Drug companies to publish test details

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The Independent Online

The pharmaceuticals industry has agreed to publish details of all its drug trialsto head off scandals over the safety and usefulness of its medicines.

The pharmaceuticals industry has agreed to publish details of all its drug trialsto head off scandals over the safety and usefulness of its medicines.

Trade organisations representing the giants of the US, European and Japanese industry said yesterday they would post the safety and efficacy conclusions of all their significant human trials on a designated website. They will also create a register of soon-to-start trials.

Richard Barker, the director general of the Association of the British Pharmaceutical Industry, said: "By publishing not just the results of trials that have taken place ... but also those that are just starting, the industry has made a major step towards achieving greater transparency."

Until now, only 80 per cent of trials have been published in scientific journals. Some companies, including the UK's biggest drugmaker, GlaxoSmithKline, have already begun publishing outline results from all their finished trials, but the new worldwide agreement creates an industry standard. The aim of the voluntary agreement is to head off political pressure for a statutory body and tougher regulation of trials.

The industry has come under fire for allegedly failing to publish trials where they conclude that a drug is not effective or, worse, unsafe. GSK was stung into starting its unilateral database last year after being sued by Eliot Spitzer, New York state's attorney-general, for allegedly suppressing a trial that showed Seroxat, the anti-depressant, was ineffective and possibly dangerous for under-18s. The lawsuit was settled for a modest $2.5m.

Only the very earliest human trials will be exempt from the agreement, with the industry suggesting that publicising these "earliest hunches" on a potential new drug are commercially sensitive.

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