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September 2016 Newsletter

Recent Project News

  • Following up the debate at the American College of Obsterics and Gynecology conference in May, Dr. Fugh-Berman and Alessandra Hirsch argue in Contemporary OBGYN that physicians should not prescribe Addyi (flibanserin). In their piece they state that Addyi is "not very effective, not very safe, and should not be prescribed." Alessandra Hirsch is a former PharmedOut project manager, now a medical student at the University of Illinois.

  • In the Hastings Center Bioethics Forum, Dr. Sharon Batt and Dr. Fugh-Berman published an article on how industry money is used to silence patient advocacy groups. Their article uses the example of EpiPens, citing the silence of pharma-funded food allergy advocacy groups on outrageous EpiPen prices. Look out for Dr. Batt's book on patient advocacy groups and pharma, coming out in early 2017.

  • Our article on Salespeople in the Surgical Suite was covered in Modern Healthcare by Adam Rubenfire, who also examines alternatives to medical device salespeople, including in-house device technicians.

  • Our article Direct-to-Consumer Marketing in Hemophilia inspired a follow-up article by Peter Korn from the Portland Tribune, who interviewed Matthew Tache, a patient with hemophilia who talks about relationships between industry and patients. “The use of bribes that don’t look like bribes has been a hallmark of marketing to physicians for many years. It's not widely known that these same tactics are used to target patients,” Fugh-Berman says. 

  • On August 25, Dr. Fugh-Berman was quoted in an article on Patient Assistance Programs (PAPs) published in Cancer Therapy Advisor. PAPs are used by pharmaceutical companies to deflect criticism of high drug prices, while maintaining profits for their company. “By paying the co-pays, pharmaceutical companies save patients a little money while costing insurers a lot of money. They are getting around insurers' efforts to save money,” said Fugh-Berman.

  • PharmedOut launches RxFiles, a new column on drug uses and misuses by Andrea Sikora Newsome, PharmD, Critical Care Pharmacy Specialist at Georgia Regents University, North Augusta, South Carolina. See Dr. Newsome's first column below.

Mark Your Calendars

Its official! Our sixth conference will be held June 15-16, 2017 in Washington, DC. The PharmedOut conference always has engaging talks, delicious food, and unparalleled networking opportunities for students, researchers, healthcare providers, and consumer advocates. Don't miss it! And if you have ideas for specific conference topics, send them to


Andrea Sikora Newsome, PharmD

“Don’t you put that damn thing on me again!” The patient hollers over the white noise of empty IV pump alerts and ventilator alarms. The nurse is trying to replace the patient’s condom catheter. At this point, other nurses are filing in, and the resident looks up and asks me what the dose is that I would recommend for quetiapine (Seroquel, an atypical antipsychotic, with some data supporting its use for ICU delirium, though this is an off-label use). The patient continues in a raised voice, “It hurts, and I’m plum sick of wetting all over myself.” His voice is angry, frustrated. This broad-shouldered, 6-foot man who works with his hands is now barefoot in an open-back gown in a room smaller than a prison cell, and the nurse wants to place a sticky plastic condom catheter on him. I shake my head at the resident, “Sounds like a pretty reasonable argument to me. He isn’t delirious. You think you’d want to wear one of those things?”

Delirium is a leading cause of agitation in the intensive care unit. Defined as a lack of attention, waxing and waning in nature, it makes people answer the question, “Does a stone float on water?” “Yes.” It is associated with increased length of hospital stays and mortality. But this wasn’t ICU delirium, this was a man giving a rational argument regarding his preferences. “I think the bigger question,” I continued, “is if we really need accurate ins and outs on him.” This sparked a conversation with the patient, and he ultimately agreed to measure his urine output for us.

“You know for being a pharmacist, you spend a lot of time telling us not to use drugs,” someone says. “Only the ones that won’t help,” I reply. The team laughs, but in some way, becoming an expert means not just knowing about our tools but knowing about their limitations, and knowing where there are gaps in our knowledge. Expertise is knowing enough to realize all that we do not know.

Delirium is deeply misunderstood by many practitioners. Many patients become disoriented, and we often don’t do the little things that make a difference - like turning the lights on in a patient’s room. Instead, we rely on pharmaceutical restraints. Vanderbilt’s ICU Delirium study group ( has excellent resources on the topic and recommends that clinicians STOP and THINK. This approach recommends stopping offending agents and interventions that may be causing delirium and then thinking about and working up possible causes of delirium such as electrolyte imbalances or sepsis.

