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Why the FDA Isn't Really Protecting Americans
The thing that bugs me most is that the people think the FDA is protecting them - it isn't. What the FDA is
doing and what the public thinks it is doing are as different as day and night.
Dr. Herbert Ley, Former FDA Commissioner
San Francisco Chronicle
January 2, 1970
A study reported in USA TODAY (9/25/2000) found that half of the experts hired to advise
the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies
that will be helped or hurt by their decisions. The experts are supposed to be independent, but 54 percent
of the time they have a direct financial interest in the drug or topic they are asked to evaluate. Federal
law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has
waived the restriction more than 800 times since 1998. Approximately 65 percent of FDA employees go to work
at pharmaceutical companies upon retiring from the FDA. Therefore, one begs the question how does the FDA
remain unbiased towards treatments when they have employees with financial interests related to the success
of the product involved in the same clinical trials?
A recent study identified that 225,000 deaths a year are caused by medical errors and adverse effects of FDA
approved medicines. Thus, adverse effects of our modern medical system are now the third leading cause of death
in the U.S., after death from heart disease and cancer (JAMA 284:483-485,2000).
The risks of modern medicine including heart failure, anaphylaxis, respiratory depression, convulsions, seizures,
kidney and liver failure are clearly stated on television advertisements for FDA approved drugs. In 2002, a study
by the Harvard School of Public Health and the Kaiser Family Foundation found that 35 percent of physicians and
42 percent of the public say that they have experienced errors in their own or in a family member's care. Beyond
the enormous human toll, the cost of medical errors due to lost income, disability, and healthcare expense is about
$29 billion annually. With so many deaths, hospital admissions, and the bombardment of TV advertisements telling
us the risks of drugs, why does the public not demand better research methods to prove safety? Clearly, the
multimillion dollar processes that the FDA has developed for drug approval are not meeting the objectives
established in 1938 to protect Americans from toxic therapies. The public must demand that
the FDA approval system for medical treatments be overhauled. A world view perspective that is more rigorous,
unbiased, motivated by safety not profit, and geared toward innovative lowcost therapies must be established to
stop this death toll that only continues to rise.
The ancient wisdom of the Physicians Oaths of Hippocrates and Maimonides to "first of all, do no harm" has become
rhetoric in our modern medical system. When biased medical bureaucrats say that herbal medicine is dangerous, they
are on shaky ground. First, they use rare reports of toxicity to make their cases, just the sort of "anecdotal
evidence" that they deride proponents of alternative medicine for using. Second, they are throwing stones from a
most vulnerable glass house. Problems caused by herbal toxicity pale into insignificance next to the everyday
calamities caused by pharmaceutical drugs. The general belief of the American Medical Association (AMA), first
presented in the 1930's, that allopathic medical treatments were or soon would be universally effective for the
treatment of diseases, has not stood the test of time. Forty years later this belief has been shattered by the
unsustainable system that has been created.
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