A Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given Congressional investigators,The New York Times reports.
By failing to report income, the psychiatrist, Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Timothy Wilens, may have violated federal and university research rules governing conflicts of interest, US Senator Chuck Grassley, an Iowa Republican tells the Times, since some of their research is financed by government grants.
Grassley has been investigating the interplay between academics who receive grant money from both pharma and the NIH. Another recent example he uncovered involved a University of Cincinnati professor who received funds from AstraZeneca while studying one of their drugs, but allegedly failed to report the outside income to the university while also receiving NIH grants.
Like Biederman, Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Thomas Spencer, reported earning at least $1 million after being pressed by Senate investigators. But even these amended disclosures may understate their outside income because some entries contradict payment info from drugmakers, the investigators told the Times.
In one example, Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But J&J told Grassley that Biederman was paid $58,169 in 2001. The Harvard group’s consulting arrangements were already controversial because of their advocacy of unapproved uses of psychiatric meds in children.
"The question you might ask is: Why weren't Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money," according to Grassley's statement in the Congressional Record. Want to see Biederman's lack of disclosure? How about Grassley's letters to the NIH and Harvard? Look at the Congressional Record (just search for 'Biederman' once you open the link).
In an e-mail to the paper, Biederman wrote: “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Wilens and Spencer wrote e-mails saying they thought they had complied with conflict-of-interest rules.
John Burklow, a spokesman for the National Institutes of Health, told the Times: “If there have been violations of NIH policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and NIH will not tolerate it.”
The federal grants received by Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants, the Times writes, adding that the health institutes could place restrictions on the hospital’s grants or even suspend them altogether.
Alyssa Kneller, a Harvard spokeswoman, e-mailed the Times this statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.” She added that the docs had been referred to a university conflict committee for review.
The NIH last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, officials have insisted, the Times notes, so the government relies on universities. Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.
“It’s really been an honor system thing,” Robert Alpern, dean of Yale School of Medicine, tells the Times. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”
Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients, the Times writes. Although many of his studies are small and often financed by pharma, his work helped fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotics in children, the Times writes, adding that the Senate investigation did not address research quality.
In the past decade, Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults, the Times writes. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotics, which were invented to treat schizophrenia.
Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic use in children have soared, the Times notes and then cites data from Medco, the pharmacy benefits manager, showing about 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 younger than 6 years old.