In the case of SSRI use by pregnant women, the WJS said, the industry-paid opinion leaders have become dominant authorities in the field and stated:
"They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed."
According to the WSJ, as soon as their study was published, Dr Cohen and some the other authors went out on the lecture circuit, telling doctors about their findings and pointing out flaws in the studies that found an increased risks of birth defects with infants exposed to SSRIs.
For instance, the panel of experts who criticized the Chambers study during the May 17, 2006, continuing medical education lecture, "Psychotropic Drug Use During Pregnancy," sponsored by the Massachusetts General Hospital Psychiatry Academy, was comprised entirely of psychiatrists with financial ties to drug companies.
During the lecture, the panelists were also critical of the FDA for adding new warnings about birth defects to Paxil's label. On December 8, 2005, the FDA issued a Public Health Advisory after US and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy to be associated with an increased risk of heart birth defects.
With the warning, the agency for the first time placed an SSRI in the D category, its second highest for the risk of birth defects. Category D means that either controlled or observational studies of pregnant women "have demonstrated a risk to the fetus."
The agency did not ban Paxil from use with by pregnant women, but it did go so far as to say, "FDA is advising patients that this drug should usually not be taken during pregnancy."
At the May 17 conference, panelist, Zachary Stowe, from the women's mental health center at Emory University, described the FDA's decision to change the label as "driven by a single set of data that is unpublished, non-peer reviewed, and somehow this trumps the very nicely done prospective investigations that have really failed to find this risk."
However, here once again, according to the WSJ, Dr Stowe has served as an paid adviser and speaker for several SSRI makers.
In July 2006, corresponding with the WSJ's expose about the undisclosed financial relationships of the Cohen study authors with SSRI makers, JAMA published a correction to announce that 7 of the authors of the February 2006, study had failed to reveal their financial ties with drug companies.
Critics of Big Pharma's influence over studies published in medical journals were quick to respond to the disclosure. On July 11, 2006, Merrill Goozner, director of the Center for Science in the Public Interest, issued a statement saying: "It's clear that the Journal of the American Medical Association does not evaluate conflict of interest disclosures when articles are submitted."
"As a result," Mr Goozner said, "some authors with blatant conflicts of interest apparently feel they can ignore the journal's policy with impunity."
"The only solution," he added, "is for journals to adopt strong penalties for authors who fail to disclose – a three-year ban from publishing in the pages in the journal."
A month later in August 2006, another study in the Archives of General Psychiatry, by Canadian researchers at the University of British Columbia, found babies born to women who took SSRIs during pregnancy to be at an increased risk of having respiratory distress and low birth weight.
Lead investigator, Dr Tim Oberlander, told Reuters Health on August 25, 2006, that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."
The researcher reviewed health records for almost 120,000 live births between 1998 and 2001 and determined that 14% of the mothers were diagnosed with depression. They then compared the outcomes of infants born to women treated with SSRIs to those born to depressed women who were not treated with SSRIs and found a significantly higher incidence of respiratory distress in infants exposed to SSRIs by a ratio of 13.9% to 7.8%.
Must Read (
Well Said (
News (
Touching (
Funny (
Supported (
Interesting (
Inspiring (
Valuable (