In this case, the patient just needed something stopped, not started.

Check these out!

If you have been following the saga of Addyi (flibanserin), you might be curious to know how the drug is doing. In July, FiercePharma reported that there are fewer than 1,000 prescriptions per month. The National Women's Health Network has created the 1 year report card for Addyi. (Spoiler: the drug failed on almost all counts.)

With summer winding down, don't fall behind on your CME/CPE! Physicians, Pharmacists and Physician Assistants: Check out our great industry-free continuing education modules on Rational Prescribing for Older Adults, medical cannabis, generic drugs, and more at Free to Washington DC health care providers and $20 for unlimited CME/CPE credits outside of DC. (Anyone can view the modules at no cost.)

Just out! Alan Schwarz' new book, ADHD Nation: Children, Doctors, Big Pharma, and the Making of an American Epidemic (Scribner, 2016). A great book. Read the review here.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)


Aug 26

Duchenne Lessons: Advocates For Rare Spinal Disease Have Eyes on FDA by Ben Fidler (Xconomy)

How Copay Coupons Could Raise Prescription Drug Costs By $32 Billion Over the Next Decade (Visante)

EpiPen is trying to win over critics by issuing "coupons." Don't be fooled by Sarah Kliff (Vox)

Aug 25

Sarah Jessica Parker cuts ties with Mylan in anger over EpiPen price hikes by Rebecca Robbins (STAT)

Mylan may have violated antitrust law in its EpiPen sales to schools, legal experts say by Ike Swetlitz and Ed Silverman (STAT)

How Mylan, the maker of EpiPen, became a virtual monopoly by Carolyn Y. Johnson and Catherine Ho (The Washington Post)

How Parents Harnessed the Power of Social Media to Challenge Epipen prices by Tara Parker-Pope (The New York Times)

Aug 23

Congress Presses Pharmaceutical Company to Explain Surge in Cost of EpiPen by Carl Hulse (The New York Times)

Aug 22

Drug makers continue to abuse citizen petitions, FDA tells Congress by Ed Silverman (STAT)

Aug 18

Valeant gets poor grades for its Addyi female libido pill by Ed Silverman (STAT)

Aug 15

Whistleblower case contends surgical device maker misled FDA — and patients paid the price by Sheila Kaplan (STAT)

Aug 14

A secretive board controls access to prescription drugs for millions of Americans by Samantha Liss (St. Louis Post-Dispatch)

Aug 11

Pharmaceutical Lobby Shakeup Precedes Drug Price Battle by Erin Mershon (Roll Call)

Aug 10

NEJM editorial doubles down on resistance to data sharing by Ivan Oransky and Adam Marcus (STAT)

Aug 9

BIO president defends Orphan Drug Act after op-ed criticism by Nicole Gray (BioPharmaDIVE)

Cancer-Drug Ads vs. Cancer-Drug Reality by Matt Jablow (The New York Times)

Pharma should not be allowed a loophole for reporting financial ties to docs by Ed Silverman (STAT)

Aug 8

Think Tank Scholar or Corporate Consultant? It Depends on the Day by Eric Lipton, Nicholas Confessore, and Brooke Williams (The New York Times)

Pfizer suspends work at Hospira India plant as FDA turns up heat by Eric Palmer (FiercePharma)

Aug 4

Vexing Question on Patient Surveys: Did We Ease Your Pain? By Jan Hoffman and Sabrina Tavernise (The New York Times)

High prices make once-neglected ‘orphan’ drugs a booming business by Carolyn Y. Johnson (The Washington Post)

Patients' Groups and Big Pharma (Public Citizen)

Aug 2

Researchers press American Psychiatric Association to retract a study by Ed Silverman (STAT)

Big Pharma benefits more from breakthrough therapy designations: report by Nicole Gray (BioPharmaDIVE)

Aug 1

FDA-Approved Knock-Offs Of Biotech Drugs Could Safely Save Big Bucks by Alison Kodjak (National Public Radio)

Celgene Accused of Using Charities ‘Scheme’ to Gain Billions by Ben Elgin and Robert Langreth (Bloomberg)

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