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Drug data ‘should be made publicly available’

By Amy Fallon

GPs cannot choose the best treatments for their patients because medicines regulators are withholding unpublished drugs trial data, due to concerns over 'commercial confidentiality', claim researchers.

The Danish researchers – writing in the British Medical Journal this week – say drugs regulators are putting drug company profits ahead of the lives and welfare of patients, and argue that this could have fatal consequences.

The academics argue for full access to published and unpublished reports so that the benefits and side-effects of treatments can be independently assessed by the scientific community.

'Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available,' say the authors of the BMJ article, Professor Peter Gøtzsche and Dr Anders Jørgensen.

'There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients.'

The researchers, from the Nordic Cochrane Centre in Denmark, claim they endured a three-year struggle to access unpublished trial reports for two anti-obesity drugs, but the EMA refused access to them, arguing it would undermine commercial interests and that there was no overriding public interest in disclosure.

They appealed to the European ombudsman, P Nikiforos Diamandouros, who criticised the EMA's refusal to grant access. But it was only after the ombudsman accused EMA of 'maladministration' that they agreed to increase public access to documents, said the academics. They finally received their information in February.

An EMA spokesperson defended the agency's record on transparency and said the author's conclusions were 'oversimplified'.

'Access to information and transparency has to be reconciled with the protection of other fundamental rights, such as the right of privacy,' she said.

Story updated on 13 May 2011 at 12:45

Drug data ‘should be made publicly available'