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Pharma firms told to end secrecy in drug trials

May 18, 2006 By Jim Giles This article courtesy of Nature News.

Early stages of testing should be made public, say public-health experts.

The World Health Organization (WHO) has rebuffed requests from the pharmaceutical industry to tone down its plans for openness in drug testing.

Industry groups had asked for critical details about clinical trials to be omitted from a new WHO database, which will bring together information on trials from around the world and provide each study with a stamp of approval. They argued that making such details public would amount to disclosing commercial secrets, and said that the information could be misused by patients desperate for a cure.

The WHO remained unconvinced by industry's pleas. "We said: give us your best case," says Ida Sim, a clinical-trials expert at the WHO who discussed the organization's plan with industry. "But it was clear that the strongest case was not sufficient to counter the need for transparency and other ethical arguments."

The system is being set up in part because major pharmaceutical firms have been accused of hiding evidence that some new drugs, such as anti-depressants, can be harmful. By bringing together data on all known trials, the WHO hopes to make it harder for drug companies to bury trials when the results do not go as planned.

Company compromise

Sim and her colleagues have discussed the matter with industry representatives and other stakeholders for more than a year, and the groups have moved closer on some issues. Drugs firms had, for example, initially asked for key trial data, such as the scientific name of the drug being tested, to be kept confidential at the start of the trial. Some firms now say they are happy to publish this information, along with the other data requested by the WHO.

But other issues continue to cause divisions. Most prominent is the WHO call for registrations of early-stage trials, which assess factors such as safety. Although drug firms routinely register advanced trials, they prefer to keep initial tests secret.

Beat Widler is a clinical-quality manager at Roche, headquartered in Basel, Switzerland. He says that the secrecy is necessary to stop rivals from building on proprietary research and also prevents patients from attempting to access treatments before the proper safety tests have been done.

"It's about eliciting false hopes," Widler explains. "About 80% of molecules that are tested never make it to market." He adds that Roche currently has no plans to comply with the WHO request on this point.

Powers of persuasion

The WHO has no legal power to force firms to comply with its guidelines, but the standards it has announced could influence other players. The editors of several prominent medical journals were involved in the discussions and WHO officials hope they will publish only clinical trials that have been tagged with a reference number from the WHO database.

And An-Wen Chan, a colleague of Sim's, says the WHO is talking to the ethical review boards that are required to approve all trials, including early stages. Chan wants to persuade the boards to make registration a condition of ethical approval, although these discussions are only just beginning.

The WHO database, which will incorporate existing trial registries such as the US government's, is scheduled to launch within the next 12 months.

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