The Cost of Doing Business: Same Song, 83rd Verse

And today, the drug company settling with the Federal government on criminal charges against off label marketing is:
AstraZeneca
The drug involved is: Seroquel (quetiapine)
The amount of the settlement is: $520M
The settlement equals what percentage of one year's sales of the drug?: 10.6%
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage: http://www.nytimes.com/2010/04/28/business/28drug.html?emc=tnt&tntemail0=y

As you can see, it saves time if I just make it a fill-in-the-blank form.

First, general background: Seroquel is one of the supposedly new-generation antipsychotics that was initially touted as both more effective and safer than the older antipsychotics of the thorazine-haloperidol era. More recent research has disputed the claims of both greater efficacy and greater safety, and calls into question the entire concept of "generations" of these drugs--see for instance http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html. We are sadly not surprised to learn that at every step of the way, the drug companies sponsoring the research, and their physician lackeys, have worked their tails off to distort the research record and to make these sows' ears look like silk purses. In the process they have especially pushed the drugs (due to their supposed safety profile) for use in the elderly, despite the fact that the drugs can cause serious weight gain and tip susceptible patients over into frank diabetes. Because psychiatrists see too few patients to create a really blockbuster market, and expert psychiatrists might actually know something about the downside of these drugs, much of the marketing focus has been on my colleagues in primary care--again relying on the supposed safety profile of the drugs to encourage non-psychiatrists to feel comnfortable prescribing them.

The Feds charge that AZ paid kickbacks to docs as part of a scheme to market the drug for unapproved uses, especially in kids and the elderly. The specific Fed claims include:

• AZ inapproprately influenced the content of CME courses they funded
• AZ hired docs to give talks and do research on unapproved uses
• AZ recruited medical "opinion leaders" to be the fake authors of ghostwritten articles touting Seroquel for unapproved uses, and AZ then used those articles for marketing
• AZ paid docs to come to fancy resorts to "advise" AZ on how best to market Seroquel for unapproved uses

All of this is in violation of Federal anti-kickback statutes.

Based on some of the buzz on the Healthy Skepticism listserv, it appears that this story will not go away quickly. The Feds appear ready to out the academic and other physicians who took those kickbacks.

Being held to public ridicule for taking drug company money to shill for them, illegally, may produce a small incentive among academic physicians at least to watch out for these sorts of entanglements with Pharma in the future. As we have seen many times before, the amount of the settlement, by itself, is hardly a factor, since the company gets about 9 times that much in revenues for every year the drug remains on the market. You can add to that the $656M that AZ has reportedly spent so far to defend itself against about 25,000 civil lawsuits over Seroquel. (If the Vioxx/Merck example is any indication, AZ stands ready to win the vast majority of those suits, given the near-impossibility of proving in a court of law that any individual patient developed diabetes or any other complication solely due to Seroquel and not due to any other co-existing conditions.)

As we have said before, so long as the "cost of doing business" is so reasonable, we can expect drug companies to push the legal envelope regularly, and like Pfizer, swear never to do such dastardly deeds again at the same time as they are planning the next set of dastardly deeds with a newer drug (see http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).