AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?

(MoneyWatch)  An AstraZeneca executive in charge of clinical research on Seroquel had sexual affairs with a researcher and a study writer, plaintiffs in a Florida lawsuit claim. BNET first wrote about the sex-for-secrets aspect of the Seroquel litigation on Feb. 17. Now Furious Seasons blogger Philip Dawdy revealed a dynamite legal filing describing how Dr. Wayne MacFadden, AZ's former US medical director for Seroquel and director clincial research in CNS had affairs with a clinical researcher who authored publications favorable to Seroquel, and a medical marketer who promoted Seroquel through medical publications and other means.

The plaintiffs claim the affairs may have biased the science. AZ is seeking to exclude the evidence. AZ made this statement to FS:

"AstraZeneca had no knowledge of these relationships at the time," says Laura Woodin, an AstraZeneca spokeswoman in an email. Macfadden's relationships with the women ran from 2002 to 2006, according to court records. "Dr. MacFadden is no longer employed with the Company." Woodin added, "AstraZeneca has audited and stands behind the integrity of its Seroquel trial data."

You can download the filing for yourself here. But if you can't be bothered to read it, here's a digest:

MacFadden became involved in a sexual relationship with an (Institute of Psychiatry) researcher who, as well as being involved in other Seroquel-related projects, participated in the clinical research and abstract preparation relating to the effectiveness of Seroquel for use in the treatment of schizophrenia. Their affair lasted from 2002 to 2006.

Sometime during 2004, while collaborating with Parexel and while still involved in a sexual relationship with the IOP researcher, MacFadden became involved in a sexual relationship with the Parexel Program Manager responsible for AstraZeneca.

The nature of their communications suggest a level of control and dependence between Macfadden and these women.

The IOP researcher suggested that Macfadden would 'punish' her if she even looked at studies that were favorable to Seroquel's competitors. He actively encouraged her to conduct research the results of which would be favorable to Seroquel and AstraZeneca, and promised sexual favors in exchange for intelligence on Astrazeneca's competitiors.

In addition to his sexual involvement with the Parexel program manager, it appears he [Macfadden] also provided her with prescription painkillers.

Macfadden agreed that sexual relationships between clinical researchers and management members of pharmaceutical companies can create bias which can affect the integrity of the science. Macfadden also acknowledged that sexual relationships can affect a person's judgment. Although Macfadden denies that his multiple sexual relationships with these women created a conflict of interest, he in fact teased the IOP researcher about the obvious conflict of interest as he reviewed drafts of her papers on Seroquel."

Macfadden has admitted to additional sexual affairs with a clinical researcher assistant at AstraZeneca and a clinical researcher in California also involved in the Seroquel clinical trials.

• BNET's previous coverage of Lilly and Seroquel:
• Seroquel Trial: Allegations of Sex-for-Secrets; AZ Wants Papers Sealed
• FDA Asks AZ to Tighten Seroquel Label; 9,000 Lawsuits Start Trials Next Week
• The History of AstraZeneca's Mismarketing of Seroquel
• FDA: J&J's Risperdal and Lilly's Zyprexa Are Over-Used in Kids
• AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel