Academic journal article Ethical Human Psychology and Psychiatry

The SSRI Trials in Children: Disturbing Implications for Academic Medicine

Academic journal article Ethical Human Psychology and Psychiatry

The SSRI Trials in Children: Disturbing Implications for Academic Medicine

Article excerpt

The recent announcement by the Food and Drug Administration (FDA) requiring pharmaceutical companies to warn patients about the increased likelihood of suicidal thoughts when taking antidepressants was largely due to the recent availability of data that had gone unreported in the original research reports. The current article is a summary of the comparison between the published literature and the recently released data available on the FDA web site, with a focus on Prozac, Paxil, and Zoloft. The discrepancies between the two versions suggest that the scientific community was not given enough information in the published medical literature to make adequately informed decisions about the optimal method for treating emotionally distressed children. There are many voices that want to blame the FDA for its role in the widespread use of these medications. The current article focuses on the role that academic medicine, played in the process whereby these medications became so widely accepted.

Keywords: SSRI; suicide; pediatric depression; FDA

"Confusion, manipulation, and institutional failure" was the recent summary on The Lancet's editorial page about the research into selective serotonin reuptake inhibitor (SSRI) use in childhood depression (Editors, 2004). The editors' conclusions were based on revelations that pharmaceutical companies had selectively reported favorable research about the use of antidepressants in children. However, the medical community makes a mistake if it believes that the current problem is just one of unpublished data, which the pharmaceutical companies have kept hidden. If it were only as straightforward as a relatively few acts of corporate irresponsibility, then the solution would be fairly simple, but virtually everyone knows it is more complicated. The SSRIs are not the only drugs involved and, moreover, the pharmaceutical companies are not the only players involved. The more important problem is that for 10 years the system of academic medicine failed to the point that the academic journals were circulating a myth about the benefits of psychotropic drugs for children that had little to do with the truth.

BACKGROUND

Marketing Antidepressants

In October 2004, the Food and Drug Administration (FDA) announced that commonly used antidepressants likely lead to an increase in suicidal thoughts or actions in some children and teens; they also announced that the same problem might exist for adults. Almost 1 year prior to this, the Medicines and Healthcare products Regulatory Agency (MHRA), the British equivalent of the FDA, effectively banned the use of these drugs, except for Prozac, in children and adolescents under 18 years of age. Ten years ago, the market for antidepressants in children was practically nonexistent, 5 years ago it was booming, and now, it seems to be in jeopardy. Considering how much money we have spent over the past decade on the search for the causes and treatment of mental anguish, who would have thought we would end up with a warning label saying that these drugs might lead to an increased rate of suicide?

In the late 1980s, adults started to use the selective serotonin reuptake inhibitors (SSRIs) for depression, and since then the brand names, such as Prozac, Paxil, and Zoloft, have become household names. Indeed, three of the seven most commonly used drugs are now mood elevators. By the early 1990s, it didn't matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old. In some cases prescriptions were written for infants under twelve months (Grinfeld, 1998).

Although you would never know it from a perusal of the mainstream psychiatry journals over the last decade, when the SSRIs first came on the market in the late 1980s there were hints of increased suicidality in people taking the drugs (Healy, 2003a). It is not surprising that some psychologically distressed people commit suicide; after all, a distressed state is a predisposing factor for suicide. …

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