Friday, February 27, 2009
Back to the 'Quel. First off, a big-time round of applause for Philip Dawdy at Furious Seasons. He's been covering the unfolding Seroquel mess like a hawk, which is exactly what he did during the days of the Zyprexa documents scandal, which is still costing the admittedly criminal corporation of Lilly billions. According to legal documents, Wayne Macfadden, former U.S. Medical Director for Seroquel, admits to being engaged in sexual relationships with a British researcher at the Institute of Psychiatry (IOP) who participated in Seroquel research. Incredibly, Macfadden was also apparently entangled in a sexual relationship with a ghostwriter who wrote up results of Seroquel studies. The attorneys who are suing AstraZeneca claim that: "The IOP researcher suggested that Macfadden would punish her if she even looked at studies that were favorable to Seroquel's competitors." Better yet, Macfadden was alleged to have "promised sexual favors in exchange for intelliegence on AstraZeneca's competitors." It would seem a relevant conflict of interest to note that one was engaged in sexual relations with the Seroquel Medical Director, wouldn't it? I don't typically care about people's sex lives and am in favor of respecting people's privacy. Except when it is potentially related to poor science and/or poor care of patients.
So that's a little weird. And then... according to the Wall Street Journal, internal documents from AstraZeneca suggest that AZ hid concerns that the drug caused diabetes. Gee, that sounds like a page from the Zyprexa playbook. AZ sales reps were instructed to inform physicians that there was no causal link between Seroquel and diabetes. However, according to the WSJ, "In a 2000 position paper about the safety of Seroquel sent to Dutch regulatory authorities, an AstraZeneca doctor named Wayne Geller wrote that there was a relationship between the drug and diabetes. 'There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes melliutus in certain individuals,' Dr. Geller wrote." Expect a few more stories to appear in the mainstream press followed by AZ doling out decent chunks of change to settle lawsuits. This may kill Seroquel's chances of FDA approval for depression, generalized anxiety disorder, and the common cold (OK, I made that one up). Let's hope the documents make their way to the internet so that bloggers such as myself and Philip Dawdy can dig through and go into more depth than the mainstream press. Just like we did with Zyprexa (1, 2, 3).
Can we call this the Sex-o-quel scandal or is that too cheesy?
By the way, Furious Seasons is currently running a fundraiser. I will be making my donation today, and you should do the same if you are in favor of mental health journalism that breaks important stories and is bold enough to cover a wide variety of important issues, regardless of their level of controversy.
Friday, February 13, 2009
Looks like Schatz is out. I have noted previously that Schatzberg was deeply involved with a duplicate publication that pimped Cymbalta. Schatzberg's close involvement with Corcept, maker of mifepristone (Corlux), has also raised eyebrows. Mifepristone has been an utter failure in clinical trials, but the manufacturer has attempted to spin the data in ways that should be obvious to anyone with a smidgen of critical thinking skills. Charles Grassley has hit Schatzberg as part of the investigation into the tangled web of conflicted interests involving psychiatrists and drugmakers. There is also some evidence that Schatz was involved in the launch of Zyprexa for bipolar disorder.
Under the direction of the Chairman and Chief Alan F. Schatzberg, M.D., the Stanford University Department of Psychiatry and Behavioral Sciences, a center for the advancement of psychiatric practice, research and education, has three goals:
- To advance the understanding of the etiologies of psychiatric or sleep disorders and to lay the foundation for new treatment development.
- To develop innovative treatments and to deliver comprehensive services on a continuum of care to patients in a high quality efficient and compassionate manner.
- To train medical students, residents and clinical and research fellows in the science and practice of psychiatry and sleep medicine.
Schatz is apparently out as department chair. I wonder who will take his place...
Thanks to an alert reader for the tip.