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December 2016 Newsletter

Help Us Grow Our Team

Dear PharmedOut Friends,

We have raised $16,000 towards our $50,000 fundraising goal to expand our team so that we can finish – and take on more of – the unique, impactful projects that are our trademark. If you haven't donated, please donate today! All gifts are tax-deductible and may be made online. Or write a check payable to Georgetown University and mail it to us.

Thank you! 
Alycia and Adriane

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Recent Project News

  • On November 10, Alycia Hogenmiller, PharmedOut's project manager, and Dr. Fugh-Berman testified at the FDA stakeholders meeting on "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products" during which companies asked the FDA for permission to promote products off-label. Our testimonies can be viewed here (starts at 1:55). DCRx project manager Joy Eckert's testimony can be viewed here (starts at 33:00). Dr. Fugh-Berman was quoted in Medscape, ". . . there are several phrases used by industry that we have heard over and over again; what if we reframed some of those phrases? For example, 'unmet medical needs' could be translated as 'untapped profit opportunity'; 'timely' means 'premature,' 'emerging evidence' means 'hope,' 'best evidence available' equals 'rumor,' and 'real-world evidence' means 'not evidence-based." 

    Alycia Hogenmiller, Joy Eckert, and Dr. Fugh-Berman testifying at the FDA hearing.

  • On November 14, our article Salespeople in the Surgical Suite was covered in the Washington Post/Kaiser Health News.

  • On November 21, Treatment of Men with 'Low Testosterone' was covered in Mad in America

PharmedOut Conference: Call for Abstracts

Save the date: June 15-16, 2017! Registration will open soon. For our 2017 conference, we will be featuring abstracts of students, residents, and fellows. Selected abstracts will win free conference registration. Submission requirements and more information are available on our website. Submission deadline has been extended to December 19, 2016.

Do you make the cut?

Apply to be on the List of Industry Independent Experts!

Help us expand a list of non-industry-funded physicians, researchers and journalists to be used as a resource for media, government agencies and professional bodies worldwide that are seeking truly independent reviewers. Industry makes sure that industry-friendly experts are in the limelight; let’s fight back by expanding The List of Industry Independent Experts.

The List includes those who have recognized expertise in a health area (this includes clinical fields, health policy, basic science methodology, etc.) We particularly need industry-free physicians in medical specialties. List members cannot have received any industry funding for the past five years and must have no plans to work for industry. The list includes people with conflicting ideas – there is no unifying ideology other than a belief that there is a need for non-commercial science and research. A secondary list  has been added for those who have had competing interests – such as expert witness work (testifying for or against a drug or medical device company), or taking funding from drug company settlements, or who may have received industry funding within the past five years but who have provided important information about the inner workings of industry.

First established in 2007, "The List" is currently maintained at Gary Schwitzer’s Contact information for list members is released only to bona fide journalists or vetted organizations seeking reviewers and are not publicly published. If you are willing to be considered for The List, please contact Jeanne Lenzer ( for an application.

RxFiles: Staying Up to Date

by Andrea Sikora Newsome, PharmD

“Well, UpToDate says that PPIs are superior for stress ulcer prophylaxis.”

As a pharmacist, most sentences starting with “UpToDate says” do not bode well. UpToDate is one of several electronic tertiary resources that attempts to summarize a myriad of medical topics ranging from seasonal allergies to management of neuromuscular blockade in acute respiratory distress syndrome. Overall, these resources provide a wealth of information. The figures and flowcharts are top notch. Plus, it provides primary literature citations that links directly to Medline. The issue is user error, wherein a resident reads the one-liner on a topic and does not dig any deeper.

This particular resident was replying to my recommendation that we utilize famotidine over pantoprazole for stress ulcer prophylaxis (SUP). Although this is an area of some clinical controversy, many clinicians interpret the available literature as saying that famotidine and other histamine two (H2) receptor blockers provide similar stress ulcer protection to pantoprazole and other proton pump inhibitors (PPIs), and that H2 blockers may have a reduced incidence of infections like ventilator-associated pneumonia, Clostridium difficile infections, and other infections. The cost difference has historically been very significant as well (although as PPIs become generic, this difference has diminished). Thus, in the absence of a compelling indication for a PPI, H2 receptor blockers are generally considered the preferred agent for SUP.

