AstraZeneca set a strategy of marketing its Seroquel antipsychotic drug for unapproved, or “off-label,” uses as early as 2000, according to documents unsealed as part of litigation over the medicine.
“Key Success Factors: Broaden Seroquel use on and off label,” AstraZeneca officials wrote in a December 2000 “Seroquel Strategy Summary” provided by a spokeswoman for the plaintiffs’ lawyers in the cases. Under required actions by the company, the plan called for sales managers to “utilise whole selling team. Educational programmes to share off label data,” according to the documents.
The plan is among thousands of pages of files lawyers suing AstraZeneca over Seroquel are set to release on a Web site today, according to Kerri Axelrod, a spokeswoman for the plaintiffs’ lawyers, who released some of the documents yesterday, along with a chart describing dozens more.
“These documents do not advocate the inappropriate promotion of Seroquel,” Tony Jewell, AstraZeneca’s spokesman, said in an e-mailed statement. He noted the company’s researchers have “invested significant resources” seeking to find new ways to have the drug help mentally-ill 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 users of the drug.
Seroquel, which generated sales of $4.45 billion last year, is the company’s second-biggest seller after the ulcer treatment Nexium.
The U.S. Food and Drug Administration first approved Seroquel in 1997 for use in treating symptoms of psychotic disorders and then granted AstraZeneca the right in 2001 to market it as a schizophrenia treatment. Its usage was expanded twice more during a two-year period starting in 2004 to treat bipolar disorders.
Many of the lawsuits contend AstraZeneca promoted the drug for unapproved uses. Some of the suits have been consolidated before a federal judge in Florida. The company has denied any wrongdoing.
The documents are being made public after London-based AstraZeneca agreed earlier this month to drop their confidential status in a deal with lawyers representing former Seroquel users, Jewell said.
A chart of the documents that were unsealed was made available by the Association for American Justice, an advocacy group representing plaintiffs’ lawyers. Axelrod, a spokeswoman for the group, said lawyers representing ex-Seroquel patients asked her organization to handle the public release of the documents.
The chart notes that AstraZeneca has unsealed documents that include marketing advice from the drug’s brand manager in 2002. The manager advised in handwritten notes to “grease the skids for dementia” and market the antipsychotic Seroquel for the elderly, according to the documents.
“Turn on the DTC machine,” referring to direct to consumer marketing, Consumer Brand Director Denise Campbell said in the 2002 notes, according to an e-mail exchange produced for lawsuits over the drug, Axelrod said. The drug hasn’t been approved for dementia treatment.
Under U.S. law, doctors may prescribe drugs approved by the FDA for any ailment they believe the medicine can treat. Drugmakers may only promote their products for approved illnesses and not for so-called “off-label” uses.
‘Available to Them’
Off-label prescriptions are common because “doctors make use of the medicines they have available to them in order to provide treatment they believe is best for their patients,” Jewell said in a statement.
“The company has sought to generate long-term revenue growth by pursuing the investigation of new indications, formulations and comparative data to provide important clinical information to prescribers,” he added.
A 2001 public-relations plan for Seroquel said the company should focus on achieving “aggressive market penetration” among adolescents, the elderly and patients with bipolar disorder to protect the drug’s market share against rival antipsychotics such as Eli Lilly & Co.’s Zyprexa or Johnson & Johnson’s Risperdal.
AstraZeneca’s effort to market Seroquel for unapproved uses continued in 2003 when it prepared a paper to highlight the drug’s performance in clinical tests on bipolar patients, according to the documents.
One of the paper’s objectives was to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” officials noted in the unsealed documents.
AstraZeneca executives also indicated in the papers that they were aware that issues involving off-label marketing and information were sensitive.
Officials of AstraZeneca’s U.S. unit, based in Wilmington, Delaware, noted in a May 2004 e-mail that slides prepared in connection with a study involving off-label use of Seroquel were “financed outside of commercial for obvious legal reasons.”
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