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
Catalogue details

Licence: Public Domain Mark

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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    The reason for her going to Mayo Clinic was that she had read an article about the investigation going on. This lady is very seriously injured and we would like to determine what should be done under the circumstances. Very truly yours, EVERETT HULLVERSON. (Internal Agency Document) October 27, 1961. JOHN O. NEstTor, M.D. To: William H. Kessenich, M.D., Medical Director. From : John O. Nestor, M.D., Medical Officer. Subject: MER/29 Triparanol (NDA 12-066). Ww. S. Merrell Company, Cincinnati, Ohio—AF 1-542, NDA 12-066. After a thorough reviewing of the contents of NDA 12-066, consultation with} outside authorities, interviews with representatives of William S. Merrell Com- pany, and review of the most recent data submitted by the company on October 26, 1961, I have the following comments. 1. There is no objective evidence that the drug has any effect on either the pre- vention or alleviation of atherosclerosis and its resulting deleterious effects on humans. 2. It has been offered for use on the basis that it lowers blood and body: cholesterol and that this in turn prevents or decreases atherosclerosis and its as- sociated deleterious effects. No one has demonstrated that lowering blood cholesterol reverses or inhibits the development of atherosclerosis in humans. This is outlined in the official view recorded in the Federal Register on Decem-. ber 10, 1959. 3. The William S. Merrell Company has made unsubstantiated claims for the: effectiveness of T'riparanol in lowering blood cholesterol levels and this is re-. flected in their labeling. In fact, latest available data indicated that it does: not significantly effect blood cholesterol levels in the hands of the Mayo Clinic group. 4. Overwhelming evidence has accumulated to demonstrate that _MER/29' (Triparanol) produces severe adverse reactions and toxicity in both animals: and humans. Much of this evidence was available in the NDA when it was: made effective. Much of it has accumulated since. 5. Serious toxic effects in humans include (1) cataracts, (2) diminished libido, (8) impotence, (4) loss of hair, (5) change in color of hair, (6) icthyosis, and! (7) the depression of production of adrenal cortical hormones which are so: important in resistance to stress and shock. There have also been suggestive: reports of liver damage (fatty metamorphosis). 6. In experimental animals Triparanol has prevented ovulation and concep-. tion as well as producing defective offsprings in those that did conceive. 7. The William S. Merrell & Company has withheld from us some of this evidence of serious toxicity in animals and humans which has been in their pos-. session for months. 8. The entire NDA plus the new information given to us by the company) representatives on October 26, 1961, is being referred to the Division of Phar- macology for immediate review and comment. 9. Since Triparanol produces serious toxic effects in humans and since this: drug has not been conclusively demonstrated to have any material clinical! benefit consideration should be given to immediate suspension of this NDA) as the potential benefit is not warranted by the definite risk. It should be clearly noted that the company knowingly has withheld certain pertinent information: relating to these severe toxic reactions. is) The physicians of the country should be alerted to this situation immed-: ately. JOHN O. Nestor, M.D.