Healthy Skepticism Library item: 17284

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Publication type: news

Feeley J, Cronin Fisk M
AstraZeneca Tied Studies to Marketing, Witness Says (Update2)
Bloomberg.com 2010 Feb 23
http://www.bloomberg.com/apps/news?pid=20601202&sid=aOFC9Z7ZZXPs

Full text:

AstraZeneca Plc executives tied approval of funding for outside studies on the antipsychotic Seroquel to whether the reviews would help market the drug, a former researcher testified.

Dr. Jeffrey Goldstein, who helped develop Seroquel during his 32 years with the U.K.’s second-largest drugmaker, told jurors that AstraZeneca shifted the budget for financing studies of the drug to its sales department from its research and development unit in 1997. A New Jersey jury is hearing a Vietnam veteran’s claims that Seroquel helped cause his diabetes and the company hid the drug’s risk to pump up sales.

AstraZeneca executives would approve funding only for Seroquel studies that would “translate into marketing messages that will impact sales,” Goldstein said in videotaped testimony shown today in the trial of Ted Baker’s lawsuit.

Baker’s case is the first of about 26,000 claims that Seroquel can contribute to the development of diabetes to go to trial. The trial, in state court in New Brunswick, is expected to last more than three weeks.

Lawyers for ex-Seroquel users contend AstraZeneca mishandled Seroquel, ignoring or downplaying its links to diabetes and weight gain to protect sales. The drug, with sales of $4.9 billion last year, is the London-based company’s second- biggest seller after the ulcer treatment Nexium.

Disappointing Sales

AstraZeneca on Jan. 28 fell 4.6 percent, the most in more than 10 months, after fourth-quarter profit missed estimates and sales forecasts disappointed some analysts. The company plans to eliminate 11 percent of its workforce by the end of this year as part of a restructuring to cost $2 billion from now to 2013.

AstraZeneca’s lawyers told jurors yesterday that Seroquel doesn’t cause diabetes and that Baker’s disease stemmed from his lifestyle and diet. The company also contends it provided adequate warnings about the drug’s risks on the medicine’s label and marketed it appropriately.

AstraZeneca tested Seroquel in 50 percent more patients than are required by U.S. Food and Drug Administration regulators who approve drugs for sale, Diane Sullivan, one of the company’s lawyers, said in opening statements.

“Does that sound like a company that is rushing a medicine to market?” Sullivan asked. Baker’s lawyers are “cutting and pasting documents” together in hopes jurors will “see stuff that really isn’t there,” she added.

Research Funding

Goldstein, who retired from AstraZeneca in 2007, said he told a colleague from outside the company, who was inquiring about funding for a Seroquel study involving animals, that researchers no longer controlled the budget for such reviews.

“Research and development is no longer responsible for Seroquel research,” he wrote in the November 1997 e-mail. “It is now the responsibility of sales and marketing.”

Goldstein, who turned down the request to fund the animal study involving Seroquel, noted the organizational move of shifting the budget from researchers to sales executives didn’t mean the company downgraded the importance of drug safety.

“It doesn’t matter where the budget resides. It’s more important to look at the studies in a scientific and clinical fashion,” he said in the videotaped testimony. “It’s immaterial where the budget resides.”

He also said the shift came after Seroquel had been approved for sale by the U.S. Food and Drug Administration and that Seroquel went through “extensive pharmacological and toxicological testing” before being approved by regulators.

‘Muddy the Waters’

Baker’s lawyers noted that in another e-mail, Goldstein indicated he’d approve a study involving Seroquel if the author would agree not to publish the results if they “muddy the waters” about the drug.

Goldstein acknowledged he served as director of clinical science at AstraZeneca at one point during his tenure at the drugmaker and also was responsible for helping to disseminate information about Seroquel to U.S. physicians.

Baker, who served in the Navy in Vietnam, took the drug to deal with lingering symptoms of post-traumatic stress disorder and contends he wasn’t properly warned by the company about its risks.

The 61-year-old Baker sued AstraZeneca in July 2007 after taking the drug for three years. Judge Jessica Mayer, who is presiding over the trial, rejected AstraZeneca’s bid to have the Bastrop, Louisiana-based construction worker’s claims thrown out.

The case is Baker v. AstraZeneca Pharmaceuticals LP, MID L 1099 07 MT, Superior Court of New Jersey, Law Division, Middlesex County (New Brunswick).