The EU's medicines regulator is under fire from the European Ombudsman for refusing to grant Danish researchers access to documents on two anti-obesity drugs so they can conduct independent analysis.
Researchers claim studies supporting some medicines is biased and want to validate the evidence behind the weight-loss drugs.

However, the European Medicines Agency (EMA) says the files are commercially sensitive and must remain confidential.

The Ombudsman, P. Nikiforos Diamandouros, has called on the EMA to grant access to clinical study reports and trial protocols, dismissing the agency's argument that drugmakers’ commercial interests should be prioritised.
The Danish scientists at the centre of the complaint, which began in October 2007, said patients' welfare should trump concern for the commercial interests of the pharmaceutical industry.
During his investigation, the Ombudsman inspected the relevant reports and protocols and concluded that the documents did not contain information on the composition of the anti-obesity medicines, nor did they contain other commercially confidential information. In his view, their disclosure would consequently not undermine commercial interests.

The Ombudsman criticised the EMA's refusal to grant access to the reports as an instance of "maladministration" and called on the agency to disclose the documents or provide a convincing explanation as to why access cannot be given. The EMA must reply by 31 August 2010.

Obesity drugs are a source of considerable controversy, with a number of leading medicines taken off the market amid safety concerns. Acomplia has been linked to psychiatric disorders, while sibutramine was suspended due to apparent connections with increased risk of heart attacks and strokes.

Neither the EMA nor the Ombudsman specified which anti-obesity drugs the current transparency case relates to.
This is not the first case against the medicines regulator to hit the headlines this year, despite the agency's public campaign to put transparency at the heart of its work.

The EMA came under pressure last month in a separate case relating to controversial acne medication. An Irish citizen had requested access to reports linking the drug to suicidal tendencies but the EMA refused, saying EU transparency rules do not apply to adverse reactions to medicines.

The Ombudsman disagreed, saying the medicines agency's work has a direct impact on the health of citizens and it should give the widest possible access to documents when requested.

The EMA has until 31 July to respond to the criticism arising from the acne drug controversy. In an initial response, the agency said it had launched a range of transparency initiatives and public consultations since the original complaint in 2008.