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“An important scientific innovation rarely makes its way by gradually winning over and converting its opponents: it rarely happens that Saul becomes Paul. What does happen is that its opponents gradually die out, and that the growing generation is familiarized with the ideas from the beginning.”

—Max Planck Autobiography (New York, 1949)

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Drugs for Children with Bipolar Disorder

by Dr. Michael Merzenich

Joseph Biederman is probably THE leading advocate for more aggressive diagnoses and more aggressive medical treatments of children with severe neuro-behavioral problems. If you track the research history of this prominent Harvard scientist and his Massachusetts General Hospital colleagues, it documents the development of a new diagnosis of the misbehaving, out-of-control child as “bipolar,” and ultimately identifies a number of anti-psychotic and anti-depressant drugs that, initially used off-label, can effectively ameliorate its expressions.

The medical diagnosis of bipolar disorder, rare 15 years ago, is now commonplace. There are now more children under 6 being given brain-busting drugs to treat this disorder than there were children of all ages being given them 15 years ago. For children of all ages, the incidence of this “illness” has increased more than 40-fold. Drug companies like Johnson and Johnson, Eli Lilly and Pfizer had almost no business targeting this malady 15 years ago; in 2006, these children represented a $5 or $6 or $7 BILLION market for them; almost every prescription made for these children was for a drug that was actually approved for only adult use, i.e., this great new-found profit was achieved by the off-label (non-FDA-approved) distribution of these drugs to minor children.

“Off-label” use applies for drugs approved for other purposes that have not been carried through an FDA trial to demonstrate efficacy in an identified patient population. How did child psychiatrists determine what drugs might help these children, if their usefulness was not determined by gold-standard, FDA-standard trials? This is an arena in which medical school-based researchers like Dr. Biederman and his colleagues can really play a key role. For kids with severe emotional problems,this team does not appear to have tested a drug that they did not really like. Risperidone, olanzapine, aripiprazole, atomoxetine, bupropion, divalproex, ziprasidone, et alia. They ALL worked. In real life, add an anti-psychotic drug to an anti-depressant and an anti-ADD drug with an anti-convulsant and anti-anxiety meds and maybe a drug or two to slow down the weight gain from the anti-psychotic and to offset the side-effects that emerge from the anti-convulsant…

Think I’m exaggerating? This is EXACTLY the kind of drug stew that I recently discovered was being given to a young 14-year-old girl that my family has known for years. 5 powerful drugs (anti-psychotic, anti-depressant, anti-anxiety, anti-ADD, anti-convulsant, plus 2 to treat side effects). Her malady: Difficulty over a several month long period in completing her homework; ultimately, great difficulty and reluctance about going to school.

Such a treatment, in such a child, is just plain nuts. The brains of hundreds of thousands of children out there are now being given powerful drug cocktails like these. It’s a beautiful thing, for almost everyone concerned: child psychiatrists have busy clinics; drug companies have healthier bottom lines; hyperactive out-of-control children are brought under control, iand hypoactive children wake up, in large numbers, and their parents are certainly happier for that; and this industry has prospects for still greater (perhaps even accelerated!) growth. As for the child and her/his (their) brain(s), and its(their) future(s)....

It is interesting to discover, as was reported in the New York Times earlier this month, that Dr. Biederman and his Harvard colleagues have been given more than $4 million in consulting fees from the drug companies that support their research, over the period of time in which they published many reports elaborating how to find one of these children under almost every rock, and once identified, essentially promoting the off-label use of these drugs to help them. They did not tell their University about most of these fees. I can assure the reader of this blog that his Department members have also not been paying very much toward the costs of their retreats, departmental parties or dinners, for fees to host and entertain their guests and friends, or for really nice “working” holidays that seem to become available to them every so often. You might also be assured that my experience as a University professor tells me that bringing in many millions of dollars in grant research to their University has not exactly hurt Dr. Biederman’s university-delivered prestige, compensation or benefits.

Is this eminent scientist unduly influenced by taking these fees? Are American children paying an undue price for his promotion of this diagnosis and these treatment strategies? Should his University take a hard look at whether or not attaching their good name to this class of academic activity is really something they should be doing? Should they call him on the carpet? Should lawyers include him, his colleagues, and his University in the inevitable class-action lawsuit that shall arise from the untoward downstream consequences of feeding all these children all these off-label drugs in all of these complicated combinations?

Let me close this blog by telling a short story. When I co-founded Scientific Learning Corporation, I served as the President & CEO (with my university’s knowledge and permission) for a period of about 18 months. About a year into this process, we initiated an executive search for a Vice President for Marketing. One of our co-founders suggested that we contact someone that she knew who was a Vice President for Marketing for a drug company (one of those companies that supported Dr. Biederman), who she knew was not terribly happy with her job (because of its enormous pressures). I was surprised when this young executive expressed a genuine interest in our little company and in moving to San Francisco, and said that she could visit us to discuss it over a following week, because she had business appointments at my university (the University of California at San Francisco). The plan was to meet at my home for dinner, just after her meetings with UCSF scientists.

She arrived in a state of high excitement and enthusiasm. She explained that her group normally wrote the scientific papers for scientists who conducted studies of her company’s drugs (just as they prepared all of the materials for their contractors describing the outcomes of those studies for scientific meetings and presentations), but that this UCSF group had altered the Discussion section of a manuscript that her team had written by adding an offensive paragraph. It said that a) Her company’s drug was effective; but b) that it was no more effective than a generic drug that costs a few $$ (her company’s drug would be sold for more than $1500). She had come to San Francisco to get the UCSF scientists to delete this paragraph.

Her ebullience stemmed from the fact that she had achieved her goal. I do not know what incentives (if any) she may have offered to achieve this end. She implied that it was in this UCSF team’s best interests to agree with her.
I don’t know if this very clever young woman ever understood why her story abruptly ended all consideration and discussion with her about joining our little San Francisco company.

Posted in Brain Fitness, Brain Fitness Program, Brain Plasticity, Brain Science, Childhood Learning, Cognitive Impairment in Children, Cognitive impairments, Neuroscience, Posit Science, Schizophrenia, Bipolar Disorder, et alia, Uncategorized |