Seroquel Documents: AstraZeneca Exec Admits "Fuck-Ups" In Seroquel Study, Published Article

Many of you remember that in February I broke the story that Wayne Macfadden, a psychiatrist and StraZeneca's US medical officer on Seroquel and the head of CNS research at AZ, had a string of sexual affairs with women intimately involved in outside academic research of the drug as well as with writing up medical studies of the drug that were the basis for its approval for bipolar depression in 2006. My earlier reporting was based upon a filing in the case. Now, the full set of Macfadden's sexy emails with a researcher at the Institute of Psychiatry in London, England and with a ghostwriter at Paraxel MMS in the US have been released.

I'm making them public because they show how deeply conflicted the relationships between Macfadden and these women were and because the editors of the American Journal of Psychiatry and the Journal of Clinical Psychopharmacology refused to take seriously my earlier queries about whether they had any concerns about any of the data in papers published in their journals where the Macfadden affairs were involved. The FDA also blew off my query on the matter.

While the emails are mostly pedestrian (although I enjoyed reading about Macfadden's three beers and bratty kids at a Phillies game) and sometimes sexual in nature, there are some significant issues that arise from them beyond the conflicts of interest.

In an email, which is undated, Macfadden states:

"There was a crisis here about our data (again!). Turns out the effect size on the MADRS in bipolar depression was calculated wrong, and needs to be changed in the manuscript that's in press at the Am J Psych...this is especially bad, as it's the 3rd time that statistic changed since study end, and the old effect size has been on numerous posters and abstracts...too long to get into, but it's mostly worked out now......will be meeting with [NAME REDACTED, presumably an academic researcher who worked on the Seroquel for bipolar depression paper] at the APA on Saturday, trying to convince him we are not the fuck-ups we appear to be...this, along with telling him his forensic study that we agreed to fund--well, we've changed our minds and will no longer be funding it.....won't blame him if he's furious with us.....I hope alcohol will soften the blow!"

Three times they changed the effect size! Nice. I really admire and trust how research is done in the US and the AJP's integrity and attention to detail in sorting this all out!

Seriously, my hunch is the email is to the woman at Paraxel MMS and that it is from early 2005, as a Macfadden co-authored paper on Seroquel in bipolar depression (BOLDER I) appeared in the AJP in July 2005. The AJP should undertake a careful review of this paper as should the FDA with the underlying data, because BOLDER I was one of the two studies the FDA used to approve the drug for bipolar depression in 2006. The editors of the JCP might also want to take a look-see at the BOLDER II study of Seroquel for bipolar depression which it published in December 2006 just to make sure everything is on the up-and-up.

Some wonderful nonsense pops in this May 6, 2002 email between Macfadden and the British researcher:

"was assigned to be part of a 'Bipolar SWAT' team, to learn of the competitions' strategies...very cloak and dagger stuff--I wonder if I'll have a 'License to Kill.'"

Since Macfadden was heavily involved in getting Seroquel out into the world, I'd say he must've had a license to kill...or perhaps a license to ill.

The other emails mostly cover routine business matters and of course Macfadden's relations with the women.

Macfadden 58.

Macfadden 59.

Macfadden 63.

Macfadden 64.

Macfadden 65.

Macfadden 66.

Macfadden 68.

Macfadden 70.

Macfadden 74.

Macfadden 75.

Macfadden 76.

Macfadden 77.

The numbers refer to the documents' court records numbers. Happy reading.

Posted by Philip Dawdy at May 20, 2009 01:17 PM
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