Public Release:  Association found between industry funding and promotional pieces on menopausal hormone therapy

PLOS

There may be a link between receiving industry funding for speaking, consulting, or research, and the publication of apparently promotional opinion pieces on menopausal hormone therapy. Furthermore, such publications may encourage physicians to continue prescribing these therapies to women of menopausal age. These are the key findings of a study by Adriane Fugh-Berman from Georgetown University Medical Center, Washington D.C., USA, and colleagues, published in this week's PLoS Medicine.

Over the past three decades, menopausal hormones have been heavily promoted for preventing disease in women. However, the 2004 federally-funded Women's Health Initiative study that enrolled more than 26,000 women in the USA found that the most popular estrogen-progestin and estrogen-only formulations (often prescribed to women around the age of menopause) increased the risk of stroke, deep vein thrombosis, dementia, and incontinence; the combined therapy also increased breast cancer risk. Two years after the results of the Women's Health Initiative were published, a survey of more than 700 practicing gynecologists--the specialists who prescribe the majority of hormone replacement therapies--in the USA found that almost half did not find the findings of the Women Health Initiative Study convincing. This current study investigated whether promotional tone could be identified in narrative review articles regarding menopausal hormone therapy.

The authors conducted a comprehensive literature search that identified 340 relevant articles published between July 2002 and June 2006--the 4 years following the cessation of the estrogen-progestin arm of the Women's health Initiative study. Ten authors had published 4-6 articles, 47 had published 2-3 articles, and 371 had published one article each. The researchers focused on authors who had published four or more articles in the four-year period under study. After author names and affiliations were removed, 50 articles were independently evaluated by three readers for scientific accuracy and for tone.

Although most of the articles were scientifically accurate, common themes in the 50 articles included arguments that clinical trial results should not guide treatment for individuals, and suggestions that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been, or will be, proven. Of the ten authors studied, eight were found to have received payment for speaking or consulting on behalf of menopause hormone manufacturers and 30 of 32 articles evaluated as promoting hormone therapy were written by those with such potential financial conflicts of interest. Articles promoting the use of menopausal hormone therapy were more than twice as likely to have been written by authors with potential conflicts of interest as by authors without such conflicts of interest.

The authors say: "There may be a connection between industry funding for research, speaking, or consulting and the publication of promotional pieces on menopausal hormone therapy." They add: ''Health care providers should exercise caution if they choose to read such articles."

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Funding: This study received no external or internal funding, and none of the authors received any funds or salary support for conducting this study.

Competing Interests: Adriane Fugh-Berman directs PharmedOut (http://www.pharmedout.org/), a Georgetown University Medical Center project that educates physicians about inappropriate pharmaceutical marketing practices. Dr. Fugh-Berman is also a paid expert witness on behalf of women who developed breast cancer while taking menopausal hormone therapy. Alicia M. Bell was the paid project manager of PharmedOut during part of the time this study was conducted. Christina McDonald and Emily Catherine Bethards received graduate school credit for their work on this study while they were master's students in Physiology at Georgetown University Medical Center.

Citation: Fugh-Berman A, McDonald CP, Bell AM, Bethards EC, Scialli AR (2011) Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles. PLoS Med 8(3): e1000425. doi:10.1371/journal.pmed.1000425

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CONTACT:

Adriane Fugh-Berman

Georgetown University Medical Center
Department of Pharmacology, Med-Dent SE-402
3900 Reservoir Rd. N.W. Washington, DC 20007

United States of America
202-687-7845

ajf29@georgetown.edu

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