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In the Oval Office again
“Conclusion and Personal Note” was written sixteen years ago. I’ll try to summarize what has happened since then.
Complaining is not my game. But sometimes telling the facts is essential—and may sound like complaining. Please read Contents of The Broad Range of Clinical Use of Phenytoin. Then consider. Phenytoin, a drug introduced in the U.S. fifty-five years ago, has been reported useful for over seventy symptoms and disorders by thousands of independent physicians from forty-eight countries, yet it is still listed with our FDA only as an anticonvulsant. This is such a detriment to the health of the American people that it is the cause of a great catastrophe.
We are used to the word catastrophe being applied to volcanoes, hurricanes and earthquakes, where hundreds or more people are killed. We can count them, they’re before our eyes. These are overt catastrophes. The labeling of PHT exclusively as an anticonvulsant by our FDA is the cause of a covert catastrophe. Millions of people suffer and die because of it. We just can’t count them.
This has been discussed before, so I’ll be brief.
In l938 Drs. Putnam and Merritt, looking for a better anticonvulsant drug, jolted cats with electricity until the cats had convulsions. PHT was the most effective medicine tried in preventing these convulsions. Putnam and Merritt had an anticonvulsant, and it was approved as an anticonvulsant by the FDA. Shortly after PHT was used in epileptic patients, physicians published studies saying that those who’d received it had improvements in personality, mood, memory, concentration, and amenability to discipline. That was the beginning of physicians around the world starting to report, in medical journals, PHT’s use for an ever-increasing number of symptoms and disorders.
There are almost thirty-four hundred medical journals. The average physician receives seven or eight. Thus he has less than quarter of one percent of the world’s medical literature. Since these published studies on PHT were not sponsored by a drug company, it follows that they are independent and objective, and the volume of them makes them evidential to the greatest degree. In our system, a physician is made aware of drugs that are therapeutic by the drug companies, through advertisements and salesmen. If the physician doesn’t learn about a drug this way, he’s apt to be skeptical. In recent years, there’s been a game called “sue the doctor” in which lawyers sue for valid reasons and for no reason except to make money. It’s understandable that physicians and hospital committees try to do things in a conventional way, and the lack of an FDA listing has more influence than was ever intended.
As related, in some detail, in the chapter, “A Flaw in the System,” Parke-Davis has done little or nothing to get PHT listed for its many uses with the FDA. Since A Remarkable Medicine was written there is much more evidence of this. I’ll give just one example.
Dr. Stephen Preston, former Head of Research at Parke-Davis, visited our offices, on two occasions, to discuss phenytoin. After he left Parke-Davis he wrote me a heart-warming letter: “PHT is now a daily part of my life since I have developed a familial type of Chorea. After suffering through several experimental drugs I finally demanded that my neurologist put me on PHT and I found that Dr. Dreyfus knew what he was talking about. Except for you...I would not be leading the happy and productive life which I presently am. In closing I would like to state that neither the Food and Drug Administration nor Parke-Davis could ever have done such a magnificent job of making the medical profession aware of the therapeutic value of DPH as you have.”—(excerpt)
A lovely letter, from a former Head of Research at Parke-Davis.
Let us go to the FDA. I realize they don’t know better. Nothing like this had ever happened. Physicians around the world had published thousands of studies about a remarkable drug, and its parenting drug company had not brought the facts to the FDA. When a Charitable Foundation organized a vast amount of this published information into bibliographies to help the FDA, it didn’t occur to the FDA that they should do anything about it. It was not custom. They don’t seem to be aware that they were established to help with the health of the American public, custom or no custom.
You have read my travail with the U.S. Government in the section, Travels with the Government. There has been much more travail since then. I’ll relate just two experiences.
In 1982, Senator Paul Laxalt, a friend from Nevada, introduced me to Secretary of HEW, Richard Schweiker, and Commissioner of the FDA, Dr. Arthur Hull Hayes. It was agreed by all that a committee of ten should be set up to study this matter. Dr. Hayes wiggled on this agreement, and put the matter in the hands of Dr. Marion Finkel, Director of Orphan Products Development. I told Dr. Hayes this was not an orphan drug, this was an orphanage. However...
Dr. Finkel studied the literature conscientiously, even went to Mexico with Dr. Smith and me and saw a variety of uses of PHT, including topical. After three months Dr. Finkel was convinced. At a meeting, at which I was present, Dr. Finkel recommended to the Senator, the Secretary, and the Commissioner, that five or six uses of PHT be published in the May FDA Bulletin. This was agreed upon unanimously. About ten days before the May Bulletin was to be published, I was told that the five or six uses of PHT would not be published. “Someone” in the FDA had ruled against it. Imagine. A Senator, a Secretary of HEW, and a Commissioner of the FDA had been overruled by “someone” in the FDA. This was like the Joint Chiefs of Staff being overruled by a sergeant. I was given no explanation.
