AstraZeneca Pays $520M To Settle Seroquel Probes
11 CommentsBy Ed Silverman // October 30th, 2009 // 7:11 am
This was predictable. After Lilly and, more recently, Pfizer settled long-running investigations into off-label marketing practices of their various drugs - notably, antipsychotics - it was expected that AstraZeneca would follow suit. And so AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistleblower lawsuits over its Seroquel antipsychotic.
Antipsychotics, you may recall, have become extremely controversial in recent years as the pills were more widely prescribed for young children and the elderly for indications not approved by the FDA (see this). In some nursing homes, for instance, seniors are experiencing tremors and a higher risk of harmful falls or even death while on the meds, which are known to cause weight gain and diabetes.
The investigation, which was underway at the same time that AstraZeneca has been battling numerous lawsuits over allegedly undisclosed Seroquel side effects, was led by the US Department of Justice’s Philadelphia office. Interestingly, the investigators reviewed not only Seroquel sales and marketing practices, but some physicians who participated in Seroquel clinical trials.
Separately, at least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes. In other words, AstraZeneca may have to dole out more money for its practices.
An AstraZeneca spokesman says the drugmaker “is committed to strong, effective compliance programs, both in the U.S. and globally, to embed a culture of ethics and integrity in all our business practices. It has been and remains a key goal.”
pharmagossip
http://pharmagossip.blogspot.com/2009/10/astrazeneca-seorquel-lets-not-forget.html
Have decided to personalise the story - just in time for Halloween!
BP Watch
Pittance when compared with what they made by off-lable promotion! Also, we shouldn’t forget about all the metabolic problems patients developed as well as all of the elderly and kids that took this drug needlessly. What about personal fines for all the marketeers involved as well as some criminal cases and jail time? Never, says Big Pharma.
Realist
The last paragraph is BS. Companies like AZ don’t seem to know what compliance is and certainly don’t have a culture of “ethics and integrity.”
larry fields
NAMI and Astra. like another person said in another post. LOVE
Anonymous
It’s just the cost of doing business for Big Pharma. Corrupt, greedy management unsatisfied with the money to be made from an actual FDA indication. Sad.
Anon
The quote at the end is striking. I don’t believe AZ has less of a “culture of ethics” than other companies. Relative to the Seroquel competitors–J&J and Lilly–it is probably a more ethical company overall.
Thus the impact of reading about its internal documents mentioned in another thread in which burying studies, etc., is discussed directly. Perhaps things are getting better. But if AZ has gone ethically south, it suggests how much change is needed.
Has it begun? I’d love to believe it has.
Doc
Another day another dollar. To exactly quote one director I know in big pharma, “These fines are just the cost of doing business”.
Said with no shame, remorse or concern about patient well being.
I’d like to think that he was an outlier, but I don’t think so.
Justice in Michigan
I guess this makes Astra/Seroquel #4 all-time fine leader, after Pfizer, Lilly, Warner-Lamber/Pfizer. Or would the TAP/Lupron bust, somewhat different, beat out Neurontin and Seroquel.
follow-on
Tap/Lupron was an $875 M fine, but did not involve off-label, “just” pure Medicare/Medicaid fraud.
Been There
Morals and ethics are checked at the door every day for Big Pharma executives. Most are absolutely shameless and will never change unless there are real penalties. Sins against the public are rampant in the industry!
anon been in industry long time
Talk about ignorance. You all would love to believe that the industry prides itself on how badly business is conducted, and how little concern we have for pts. WRONG, the drug industry is more highly regulated, and monitored, internally and externally than ever; and more than any other business in this country. I spend more time telling prescribers where not to use my product and what is not an approved use; and passing out prescribing information which rarely is read, and usually is trashed. In fact, most pts would benefit much more if prescribing information was followed more closely by prescribers, esp in this therapeutic area.
Better be more worried about the politicians and bankers, as they are picking our pockets and we aren’t even aware, as we head over the edge towards pure socialism. And soon, the IRS will take on a new role of tracking down people who don’t buy health insurance. Wake up people !!