Seroquel, preemption, prosecution, sex - Is the tide turning?

I'm having difficulty even reading, much less posting about, the river of stories about pharma and device industries, FDA regs, conflicts of interest, and so on. But I'll take a stab here at spotlighting the main events and making some sense of where this is headed. For I don't think it's just coincidence that brings in a few days an archetypal pharma scandal, an unexpected and emphatic Supreme court reversal, an underwear check administered to the entire faculty of the Harvard Medical School, and the decision to "make an example" of surgeons who took kickbacks for using medical devices.

The latest pharma scandal is the spill of documents from lawsuits about Astra-Zeneca's alleged cover-up of unflattering data about its antipsychotic Seroquel, and the company's alleged subsequent off-lable marketing of that drug as well. These documents, including many eyebrow-raising emails, appear to reveal not just the burying of unflattering drug-trial data (in this case, about obesity and diabetes risk) but also allegations of sex between the company's U.S. medical director and with an AstraZeneca researcher and (separately -- you can ask for only so much) a ghostwriter whose job it was to help write up the research. Did you read that right? You did.

Even the bare unadorned more mundane allegations startle. Bloomberg News outlines the core allegations made in lawsuits in Florida, Delaware, and about 8,998 other venues -- representing many thousands of patients -- that have knocked over the beanjar:

The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in "cherry picking" of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

"The larger issue is how we face the outside world when they begin to criticize us for suppressing data," John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.

More than 15,000 patients have sued AstraZeneca, claiming the company withheld information of a connection between diabetes and Seroquel use from doctors and patients. Many of the lawsuits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses. "

Philip Dawdy has been covering the Seroquel vigorously, and has published the entire set of released documents so that others can pore over them. Bloomberg is also covering it closely, as is Jim Edwards, the Times, Danny Carlat, and Clinical Psychology and Psychiatry, among others.

Meanwhile, another suit, against Forest Labs, alleges similar off-label marketing of antidepressants Lexapro and Celexa, in this case to children. Even people duly impressed with the industry's better products and practices, as I am, can't help but be shocked, even if not longer surprised, at this sort of thing.

It is getting old? Or is it getting bigger?

Dawdy noted somewhere in his many posts that this Seroquel case is getting much broader and more prominent play, both in the blogosphere and the MSM, than did Zyprexa case of early 2007, in which he felt more alone. (As I noted elsewhere, Dawdy and the Times formed a strange tag-team on the Zyprexa case.) I haven't done a Lexis search, but it strikes me too that this coverage is much heavier, broader, and less cautious.. More people are attuned; the several preceding similar scandals have made it clear this is a big and pervasive trend; and the coverage has much the feel of the stories of excesses at banks and brokerage houses.

It seems to me that, whether from those elements or from the change in administration, something has turned here. There's a sense that these things can perhaps be rolled back. The pattern is clear; public and patients are alarmed and up in arms; and psychiatry, anyway, as a discipline is more widely alarmed and concerned, as suggested by a commentary [pdf] in the March issue of the American Journal of Psychiatry about conflicts of interest. People are realizing this stuff is prevalent, far too common, and needs to change -- and change seems more possible than before. Suddenly both the usual suspects and some not so expected are pushing back. Charles Grassley, who scares bloodless researchers and doctors in far too many research centers, is now going after not just individual researchers but the entire Harvard Medical School. The Supreme Court today made it easier for states to sue device and drug makers, reversing earlier trends. And the feds may soon turn from busting device and drugs makers to busting docs. From the Times yesterday:

Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.


For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.

"What we need to do is make examples of a couple of doctors so that their colleagues see that this isn't worth it," said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. "We want to send the message to the physician community -- particularly surgeons -- that you can't do this."

The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.

This is going to shake some people up.

Are we seeing a reversal here, where cherry-picking of data, off-label marketing, ghostwriting, huge payments to researchers and docs, and ghostwriting will be curbed and become unthinkable instead of depressingly, destructively common? Everything above argues for this possibility, as does an administration dedicated to evidence-based decision-making, transparency, and to health-care reform that depends heavily on reducing health-care costs by using more open and abundant data to discourage unneeded and ineffective treatments.

A key question is how the medical profession will react. My own conversations with doctors and researchers suggest there's tremendous concern about the harm done by the sort of hanky-panky catalogued above. But the official associations have been slow to turn dramatically. I suppose that's to be expected. But at some point leadership needs to recognize the need for a re-reckoning, This will strike some as an unwelcome downgrade -- a move from first to business or business to coach. Drug and device-maker money have made the lives of many a doc and researcher far more comfortable than the lives of colleagues who have Just Said No. And we all naturally resist giving up something that has brought comfort, pleasure, or status; even once you realize you need to give it up, there's that lag between recognition and surrender.

But in a time when the entire medical system is under pressure to make substantial changes to make health care more widely available, leaner, more efficient, and more effective, a sustained or stiff hesitance to embrace that sort of change may prove costly to a profession that is already badly tarnished. I'm immensely interested in how this plays out.


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Great piece, Dave. Did you see the Rolling Stone article on Zyprexa? Same ole bury-the-evidence, push off-label marketing sad story. Glad the Supreme Court made the move.

By Cynthia Dobbs (not verified) on 04 Mar 2009 #permalink