About six years after my book was written, I met with President Reagan. He asked John Svahn, an assistant, to look into the matter. Mr. Svahn did the opposite of what we’d asked and went to the FDA and received the following comment: “The FDA knows of some anecdotal reports of the success of Dilantin for some few patients but is unaware of scientific studies supporting the claim.” The President quoted this in a letter to me.
This statement upset me so much I wrote the following letter—which I didn’t send.
My dear Mr. President:
Thank you for your letter. I have been trying to figure out why it’s taken me so long to answer it. I’ve worked on it every day, including Saturdays and Sundays. But something has had me stumped. Finally I realized what it was. I have run out of hypocrisy—with Government, that is—I have plenty left for civilian life.
For over twenty years, the basis of my approach to Government has been “you can catch more flies with honey” and it’s worked—we have barrels of flies. But we’re out of honey—or hypocrisy in this case. So, to the truth.
The memo you received was an insult to the office of the President. It was also an insolence, an ignorance, and an arrogance.
The notion that the FDA is an authority on everything medical underlies this matter. It is a bizarre notion. But the author of the memo, note I do not say “the FDA,” must believe it. With his twenty minutes of experience on the subject, you would think he would have referred you to this Foundation, which has had twenty years of experience. But no. He gives his considered opinion, “we know of anecdotal reports of some few patients.” He could as sensibly have said, “we know of anecdotal reports of some few elephants in Africa.”
I wrote the President a calmer letter—which I did send. The President called me on the phone, twenty minutes after he’d read the letter, he said, and told me he’d put the matter into the hands of James Miller, Director, Office of Management and Budget.
Mr. Miller arranged for Dr. Frank Young, Commissioner of the FDA, to visit our offices. In three long sessions, we discussed with the Commissioner the tragically misleading listing of PHT. At the end of the third session, Commissioner Young told Dr. Smith, Ms. Raudonat and me, “Jack’s been jerked around.” I said, “Frank, I haven’t been jerked around. The American people have been jerked around.”
Well, one couldn’t ask for anything better from the Commissioner of the FDA. I was sure something good would happen. Unfortunately, Dr. Young left, or was removed from office a few weeks later. However, I knew the word would be passed along, with emphasis. Would you believe it, Dr. Young wasn’t even able to get me an appointment with the new Commissioner, Dr. David Kessler. Of course you wouldn’t believe it. But it’s a fact. Frank Keating, Governor of Oklahoma, who’d studied this matter thoroughly, couldn’t get me an appointment with Commissioner Kessler either. Governor Keating’s letter said embarrassingly nice things about me, but the letter is pertinent: “For the past 25 years, Jack Dreyfus has selflessly devoted his energies to the health and well-being of our citizenry...Almost single-handedly and with no financial interest, Dreyfus has championed the expanded use of phenytoin...Physicians around the world have made remarkable contributions...Two FDA commissioners (Ley, Edwards) have decried the neglect of phenytoin. Like Cornwallis at Yorktown, to whom does Jack surrender his sword? Who will take this magnificent man’s life treasure and apply it to the needs of suffering people?”—(excerpt)
In the Commissioner’s response to Governor Keating he said, “Our scientific review staff has reviewed data on Dilantin for various uses and has concluded that effectiveness has not been shown for any of the indications.”
If I knew the “scientific” word for rubbish I would use it.
But this statement requires some thought. It’s so ridiculous you’d think that Dr. Kessler might be lying. But let’s presume he’s telling the truth. In 1970, 1975 and 1988 extensive bibliographies on PHT were sent to all the physicians in the U.S. including those on the scientific review staff of the FDA. The last bibliography contained 3,100 medical references, and hundreds of double-blind and other controlled studies. Either of two things happened. The “scientific” review staff didn’t even glance at these bibliographies, which would be a disgrace. Or, if they read a tiny amount of this literature, you could say this is not a scientific review staff.
Dr. Kessler’s letter continued, “Our Center for Drug Evaluation and Research remains prepared to review formally any fully developed submission of organized data Mr. Dreyfus or his associates is prepared to generate in support of one or more new uses of Dilantin.”
Imagine that. The government prates about the private sector helping them. I got out of two highly successful businesses, the Dreyfus Fund and Dreyfus & Co., and have spent $80 million of my own money, and thirty-five years of my life trying to help the government. The fact that I tried doesn’t mean much, but the fact that I’ve been working in a gold mine of good health means a lot. And Commissioner Kessler won’t even meet with me.
