AstraZeneca To Pay $520M To Settle Seroquel Probe
14 CommentsBy Ed Silverman // April 26th, 2010 // 6:35 pm
The drugmaker has formally agreed to a settlement with US Department of Justice that calls for paying $520 million to resolve charges that it improperly marketed its widely used Seroquel antipsychotic for unapproved uses, The New York Times reports. The deal is expected to be announced in the morning UPDATE: Here is the DOJ statement and this is the settlement.
Although a corporate integrity agreement is part of the deal, there are no criminal charges. This is not surprising, though. A settlement was expected ever since AstraZeneca set aside the money last fall to resolve two federal investigations and two whistleblower lawsuits over off-label marketing (background). The move also followed huge fines paid by Pfizer and Eli Lilly last year.
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.
M Helm, MD
Off-label promotion continues to prove highly proifitable for manufacturers. Do the deed, establish new practice paradigms without bothering with establishing safety and effectiveness, reap the revenue, and a few years later, pay a small portion of the profits back to the feds. The cost of the fine is probably more than an investment in clinical trials would have been, but then again the trials might prove something you didn’t want to know. Clinical trials also slow down the process (and the increased revenue) by several years while the patent clock keeps ticking. Not to mention the greater certainty that some clinicians will prescribe off-label if they are given even the slightest “expert opinion” encouragement, whereas the results of clinical trials are 1) risky, and 2) not especially influential in changing presciber behavior. As long as there are Biederman types in the world, a manufacturer can come up with someone to shill for the unapproved use.
There is really no incentive for doing the right thing (nor effective disincentive to discourage bad corporate behavior) for the benefit of providers and patients.
Justice in MI
What is egregious about the Seroquel story, in my view, is not simply off-label promo, but the “burial” of studies showing risk data.
To both illicitly promote and camouflage risks is about as contemptible as it gets.
kim
Astra already made their billions- whats a 400 plus million dollar fine???
Jack Friday
JiM
You said it!
MsPiggy
This is paramount to someone committing a violent felony with malice, intent, and forethought; then getting off with a small fine, probation, and then having their record wiped clean while admitting no culpability for their crime. I believe most would find that completely unacceptable on the part of our judicial system and government.
Then when we have a huge corporation repeatedly and brazenly breaks the law, while injuring or even killing thousands. They get off with another CIA (that they ignored last time they signed one) pay a fine that has already been adsorbed into the price structure of their drug.
Yet some how the people are not completely outraged and protesting in the streets?
welcome to the beginning of the end.
Justice in UK
MsP you’re spot on!
Without sounding too patronising to the general public, people have been administered the opium of the masses (cheap junk TV, cheap junk food, poor education, low expectations) and their senses are dull to what really matters.
The cynical economics of the drug industry is pervasive.
Indeed, welcome to the beginning of the end.
Matthew Holford
Interesting… The thing is, without a criminal conviction, one may not state as a matter of fact that AZ is a bunch of scheming fraudsters, because one would lay oneself open to an actino in libel. So I won’t say that.
Only the Law may say what is fact - we do not have that right. I wonder if that’s why the people who run the legal systems of the world are declining to take these organizations to court, or whether it’s because they’re just following the path of least resistance. That is, provided one can announce a settlement, involving a relatively large sum of money, one may make it look as though one is doing one’s job, even though one has made no effort whatsoever to change the system, and thus the thing that one perceived to be wrong is allowed to proceed, unchecked.
We’ve had to penetrate the system deeply, in order to understand how it operates. Most people don’t need to do that, because they’ve not been impacted, or they can’t allow themselves to believe the extent of the deceit.
Hmmm. Let’s put this simply: the drugs don’t work, but everybody apart from affected patients are behaving as if they do. And they’re doing that because they have a vested interest in doing so - they cease to be important if they acknowledge that their product is shite. And because these people control the system that says they’re important, they’re unlikely to change anything…
Time to get out, I think.
Matt
patrons99
Agreed! MsP has nailed it.
“Welcome to the beginning of the end.”
In another recent pharmalot post, harpy made an interesting comment, or prophecy if you will:
“I think the end will actually be brought about by Monsanto. look what a great start they’ve made by almost taking out the honeybees!
or some unnatural collusion between the defense contractors, big pharma, and Monsanto will bring about the Zombie Apocalypse. mark my words…”
http://www.pharmalot.com/2010/04/fly-away-depressed-pilots-can-now-take-prozac/#comment-486985
Pharma is succeeding in “dumbing down the population”.
http://www.picassodreams.com/picasso_dreams/2009/04/mercury-fluoride-and-the-dumbing-down-of-the-population.html
http://www.experienceproject.com/question-answer/Did-You-Know-Flouride-Was-Used-In-Nazi-Concentration-Camps-And-Soviet-Gulags-To-Keep-The-Pop-Docile/40621
One thing is probably certain. The way that pharma has taken over nearly every aspect of our lives, and has gained control over governments, “we won’t go out the way of the dinosaurs”. Big Pharma are now government-endorsed untouchables.
Jack Ingram
The use of anti-psychotic drugs, is highly debatable at any point of time, and to that extent, the decision of AstraZeneca to pay $520Mn to the US Department of Justice is well received. This could at least warn the manufacturers of these drugs that they would need to heed to FDA norms. The fact that two other giants, Pfizer and Eli Lilly too had to contend with lawsuits meant that somewhere, a strong message had to be delivered. Hope this settlement brings about some more diligence on the part of the manufacturer of these drugs.
pharmavet
With 26K lawsuits pending, AZ will not be buried by the settlements but rather by the legal fees in defending itself. They will probably follow Pfizer in either moving legal work in house or negotiating lower billable hours for outside counsel. Of course, Pfizer is well positioned to do this because the CEO is a lawyer himself.
Derek
It is past time for the assessment of such swingeing fines for this kind of activity as will make it actually unprofitable to do it - how about several billion dollars? And how about CIAs under which senior executives become personally liable to huge fines (huge even considering their extravagant salaries) and/or a little time in the slammer the next time it happens? What we’ve got now is just a cost of doing business, and not even a big cost at that.
likeitis
Whistleblower James Wetta will be paid a $45m REWARD (Hat tip to Pharmagossip)
Nice work if you can get it……
likeitis
………continued
James Wetta certainly knows how to get it;
Shared in the $100M REWARD from the Lilly $1.2B blow-out too…….(Pharmagossip)
So when is the media gonna interview this fascinating guy (cannot be his real name, and must have undergone cosmetic surgery to protect his identity, so don’t expect videos/photos), and ask him to explain how he does it…..so I can cash in and retire too!
Dee
Where does the lawsuits go from here. My son died from taking this medicine for 7 years. His pancreas died and so did he. Age 37