Seroquel Lawsuit News

AstraZeneca Sharpens Focus on Ethics

 

-Bloomberg

12/23/2009 - U.S. government fines have made big drug makers "more sensitive than we've ever been" about preventing illegal promotion of their drugs, the chief executive of AstraZeneca PLC said in an interview.

AstraZeneca in September reached a preliminary agreement to pay $520 million to settle a U.S. investigation into its marketing of the schizophrenia drug Seroquel, including allegations that the company promoted the drug for uses for which it isn't approved by the Food and Drug Administration. This practice, called "off-label marketing," is illegal.

AstraZeneca officials have declined to say whether the company will admit wrongdoing as part of the settlement, the terms of which are still under discussion. In an interview in London, chief executive David Brennan said: "We don't promote products off-label."

But he said off-label marketing has become "a much bigger issue in the last few years as a result of the government's position on this."

"If you go back ten years in this industry, this was not an issue. I mean, we trained our people not to promote off-label....so it's always been sensitive. But now, it's even more sensitive because we're paying fines," he said.

The government "investigated this stuff and they've said, 'We don't like the way you guys did this.' So we're more sensitive than we've ever been," he added.

Last year, AstraZeneca took a number of steps to strengthen its ethics training for employees, including introducing a new "openness" program designed to encourage staff to report alleged ethics violations, a company spokeswoman said.

A number of drug companies, including Pfizer Inc. and Eli Lilly & Co., have reached large settlements in recent months with U.S. investigators probing marketing practices.

Seroquel had global sales of $4.5 billion last year, making it one of AstraZeneca's top products. It was first approved for sale in the U.S. in 1997 for treating symptoms of psychotic disorders. In 2001, it was approved as a schizophrenia treatment. The FDA extended its use in 2004 to bipolar mania and in 2006 to bipolar disorder. Only this month did the FDA approve its use in children and adolescents.

Doctors are free to prescribe drugs any way they see fit, but drug makers aren't allowed to promote them for unapproved uses.

Controversy has long dogged Seroquel. AstraZeneca is facing thousands of lawsuits filed by patients who allege that Seroquel caused them to develop health problems including diabetes.

Earlier this year, lawyers representing those plaintiffs released documents that they said showed that AstraZeneca executives discussed promoting the drug for unapproved uses. The documents cited plans to "broaden Seroquel use on and off-label," including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups.

An AstraZeneca public-relations plan dated 2001 said a company objective was to "encourage and support" Seroquel's "use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly." It also said there needed to be "aggressive market penetration" among adolescents, the elderly, patients with bipolar disorder and other groups for Seroquel to grow faster than rivals.

Asked about these documents, Mr. Brennan said: "There were a wide variety of documents. Stuff that said we don't promote off-label. Others that said different things. You know, that's just the nature of how business runs over ten or twenty years."

He added: "There's millions of documents floating around. I don't have any particular comment" on individual documents.

If you or a loved one have experienced any of the serious Seroquel side effects such as hyperglycemia or diabetes during or after Seroquel treatment, you may be entitled to compensation. Contact the Seroquel attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Seroquel side effects, a possible Seroquel class action lawsuit, or any other type of Seroquel litigation.