Healthy Skepticism Library item: 15675

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Publication type: news

Cronin FIisk M, Feeley J.
AstraZeneca Planned Off-Label Drug Sales in 2000 (Update6)
Bloomberg.com 2009 May 20
http://www.bloomberg.com/apps/news?pid=20601085&sid=akGbE1_8hvu0

Full text:

AstraZeneca Plc 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.

“We have plans that are strategy plans that are not accidental that were approved by people at higher levels of the company,” Ed Blizzard, a lawyer with Blizzard McCarthy & Nabers LLP, said during a conference call today. “It’s a clear plan to broaden the use both on and off label.”

The plan was among thousands of pages of files released on a Web site today by lawyers who are suing AstraZeneca over Seroquel, including Blizzard and Camp Bailey of Bailey Perrin Bailey. They 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 about a connection between diabetes and Seroquel use from doctors and users of the drug.

The Lawsuits

Seroquel, which generated sales of $4.45 billion last year, is AstraZeneca’s second-biggest seller after the ulcer treatment Nexium.

American depositary receipts of AstraZeneca, each representing one ordinary share, rose 82 cents, or 2 percent, to $41.12 in New York Stock Exchange composite trading. They have fallen 7.7 percent in the past year.

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.

Documents Released

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. Another batch of documents will be released by June 3, Blizzard said.

A chart of the documents that were unsealed was made available by the American Association for Justice, an advocacy group representing plaintiffs’ lawyers. Kerri 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.

‘DTC Machine’

“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 included in the documents. 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.

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.

Protecting Share

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 said 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.”

Weight Risks

AstraZeneca officials have denied claims that the drugmaker failed to warn Seroquel users about the risks of diabetes. The company has said that since its approval, Seroquel labeling has included risk warnings about weight gain and diabetes. Increased weight is considered to be a risk factor in Type II or adult- onset diabetes.

In a 2006 e-mail, the company’s medical science director for the drug, Martin Brecher, wrote to a patient safety director about the company’s position on glucose and lipids.

“I don’t know how you can spin that,” Brecher said in the e-mail providing in the released documents. “Hope team can settle on positioning glucose metabolism that will largely de- emphasize weight gain.”

A presentation called “Weight Change over 52 and 104 Weeks – Schizophrenia Monotherapy,” made in Sweden in May 2005 showed that almost 40 percent of long-term Seroquel users saw a 7 percent increase in weight after a year on the drug. Another 30 percent of users gained 10 percent in the same period.

Weight ‘Plateau’

AstraZeneca argued that the weight gain may “plateau” after 52 weeks and that the increase was greater for underweight and normal weight patients.

“There is no apparent dose response for weight gain,” the company said in the presentation.

AstraZeneca faces several lawsuits brought on behalf of state Medicaid programs, alleging the company withheld information about the risks of Seroquel and promoted the drug for off-label purposes. The states, which include South Carolina and Pennsylvania, are seeking reimbursement of funds spent on prescriptions and alleged injuries to patients.

Philadelphia Probe

The company has reported in regulatory filings that the U.S. attorney in Philadelphia is investigating its practices in marketing Seroquel. AstraZeneca received subpoenas in September 2006 from the state attorneys general of California and Alaska seeking information about Seroquel marketing practices, the company disclosed.

Drugmakers this year have paid billions of dollars to resolve litigation and government investigations over marketing of medicines for conditions not approved by the FDA.

Pfizer Inc., the world’s largest drug company, said Jan. 2 it would pay $2.3 billion to end a marketing probe over the painkiller Bextra and other drugs. Eli Lilly said Jan. 15 it would pay $1.42 billion to settle probes over the promotion of its antipsychotic medicine Zyprexa.

Thousands of pages of documents have been released in federal court in Orlando, Florida, this year over AstraZeneca’s internal studies on Seroquel. The company is set to face the first trial over the drug June 29 in state court in Delaware.

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