The Battle Begins Chapter Five
My first confrontation with the FDA came when Patrick Mahoney, a long time friend, who was
then working for Birch Research Corporation, contacted me. Part of Patrick's job was to
review all major newspapers and government documents and to file any information which may
at sometime be of any news value. Patrick had run across a notice in the Federal
Register which said that there were going to be Administrative Hearings on Laetrile in
Kansas City, Missouri, on May 2-3, 1977. According to the notice, anyone who wished to
speak for or against Laetrile was to write to the given address and ask for time to
present testimony. At Patrick's urging, I wrote to that address and asked for fifteen
minutes.
I really had no idea what this was all about. But, by this time, I had three years of experience using Laetrile as a part of a total nutritional program. I knew that it was part of what was necessary to improve the quality and quantity of life of many cancer patients. Again, I felt that I had a moral obligation to present my findings at that Administrative Hearing, so Betty and I went. It wasn't until after we got there that I fully understood what was going on.
In early 1977, Mr. Glen L. Rutherford from Oklahoma City developed cancer. He chose to go to Mexico for the treatment of his cancer because they were using a nutritional program that included Laetrile. A few weeks later, when Mr. Rutherford returned to the United States, his Laetrile was confiscated when he crossed the border. This was done by Government order. Mr. Rutherford then filed suit in Federal Court against Joseph A. Califano, Secretary of Health, Education and Welfare and against Donald Kennedy, Commissioner of the Food and Drug Administration et al. for the right to have his Laetrile. This I know to be true because I have the court record. What follows I do not know to be true because I was not there, but I will relate the story to you as it was told to me by those who were there.
The trial between Mr. Rutherford and the Government went on for several weeks. Federal Judge Luther Bohanon presided. Each day the FDA attorneys would tell the court that the FDA had hundreds and hundreds of studies that proved that Laetrile would not work. Toward the end of the trial Judge Bohanon said to the FDA attorneys, "Tomorrow, when you come into court, I want you to bring with you all of these studies that have been done by the FDA on Laetrile."
The following morning, when the trial began again, the Judge asked for the studies. The FDA attorneys said, "Your Honor, we did not bring the studies because they are so scientific that we don't think you can understand them." This, as you can well imagine, did not please the Judge. He insisted that all of the studies must be in his court room the following morning.
The next morning there were no studies. When the Judge asked why, the FDA attorneys said the studies were so voluminous they were not sure that all of the studies would fit in his court room. The Judge then stated that, if necessary, he would empty the entire court house, but he wanted all of those studies in his court the following morning.
The following morning there were no studies. Again, the Judge asked why. The FDA attorney said very simply, "Because, Your Honor, there are no studies." Of course, the Judge was irate. The FDA attorneys explained that each evening after the trial they would call Washington. Each evening the Washington office of the FDA would assure the attorneys that they had all of these studies. When the attorneys finally pinned down the Washington office, they said that they had done no studies at all on Laetrile. This was when Judge Bohanon called for Administrative Hearings.
In truth, as time has gone on, I have found much evidence to make me believe that the FDA had, indeed, done a great many studies on Laetrile. The problem was they apparently had found that — when properly used with other vitamins, minerals, enzymes and diet — Laetrile could be very beneficial to many cancer patients. There was no way the FDA was going to admit this! For more than fifteen years they had been saying that Laetrile was of no value. To come out now and say that they had been wrong was unthinkable. The fuss and furor that would have come from the people of this country would have been tremendous. Congress, rapidly, would have been forced to do away with the FDA. To the government, this would have been a terrible loss. After all, the "most important" function of any government bureaucracy is to perpetuate itself. It is my opinion, and only an opinion, that it was easier for the FDA to say that they had done no studies than to reveal what their studies had actually shown. It was far less dangerous to go through Administrative Hearings than to admit that they were wrong.
These Administrative Hearings were something else. Of the perhaps two hundred to three hundred people who were there, almost all were pro-Laetrile. There were, of course, many doctors from the FDA who testified against Laetrile. The thing I remember most about these hearings was that, shortly before I testified, a doctor from the FDA testified that if you open a vial of Laetrile, it must be done in a large room with all of the windows open and that everyone in the room must wear a gas mask. Otherwise, he said, everyone would die from the cyanide fumes from that vial of Laetrile. Shortly thereafter I testified that I had opened some four thousand vials of Laetrile. I stated that I had opened them in a small room with all of the windows closed and that neither I, nor any of my staff, had worn a gas mask. I assured the Administrative Judge that I, and all of my staff, were alive and quite well.
