Life Science Compliance Update

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July 08, 2011

Harvard Physicians Sanctioned for Failing to File Proper Disclosure

DoctorPaperwork 
Last week, Massachusetts General Hospital and Harvard Medical School sanctioned renowned child psychiatrist Dr. Joseph Biederman and two colleagues after finding they violated conflict of interest rules.  The sanctions came at the end of a three year investigation, according to an article in the Boston Globe.  

In a letter to coworkers, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school determined they had violated certain requirements of the institutions policies. They did not specify the nature of the violations.

Harvard revised its conflicts of interest policies last year.

In a statement from Massachusetts General Hospital said that a committee at from the hospital had been looking into conflict-of-interest questions involving the three MGH child psychiatrists note above and completed its review.  The statement said that, “appropriate remedial actions have been taken by the hospital to address specific issues.”

Background

According to the Globe, Biederman is the country’s most prominent advocate of diagnosing bipolar disorder in children, even in those under age 6, and using antipsychotic drugs to treat many of them. He became one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine.  Some say that his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

In 2008, Senator Charles Grassley (R-IA) accused the three doctors of accepting millions of dollars in consulting fees from drug makers from 2000 to 2007, and of failing for years to report much of the income to university officials.

Congressional investigators led by Grassley accused Biederman, Spencer, and Wilens of failing to disclose more than $1 million each in payments they received from industry over the eight years. In addition, documents in a lawsuit portrayed Biederman as courting drug company money by promising that his work at Mass. General would help promote the use of antipsychotic drugs for youngsters - a characterization Biederman has said is untrue.

During a speech on the Senate Floor, Senator Grassley asserted that the conflict of interest forms he received from the university for these three doctors were a “mess” and that his “staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

Physicians are required to disclose payments from pharmaceutical and medical device companies so that hospital and university officials can police potential conflicts of interest that may create bias in research or in the treatment of patients, or the appearance of bias.  Every hospital and medical school has a different conflict of interest or disclosure policy, and federal agencies have their own reporting requirements for research grants for the National Institutes of Health (NIH), and for serving on advisory committees at the Food and Drug Administration (FDA).

 

Medical journals also have disclosure policies, as do professional organizations and societies, but these policies vary as well.

The three psychiatrists apologized in their letter for the unfavorable attention that this matter has brought to these two institutions. They called their mistakes “honest ones but said they now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

Sanctions

The three doctors explained that the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer a delay of consideration for promotion or advancement.

Dr. Jerome Kassirer, a Tufts University School of Medicine professor and outspoken critic of close ties between the drug industry and physicians, called this punishment a “slap on the wrist.”  He pointed out that He pointed out that Biederman is already a full professor at Harvard Medical School, so it’s unclear how a delay in promotion or advancement would affect him. Dr. Kassirer also noted that Biederman severed his industry ties soon after Mass. General and Harvard began their separate but coordinated investigations.

However, Dr. Benjamin Liptzin, chairman of psychiatry at Baystate Medical Center in Springfield, said he believes the actions “send a serious message that the hospital and medical school take this seriously.’’

Doctors agreed that since the mid-2000s physicians, particularly psychiatrists, are more cautious about taking money from drug companies, and about disclosing the money they do earn. Responding in part to public distrust, hospitals and universities - including Mass. General and Harvard - have further limited how much money doctors can accept and are more stringently enforcing disclosure requirements.

Liptzin said that, during those years, it was common for companies to fund clinical trials of psychiatric drugs and then hire the physician investigator as a consultant to speak about the results across the country.  Now, he said, “far fewer doctors accept payments, and those that do are far more careful about disclosure. People understand that we need to be as objective as possible in advancing our knowledge.’’

Conclusion

Ultimately, while Harvard an Mass General have taken the necessary actions to address these events, media and the general public should not use this example to generalize about physician industry relationships or the collaboration that exists between doctors an companies.  As it is clearly stated in almost every story, Biederman is one of the leading experts in the world on psychiatric issues, and as such, his work and expertise is necessary to advance the field to improve patient outcomes and help teach other physicians.  While his mistakes and omissions for disclosure are important, the overwhelming majority of physicians who work and collaborate with industry accurately and adequately file disclosure forms with their institutions. 

Transparency is important for advancing science and medicine. However, when there is a rare failure in transparency, as in this case, it should not be an excuse for others to generalize about industry-physician relationships.  These partnerships are beneficial, and should be continued.    Once has to ask themselves what is the most valuable use of a researchers time, filling out disclosure paperwork or research and patient care.   It has not been proven how people can effectively do both at the exact same time, there has to be a sacrifice of one (patient care and research) to achieve the other (great disclosure paper work to their institutions).

As transparency comes to the forefront with the Sunshine act, these issues will eventually disappear or perhaps not as it may take a life of its own, as physicians will report to their institutions 1099 income and companies will be reporting all transfers of value, from transportation to meals.

The system is a mess and it is just going to get messier.

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