PharmedOut Newsletter
April 2015

Recent Project News

  • Have you registered for PharmedOut's upcoming conference, "The Real Risks of Rx Drugs"? Join us on June 11-12, 2015 at Georgetown University in Washington, D.C. Find out more at or by calling 202-687-1191 with questions!
  • On March 11th, Dr. Fugh-Berman was quoted in the Santa Cruz Sentinel on California's new policy aimed at curbing excessive antipsychotics prescribing for foster kids in order to control behavior. Prescribers now have to take extra steps to demonstrate the need for these patients to use antipsychotics, and as a result, thousands of requests have been rejected due to lack of medical necessity.  “It really shows the power of prior authorization,” Dr. Fugh-Berman said, "Just indicating that ‘we’re watching you’ makes a difference.”

    The story was also picked up by California Healthline.

  • On March 15th, Dr. Fugh-Berman was interviewed about PharmedOut's work for C-SPAN's show "Q&A". Watch the video here
  • On March 17th, "The Drug That Cried 'Feminism'" by Dr. Fugh-Berman, Project Manager Alessandra Hirsch, and volunteer staffperson Rebecca Holliman was published on the Hastings Center's Bioethics blog.
  • On March 19th, Dr. Fugh-Berman was quoted in the NPR story "Why Is Insulin So Expensive?" New treatments are often sold at a higher price, but they "aren't always better," Dr. Fugh-Berman said. "In government-funded studies that have compared older drugs to newer drugs, often older drugs come out looking better or equal to newer drugs."
  • PharmedOut's Resource of the Month: View our 2015 conference website for information on speakers, conference accommodations, and forthcoming updates.
April's PharmedOut Fodder: 21st Century Pandering

In March, the Senate Health, Education, Labor and Pensions Committee held several hearings to discuss many of the themes presented in the House of Representative's "21st Century Cures" draft legislation. The Senate is considering its own version of the bill, which is 
described as Congress's opportunity to, "for the first time ever ... take a comprehensive look at what steps we can take to accelerate the pace of cures in America." Why? Because although FDA approved 51 new drugs in 2014 (nearly a 20-year high), and the agency's average approval rate is faster than all other advanced nations, some lament federal agencies like the FDA as barriers to "innovation."

As Senator Elizabeth Warren noted at one of these hearings, "we could abolish the FDA tomorrow and we'd see tons of new products on the market," but the goal is not just more products, but safe and effective ones. While the Pharmaceutical Research and Manufacturers of America (PhRMA) is a big fan (and participant) in the 21st Century Cures efforts, we have concerns. 

Here are areas of the draft bill that, if it becomes law, could pose harm to patients:
  • Pharmaceutical companies would be allowed to promote off-label (non-FDA-approved) uses of drugs to physicians and other prescribers (such promotion has been illegal, and efforts are already underway to reverse that).
  • For drugs found to be “promising” in early studies, the law would encourage the FDA to grant approval based on very preliminary evidence, no longer requiring evidence from any controlled clinical trials until years after the drug is on the market. 
  • FDA staff would be required to receive training every year on ensuring that safety and efficacy studies would be less burdensome to pharmaceutical companies.
  • Several changes to market exclusivity limits would allow companies to charge higher prices for longer periods of time, with no competition. "Specialty drugs," those that meet a complicated or rare medical need, would get 15 years of market exclusivity instead of their current 12. Two additional years of exclusivity would be granted to existing drugs if "improvements" are made, which may have nothing to do with the drug's beneficial effects. And finally, to incentivize antibiotic development, companies introducing new antibiotics will be able to transfer a year's worth of exclusivity to "one or more drugs."
The bill also seeks to create a "fast lane" for certain medical devices and drugs. However, we see the lane as already too fast for the 95% of moderate- and high-risk medical devices that were not required to be tested in humans, and the drugs found to be dangerous after they're on the market.

Government's role ought to be protecting public health before industry profits. FDA Commissioner Margaret Hamburg said, shortly before resigning at the end of March, that seemingly burdensome regulations were put in place for a reason — often, after medical disasters that resulted in injuries and death. Those lessons should not be forgotten as this legislation is discussed.


News Round-Up 
(for more, please follow @pharmed_out on Twitter!)

March 1: New York Times: "Psychiatric Drug Overuse Is Cited by Federal Study" by Robert Pear

March 2: Science Magazine: "Human subjects protections under fire at the University of Minnesota" by Jennifer Couzin-Frankel

March 2: Government Accountability Office: "HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings"

March 3: WSJ Pharmalot: "FDA Warns Testosterone Drugs Can Increase Heart Risks" by Ed Silverman

March 3: Los Angeles Times: "Testosterone replacement products boost heart attack, stroke risk, FDA says" by Melissa Healy

March 10: CBS News: "New FDA warning for anti-smoking drug Chantix

March 12: Psychology Today: "Buying And Selling Binge Eating Disorder" by Allen Frances

March 15: The Atlantic: "How to Teach Doctors Empathy" by Sandra Boodman
March 16: WSJ Pharmalot: "FDA Proposal Spurs Fight Over Free Speech and Patient Safety" by Ed Silverman

March 17: Wall Street Journal: "Holy Grail: Pain Pills Without the High" by Jeanne Whalen"

February 17: New York Times: "Doctors Strive to Do Less Harm by Inattentive Care" by Gina Kolata

March 23: WSJ Pharmalot: "A University’s Handling of Clinical Trial Practices Raises ‘Serious Ethical Issues’" by Ed Silverman

March 23: Vox: "This is why you shouldn’t believe that exciting new medical study" by Julia Belluz

March 24: Washington Post: "The testosterone and HGH boom: How critics say ‘disease mongering’ created a multibillion-dollar industry" by Amy Brittain

March 24: Medical Marketing & Media: Lawmakers propose allowing pharma companies to share some off-label information by Jaimy Lee

March 26: CBS News: "Foster care kids put on too many psych drugs, report says"

March 26: Washington Post: "How the FDA could make prescription drug ads less annoying By Jason Millman

March 27: National Women's Health Network: "National Women’s Health Network Supports Parity in Generic Drug Labeling"


Check These Out!

You can still register for the Harvard University Edmond J. Safra Center for Ethics conference "Ending Institutional Corruption" on May 1-2, 2015, in Cambridge, Mass. Admission is free but registration is required. Find out more and see the full list of panel discussions and workshops here

Some interesting infographics, including one showing how much pharmaceutical companies spend on marketing versus research and development.


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