Thursday, June 18, 2009
ADHD drug study swerves way off course
Recently, parents of children with ADHD were subjected to some alarming headlines warning of a possible association between the use of stimulant medications for the disorder and sudden cardiac death.
The study, published in the American Journal of Psychiatry, seemed to carry some weight and even prompted a communication from the FDA (who provided funding, along with the National Institute of Mental Health), but pay close attention to the study's many limitations. Consider the unusual design of the study: researchers compared two groups of healthy children using stimulant medications. Half died suddenly in car accidents while the other half died suddenly from other causes. Because fewer kids in the car accident group died than in the other causes group (10 vs. 2), while taking the drugs, researchers surmised that there may be an association betwen the drugs and sudden death in healthy children. Huh?
And how did the researchers determine whether the deceased children were taking stimulants at time of death? They simply asked the grief-stricken parents, often years after the fact -- that's one of the "limitations" mentioned by the FDA. Another is the very real possibility that a child's death from unexplained causes prompted an autopsy investigating medication use. According tothe FDA, "the low frequency of stimulant use in both groups, as well as possible differences in the type of post-mortem inquiry, could have a profound biasing effect on the results." No kidding.
It's bewildering as to how this study even got funded. With so many problems with the methodology and possibilities for biases, the only effect of publicizing the results appears to be stirring up needless panic in the many parents whose children are being treated for ADHD.
ACP Internist hosted Grand Rounds on June 16, wrapping up the best of the medical blogosphere. Click here for the complete wrap-up.
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2 Comments:
Very interesting critique. Thank you. I'm going to post a link on Twitter.
Leigh Ann Otte
Managing Editor
My Family Doctor magazine
Written by health-care professionals for the general public
It's good to know that I am not the only person puzzled by this piece of work. I wonder whose idea it was to use MVA deaths as a control group in a study which aims to investigate stimulant associated sudden-death?
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