Drug giant Astra Zeneca has agreed to pay over half a billion dollars to settle allegations that it illegally promoted a powerful anti-psychotic drug as a treatment for medical conditions it was never approved for.
The company will pay the US federal government $300 million and state public health programmes and the District of Columbia $220 million. However, as Astra Zeneca makes clear in its statement, under the terms of the agreement the company continues to deny the allegations.
According to the US government, the company illegally marketed the drug Seroquel as a treatment for Alzheimer’s, anger management, depression and sleeplessness when it has only an approval for schizophrenia, bipolar depression and bipolar disorder in the country. By this marketing the company caused false claims for payment to be made to government health programmes such as Medicaid, it says.
The company also violated ‘anti-kickback’ laws in paying doctors recruited to put their names on articles written about off-label uses of Seroquel, according to the government.
“These were not victimless crimes – illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General Eric Holder in a statement.
According to Holder this is the largest amount ever paid to settle an off-label marketing allegation that doesn’t involve criminal charges. The agreement was reached in principle last year.
Astra Zeneca’s 2009 annual report says sales of Seroquel were “up 12% to $4,866 million”.
Whistleblower James Wetta, whose 2004 lawsuit kick started the government investigation, stands to become a millionaire by pocketing a proportion of the settlement money. Intriguingly, according to Dow Jones Newswires, “Before he worked for AstraZeneca, Wetta, a resident of California, was a sales rep for Eli Lilly & Co, and he assisted a separate government probe of Lilly’s marketing practices that was settled last year when Lilly paid more than $1.4 billion and pleaded guilty to a criminal charge, according to court documents.”
The Wall Street Journal says, “It’s a fair bet his photo is now hanging in pharma H.R. offices everywhere. … It might be tough for James Wetta to get his next pharma job – then again, now that he’s a millionaire, he probably doesn’t need it.”
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