July 24, 2007 at 07:35:38

CDC Downplays Birth Defects of SSRIs to Boost Sales

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By Evelyn Pringle (about the author) Page 4 of 5 page(s)

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Since 1990, JAMA has required authors of studies to list all financial interests and has published the disclosures. In an online editorial in July 2006, JAMA editor, Dr Catherine DeAngelis announced her intention to enforce the policy in part by publicizing any author's failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard Medical School and included Dr Cohen's study.

On July 11, 2006, citing material promoting the events, the Wall Street Journal reported that the Massachusetts General psychiatry academy planned to conduct Continuing Medical Education seminars in a dozen cities across the US, with Dr Cohen overseeing a segment on the treatment of pregnant women with psychiatric disorders.

One of the funding sources for the seminars was revealed less than a year later on May 1, 2007, when the Journal reported the major recipients of the $11.8 million that Eli Lilly gave out during the first three months of 2007, and said the largest single grant "was $825,000 to Massachusetts General Hospital's psychiatry department for a year-long educational program with more than 150,000 registrants."

It should be noted that Lilly introduced the first SSRI, Prozac, in the late 1980s and its current best-selling antidepressant Cymbalta earned the company $1.3 billion in 2006.

The financial ties between the researchers and SSRI makers was brought to the attention of the JAMA editor by Dr Adam Urato and a letter from Dr Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

However, all that being said, the Cohen study is still being cited to promote the use of SSRIs with pregnant women, and as recently as April 26, 2007, in a paper by Dr Claudio Soares, director of Women's Health Concerns Clinic, McMaster University, Ontario in Journal Watch Women's Health, a publication put out by the NEJM.

"Results of a recent prospective study of pregnant women," he wrote, "who were taking antidepressants at or near the time of conception demonstrated that women who opted to discontinue treatment during pregnancy were five times more likely to relapse than were those who stayed on treatment."

"Despite the cautionary remarks commonly made by most regulatory agencies and medical societies about the use of psychotropic medications during pregnancy," Dr Soares states, "considerable data supporting the efficacy and reproductive safety of antidepressants have accrued."

"Conversely," he warns, "evidence suggests that untreated depression has negative consequences for both mother and child."

"In summary," Dr Soares states, "clinicians should bear in mind the mounting evidence about the adverse effects of uncontrolled depression during pregnancy."

But here too, Dr Urato, wrote a response to this obvious sales pitch objecting to the total lack of citations to studies that support the assertion that the risks of birth defects associated with SSRI are rare and that the benefits of SSRIs use to avoid relapse into depression outweigh the risks.

But most concerning, Dr Urato wrote, "is the complete lack of financial disclosure information to go along with the article."

"As I was reading this piece," he wrote, "I kept thinking to myself "'Boy, this sounds like it was written by someone working for the antidepressant makers.'"

And sure enough, Dr Urato found that Dr Soares is on the Speaker's Bureau for Forest Labs, Wyeth, Glaxo, and Pfizer and has received honoraria as a research consultant for Sepracor, Glaxo, Wyeth, and Neurocrine.

Mr Kwok is also highly critical of the increasingly common practice of using "opinion leaders" like Dr Soares to sell SSRIs to pregnant women, but states, "there will come a time when the drug manufacturers will have to face the music on SSRIs causing PPHN, and that time is coming soon."

He says his firm has an abundance of new cases that prove it's no coincidence that pregnant mothers on SSRIs have an increased likelihood of giving birth to babies with PPHN in families where there is no history of respiratory illness.

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