October 2015 Newsletter

Recent Project News

  • On September 21st, Dr. Fugh-Berman testified to the Federal Trade Commission on the advertising of homeopathic products. She addressed the misleading labeling and promotion of homeopathic remedies, the high potential for a placebo effect, and the importance of randomized controlled trials, stating "there is no alternative science."

    A video of the panel is available here, and Dr. Fugh-Berman's testimony begins at 1:53:30.
  • On September 25th, Dr. Fugh-Berman published "Flibanserin and Regulatory Failure" on BMJ's Journal of Medical Ethics blog, about how the FDA failed women with its August approval of Addyi, also called "female Viagra". She warns about the dangers of the drug itself, as well as the implication that women should take a drug for her sex life if her spouse is unhappy. "Note that even if the putative patient isn't distressed, she is still eligible for being drugged if her partner is creating interpersonal difficulty. Here's a thought – why not sedate [the partner] instead?"

    Addyi is expected to go on the market this month.
PharmedOut's Resource of the Month: There is a new Advocacy tab and Flibanserin/Addyi page on our website summarizing PharmedOut's work and efforts surrounding the drug, including copies of petitions that we and other organizations have sent to the FDA.

October's PharmedOut Fodder:

Making an Example of Martin Shkreli

In late September, it was reported that the price of a 62-year old little-known drug, Daraprim (pyrimethamine), rose overnight from $18 to $750 a pill. About 100 pills are needed to treat toxoplasmosis, a disease caused by a parasite that lives inside a third of humans but can cause life-threatening infestations in people with AIDS, cancer, or other conditions that compromise the immune system. The eye-popping price increase followed Daraprim's acquisition in August by Turing Pharmaceuticals, a small drug company founded and led by 32-year old Martin Shkreli, a former hedge fund manager. Shkreli handled the newfound press attention less than gracefully, and quickly became the face of cold-hearted greed in the pharmaceutical industry.

Since then, pundits have disparaged the ability to do what Shkreli did, presidential candidates have vowed to restrict price gouging, and Democrats in the House Committee on Oversight and Government Reform requested a hearing with Shkreli. We're fine with making an example of the young CEO, as long as we remember that Turing is one of dozens of drug companies — large and small — doing exactly the same thing.

The antibiotic tetracycline (around since 1948) and the antidepressant clomipramine (used since the 1960s) went up in price 2,200% and 3,600% respectively over the last few years. Another infamous case is of colchicine, a drug derived from the autumn crocus, a plant used in ancient Greece and ever since to treat gout. Available as a generic drug since the 1800s, exclusive rights for colchicine were sold to a drug company in 2009. The company promptly raised the price from about 10 cents to six dollars per pill.

According to the National Prescription Coverage Coalition, so far in 2015, the average wholesale price of almost 50 drugs more than tripled since last year. An AARP study found that prices of brand-name drugs are rising more from year to year — from 5.7% in 2006 to 12.9% in 2013.

The reasons, or lack thereof, for price increases of Daraprim and other drugs are the same, and they go back to the lack of regulation of drug prices in the United States. As Marcia Angell explained in the Washington Post, companies raise prices simply because they can.

Drug companies cite many reasons for the increases. A popular one, deployed by Shkreli, is that higher prices cover the cost of innovation, or research and development. In fact, drug companies spend at least three times as much on marketing as they do on research. Angell also pointed out that many drug discoveries come out of university labs with public funding from NIH, with little real innovation coming from drug companies.

Amid all the outrage, Shkreli announced that Turing would lower Daraprim's price. The new price has not been set, but it will probably still be closer to $75,000 for a course of treatment than the original $1,800 price tag before Turing bought the drug.

The pharmaceutical lobby is still incredibly powerful, so we are not optimistic about a policy change. But if the Daraprim incident raises Americans' understanding about the Wild West of prescription drug pricing, that is a major step.

Check These Out!

