Personal Injury Law

Harvard Psychiatrists Under Fire for Failing to Report Drug Payments

By Jane Akre

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

Dr. Biederman was found to have received more than $1.6 in consulting fees from drugmakers over the last eight years. 

He is known worldwide for his controversial work in researching and promoting antipsychotic medicines for children.

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."

In March, Sen. Charles Grassley (R-IA) requested additional documentation, after his staff compared records of payments with conflict-of-interest forms and the numbers failed to add up.

The forms were reported to be a "mess" and under-reported the income of researchers. The doctors then submitted revised totals of more than $1 million each from pharmaceutical companies between 2000 and 2007.

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. The payments for consulting came from several drug makers including Eli Lily Co. and Johnson & Johnson.

"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.

The current method for disclosing conflicts-of-interests among medical researchers is an honor system in which researchers report their relationships with drug and medical device makers, but 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.  

The school and hospital said they are planning to launch a formal investigation of the researchers and review current ethics policies.

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.

Recently, doctors in training who belong to the American Medical Student Association (AMSA), issued a scorecard on conflicts of interest by pharmaceutical companies and universities across the country.

The research finds most of the 150 medical schools in the U.S. are failing when it comes to erecting conflict of interest policies that ensure pharmaceutical marketing cannot take hold on campus.  

A survey of doctors called What Doctors Think, finds that physicians were okay with revealing online a database of drug makers financial arrangements with doctors. 78% of doctors thought that medical companies should post their payments to physicians online, and 67% were in favor of posting details on payments they receive online.

Minnesota recently became the first of a handful of states that require open disclosure of payments to doctors from pharmaceutical companies. Those on the receiving end usually become consultants and speak to other doctors about a drug.  #

Full post as published by InjuryBoard on June 10, 2008 (boomark / email).