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Zachary Stowe Doesn’t Get to Claim “Paroxetine Undetectable in Amniotic Fluid” for GSK

June 11, 2009

Go to this PDF and scroll to the last page (28) to read this email from Emory psychiatrist Zachary Stowe to GSK (http://www.box.net/shared/cl96iq53eb). Here’s a relevant excerpt:

Hi ____

DAMN IT – just wanted to let you know the amniotic fluid results are now complete for about 20 subjects (4 on paroxetine <2, <2, <2, 3 ng/ml) certainly lower than the others but lost my title of paroxetine undetectable in amniotic fluid. She was taking 60 mg/day+other medications. This is still the least. I will have the manuscript to you for review right after I finish grant stuff.

Zachary “DAMN IT” Stowe loses his title of “paroxetine undetectable in amniotic fluid.” That’s right, he was writing a manuscript called “paroxetine undetectable in amniotic fluid.” He had the title all picked out before even doing the research. And from the looks of this there were potentially other women tested prior to this batch of 20, who had amniotic fluid with higher concentrations of some kind of psychotropic drug.

And, in case you missed it, GSK reviews his scientific papers before he publishes them. Oh, and he’s getting FEDERAL grants to study antidepressants in pregnant women. MOTHERS Act, anyone?

Earlier on in the letter, Grassley refers to a disturbing memo regarding a Paxil and Breast Milk press release. According to this blog, it went something like this:

Meanwhile, Stowe outlined some dealings with Glaxo in a deposition last year taken as part of a lawsuit claiming that Paxil isn’t safe for pregnant women. Stowe was questioned in detail about a 2000 email from an outside public-relations firm to a marketing executive at Glaxo about a planned press release for a new study. The study, conducted by Stowe, found Paxil is safe for breast-feeding mothers. The PR firm’s email to Glaxo reads:

Please review the attached press release and forward me any comments/edits. As you may know, Dr. Stowe is on board for publicity efforts and Sherri and I are coordinating time to meet with him next week to arm him with key messages for this announcement, which is slated for early February. We are sending the release for his review at the same time in efforts to secure distribution on Emory letterhead (as you know, would provide further credibility to data for the media).

In the deposition, Stowe said the quotes in the press release were his own. “They wrote it, we said it,” Stowe said of the involvement of the public-relations agency. As for the assertion by the PR official that Stowe was being provided with “key messages,” the psychiatrist called that “just typical public relations crap” and he said in the deposition he never received help from the PR officials.

I found numerous reports in the MedWatch tables of an Adverse Event that included Drug Exposure Via Breast Milk for Paxil. These included sedation and “hypersomnia.” The SIDS report in the tables for Paxil was “Drug Exposure Via Pregnancy” and “Drug Exposure Via Breast Milk.”

FDA MedWatch Reports show the following infant deaths from SSRIs alone:

Class Drug Name Cases ISRs Abortions & Miscarriages Deaths Deaths Neonatal Intra-Uterine Deaths Stillbirths Sudden Infant Death Syndrome Total
SSRIs Celexa (citalopram) 204 315 41 1 3 9 2 1 57
  Cipralex, Lexapro (escitalopram) 174 300 36 1 1 6 1 2 47
  Luvox (fluvoxamine) 16 25 5 1         6
  Paxil, Seroxat (paroxetine) 2,516 4,140 104 39 4 15 11 1 174
  Prozac (fluoxetine) 358 435 45 4 2   1   52
  Zoloft (sertraline) 410 537 57 2 7 7 15   87
SSRI Totals 3,678 5,752 288 48 16 37 30 4 423
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