wtf?…

Posted on Tuesday 22 January 2013

The Honorable Jacob J. Lew
Chief of Staff
The White House
Washington, DC 20500

Dear Chief of Staff Lew:

In March 2010, President Barack Obama signed the Affordable Care Act into law, which included the Physician Payments Sunshine Act (PPSA). We applauded its passage but, nearly three years later, we are disappointed that the PPSA has yet to be implemented—especially in light of reports that the final rules are being held up at the White House Office of Management and Budget.

Financial relationships between physicians and drug and medical device companies can create conflicts of interest that threaten the quality of patient care and drive up healthcare costs. As our nation struggles with these problems, it is imperative that the administration implement the PPSA without any further delay.

In 2011, drug makers spent about $4 billion in direct-to-consumer ads and over $25 billion marketing to physicians. Just last week, fresh evidence emerged demonstrating once more that these tactics are driving up healthcare costs. According to a survey of some 1,800 physicians published in the Journal of the American Medical Association, more than a third of doctors “sometimes or often” prescribe brand-name drugs in place of their generic equivalents when their patients ask. They are more likely to do so if they receive food, drinks or drug samples from pharmaceutical manufacturers.

Late last month, the Washington Post published an investigation revealing that financial transactions between doctors and drug companies contributed to the epidemic abuse of prescription painkillers. According to the article, prescriptions for painkillers have roughly tripled in the past year, and the Post’s analysis of key scientific papers and court documents revealed that “the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice.”

In the Sunshine Act, Congress laid out a clear timeline for the law’s implementation. A final rule was due by Oct. 1, 2011. Drug and device companies were supposed to have started collecting their own physician payment information as of Jan. 1, 2012, and to submit the information to the Department of Health and Human Services by March 31, 2013. The data were supposed to become publicly available—the linchpin for making this law effective — by September 2013. We are now more than 15 months past the deadline for the final rule, making it unlikely that the public will have access to these data before 2015.

The administration should implement the Act without any further delay so that it can begin, as soon as possible, to rein in the undue and harmful influence of money on medicine.

Sincerely,

Marcia Angell, MD
Senior Lecturer in Social Medicine,
Harvard Medical School
Former Editor-in-Chief, New England Journal of Medicine

Jerry Avorn, MD
Professor of Medicine, Harvard Medical School
Chief, Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital

Jerome Kassirer, MD
Distinguished Professor, Tufts University School of Medicine
Visiting Professor, Stanford University
Former Editor-in-Chief, New England Journal of Medicine

 
Steve Nissen, MD
Professor of Medicine
Cleveland Clinic Lerner School of Medicine
Chairman, Department of Cardiovascular Medicine
Cleveland Clinic Foundation

Charles D. Rosen, MD
President, Association for Medical Ethics
Clinical Professor of Orthopaedic Surgery
University of California, Irvine, School of Medicine

Now this is a real problem. What good is a law, or a reform, if it’s not implemented? It reminds me of the Clinical Trials site [clinicaltrials.gov]. It’s a really good idea, but the compliance is way too low [bring on the hoops! [at least the ones that matter]…], and nothing is done about it.

What will happen with the TEST Act? Are these government snafus or the result of lobbying? With this kind of enforcement record, I may have to retract my optimism below…

hat tip to Pharmagossip 
  1.  
    Stan
    January 23, 2013 | 8:44 AM
     

    It’s just all smoke (pass a law), and then never implement (mirrors) it…no enforcement, and thus no accountability…and this is how the game is played…pay to play…the industry pays big time…lobby money…campaign money….money funneled everywhere….and they always get what they want….after all, it’s just business as usual….

  2.  
    berit bj
    January 23, 2013 | 9:04 AM
     

    Stan
    Hubris does not last forever. Empires have crumbled, this one will too. People fighting for change are way past your fence-sitting position, miles ahead. Joining is much more constructive – more fun too!

  3.  
    Stan
    January 23, 2013 | 3:56 PM
     

    berit bj: Fence Sitting? You have absolutely no idea what your talking about….Just another capitulating “can’t we all get along” drone…when you have any real results or substantive changes to share with everyone….please feel free to come down off your high horse “open dialogue” fence and join the rest of us in the world of reality…. :)

  4.  
    January 23, 2013 | 4:07 PM
     

    Points made. War averted…

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