Healthy Skepticism Library item: 16785

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

Silverman E
AstraZeneca Pays $520M To Settle Seroquel Probes
Pharmalot 2009 Oct 30
http://www.pharmalot.com/2009/10/astrazeneca-pays-520m-to-settle-seroquel-probes/

Full text:

This was predictable. After Lilly and, more recently, Pfizer settled long-running investigations into off-label marketing practices of their various drugs – notably, antipsychotics – it was expected that AstraZeneca would follow suit. And so AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistleblower lawsuits over its Seroquel antipsychotic.
Antipsychotics, you may recall, have become extremely controversial in recent years as the pills were more widely prescribed for young children and the elderly for indications not approved by the FDA (see this). In some nursing homes, for instance, seniors are experiencing tremors and a higher risk of harmful falls or even death while on the meds, which are known to cause weight gain and diabetes.
The investigation, which was underway at the same time that AstraZeneca has been battling numerous lawsuits over allegedly undisclosed Seroquel side effects, was led by the US Department of Justice’s Philadelphia office. Interestingly, the investigators reviewed not only Seroquel sales and marketing practices, but some physicians who participated in Seroquel clinical trials.
Separately, at least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes. In other words, AstraZeneca may have to dole out more money for its practices.
An AstraZeneca spokesman says the drugmaker “is committed to strong, effective compliance programs, both in the U.S. and globally, to embed a culture of ethics and integrity in all our business practices. It has been and remains a key goal.”