About every eight weeks, a resident explains what UpToDate says to me about PPIs, so my answer is already prepared. “I know the line you’re talking about, but have you read the 2013 Critical Care Medicine meta-analysis it actually cites supporting that statement?”

So far, none of them have, which is really unfortunate. First and foremost, the information they have is incomplete, compromising the quality of patient care delivery. Secondly – perhaps more disheartening – it implies that residents do not appreciate how much of medicine is practiced where there are no absolute answers. Realizing how rarely one can assuredly cite a medical fact like “Smoking is globally detrimental for your health” is an important concept to appreciate. The line the residents were citing (“For critically ill patients who are able to receive enteral medications and in whom stress ulcer prophylaxis is indicated, an oral proton pump inhibitor (PPI) is preferred rather than an alternative prophylactic agent.”) sounds definitive but warrants further investigation.

If the resident had even just pulled up the abstract, they would have noted caveats. The abstract cautions, “The robustness of this conclusion is limited by the trial methodology, differences between lower and higher quality trials, sparse data, and possible publication bias.” If one went a step further to read the actual discussion of the article, the authors dedicate an entire paragraph to recommending “cautious interpretation of these results” due to trial quality (lack of blinding, poorly defined endpoints, etc.) and evidence of publication bias. 

This practice of just reading the one-liner appears disturbingly pervasive, especially when I see this cited in medical notes in the patient’s chart. Truly staying up to date requires a love of learning and playing devil’s advocate to what you read.

Andrea Sikora Newsome, PharmD, is a Critical Care Pharmacy Specialist at Georgia Regents University, North Augusta, South Carolina.

Check these out!

The United Kingdom does not have an Open Payments system but you can still check to see if your physician gets paid by pharmaceutical companies. Who pay this doctor? is a voluntary register of doctors' declared interests.

Drug Dealer, MD by Anna Lembke, Chief of Addiction Medicine at Stanford University. You can also see Dr. Lembke in our DCRx modules "Myths and Facts about Opioids" and "Getting Patients Off Of Opioids" at
You can order Dr. Lembke's book at Johns Hopkins University Press.
Use the code "NHAF" to get 30% off.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

Nov 22

Do cancer clinical trials exaggerate the real-world benefits of drugs? by Sharon Begley (STAT News)

Could the FDA be dismantled under Trump? by Sheila Kaplan (STAT News)

Fentanyl Billionaire Comes Under Fire as Death Toll Mounts From Prescription Opioids by Joseph Walker (Wall Street Journal)

Simple ways to deter improper antibiotic prescribing by Kevin B. O’Reilly (AMA Wire)

Nov 21

How Kellogg worked with ‘independent experts’ to tout cereal by Candice Choi (STAT News)

Nov 19

How AHRQ's low profile threatens work on healthcare best practices by Elizabeth Whitman (Modern Healthcare)

Nov 16

Boxed warning added to label of Bayer's Essure by Ned Pagliarulo (BioParma DIVE)

Lowering the Bar: How PMDD Went from an Idea to a Diagnosis by John Fauber, Kristina Fiore, and Matt Wynn (MedPage Today)

Chicago to require pharmaceutical rep licenses despite industry objections by Lisa Schencker (Chicago Tribune)

FDA regulator defends decision to OK Sarepta drug by Robert Weisman (Boston Globe)

Nov 7

The bizarre reason two competing drug prices rose in tandem By Carolyn Y. Johnson (Washington Post)

Nov 3

Drug Industry Mounts Defense of Pricing by Peter Loftus (Wall Street Journal)

FDA’s drug approval team copes with 700 unfilled jobs as industry lures staff by Sydney Lupkin and Sarah Jane Tribble (STAT News, KHN)

What clinical trial results? Now you can see who isn’t sharing their findings by Ed Silverman (STAT News)

Nov 2

Dealmakers Behind Soaring Drug Prices Hit the Jackpot by Robert Langreth (Bloomberg)

Valeant Accused of Bungling Marketing of Female Libido Drug by Cynthia Koons and Jef Feeley (Bloomberg)

Nov 1

This 90-year-old fight over insulin royalties reveals just how much has changed in medicine by Carolyn Johnson (Washington Post)

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