Pharmaceuticals 'need clinical trial regulation'
Pharmaceuticals 'need clinical trial regulation'
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Thursday, 29, Jun 2006 08:17
Britain's pharmaceutical industry cannot be trusted to safely run clinical trials without outside regulation, a healthcare expert has claimed.
An article published in today's Journal of the Royal Society of Medicine by Sir Iain Chalmers argues that the untrustworthiness of clinical health trials has reached endemic proportions in the UK.
Sir Iain, editor of treatment monitoring organisation the James Lind Library, also criticises doctors who he claims "collude" with the drugs industry by collaborating with "scientific misbehaviour driven by the marketing departments of pharmaceutical companies".
"Research undertaken by pharmaceutical companies cannot be trusted," Sir Iain writes.
"Their systematic under-reporting of negative results and lack of transparency is blatant scientific misconduct and unethical. Without radical change this will continue."
Sir Iain's article points out that the pharmaceutical industry has slipped back from progress in advancing accountability during the 1990s. It singles out Glaxo Wellcome, which had led efforts to improve good practice, as having regressed following its merger with SmithKlineBeecham to create the current company GlaxoSmithKline.
He calls for the Association of the British Pharmaceutical Industry to unilaterally adopt good practice guidelines, but predicts that as this is unlikely, "stricter government regulation is likely to be needed".
The dangers of unmonitored clinical health trials came to light earlier this year when two men were placed in a deep coma following participation in a private trial run by US testing firm Parexel for a German pharmaceutical company, TeGenero.