Harvard scientists disciplined for not declaring ties to drug companies - July 04, 2011
Posted on behalf of Penny Sarchet.
Three US psychiatrists, responsible for trailblazing the use of antipsychotic drugs in children, are facing sanctions for their failure to declare their acceptance of millions of dollars from pharmaceutical companies between 2000 and 2007.
Joseph Biederman, Thomas Spencer and Timothy Wilens, child psychiatrists at Harvard Medical School and Massachusetts General Hospital, were first identified three years ago in an investigation led by Iowa Republican Senator Charles Grassley as failing to disclose potential conflicts of interests that could have arisen due to payments from pharmaceutical companies.
Biederman had pioneered the diagnosis of bipolar disorder in children and adolescents, a disorder previously thought to affect only adults. One of the world’s most influential child psychiatrists, Biederman’s work led to a 40-fold increase in paediatric bipolar disorder diagnoses and an accompanying expansion in the use of antipsychotic drugs – developed to treat schizophrenia and not originally approved for use in children – to treat the condition.
However, Biederman and his colleagues Spencer and Wilens failed to accurately disclose the large consultancy fees they were receiving from pharmaceutical companies that make antipsychotics whilst conducting this research. At the time, Harvard and Mass. General rules forbade researchers from running trials of drugs that were made by companies paying them more than $10,000 a year, whilst National Institutes of Health regulations stipulated that grant recipients report any payments from pharmaceutical companies above this value to their universities.
Grassley revealed the trio’s misconduct in 2008, following his high-profile investigation of the psychiatrist Charles Nemeroff, and the three eventually admitted to receiving a combined total of $4.2 million from drug companies. The large number of psychiatrists investigated by Grassley’s probe poses the question of whether this field is more susceptible to competing interests or, as some suggest, suffers from higher scrutiny due to prejudices against psychiatry.
The Massachusetts General Hospital announced last Friday that it had completed its review of Biederman, Spencer and Wilens, and that “appropriate remedial actions” were being taken. In a letter to their colleagues, the three scientists explained that they were banned from participating in “industry-sponsored outside activities” for one year, to be followed by a two-year period of close monitoring and a delay in consideration for promotion.
The NIH relies upon research institutions themselves to monitor the interests of researchers and universities do this by requesting academics to voluntarily declare conflicts. The three Harvard scientists, who failed to report the full extent of their industrial payments, say that their collective misconduct was an honest mistake and that they had always believed that they were “complying in good faith with institutional policies”.
Last month, Pfizer announced its new collaborations with eight Boston research facilities. Cooperative efforts between academia and industry are on the rise as both face pressures to cut costs and it is hoped that by brokering more formal research agreements and paying money to institutions rather than individuals, conflicts of interests can be avoided.
Meanwhile, Grassley continues to push forward the Physician Payment Sunshine Act, which would require organisations to report all cumulative payments over $100,000 to physicians to the government. Each violation of the law would warrant a fine between 10,000 – 100,000 dollars - a punishment somewhat more severe than that faced by Biederman and his colleagues.