Omissions, biases, and nondisclosed conflicts of interest: is there a hidden agenda in the NAMS position statement?

On September 8, 2005, a public relations company press release announced a new North American Menopause Society (NAMS) position statement, “The role of testosterone therapy in postmenopausal women.”[1] The full 15-page statement was concomitantly published in the September/October 2005 issue of the NAMS journal, Menopause.[2] At first glance, it appears that this position statement expresses timely and important concerns about the potential overprescription and misprescription of testosterone products as treatments for women's sexual (and other menopausal) complaints. This worrisome trend has been noted by many, including The New View Campaign, a medicalization watchdog group I founded in 2000 (see http://www.fsd-alert.org). Along with other groups, such as the National Women's Health Network, Public Citizen's Health Research Group, and Breast Cancer Action, our New View Campaign group testified against the approval of Intrinsa, Procter & Gamble's testosterone transdermal system for the treatment of low sexual desire at the Reproductive Advisory Committee meeting of the United States Food and Drug Administration (FDA), which was held on December 2, 2004.[3] Our reasons for recommending rejection had to do with poor data on testosterone safety and efficacy, inadequacies in sexual desire definition, concern about pharmaceutical industry marketing plans, and the overall negative implications of the medicalization of menopause and sexuality.[4] At the conclusion of all the testimony on December 2, the Advisory Committee voted unanimously against approving Intrinsa, and shortly afterwards Procter & Gamble withdrew its application.[5] Nevertheless, publicity about testosterone as “the hormone of desire” has continued. In the absence of competing publicity about attraction as “the engine of desire,” sex education as “the lubricant of desire,” sensuality as “the foundation of desire,” or a speed-up society as “the death of desire,” physicians continue to receive requests for testosterone treatment. And because of the relaxed rules about off-label prescribing and its widespread practice,[6–9] it seems there is a continuing stream (or is it a flood) of testosterone-using patient-guinea pigs.[10,11] Given the ongoing media and industry hype, it makes sense that NAMS might want to generate a paper presenting the scientific evidence for the use of testosterone in postmenopausal women. But this NAMS “evidence-based” position statement suffers from some odd lacunae of evidence. The value of testosterone in the treatment of sexual complaints is overstated; the importance of psychosocial variables is dismissed; measurement issues are stated without exploration; dangers in the concomitant and seemingly mandatory use of estrogen with testosterone are underemphasized; conflicts of interest of the position paper's authors, consultants, and reviewers are omitted, and, perhaps most serious of all, the entire document seems, paradoxically, to represent a covert promotion of one particular testosterone product, Intrinsa, which has been rejected by both the FDA and the European Union.[12] The New View Campaign Group sees this as a violation of proper medical practice and a flagrant abuse of NAMS' public platform, and we call on the NAMS membership and Board of Trustees to revise this statement and limit future involvement of pharmaceutical companies in NAMS publications and activities.