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Sex, lies, and drugs: How Big Pharma overhyped women’s sexual problems

Consumer Reports News: November 11, 2010 03:10 PM

Ray Moynihan, an investigative journalist, described his recently released book, "Sex, Lies and Pharmaceuticals," to the Cochrane Collaboration meeting in Keystone, Colo., in mid-October. The book explores a decade-long effort by several drug companies to define, diagnose, and market pills to treat female sexual dysfunction (FSD).

Moynihan details a well-planned sequence of events orchestrated by the drug industry that began in 1997. He starts with a description of a conference for doctors, researchers, and pharmaceutical marketing staff at Cape Cod to discuss female sexual issues and physiology. Expert convenings were then held to identify the key "features" of the new disease–with most of the experts paid by the industry. Moynihan then describes survey research and analyses that were commissioned to support the emerging hypothesis that millions of women suffered from a range of sexual concerns and dysfunction. 

A good bit of this research was published in prestigious journals. That included a widely publicized 1999 JAMA article by drug industry-supported researchers asserting that 43 percent of women had some form of sexual dysfunction. A note in the piece stated that the findings were not equivalent to a “diagnosis” but, as Moynihan asserts, caveats like this one are often lost. Indeed, media coverage of the article lasted for months, and to this day, Moynihan says, the survey questions used have not been proved scientifically reliable as a measure of any established diagnosis or disease state.  

Moynihan focuses on the activities of three companies—Pfizer, Procter & Gamble, and Boehringer Ingelheim. All had medicines with the potential–or so they thought—of treating women’s sexual problems. Pfizer had Viagra, a drug increasing blood flow to the genital organs. Procter & Gamble had a testosterone patch. And Boehringer had a failed antidepressant. Each company hypothesized a female sexual dysfunction syndrome responsive to its drug, Moynihan says.

At the same time companies prepared strategies that would help physicians quickly diagnose and treat these emerging disorders. Boehringer, for example, funded the development of a “Decreased Sexual Desire Screener” that allowed doctors to diagnose “hypoactive sexual desire disorder” in a few minutes. The study was published in the Journal of Sexual Medicine, sparking some momentum among physicians. Several of the physicians and researchers involved in the study had financial relationships with Boehringer and other drugs companies.  

None of the drugs were ever approved by the Food and Drug Administration for the female sexual indications the companies were exploring. And, between 2000 and 2009, other independent research documented significantly lower incidences of serious sexual dysfunction among women. There’s no question that many women do suffer from sexual dysfunction and some are even helped by a drug like Viagra, but the vast majority are probably not.

Should pharmaceutical companies be “identifying” diseases without an independent review of their work? Is this how “research driven” drug companies should operate—start with the drug and then find a “disease?” Do the best approaches to research really start with conferences involving researchers, clinicians, and marketing folks? Is this approach the best use of investor and stretched health-care dollars?

There is an alternative. Start with the evidence, that is, research done by independent researchers, reviewed and checked by independent reviewers, with consumers included throughout the process to make sure the focus is on real health concerns.

John Santa, M.D., director, Consumer Reports Health Ratings Center

 


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