Are Antidepressants Faith-Based Treatment?

While millions of people swear by Prozac, Zoloft, and other antidepressants, do they work any better than a placebo or no treatment at all?

Answering that question would be much easier if: (1) the U.S. Food and Drug Administration (FDA) revealed all drug study findings without requiring a Freedom of Information Act request, (2) drug studies with negative results were routinely published in medical journals, (3) the FDA did not rely on drug company studies employing biased research designs, (4) FDA advisory panels did not include advisers financially connected to drug companies and (5) the National Institute of Mental Health (NIMH) did not fund drug studies by researchers who have financial relationships with drug companies.

The good news? There are antidepressant researchers without ties to drug companies, and there is wisdom about overcoming depression that remains available.

On Jan. 17, 2008, the New England Journal of Medicine analyzed both published and unpublished antidepressant studies registered with the FDA between 1987-2004. Examining 12 antidepressants, Dr. Erick H. Turner, a former FDA medical reviewer, and his research team included data gained via the Freedom of Information Act.

Dr. Turner discovered that most studies with negative results were never published in journals, and so doctors had no way of knowing how poorly antidepressants have actually fared. While 94 percent of antidepressant studies published in journals show antidepressants to be more effective than placebos, only 51 percent of all registered studies were determined by the FDA to show antidepressants superior to placebos.

Why are most negative results not published in journals? Drug studies are routinely funded by the drug's manufacturer, which has no interest in the publication of negative results. Also, medical journals are increasingly dependent on advertising revenue from drug companies, which results in a disincentive to publish negative results.

Antidepressant advocates point out that when comparing all research subjects, antidepressants retain an advantage -- albeit a modest one -- over placebos. However, that belief is based on studies funded by drug companies, utilizing research designs biased in favor of antidepressants.

One such research-design bias is the use of depression measurements that weigh heavily depression symptoms most likely to improve with antidepressants (such as sleep problems and agitation), and weigh less heavily depression symptoms not as likely to improve with antidepressants (such as suicidal thoughts and joylessness).

Why does the FDA allow measurement bias and other dice loading that favors antidepressants? Marcia Angell, former editor in chief of the New England Journal of Medicine, concludes that the FDA has been compromised by drug companies. Dr. Angell reports that, for example, in the majority of FDA drug-approval advisory meetings through 2000, half or more of the FDA advisers had conflicts of interest -- financial relationships with drug companies.

A critical scientific standard in drug studies is the double-blind control (neither subject nor experimenter knows who is getting the drug and who is getting the placebo), but drug-company antidepressant studies use blinds that can be peeked through. How? Inactive placebos such as sugar pills, which don't create side effects, are used, and so subjects can more easily guess if they are getting the actual drug. In order to make it more difficult to penetrate the blind, an active placebo, which creates side effects, should be used. In 2000, a Psychiatric Times article concluded: "In fact, when antidepressants are compared with active placebos, there appear to be no differences in clinical effectiveness."

In addition to biased depression measurements and an absence of a true double blind control, the FDA also accepts antidepressant research in which subjects who respond favorably to placebos are weeded out from final trials.