The psychiatrist is the country’s most prominent advocate of diagnosing bipolar disorder in children, even those under age 6, and using antipsychotic drugs to treat many of them, even when federal regulators have not approved the drugs for that use. Congressional investigators led by Senator Charles E. Grassley, an Iowa Republican, accused Biederman this summer of failing to disclose more than $1 million in payments from drug companies. Harvard Medical School is investigating those reporting discrepancies.
He is now also emerging as a key witness in a huge, multistate lawsuit brought on behalf of more than 2,000 patients, including children, who claim to have been injured by psychiatric drugs known as atypical antipsychotics, including the Johnson & Johnson drug Risperdal, also known as risperidone.
Biederman is not a defendant in the case, but the plaintiffs’ lawyers submitted more than two dozen documents aiming to present him as an example of how drug companies and researchers conspired to boost “off-label” prescriptions that go beyond federally approved uses of a drug.
The plaintiffs’ lawyers sought to compel Biederman to let them interview him – a legal fight they won. He is expected to be interviewed under oath by January.
Biederman issued a statement earlier this year saying he had complied with conflict of interest rules at Mass. General and Harvard.
It is legal for doctors to prescribe drugs for off-label purposes, but not for drug companies to actively market such uses. To get around that restriction, drug marketers recruit and pay respected “opinion leaders” like Biederman to discuss their off-label prescribing experiences with colleagues at company-sponsored “educational” talks or meetings.
In one internal 2002 e-mail that the plaintiffs’ lawyers submitted, executives of Janssen Pharmaceuticals – the Johnson & Johnson subsidiary that markets Risperdal – discuss Biederman’s repeated proposals for the company to help fund a center on pediatric bipolar disorder at Massachusetts General. “The rationale of this center is to generate and disseminate data supporting the use of risperidone in this patient population,” it says.
It wasn’t until five years later, in 2007, that the Food and Drug Administration approved Risperdal for children with bipolar disorder.
Another document, the 2002 annual report of the center that was ultimately created and directed by Biederman, states that one of the center’s “essential features” is its ability to conduct research that “will move forward the commercial goals of J&J” – Johnson & Johnson. An e-mail from November of that year mentions at least $700,000 in Johnson & Johnson payments to the center.
Massachusetts General Hospital issued a statement yesterday saying that the center, the MGH-Johnson & Johnson Center for the Study of Pediatric Psychopathology, existed from 2002 to 2006 and gave many researchers “the infrastructure necessary to complete projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner.”
The hospital controlled the center’s programs, it said, and, “The grant agreements stated that the center was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”
The allegations in the Risperdal case “have raised significant questions and concerns about the implementation of those agreements,” the statement said. “The MGH takes these allegations very seriously and intends to investigate these issues thoroughly.”
Attempts to reach Biederman at his office were unsuccessful.
Some of the legal documents reflect the ticklish dealings that drug company employees had with Biederman.
In one 1999 e-mail, a Janssen employee seeking to make sure Biederman receives $3,000 that the company owes him writes frantically to his superiors: “Dr. Biederman is not someone to jerk around. He is a very powerful national figure in child psych and has a very short fuse.”
Another document in the court case suggests that Janssen employees ghost-wrote a summary of a study, to be presented at a 2002 meeting of child psychiatrists, on which Biederman was to be listed as presenting author. They appeared to seek his help in making the results appear more positive for Risperdal. In a reply, he agreed to be named as author but it was not clear whether he provided the requested help.