BNET Focus on Antidepressants: Part 2, Controversies

While the antidepressant market is both robust and lucrative, as we saw in part 1 of this three-part series, it is also controversial. No drug category is so dogged by doubts and questions, and yet so widely prescribed, as antidepressants.

The most recent major event in the antidepressant news cycle was the FDA’s decision to publish a list of drugs associated with concerns that they may, in some patients, cause suicide. Top of the list? As the AP put it, “all antidepressants.” Drug companies are now required to specifically study suicidal thoughts in test subjects prior to getting new antidepressants approved.

The category would be less fraught if it were not for two factors. First, drug companies have put enormous resources behind their promotion of these drugs — meaning that they have a huge pile of money at stake, regardless of the drugs’ effectiveness. And second, beyond the fact that antidepressants affect serotonin levels, scientists don’t really know exactly why they work the way they do. Antidepressants thus attract criticism because of the industry’s size and reach, and its unexpected twists and turns.

An example is NPR and its psychology show, The Infinite Mind, which aired a segment on the suicide issue earlier this year. It should have been a routine broadcast about an interesting side-issue in mental health. But the show is partially funded by Eli Lilly, maker of Prozac and Cymbalta. Chemical Imbalance’s Jonathan Leo wrote, “Much of the important information presented on this show was problematic. … The overriding theme of the show was to challenge the FDA’s recent black box warning of a potential link between the antidepressants and suicide.” (Lilly responds to this in the comments section, below.)

The debate is magnified by the fact that clinical studies of the drugs have been called into question. One recent meta-study found that many antidepressant studies overstate the drugs’ effectiveness. Another concluded that placebos have a long-lasting effect on depression. The studies potentially call into question whether antidepressants work because they work or because patients believe they are working.

The Senate Finance Committee is investigating scientists who study the drugs but fail to disclose payments they have taken from drug manufacturers. And Lilly was recently caught submitting the same study to two different medical journals — which some regard as a sleight-of-hand rather than a contribution to the literature of science. (Lilly responds to this in the comments section, below.)

Over the next few years look for the debate to intensify around the issue of whether antidepressants should be given to children. The FDA recently warned pregnant women not take Paxil. Antidepressants have been banned for kids in the U.K. Simply diagnosing depression in children is controversial and yet, in the U.S., more and more kids are being put on medicines that were initially introduced and tested on adults.

The New York Times Magazine did an attention-getting piece on bipolar children recently. If you want a gauge of the depth of passion surrounding this issue, scroll down from this brief post on Furious Seasons and check out the comments section.

• BNET Focus on Antidepressants
• Part 1: Sales and Strategy
• Part 2: Controversies
• Part 3: The Future of the Industry