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Note: The following
letter to former President Reagan was written in 1981. It was an introduction
to the original A Remarkable Medicine Has Been Overlooked. It is
retained here because it gives a good outline of the matter.
Dreyfus Medical Foundation
New York, New York
August 5, 1981
The White House
Dear Mr. President:
I write you about a matter of such urgency and importance that it requires the attention of your office. The properties of a remarkable and versatile medicine are being overlooked because of a flaw in our system of bringing medicines to the public. This is to the great detriment of the health of the American public, and many millions of people suffer because of it. This tragic condition can be remedied.
This letter is meant as a briefing, Mr. President. Material outlined in it will be expanded on elsewhere. The medicine is a prescription medicine. Its best known trade name is Dilantin; generic, phenytoin (PHT). The first disorder for which it was found useful was epilepsy. This was in 1938. In those days it was customary to think of a single drug for a single disorder, and PHT promptly got the tag “anticonvulsant.”
Since this early discovery, many thousand medical studies have demonstrated PHT to be one of the most widely useful drugs in our pharmacopoeia. Yet today, forty-one years later, PHT’s only listed indication-of-use with the Food and Drug Administration is as an anticonvulsant. This description is accurate but tragically misleading and plays a major role in the misunderstanding of PHT by the medical profession.
If you will look at the Table of Contents, it will give you an idea of the breadth of use of PHT. It’s been reported useful for over seventy symptoms and disorders, in over 250 medical journals throughout the world. [That was in 1981. Today the figures would be over seventy symptoms and disorders, in over 350 medical journals.]
When we see the number of symptoms and disorders for which PHT has been found therapeutic, our credulity is strained. Nothing could be that good, we say. But then we look closer, and we reevaluate. In number the studies are overwhelming. Not having been sponsored by a drug company they were spontaneous and independent, the authors’ only motivation being scientific interest and a desire to help others.
A brief discussion of the basic mechanisms of action of phenytoin will be helpful. A general property of PHT is that it corrects inappropriate electrical activity in the body, even at the level of the single cell. When we consider that most of our bodily functions are electrically regulated, our messages of pain are electrically referred, and our thinking processes are electrically conducted, it makes it easy to understand PHT’s breadth of use.
Although PHT corrects inappropriate electrical activity, in therapeutic amounts it does not affect normal function. Thus it can calm without sedation and effect a return of energy without artificial stimulation. PHT is not habit-forming, and its parameters of safety have been established over a forty-year period. [Sixteen more years since this paragraph was written.]
You may ask, Mr. President, why I haven’t brought this matter to the Department of Health or the Food and Drug Administration. Well, that was the first thing I thought of years ago. And for eight years I spent an eternity with officials in government, being shuffled back and forth from one to another with encouragement and even compliments. During this period I saw three secretaries of HEW, two assistant secretaries of HEW, two commissioners of the FDA, members of the staff of the FDA, a surgeon general, and other officials.
It took me a long time to realize this was the wrong approach. Although everyone agreed that something should be done, no official seemed to think he had the authority or responsibility to get it done. (See “Travels with the Government.”)
About the flaw in our system for bringing prescription medicines to the public: Years ago doctors concocted their own remedies, but that’s in the past. Today the origination of new drugs is left to the drug companies motivated by that reliable incentive, the desire to make profits. Between the public and the drug company is the FDA. The FDA was set up to do for many individuals what they could not do for themselves. Although its broad purpose was to improve the health of our citizens, it was set up as a defensive agency, to protect against ineffective drugs and those more dangerous than therapeutic, and was not equipped to reach out for an overlooked drug.
Since 1938 drug companies have been required to seek approval from the FDA as to the safety of new drugs and, since 1962, approval of both safety and effectiveness. When an FDA listing is granted it entitles a company to promote a drug for the purposes for which it has been approved. If the drug sells well the company has a good thing. Patent protection gives up to seventeen years of exclusive use. During this period profit margins are high. When patents expire, the financial incentive to look for a new drug is far greater than it is to study new uses of an old drug.
The process patents on PHT expired in 1963 and much of the incentive to do research on the drug expired at the same time. It should be noted that Parke-Davis, the company that had the patents on PHT, did not synthesize the drug, and physicians outside the company discovered it to be therapeutic. There is reason to believe that Parke-Davis never understood its own product. In addition to no patent incentive, this could be a reason it has not applied to the FDA for new uses. [One exception, see A Flaw in the System.]
The public’s access to a prescription medicine is through the physician. Physicians get their information about prescription medicines from the drug companies, through advertisements and salesmen, and from the Physicians’ Desk Reference, which carries only those uses for a drug that are listed with the FDA.
One can see how an FDA listing may carry more weight than is intended. In fact some people think of the lack of FDA approval as the equivalent of FDA disapproval. This is clearly wrong. How could the FDA disapprove a use for a drug if it hasn’t even had an application for it? [The FDA has made this clear in their 1982 Bulletin. See Appendix.]
Let’s look at the overall picture. Doctors were taught that PHT is an anticonvulsant. The usual sources that the doctors rely on for prescription medicines only indicate that PHT is an anticonvulsant. Is it any wonder that doctors have PHT out of perspective, and that as far as the public is concerned most of the benefits of PHT might as well not exist?
It is apparent that no drug company is going to apply for new uses of PHT. The clock has run down on that probability. Perhaps the FDA does not have a specific means to reach out for this medicine. But since the FDA’s broad purpose is to protect the health of the American public, the neglect of a remarkable drug should be in its province, and a means should be found.
A simple solution would be to put the matter in the hands of those qualified—the 450,000 physicians in this country. [Now over 510,000.] The FDA could address itself to the basic mechanisms of action of PHT and list it as a substance effective in the stabilization of bioelectrical activity, and refer the physicians to the literature of their colleagues. There are other solutions. The fact is any official nod from the FDA to the physician would let the light shine from under the bushel, and PHT would find its own level, pragmatically, by its use vis-à-vis other medicines.
Mr. President, this letter is a public one because it is also meant for government officials in health as well as for physicians and the public. The information in this book, for all to see at the same time, should be helpful if you decide to use the influence of your office in this matter. I hope you will. I think you will.
Dreyfus Medical Foundation
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