The Administrative Judge was sitting to my right and behind me. I could not see him while I was testifying. According to those in the audience who could see him, he obviously became quite angry and turned very red in the face. He had allowed some of those testifying for the FDA to run overtime with their testimony. Just as soon as my time was up, he banged his gavel and said sternly, "Your time is up!" I assured him that I would be finished in less than a minute. Down came the gavel again, and again he said angrily, "Your time is up!" I had a typewritten copy of my full testimony, which I then gave to the recording secretary. All of my testimony did appear in the full record.
The full testimony of everyone who took the stand at this Administrative Hearing was sent to Judge Bohanon. He then went through all of this material. On December 5, 1977, he rendered his final decision in the case of Rutherford vs. United States of America, Joseph A. Califano, Secretary of Health, Education and Welfare; Donald Kennedy, Commissioner of the Food and Drug Administration et al. For those of you who have access to law libraries this will be found in THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF OKLAHOMA, No. CIV-75-0218-B.
Parts of Judge Bohanon's decision are as follows:
The action of the Commissioner of Food and Drugs dated July 29, 1977, is declared unlawful and such action, findings and conclusions are hereby vacated, set aside and held for naught.
The Secretary of Health, Education and Welfare and his subordinates in the Food and Drug Administration are hereby permanently enjoined and restrained from interfering, directly or indirectly, or acting in concert with United States Customs Service or others, with the importation, introduction, or delivery for introduction into interstate commerce by any person of Laetrile (Amygdalin) ....
The Secretary of Health, Education and Welfare and his subordinates in the Food and Drug Administration are hereby permanently enjoined and restrained from interfering with the use of Laetrile (Amygdalin) for the care or treatment of cancer by a person who is, or believes he is, suffering from the disease;
The Secretary of Health, Education and Welfare and his subordinates in the Food and Drug Administration are hereby enjoined and restrained from interfering with any licensed medical practitioner in administering Laetrile (Amygdalin) in the care or treatment of his cancer patients.
In giving the reasons for reaching his decision, Judge Bohanon cited the testimony of many of us at the Administrative Hearing. I am proud to say that he cited my testimony on several occasions.
The result of this decision is what became known as "the affidavit system." The way this system worked was-if a patient wanted Laetrile, he would have to sign an affidavit, with five copies, stating that he wanted it. He would have to give his name, address and telephone number. The doctor had to sign the same affidavit (all five copies) stating that he would administer the Laetrile. Both the patient's and the doctor's portions of the affidavit had to be notarized. This was then sent to a pharmacist who kept one copy and sent the rest to the FDA. The FDA would send the purchase order to Mexico, where the Laetrile was manufactured. The order would be filled, packaged, addressed to the patient and sent from Mexico to an FDA office in California. There it would be checked with the proper affidavit and sent to the patient. It was not at all unusual for the FDA to call the patient to make sure that he had ordered that amount of Laetrile. To some patients this was merely annoying. To many others it was very upsetting because they were made to feel that they had done something illegal.
This is where we ran into an early problem. The FDA did not want to comply with Judge Bohanon's court order. When the packaged, addressed orders were sent to California, the FDA would allow the packages to sit for many days in their office before forwarding them to the patients. A pharmacist in Baltimore, Maryland found an answer to this. His customers were complaining that they were not getting their Laetrile orders. He gave them the telephone number of Judge Bohanon's office. The customers began bombarding the Judge's office with complaints. The Judge would call the FDA, and for awhile things would run smoothly. Within a few weeks, however, the problem would again occur. The result was more phone calls to the Judge's office. The pharmacist here in Ohio, who was handling my patients, was not involved in the phone call procedure to Judge Bohanon. He did, however, receive a call from the Judge's office asking him to "call off the dogs" because the Judge would take care of the matter. Exactly what the Judge told the Commissioner of the Food and Drug Administration, Donald Kennedy, I do not know. I do know that this hold-up never happened again with any of my patients.
Judge Bohanon's decision and the affidavit system went from court to court. Many courts upheld his decision. Some courts did not. His decision and his affidavit system were finally overturned in February, 1989.
I am not sure what the status of Laetrile is in most states, but I do know what it is in the state of Ohio now. No doctor in this state may write a prescription for Laetrile, but anyone in this state who wishes to have Laetrile may obtain it without prescription. If the patient buys the Laetrile and takes it to his doctor, his doctor may then give the Laetrile to the patient. This is, of course, bureaucracy at its worst. I can buy penicillin and I can give it to a patient. But, I cannot buy Laetrile and give it to a patient. The patient can buy the Laetrile and bring it to me, and then I can give it to him.
Anyway, in the state of Ohio, the patient can get Laetrile and the doctor can give it to him in the proper manner and the proper dosage. I thank God for small favors!