please ignore the obvious difference in fatality rates between a heart attack and a plane crash, and focus on the larger analogy I’m trying to draw. If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past 5 years. If you were confronted by this situation, what would be your reaction, what would you want to know and what would you do about it?
Brief History of Drug Disasters in the US
Another way to fully comprehend the enormity of the Vioxx debacle is to look briefly at recent US and FDA history. The attached figure shows a graph depicting 3 historical time-points of importance to the development of drug safety in the US. In 1938, Congress enacted the Food, Drug and Cosmetic Act, basically creating the FDA, in response to an unfortunate incident in which about 100 children were killed by elixir of sulfanilamide, a medication that was formulated using anti-freeze.
This Act required that animal toxicity testing be performed and safety information be submitted to FDA prior to approval of a drug. In 1962, Congress enacted the Kefauver- Harris Amendments to the FD&C Act, in response to the thalidomide disaster in Europe. Oversees, between 1957 and 1961, an estimated 5,000 to 10,000 children were born with thalidomide-related birth defects. These Amendments increased the requirements for toxicity testing and safety information preapproval, and added the requirement that “substantial evidence” of efficacy be submitted.
Today, in 2004, you, we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could have, should have been largely or completely avoided. But it wasn’t, and over 100,000 Americans have paid dearly for this failure. In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust. I believe there are at least 3 broad categories of systemic problems that contributed to the Vioxx catastrophe and to a long line of other drug safety failures in the past 10 years. Briefly, these categories are 1) organizational/structural, 2) cultural, and 3) scientific. I will describe these in greater detail in a few moments.
My Vioxx experience at FDA
To begin, after publication of the VIGOR study in November 2000, I became concerned about the potential public health risk that might exist with Vioxx. VIGOR suggested that the risk of heart attack was increased 5-fold in patients who used the high-dose strength of this drug. Why was the Vioxx safety question important?
Vioxx would undoubtedly be used by millions of patients. That’s a very large number to expose to a serious drug risk.
heart attack is a fairly common event, and
given the above, even a relatively small increase in heart attack risk due to Vioxx could mean that tens of thousands of Americans might be seriously harmed or killed by use of this drug.
If these three factors were present, I knew that we would have all the ingredients necessary to guarantee a national disaster. The first two factors were established realities. It came down to the third factor, that is, what was the level of risk with Vioxx at low- and high-dose.
To get answers to this urgent issue, I worked with Kaiser Permanente in California to perform a large epidemiologic study. This study was carefully done and took nearly 3 years to complete. In early August of this year, we completed our main analyses and assembled a poster presentation describing some of our more important findings. We had planned to present these data at the International Conference on Pharmacoepidemiology, in Bordeaux, France.
We concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death and that the high doses of the drug should not be prescribed or used by patients. This conclusion triggered an explosive response from the Office of New Drugs, which approved Vioxx in the first place and was responsible for regulating it postmarketing.
The response from senior management in my Office, the Office of Drug Safety, was equally stressful. I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting, and also noted that Merck needed to know our study results.
Important Vioxx Findings Shunned by the Office of Drug Safety
An email from the Director for the entire Office of New Drugs, was revealing. He suggested that since FDA was “not contemplating” a warning against the use of high-dose Vioxx, my conclusions should be changed. CDER and the Office of New Drugs have repeatedly expressed the view that ODS should not reach any conclusions or make any recommendations that would contradict what the Office of New Drugs wants to do or is doing. Even more revealing, a mere 6 weeks before Merck pulled Vioxx from the market, CDER, OND and ODS management did not believe there was an outstanding safety concern with Vioxx. At the same time, 2-4 jumbo jetliners were dropping from the sky every week and no one else at FDA was concerned.
There were 2 other revelatory milestones. In mid-August, despite our study results showing an increased risk of heart attack with Vioxx, and despite the results of other studies published in the literature, FDA announced it had approved Vioxx for use in children with rheumatoid arthritis. Also, on September 22, at a meeting attended by the director of the reviewing office that approved Vioxx, the director and deputy director of the reviewing division within that office and senior managers from the Office of Drug Safety, no one thought there was a Vioxx safety issue to be dealt with.
At this meeting, the reviewing office director asked why had I even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done. At this meeting a senior manager from ODS labeled our Vioxx study “a scientific rumor.” Eight days later, Merck pulled Vioxx from the market, and jetliners stopped dropping from the sky.
Finally, we wrote a manuscript for publication in a peer-reviewed medical journal. Senior managers in the Office of Drug Safety have not granted clearance for its publication, even though it was accepted for publication in a very prestigious journal after rigorous peer review by that journal. Until it is cleared, our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper.
My experience with Vioxx is typical of how CDER responds to serious drug safety issues in general. This is similar to what Dr. Mosholder went through earlier this year when he reached his conclusion that most SSRIs should not be used by children. I could bore you with a long list of prominent and not-so-prominent safety issues where CDER and its Office of New Drugs proved to be extremely resistant to full and open disclosure of safety information, especially when it called into question an existing regulatory position.
In these situations, the new drug reviewing division that approved the drug in the first place and that regards it as its own child, typically proves to be the single greatest obstacle to effectively dealing with serious drug safety issues. The second greatest obstacle is often the senior management within the Office of Drug Safety, who either actively or tacitly go along with what the Office of New Drugs wants. Examples are numerous so I’ll mention just a few.
