The European Medicines Agency (EMA) — Europe’s equivalent to the FDA in the U.S. — “will make thousands of pages of clinical trial reports public next week after pressure from drug-safety activists because of suicide risks linked to Sanofi-Aventis SA’s failed diet pill Acomplia,” according to this report.
The data will include results from clinical trial reports on three obesity drugs: Roche Holding AG’s Xenical, Abbott Laboratories’ Meridia and Sanofis Acomplia. Acomplia was never approved in the U.S., and EMA pulled the drug from the market in October 2008. Abbott agreed to take Meridia off the U.S. market in October. The EMA halted sales of the 13-year-old diet pill in January. But Xenical is still available in Europe and both the EMA and FDA have allowed GSK to sell Xenical’s active ingredient, orlistat, as the non-prescription diet pill Alli.
Who knows what will come to light when this data is released. Anders Joergesen, a researcher at the Copenhagen-based Nordic Cochrane Centre, which called for the release of the data, said “It’s a very detailed report describing the benefits and harms, more detail than is available for example in medical journals. The medical journal’s report is about 10-15 pages, maybe less, and these consist of 100, 200, 300 pages per trial. Let’s see what we get,” said Joergesen, “because it may be fully redacted and a blank sheet.”
After analysis of the diet drug clinical trail data, Joergesen and colleagues may do for Xenical and Alli what Cleveland Clinic’s Dr. Steven Nissen did for Avandia — ie, put sales in the toilet, exactly where Alli’s “treatment effects” end up (sometimes; see “Alli Oops! I Just Pooped Myself!” and “Alli Newspeak: Oily Spotting is ‘Treatment Effect’“).