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March 2016 Newsletter

Recent Project News

  • PharmedOut's 2015 Annual Report is now available! It took longer than usual to compile due to our staggeringly long list of activities last year, so thank you for your patience!
     
  • In a JAMA study of 5,900 women, researchers found that flibanserin/Addyi/"female Viagra" is less effective than its manufacturer, now Valeant, has claimed. (Color us shocked.) The drug, which has seen feeble sales since its approval last fall, resulted in women having 0.5 more sexually satisfying experiences per month, rather than the 0.8 additional sexually satisfying experience originally submitted. 

    In a February 29 New York Times article on the study, Dr. Fugh-Berman said, "an additional half a satisfying sexual encounter a month — is that meaningful? I think only the women can answer that, but perhaps they already have with their lack of enthusiasm for getting prescriptions."
PharmedOut's Resource of the Month: Learn more about the opioid epidemic from Andrew Kolodny MD, Executive Director of Physicians for Responsible Opioid Prescribing, who spoke on the topic at PharmedOut's conference last June. Both a video and a transcript with slides are available.

PharmedOut Photo of the Month

Photo of Martin Shkreli, former CEO of Turing Pharmaceuticals, at the February Oversight and Government Reform Committee. Photo by PharmedOut intern, Madeleine Ringwald.

March's PharmedOut Fodder

Problems with Clinical Trials


We rely on clinical trials of drugs to be held to the highest scientific standards. FDA uses trial results to approve treatments for their safety and efficacy, and doctors trust peer-reviewed journals to share accurate information about new treatments.

But in February, and in many months before that, we have repeatedly heard about trials that aren't up to par, whether in their design or reporting of results.

Here are three top ways clinical trials can be manipulated:

1. Industry influences study reports. This was a primary concern raised in Dr. Robert Califf's nomination for FDA commissioner. His research institute at Duke University took ample pharmaceutical industry funding, and during confirmation hearings, he was questioned about industry's role in studies.

Califf explained that while drug companies consult in study designs, academic researchers have the "final say." That may be, but the link between industry funding and more favorable results has been proven repeatedly.

2. Not reporting at all. Since the U.S. does not require the registration or reporting of all clinical trials, researchers often is not published. Last month, it became apparent that this is systemic at academic institutions: One-third of clinical trials conducted at 51 top U.S. universities and academic hospitals were never published in a peer-reviewed journal or government registry, according to a new BMJ study. Two-thirds of all the trials were not published within two years.

As one of the study authors wrote in NPR, "Not reporting results violates the basic principle of the scientific method. It hurts patients, society and science. It also dishonors the people who gave their consent and bore the risk of participating in the studies. Who would agree to be in a study with the knowledge that the results wouldn't be shared?"

All clinical trial results should be reported.

3. Outcome switching. Before starting a clinical trial, researchers are supposed to pre-specify which outcomes they are studying. Doing this makes it easier to see whether outcomes have been switched. Researchers shouldn't pick and choose which outcomes to reveal. 

Journals are supposed to check for outcome switching, but too often, they do not, and cherry-picked outcomes get published, presenting false impressions of drugs. As the COMPare project reports, a recent PLOS One review of 137 randomized controlled trials found that 18% had some form of discrepancy relating to the primary outcome, 15% changed the definition of the primary outcome, and 64% of the trials had discrepancies between pre-specified and reported outcomes for non-primary endpoints.

The FDA, academic institutions, and medical journals must commit to raising expectations for clinical trials. If they don't, who will?

Check These Out!

 
ProPublica is hosting a forum on the country's "broken patient safety system" on the morning of March 23 in Washington, D.C.
Tickets are free but limited here.

The Lown Institute is holding their 4th annual conference in Chicago on April 16-17. Learn more and register here.

