Dr. Joseph Biederman, the world’s most prominent advocate of diagnosing bipolar disorder in even the youngest children and of using antipsychotic medicines to treat the disease, is in the middle of two controversies: one relates to conflicts of interest in medicine and the other involves the use of antipsychotic drugs in children.
As reported in a New York Times article, Dr. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007, but he failed to report all but about $200,000 of this income to university officials. Just a minor omission on his part, right? I hope you can sense the sarcasm, because I have more for you.
I'm also sure that this hefty paycheck must have been warranted. I mean his studies must have yielded results that benefited the company for which he wrote (Johnson and Johnson) right? You bet your britches I'm right. So what's the problem?
In drug presentations to company executives, one of Biederman's slides referred to a proposed trial in preschool children of risperidone. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”
Another set of slides in the documents listed a planned trial to compare Risperdal (risperidone) with competitors in managing pediatric bipolar disorder. He stated that the trial “will clarify the competitive advantages of risperidone vs. other neuroleptics.”
Finally, there was also a slide that mentioned a planned study in adolescents of Concerta. In this slide, he stated that the study will “extend to adolescents positive findings with Concerta."
"Will support…"
"Will clarify the competitive advantages…"
"Extend to adolescents positive findings…"
From these examples, you can see that the problem is that Biederman had promised successful studies before the studies even began. I'm not sure who taught Biederman the scientific method, but that person should be fired.
His statements could have been re-worded and included in a hypothesis (e.g., product A is non-inferior to product B), but his statements definitely should not have been included as objectives of the study. An acceptable objective would have sounded more like, "…to evaluate the safety/efficacy of product A compared to product B".
These documents raise questions about how well-designed Dr. Biederman’s trials were in that he promised a result to his funders. Especially when there was so much hidden money involved.
So not only was there a conflict of interest (i.e., payment for promise of positive outcomes), the validity of his studies could have or may actually have put the many patients' lives at risk when taking the products in question.
BW706: Blog #10
Lisa Menard
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1 comment:
It seems Dr. Biederman violated an important principle - conflict of interest. He didn't report the income, nor did he alert the IRB of his affiliations with the drug companies. Not to mention the potential for adverse affects for his victims, which may be a strong word, but given the situation, I believe it fits. What is the penalty for the good doctor? I hope it is not just a slap on the wrist, which it is in most of these cases. When will these doctors start paying for their crimes? Would this be considered a crime, especially when taking into account the children and the subjects for the clinical trials he administered, and the negative effects they experienced? If two kids can be sentenced to 25 years for burning a cat, shouldn't the good doctor be given worse for his crimes?
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