What Influences Advocates of Providing "More, Not Less, Truthful Information" About Off-Label Drug Use?

Last week's New England Journal of Medicine included a letter [Troy DE, Gottlieb S. Pharmaceutical promotion and first amendment rights. N Engl J Med 2008; 359: 536. ] supporting pharmaceutical companies' rights to promote their products for uses not approved by the US Food and Drug Administration (FDA). The letter applauded "the robust, sound constitutional protection the U.S. Supreme Court affords truthful, nonmisleading commercial communication such as that embodied in reprints of scientific articles discussing off-label uses." It asserted "appropriate off-label use that informs proper patient care is fostered by more, not less, communication of truthful, nonmisleading information."

Policy discussions about issues such as this, I believe, would also benefit from the provision of "more, not less, communication of truthful, nonmisleading information."

The first author of this letter, Daniel E. Troy, identified his affiliation with the law firm Sidney Austin LLP, and disclosed that he "represents manufacturers who submitted comments to the Food and Drug Administration (FDA) on its draft reprint guidance."

Mr Troy did not disclose that he is the future general counsel of UK-based international pharmaceutical company GlaxoSmithKline. This appointment, effective September 2, 2008, was announced the week before the NEJM letter was published. (See this article in the Wall Street Journal.)

The second author, Dr Scott Gottlieb, did not disclose any potential conflicts of interest.

Thus, Dr Gottlieb did not reveal that he is on the board of directors of Molecular Insight Pharmaceuticals, a "a biopharmaceutical company specializing in the emerging field of molecular medicine." As a member of the board, Dr Gottlieb is expected to have "unyielding loyalty" to the stockholders and their financial interests.

I admit that as a strong advocate of free speech, I too have trouble with the idea that the FDA can restrict simple written or oral communication by a drug company's representatives about their products. (Gifts or payments to physicians as part of marketing efforts are very much another story.) So I do not have a big problem with the policy position Troy and Gottlieb took on this.

But I do believe that as advocates of more "truthful, nonmisleading information" they should disclose financial relationships that might influence the policy positions they are advocating. As it stands, without such disclosures, their letter to the NEJM amounted to stealth health policy advocacy, something we now see all to much of.

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