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Menopausal hormone therapy for health promotion

January 30, 2018

Is the USPTF wrong?

The US Preventive Services Task Force (USPTF) has just reviewed their advice for the fourth time in the 15 years since the two huge Women’s Health Iniative (WHI) trials reported.  No-one questions menopausal hormone therapy for symptom control, but for long-term health promotion we need to be sure that it does more good than harm. Previous advice that long term harms outweigh the benefits has been consistent, but needs regular review.

The latest advice (click here), authored by experts selected to avoid any potential conflicts of interest with drug manufacturers (details here), following public consultation, and published in one of the world’s most prestigious medical journals, the Journal of the American Medical Association JAMA (Impact factor 44), is unchanged; don’t use hormone therapy for health promotion.

It is supplemented by a 15 page evidence report (click here) as well as 20 evidence tables, and endorsed by three independent commentaries (click here, here, and here) which provide historical and methodological context. Here are the abstract’s findings, and conclusions and recommendation.

Findings Although the use of hormone therapy to prevent chronic conditions in postmenopausal women is associated with some benefits, there are also well-documented harms. The USPSTF determined that the magnitude of both the benefits and the harms of hormone therapy in postmenopausal women is small to moderate. Therefore, the USPSTF concluded with moderate certainty that combined estrogen and progestin has no net benefit for the primary prevention of chronic conditions for most postmenopausal women with an intact uterus and that estrogen alone has no net benefit for the primary prevention of chronic conditions for most postmenopausal women who have had a hysterectomy.

Conclusions and Recommendation The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal women. (D recommendation) The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal women who have had a hysterectomy. (D recommendation)

This seems clear and measured. But another group of nine self-styled “experts” have written a response in a low impact scientific journal Menopause (IF 2.7) (click here), titled “Menopausal hormone therapy for primary prevention: why the USPSTF is wrong”. They’ve written the same article in an even less prestigious journal Climacteric (IF 1.7) (click here) as well. Both journals are behind paywalls so few will read them, and I’m certainly not going to buy access. But in case hormone manufacturers distribute reprints at menopause meetings, or to naive journalists or non-expert doctors, let’s check the Menopause and Climacteric authors’ conflicts of interests.

RD Langer, Professor of Family Medicine, University of Nevada has signed his name to “medical writer” authored articles for Novo Nordisk (click here), received research support from Glaxo Smith Kline and served as a consultant and expert witness for Wyeth.

JA Simon, Professor of Obstetrics and Gynecology, George Washington University has also signed his name to “medical writer” authored articles (click here) and served as a consultant to or on the advisory boards of AbbVie, Allergan, AMAG, Amgen, Inc., Apotex, Inc., Ascend Therapeutics, Azure Biotech, JDS Therapeutics, Merck & Co, Millendo Therapeutics, Noven, Novo Nordisk, Nuelle, Perrigo Company, PLC, Radius Health, Regeneron Pharmaceuticals, Roivant Sciences, Sanofi SA, Sebela Pharmaceuticals, Sermonix Pharmaceuticals, Shionogi, Inc., Sprout Pharmaceuticals, Symbiotec Pharmalab, TherapeuticsMD, and Valeant Pharmaceuticals; and has received grant/research support from AbbVie, Actavis, PLC, Agile Therapeutics, Bayer Healthcare, GlaxoSmithKline, New England Research Institute, Novo Nordisk, Palatin Technologies, Symbio Research, and TherapeuticsMD; and has also servedon the speaker’s bureaus of Amgen, Eisai, Merck, Noven Pharmaceuticals, Novo Nordisk, Shionogi, Inc., and Valeant Pharmaceuticals; and is a stockholder in Sermonix Pharmaceuticals.

A Pines, Professor of Internal Medicine, Tel-Aviv University is one of five “prolific partisan editorialists” identified by Athina Tatsioni and colleagues in 2010 (click here). In most of his publications he reports no conflicts of interest. However, on the Climacteric editorial board he acknowledges being a consultant for a local, Israeli distributor that represents about 20 international pharma companies with niche products in all fields of medicine (click here).

RA Lobo, Professor of Obstetrics and Gynecology, Columbia University Medical Center, New York was identified by Adriane Fugh-Berman and her colleagues in 2011 (click here) as one of ten conflicted authors repeatedly using “promotional tone” in articles about hormone therapy.  In 2014 the website of the International Menopause Society reported that he “has provided consulting services for many large pharmaceutical laboratories”, although the link is now dead. He does not report conflicts of interests in his more recent articles, although many are behind paywalls so difficult to check.

HN Hodis, Professor of Cardiology, University of Southern California has no declared conflicts of interest.

JH Pickar, Professor of Obstetrics and Gynecology, Columbia University Medical Center, New York has signed his name to “medical writer” authored articles funded by Pfizer (click here) and received consultant fees from Wyeth/Pfizer, Shionogi Inc., Radius Health, and Therapeutics MD and has stock options in TherapeuticsMD

DF Archer, Professor of Obstetrics and Gynecology, Eastern Virginia Medical School (click here) has received grant support from Actavis and Glenmark, received grant support, honoraria, and travel support from Bayer Healthcare, Endoceutics, Merck, Radius Health, Shionogi, and TherapeuticsMD, receiving honoraria and travel support from Exeltis/CHEMO France, Pfizer, Sermonix Pharmaceuticals, and TEVA/HR Pharma, received honoraria and travel support from and has an equity interest in Agile Therapeutics and Innovagyn

PM Sarrel, Emeritus Professor of Obstetrics, Gynecology, Reproductive Sciences, and Psychiatry, Yale University (click here) has served as a medical consultant for Noven Therapeutics

WH Utian, Professor Emeritus, Reproductive Biology, Case Western Reserve University, Cleveland (click here) has been a consultant/advisory board member for Bayer, Bionovo, Hygeia (Orcas Therapeutics), Lupin, Merck, Novogyne, Pharmavite.

Readers might wish to bear the above in mind when they decide whether or not to take these doctors’ advice to go against the USPTF recommendations to avoid menopausal hormone therapy for health promotion.

Jim Thornton

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One Comment leave one →
  1. Kiran Kalian permalink
    January 30, 2018 6:58 pm

    Medical advisors to large pharmaceutical companies should never be involved in clinical research . Conflict of interests are so high promoting unethical advise to the larger medical fraternity . A pathetic state of affairs worldwide ! Wholeheartedly agree with Jim Thornton!

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