Travels with the Government: Page Three

I had placed a lot of hope on the government’s taking over PHT. I admit that part of this was because I wanted to be relieved of the responsibility and the work. But there was a more important reason. With its medical institutions, and its enormous resources and authority, the government could do a far better job than a single foundation. However, it wasn’t long after the Finch conference that I began to get the idea that government lacked enthusiasm about taking over its responsibilities.

Maybe I should sum up my thoughts during this period. At the outset, when I became convinced that PHT had been overlooked, I knew that medical studies would be necessary to persuade others. After the initial unsuccessful attempts, the Foundation had sponsored numerous successful studies on PHT and was continuing in this effort. But by far the most important source of evidence was already in the medical literature. This evidence had been there for the picking, like good apples under a tree.

I don’t know exactly when we passed the equator of ample evidence, but at some point our goal changed, and we decided that communicating already existing evidence was more important than finding new evidence. You know that old philosophical question about the tree falling in the forest—if nobody hears it, was there a sound? I’m not sure about that, but here was a practical question. If a great amount of evidence exists for the usefulness of a medicine, and the physician doesn’t know about it, does it do any good? The answer is obvious. So communication became our number one objective.

Something other than trying to tell the story to the government had to be done. By this time we had collected so many published studies on PHT they would have filled a barrel. I would like to have Xeroxed the studies and sent each physician a barrelful saying, “You’ll find this useful.” But it wasn’t practical. We had to attack the barrel ourselves, organize the studies, and condense them for the physicians. And that is what we did.

When we finished we had a bibliography and review of PHT, the clinical section arranged chronologically, the contents fairly evenly divided between clinical and basic mechanism of action studies. It was exhausting work for our group, and just the writing of it took over a year and a half. To keep our spirits up we worked on the theory that if a doctor matched a thousand hours of our effort with ten minutes of his own (aye, there’s the rub) we’d show a profit—with 350,000 doctors in the U.S.A. The bibliography, The Broad Range of Use of Phenytoin, was the first of two that the Foundation published. About 400,000 copies were sent to physicians and basic scientists in the United States in 1970. The response was excellent, and we had letters of thanks from nearly a thousand physicians. Still, the facts about PHT did not spread as fast as I had hoped.

One Sunday morning in July 1971, my brain was playing with the communication problem. The Foundation was sponsoring studies of PHT, mostly in new fields, but we had no other immediate plans. The thought that government had the key responsibility for PHT was always in my mind. But I had taken my best shot with the government—President, Secretary of Health, and Surgeon General. Something else had to be done; I couldn’t figure out what, and it bugged me.

It’s funny how we remember unimportant things if they are associated with something important. That Sunday, my housekeeper Ida Thomas, whom I love and who has a feeling for me, sensed my mood and said, “Let me fix you something for breakfast instead of those old eggs and tomatoes you eat every day.” I thanked her, and went back to thinking about the government. Interesting smells started coming out of the kitchen. Soon a delicious-looking pancake arrived, with powdered sugar and hot blueberry sauce. The first bite was on my fork when the phone rang.

A voice said, “This is Walter Tkach at the White House. I’m President Nixon’s doctor, and I was just telling the President and Mrs. Nixon what a wonderful piece of work I thought you’d done.” If an ancestor had called I couldn’t have been more surprised. Just when I was wondering how to get back to the government, here was a spontaneous recommendation to the President, from his own doctor. I steadied my voice and thanked Dr. Tkach. Dr. Tkach went on to say, “The President suggested that I invite you to visit me in Washington and I hope you can make it soon.” I said I could. We made a date for the following Tuesday. Then I ate Ida’s pancake and two more.

Tuesday I took a sensible morning plane to Washington that got me there at 9:45. Dr. Tkach met me and drove me to the White House in his car. During the drive he told me that after a personal loss he had benefited from PHT, and had the Life article to thank for it. I was glad he had first-hand experience with PHT; there’s nothing like it to get an understanding of the medicine.

When we got to the White House, Dr. Tkach walked me past the gendarmes, and for a moment I had the feeling I was infiltrating the place. But when we got to his office Walter made me feel like a dignitary. He put me in a comfortable chair, got me a jug of coffee, and became a voluntary and patient listener for several hours. In that sympathetic atmosphere I did a good job of summarizing the PHT story. At about 12:30 Dr. Tkach suggested lunch would be appropriate. He didn’t have to drag me—I’ve always noticed that mental effort uses more calories than physical effort—and we went to the White House cafeteria. Walter hadn’t told me we would have company for lunch, but he had invited Kenneth R. Cole, Jr., and James H. Cavanaugh, two members of the President’s staff, to join us. I didn’t get to eat as well as I’d hoped because I had to give a forty-five-minute summary of PHT. I emphasized the government’s responsibility. Ken and Jim ate well and listened well.

When lunch was over Ken Cole, who outranked Jim Cavanaugh on the President’s staff, said they would both try to be helpful in getting the story to the FDA. He said I could call him whenever necessary, but Jim would work with me on a regular basis. In the past I had been treated with courtesy by the government, but I’d felt a little like a salesman, carrying samples in his briefcase. Now I was being offered help without soliciting it and it put me in a different posture. When lunch was over I thanked them all. Dr. Tkach drove me back to the airport. He said there wasn’t any question that the government should do something about the PHT matter. But he cautioned me against being too optimistic. He said the problem wouldn’t be with people I would meet but with the nature of bureaucracy. It was so big, and so besieged on all sides by people clamoring for its attention, that it was distracted from important matters—even if it could figure out which they were. A few years earlier I would have argued with Walter. Now I just kept my fingers crossed.

