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Does Botox Prevent Migraines or Is It Just Acupuncture?

After Allergan (AGN) settled a Department of Justice investigation that it was marketing Botox illegally, I suggested that allegations in one of the lawsuits that triggered the probe might cause the FDA to think twice about whether Botox ought to be approved as a migraine treatment. Nine of 10 studies showed no better performance than a placebo prior to 2006, one suit claimed.

Until recently, Wall Street believed the FDA probably would allow Allergan to market Botox as a therapy for migraines. But a look at some of Allergan's published data suggests that Botox isn't that effective as a headache treatment.

Botox was approved for headaches by European authorities in July. Here's the data, as published by Allergan, behind that decision:

BOTOX(R) treated patients averaged 8.2 fewer migraine days, which was significantly greater than the change from baseline observed in placebo treated patients (6.2 days), ...
That looks as if Botox provides a straightforward 24 percent reduction in the number of headache days, down from 8.2 to 6.2. But bear in mind that those are headache days per month, and that the course of injections lasted 24 weeks. The placebo effect of having needles jammed into your head for four months straight seems to be almost as strong as the drug itself, and it only produces a two-day difference per month.

Similarly, in 2008, Allergan released this data:

Results from the first Phase III clinical trial indicated that although both the BOTOX(R) and placebo treatment groups showed a statistically significant improvement from baseline, there was no significant difference in the reduction of number of headache episodes between patients receiving BOTOX(R) and placebo.
Note that in this release no actual numbers were given; we just know that there's no difference between the placebo and Botox. That makes two studies where the placebo effect is statistically significant, and almost as great as the drug effect.

The medical literature is littered with smaller studies of Botox as a painkiller, many of them supported by Allergan one way or another. Here's one in which Allergan supplied its drug for free. But even some studies done by Allergan's own consultants don't make much of a case for Botox. Alexander Mauskop is a neurologist at the New York Headache Center in Manhattan. He's also a consultant for Allergan. He did a study of "20 years of extensive clinical experience" and found that using Botox was safe -- but he didn't come to any conclusions as to whether it works.

Could it be -- as Dr. Sydney Wolfe of Public Citizen (and some of the FDA's own advisory committees) suggests -- that Botox headache injections are basically just acupuncture?


Image by Flickr user gruntzooki, CC.
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