Friday, March 27, 2009
Dr. Joseph Biederman, chief of the Massachusetts General Pediatric Psychopharmacology Clinic, is already under investigation by Harvard University and the National Institutes of Health for failing to report income received from drug companies. Now, in newly released court documents, Biederman appears to be promising drugmaker Johnson & Johnson in advance that his studies on the antipsychotic drug risperidone will prove the drug to be effective when used on preschool age children.
Biederman's status at Harvard and his research have arguably made him, until recently, America's most powerful doctor in child psychiatry. Biederman has strongly pushed treating children's mental illnesses with powerful antipsychotic medicines. Diagnoses like ADHD and pediatric bipolar disorder, along with psychiatric drug use in American children, have soared in the last 15 years. No other country medicates children as frequently.
Reports from court actions, along with an ongoing investigation of conflict of interest charges led by Sen. Chuck Grassley, R-Iowa, threaten to topple Biederman from his heretofore untouchable Olympian heights. Biederman has cried foul.
He says the drug company dollars (declared and undeclared) have not influenced him or his research. He had agreed temporarily to sever most of his financial ties with the drug industry pending the outcome of the ongoing inquiry.
He claims his science and publications are pure, supported by a peer-review system that is supposed to verify accuracy and authenticity. Finally, he challenges as office gossip reports of his legendary anger and intolerance of those who disagree or don't support his proposals.
In a contentious exchange with a deposing lawyer, he also indicated he ranks just below God in the Harvard faculty hierarchy or firmament.
Biederman's situation is emblematic of a very compromised medical research and academic community that has become dependent on industry money for its existence.
Virtually all researchers say they are not influenced by drug company money. Doctors rarely out-and-out lie about their research, but spin influences how a study is set up, its statistical analysis and interpretation. Research on drug studies repeatedly shows that drug trial results are tilted toward a positive description of the drug's effects when the research is funded by a drug company rather than the government or an independent agency.
Big Pharma money is most powerful when promoting Biederman's research and point of view over competing models. Drug companies copy and mail his important papers on psychiatric drugs to every American physician working with children. A member of the Biederman team is at every important meeting on children's psychiatric issues and medical education. Their presence, and often the conference, itself, are supported by drug industry dollars.
Only when children die or side effects are severe - as in the FDA hearings on children and antidepressants in 2004, and in the recent publicity over obesity and diabetes caused by the bipolar drugs - do opposing viewpoints get the country's eyes and ears.
Biederman's conflict of interest problems have exposed his strong pro-drug views to the public for scrutiny. Until now, fear of the Biederman team has operated quietly on the small club of child psychiatric researchers. Only when 2-year-olds started taking three psychiatric drugs simultaneously under a Biederman protocol for bipolar disorder did the emperor's clothes become so invisible as to begin the naming of names.
Business ethics, whose main concerns are profit and legal operation, collide with medical ethics, which are directed to the patient's benefit, when academic research is dependent on industry money. We must formulate and enforce a new set of rules to restore doctors' credibility.
The federal government has recently promised funds to compare existing drugs with newer, more expensive competitors. This is a welcome shift of emphasis away from previous drug-company-sponsored studies that only had to prove that their drug, short term, was better than a placebo. In the meantime, Biederman's personal travails tragically inform us about a crisis in academic medicine that must be resolved.
Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF.
This article appeared on page A - 13 of the San Francisco Chronicle