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From the November 1992 issue of Smart Drug News [v1n9]. Copyright (c) 1992, 2009. All rights reserved.
by Steven Wm. Fowkes
The rise of FDA violence against American doctors, patients, businesses and consumers is a graphic testament to the vision of our founding fathers. The American revolutionaries distrusted governmental bureaucracy and fought to codify their liberty first in a Constitution which specified a balance of powers between legislative (populist), judicial (aristocratic) and executive (authoritarian) branches of government, and subsequently with the first ten amendments to the Constitution which strictly forbade the new government from certain activities.
One of these founding fathers, Dr. Benjamin Rush, strongly argued for a medical amendment, strictly establishing medical freedom with the same unqualified language used in the first amendment. He believed that the medical profession, if unprotected and unrestrained, would degenerate into a medical state that would exhibit the same intolerance of medical alternatives that European religious states of the time exhibited to alternative religious beliefs. Unfortunately, other revolutionaries considered his vision too improbable and a medical-freedom amendment was judged superfluous. Sadly, in hindsight, we can see that Rush was correct. The tyrannical medical state has indeed arisen in the intervening two centuries. Rushs nightmare prediction was prophetically accurate.
In our present day, medical authorities decide what treatments can and cannot be used by patients and practitioners. Their power is obtained from laws ostensibly passed to protect the public from harm. One of the most pervasive laws is the Food, Drug and Cosmetics Act (FD&C Act) which specifies that only approved treatments will be allowed and that no drug or treatment will be approved unless it is proven safe and effective. Under this protective legislation, medical authorities decide what treatments will be labeled unsafe, unproven and ineffectivewithout any requirement to provide proof or justification of their decisions.
The drug-approval process is clearly illustrated by the FDAs decision about low-dose aspirin products. Low-dose aspirin (30 mg) has been found to be just as effective (and maybe more effective) than standard-dose aspirin (300 mg) in the treatment of cardiovascular disease, strokes, and the prevention of heart-attacks. Standard-dose aspirin is already approved by the FDA 1) to reduce the risk of myocardial infarction in patients with a previous infarction or unstable angina, and 2) to reduce the risk of recurrent transient ischemic attacks or stroke in patients who have had transient ischemic attacks. But the FDA has decided that low-dose aspirin is a new drug and requires a new-drug application, complete testing, and independent FDA approval. With this decision, the FDA has simultaneously eliminated low-dose aspirin products and lifesaving consumer education relating to low-dose aspirin.
The FDA states that only dosages of aspirin at 300-325 mg and 13000 mg are approved for these cardiovascular uses. FDA has not sanctioned the use of aspirin for these conditions at other dosages. FDA has not sanctioned the use of aspirin for any other cardiovascular-related indication at any dosage. With these pronouncements, the FDA has passed judgment on proper medical orthodoxy and condemned uninformed Americans to the multi-fold higher toxicity and increased mortality of high-dose aspirin all with the carelessness of bureaucratic certainty. Such is the unfortunate nature of enlightened protection by our appointed medical authorities.
The FDAs illogical follies would be laughable if lives were not being actively endangered by such bureaucratic excess. But such decisions are far from rare. As another example with much broader implications, the FDA medicrats have decided that above-RDA vitamin supplements are worthless and that any medical claims for nutrients (beyond deficiency conditions) constitute fraud. The FDAs anti-vitamin dogma, however, is directly contradicted by thousands of studies which document hundreds of therapeutic applications of nutrients. One ten-year study of over 11,000 people concluded that vitamin C decreases incidence of cardiovascular disease by 25-42% and increases life expectancy by 1-6 years. Such numbers are not insignificant.
The vitamin C story is paralleled with other nutrients. The FDA has repeatedly blocked above-RDA uses of folic acid, but researchers have established that neural-tube defects (a birth defect) can be drastically curtailed by folate supplements.
True of false? The FDA does scrupulous research to establish the medical merits of different treatments before making regulatory decisions about those treatments. False. The FDA doesnt do research at all. Even when they fund a study, they contract with independent educational and research institutions across the United States. The FDA doesnt even perform computer searches of published scientific literature before making decisions. Although most Americans think that the FDA does research, this is entirely a myth.
The FDAs sources of information for most of their decisions comes from data submitted by pharmaceutical companies seeking approval of drugs. In other words, the FDA relies on information from interested parties. These drug companies spend hundreds of millions of dollars and more than ten years to obtain exclusive right to market an FDA-approved drug for FDA-approved uses. This exclusivity is a necessary and essential component of the process. Without a patent to control competition, a drug company cannot charge the thousand-fold markup required to recoup the cost of FDA approval. Within such an approval system, what economic incentives exist for unpatentable (generic) substances like vitamins and nutrients?
