Sex and Money Created Drug "Safety" Studies

Correction: In a previous version of this article Dr. Michelle O'Donovan was wrongly identified as the Parexel employee (whose name is unknown) with whom Wayne MacFadden, the former US Medical Director for AstraZeneca's drug Seroquel, testified to having an affair in the multi-district litigation, In re Seroquel. Dr. Michelle O'Donovan is not the Parexel employee in question and we regret the error.

Sex and Money Created Drug "Safety" Studies--Court Documents

by Martha Rosenberg

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When the US satirical newspaper the Onion writes, "Ann Coulter not a hate monger says Ann Coulter," people laugh. But when pharma uses the same logic--its scientific studies get published and its drugs get approved and prescribed.

In February, New York-based Forest Laboratories was the latest pharma company to be outed for perpetrating tautological science.

Forest "illegally marketed two related antidepressant drugs, Celexa and Lexapro, for off-label use in pediatric patients," says a complaint filed in US District Court in Boston. It promoted results of a positive Celexa pediatric study conducted at the University of Texas while burying a damning study by Danish company H. Lundbeck that was so riddled with suicidal side effects the FDA rejected Celexa for pediatric use in 2002 on the basis of it.

And that's not all. Forest paid Dr. Jeffrey Bostic, director of school psychiatry at Massachusetts General Hospital, $750,000 over seven years to give 350 presentations promoting pediatric use of Celexa and Lexapro, despite the buried study and FDA rejection, say court filings.

In Florida, London-based AstraZeneca is suffering a similar tsunami over unsavory science pertaining to its atypical antipsychotic Seroquel.

Documents unsealed in US District Court for the Middle District of Florida in Orlando in February charge its US Medical Director for Seroquel, Dr. Wayne MacFadden, who authored the two studies upon which Seroquel got bipolar disorder FDA approval, was, if not on the take, on the make.

As Director of Clinical Research in the CNS Therapeutic Area, MacFadden contracted clinical research of Seroquel and its competitors at third party locations including the Institute of Psychiatry (IOP) in London, a school of King's College London, where he became, well, overly involved in his work, says a plaintiff document in Bailey v. AstraZeneca Pharmaceuticals.

The IOP researcher with whom MacFadden had an affair from 2002 to 2006 was simultaneously publishing research papers about Seroquel's effectiveness which were presented at medical conferences and sent to US doctors upon request. No conflict there!

And it gets worse.

MacFadden also hired a medical communications firm, Parexel, based in Waltham, MA to ghostwrite manuscripts about Seroquel for medical journals and create scientific slides, posters and fliers for medical conferences and association meetings.

Not only were ghostwriters the source of the BOLDER 1 and II studies on which Seroquel's bipolar FDA approval was based--think about that tax payers and drug takers--MacFadden was having a second affair with a Parexel ghostwriter, say plaintiff filings.

In court obtained communications, MacFadden teases both women about the COIs (conflicts of interest)--though not about his COI which we don't know if the women knew about--and promises sexual gratitude to the IOP researcher if she turns up intelligence on Seroquel competitors. (see: scientific inquiry as foreplay.)

He provided his Parexel paramour, who was in charge of Seroquel Global Publications Business with prescription painkillers say documents--maybe she did find out about her rival.

Though MacFadden exited AstraZeneca when the sordid rondo surfaced the on-the-make science stands…as do the drugs it helped approve and prescribe.

Which is not to say AstraZeneca rejected on-the-take science.

Court documents reveal AstraZeneca paid Chicago psychiatrist Dr. Michael J. Reinstein $40,000 a year for ten years to chat up Seroquel to other doctors and promoted his "study" that showed Seroquel caused weight loss not weight gain--you heard right--despite its diabetes and weight gain dangers which were known by the company since 2000.

To keep internal records like February's damaging court documents sealed, companies like Forest and AstraZeneca usually say they are "proprietary" and could help the competition. No kidding.

Martha Rosenberg is a columnist/cartoon who writes about public health.

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