It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug’s use being based on the selective reporting of favourable research should be unimaginable. In this week’s issue of The Lancet (p 1341), however, a meta-analysis by Craig Whittington and colleagues (free registration required) suggests that this is what has been happening for research into the use of antidepressants in childhood. Their results illustrate an abuse of the trust patients place in their physicians. They also represent an abuse of the trust placed by trial volunteers in the medical and pharmaceutical establishments.
The story of research into selective serotonin reuptake inhibitor (SSRI) use in childhood depression is one of confusion, manipulation, and institutional failure. Although published evidence was inconsistent at best, use of SSRIs to treat childhood depression has been encouraged by pharmaceutical companies and clinicians worldwide. Last month, the Canadian Medical Association Journal revealed excerpts from an internal GlaxoSmithKline memorandum demonstrating how the company sought to manipulate the results of published research. Concerning a study of paroxetine use in children, the memorandum states “It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine”. Last year the UK Committee on Safety of Medicines prohibited the treatment of childhood depression with any SSRI except fluoxetine. Despite this, the Food and Drug Administration in the USA appears last week to have failed to act appropriately on information provided to them that these drugs were both ineffective and harmful in children. Read the rest of the Lancet editorial (free registration required).
How can the FDA claim that we can’t import prescription medications from Canada because we can’t be sure they’re “safe,” when the same FDA charged with protecting patients allows this to occur? The patients who need the most protecting — helpless children — are often short-changed by a pharmaceutical industry that manipulates both consumers and physicians into believing their drugs (sometimes barely tested on child populations) are just as safe and effective for children. It’s time for the pharmaceutical industry and the FDA to get their priorities straight.
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One Comment to
“Depressing research (for children)”
I am glad to see you raise this point about the FDA. Many people assume that they do much more than they actually do with regard to testing for safety and effectiveness.
You may wish to see my outline of the history of the FDA, with regard to the issue of pediatric safety testing. It shows that they are just now getting up to speed on this; and that the process was delayed by bizarre political nonsense.
link
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Last reviewed: By John M. Grohol, Psy.D. on 30 Apr 2004
