Child Bipolar Research and Drug Company Payola

Clinical Psychology and Psychiatry alerted me to an article in yesterday’s New York Times. Here’s the lead from the Times story:

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

And another excerpt:

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

And here are some comments from Clinical Psych:

I’m still awaiting any impressive outcome dataon the “bipolar” kids being treated with antipsychotics. Especially the young kids. 4 year olds on Seroquel — I’m glad I’m not on Joe’s level. Are we better off now that the diagnosis of bipolar has run rampant in kids?

Dr. Carlat has a little more perspective on the issue, and some familiarity with the researchers involved:

A little sleazy? Maybe. Malevolent? I don’t think so.

The big lesson here is that Congress must pass the Physician Payment Sunshine Act, because we will never be able to grasp the extent of the complex financial relationships between companies and thought leaders without this legislation….

I have been reading the pertinent documents in the Congressional Record in order to figure out whether these three psychiatrists, all of whom I know from my training days at MGH, behaved very badly or just a little badly. All three are highly intelligent and committed researchers. During my residency days, I received a few lectures from Dr. Wilens, and he is a good, solid person. I didn’t have as much contact with Dr. Biederman or Dr. Spencer.

And Furious Seasons picked up on these details from the article:

“The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard.”

And the money:

What’s stunning to me is just how much money these researchers were pulling in.

Biederman: $1.6 million from 2000 to 2007

Wilens: $1.6 million from 2000 to 2007

Thomas Spencer: $1 million from 2000 to 2007.


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