Volume 6

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 Congress, as amended : review of cooperation on drug policies among food and drug administration, national institutes of health, veterans' administration, and other agencies.

  • United States. Congress. Senate. Committee on Government Operations. Subcommittee on Reorganization and International Organizations
Date:
1964
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 Congress, as amended : review of cooperation on drug policies among food and drug administration, national institutes of health, veterans' administration, and other agencies. Source: Wellcome Collection.

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    program is designed to make the AMA the clearinghouse for such information. REGISTRY ON BLOOD DYSOCRASIAS In the latter part of 1952, it was noted by several hematologists, including myself, that damage to the blood and blood-forming organs was associated, in some instances, with the administration of the anti- biotic, chloramphenicol. This and several published reports occa- sioned a meeting of hematologists with representatives of the Ameri- can Medical Association and the pharmaceutical industry which re- sulted in the establishment of an American Medical Association Com- mittee on Blood Dyscrasias. The stated purpose of the committee was to develop a registry which would “alert the profession to the potential hematotoxicity of drugs.” The registry received only 387 re- ports from the participating hematologists in the first 6 months and 85 reports by the end of the first year. By 1956, a revised report form was devised for greater clarity and simplicity. This was followed by a “pilot study” which enlisted the help of more physicians and hema- tologists and provided the reports for the tabulation which is now dis- tributed on a semiannual basis to all participating physicians. In 1959, to widen the scope of the registry and to insure that more physicians and institutions were aware of the reporting system, the tabulated information was distributed with an explanatory cover let- ter to: 1. Departments of medicine, pediatrics, pharmacology, pathology, and neuropsychiatry, and the libraries of the medical schools of the United States and Canada; 2. All of the State and local medical societies in the United States; 3. The medica] departments of the member firms of the Pharma- ceutical Manufacturers Association; and: | 4, The members of the American Society of Hematology, the Euro- pean Society of Hematology, the International Society of Hema- tology, and the Royal Australasian College of Physicians. The most recently distributed tabulation (exhibit Q) contains 1,817 reports involving 448 drugs or chemicals received by the registry through June 30, 1962, from approximately 600 reporting physicians. The reports are made to the members of a study group consisting: of 8 hematologists for review of the diagnosis and study of the possible causal relationship between the dyscrasia and the use of the drug.: Should the study group decide that there is a need for publication) of a cautionary statement, the manufacturer is given the opportunity’ to comment prior to the publication of the statement in the Journal of the American Medical Association (exhibit R). It is always clearly) understood that the study group is not committed to accept or publish. any comment received. The registry makes a summary of all reports received and on a semiannual basis distributes to a mailing list of 5,000 selected names (exhibit S) a copy of the tabulation. LIMITATIONS AS TO BLOOD DYSCRASIAS REGISTRY It should be noted that the registry was established initially for the purpose of “alerting the profession to the potential hematotoxicity