Healthy Skepticism Library item: 16603

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Publication type: news

O’Reilly C, Cronin Fisk M, Feeley J
AstraZeneca Promoted Seroquel as ‘Weight Neutral’ (Update1)
Bloomberg.com 2009 Oct 7
http://www.bloomberg.com/apps/news?pid=20601102&sid=a7jcYzKvq284

Full text:

AstraZeneca Plc advised its sales force to promote the antipsychotic drug Seroquel as “weight neutral” four years after company research found “clinically significant” weight gains in users, internal documents show.

AstraZeneca’s “global strategy is to demonstrate to consumers that Seroquel has a weight-neutral profile,” Debbie Holdsworth, a marketing official, wrote in a “dear colleague” letter dated May 14, 2001. The document was produced during a pretrial examination of former executive John Patterson.

“If 45 percent of patients gained significant weight in a year, how could that be weight-neutral?” patient attorney Ed Blizzard asked Patterson, citing a internal 1997 e-mail written by an AstraZeneca doctor, at a hearing in Orlando Oct. 5.

“If you look at the population as a whole, some are below weight, some are average weight and some are above weight, so that taken together, the effect of Seroquel is weight neutral,” Patterson said. Some underweight patients may even be helped in gaining weight by using the drug, he said.

Patterson, who reported directly to AstraZeneca’s chief executive officer, was paid more than $1 million at one point during his tenure at the company. He retired April 1 as executive director of product development, and is the highest- ranking AstraZeneca executive to testify in open court in lawsuits claiming the company withheld information about the risks of Seroquel.

The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes, high blood sugar and other health issues.

15,000 Patients

More than 15,000 patients have sued AstraZeneca, claiming the company withheld information of a connection between diabetes and Seroquel use from doctors and patients. Many of the lawsuits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder in 1997, for unapproved uses.

Patterson was asked about a “Seroquel Strategy Summary” issued in December 2000, which described the broadening of Seroquel use “on and off label” as a sales goal. While doctors are free to prescribe any medicine to treat a given condition, it is illegal for drug companies to promote medicines for uses not approved by the U.S. Food and Drug Administration.

“The company has standards and procedures to ensure its sales representatives do not promote off label,” Patterson testified. Still, the goal of off-label promotion remained in strategy summaries for the years 2001 or 2002, he acknowledged. Patterson estimated that 30 percent to 40 percent of Seroquel U.S. sales were off label from 2000-2004, though he didn’t dispute Blizzard’s assertion that the figure could be higher.

$4.45 Billion in Sales

Seroquel, which generated sales of $4.45 billion in 2008, is the company’s second-biggest seller after the ulcer treatment Nexium. AstraZeneca has denied wrongdoing in its handling of the drug and is vowing to fight the lawsuits in court.

Company spokesman Tony Jewell said Seroquel’s labeling has always contained information to alert doctors about its affects on patient weight. He said the strategy summaries highlight AstraZeneca’s efforts to seek approval for new indications for a medicine are not intended to encourage off-label promotion.

“We’ve constantly updated the label as the science developed,” Jewell said in an interview. “AstraZeneca has continued to study Seroquel in the years after it went on the market. In fact, the FDA has approved Seroquel as safe and effective for new indications on several occasions over the past 10 years.”

AstraZeneca fell 23 pence to 2,760 pence in London trading. The shares are little changed this year.

The case is In Re Seroquel Products Litigation, 06-MD- 01769, U.S. District Court, Middle District of Florida (Orlando).