With Lotronex, even though there was strong evidence in the pre-approval clinical trials of a problem with ischemic colitis, OND approved it. When cases of severe constipation and ischemic colitis began pouring into FDA’s MedWatch program, the reaction was one of denial. When CDER decided to bring Lotronex back on the market, ODS safety reviewers were instructed to help make this happen. Later, when CDER held an advisory committee meeting to get support for bringing Lotronex back on the market, the presentation on ways to manage its reintroduction was carefully shaped and controlled by OND.
When it came to presenting the range of possible options for how Lotronex could be made available, the list of options was censored by OND. The day before the advisory meeting, I was told by the ODS reviewer who gave this presentation that the director of the reviewing office within OND that approved Lotronex in the first place came to her office and removed material from her talk. An OND manager was “managing” an ODS employee. When informed of this, ODS senior management ignored it. I guess they knew who was calling the shots.
Rezulin was a drug used to treat diabetes. It also caused acute liver failure, which was usually fatal unless a liver transplant was performed. The pre-approval clinical trials showed strong evidence of liver toxicity. The drug was withdrawn from the market in the United Kingdom in December 1997. With CDER and the Office of New Drugs, withdrawal didn’t occur until March 2000. Between these dates, CDER relied on risk management strategies that were utterly ineffective and it persisted in relying on these strategies long after the evidence was clear that they didn’t work.
The continued marketing of Rezulin probably led to thousands of Americans being severely injured or killed by the drug. And note, there were many other safer diabetes drugs available. During this time, I understand that Rezulin’s manufacturer continued to make about $2 million per day in sales.
The Big Picture
The problem you are confronting today is immense in scope. Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless. It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people.
Simply put, FDA and its Center for Drug Evaluation and Research are broken. Now, I’m sure you have read the recent proposal to have the Institute of Medic ine perform a review of CDER and its drug safety program and make recommendations for fixing things up. Don’t expect anything meaningful or effective from this exercise. Over the history of CDER’s drug safety program, a number of similar reviews have been done. In the late 1970’s, I believe that a blue ribbon panel recommended that there be an entirely separate drug safety operation in FDA with full regulatory authority. It wasn’t implemented.
During the 1980’s and early 1990’s, CDER organized its own “program reviews” of drug safety. The basic premise underlying each of these reviews was that the “problem” was with the drug safety group; it didn’t fit into the Center. So, the charge given to the review panel members was always framed as “figure out what’s wrong with drug safety, and tell us what to do to get it to fit in.” There was and is an implicit expectation that the status quo will remain unaltered.
The organizational structure within CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is “safe and effective.” When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat. They approved the drug so there can’t possibly be anything wrong with it. The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest.
At the same time, the Office of Drug Safety has no regulatory power and must first convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done. Often, the new drug reviewing division is the single greatest obstacle to effectively protecting the public against drug safety risks. A close second in my opinion, is an ODS management that sees its mission as pleasing the Office of New Drugs.
Corporate Culture Tainted by the Phamaceutical Industry
The corporate culture within CDER is also a barrier to effectively protecting the Americ an people from unnecessary harm due to prescription and OTC drugs. The culture is dominated by a world-view that believes only randomized clinical trials provide useful and actionable information and that postmarketing safety is an afterthought. This culture also views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards and disrespects drug safety.
Finally, the scientific standards CDER applies to drug safety guarantee that unsafe and deadly drugs will remain on the US market. When an OND reviewing division reviews a drug to decide whether to approve it, great reliance is placed on statistical tests. Usually, a drug is only approved if there is a 95% or greater probability that the drug actually works. From a safety perspective, this is also a very protective standard because it protects patients against drugs that don’t work. The real problem is how CDER applies statistics to post-marketing safety. We see from the structural and cultural problems in CDER, that everything revolves around OND and the drug approval process.
When it comes to safety, the OND paradigm of 95% certainty prevails. Under this paradigm, a drug is safe until you can show with 95% or greater certainty that it is not safe. This is an incredibly high, almost insurmountable barrier to overcome. It’s the equivalent of “beyond a shadow of a doubt.” And here’s an added kicker. In order to demonstrate a safety problem with 95% certainty, extremely large studies are often needed. And guess what. Those large studies can’t be done.
There are 2 analogies I want to leave you with to illustrate the unreasonableness of CDER’s standard of evidence as applied to safety, both pre- and post-approval. If the weather-man says there is an 80% chance of rain, most people would bring an umbrella. Using CDER’s standard, you wouldn’t bring an umbrella until there was a 95% or greater chance of rain.
The second analogy is more graphic, but I think it brings home the point more clearly. Imagine for a moment that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug and the bullets represent a serious safety problem. Using CDER’s standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let’s remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.
Table 1. The percentage of each State’s population age 18 years or older that would be affected if an estimated 100,000 excess cases of heart attack and sudden cardiac death due to Vioxx had all occurred in that State. The States are presented alphabetically. These are the States represented by members of the Senate Finance Committee.
Table 2. The percentage of the population age 18 years or older from selected cities in the US that would be affected if an estimated 100,000 excess cases of heart attack and sudden cardiac death due to Vioxx had all occurred in that city. The cities chosen were from the more highly populated States shown in Table 1. These cities are in States represented by members of the Senate Finance Committee.