EU Drugs Agency Under Fire Again For Data Secrecy
The European Medicines Agency has been criticised for a second time by the European Ombudsman for not allowing outside investigators access to drug data. The latest case, centring on two obesity drugs from Roche and Sanofi-Aventis, underscores the pressures on the EU regulator to increase transparency.
Ombudsman Nikiforos Diamandouros said this week the decision by the agency not to give Danish researchers access to clinical study reports and trial protocols, as they had requested in 2007, was "an instance of maladministration".
The team had asked for access to Phase III study results on rimonabant, the generic name for Sanofi's now-withdrawn Acomplia, as well as orlistat, which is sold by Roche as Xenical and in a low-dose form by GlaxoSmithKline as Alli.
The researchers from the Nordic Cochrane Centre wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common. But the European Medicine Agency (EMA) refused, on the grounds that disclosure would undermine the drug producers' commercial interests.
Diamandouros, in assessing the case, decided that handing over the data would not be commercially damaging to the companies and he asked the agency to disclose the documents or provide a convincing explanation why not by Aug. 31.
It is the second time that Diamandouros, whose role is to investigate complaints about EU institutions, has criticised the EMA this year, following a case concerning its refusal to release documentation on severe adverse reactions linked to Roche's acne drug Accutane.
That earlier case led the Lancet medical journal to call for greater transparency at the EMA, in a critical blast reminiscent of past attacks on the U.S. Food and Drug Administration.
