Healthy Skepticism Library item: 15780

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Publication type: news

Hundley K.
Documents: AstraZeneca hid study results to sell Seroquel
St Petersburg Times 2009 May 21
http://www.tampabay.com/news/business/article1002805.ece

Full text:

Behind the scenes at the global pharmaceutical company AstraZeneca, the team in charge of the blockbuster antipsychotic Seroquel had one mission: make the multibillion-dollar seller even bigger.

To that end, internal company documents released Wednesday show how the British drugmaker hid unfavorable study results, promoted unapproved uses and even considered pitching the drug as less likely to lead to suicidal thinking than competitors’.

Despite scant data supporting the “reduced suicidality” claim, Seroquel’s director of clinical research said in late 2005 that AstraZeneca could approach the FDA without undue embarrassment. “We believe we … pass the red-face test,” he wrote.

Those revelations were part of hundreds of confidential AstraZeneca emails and memos that were made public in U.S. District Court in Orlando. The judge is handling pretrial discovery for more than 6,000 lawsuits in which patients claim Seroquel caused weight gain, diabetes and other health problems.

The documents are the second batch released since February as a result of court-ordered negotiations between AstraZeneca and plaintiffs’ lawyers.

Ed Blizzard, a Houston lawyer whose firm is representing thousands of patients, said a third round of documents should be available by late June as the parties continue haggling over confidentiality issues.

“Secrecy prevents the public from learning about dangerous products,” Blizzard said. “We want to make sure the public knows how AstraZeneca has conducted itself with respect to Seroquel.”

AstraZeneca has defended the safety of Seroquel, which had sales of $4.45 billion last year. Spokesman Tony Jewell said the company “has studied Seroquel extensively and shared all required data with the FDA, both before and after the agency approved it as safe and effective” in 1997.

Blizzard said there have been no settlement discussions regarding the claims, which number about 10,000, including those pending in state courts. Eli Lilly & Co., the maker of another leading antipsychotic, agreed last year to pay $1.2 billion to settle similar patient claims, and a $1.4 billion fine to resolve charges of illegal marketing.

Antipsychotics, approved by the FDA for severe mental illnesses that affect a small percentage of the population, have become megabrands because doctors prescribe them for everything from insomnia in the elderly to hyperactivity in adolescents. While doctors can prescribe off-label, it is illegal for drugmakers to market such uses.

But in a discussion about marketing Seroquel to primary care doctors, AstraZeneca’s consumer brand director jotted a note about “greasing the skids for dementia” and “turn(ing) on the DTC (direct-to-consumer ads) machine.” A third party was paid to make educational slides about off-label uses, “for obvious legal reasons,” according to another e-mail.

Chief executive David Brennan responded to an employee’s concern about sending Seroquel salespeople into child psychiatrists’ offices by saying they would focus on “the adult patients only.” Seroquel’s brand team deemed the 2005 meeting of the American Academy of Child and Adolescent psychiatrists an “excellent venue” for its data.

Jewell, the AstraZeneca spokesman, said the documents reflect no wrongdoing.

“These documents do not advocate the inappropriate promotion of Seroquel,” he said. He said the company consistently pursued research supporting new uses of the drug, including four for pediatrics and two for the elderly.

But the documents suggest Seroquel studies were repeatedly subordinated to commercial goals.

When a study in 2002 failed to show that Seroquel’s sustained release formula was any more effective than a placebo in treating schizophrenia, orders from the top were to keep the results “in strictest confidence.”

When a scientist in England wanted to study the weight gain in rats on Seroquel, AstraZeneca declined to fund the research, saying “we could wind up with results that are not clearly advantageous.”

In one discussion, it was suggested that authors of potentially helpful research reports who raised too many questions, slowing publication, should be asked to step down.

A researcher who pressed for results of an unfavorable trial was rebuffed for weeks before being given “three or four sentences describing high-level results.”

AstraZeneca marketers were jealous of what they saw as competitor Lilly’s ability to cast questionable study results in a positive light. “They (Lilly) are able to spin the same data in many different ways through an effective publications team,” according to a 2003 memo. “Negative data usually remains well hidden.”

As Seroquel’s sales soared, documents reflect an ongoing struggle between the safety and marketing teams over the potentially damaging issue of weight gain. In 2000, the company’s scientists said data did not support the marketing claim that Seroquel resulted in only “limited” weight gain. Close to 23 percent of the people who took the drug gained more than 7 percent.

Despite the safety team’s objections, the word “limited” remained on Seroquel’s label for two more years.