For the second time in two months, the European Medicines Agency has been criticized by its ombudsman for refusing to release data about drugs. Last month, Nikiforos Diamandouros chastised the EMA for refusing to release documents containing suspected adverse reactions caused by Accutane (background).

This time, he upbraided the agency for not allowing outside investigators access to clinical trial data on two obesity pills - Acomplis, which was withdrawn by Sanofi-Aventis, and orlistat, which is sold as Xenical by Roche and as Alli, an over-the-counter med marketed by GlaxoSmithKline. Researchers at the Nordic Cochrane Centre wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common, according to Diamandouros. But the EMA refused to provide the data, citing disclosure would undermine commercial interests.

And so Diamandourous reviewed the documents and concluded they did not contain “commercially confidential information” and that disclosure would not “undermine commercial interests.” He went on to say that the agency’s refusal to grant access to the reports and protocols is an example of “maladministration.” So far, there is no statement from the EMA, which last time quickly issued a defensive rejoinder and was criticized by The Lancet for failing the transparency test (see this).