Copy

 
PharmedOut Newsletter, August 2014

Recent Project News

  • PharmedOut is pleased to confirm that we have raised enough funds to commit to holding a 2015 conference, with a June date to be determined. If you know of any academic or other meetings in June 2015 that might conflict, please let us know!
     
  • Our interns staffed a booth at the Physicians Committee for Responsible Medicine's International Conference on Diabetes this past July 18th-19th. Conference attendees were excited to stop by PharmedOut's booth, read project materials, and share personal experiences with sales reps.
     
  • Sadly, Nicole Dubowitz is departing her position as PharmedOut project manager this month to pursue an MPH at the George Washington University Milken Institute of Public Health. But never fear, she will continue writing PharmedOut's newsletter each month! Anyone who has interacted with Nicole knows that she has done a fabulous job for the last 2½ years, and we will miss her terribly. If you would like to send good wishes, Nicole’s email is nzd2@georgetown.edu. In the meantime, we are looking for a new project manager to begin this fall.
     
  • PharmedOut's Resource of the Month: Our Don't Be Duped brochure explains the manipulative tactics used by drug reps, and how prescribers can identify and report illegal off-label marketing.
     
***
July's PharmedOut Fodder: Sunshine Still Misses CME

One story in July's News Round-Up barely made waves in the media, but it made PharmedOut do a double-take. The announcement was that continued medical education (CME) would no longer be exempt from the Affordable Care Act's "Physician Payments Sunshine" provision requiring drug companies to disclose any payments to physicians. 

This is an important issue for PharmedOut since one of our primary goals is to rid CME of drug industry influence. Physicians are required to obtain CME credits each year to renew their medical licenses, but CME options are frequently funded by pharmaceutical companies looking to promote a treatment or "disease awareness." At first, this news seemed to imply that drug companies would have to disclose payments made to physician speakers or authors involved in CME. That would allow conscientious physicians to avoid, or at least be aware of, CME activities with drug company influence.

However, further inspection clarified that the change will not have the impact we hoped. The vast majority of drug company CMEs are produced through third-party medical education and communication companies (MECCs), who are hired to create pharma-friendly content with cooperative physicians. Drug companies are not currently required to disclose indirect payments, so most physician payments for involvement in industry-funded CME will continue to fly under the radar. 

"Indirect payments" have long provided a loophole that needs to be closed. Middlemen between drug companies and physicians come in the form of MECCs, ghostwriters, PR companies, and others who obscure trails of money and influence in medicine. 
CMS's new wording on the exemption appears to have been done for "consistency" reasons, but the outcome won't be consistent with the intentions of the Physicians Payment Sunshine Act.

We can voice our concerns by going to www.regulations.gov and "submitting a comment" on CMS-1612-P. Tell CMS that indirect payments should not be exempt from reporting requirements, 
 and help us raise the standard for CME.
 

***

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

July 1: Health Care Renewal blog: "Health Care Corruption, "No Dirty Little Secret," but "An Open Sore" - Lessons from India for the US" http://hcrenewal.blogspot.com/2014/07/health-care-corruption-no-dirty-little.html

July 2: Medical Marketing & Media: "The $3 generic and the $1,000 pill: pharma outsiders just don't get it" http://www.mmm-online.com/the-3-generic-and-the-1000-pill-pharma-outsiders-just-dont-get-it/article/359201/

July 7: Forbes: "Merck Says It Regrets Strong-Arming Italian Researcher" http://www.forbes.com/sites/matthewherper/2014/07/07/merck-says-it-regrets-strong-arming-italian-researcher/

July 7: Medical Marketing & Media: "CMS plans to end CME Sunshine exemption" http://www.mmm-online.com/cms-plans-to-end-cme-sunshine-exemption/article/359663/


July 7: The Atlantic: "How Childhood Trauma Could Be Mistaken for ADHD" http://www.theatlantic.com/health/archive/2014/07/how-childhood-trauma-could-be-mistaken-for-adhd/373328/

July 9: Science Daily: "Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment" http://www.sciencedaily.com/releases/2014/07/140709151626.htm

July 9: The Washington Post: "FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules" http://www.washingtonpost.com/national/health-science/2014/07/09/3708dd6a-fbc4-11e3-8176-f2c941cf35f1_story.html

July 10: The Wall Street Journal: "Doctor Quits Uterine-Device Safety Panel Over Conflicthttp://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

July 10: The New England Journal of Medicine: "Drug Companies' Patient-Assistance Programs — Helping Patients or Profits?" http://www.nejm.org/doi/full/10.1056/NEJMp1401658

July 10: The New York Times: "Crack Down on Scientific Fraudsters" http://www.nytimes.com/2014/07/11/opinion/crack-down-on-scientific-fraudsters.html

