A Flaw in the System: The FDA

This is not going to be a treatise on the Food and Drug Administration. I haven’t the facts or the desire to write such a treatise. The FDA is in this book because of its relation to PHT. The FDA was established, in the best tradition of good government, to help American citizens in matters of health, in ways they can’t help themselves. But it was conceived as a defensive unit. If it were a football team it would have six tackles and five guards, and no one to carry the ball. All that was expected of the FDA was defense—to protect us from dangerous substances and unwarranted claims of effectiveness.

Understandably the founding fathers of the FDA presumed that the drug companies, with their profit incentives, would furnish the offense. It could hardly have entered their minds that a drug company would leave a great medicine “lying around.” Nor would they have been able to figure out how to equip the FDA against such an eventuality unless the FDA were put into the drug business, which is a far cry from the original premise—and is not being recommended here.

The FDA has done nothing about PHT. That is to be expected when a drug company doesn’t play its role. Unfortunately this does not leave the FDA in a neutral position. Through no fault of the FDA’s, PHT’s narrow listing has a negative effect. Absence of FDA approval is thought of by many as FDA disapproval—or at the least that something is lacking. The system of drug company through FDA to physician has become such a routine that the physician, with other things on his mind, waits for the system to bring him PHT. It’s been a long wait.

The real purpose in establishing the FDA was to improve the health and well being of the citizens of the United States. The neglect of a great drug certainly falls into that category. If a man were drowning and a doctor was prepared to throw him a life preserver that had more lead than cork, the FDA would say, “Hold it! That thing might hit him and kill him, and even if it doesn’t it can’t help him.” Nice work, FDA. But suppose the FDA knew there was a good life preserver under a tree, which the doctor didn’t see. Shouldn’t they say, “Try that one, Doc”? Of course they should.

It is not suggested that the FDA go into the drug business. It is more than suggested, in this extraordinary case, where thousands of physicians have furnished us with many times the evidence required to get approval of a new drug (keep in mind this drug has been approved for comparative safety and has stood the test of over forty years of use), that the FDA should no longer take a hands-off policy. It’s a sure thing our public shouldn’t suffer any longer because Parke-Davis stayed in bed after Rip Van Winkle got up.

Let us understand the magnitude of what we’re talking about. The non-use of PHT has been a catastrophe. We are not accustomed to thinking of the non-use of a medicine as a catastrophe. We think of a catastrophe as a flood, a famine, or an earthquake. Something tangible, overt, something in the positive tense. But something passive, such as the non-use of a great medicine that can prevent suffering and prolong lives, is also a catastrophe.

Something must be done. How it is done is for the government to decide. But here is a suggestion. It would seem a waste of time, and thus to the disadvantage of the American public, for the FDA to attempt to approve the many clinical uses of PHT separately. That could take forever. It would be far simpler for the FDA to address itself to the basic mechanisms of action and give PHT a listed indication-of-use as a stabilizer of bioelectrical activity, or as a membrane stabilizer. Certainly the published evidence for this is overwhelming. Such a listing would stimulate the physician to think of clinical applications of PHT and to refer to the existing medical literature.

Even a nod from the FDA to the physician would help. It could take the form of a letter to the physician, calling attention to the literature of his colleagues, and reminding him that since PHT has been approved for safety he is permitted to use it for whatever purposes his judgment suggests. Certainly the FDA would never try to tell the doctor how he should use PHT. That’s always the doctor’s decision. But such a letter would lift the cloud of negativism, and the physician would get an unobstructed view of PHT and the work of his colleagues.

I’m sure the problem–agriculturists will say that if the FDA takes any action in this matter it will set a precedent. Fine. Good. If this happens again, if another established drug is found useful for fifty or more disorders by thousands of physicians, then the FDA should take this as a precedent.

Every once in a while, routine or no routine, a little common sense should be permitted. This is an extraordinary matter, vital to our health. If the FDA was set up to help the American public, here’s a chance to do something great for them—with no one’s feelings hurt except routine’s.

Next Section: Evidence

Advisory