Novartis (NVS) gave research funds to a doctor who advocated using the anti-seizure drug Trileptal as an anti-bipolar depression treatment in children — an unapproved use of that drug — the company confirmed to BNET. The doctor, Michael Jay Reinstein, once told a newsletter for parents with bipolar children that “high enough” doses of Trileptal were useful in quelling aggression in bipolar children. Novartis spokesperson Anna Fradle said:
He has done clinical studies on Trileptal on our behalf.
She declined to detail how much money Novartis had paid Reinstein over the years. The use of antidepressants and other pyschiatric drugs in children is controversial. It is not well-established that conditions such as depression, bipolar disorder or mania exist in children, or that if they do the appropriate treatment is a seizure medicine like Trileptal. Yet Johnson & Johnson (JNJ), Shire(SHPGY) and AstraZeneca (AZN) have all funded research by doctors who advocate antidepressants for kids, and so did Forest Labs (FRX).
The admission illustrates how a small group of doctors can end up on the payroll of multiple drug companies, triggering illegal “off-label” sales.
Novartis agreed to pay $422 million to end Department of Justice allegations that the company promoted Trileptal for unapproved uses and paid kickbacks to health care providers to induce them to prescribe the drug. In the whistleblower complaint that led to the settlement, former Novartis pharmaceutical sales rep Steve McKee alleged that he and other reps would encourage doctors to ask about off-label uses of Trileptal...
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