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Drugs regulators “put profits before patients”

Louise Prime

Wednesday, 11 May 2011

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Drugs regulators put protecting profits ahead of protecting patients, argue researchers on bmj.com. They accuse the European Medicines Agency of preventing access to important unpublished trial results in order to protect drugs manufacturers’ commercial interests.

Authors of today’s Analysis, from the Nordic Cochrane Centre in Denmark, say: “Widespread selective reporting of research results means we don’t know the true benefits and harms of prescribed drugs,” and they demand  full access to both published and unpublished trial reports so that these can be independently assessed.

The researchers contend that selective publication of drugs trials mean that clinicians are unable to make an informed decision about the safety of a particular drug for their patients, with potentially “disastrous consequences”.

They point out that in the US alone, class 1 anti-arrhythmic drugs probably caused about 50,000 premature deaths in the 1980s. An early trial of the anti-arrhythmic lorcainide, in patients with suspected acute myocardial infarction, had shown nine deaths among 49 lorcainide users compared with one death in the 46 patients taking placebo. But the study was never published because the drug was abandoned for commercial reasons.

They add that about 100,000 unnecessary heart attacks probably occurred among US residents taking the non-steroidal anti-inflammatory drug rofecoxib (Vioxx).

The Analysis authors write of their tough 3-year fight to get the EMA to release unpublished trial reports for the anti-obesity drugs rimonabant (Acomplia) and sibutramine (Reductil), which manufacturers had submitted to the EMA as part of the approvals process.

They write: “The information was important for patients because anti-obesity pills are controversial ... People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons.”

The EMA denied the researchers the right to see the trials reports, claiming that public interest was not a strong enough factor to override manufacturers’ commercial interests – and adding that the administrative burden would be too onerous.

Eventually the European Ombudsman, to whom the authors complained, accused the EMA of maladministration, after which the EMA finally allowed public access to the documents.

But the authors conclude: “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.”

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