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BRISTOL-MYERS' ONCOLOGY UPDATES ARE "ACCURATE AND USEFUL" -- NCI's CHABNER

Executive Summary

Bristol-Myers' "Oncology Commentary '90" cancer drug meeting descriptions, although acted against by FDA for promoting off- label oncology drug uses, were for the most part accurate and useful to researchers, National Cancer Institute Division of Cancer Treatment Director Bruce Chabner, MD, asserted at a June 10 NCI meeting. Addressing a meeting of the division's board of scientific counselors, Chabner said: "While it is true that some meetings described in [Bristol-Myers' publication] were concerned solely with drug company products, others represented the best of current cancer research presented at a meeting. In the latter instance," he said, "the meeting reports were accurate and useful summaries of state-of-the-art research." Chabner maintained that the "therapeutic research, by its very nature, encourages the off-label use of approved drugs." He noted that "an article in the New England Journal of Medicine may present evidence that would encourage off-label use of a drug, and this is allowed. The NCI or a private institution could publicly endorse and disseminate the same information without FDA restriction. What really matters is the content of the report, not its sponsorship." Chabner's comments came in response to FDA action against the Bristol-Myers Oncology Division's controlled circulation publication "Oncology Commentary '90," which included information on current clinical practice and summaries of reports from medical meetings. As part of a settlement with FDA over alleged promotions of unapproved cancer indications, Bristol-Myers agreed to begin sending out over 8,000 "Dear Doctor" letters on June 4 ("The Pink Sheet" June 3, p. 4). The letter states that only favorable opinions and data on Bristol oncology products were included in the publication, which was discontinued last summer. Chabner told the NCI meeting that he wanted to express his "personal concern about the recent zealous FDA efforts to curb the distribution of meeting newsletters under company sponsorship." FDA's requirement that Bristol-Myers Squibb send "Dear Doctor" letters is just one element of a two-part corrective action. The agency also is requiring Bristol-Myers Squibb to preclear all its oncology promotional materials with FDA for the next two years ("The Pink Sheet" June 3, p. 6). "The whole episode really calls into question the current FDA policy of approval of drugs for new indications," Chabner declared. "If the FDA is going to be hard-nosed about dissemination of research results that relate to off-label uses, then it needs to devise a more rapid way for approving drugs for off-label use." Package inserts in most cases "bear little relationship to the current use of these agents," Chabner said. He continued: "It seems to me to be anti-intellectual, unrealistic and inhibitory to technology transfer to restrict the dissemination of valid research results concerning a new use for an approved drug."
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