Many bad things have been reported lately about Astra Zeneca’s efforts to bury negative data about Seroquel. This revolting story of data manipulation, deceit, and academics selling their opinions to the highest bidder is being covered widely. See these excellent stories in the Washington Post, the Minneapolis St. Paul Star Tribune, The St. Paul Pioneer Press, as well as incisive blogging at Clin Psych and BNET.
These days, we hear so much about drug companies behaving badly that “accusation fatigue” sets in. We’re tempted to throw up our hands and say, “All the drug companies do this, what else is new?”
Resist the temptation. Yes, Eli Lilly's behavior was wretched, and it recently pled guilty to off-label marketing of Zyprexa for treating agitation in dementia.
But AstraZeneca has truly grabbed the brass ring of subterfuge. The Seroquel documents are revealing a company-wide pattern of blatant deceit and manipulation that is astonishing, and should make any psychiatrist think twice before believing anything Astra Zeneca has to say about Seroquel, either in the past, the present, or the future.
I'll contribute to the discussion by adding yet another data point to the mix. Here is an AstraZeneca-supported CME article which appeared as a supplement to Current Psychiatry. The title is “Issues associated with the use of atypical antipsychotic medications,” and it is dated December 2008. The identified authors are Henry A. Nasrallah, Donald W. Black, Joseph F. Goldberg,
David J. Muzina, Stephen F. Pariser, but presumably the text was written by ghost-writers at Dowden media.
Ultimately, you can most accurately think of the author as being AstraZeneca itself.
The article begins by trying to distract attention from the metabolic side effects of Seroquel by blaming the patients rather than the drug:
While the incidence of both obesity and diabetes is soaring among the general population, these conditions are more prevalent in patients with schizophrenia, even those who have no history of antipsychotic drug use.7 Prevalence rates for both diabetes and obesity are approximately 1.5 to 2 times higher in people with schizophrenia and other affective disorders than in the general population.4… Thus, it is difficult to predict which patients will be affected and the precise role drug treatment might play in this process.
The argument here is that these patients get fat because there are schizophrenic, not because they use Seroquel or similar obesity-promoting drugs.
Of course, AZ is forced to reference the well-known official statement co-published by the American Diabetic Association and the American Psychiatric Association which implicated Seroquel and other atypicals as causing weight gain and diabetes:
The ADA/APA statement ranked clozapine and olanzapine as being associated with the greatest risk of weight gain, diabetes, and dyslipidemia.4 Risperidone and quetiapine were put into an intermediate risk category for weight gain, while aripiprazole and ziprasidone were, at the time, too new to categorize. More recent data have shown ziprasidone and aripiprazole to be relatively weight-neutral.8
But check out how they go on to back-track, creating an alternative reality in which people are supposedly questioning this data:
However, the consensus statement must be interpreted with caution. Criticism has been leveled at the report from many corners, including the Division of Neuropharmacological Drug Products of the FDA, which argued that insufficient data were available to appropriately “rank” obesity/diabetes risks for the atypical antipsychotic agents.18
The criticism they are referring to was a one page letter from the FDA, but it had nothing to do with weight gain. The letter cautioned that actual data connecting the atypicals to diabetes was minimal, and that more studies needed to be done to better characterize the relative ranking of each drug in terms of the potential to cause diabetes. But the FDA officials were clear that some drugs cause more weight gain than others: “The ADA correctly points out that SGAs have different weight gain liabilities.” Obesity, of course, is one of the main risk factors for diabetes—so you do the math.
Finally, the authors return to their main theme—insulting schizophrenics:
Other authors pointed out that efficacy considerations of these drugs are a critical and overlooked component of the discussion and that the data used to compare the agents did not adequately control for key lifestyle factors such as overreliance on “junk food.”19,20
That’s right—the problem isn’t Seroquel; the problem is that crazy people are junk food junkies!
Here is my modest proposal. Because of these documents, Astra Zeneca’s credibility is officially out the window. They should not be allowed to be involved in any medical education event. They should be banned from hiring promotional speakers and from supporting CME. AstraZeneca has lied to the medical community once too often.