The answer, of course, is none. No company can spend millions of dollars getting vitamin C approved for cancer or heart disease when anybody can sell vitamin C for $20/kilogram. Only the government can spend money without regard for some kind of economic payoff. Unlike governments, businesses must get their capital on a voluntary basis.
This patent-bias within the drug-approval process not only eliminates any possibility of accommodating non-patentable substances, it is a selective filter for the information that the FDA receives. Only drug companies seek approval, so the FDA only gets information about the medical uses of drugs. Companies do not seek approval for unpatentable nutrients, and, predictably, the FDA gets little or no information about nutrients.
If the FDA did literature searches and read the published scientific literature, this bias could be compensated for and the ignorance partially ameliorated. But, unfortunately, they dont. They merely pronounce their judgment based on ignorance ensured by a drug-approval system designed for drugs and applied to non-drugs.
If the FDA were to regulate foods like they do drugs, we would all starve.
The hardest thing for Americans to understand about the FDA is that their decisions are not based upon considerations of medical risks and benefits, but rather upon non-medical issues such as the FD&C Act and the internal political considerations of the FDA. On a cost/benefit basis, the decision to approve or not approve would be based on lives lost (due to toxic side effects and improper drug use) compared to lives gained by the availability of the drug. Instead, the FDA approves drugs based on 1) procedural regulations, and 2) their political risk. The FDA knows that a couple of deformed babies has far more political reality than tens of thousands of middle-aged heart-disease patients or elderly cancer patients passing away in anonymity.
In a strict sense, the FDAs failure to develop separate approval standards for generic non-patentable substances like vitamins and nutrients is substantially Congress oversight. The FD&C Act does not make such distinctions, and it does not direct the FDA to compensate for the economic disadvantage that unpatentability entails. FDA reform, realistically, must begin at the Congressional level.
The FDAs arbitrary power to regulate the drug-approval process and the huge economic interests of the drug companies has led to close associations between the FDA and drug industry agents. Indeed, drug company employees often leave the FDA to work for pharmaceutical companies, and vice versa. Getting drugs approved expeditiously is a matter of economic survival in the competitive world of the pharmaceutical industry. The friendlier one companys representatives are with their FDA counterparts, the faster their drugs are approved and the sooner that company can turn a financial bottomless pit into a cash cow.
The close association between the FDA and the pharmaceutical industry leads to a consolidation of their world views. FDA agents think like pharmaceutical employees and pharmaceutical employees think like FDA agents. Drug companies do not like competition from non-drug therapeutic agents, especially when they are more effective, less toxic and lower priced. It is the FDAs job to eliminate such therapies when they start to get legitimate.
The FDAs power to classify vitamins and nutrients as drugs gives it the absolute power to prohibit the marketing of nutrient-based medical therapies. Despite this power, hundreds of small companies are developing nutrient products with medical applications. These companies are largely ignored by the FDA. However, some become too successful and receive the FDAs wrath. They get armed raids, product prohibition, and bureaucratic Catch-22 harassment until they fold from the economic hardships of legal fees and product detentions. It is interesting that the FDA pays disproportionate attention to the high-tech, reputable companies that are developing the state-of-the-art products that knowledgeable physicians and informed consumers want. Oddly, they do not seem to be much interested in pursuing the cases of overt fraud in the nutrient industry. Why?
One reason is legitimacy. The presence of health fraud creates a need for FDA enforcement power much like the Soviet threat created a need for U.S. military spending. The fraud doesnt even have to be real. Instead of going after blatant fraud, the FDA spends most of its attention on extending its designation of fraud to include legitimate nutrient technologies. This way the FDA wins both ways: alternatives are eliminated, and fraud continues. One can only conclude that the FDAs highly selective enforcement actions are intentionally anti-competitive in nature.
A simple mistake made decades ago has given the FDA the ability to arbitrarily restrict the nutritional status of American citizens. This mistake was the definitions of foods and drugs by the FD&C Act. Instead of defining foods as naturally occurring nutritional substances (or combinations thereof) and drugs as non-biological xenobiotic substances (synthetic-only drugs), foods were vaguely defined as animal, vegetable and mineral, and drugs as anything with medical effects. Of course, technically, all substances have medical effects and fit this definition of drug, even foods and water. With this ambiguity, the FDA can classify anything as a drug and regulate it accordinglyeven vitamin C, fiber and carrots.
A solution to the problem of the FDAs ability to abuse the nutrient industry and maintain the drug monopoly for the pharmaceutical industry is to eliminate the FDAs control over nutrients and biologically occurring (natural) chemicals. By restricting the FDA to drugs, we can allow the emerging science of nutrition to be applied to the health care arena and we can reap the benefits of higher efficacy and lowered health-care costs.