PharmedOut Newsletter, October 2014

Recent Project News

  • 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?" 

    We were pleased that at the end of the meeting, the Advisory Committee voted to change the label on testosterone in order to limit its use!
  • On September 29th, Dr. Fugh-Berman was quoted in the Medscape Medical News article "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.


News Round-Up 

(for more, please follow @pharmed_out on Twitter!)

September: Consumer Reports: "Some Americans take risks with needed drugs due to high costs"

September 2: Vox: "8 facts that explain what’s wrong with American health care"

September 2: The Guardian: "Double mastectomy for breast cancer 'does not boost survival chances'"

September 4: New York Daily News: "Massachusetts pharmacist arrested in connection to deadly 2012 meningitis outbreak"

September 4: WSJ Pharmalot: "FDA Lowdown on ‘Low T’ Drugs: Little Evidence to Support Widespread Use"

September 5: Pharma Marketing Blog: "FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events"

September 8: The New York Times: "Doctors' Magical Thinking About Conflicts of Interest"

September 8: The New York Times: "D.E.A. to Allow Return of Unused Pills to Pharmacies"

September 9: Los Angeles Times: "Drugs used for anxiety, sleep are linked to Alzheimer's disease in older people"

September 11: Regulatory Focus: "Comparative Claims in Advertising Make Drugs Seem Safer, More Effective"

September 13: Médicos Sin Marca: "Peter Gøtzsche: The Drug Industry Routinely Lies To Doctors"

September 14: Psychology Today: "Saving Normal"

September 16: WSJ Pharmalot: "The Eyes Have It: Study Says Avastin is Just as Safe to Treat AMD as Lucentis"

September 16: The Daily Show: "The Pharmaceutical Drug Epidemic"

September 17: The New York Times: "How Insurers Are Finding Ways to Shift Costs to the Sick"

September 17: The New York Times: "F.D.A. Panel Weighs Restrictions on Testosterone Drugs"

September 18: WSJ Pharmalot: "FDA Panel Says Testosterone Drugs Need More Study and Reduced Use"

September 19: The New York Times: "China Fines GlaxoSmithKline Nearly $500 Million in Bribery Case"

September 24: WSJ Pharmalot: "Smoke This: Pfizer Wants Serious Warnings Removed From Chantix"

September 24: The Wall Street Journal: "As Doctors Lose Clout, Drug Firms Redirect the Sales Call"

September 29: Medical Marketing & Media: "Pacira gets OPDP opioid promotion Warning Letter"

September 29: ProPublica: "What We’ve Learned From Four Years of Diving Into Dollars for Docs"

September 29: Pew Charitable Trusts: "Data Visualization: What Is Your Doctor Getting Paid?"


Check This Out!

Even if you can't make it to October's FDA meeting on FSD, the New View Campaign has a petition asking the FDA to rely on science instead of PR. You can view and sign it here.

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