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Refusal to publish clinical trial data

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3. Drug

regulators accused of risking patient safety by not publishing clinical trial

data

Pressure is growing to ensure doctors and the public are fully informed about

all clinical trials which are carried out to test the safety of medicines. The

European Medicines Agency (EMA), which evaluates medicines licensed in the

European Union, including Ireland, was recently criticised by the European

ombudsman for failing to make all information it has accessible to public.

Researchers writing in the 'British Medical Journal' say medicines regulators

are protecting drug company profits rather than the lives and welfare of

patients by withholding unpublished trial data. They call for access to trial

reports to allow the benefits and harms of treatments to be independently

assessed. Despite the existence of thousands of clinical trials, doctors are

unable to choose the best treatments for their patients because research

results are being reported selectively, said Prof Gotzsche and Dr Anders

nsen from the Nordic Cochrane Centre in Denmark. Selective reporting can

have disastrous consequences. For example, Rofecoxib (Vioxx) has probably

caused 100,000 unnecessary heart attacks in the US alone.

Independent.ie

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