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PharmedOut Newsletter
February 2015

Recent Project News

  • This month, PharmedOut released its 2014 Annual Report. Read it here.
     
  • On January 14th, Dr. Fugh-Berman participated in the Capitol Hill panel discussion on "The Physician Payment Sunshine Act: What Have We Learned? What More Must Be Done?", hosted by the National Coalition on Health Care. The panel of health care experts contributed different perspectives to this issue, and Dr. Fugh-Berman call the Sunshine Act "a success" that could go further; namely, to expand disclosure requirements to advanced practice nurses, physician assistants, and organizations, who are increasingly becoming the main recipients of industry payments. 

    Watch CSPAN's coverage of the event here, and read coverage by MedPage Today, Medill On The Hill, and Fierce Practice Management
  • On January 23rd, Dr. Fugh-Berman was quoted in Paul Thacker's article "Database may uncover conflicts of interest for TV doctors" in Columbia Journalism Review. Pharma payment data has revealed gifts made to Dr. Jonathan LaPook of the CBS Evening News with Scott Pelley, Dr. Jennifer Ashton of Good Morning America, Dr. Keith Ablow of Fox News, and others. "Viewers deserve to know whether an expert is being paid by a company, even if the link between the company and what they are saying isn’t clear," Dr. Fugh-Berman said. 
     
  • On January 12th, Project Manager Alessandra Hirsch published "Modern Day Mengele" in the Hastings Center's Bioethics forum. The editorial focused on the similar "perversions of medical procedures" conducted by the CIA torture program and those of infamous Nazi doctor Josef Mengele.
     
  • Also on January 12th, a letter to the editor by PharmedOut conference co-chair Dr. Anthony Scialli was published in response to an article about the pressure on pregnant women to have C-sections. As Clinical Professor of Obstetrics and Gynecology at GWU, Dr. Scialli explained how he advises patients who want to avoid a C-section and said that the rate of the procedure should be far lower than the World Health Organization's goal of 10 to 15 percent.
     
  • PharmedOut's Resource of the Month: Even if you don't tweet, keep up with what we're doing and reading through our live Twitter feed at pharmedout.org.


     
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February's PharmedOut Fodder: Demanding Results of Clinical Trials

Imagine you have enrolled in a clinical trial. You made the difficult decision to take an untested drug or remain untreated with a placebo, and dutifully performed your regimen every day. Maybe you got better, or maybe you experienced adverse effects and were left in worse shape than when you started. At the very least, you would expect that your experience would ultimately contribute important information to the medical community and other patients.

But as we know, clinical trial data are often never shared. Around half of clinical trial results are kept hidden, and trials that had negative results are twice as likely to go unreported. Many don't get officially registered in the first place, making them that much easier to sweep under the rug. It might be good business for industry to pretend that their unflattering data doesn't exist, but it's not good ethics. In the words of one trial participant regarding Ben Goldacre's AllTrials campaign, "I believe it is immoral to recruit patients to clinical trials and then not report or share the results. We participate in order to increase knowledge and to help others. We do not expect the knowledge to be kept secret or the help for others to be denied.” 

This month, the Institute of Medicine (IOM) released a report calling on trial sponsors to share details of their data. As Katie Thomas for The New York Times reported, IOM recommends that trial data be published within 30 days of the product’s approval or 18 months of the study's completion — even if the company decides to drop the product. IOM President Victor Dzau stated, "The rapidly changing landscape of clinical trials and the movement toward greater transparency create a need to establish professional standards and set expectations of how to share clinical trial data ... We need to develop a culture that supports data sharing, and we need to provide incentives and develop trust."

Professional standards and expectations for researchers must include the release of clinical trial data. The IOM emphasizes the role of funders, journals, the IRB, and universities in accomplishing this. One huge funder, Johnson & Johnson, has set the precedent by agreeing to share detailed results from their medical device and diagnostic test trials, "making it the first large device manufacturer to systematically make such data public," Thomas also reported. In addition, requiring trial sponsors to register with ClinicalTrials.gov would keep trials from disappearing into oblivion.

That is not too much to ask when trial participants are risking their lives, regulators are entrusted with protecting the public health, and the rest of us are waiting for evidence. If you agree, you can sign AllTrials's petition and donate to their campaign here.

 

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News Round-Up 
(for more, please follow @pharmed_out on Twitter!)


January 2: Consumer Health Choices via YouTube: "Questions to Ask Your Doctor About a New Drug" https://www.youtube.com/watch?v=jR5I-932T9c

January 3: NJ.com: "Fentanyl, up to 50 times more powerful than heroin, a growing worry in N.J." by Ashley Peskoe and Stephen Stirling http://www.nj.com/healthfit/index.ssf/2015/01/fentanyl_up_to_50_times_more_powerful_than_heroin_a_growing_worry_in_nj.html

January 4: The New York Times: "Doctor, Shut Up and Listen" by Nirmal Joshi http://www.nytimes.com/2015/01/05/opinion/doctor-shut-up-and-listen.html


January 5: NPR: "'America's Bitter Pill' Makes Case For Why Health Care Law 'Won't Work'" http://www.npr.org/blogs/health/2015/01/05/375024427/americas-bitter-pill-makes-case-for-why-health-care-law-wont-work

January 6: Fierce Pharma Marketing: "FDA's marketing police wrote only 10 tickets in 2014" by Tracy Staton http://www.fiercepharmamarketing.com/story/fdas-marketing-police-wrote-only-10-tickets-2014/2015-01-06

