Antidepressants During Pregnancy: The Drug Companies Tip the Scale
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The Risk/Benefit Analysis   
Mothers and their treating physicians must do a risk-vs.-benefit assessment in deciding whether to continue taking antidepressants during pregnancy based on the existing data. In order to perform this risk/benefit analysis, physicians and their patients need to know the true risks and benefits.

Unfortunately, drug companies have been loath to divulge negative information about their drugs and the FDA has failed miserably at its job in monitoring drug safety. To complicate matters, details of clinical trials have been concealed due to their negative outcomes, and published studies have been distorted due to drug company influence. See, e.g., ADepressing research,@ The Lancet, April 24, 2004, 363(9418):1335; S. Okie, "What ails the FDA?@, N. Engl. J. Med., March 17, 2005, 352(11):1063-6.

Physicians cannot simply rely on research funded by the pharmaceutical industry to educate them on risks and benefits. It has been found that studies showing a drug works effectively are three times more likely to be published than those showing they do not work or do more harm than good. Studies that do make it to publication often are ghost-written by drug companies, with names of "opinion leaders" who have not seen the raw data inserted as authors. As a result, many doctors have unwittingly relied on flawed or incomplete data provided by the drug industry, through either marketing material or medical literature influenced by the industry.

The pharmaceutical companies have not only downplayed the side effects of their antidepressants, they have also exaggerated the benefits. In an analysis of efficacy data submitted to the FDA for six of the most popular SSRIs between 1987 and 1999, 75 to 80 percent of the response to medication was duplicated in placebo groups. Kirsch and Moore, "The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration,"5 Prevention & Treatment, Article 23, July 15, 2002. The authors of that study wrote that the "small difference between the drug response and the placebo response has been a 'dirty little secret' known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data." Kirsch, Moore et al., "Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions," 5 Prevention & Treatment, Article 33, posted July 15, 2002.

According to an internal FDA memorandum by Dr. Paul Leber, formerly of the FDA: "Approval [of the antidepressant] may Y come under attack by constituencies that do not believe the agency is as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products." An article in the British Medical Journal confirmed these concerns, concluding that "selective serotonin reuptake inhibitors have no clinically meaningful advantage over placebo"; "[c]laims that antidepressants are more effective in more severe conditions have little evidence to support them"; and "[m]ethodological artefacts may account for the small degree of superiority shown over placebo." J. Moncrieff, "Efficacy of antidepressants in adults," British Med. J., July 16, 2005 (7509):155-7.

In our opinion, women have a right to be informed of the risks and benefits revealed by the data.  For pregnant women, the risk/benefit analysis comes down to this: the baby is at least three times as likely to have a life-threatening congenital heart defect, is at least six times as likely to have PPHN and has a 20 to 30 percent chance of being born with breathing complications -- not to mention SSRI withdrawal syndrome. The benefit is the "mental well-being" that comes from taking a drug that has been shown to have little more effect than a placebo.

It is difficult to fathom the mentality of drug companies that would place profits over the health of newborn children. Physicians need to put on their critical thinking caps and mothers need to be more discerning in accepting the advice of physicians influenced by drug company hype. The lives of their children are at stake.

By Baum Hedlund
Original version of the article first published on, February, 2007

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