Millions of people, in this country alone, suffer because of those letters F D A. Another way of spelling FDA is USA. The FDA was established by our Congress with approval of our President, yet Congress doesn’t even know who’s in it.
To become a member of the Supreme Court a candidate is put through many weeks of grueling questioning by Congressmen. Congress knows all the members of the Supreme Court, and almost none of the members of the FDA. We have a strange situation here. If the Supreme Court makes a dumb ruling, and I don’t say they do, there would be a public outcry, because we would all know about it. If the FDA does something dumb, and I do say they do, the public says, “It must be so, the FDA said so.”
We hear, “The FDA says this,” “The FDA says that,” “The FDA needs more time to study this,” and we get the impression that the FDA is the second edition of The Gideon Bible. I assure you it’s not. There are many good people in this organization and some of the other kind. But that doesn’t matter, they have tenure. The listing of PHT, only as an anticonvulsant, is a sin. (Sin—commit an offense of any kind. To do wrong.—Webster)
A wise man said, “No man can be a prophet in his own country.” Largely due to this Foundation’s work, PHT, a drug parented in the United States, is being used widely in many countries. The Broad Range of Clinical Use of Phenytoin and A Remarkable Medicine Has Been Overlooked have been translated into Russian by the Russians, and Chinese by the Chinese. On the next page is a listing of current uses of this American drug in Russia, China, Ghana, India and Mexico. Additional uses are constantly being reported.
The FDA is different people at different times. The FDA has done some excellent things. In 1972 the FDA, under Dr. Charles Edwards, in 1972, had Secretary Elliot Richardson write the letter to Governor Rockefeller:
In their April l982 FDA Bulletin, the FDA made an excellent statement: “Once a product has been approved for marketing, a physician may prescribe it for uses...not included in approved labeling. Such ‘unapproved’ or, more precisely, ‘unlabeled’ uses may, reflect approaches to drug therapy that have been extensively reported in medical literature.” (excerpt)
Although this matter is not your conventional work, please don’t think it’s not one of the most important matters ever to come before you. Look at it this way. This is not a problem. This is a solution for some of our most serious problems. The most versatile and benign medicine ever given us is listed with our government agency for only one use. And the reason—it’s so cheap. Think of that. For God’s sake, I do not use His name in vain, shouldn’t the President and Congress set up a committee of intelligent and conscientious people to study this matter? It would only take a week or ten days. And the rewards for the American people would be inestimable.
In addition to improved health for millions of people, PHT could have a marked beneficial effect on crime and violence, one of our greatest problems. In our present Bibliography there are twenty-nine studies reporting PHT’s beneficial effects on violent behavior, and synonyms for it such as assaultive behavior, destructive behavior, and episodic dyscontrol. Eight of the studies deal with large numbers of patients (over 100 on avg.). Seven other studies are double-blind studies. An exercise in probabilities will help. If we assess the chance of being correct to the double-blind studies of ten in eleven, the large studies of five in six, and the other studies of one in two, the chance of PHT being useful for violent behavior is slightly more than 275 quadrillion-to-1.
PHT’s Use in Prisons
Some of those in prison have committed crimes because of nervous disorders. Being confined gives them time to brood. This exacerbates their tensions. Fear, anger, inability to concentrate, poor mood, sleep problems, pain, and an over-busy brain are symptoms common in prisoners. (Careful reading of the chapter Eleven Angry Men will make this clear.) Allowing prisoners to have phenytoin, a nonhabit-forming medicine, on a voluntary basis, would be an act of responsibility on our part. It would also be a great kindness.
There would be tremendous collateral benefits. As prisoners become healthier, tensions in prisons would decrease. Further, when prisoners got out, if they continued to take phenytoin, as they likely would, the physiological need for violence would be reduced. And the terrible cycle of crime and drug abuse would start to be reversed. Let me stress—it’s hard to get this point across—PHT should not be given to prisoners to control their anger. It should be given to prisoners to improve their health. Uncontrolled anger would be one of many symptoms that would be improved. And let me stress again, it should be given on a voluntary basis.
If the FDA tried to approve PHT, use by use, in their usual fashion, it would take forever, and a century. What they could do (without delay) is allow Secretary Richardson’s letter, which he said could be made public (remember the FDA wrote that letter for him), to accompany phenytoin’s package inserts. The FDA could then remind the physicians of the April 1982 FDA Bulletin: “Once a product has been approved for marketing, a physician may prescribe it for uses...not included in approved labeling. Such unapproved uses may reflect approaches to drug therapy that have been extensively reported in medical literature.”
Having these two simple statements accompanying phenytoin’s package inserts would open up the matter for the physicians and hospital committees in this country and be of great benefit to the American public.
Mr. President and Congress and American public, it’s in your hands now.
Current Countries Using PHT