Mark your calendars! PharmedOut's 2015 conference will be held on June 11-12, 2015. Watch for more information and details in the coming months.
On September 17th, Dr. Fugh-Berman testified at the FDA's hearing on testosterone therapy and cardiovascular risks. As many of you know, "Low-T" treatments were in the news earlier this year as a growing number of men had heart attacks while using the drug. In response, the FDA Advisory Committee convened to determine future labeling requirements on testosterone products.
Dr. Fugh-Berman spoke to the Committee about the overuse of testosterone in normally aging men. She called this "a public health concern" and said "the current labeled indication of testosterone therapy is so broad and vague that any man with a single low testosterone level [when tested] can be diagnosed with hypogonadism. Testosterone levels can vary hourly, daily, weekly, and seasonally. Levels are affected by exercise, sexual activity, handling a gun, handling a baby, marriage, divorce, and the performance of one’s favorite sports team. Given that the diagnostics are questionable, and the benefits are unconvincing, are any life-threatening risks of testosterone worth taking?"
On September 29th, Dr. Fugh-Berman was quoted in the Medscape Medical Newsarticle "Open Payments Web Site Debuts, Ready or Not". The website, which allows patients to look up payments to their doctors from drug and device companies, became public in late September.
Ahough many physicians, and the American Medical Association, maintain that doctor-industry relationships benefit patients and don't influence prescribing choices, Dr. Fugh-Berman said "physicians can be bought, and those who don't think that they can aren't paying attention to the literature ... and it's not the specific amount of money, it's the relationship. If this didn't work, they wouldn't be doing it."
PharmedOut's Resource of the Month: Curious about how much drug companies pay out to physicians, organizations, and others? Some disclose this information, and we link to their records here.
October's PharmedOut Fodder: "Where's The Female Viagra?"
PharmedOut distributed flyers countering misleading information at a September 16th Senate briefing on Female Sexual Dysfunction (FSD). The Senate briefing was called "Where's the female Viagra?" and was arranged as part of "Even The Score", an aggressive PR campaign created by Sprout Pharmaceuticals and renowned PR firm Edelman. Sprout owns flibanserin, a drug meant to treat Hypoactive Sexual Desire Disorder (a subset of FSD), but has been rejected twice by the FDA for failing to show adequate efficacy and safety. Hypoactive Sexual Desire Disorder no longer exists as a diagnosis; the newest wording is Female Sexual Interest/Arousal Disorder.
Sprout has raised $15 million to try to get the FDA to approve the drug in 2015. The “Even The Score” campaign accuses the FDA of sexism, claiming that there are 26 drugs to treat male sexual dysfunction, but none for its female counterpart. Our flyer clears up that rumor and skewers other myths created to pressure the FDA.
Most of the panel of six women who spoke at the Senate briefing were paid by Sprout, as we found out when we asked at the end of the panel. It was a good opportunity for PharmedOut to pass out our flyers with our own message: “Don’t Need Drugs to Score”.
Is Sprout behind the FDA's decision to prioritize FSD for patient-focused drug development this year? On October 27th and 28th, the FDA will host a public meeting and scientific workshop on the subject. PharmedOut will attend these meetings; we ask others to do the same so that we can counter Sprout’s efforts and make our voices heard.