ABOLISH THE FDA?

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

SHOULD WE ABOLISH THE FOOD AND DRUG ADMINISTRATION?

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.

• The FDA causes patentable drugs to be favored over non-patentable drugs, even if the non-patentables are shown to be as-or-more effective and safer in any number of studies conducted by research facilities not associated with the company that plans to sell the drug (FDA oversight is merely the review of testing funded by the same company seeking approval and the resultant profits). No company will fund research for FDA Approval of a nonpatentable drug if all other companies can also sell the drug without having paid for the Promotional approval. Patent rights and the surety of large profits derived therefrom, not safety and efficacy, define the structure of contemporary medicine. The fact that FDA-Approval protocols inherently favor patentable drugs is the single largest feature promoting this harmful situation.

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.

• FDA Approval acts as a legal shield in cases where FDA- approved drugs are causing harm to some. The fact that a drug is FDA Approved and has not been revoked is seen by jurors in court cases against a drug manufacturer as powerful evidence that the drug is not culpable in the case at hand, regardless of the facts in that case. The fact of this is verified when the FDA does revoke approval, as it did of the drug Fen-Phen, whereupon a flood of libel suits followed, even though Fen-Phen was just as harmful the day before and numerous studies showing its harmful nature were published years before FDA revocation. The fact that law suits start en mass after approval is revoked is the very measure of the legal protection provided by FDA Approval. Lawyers know that juries will be swayed by FDA directives more so than by any research or the facts in a given case.

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."

• FDA Approval and the "bullet proof" legal status it provides approved drugs establish logical incentives for fraud that would be expressed in the following thinking on the part of a drug manufacturer: "Gee, in our studies that we will submit to the FDA for approval it looks like this drug may be harmful, but if we simply fudge the numbers a little to get it past the FDA-review panel, it will then be 'safe' and insulated from liability, and it will take years for the FDA to revoke it, if they ever do, and by then we'll have made millions anyway." However, in a free market they would think: "Gee, it looks like this drug might not be safe, we'll probably get sued if we sell it, better trash this one." In this case "safe" is a matter decided by independent research and in the courts per case, not by authoritarian decree. This shows how FDA-Approval status provides an incentive that could/should lead to unsafe and/or ineffective drugs.
• FDA Approval defines what 99% of medical practitioners will prescribe BECAUSE FDA Approval is a legal shield. Doctors are more vulnerable to a lawsuit if they prescribe a non-FDA-Approved medicine than if they prescribe an FDA- medicine. If an FDA-Approved drug is prescribed and it causes harm, the doctor can say "it was approved," but if they prescribe a non-FDA-Approved drug that causes harm or fails to save the patient, they are more vulnerable to law suits. Doctors know this, and will therefore tend to stick with the FDA program. The result once again is that consumers are led towards therapeutic options that EXIST PRIMARILY BECAUSE THEY CAN BE PATENTED, NOT BECAUSE THEY ARE THE SAFEST AND MOST EFFECTIVE TREATMENTS. The result is that the function of the FDA is the promotion and protection of the pharmaceutical-industrial complex at the expense of consumer safety and access to options.

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.

• To prove that the FDA is working to benefit society, we must show that there has been a decrease in harmful drugs after the FDA's existence and a steady rate or increase of new effective drugs coming to market. A problem here is that the standard by which most will measure the FDA is the FDA itself, that is, to determine the number of unsafe drugs approved by the FDA we have to count the number of drugs the FDA has revoked its approval of. Like any enterprise, the FDA would have a disincentive to admit that it is making things worse, and thus would have a disincentive to revoke too many approved drugs, just as laws that prove to be more harmful are rarely ever revoked. Of course, there can be other means of measuring drug safety, such as adverse reaction reports.

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:

  http://clipper.spinnaker.com/liberty/docs/fda.txt 
  http://www.ncpa.org/~ncpa/studies/s208/s208.html 
  http://www.aynrand.org/medialink/fda.html 
  http://www.internetwks.com/pauling/cando.html
  http://www.iahf.com/index1.html 
  
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