Last December, The New York Times reported, “ Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly’s primary concern was that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes ….
Atypical antipsychotic medicines have become one of the biggest and fastest-growing drug classes . Overall sales for the category are projected at close to $13 billion this year, despite little evidence that the new drugs work better than older generics that cost just pennies a pill. Zyprexa, specifically, had global sales of more than $2.3 billion in the first half of this year and nearly 3 million prescriptions in the United States alone.
The Times went on to report that, Lilly documents revealed a 1999 email from Dr. Alan Breir (the chief scientist on the Zyprexa program) stating: “'Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule. In response, Lilly expanded its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness. Furthermore, Lilly’s market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.
The FDA has asked Lilly has been asked to add stronger warnings to the label of Zyprexa multiple times The label confirms that the drug has a tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems. The warning comes (a) eleven years after first approval of sales, (b) 12 years after a large Lilly clinical trial first showed that Zyprexa might have negative effects on weight and blood sugar; and (c) after settling over 18,000 claims. Investigations and Third Party Payor claims are ongoing.
Nevertheless, Lilly continues to look for way to expand the market, and has asked the F.D.A. to allow it to begin marketing Zyprexa for adolescents, despite clinical trial data showing that Zyprexa causes weight gain and metabolic problems in teenagers that can be even more severe than in adults. Lilly also tried to expand the market to treat dementia. The FDA has advised against this indication for this class of drugs.
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