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Glaxo Birth Defect Litigation Reveals Paxil Promoters on Speed Dial

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Yet, in a 2003 supplement titled, "Special Issues Related to the Treatment of Depression in Women," for the Journal of Clinical Psychiatry, Yonkers published an article derived from the teleconference, "Treating Depression: New Choices for a Chronic Problem," supported by an unrestricted educational grant from Glaxo, which promoted the use of SSRIs by women from youth to old age.

In the conclusion section, Yonkers wrote, "SRIs (SSRIs) appear to be an efficacious treatment for women suffering from various depressive disorders throughout the life cycle. These agents have expanded treatment options for many women, especially women who experience intermittent symptoms such as with PMDD, and side effects of SRIs are typically less severe than those of TCAs."

"SRIs appear to improve depressive symptoms in pregnant women and women suffering from postpartum depression, and they are a relatively safe option for breastfeeding mothers," she said. "Additionally, their effectiveness appears to be enhanced by estrogen, making them a favorable treatment option for older women suffering from postmenopausal depression."

In 2004, Yonkers, Cohen, and authors that included two Glaxo employees, published a paper in, "Psychosomatic Medicine," on a study titled, "Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo Controlled Trial."

In the November 1, 2006 issue of "Journal of Women's Health," Yonkers, Cohen and others, published a paper titled, "Expert Guidelines for the Treatment of Severe PMS, PMDD, and Comorbidities: The Role of SSRIs."

This work was supported by an educational grant-in-aid from Glaxo, the disclosure advised. "Several treatment modalities are beneficial in PMDD and severe PMS, but the selective serotonin reuptake inhibitors (SSRIs) have emerged as first-line therapy," the abstract states.

"A burgeoning body of literature has emerged that supports the role of the SSRIs as first-line treatment of PMDD and severe PMS," the authors wrote in the discussion section.

Back in December 2005, Yonkers was out doing damage control for Glaxo when the FDA changed the Paxil pregnancy category from C to D, and warned that, "studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus," and said the FDA "has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations."

On December 14, 2005, the Washington Post wrote, Kim Yonkers "cautioned that the database studies that the FDA had used had limitations: Unlike controlled studies, Paxil may have been prescribed far more than other drugs, skewing the results."

She also claimed the databases sometimes concealed unrelated medical problems that could alter outcomes, the Post reported.

"Depression is still undertreated," Yonkers said. "Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened."

Yonkers' September, 2009 report noted that in 2003, approximately 13% of pregnant women took an antidepressant sometime during their pregnancy. There are over 4 million babies born each year in the US, according to the CDC, which means about 520,000 pregnant women took antidepressants in 2003, and that would only cover live births. There is no telling how many infants may have died before birth, as a result of their mother's use of SSRIs.

In 2006, Yonkers became president of the North American Society for Psychosocial Obstetrics and Gynecology, after Diana Dell turned the job down. The April 2006 Spring Newsletter discussed this group's annual meeting, held in Hawaii no less. "The symposia at our 33rd Annual Meeting were fabulous, and we all appreciated the luxurious hotel and beautiful Big Island's many charms," the newsletter stated.

"Kim Yonkers' unending drive, and with significant assistance from Meir Steiner and Claudio Soars culminated in our Sponsors contributing generously towards the symposia," it said. The sponsors listed included the drug companies Berlex, Sepracor, and Wyeth.

Although the judge ruled that Healy could not elaborate on the Nemeroff and Stowe saga, during cross-examination, Varner opened the door a crack by directly asking Healy about the reputations of the various doctors shown to be on Glaxo's payroll.

"The last question I have about the documents that you reviewed with Mr. Tracey yesterday goes to the portion of your testimony when you and Mr. Tracey talked about various doctors who had received honoraria from GSK for various speaking engagements," she said.

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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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