Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

United States. Congress. Senate. Committee on Government Operations

Date:: 1963

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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tion, and a low grade osteomyelitis infection in my right foot. I was given Altafur because the manufacturer’s brochure stated that Altafur was developed as a potent agent against just these types of infection. Almost immediately my blood level became depressed to such a low point that the osteo became very active and within a short time the only way to save my life was to amputate my right leg. These hospital records are available to your committee and I would gladly testify before your committee. Thanking you in advance for the facts that I have requested, I am Respectfully yours, {Name withheld. ] NEw JERSEY, March 26, 19638. The physicians of the present decade who have available such a powerful and varied armamentarium of drugs usually feel grateful to the manufacturers who have made these preparations available to us. Since the development of the various chemotherapeutic and antibiotic agents, many illnesses are no longer seen in their full-blown, classical, clinical picture and others, for all practical purposes, have disappeared from the scene entirely. Although innumerable new preparations have appeared on the market in the 15 years I have been in practice and although the efficacy of some of these was not as great as may have been claimed by the initial presentation of the manufacturer’s representative, I recall few, or, if any, instances in which a potentially dangerous preparation was sold to us because of a lack of previous laboratory testing by the manufacturer. Although, as I stated above, physicians are grateful to drug manufacturers for the excellent tools which they provide us, we maintain a healthy skepticism regarding salesmen’s claims for these preparations. We are more likely to wait for reports in our established journals before beginning to use the newer agents. It has been our observation that when widespread use of a new agent begins to produce in the literature scattered reports of untoward effects, the drug companies seem to be very prompt in notifying the physicians of the country of these facts ; to advise caution in the use of the preparation and, if necessary, to voluntarily withdraw the drug from the market. Although I believe that the people who manufacture these agents are men with a conscience who do not wish to do their fellow men a wrong, the chief factor in their eagerness to detect unexpected dangers in the use of the drugs is the threat of a civil action by a patient who feels that he has been injured by such a preparation. I believe Mr. Belli of California, who has been called “The King of the Torts,” has been a far greater influence on the conscience of drug manufacturers than Mr. Kefauver. The whole country should be grate- ful to Dr. Kelsey for delaying the introduction of thalidomide to the United States. If more stringent Government regulation of testing of pharmacologicals will protect us from such a tragedy as occurred in certain of the European countries, we certainly must be in favor of such regulation. One cannot dis- count, however, the American public’s desire to decide for itself what may be good for it. For many years, the public has completely disregarded all con- clusive scientific evidence reported by the Federal Government, private medi- cine, and learned scientists throughout the country and has insisted upon using such agents as the Hoxey treatment for cancer, Krebiozen, another worthless treatment for cancer, chiropractic and “naturopathic” treatment involving the use of complicated and ineffective machines, plus literally millions of gallons of attractively packaged and worthless proprietary remedies. To summarize, I would say that the physicians whom I represent are grateful to the drug manufacturers for the fine products with which they supply us despite occasional overenthusiasm on their part, an occasional mistake, and some flagrant examples of overpricing. If some judicious policing by Federal agencies without undue interference in the competitive nature of the drug industry can elevate the standards of this industry even higher, such an effort is certainly to be encouraged. We are well pleased with things the way they are and if they are going to be better, we shall be even happier. Thank you very much for the opportunity to state this opinion. [M.D.’s name withheld. | Marcu 28, 1963. Dear SENATOR: The [name of newspaper] has been carrying daily reports on your commendable investigation into the marketing of dangerous drugs. I enclose two clippings.

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