September 2015 Newsletter

Recent Project News

Well, it's official: "Female Viagra" pill "flibanserin" (now known by its catchier branded name, "Addyi") was approved by FDA on August 18th. But not without continued criticism from PharmedOut on its lackluster efficacy and questionable safety:
PharmedOut's Resource of the Month: For longer-form reading on overprescribing, disease mongering, and the pharmaceutical industry, check out our lengthy list of books on these topics. To get started, we recommend the eye-opening Hard Sell by former Viagra salesman Jamie Reidy (which was also the basis for the movie Love and Other Drugs).

September's PharmedOut Fodder:

Opioids for Kids

On August 13th, the FDA approved the use of OxyContin (oxycodone), an opioid painkiller, for kids between 11 and 16 years old who have severe pain. Until now, generic painkiller oxycodone has been used in this age group on an off-label basis, mainly for long-term illnesses such as cancer or back injuries.

The approval, however, was for extended-release OxyContin, which is still on patent; the company will ask for a six-month patent extension based on the pediatric approval, enhancing the profits for a company that has marketed OxyContin unethically. Senator Joe Manchin (D-W. Va), slammed the decision in a letter to the FDA. The FDA claims that the guidance available in a label will help physicians. "What you really have to understand is these kids are already on opioids,” agency spokesman Eric Pahon said. "Since the drug was being used to treat children, we wanted prescribers to have the information they needed to ensure safety and efficacy. That was the underlying reason for this approval."

FDA and other proponents call it a step in the right direction that will lead to more responsible and educated prescribing of a strong and potentially dangerous medication.

But we think the decision overlooks the problem of opioid addiction plaguing communities across the country; one the Centers for Disease Control calls an "epidemic." Half of drug overdose deaths (the leading cause of injury death in the United States) were related to prescription drugs; almost three-quarters of prescription drug-related deaths involved opioids. Overdose deaths surpass deaths from traffic accidents, guns, and falling. 

In light of this FDA decision, some have said young adults are less prone to opioid addiction and abuse. In fact, adolescents may be more likely to become addicted than adults. Surveys continually show that young people underestimate the power of prescription painkillers, and believe they are safer or less addictive than heroin. And, 70% of people who have misused prescription painkillers, and over half of teens, obtained the drug from someone else to whom they were prescribed.

Expanding access to OxyContin increases the opportunity for addiction and abuse among children, both those who were prescribed the drug and those who got the drug from someone else. If the goal is to curb the opioid epidemic, FDA's decision is a step backward, not forward.

Check These Out!

Registration is open for the National Physicians Alliance's 2015 annual conference! "Truth to Power: Alliance for the Public Good" will take place on October 17-18 in Washington, D.C. Learn more here.

Are you a medical student interested in holding the pharmaceutical and medical device industry accountable? Consider registering for the American Medical Students Association's "Just Medicine" scholars program.

And, for fun: The Onion answers some of the most pressing questions about the new 'Female Viagra'.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)


August 31

Take As Prescribed (Al Jazeera)

August 28

The Little Pink Pill (On the Media)

August 27

Many Psychology Findings Not as Strong as Claimed, Study Says by Benedict Carey (New York Times)

August 25

Addyi’s Alcohol Safety Was Tested Mostly on Men by Melissa Dahl (New York Magazine)

Voters want candidates to address drug prices by David Nather (Boston Globe)

August 24

'Female Viagra' Approval: Did Sprout Pharmaceuticals Set A Dangerous Precedent In Earning FDA Go-Ahead For Addyi? by Amy Nordrum (International Business Times)

Pharma junkets for U.K. docs trigger tough new Sunshine rules, penalties by Tracy Staton (Fierce Pharma)

August 23

Here's What Sexperts Think About "Female Viagra" and Why You Shouldn't Call It That by Becca Andrews (Mother Jones)

August 21

Dr. Lori Brotto Is Not Impressed with the New "Female Viagra" by Dan Savage (The Stranger)

Stryker recalls 16,000+ orthopedic implants due to poor packaging integrity by Varun Saxena (Fierce Medical Devices)

August 20

The FDA Is Basically Approving Everything. Here's The Data To Prove It by Matthew Herper (Forbes)

Valeant to Buy Maker of Women’s Libido Drug for $1 Billion by Jonathan D. Rockoff (Wall Street Journal)

For Asexual Community, Flibanserin Is a Bitter Pill to Swallow by Jessica Firger (Newsweek)

Doubt Is Raised Over Value of Surgery for Breast Lesion at Earliest Stage by Gina Kolata (New York Times)

Americans Don't Like Pharma And Think They're Getting Ripped Off by Jeffrey Young (Huffington Post)

FDA official encourages makers of Low T drugs to work together on a single risks trial by Eric Palmer (Fierce Pharma)

August 19

The FDA blundered badly on the Addyi approval by John Carroll (Fierce BioTech)

Statistics Could Do More For Your Sex Life Than ‘Female Viagra’ by Leah Libresco (FiveThirtyEight)

August 18

F.D.A. Approves Addyi, a Libido Pill for Women by Andrew Pollack (New York Times)

Major publisher retracts 64 scientific papers in fake peer review outbreak by Sarah Kaplan (Washington Post)

Doctors write 10m needless antibiotics prescriptions a year, says Nice by James Meikle (The Guardian)

August 17

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma by Jaimy Lee (Medical Marketing & Media)

Flibanserin: The Female Viagra is a Failed Me-too Antidepressant by Emily Wheeler (Mad in America)

August 14

The Truth Behind the 'Female Viagra' (video by Think Progress)

August 13

FDA Approves OxyContin for Children 11 and Older (AP)

August 10

Why two brand name erectile dysfunction drugs aren’t the same price by Carolyn Johnson (Washington Post)

Understanding the Controversies Over a Groundbreaking New Health Care Law by Diana Zuckerman (Milbank Quarterly)

August 9

Op-Ed: No Surprise in FDA Side Effect Reporting Delays by Brian Overstreet (MedPage Today)

August 7

Frances Oldham Kelsey, Who Saved U.S. Babies From Thalidomide, Dies at 101 by Robert D. McFadden (New York Times)

August 6

Drug companies quietly funnel funds to doctors by Tracy Jan (Boston Globe)

August 5

Nurse Practitioners Can Increase Treatment Accessibility For Opioid Addiction by Karen Robinson, Mona Shattell, and Madeline Naegle (Health Affairs Blog)

August 4

Study finds no benefit in adding third drug to therapy for older patients with afib, heart attack (Medical News Today)

Call to curb PBS subsidies for anti­psychotics for aged by Joel Magarey (The Australian) 

The 3 deadliest drugs in America are all totally legal by German Lopez (Vox)

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