The Boston Globe
July 2, 2011 Saturday
Harvard doctors punished over pay;
3 accused of not disclosing consulting fees
BYLINE: By Liz Kowalczyk, Globe Staff
SECTION: NEWS; Metro; Pg. 1
LENGTH: 897 words
Concluding a three-year investigation, 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.
In a letter to co-workers yesterday, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school “have determined that we violated certain requirements” of the institutions’ policies.
They did not specify the nature of the violations. But in 2008, Senator Charles Grassley, an Iowa Republican, 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.
Officials at Harvard and Mass. General released the letter to the Globe, but would not answer questions about the probe. Biederman, Spencer, Wilens, and their lawyers did not return phone calls and e-mails. Grassley’s office did not return calls seeking comment.
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.
Grassley’s investigation sparked the Mass. General and Harvard inquiries.
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.”
They said 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.”
Physicians said it is difficult to know if the sanctions are appropriate without knowing the Harvard and Mass. General findings.
“It’s hard for me to make that judgment, but this all sounds like a little slap on the wrist,” said Dr. Jerome Kassirer, a Tufts University School of Medicine professor and outspoken critic of close ties between the drug industry and physicians. He pointed out that Biederman is a full professor at Harvard Medical School, so it’s unclear how a delay in promotion or advancement would affect him. Also, Biederman severed his industry ties soon after Mass. General and Harvard began their separate but coordinated investigations.
But 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.
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.
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.
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.
“It’s very seductive because doctors were able to make substantial money,” he said. Liptzin said he became uneasy when, after giving talks, drug sales people would tell him “you could have made more nice statements about the drug.”
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.”
Dr. Daniel Carlat, a psychiatrist, Tufts medical school professor, and critic of the drug industry, said “it was almost expected that if you were an academic that you were working with industry.
If you were at a very high level institution like Harvard, there was almost a sense that you were entitled to receive a lot of perks and money for various activities from industry,” he said.
“When I get on the phone now and talk to a colleague about a study that just came out, there is much more talk about, `Was this industry funded, and can we trust the study?’ ”