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Ghostbusting in Paxil Birth Defect Litigation

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"He influenced an awful lot of heads of departments, professors of psychiatry, general people within the field of academic mental health, and through them and an awful lot of prescribing doctors here in the U.S. And, indeed, perhaps worldwide," Healy testified.

A link to "Articles" on the Emory website in mid-2009, brought up roughly 90 studies and papers that include the co-author Nemeroff.

Healy said he believed Nemeroff was one of the founding members of the Paxil advisory board and he participated in continuing medical education seminars with talks on Paxil.

Nemeroff would have been "the key person in producing the kinds of talks with slides that would have been held for large audiences of doctors, and then those slides and talks would have been distributed out to different doctors in the field who hadn't been at the major meetings as he gave his talk," Healy told the jury.

During his testimony, Tracey showed Healy a document from a continuing medical education seminar titled, "Fertility, Mood and Motherhood," and Healy said the material for the seminar was prepared by Glaxo for Nemeroff. It was again supported by unrestricted educational grant from Glaxo and Nemeroff "was reimbursed for his role in this," Healy pointed out.

Healy was also not allowed to testify about Nemeroff's fall from grace at Emory, how much he was paid by Glaxo, or his failure to disclose over a million dollars from drug companies.

Dr Bernard Carroll, a past chairman of the department of psychiatry at Duke University Medical Center, summarized the Nemeroff saga well on the Healthcare Renewal website on November 3, 2008, in writing: "The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory's chair of psychiatry while an internal investigation proceeds."

During her cross examination of Healy, Glaxo's lead attorney, Chilton Varner, presented an exhibit showing a continuing medical education presentation given by Nemeroff.

"Can you see that in this continuing medical education program Doctor Nemeroff says that paroxetine, sertraline, fluvoxamine, (are) not associated with increased risk of teratogenicity or other complications?" she asked Healy.

"Yes, I do," he replied.

In small print, the disclosure for the presentation showed Nemeroff had received research grants and participated in the speakers bureau and consulted for Glaxo, Eli Lilly, Solvay and Pfizer.

During re-direct, Tracey asked Healy to tell the jury what the actual results of the study that Nemeroff was discussing in the presentation showed, and specifically when Paxil was looked at alone. The results "showed that there was a 1.8-fold increase in the odds ratio of a birth defects to the women who have been taking Paxil during pregnancy," Healy testified.

"Overall, for this group of drugs there was an increase in risk," he said, "but specifically for Paxil the risk was greatly increased."

"And beyond that," Healy stated, "what isn't included here in the conclusions, overall there was a -- on this group of drugs, there was a doubling of the rate of miscarriages on the drug compared with the rate of miscarriage for the women who are being compared who weren't on the drug."

"There was also an increased rate of women going on to voluntarily abortions on the drug," he added.

One of the lead authors on the study was Gideon Koren. "Doctor, without giving any details," Tracey asked Healy, "do you know whether Doctor Koren has ties to the pharmaceutical industry?"

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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.

The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.

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