A Harvard psychiatrist who promised positive results for some drugs even before their clinical trials were started is facing a congressional inquiry.
Joseph Biederman is one of a number of prominent doctors targeted by Sen. Chuck Grassley's investigation into conflicts of interest among doctors. Late last year, he agreed to stop working on clinical trials sponsored by industry until completion of a probe of his alleged lack of disclosure of more than $1.6 million in payments he received from companies including J&J and Eli Lilly, both makers of prominent psychiatric drugs.
Biederman's attorneys are trying to get a judge to seal his testimony and accompanying documents in a multistate suit in which he is a key witness, saying they "could be immensely damaging to him, both personally and professionally," the Boston Globe reports. The suit involves more than 2,000 patients, including children, who say they have been injured by drugs known as atypical antipsychotics. Growing use of psychiatric drugs in children has been a center of controversy in the past couple of years.
According to court documents, Biederman made a presentation to Johnson &Johnson executives in which he displayed a slide that referred to a proposed study of the company's antipsychotic Risperdal, known generically as risperidone, in preschool children, the New York Times reports. The trial "will support the safety and effectiveness of risperidone in this age group," as NYT quotes the slide.
Another slide discussed a trial that would compare Risperdal with competitors in managing pediatric bipolar disorder. The trial "will clarify the competitive advantages of risperidone vs. other neuroleptics," says the slide
Biederman didn't comment in the NYT or Globe stories, but he has written before that J&J's financial support for a research center with which he was involved didn't interfere with the center's research findings. J&J has also said funding it provided the center "followed strict guidelines to ensure scientific independence and did not direct the content or conclusions of the research."
Also Biederman had committed at least six violations of research protocol, according to an April 2004 letter from Massachusetts General Hospital's Human Research Committee, which is responsible for monitoring patient studies at the facility. Biederman and several of his colleagues involved in the research hold dual appointments at the Boston hospital and the Harvard Medical School.
In one instance, which the research committee deemed "a serious breach of the protocol procedures and provisions," a child in the 2005 study was given a 12.5 milligram dose of olanzapine, although the maximum dose allowed in the study was 7.5 milligrams, according to a letter from the committee to Biederman. Olanzapine, sold by Eli Lilly, is known more commonly by the brand name Zyprexa.
Biederman, in a response to the hospital committee, called the violation "serious" and wrote it "should never have occurred and is not justified." However, he also reported that "in no way was the subject's safety jeopardized." He also said the higher dose was used to stabilize a "very sick child."
The age of the child wasn't specified in the letter, but the children in the study ranged 4 to 6 years old.
The study, published in journal Biological Psychiatry in 2005, concluded that treating the preschoolers with olanzapine and risperidone, sold as Risperdal by a unit of Johnson & Johnson, "may result in a rapid reduction of symptoms of mania in preschool children with" bipolar disorder, reports Sarah Rubensteinfor Wall Street Journal.