That same week Jim Cavanaugh came to New York and spent a day with Dr. Bogoch and me. It was one of those calorie-consuming days. I spent at least four hours going over clinical evidence, and Sam spent nearly half that time on the basic mechanisms. When he left, Jim had a good grasp of the facts. He said the next move would be for us to talk to Dr. Charles Edwards, Commissioner of the FDA. Jim Cavanaugh made the appointment with Commissioner Edwards, and Dr. Bogoch and I spent a morning in the offices of the FDA. After a long talk with the Commissioner, he said he’d like us to explain this matter to senior members of his staff. I don’t remember their names, I saw them only once, but they were sympathetic and tried to be helpful. After we outlined the story, they told us that the Foundation itself might be able to apply for new listings of PHT. They suggested that Dr. Herbert Ley, the previous Commissioner of the FDA, would be a good person to consult about procedure. (We got in touch with Dr. Herbert Ley. Dr. Ley said he would like to review the summaries of the PHT studies in our bibliography; they seemed almost too good to be true. After spot-checking the summaries for a day and a half, he was satisfied. Subsequently, Dr. Ley became a member of the Foundation’s Advisory Board.) I didn’t understand why the Foundation should apply to the FDA in a matter of health for the American public when that health was a direct responsibility of the FDA itself.

Still, I would have considered following the suggestion except for two reasons. One was that PHT appeared to be useful for so many disorders that to get them through the FDA in the routine way, single-file so to speak, would have taken forever. The second reason was that if the Foundation did make applications for new uses of PHT, we might be required to be silent on the subject while applications were pending. We couldn’t risk that.

Dr. Edwards visited the Foundation a few weeks later. When he had spent most of a day absorbing the medical information, he agreed that a conference with medical officials would be appropriate and said he would help set up such a conference.

Dr. Edwards made the arrangements and a two-day conference was held in our offices in February 1972. Since Dr. Edwards had already spent a day with us on PHT, he attended only the first day of the meeting. Others in attendance were Dr. Theodore Cooper (director, the National Heart and Lung Institute), Dr. John Jennings, Dr. James Pittman, Dr. Samuel Kaim, James Cavanaugh, Dr. Samuel Bogoch, and myself.

This conference was hard work. There were four two-hour sessions in the two days. Dr. Bogoch and I conducted them and, except during the discussion periods, we did all the talking. I assure you I looked forward to lunch and coffee breaks (see Agenda). By the time we got to the last discussion period, on the afternoon of the second day, the clinical effects of PHT and its basic mechanisms of action had been outlined, and we got down to cases—what the government could do. But none of our visitors could think of a handle for the FDA to grab PHT by; nothing like this had happened before. The only suggestion I remember was that perhaps the government could give the Foundation a grant. I appreciated this, but I didn’t want us to lose any freedom of action.

As the meeting was breaking up, Dr. Kaim said to me, “Well, the ball is in your court.” This struck my unfunny bone. “In my court?” I said. “Where the devil do you think it’s been all these years and when should it get in your court?” As many of us do, I make the mistake of thinking that an individual in the government is the government itself. Dr. Kaim meant no harm by his comment, but I repeat it because it is typical of a thousand I’ve heard from people in a position to do something about PHT themselves. They seem to clear their consciences by giving me advice as to what I should do. I’ve got enough of this advice. It’s saved up in a hermetically sealed tank and I plan to sell to a utility—when fuel prices rise a bit more.

Although nothing specific came of the meeting, at least some members of the government had a better understanding of PHT. Jim Cavanaugh kept in touch with me regularly. Jim had a way of saying, “I’ll get back to you next week.” And he always did. I appreciated his efforts so much that I never pressed him as to when he would call. It was usually about 4:45—on Friday.

Elliot Richardson

Occasionally I was able to get Commissioner Edwards on the phone. Charlie, who told me he was trying to work out something with members of the department, finally came up with a suggestion. He said that if we could get a political figure to write a letter of inquiry about PHT to Secretary of Health Richardson, the reply—which would be an official statement and could be made public—might shed light on the matter. By that time I was so worn out I would have settled for an old shoe. But Dr. Edwards’ idea seemed constructive.

Since the Foundation was located in New York, I asked Dr. Edwards if a letter from Governor Rockefeller would serve the purpose. He said it would. When I asked Governor Rockefeller, to whom I had spoken previously about PHT, he said he would write such a letter. And he did.

Secretary Richardson’s response meant more to me than it would to someone unfamiliar with the background. It showed that the Foundation’s efforts had had some effect. The Secretary’s comment: “Conversations with health officials in the Department...” indicated the letter had FDA approval.

From Secretary Richardson’s Letter: “Conversations with health officials within the Department have revealed that phenytoin (PHT) was introduced in 1938 as the first essentially nonsedating anticonvulsant drug…. A review of the literature reveals that phenytoin has been reported to be useful in a wide range of disorders. Among its reported therapeutic actions are its stabilizing effect on the nervous system, its antiarhythmic effect on certain cardiac disorders, and its therapeutic effect on emotional disorders. The fact that such broad therapeutic effects have been reported by many independent scientists and physicians over a long period of time would seem to indicate that the therapeutic effects of phenytoin are more than that of an anticonvulsant. The FDA encourages the submission of formal applications…”

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