Recently, in October 2014, the Texas Attorney General filed a lawsuit against AstraZeneca for illegally marketing Seroquel for unapproved uses, paying kickbacks to physician and state health officials, and its fraudulent marketing scheme such as its misrepresentation of the risk of weight gain.
How does AstraZeneca misrepresent the risk of Seroquel weight gain in its marketing of the drug? We learn more about this misrepresentation in a lawsuit filed against the company by former sales rep Tracy Miksell-Branch:
Misrepresentation of Risk of Weight Gain
One of the most prevalent adverse events accompanying use of Seroquel IR and Seroquel XR is clinically significant weight gain. In response to physicians’ objections to prescribing the drugs due to risk of weight gain, sales representatives told physicians that, while some weight gain with any atypical antipsychotic was inevitable, weight gain with Seroquel IR and Seroquel XR was modest and limited to 5 pounds.
This claim, however, was contradicted by AstraZeneca’s own analysis showing that over the course of a year, 37% of schizophrenia patients taking Seroquel IR experienced weight gain of greater than 7% their baseline weight or, approximating based on the average patient weight, a gain of at least 12 pounds. [Martin Brecher et al., Quetiapine and Long; Term Weight Change: A Comprehensive Data Review of Patients with Schizophrenia, 68 J. Clinical Psychiatry 597, 599 (2005).]
Over the course of two years using quetiapine, the portion of patients experiencing clinically significant weight gain increased to 45%. [Id.] The Prescribing Information for Seroquel XR likewise shows significant incidences of weight gain.
AstraZeneca multiplied the falsity of its misrepresentations with respect to Seroquel XR by telling physicians that Seroquel XR caused less weight gain than Seroquel IR due to Seroquel XR’s “smooth release profile,” which purportedly resulted in fewer carbohydrate cravings.
There was no adequate clinical data to support this claim. It was simply false. Nonetheless, during district meetings, sales representatives in Relator’s district practiced delivering this unsubstantiated promotion during role play exercises, facilitating their delivery with a graph from the Seroquel XR core visual aid that showed the comparative blood plasma levels of Seroquel IR and Seroquel XR during the course of a day.
Sales representatives also misrepresented to physicians that weight gain associated with Seroquel XR was limited to patients who took the drug as monotherapy, and that there was no weight gain observed among those taking the drug as adjunctive therapy.
Again, this promotion was also simply false. The Seroquel XR Prescribing Information shows that the incidence of clinically significant weight gain for patients taking Seroquel XR as adjunctive therapy was more than double the incidence in patients taking placebo.
AstraZeneca is a very, very bad boy, no? We’d say it deserves to be spanked but spanking is not enough of a punishment for a corporate behavior that victimizes thousands of people.
Seroquel Weight Gain Side Effects: Lawsuit Updates posted 12 April 2015. Updated 27 April 2017.