Saturday, November 12, 2005

The FDA, the Patch, and AP

In my last post I mentioned I might have poor reading comprehension skills. Come to find out I'm in good company, that of professional health reporters employed by a major wire service.

Articles from Reuters and AP, out the same day, discuss the FDA's updated labeling for the birth control patch, Ortho Evra.

From Reuters (emphasis mine):

The U.S. Food and Drug Administration said new labeling for the patch will include information about the higher levels of estrogen, but that it was not clear whether women using the once-a-week product were more at risk for clots.

From AP (emphasis mine):

The Food and Drug Administration warned users of the popular Ortho Evra birth control patch that they are being exposed to more hormones, and are therefore at higher risk of blood clots and other serious side effects, than previously disclosed.

I've already discussed most of the claims mentioned in the AP article here. The issue today is the accurate reporting of an FDA labeling update for the patch.

Reuters reports the FDA is saying that it's not clear whether patch users are at increased risk of blood clots. AP reports something completely different. It asserts the FDA warns patch users that they're at an increased risk of blood clots. Did the Reuters and AP reporters even bother to read the text of the FDA update? One of them did. How the other prepared for the article--your guess is as good as mine.

From the FDA warning:

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

Bottom line: If you are a health reporter, you need to read the source material before reporting on it.

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