Conflict of interest issue with doctor promoting off-label use

An emerging case against a psychiatrist highlights conflict of interest issues involved when physicians promote products, particularly those involving off-label drug use.

In this case, an MGH-affiliated physician was also involved in marketing off-label use of drugs for which he had garnered research grants. The drug use allegedly injured patients, resulting in a large legal action:

Newly disclosed court documents portray Dr. Joseph Biederman, a leading Harvard child psychiatrist, as courting drug company money by promising that his work at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder.

Biederman is one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry. He could not be reached for comment yesterday, but Massachusetts General Hospital said it would thoroughly investigate the allegations against him.

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.

According to the story, the line between receiving payments for "educational" purposes and monies for "promotion" of a drug is thin:

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."

Our law office advises physician clients who are involved in marketing and promoting health products (such as dietary supplements). For example, there can be significant anti-kickback and other conflict of interest issues when physicians steer their patients toward products in which the MD's have a financial interest. This latest case, though it involves off-label use of drugs and not dietary supplements, could also have implications for medical doctors promoting CAM products.