 Letter
to Ronald Reagan
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 President
The White
House
Washington, D.C.
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.
Respectfully,
Dreyfus Medical Foundation
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