Seroquel Documents: Company Ordered Sales Reps To Lie

From this morning's Wall Street Journal:

" ORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representatives to tell doctors that its powerful psychiatric drug, Seroquel, didn't cause diabetes even though a company physician had at one point stated years earlier that such a link was probable in some individuals, documents unsealed in a federal court case here show.

"The documents -- ranging from unpublished study results to previously undisclosed depositions -- are among more than 100 the U.K. drug maker agreed to unseal Thursday in lawsuits brought by plaintiffs who allege they were harmed by the multibillion-dollar antipsychotic drug. Many of the cases have been consolidated ..."

The rest of the story is behind the subscriber firewall, so until someone passes it along to me or another paper covers those documents, that's all I've got for you. This document is out in the public realm because in federal court yesterday AZ agreed to release over 100 documents in the case, but fought to keep some others under seal.

So it sure looks like AstraZeneca took a page out of the Lilly playbook and had its sales force lie about Seroquel's propensity to cause diabetes.

I'm sure there's much more to come.

Well, someone passed it on to me:

"In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a 'weight and diabetes sell sheet' they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug.

"'Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile,' Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to 'refocus the call' away from diabetes to the drug's tolerability, the transcript shows.

"The voicemail to the sales representatives raises questions about whether there was a contradiction between Ms. Ney's instructions and an AstraZeneca drug-safety expert's own assessment of Seroquel's link to diabetes years earlier. In a 2000 position paper about the safety of Seroquel sent to Dutch regulatory authorities, an AstraZeneca doctor named Wayne Geller wrote that there was a relationship between the drug and diabetes.

"'There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes melliutus in certain individuals,' Dr. Geller wrote."

Reportedly, Geller retracted his statement in a deposition last year.

"Among the unsealed documents, another set goes back to the late 1990s and raises further questions about whether AstraZeneca kept a lid on unflattering Seroquel studies.

"A document dated Feb. 12, 1997, describes internal company deliberations over how to report 'Study 15,' a study comparing Seroquel to Haldol, an older-generation psychiatric drug. In the document, an AstraZeneca employee named Richard Lawrence writes to his team that one of his colleagues had done a great 'smoke and mirrors job,' which 'should minimise (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.'

"It isn't clear what Mr. Lawrence's comments were referring to. He couldn't be reached late Thursday, and AstraZeneca declined to discuss the emails. Ed Blizzard, an attorney with the Houston law firm Blizzard, McCarthy & Nabers, who is one of the lawyers for the plaintiffs, says the document refers to the fact that 'the weight gain data was bad, and that's why we believe the study was buried.'

"In a series of emails in 1999, AstraZeneca executives discuss withholding the results of another Seroquel study, known as COSTAR. That study compared Seroquel to Risperdal, another antipsychotic drug made by Johnson & Johnson.

"On Dec. 6, 1999, an AstraZeneca employee named John Tumas, the publications manager for Seroquel, wrote to his colleagues, 'There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried' certain studies. Referring to COSTAR, he added: 'We must find a way to diminish the negative findings. But in my opinion we cannot hide them.'"

"Mr. Tumas couldn't be reached late Thursday. AstraZeneca's Mr. Jewell declined to comment about the 1990s emails and documents other than to note that the FDA 'vetted and substantiated the safety data for Seroquel,' including the data from both Study 15 and COSTAR. 'The FDA has approved the medicine as a safe and effective treatment for schizophrenia and bipolar disorder,' he says."

Speaking of Seroquel and weight gain data, I hear through the rumor mill that the reason for the much-delayed FDA decision on approving the company's applications to have the drug approved for depression and/or anxiety is because the clinical trials showed loads of weight gain in patients.