Allergan's $600M Headache: DOJ Probe Could Spur FDA Scrutiny of Botox Data

Last Updated Sep 2, 2010 12:52 PM EDT

Allergan (AGN)'s $600 million settlement with the Department of Justice -- over illegally marketing Botox for unapproved uses such as headache -- looks bad for the company's pending application with the FDA to sell Botox for migraines.

Separately, the settlement also forced Allergan's management to admit in a press release that they do not have First Amendment free-speech rights to discuss off-label uses of Botox while promoting the drug. (Allergan had sued the FDA on that issue; the settlement requires the company to abandon the suit.)

Until recently, Wall Street believed the FDA probably would allow Allergan to market Botox as a therapy for migraines. However, the whistleblower cases behind the settlement reveal that some Allergan executives do not believe the drug is effective on headaches. One suit alleges that Chandra Coleman, Allergan's regional scientific services manager, stated in a February 2007 meeting that "the data just isn't there for headache."

Moreover, Allergan's own published study data on Botox for headache is negative, the same suit alleges:
... a 2000 Silberstein study published in [the medical journal] Headache (Vol. 40:445-50) concluded that Botox reduces migraine severity. In fact the data was mixed, inconclusive, and the study is regarded as negative, even by Allergan.
... As of December 2006, there were ten randomized, placebo controlled studies of Botox in patients with headache. Botox fared no better than placebo on the primary outcomes measures in nine of these studies.
Given that the FDA is already angry that one drug company -- GlaxoSmithKline (GSK) -- has presented it with data that was allegedly manipulated to show non-existent benefits, it shouldn't be surprising if FDA reviewers now go back over Allergan's headache data with a fine-toothed comb looking for inconsistencies.

The FDA already requested Allergan provide it with more data for its headache application. Wall Street took this as a positive sign. But there was a caveat:
In one late-stage trial, Botox failed its primary goal of reducing the number of headache episodes compared with a placebo. But it met a secondary goal, as those on Botox had headaches on average 7.8 fewer days each month, compared with a drop of 6.4 days among patients taking placebo.
Add to that Allergan's failed lawsuit against the FDA and the new allegations regarding the quality of Allergan's headache data, and it's hard to see how all this increased scrutiny could in any way benefit Allergan's hope that Botox will become a migraine treatment.

And finally: Note that when the DOJ probe began, Allergan chief administrative officer Douglas Ingram told Reuters that the investigation and its FDA lawsuit were separate issues. Given that they're now wrapped into the same settlement, can we now admit that Ingram was talking complete rubbish?

Related: Image by Flickr user gruntzooki, CC.

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