The Centre for Evidence-Based Medicine tried to correct 20 of the New England Journal of Medicine's misreported trials. See how the journal responded.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

 

February 29

US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up by Steven Woloshin and Lisa M. Schwartz (JAMA)

Doctors promoting treatments on social media routinely fail to disclose ties to drug makers by Sheila Kaplan (Stat)

Pharma wants more freedom to pitch drugs. A separate review panel could be a problem by Ed Silverman (Stat Pharmalot)

'Female Libido' Pill May Not Be Worth It: Report by Dennis Thompson (WebMD)
 

February 28

Bad Science Means Good Business for Abbott in India by Frederik Joelving (MedPage Today)
 

February 25

Why senators blame the FDA for the spread of opioid addiction by Stephen Koff (Cleveland.com)

Why critics are worried about the new FDA boss by Julia Belluz (Vox)

These doctors want to fix a huge problem with drug trials. Why isn't anyone listening? by Julia Belluz (Vox)

Drug maker slammed for ‘ridiculously high’ price of TB drug by Ed Silverman (Stat Pharmalot)
 

February 24

Academic Medical Centers Get An F In Sharing Research Results by Harlan Krumholz (NPR)

Do big name journals have a 'marketing trial' problem? by Nicole Gray (BioPharma Dive)

Pharmaceutical companies cause doctors to receive biased information about drugs ‘costing hundreds of thousands of lives’ by Loulla-Mae Eleftheriou-Smith (The Independent)


February 23

Why reporting on health and science is a good way to lose friends and alienate people by Julia Belluz (Vox)

Most drug makers report incomplete side effects to the FDA by Ed Silverman (Stat Pharmalot)
 

February 22

How Off-Label Prescribing Can Put You at Risk by Teresa Carr (Consumer Reports)

Lawmaker seeks moratorium on consumer drug ads by Ed Silverman (Stat Pharmalot)

Former sales rep for opioid drug maker pleads guilty to kickbacks by Ed Silverman (Stat Pharmalot)


February 19

Homeopathy effective for 0 out of 68 illnesses, study finds by Siobhan Fenton (The Independent)


February 18

How drug ad narrators take the scariness out of side effects by Megan Thielking (Stat)

Testosterone therapy gets mixed report in study by Marie McCullough (Philly News)

Pricing debate changes perception of patient assistance programs by Kevin McCaffrey (Medical Marketing & Media)
 

February 17

Early Behavior Therapy Found to Aid Children With A.D.H.D. by Benedict Carey (New York Times)

Testosterone Gel Has Modest Benefits for Men, Study Says by Gina Kolata (New York Times)

One-Third of Clinical Trial Results Never Disclosed, Study Finds by Rebecca Spalding (Bloomberg Business)

Misuse Of ADHD Drugs By Young Adults Drives Rise In ER Visits by Allison Aubrey (NPR)

STAT investigation sparked improved reporting of study results, NIH says by Charles Piller (Stat)
 

February 16

With drug costs rising, it’s time for pharma companies to open their books by Ed Silverman (Stat Pharmalot)

Drug companies wine and dine family physicians by David Bruser, Jesse McLean, and Andrew Bailey (The Star)

Looking ahead at orphan drugs' future: More breakthroughs, exploding sales by Ned Pagliarulo (BioPharma Dive)

It's not just payers waiting on PCSK9 outcomes data. Doctors are holding back, too by Tracy Staton (Fierce Pharma Marketing)


February 12

Glaxo Fined $54.3 Million in `Pay-for-Delay' Antitrust Probe by Stephanie Bodoni (Bloomberg Business)


February 11

Big pharmaceutical companies are spending far more on marketing than research by Ana Swanson (Washington Post)
 

February 10

What the Super Bowl constipation ad didn't say by Matt Pearce (Los Angeles Times)

Groups push pharma agenda under the guise of patient advocacy by Trudy Lieberman (Health News Review)
 

February 7

Drug Industry Launches Ad Campaign Aimed at Lawmakers by Joseph Walker (Wall Street Journal)
 

February 4

‘It’s not funny, Mr. Shkreli. People are dying.’ by David Nather (Stat)
 

February 2

How pharma bro Martin Shkreli described his own drug price hike: ‘Almost all of it is profit.’ by Carolyn Johnson (Washington Post)

Shkreli Was Right: Everyone's Hiking Drug Prices by Robert Langreth and Rebecca Spalding (Bloomberg Business)

Suing over drug prices, although a clever ploy, is unlikely to succeed by Ed Silverman (Stat Pharmalot)

Damaging House memos reveal calculated drug price increases at Turing, Valeant by Ned Pagliarulo (BioPharma Dive)
 

February 1

Study: Doctors’ texts can prod patients to take drugs, but questions linger by Shefali Luthra (PBS Newshour)

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