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Harvard Psychiatrist Must Suspend Clinical Trials Over Conflicts

Posted by Jane Akre
Wednesday, December 31, 2008 10:42 AM EST
Category: Major Medical, Protecting Your Family
Tags: Pharmaceutical Industry, Risperdal, Bipolar Disorder, ADHD, Harvard University, Sen. Grassley, FDA and Prescription Drugs, Antipsychotics

Dr. Biederman suspended from clinical trials while conflicts are probed.

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IMAGE SOURCE:  Harvard University Bio on Dr. Biederman

Drug makers hoping to find a sympathetic ear in controversial Harvard psychiatrist Joseph Biederman will have to turn elsewhere.

Dr. Biederman will stop working on clinical trials paid for by industry for the time being, while Massachusetts General Hospital probes allegations, made by Sen. Charles Grassley, that Biederman didn’t adequately reporting more than $1.6 million in funding he received from the pharmaceutical industry, primarily Johnson & Johnson (J&J)and Eli Lilly.  

Mass General is the teaching hospital for Harvard University and Dr. Biederman is a leading child psychiatrist there.

The New York Times reports, “Dr. Biederman’s work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.”

Parents who are suing Dr. Biederman, alleging their children were harmed by the antipsychotics he widely promotes, want him deposed.

As part of the litigation, e-mails gathered show the cozy relationship between the doctor and J & J.

A 2002 e-mail says of Dr. Biederman, “He approached Janssen multiple times to propose the creation of a Janssen-MGH center for C & A Bipolar disorders. The rationale of this center is to generate and disseminate data supporting the use of risperidone in this patient population.”

Risperidone is the chemical name for Risperdal. Janssen is a division of J & J.

Its stated goal in its 2002 annual report, is to improve psychiatric care for children and to, “move forward the commercial goals of J & J,” according to court documents.

J. & J. gave $700,000 in supporting funds in 2002 alone, according to documents obtained by the New York Times.

In November,  a federal panel said Risperdal and other similar drugs are being used too widely on children and carry substantial risks. Other drugs include, Abilify (Briston-Myers Squibb); Zyprexa ( Eli Lilly); Seroquel (AstraZeneca); Geodon (Pfizer).  

Dr. Biederman is now on a tight leash and has agreed not to participate in any speaking or consulting arrangements until his actual income from industry is determined. He says he and the hospital agreed mutually on that decision.

In a letter to the Wall Street Journal, published December 18, Biederman wrote that “any implication that J&J’s interests interfered with the center’s work is wrong.”   

Biederman says the Johnson & Johnson Center, which operated from 2002 to 2005, was so named to be transparent about its funding while it conducted research on ADHA and bipolar disorder.

He adds that,  It greatly concerns me that the Journal has damaged my personal and professional reputation, and profoundly harmed the field of child psychiatry.”  Dr. Biederman had focused on pediatric bipolar disorder and its symptoms, impairments and neurobiology. He says his research did not focus on medications.

Last March, when Sen. Charles Grassley (R-IA) and his staff probed the records of payments by industry, the numbers failed to add up. The forms were reported to be a “mess” and under-reported the income of researchers.

Altogether three Harvard psychiatrists failed to report over three million dollars in payments they received from drug makers, violating U.S. government and Harvard University rules.

Dr. Joseph Biederman, Dr. Thomas Spencer and Dr. Timothy Wilens conducted studies on how children are affected by drugs such as Strattera, used for the treatment of attention deficit disorder.

The Boston Globe, in a profile on him last year reported, “No one has done more to convince Americans that even small children can suffer the dangerous mood swings of bipolar disorder than Dr. Joseph Biederman of Massachusetts General Hospital.”

Researchers are supposed to limit payment to $20,000 on any drug they are researching. They are also required to file accurate reports in disclosure forms with Massachusetts General Hospital and Harvard University. “If researchers are taking money from drug companies while receiving federal dollars to research that company’s product, there is a conflict of interest, Sen.Grassley said in a statement.

Currently, reporting conflicting interests is an honor system that relies on the honesty of medical researchers. No one oversees the information for accuracy.

A violation of ethics puts the medical school and affiliated Massachusetts General Hospital at risk of losing future federal funding. The National Institutes of Health rules on taking money from drug makers could lead to sanctions. Harvard policies can include removing the doctor from a “good-standing” list, a formal admonition and/or a non-renewal of appointment.  

Senator Grassley is now calling for a national reporting system, the Physician Payments Sunshine Act that will require drug companies to disclose payments made to doctors. #


2 Comments

Anonymous User
Posted by immbas
Wednesday, December 31, 2008 12:51 PM EST

Thank you!!! Thank you!!! He and his cronies should be jailed!

Posted by Steve Lombardi
Wednesday, December 31, 2008 1:58 PM EST

This story demonstrates what is wrong with so-called "independent research opinions" from university professors as those opinions relate to what people can believe are really based on independent research/analysis and not profit motivated opinions. Not only are his past opinions tainted but resigning only after the profit relationship is exposed makes all future opinions suspect. What can we believe is independent and what opinions simply have not had profit relationships exposed? And the problem is deeper and wider and taints all Harvard faculty opinions. How can we rely on Harvard for independent research when the University system allows faculty to issue opinions and not fully disclose all profit relationships? Harvard isn't alone. What about all university research where conflicts exist but not disclosed?

What this case demonstrates is that the research system at Harvard is flawed and can not be relied on as providing truly independent research. Harvard isn't alone. The problem exists for most universities.

The hole in the research dike started with the Tobacco Institute and has only gotten worse over time. The only way to fix the problem is for universities to demand complete disclosure with sanctions for those who do not comply.

The public has a right to know what conflicts exist and the full extent of what all researchers have been paid - PERIOD.

Comments for this article are closed.

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