January 7: WSJ Pharmalot: "Overdose Deaths due to Prescription Painkillers May Peak Soon: Study" by Ed Silverman http://blogs.wsj.com/pharmalot/2015/01/07/overdose-deaths-due-to-prescription-painkillers-may-peak-soon-study/

January 7: The Huffington Post: "Placebo Surgery: More Effective Than You Think?" by David H. Neuman 
http://www.huffingtonpost.com/david-h-newman-md/placebo-surgery_b_4545071.html

January 8: Vox: "Pharma's terrible secret: companies spend the most to promote their least helpful drugs" by Sarah Kliff http://www.vox.com/2015/1/8/7510725/pharma-marketing-me-too-drugs

January 11: Consumer Reports: "Can you trust drug ads on TV?" http://www.consumerreports.org/cro/news/2015/01/can-you-trust-drug-ads-on-tv/index.htm

January 14: Institute of Medicine Report: "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk" http://iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx

       > Press Release by National Academy of Sciences here: "IOM report proposes standards for sharing clinical trial data"
 http://www.eurekalert.org/pub_releases/2015-01/naos-irp011415.php 


January 14: The New York Times: "Johnson & Johnson Will Make Clinical Data Available to Outside Researchers" by Katie Thomas http://www.nytimes.com/2015/01/15/business/johnson-johnson-to-make-clinical-data-available-to-outside-researchers.html

January 14: The New York Times: "Why Drugs Cost So Much" by Peter B. Bach http://www.nytimes.com/2015/01/15/opinion/why-drugs-cost-so-much.html

January 15: Forbes: "Why Transparency And Data Sharing In Clinical Trials Matters" by Judy Stone http://www.forbes.com/sites/judystone/2015/01/15/why-transparency-and-data-sharing-in-clinical-trials-matters/

January 15: Bloomberg: "Biotech Rivalry Gets Nasty in Mudslinging Battle Over Data" by Caroline Chen and Sonja Elmquist http://www.bloomberg.com/news/2015-01-15/biotech-rivalry-gets-nasty-in-mudslinging-battle-over-trial-data.html

January 20: WSJ Pharmalot: "What did the FDA do With Some of Those old Warning Letters?" by Ed Silverman http://blogs.wsj.com/pharmalot/2015/01/20/what-did-the-fda-do-with-some-of-those-old-warning-letters/

January 21: WSJ Pharmalot: "High Prices for Cancer Drugs are set at Launch: 'It’s Where the Action Is'" by Ed Silverman http://blogs.wsj.com/pharmalot/2015/01/21/high-prices-for-cancer-drugs-are-set-at-launch-its-where-the-action-is/

January 22: The Huffington Post: "Elizabeth Warren Proposes Big Pharma 'Swear Jar' To Fund Medical Research" by Sam Stein http://www.huffingtonpost.com/2015/01/22/elizabeth-warren-pharma_n_6520746.html

January 22: ProPublica: "Why Pharma Payments to Doctors Were So Hard to Parse" by Charles Ornstein, Mike Tigas and Ryann Grochowski Jones http://www.propublica.org/article/why-pharma-payments-to-doctors-were-so-hard-to-parse


January 22: WSJ Pharmalot: "Digital Sales Tools are Influencing More Docs to Consider Prescriptions?" by Ed Silverman http://blogs.wsj.com/pharmalot/2015/01/22/digital-sales-tools-are-influencing-more-docs-to-consider-prescriptions/

January 23: CDC's Morbidity and Mortality Weekly Report: "Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012" http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6402a1.htm

January 23: The Chronicle of Higher Education: "A Modern Clinical Trial: 7 Years, 1,000 Patients, and Plenty of Questions About Cost" by Paul Basken http://chronicle.com/article/A-Modern-Clinical-Trial-7/151355/

January 27: Vox: "Read this before you ever believe another guest on the Dr. Oz Show" by Julia Belluz http://www.vox.com/2015/1/27/7920779/dr-oz-ftc-complaint

January 28: The Washington Post: "An ‘expensive’ placebo is more effective than a ‘cheap’ one, study shows" by Lenny Bernstein http://www.washingtonpost.com/news/to-your-health/wp/2015/01/28/an-expensive-placebo-is-more-effective-than-a-cheap-one-study-shows/

January 29: The BMJ: "California doctors under investigation for prescribing practices" by Jeanne Lenzer http://www.bmj.com/content/350/bmj.h74.full


January 30: BMJ Blogs: "Sharing data from past clinical trials" by Stuart Buck" http://blogs.bmj.com/bmj/2015/01/30/stuart-buck-sharing-data-from-past-clinical-trials/

January 30: Philly.com: "Mother brought to tears hearing Johnson & Johnson's Risperdal tactics" by David Sell http://www.philly.com/philly/blogs/phillypharma/Mother-brought-to-tears-hearing-Johnson--Johnsons-Risperdal-tactics---.html


January 31: San Jose Mercury News: "California lawmakers set to tackle excessive prescribing of psych meds to foster children" by Karen de Sá http://www.mercurynews.com/ci_27432987/california-lawmakers-set-tackle-excessive-prescribing-psych-meds
 

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Check These Out!

Search ProPublica's Open Payments Explorer by company, drug, or device.

On January 27th, UC San Francisco posted 115 documents to their Drug Industry Document Archive from the class action lawsuit against Forest Pharmaceuticals for its marketing of antidepressants Celexa and Lexapro. Click through here to view them.

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