Seroquel Documents: Allegations AZ Planned Off-Label Marketing To Kids, Elderly, Tried Obscuring Weight Gain, Hyperglycemia

Another batch of Seroquel documents is being released this morning by plaintiffs attorneys for people suing AstraZeneca over allegations involving its atypical antipsychotic. I'll get them myself this morning and get online what makes sense as soon as I can.

Meanwhile, the Wall Street Journal and AP got a sneak peek yesterday and picked off different pieces of the documents. The WSJ reports that:

"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.

"Tony Jewell, a spokesman for AstraZeneca, denied that the company sought to encourage off-label uses of the drug. 'These documents do not advocate the inappropriate promotion of Seroquel,' he said. Instead, they 'show the company was seeking to explore additional indications for Seroquel and included that in clinical-development plans designed to support efforts to investigate potential additional indications,' he added.

"In an AstraZeneca public-relations plan dated 2001, one company objective was defined as to 'encourage and support' Seroquel's 'use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly.' The document 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."

Why does this begin to sound even more like the Zyrprexa documents all over again?

I think what the paper is quoting speaks for itself. If AZ plans to spin this kind of evidence in court as "We were just hypothesizing," then good luck to them with a jury. There is good evidence that the company encouraged off-label uses of Seroquel, including the FDA busting the company last year for off-label marketing of the drug for depression. Based upon the evidence which the agency made public, it's fair to say that there was plenty of encouraging going on. And I know of other off-label marketing of Seroquel which the company should hope I cannot continue to get on the record.

Meanwhile, the AP reports that AZ wrestled intenrally with how to cast weight gain and blood sugar increases associated with use of the drug:

"In a chain of e-mails in one document, a scientists' safety evaluation committee in June 2000 recommended removing 'limited' before the words 'weight gain' in the list of Seroquel side effects, because many patients gained significant weight.

"Marketing staff suggested trying other explanations, such as whether patients took other drugs that could be blamed. One marketing executive, Medical Affairs Manager Richard Owen, then wrote that such a change 'is potentially damaging to Seroquel.'

"The change in the drug's label was finally made in 2002. That was after Barry Arnold, the vice president for clinical drug safety, complained repeatedly to the physician in charge of Seroquel drug safety about 'Commercial (executives) having such an influence.'

"Yet soon after the label change, AstraZeneca trademarked the term 'weight-neutral' as an advertising slogan for Seroquel, Blizzard noted. He said data showed about one-quarter of patients taking Seroquel increased their weight by more than 7 percent.

"Later in 2002, Simon Hagger, global brand manager for Seroquel, e-mailed nearly 20 marketing staffers to say 'we are under clear instruction from the highest level within AstraZeneca at this time not to discuss details surrounding trial 41,' outside the company. That patient study, concluded that year, found elevated levels of blood sugar."

More later today.