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Executive Summary

Participants in industry-sponsored scientific or educational meetings "must insist" on being able to discuss competing products, FDA Commissioner Kessler advised in an article published in The New England Journal of Medicine July 18. Participants in symposia "must insist on their right to discuss the merits of competing products and to present opposing viewpoints if the event is to be truly a scientific one," Kessler wrote. Physicians should also be alert to the corporate groups sponsoring the meetings: are they primarily interested in marketing or scientific research and medical education? The article, entitled "Drug Promotion and Scientific Exchange: The Role of the Clinical Investigator," appears to be a way for Kessler to spur the medical community toward self-policing in advance of an official policy on seminars and scientific meetings. The NEJM article is Kessler's second on medical product promotions in a prestigious medical journal. An article in the Journal of the American Medical Association was published late last year ("The Pink Sheet" Nov. 19, p 3.). In a preview of the upcoming scientific seminar guidelines from FDA, Kessler says the key to the acceptability of the programs is that they must demonstrate "independence, objectivity, balance, and scientific rigor." Kessler previously has predicted that the guidelines will be issued by the end of this year ("The Pink Sheet" June 24, p. 4). "Scientific exchange" encompasses more than symposia, Kessler said. "Other industry-sponsored activities involving medical experts include programs of continuing medical education, grand rounds, press releases and press conferences, videotaped news releases, journals, and special supplements to otherwise peer- reviewed journals," he said. "In general," Kessler wrote, "physicians on the payroll of a drug company should do their best to avoid becoming unwitting participants in promotional activities. A wise precaution for both presenters and their audiences is to exercise a healthy skepticism about a firm's motives in asking certain experts to speak, and to consider the possibility that industry sponsorship may have influenced the content of their presentations." The commissioner repeated a warning that improper physician involvement in drug promotion will leave the doctors themselves open to enforcement action. FDA "will examine the role of experts involved in illegal promotional efforts to determine whether they bear responsibility for the violations," Kessler wrote, "Such experts, like the companies that support the activities, may be subjected to civil injunctions or criminal prosecutions." Kessler made similar statements before Rep. Weiss' (D-N.Y.) House Government Operations/Intergovernmental Relations Subcommittee June 11 ("The Pink Sheet" June 17, p. 7). "The agency has tried in the past to minimize any chilling effect of its policy on the free exchange of scientific information and ideas by directing its actions against the sponsors of questionable activities rather than the participating professionals," Kessler wrote. "Because of its increased concern about promotional practices for drugs, however, the FDA will no longer exercise this regulatory restraint across the board." In addition to insisting on their right to discuss any competing products, participating physicians can take a number of other steps to preserve the scientific integrity of symposia, Kessler wrote. Before agreeing to do industry-sponsored work, Kessler said, doctors should be sure they have the time to do it themselves. "If physicians cannot devote sufficient time to preparing a symposium or writing an article, they should turn the project down." If doctors agree to do projects when they do not have the time, Kessler cautioned, "they may be tempted to save time by accepting a pharmaceutical company's offer to suggest participants for a symposium, draft a journal article, or prepare slides for a presentation. Such offers open the door to undue influence, however, and should be resisted." Physicians must actively ensure that a symposium's content is scientifically sound, Kessler advised. "Participants should make sure that scientific and educational activities present timely and important information, grounded in adequate, well-controlled studies," he wrote. They must make sure that information presented is "balanced and not unduly focused on a sponsor's product," he said. Participants should be especially careful when the information involves comparisons or unapproved uses, Kessler added. "Any suggestion that one product is superior to another should be supported by the entire body of available data, not a selected set," Kessler said. That full-weight-of-evidence approach is being applied with new vigor by FDA in its current reviews of promotions (see related story, p. 19). Any discussion of unapproved products or indications must "be provided with rigorous objectivity," Kessler said. "In evaluating industry-sponsored activities, the FDA is very alert to situations in which either unapproved products or new indications for products already on the market are discussed," he added. Center for Biologics Evaluation and Research officials echoed this statement at a Food and Drug Law Institute Meeting July 16 (see related T&G). Doctors also should be aware of who is arranging the conference. "Physicians should avoid affiliating themselves with organizations that are either unqualified or not dedicated to scientific rigor," Kessler wrote. Activities arranged by marketing groups are particularly suspect, Kessler cautioned. "Many medical symposiums that are arranged through the marketing arm of a firm rather than its research or medical-education division tend to jeopardize scientific legitimacy, objectivity, and compliance with regulations," he added. In addition, "physicians should avoid events in which the choice of participants is unduly influenced by the sponsor, as well as those with ancillary promotional activities, such as the passing out of flyers about a sponsor's product." Doctors also should "insist" on full disclosure, Kessler advised. "I urge physicians who give presentations or attend them to insist that the source of the sponsorship be explicitly revealed, as well as the extent to which a sponsor has exercised control over the material," Kessler explained. "Any financial or other relationship, past or present, between the sponsor and a presenter should also be disclosed," Kessler added. "In line with the new policy of the American Medical Association, the audience should not be offered financial inducements to participate," he said. Medical experts' responsibilities do not end after a conference, Kessler said in the article. Noting that subsequent company communications may distort the events of the conference, Kessler wrote that "clinical investigators should accept some responsibility for keeping the record straight by attempting to monitor subsequent uses of their work." FDA "is determined to ensure that the promotional activities of pharmaceutical firms are identifiable as such and that they conform to the laws," Kessler wrote. "To succeed at this demanding task, the agency needs the cooperation of the country's physicians." Individuals "with questions about their participation in an industry-sponsored activity may direct their inquiries to Ann Witt, the acting director of the FDA's Division of Drug Marketing, Advertising, and Communications," Kessler wrote. FDA called attention to the article with a July 18 "Talk Paper." The agency "has stepped up its emphasis on monitoring compliance with ethical and legal standards in the promotion of prescription drugs," the "Talk Paper" says.

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