Healthy Skepticism Library item: 18830
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Edwards J
Novartis Paid Doc Who Urged Use of Seizure Meds on Bipolar Kids
BNet 2010 Nov 11
http://www.bnet.com/blog/drug-business/novartis-paid-doc-who-urged-use-of-seizure-meds-on-bipolar-kids/6050
Full text:
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:
Novartis also instructed its sales representatives to carry “Medical Request Forms” on their sales calls to psychiatrists and use them to “prompt” the psychiatrists to “ask” for information on Trileptal’s off-label uses. While a physician is free to inquire about off-label uses of a drug, a sales representative may not initiate that communication or use a Medical Request Form for such a purpose …
In many cases, the Novartis sales representative even filled out the Medical Request Form in advance of the sales call. They then explained to the psychiatrist that in response to the doctor’s “request,” the company would provide him or her with all the medical data and studies regarding the off-label use.
As it turns out, decision-makers at Novartis’ corporate headquarters decided to select out certain positive information in response to the purported requests (consisting mostly of “chart reviews” and single patient or small group studies) and to conceal the negative data and studies suggesting Trileptal is neither safe, nor effective in the treatment of bipolar disorder.
One of the responses Novartis provided to such requests was a summary of research into the use of Trileptal for mania, bipolar and aggression disorders. It mentions a study by “Reinstein et al” in 2002 of patients aged “11-83 years” and another study by Reinstein et al from 2001 in 47 adults.
At about that time, Reinstein published a third study of 57 patients on Trileptal vs. patients taking divalproex sodium. And, according to The Bipolar Child, a medical newsletter, Reinstein presented a fourth set of data in 2001 on Trileptal vs. Depakote to the American Psychiatric Association Conference in New Orleans. The Bipolar Child newsletter asked Reinstein about using Trileptal in children. He replied:
When the dose gets high enough, the aggression tends to subside.
Reinstein is a controversial figure in psychiatry. He was the subject of a Propublica investigation that found he received nearly $500,000 from AstraZeneca (AZN) and became one of the company’s top prescribers of Seroquel, an antipsychotic drug that’s associated with weight gain:
“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.
Reinstein has been criticized for writing prescriptions for “an improbably large number of patients“:
In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show.
Reinstein did not return three messages left for comment at two phone numbers or an email address associated with him.
