Tuesday, June 19, 2007

Biederman Bashing: Sure, it's Fun, But....

If you're looking for an icon of the excesses of academic psychiatry's relationship with the pharmaceutical industry, Joseph Biederman is on most people's top two list (he competes with Charles "bling bling" Nemeroff for this position). Biederman-bashing has become high sport, the latest installment being a fine piece in the Boston Globe by Scott Allen.

While Dr. Biederman may be no ethical guiding light, the focus of most of this attention has been misplaced, in my opinion. Virtually all of this negative coverage has attacked his research on the treatment of bipolar disorder in very young kids. The implication is that he is hell-bent on drugging 4 year-olds, and not because he wants to help them, but because the drug companies pay him to do it. He has even been blamed for Rebecca Riley's death, because her treating psychiatrist read some of his articles.

Come on guys, let's get real. Here's the Biederman study that has generated the fuss:

Biederman and his colleagues at Mass. General identified 31 children, aged 4-6, who met DSM-4 criteria for different types of bipolar disorder. They randomized these kids to treatment with either Risperdal or Zyprexa. The kids improved significantly on all outcome scales. Side effects included 5 to 7 pounds of weight gain in both treatment groups, and prolactin elevation in the Risperdal group.

The study was not even funded by industry, which is impressive for a department in which psychiatrists can barely find the water fountain without industry support. The point is that if you are going to be picking on Biederman, this study is not a great basis for it.

Of course, Dr. Biederman does himself no favors when he is interviewed. To quote the recent Globe article:

"Biederman dismisses most critics, saying that they cannot match his scientific credentials as co author of 30 scientific papers a year and director of a major research program at the psychiatry department that is top-ranked in the "US News & World Report" ratings. The critics "are not on the same level. We are not debating as to whether [a critic] likes brownies and I like hot dogs. In medicine and science, not all opinions are created equal," said Biederman, a native of Czechoslovakia who came to Mass. General in 1979 after medical training in Argentina and Israel."

You can almost hear the great wincing sound emanating from the media relations staff at Mass. General.

Believe me, the MGH child psychopharmacology department deserves to slapped around for shady practices in industry-funded CME, and I will have plenty to post about this in the future. But the relevant diagnosis of that story is ADHD, one that is much more lucrative for hired guns than pediatric bipolar disorder.

8 comments:

Sara said...

Regarding Biederman's study: Are we talking 5-7 pounds in 8 weeks at the ages of 4-6? What percent of body weight was that then?! And what is anyone supposed to do after eight weeks? Assume it's just more of the same indefinitely? Anyone who's been on antipsychotics knows that this is not like popping a vitamin and what's true at 8 weeks is unlikely to also be true at 16 weeks or even further out? So what are clinicians supposed to do? How long are they supposed to keep these little kids on drugs? And what happens when they try to take them off? Is there any mention of this in this study?! It's been demonstrated that patients are worse than ever if they try to stop an antipsychotic, with the return of raging withdrawal-induced psychosis. Have the parents of these kids been told that?!

The fact that clinicians go on to make prescribing decisions on the basis of studies like this that rarely include any narrative details about what really happened is a disgrace. 31 participants in the trial for 8 weeks! What in heck's name can you tell from that? And on the basis of that doctors have gone on to prescribe these drugs for an indefinite period of time to thousands of children. Medical professionals should be ashamed that they don't ask more questions about these articles that are published in journals which increasingly have sold out to the pharmaceutical industry.

DocJohn said...

Yes, a wonderful and straight-forward pilot study.

A horrible study, however, on which to base the entire philosophy and foundation for prescribing powerful antipsychotic medications to children. N=31? Using adult-derived diagnostic criteria and simply applying them to children (rather than coming up with empirically-derived child-based criteria)? 5-15% weight gain? No placebo control? 8 weeks? All fine for a pilot study on which to base larger clinical trials upon, but not so good if you're going to use this as the "proof" for "bipolar disorder in children" and for treating said children with non-FDA approved medications for such a population.

I mean, if you want a better example of how *not* to conduct the foundational basis for a whole subset of diagnosis and treatment of children, you'd be hard pressed to find it.

Daniel Carlat, M.D. said...

I agree with these comments. Clearly, the study is no basis upon which to make sound treatment decisions. Unfortunately, there's not much more data than this out there. And there are some very young children who are completely out of control--way beyond hyperactive, and suicidal to boot. Atypicals can have awful side effects, to be sure, but there are times when these side effects may be worth the possibilities of real benefit.

Sara said...

I appreciate what you're saying about young children out of control and wanting to help them. I'd like to know more about the set of circumstances in which such children find themselves and be sure that all biological, environmental, nutritional, and sleep disorder issues have been thoroughly investigated before placing them on atypical antipsychotics. I am afraid I do not believe such drugs would ever be appropriate but that is my bias. Even highly addictive tranquilizers to get children through an emergency are preferable to Zyprexa or Risperdal. Surely children do not act out in this fashion unless there are some underlying issues at work in their environment. In my experience it's usually the adults and caretakers that need "treatment" (e.g. a talking to) more than the kids.

CL Psych said...

I likewise wonder about the home environment of these "bipolar" kids. The study which is being discussed is clearly not a study upon which one can base much of anything.

I can't help but wonder if any other studies have been conducted but found negative results and hence remain unpublished (much like studies regarding SSRIs for kids).

Anonymous said...

Were the raters in this study blinded????

d said...

Of course these children "improved" they were drugged into compliance (sedated) instead of being provided with consistent discipline (which may have required effort and time) *gasp*

All Biederman has proven is that he can write a paper; or many of them in his case, so what? Many people can be published. He deserves all the criticism he gets, and then some.
His arrogance is not only reckless, it is dangerous.

Anonymous said...

As a clinician, I'm not sure that we can reliably diagnosis bipolar disorder in young children -- which, of course, is the whole foundation behind Biederman's "bipolar child" construct.