Consider The Evidence: Med/Peds Journal Roundup

January 31, 2006

Adverse Effects Data Sucks

Filed under: Uncategorized — medblog @ 8:09 pm

ArchIM 1/23 – Now that COX2-gate has put adverse event reporting under the microscope, Rief et al. look at the data from placebo groups from several statin trials. Interestingly, rates of most adverse effects in placebo arms varied significantly from study to study, as well as from the “general population”. Sound fishy?If placebo arms are supposed to represent the general population then its a little odd that the adverse event rates vary from the general population- but, asking subjects abouts side effects is different than asking about what symptoms they are feeling in general.

The more suspicious result is the variation from study to study. Shouldnt the adverse effect rates be pretty similar among placebo groups of the same class of drugs?

Bottom Line: Adverse effect rates in placebo groups varies significantly between reviewed studies. This calls into question the quality of adverse effects data in the experimental arms. How can we improve drug safety warnings if we can’t even rely on the adverse effect data?

Medication-Attributed Adverse Effects in Placebo Groups: Implications for Assessment of Adverse Effects
Winfried Rief; Jerry Avorn; Arthur J. Barsky
Arch Intern Med. 2006;166:155-160.

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