Sometimes one really must wonder at the FDA’s decision-making process for allowing drugs to be approved. The antidepressant market is one of the largest in the world at the moment, with SSRI and SNRI antidepressants accounting for billions of dollars in sales each year. The makers of Paxil set aside more than $2 billion dollars this year simply for handling the drug’s legal defenses. However, there is increasing evidence that antidepressants may not actually work as expected, and in some cases may work in ways that are not understood at all.
For example, most advocates of antidepressants cite the STAR*D trial, a study conducted by the government that seems to indicate that antidepressants are effective at treading depressive disorders. However, there is evidence that the results were skewed by improper testing. The main goal of antidepressants is to alleviate Major Depressive Disorder, one of the most serious depressive conditions. In STAR*D, it seems that patients with Minor Depressive Disorder were included in the study, which skews the results; the drugs are advertised for the treatment of MaDD, but MiDD is being included in the testing sample. This is the same idea as a major car company saying that their cars receive 30 miles to the gallon, when in fact their small cars get nearly 40 and their big cars get 25. The statement is technically somewhat true, but not accurate to the details.
Further, there are recent studies showing that SSRIs and SNRIs don’t simply alleviate depressive symptoms, but fundamentally change the personality of the patient taking them. This, tied in with the indication that antidepressants can and do aggravate suicidal thoughts and attempts, is a matter to be viewed with more than passing interest. Indeed, it should be considered with alarm.
So, given that there is mounting evidence that antidepressants do not work as understood, why is the FDA still approving generic formulations and wider sales?