Cancer Drug Research:

Contrary to Allegation, NIH Hydrazine Sulfate Studies Were Not Flawed

HEHS-95-141: Published: Sep 13, 1995. Publicly Released: Sep 13, 1995.

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Pursuant to a congressional request, GAO provided information on the National Cancer Institute (NCI)-sponsored clinical trials of the anticancer drug hydrazine sulfate, focusing on: (1) NCI protocol design and data management procedures; (2) how NCI and the trials' investigators dealt with the drug's potential incompatibility with certain agents; (3) the extent to which patients received these incompatible agents; and (4) how the investigators reported the issue.

GAO found that: (1) the three large NCI-sponsored clinical trials showed that the drug did not prolong cancer patients' survival; (2) controversy surrounding the trials focused on trial participants' use of tranquilizers, barbiturates, and alcohol, which were allegedly incompatible with the drug; (3) clinical trial records showed that participants used tranquilizers under varying circumstances, particularly for relief from vomiting; (4) the investigators believed that it was unethical to withhold antiemetic medications from patients undergoing chemotherapy; (5) subsequent analyses of patients' use of concurrent medications did not invalidate NCI conclusions that the drug was ineffective; (6) the Food and Drug Administration (FDA) may have contributed to the confusion surrounding the trials due to its more conservative position on how the drug should be administered to some patients; (7) although FDA approved more than 70 applications permitting the use of hydrazine sulfate, it cautioned physicians about their patients' use of tranquilizing agents while on the drug; (8) there were lapses in recordkeeping and reporting because NCI did not require complete and accurate research records on the patients' use of tranquilizing agents during the trials; and (9) NCI-sponsored investigators only recently analyzed this issue, since published results did not accurately describe the widespread use of tranquilizers during the trials.

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