Birth-Control Patch May Pose Health Risk
The Associated Press has apparently joined the ranks of scare-tactitians like Public Citizen, who look for evidence of harm from new drugs simply to generate publicity for their cause. Any drug will do, so long as the scare-tactitian can use the story to create significant buzz.
These purveyors of shoddy pharmacoepidemiology, in this case Martha Mendoza of the AP, use the Freedom of Information Act to request Medwatch safety surveillance data from the U.S. FDA and then “analyze it” for signals suggesting harm. Ms. Mendoza used this tactic to implicate Ortho Evra, the first female contraceptive patch approved for marketing, in the deaths of “about a dozen” women among the reported 800,000 U.S. users in 2004. I’ll give her some credit, at least Ms. Mendoza went to the trouble of contacting the manufacturer, asking them to supply their side of the story. Public Citizen doesn’t usually afford drugmakers this courtesy. The article was obviously written with the intent of generating buzz by scaring women, and it seems to have at least accomplished its buzz goal.
Interpreting passively collected postmarketing safety surveillance data is difficult in the most capable hands. It is completely unreliable in untrained hands, such as those of Ms. Mendoza and the consultants she used for her story. But of course you won’t read that caveat in the lay press. Instead you’ll read conflicting “expert” opinions and the tragic tales of two young women who died while on the patch. Get used to this type of “expose.” Should FDA start making Medwatch serious adverse event reports readily available on its website in near real-time–as it is currently planning–it will trigger a deluge of shoddy drug-safety reporting like the AP’s Ortho Evra story. It won’t make for a better-informed public or safer drugs, but it will lead to confusion and further disaffection of patients from their caregivers.
