Harvard Researchers Face Heat Over Drug Company Payments

Renowned child psychiatrist, Dr. Joseph Biederman, and a colleague at Harvard Medical School’s psychiatry department—Dr. Timothy E. Wilens—may have violated federal and university research rules over conflicts of interest, according to Senator Charles E. Grassley, Republican-Iowa.  Biederman is best known for promoting the use of a “powerful antipsychotic medicines in children,” according to a New York Times.  His work earned him no less than $1.6 million in consulting fees from <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug companies from 2000-2007, which—according to information given to Congressional investigators—was underreported to university officials.

Wilens was late in reporting earnings of at least $1.6 million from 2000 to 2007; another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million, but only after “being pressed” by Grassley’s investigators.  Because some entries contradicted payment information provided by drugmakers, Grassley is concerned amended disclosures may not indicate true amounts.  Biederman did not report income from Johnson & Johnson for 2001; however, when asked to check again, he said he received $3,500.  Meanwhile, Johnson & Johnson advised Grassley it paid Biederman $58,169 that year.  In 2000, Biederman received a National Institutes of Health (NIH) grant to study an Eli Lilly drug for attention deficit disorder.  Biederman reported to Harvard he received under $10,000, but Lilly advised Grassley it paid Biederman over $14,000.  At the time, Harvard forbade professors from conducting clinical trials if they received over $10,000 from the company whose product was being studied; federal rules required such conflicts to be managed.

The Harvard group’s consulting arrangements with drug makers were already controversial due to researcher advocacy of unapproved uses of psychiatric medicines in children.  John Burklow, an NIH spokesman, said: “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.”  Federal grants received by Biederman and Wilens were administered by Massachusetts General Hospital. The NIH could place restrictions or suspend the hospital’s grants.

In recent decades, drug and device makers have conducted much medical research, not the federal government, as in the past.  While industry support is critical to university research, big industry is using researchers as marketers of emerging drugs and devices, an obvious conflict.  To protect research integrity, the NIH requires researchers to report earnings in excess of $10,000 to universities which then require money be disclosed to research subjects.

Alyssa Kneller, a Harvard spokeswoman, said the doctors had been referred to a university conflict committee for review.  Grassley sent letters on Wednesday to Harvard and the NIH outlining the findings and placed the letters and his comments in The Congressional Record.

Biederman is widely recognized for his work in the diagnosis of pediatric bipolar disorder and for the rise of antipsychotic medication use in children.  Doctors have known for years that antipsychotic drugs can quickly subdue children; however, many researchers strongly disagree over pediatric bipolar diagnoses; some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

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