July 15: Reuters: "GlaxoSmithKline recalls painkiller in Puerto Ricohttp://in.reuters.com/article/2014/07/14/us-gsk-pills-idINKBN0FJ2DH20140714

July 17: WSJ Pharmalot: "Heart Warnings for Low T Drugs? Health Canada Says ‘Yes,’ but FDA Isn’t Sure" http://blogs.wsj.com/pharmalot/2014/07/17/heart-warnings-for-low-t-drugs-health-canada-says-yes-but-fda-isnt-sure/

July 17: Reuters: "FDA committee to discuss adverse effects of testosterone productshttp://www.reuters.com/article/2014/07/17/us-fda-drugsafety-idUSKBN0FM2G320140717

July 18: Consumer Reports: "Is my prescription information private?" http://www.consumerreports.org/cro/news/2014/07/is-my-prescription-information-private/index.htm

July 18: The Wall Street Journal: "Medical Experts Press Lawmakers on Hospital Safety" http://online.wsj.com/articles/medical-experts-press-lawmakers-on-hospital-safety-1405637995

July 18: Regulatory Focus: "Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out" http://www.raps.org/regulatory-focus/news/2014/07/19775/FDA-to-Study-How-Teenagers-Understand-Drug-Ads/

July 18: The New York Times: "Doctor Accused of Overprescribing Pills Is Guilty of Manslaughterhttp://www.nytimes.com/2014/07/19/nyregion/queens-doctor-accused-of-overprescribing-drugs-is-convicted-of-manslaughter.html

July 20: The New York Times: "Missouri Alone in Resisting Prescription Drug Database" http://www.nytimes.com/2014/07/21/us/missouri-alone-in-resisting-prescription-drug-database.html

July 21: ProPublica: "Error: You Have No Payments from Pharmahttp://www.propublica.org/article/error-you-have-no-payments-from-pharma

July 21: NPR: "Big Data Peeps At Your Medical Records To Find Drug Problems" http://www.npr.org/blogs/health/2014/07/21/332290342/big-data-peeps-at-your-medical-records-to-find-drug-problems

July 22: WSJ Pharmalot: "What Clinical Trials? Many Study Results Remain Under Wraps" http://blogs.wsj.com/pharmalot/2014/07/22/what-clinical-trials-many-study-results-remain-under-wraps/

July 23: BMJ: "Dabigatran, bleeding, and the regulatorshttp://www.bmj.com/content/349/bmj.g4517

July 24: NPR: "When Federal Privacy Laws Protect Hospitals Instead Of Patientshttp://www.npr.org/blogs/health/2014/07/24/334888674/when-federal-privacy-laws-protect-hospitals-instead-of-patients

July 25: Vox: "Shop like a pharmacist: Don't buy Advil" http://www.vox.com/2014/7/25/5936739/shop-like-a-pharmacist-dont-buy-advil

July 25: Mad In America: "Stimulants Double Adverse Cardiovascular Events in Childrenhttp://www.madinamerica.com/2014/07/stimulants-double-adverse-cardiovascular-events/

July 28: WSJ Pharmalot: "Docs Complain to CMS About ‘Sunshine’ Data Disclosures" http://blogs.wsj.com/pharmalot/2014/07/28/docs-complain-to-cms-about-sunshine-data-disclosures/

July 28: WSJ Pharmalot: "Glaxo is Probed by the FBI and the SEC Over China Bribery Scandal" http://blogs.wsj.com/pharmalot/2014/07/28/glaxo-is-probed-by-the-fbi-and-the-sec-over-china-bribery-scandal/

July 28: Medium: "Is Big Pharma Testing Your Meds on Homeless People?" https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

July 30: Forbes: "Tracking Lobbyist Spending in 2014" http://blogs.wsj.com/numbers/tracking-lobbyist-spending-so-far-in-2014-1625/


 

***
Check These Out!

Physicians, do you want to review Open Payments data reported about you before it is released to the public? Register now in CMS’s Enterprise Portal.  

In case you missed the June 13 event "Evidence for New Medical Products: Implications for Patients and Health Policy", co-sponsored by the American Association for the Advancement of Science, Brigham and Women’s Hospital/Harvard Medical School, and the National Center for Health Research, videos of the talks and panels are now online.

The Senate's July 17 hearing on improving patient safety is available online. Witnesses included John James PhD, founder of Patient Safety America; Tejal Gandhi MD MPH, President of the National Patient Safety Foundation; and Lisa McGiffert, Director of Consumer Union's Safe Patient Project.

The Onion nails it again with "GlaxoSmithKline Releases New Drug To Treat People Who Just Feel Sort Of Weird Sometimes".

Email Marketing Powered by Mailchimp