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Early-warning system under threat

Two of the largest pharmaceutical companies are urging the government to do more to ensure that doctors report side-effects from new drugs.

Two of the largest pharmaceutical companies are urging the government to do more to ensure that doctors report side-effects from new drugs, in a bid to stamp out growing public concern about taking blockbuster drugs.

Executives from GlaxoSmithKline (GSK) and AstraZeneca, appearing before a committee of MPs yesterday, demanded an overhaul of the "Yellow Card" system where doctors are meant to inform the drug regulator of adverse reactions by their patients. It is meant to act as an early warning system if drugs have unrecognised side-effects.

The industry lobby group, the Association of the British Pharmaceutical Industry (ABPI) followed up their criticisms by demanding that doctors are assessed to ensure they are using the system. It also suggested that patients should be encouraged to report suspected side-effects directly.

Drug safety has become one of the central concerns of an inquiry into the influence of the pharmaceutical industry by the House of Commons Health Select Committee (HSC). The issue has been given added impetus since the inquiry began last summer due to the withdrawal of Vioxx, the arthritis painkiller linked to heart attacks, and shrill criticism in the US of other drugs on the market.

Stuart Dollow, the vice president of the UK medical division at GSK, told the committee that the Yellow Card scheme "doesn't work" and should be re-examined. The ABPI proposed that the regulator, the Medical and Healthcare products Regulatory Agency, should receive more funds for drug safety monitoring and should regularly publish Yellow Card data.

John Patterson ñ who was appointed to the board of AstraZeneca last month, charged with reviewing the company's approach to drug safety ñ rejected MPs' suggestions that the drug industry is more concerned with finding new uses for existing drugs than with monitoring their safety. He said: "We have a legal, moral and ethical duty to follow the safety of our products."

The Select Committee, chaired by David Hinchcliffe, is hoping to publish recommendations from its inquiry by the end of March. Previous sessions have heard criticism of the drug industry for "disease-mongering" to promote drugs such as antidepressants or pills for erectile dysfunction, and of other marketing practices.

However, the executives before the committee yesterday insisted that the 'checks and balances' on the industry were about right. They said patients were missing out because new medicines are slow to be adopted in the UK, where doctors are perceived as more conservative and where the National Health Service reviews new products for cost effectiveness before allowing them to be prescribed.

2nd September 2008

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