Monthly Archives: December 2008

Drug Researcher Agrees to Curb Role

Wall Street Journal
By JENNIFER LEVITZ

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Joseph Biederman, a top researcher on the use of psychiatric drugs in children, agreed to stop participating in several industry-funded drug trials and curb other activities pending the outcome of a Boston hospital’s inquiry into his potential conflicts of interest and disclosure obligations.

The deal, announced Tuesday by Massachusetts General Hospital, where Dr. Biederman conducts research, followed several allegations related to his relationships with drug companies. Dr. Biederman has been a prominent backer of childhood use of Johnson & Johnson’s Risperdal, a top-selling antipsychotic drug.

A U.S. Senate review found that Dr. Biederman had received $1.6 million in payments from drug companies between 2000 and 2007 while reporting only a fraction of that amount to Harvard University, where he is a faculty member. Separately, Massachusetts General has said it was concerned that an institute that Dr. Biederman and J&J worked together to create at the hospital was used to promote Risperdal’s use in children, rather than for scientific or educational purposes.

Dr. Biederman declined to comment but said in a letter published this month in The Wall Street Journal that J&J’s interests didn’t interfere with the institute’s work.

In a statement Tuesday, J&J’s Janssen unit said that in funding the institute from 2002 to 2004 it “followed strict guidelines to ensure scientific independence and did not direct the content or conclusions of the research.”

In its statement, Massachusetts General said Dr. Biederman would stop industry-funded activities at the hospital until its review was completed. Hospital spokeswoman Peggy Slasman said that would mean Dr. Biederman would discontinue his participation in several industry-funded clinical trials there. The hospital declined to describe the studies, which it said would continue under a different doctor.

Dr. Biederman also agreed not to participate in “any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements,” the hospital said.

Peter Spivack, Dr. Biederman’s attorney, said his client “understands the institution’s desire to have a full inquiry and supports that.”

Harvard University Medical School is also conducting its own review of Dr. Biederman, according to David Cameron, its spokesman, but hasn’t curtailed the doctor’s role at the school.

The inquiries come amid scrutiny of drug-industry payments to doctors at academic medical centers and the hospitals’ oversight of those payments. Sen. Charles Grassley, an Iowa Republican, has accused many schools of failing to supervise researchers adequately.

In a statement Tuesday, Sen. Grassley, a critic of Dr. Biederman, said, “It’s positive that Massachusetts General Hospital is taking some action.”

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Psychiatrist to Curtail Industry-Funded Activities

New York Times
Psychiatrist to Curtail Industry-Funded Activities
By PAM BELLUCK

A prominent Harvard child psychiatrist will curtail activities financed by the drug industry while Massachusetts General Hospital investigates his failure for years to disclose the consulting fees he received from drug makers.

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Dr. Joseph Biederman, a world-renowned and controversial researcher on childhood mental illness, has agreed to stop participating in speaking engagements and other activities paid for by pharmaceutical companies, and also to stop his work on industry-funded activities within the hospital. That includes some clinical trials that are currently underway at the hospital, said Peggy Slasman, a spokeswoman for Massachusetts General.

She said the trials would continue, but Dr. Biederman would not be involved.

“He’s just not going to be doing any of that as long as these review processes go on, until they wrap up and some decisions are made,” Ms. Slasman said. The hospital said in a statement that it is evaluating whether Dr. Biederman violated rules “related to potential conflicts of interest, disclosure and industry-institutional relationships.”

Ms. Slasman said that Dr. Biederman would be allowed to continue working on federally funded research during the review.

A lawyer for Dr. Biederman, Peter Spivack, said, “The agreement is one that was mutual.”

“We support M.G.H.’s desire to do an inquiry, and Dr. Biederman is cooperating with them,” Mr. Spivack added.

Mr. Spivack said that if issues arise with any of Dr. Biederman’s patients who are participating in the industry-funded clinical trials, “he’ll consult with his superiors” and will “be involved for the patient’s sake” to ensure that important information about the patient is relayed to doctors involved in the trial.

He said that the agreement will also prevent Dr. Biederman from participating in some conferences in his field that receive industry money.

Earlier this year, a Congressional investigation of payments received by physicians from industry sources found that Dr. Biederman had been paid at least $1.6 million in consulting fees by drug makers from 2000 to 2007, but had failed to report much of this income to Harvard officials for several years.

Dr. Biederman has been a leading advocate for the idea that very young children can suffer from bipolar disorder… His research contributed to a forty-fold increase in diagnoses of pediatric bipolar disorder from 1994 to 2003, as well as to a rapid increase in the prescribing of potent and potentially dangerous antipsychotic drugs to children.

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