Steven Brill, author of America's Bitter Pill: Money, Politics, Back-Room Deals, and the Fight to Fix Our Broken Healthcare System, the TIME article a similar topic, and much more, has published a 15-chapter series in The Huffington Post, America's Most Admired Lawbreaker. It delves into Johnson & Johnson's off-label marketing of antipsychotic Risperdal and cover-up of adverse events found in clinical trials.
National Physicians Alliance's 2015 annual conference, "Truth to Power: Alliance for the Public Good" is October 17-18 in Washington, D.C. Register here.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

September 30

Want to understand drug pricing? Tell pharma to open its books by Ed Silverman (Pharmalot)

What risk? Physician group questions FDA view on Testosterone drugs by Ed Silverman (Pharmalot)

Drug companies are reeling after the Martin Shkreli incident — and it could shake up the entire industry by Lydia Ramsey (Business Insider)

September 25

Why do drug companies charge so much? Because they can. by Marcia Angell (Washington Post)

The drug industry wants us to think Martin Shkreli is a rogue CEO. He isn’t. by Carolyn Johnson (Washington Post)

What's a Fair Price? Price Gouging and Pharmaceuticals (video) (Healthcare Triage)

September 24

Mylan leverages marketing savvy, price hikes to make EpiPen a go-to med by Carly Helfand (FiercePharma)

My Lunch With Shkreli: What We Should Learn From Pharma's Latest Monster by Matthew Herper (Forbes)

Why The Pharmaceutical Industry Is The Worst (video) (AJ+)

September 23

The FDA’s new clothes by Donald Light and Joel Lexchin (BMJ)

The little-known FDA program that's driving drug prices higher by Michael Hiltzik (Los Angeles Times)

Pharma Bro Is the Face of U.S. Health Care by James Hamblin (The Atlantic)

September 22

Clinton proposing $250 monthly cap on prescription drug costs for patients by Anne Gearan and Amy Goldstein (Washington Post)

A drug company raised a pill's price 5,500 percent because, in America, it can by Sarah Kliff (Vox)

September 21

Big Price Increase for Tuberculosis Drug Is Rescinded by Andrew Pollack (New York Times)

How an obscure drug’s 4,000% price increase might finally spur action on soaring health-care costs by Carolyn Johnson (Washington Post)

Doubts Rise About Surge In Statin Prescriptions For Oldest Americans by Lisa Gillespie (NPR)

September 20

Drug Goes From $13.50 a Tablet to $750, Overnight by Andrew Pollack (New York Times)

September 19

F.D.A. Nominee Califf’s Ties to Drug Makers Worry Some by Sabrina Tavernise (New York Times)

September 18

What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation by Julia Belluz (Vox)

September 17

How the U.S. could cure drug-price insanity by Peter Bach (Fortune)

Female Libido Pill Caused Dissent in FDA Ranks, Memo Shows by Anna Edney (Bloomberg)

When Crime Pays: J&J’s Drug Risperdal by Nicholas Kristof (New York Times)

Don’t Delay News of Medical Breakthroughs by Eric J. Topol and Harlan M. Krumholz (New York Times)

September 16

Antidepressant Paxil Is Unsafe for Teenagers, New Analysis Says by Benedict Carey (New York Times)

School Nurses Stock Drug To Reverse Opioid Overdoses by Michelle Faust (NPR)

September 15

Treatment of low libido for sale by Zosimo T. Literatus (SunStar)

September 14

FDA, drug companies clash over off-label uses by Ed Silverman (Boston Globe)

September 9

Congressional Leaders Ask FDA About Coumadin Safety by Charles Ornstein (ProPublica)

The Solution to Drug Prices by Ezekiel J. Emanuel (New York Times)

September 8

The Price for Lowering Cholesterol (Editorial) (New York Times)

New Cholesterol Drugs Are Vastly Overpriced, Analysis Says by Andrew Pollack (New York Times)

September 6

Pill for women’s libido carries sobering risk by Ed Silverman (Boston Globe)

September 3

With flibanserin approval, a complicated drug takes the spotlight by Bethany Brookshire (ScienceNews)

September 2

Pharma TV ads are good for the business bottom line, study says by Beth Snyder Bulik (Fierce Pharma Marketing)

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