AstraZeneca launched a public relations push to get doctors to prescribe its best-selling psychiatric drug Seroquel for a string of uses that were not approved by safety regulators, according to a damning internal document released yesterday.
The UK's second biggest drug maker is being sued by 16,000 patients in the US for "spinning, skewing and concealing" information on the drug's potential side-effects, including diabetes and weight gain, and lawyers unearthed emails and strategy documents showing what they say are repeated violations of the law.
The company was forced on to the defensive yesterday after more than 230 internal documents were made public, supporting a legal assault that wil cost it hundreds of millions of dollars if successful.
In particular, the material shows that AstraZeneca worked hard in the early years of this decade to turn Seroquel into a blockbuster drug with sales far beyond its originally approved market as a treatment for adult schizophrenia. It would be several more years before clinical trials showed it was safe and effective in a broader range of illnesses, including bipolar disorder, yet the company quickly made a substantial part of its revenues from doctors prescribing the drug for uses not officially sanctioned.
Regulators such as the Food and Drug Administration in the US carefully set out what claims can be made for every drug, and control the exact wording of the drug's label. Companies promoting products for unapproved uses face large fines.
A public relations strategy document emailed around the company in February 2001 by a brand manager, Alison Wilkie, said that "2001 communications will focus on increasing the existing off-label usage of Seroquel in [bipolar disorder], estimated to account for around 20 per cent of current prescriptions and growing strongly."
The documents also show that David Brennan, then head of AstraZeneca's US business and now chief executive of the company, was alerted by an employee that salesmen were targeting doctors who specialised in treating children, despite the fact that Seroquel has never been approved for use by minors.
A spokesman for AstraZeneca said that anti-psychotic drugs have always been widely prescribed by doctors for uses beyond the official label, and regulators are well aware that they are. "In that robust off-label environment, we sought to expand the approved indications for Seroquel," he said. "These documents do not advocate the inappropriate promotion of Seroquel."
Before the employee raised the issue to Mr. Brennan, AstraZeneca, as part of its ongoing compliance efforts, had made extensive efforts to monitor and align its sales calls with physicians who were prescribing Seroquel on label.
Other documents show AstraZeneca keeping a close eye on the legal line between promoting clinical studies of Seroquel in disorders for which it is not yet approved and outright marketing of the drug for off-label use by the commercial department. One 2004 email said that slides prepared in connection with a study involving off-label use of Seroquel were "financed outside of Commercial for obvious legal reasons". On another document, the minutes of a meeting about doctors' attitudes to anti-psychotic drugs, a brand manager had scrawled that the sales force could "grease the skids" for Seroquel's use as a treatment for dementia.
Ed Blizzard, attorney for 6,000 Seroquel patients suing AstraZeneca, said: "These strategy plans are not accidental. They are approved by people at the highest levels of the company. This is not just a few people, this is the strategy of the company." Mr Blizzard is leading the legal effort to win compensation for patients who claim that Seroquel caused their diabetes or medical complications due to their weight gain.
AstraZeneca has had two cases dismissed due to lack of evidence, but the first trial is expected in June. The company says there is no scientific evidence Seroquel causes diabetes and it is committed to a strong defence effort, taking each individual case on its merits.