Ian Goddard (Ian@goddard.net)
Sun, 31 Oct 1999 22:03:50 -0500

(a working analysis with what may be new angles of argumentation against the FDA posted for feedback)


Ideas like abolishing the FDA may sound absurd on their face, but unless cases against a given system are examined, supporting it is probably irrational. Many people accept the case for the FDA on its face, after all, who would want unsafe and/or bogus drugs? But the claim that the FDA ensures safety and a system of tort liability does not is not automatically true.

The following are a few features of what may be valid and unique points against the FDA, posted in order to acquire critique and/or supplemental supporting points:

FDA Approval provides promotion and legal protection for the wealthiest members of the pharmaceutical-industrial complex (PIC). The illusion is that the FDA is a watchdog of PIC, and to some degree this is true, but the bottom line is that (a) the FDA maximizes the profits of a few manufacturers, (b) minimizes profits of or eliminates smaller manufacturers and (c) steers consumers to drugs that are marketed primarily because they are patentable (which ensures maximum profits due to exclusive sales rights) NOT primarily because they are safe and effective.

This situation causes safer and equally-or-more effective non-patentable therapeutics like SAMe (which has been more thoroughly tested in the sum of studies done by independent research facilities than many FDA-Approved drugs) to be valued and prescribed less than dangerous FDA-Approved drugs like Prozac. The result is that consumers are steered away from safer products that haven't been FDA Approved toward far-more dangerous products that are being promoted by their FDA-Approved status. This ensures that patent holders make maximum profits while consumers are exposed to maximum harm. The irony is that this is done in the name of consumer safety and keeping businesses in line! Notice that this perversity is not an attribute of FDA corruption, but of the FDA working according to plan.

There are many FDA-Approved drugs that are causing serious harm to individuals who should be compensated for such harm, but are not because judges throw out evidence and juries are prejudiced simply because the drug is "FDA Approved."

No wonder that safe and effective alternative therapeutics, such as vitamins and herbs, that are not patentable have been under attack from the FDA, with looming threats of their being banned and forced to go through the FDA- protocol and then placed into the hands of the wealthiest members of the pharmaceutical-industrial complex who will sell those products at fantastically inflated prices, as has happened in nations that have followed through with vitamin restrictions. The con, by design or default, is that the FDA is the champion of anti-capitalist idealism when in fact it is the vehicle of the most vicious and predatory capitalism imaginable, a form of capitalism is that anti-free-market and promercantilism, ie, a form of capitalism directed not by consumer demand but by authoritarian decree and force where consumers, rather than being the directors of the economy, are ripped off and plundered via State power.

IN SUM: People usually think of life without some large government institution as a return to the jungle. They seem to forget that tort liability still exists in the free market and it exerts a powerful effect on actors in the market, such that the threat of law suits for bad drugs will cause manufacturers and sellers to be careful. We also tend to forget that it's EASIER to bribe or slip bad data past an inspector or a small review panel than to do the same to a myriad randomly-selected juries and hundreds research facilities operated around the world. Knowing that, companies would have an incentive to be more careful when it's more difficult to bribe or lie, which suggests that a free market would regulate better.

The result of slipping bad drugs past an organization that issues authoritarian decrees of safety is by far the greatest threat to public safety for it then gives a bad drug bullet-proof status and the drug will have free reign to harm the people while it makes the manufacturer millions and millions. If you study the case of Prozac and other SSRI drugs, the idea that the FDA will revoke approval of drugs due to extraordinary rates of reported adverse reactions is not indicated. A drug may be revoked if a negative study appears in one of biggest medical journals, and if you look at these journals you will find them filled with advertisements from the very companies the journal would harm if it were to publish a study showing that one of the drug manufactures it does business with is selling a bad drug. In short, if a drug manufacturer like Eli Lilly sends a journal X thousands of dollars per year, this payment is, on its face, a de-facto form of bribery to one of the main entities we have to rely upon to keep the pharmaceutical-industrial complex honest.

There is quite a lot more to be said in terms of how the FDA causes harm, which is perhaps most evident in the cases of the routine delay life-saving therapeutics, which potentially causes more harm than harm caused by bad drugs getting out in the free market. The argument is convincing that tens of thousands died of a heart condition that could have been easily treated by the drug propranolol when the FDA kept it off the U.S. market while it was available in Europe; and that up to 100,000 die each year due to the FDA's ban on truthful health information about food and supplements (See "Freedom of Informed Choice: FDA Versus Nutrient Supplements," by Durk Pearson & Sandy Shaw, 1993).

Pages Questioning The Safety & Efficacy Of The FDA:

GODDARD'S JOURNAL: http://www.erols.com/igoddard/journal.htm