Tuesday, November 25, 2008

Biederman's conflicts: a crime against troubled children and the State?

If I were the parent of a child diagnosed with bipolar disorder by doctors at Massachusetts General Hospital and prescribed anti-psychotic drugs with serious side effects, how would I feel upon learning that the head honcho of MGH's child psychiatry department not only was on the take from the makers of these powerful drugs but pushed for the establishment of a drug company-funded center at MGH whose stated "rationale" was "to generate and disseminate data supporting use" of these drugs in children?

Betrayed is how I would feel, horribly betrayed.

Moving beyond the issue of betrayal, the actions of Joseph Biederman, as revealed today in The New York Times and The Boston Globe, raise the specter of criminality. By pushing Johnson & Johnson, the maker of Risperdal, to fund a center at MGH whose stated goal was to support the use of Risperdal and "move forward the commercial goals of J&J," the question emerges: did Biederman help Johnson & Johnson illegally market the off-label use of its anti-psychotic drug in children and adolescents?

While it is legal for doctors to prescribe drugs for uses not approved by the FDA, it is illegal for companies to actively market those off-label drugs. As a number of recent books, Side Effects included, show, drug makers routinely got around that restriction by recruiting and paying key opinion leaders to promote the off-label use of their products at medical conferences, company-sponsored meetings and in medical journals. By taking millions of dollars, both personally and to fund his MGH center, Biederman seems to have raised the art of off-label promotion to an entirely new level.

As The New York Times reports, "Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive anti-psychotic medicines in children... Biederman had a vast influence on the field largely because of his position at one of the most prestigous medical institutions in the world."

Earlier this summer, Congressional investigators led by Senator Charles E. Grassley accused Biederman of failing to disclose at least $1.4 million in personal payments from companies that make anti-psychotic drugs, such as Risperdal, Zyprexa, Abilify and Seroquel (back story). Now comes the news, as revealed in documents unsealed in a lawsuit, that Biederman repeatedly pushed Johnson & Johnson to fund a center at MGH whose stated purpose was to spread the word about Risperdal in treating bipolar disorder in children. Emails unsealed from the multi-state lawsuit also reveal that Biederman was asked to author a study of Risperdal ghost-written by Johnson & Johnson that purported to show the drug was more effective than a placebo in treating children.

In other words, we give you money to fund your center and line your pockets and you spread the word about our wonderful drugs, medical objectivity be damned.

Here is another example of how the tort system that the drug company lawyers are pushing to abolish helps consumers. The reason these documents came to light is because thousands of parents sued J&J, AstraZeneca (the maker Seroquel) and Eli Lilly (the maker of Zypreca), claiming that the companies minimized the risks of the anti-psychotic drugs given to their children. Attorneys representing these families demanded reams of documents from the companies, and while nearly all of these documents remain under seal, a select few that mentioned Biederman became public as part of an effort to compel the MGH psychiatrist to testify under oath as a witness in the legal proceedings. (The plaintiffs won and Biederman is expected to be deposed sometime in January, according to The Boston Globe).

So the question becomes: how long will Mass. General and Harvard Medical School allow such unethical and possibly criminal behavior to tarnish their reputations? Hopefully not long.

1 comment:

Unknown said...

The seriousness of the problem has been ignored. Biederman promoted not only toxic drugs, but he promoted a spurious and overly inclusive concept of child bipolar. It will take a long time to change current clinical practice which lacks a meaningful scientific foundation.