US Acts Over Drug Safety Scares

American regulators yesterday tried to restore confidence in the battered drugs industry by announcing the formation of an independent board to monitor the safety of drugs on the market. The move comes on the eve of a crucial hearing to investigate certain painkilling drugs.

The Food and Drug Administration appears to be restricting the information that will be presented at the three-day hearing, beginning today, into the safety of arthritis drugs such as the withdrawn painkiller Vioxx.

The FDA said the proposed Drug Safety Oversight Board would keep medicines under review and alert doctors and patients to emergent risks. It is an important change to the industry, as the US has around half the world drugs market.

The board has been created in response to a flurry of scares in the industry, where some treatments on the market have been linked to fatal side effects.

Merck withdrew its arthritis drug Vioxx in September when it was shown to increase the risk of a heart attack or a stroke - risks the company is accused of trying to cover up. Recent studies have also cast doubt on the safety of Pfizer drugs Celebrex and Bextra, both in the "Cox-2" class of painkillers along with Vioxx.

Dr David Graham, a senior safety official at the FDA, warned in November that the US is "virtually defenceless" against another drugs scandal.

This week he is giving evidence to fellow scientists at a three-day hearing on Cox-2 drugs, but he said that he has been asked to withhold crucial data by his superiors. The meeting is to review the evidence on the safety of all such drugs. Dr Graham has already published a study which estimates that up to 140,000 people developed heart disease from taking Vioxx in the US.

His more recent study looked at Celebrex, Bextra and a number of other treatments such as Naproxen and Mobic. The results have not yet been published in a scientific journal, and Dr Graham said he would not discuss the results with the media.

He wanted to report to the scientists at this week's FDA advisory committee, but said his superiors have made it clear he is not allowed to do so. "It would raise concerns about several other marketed drugs ... I believe the FDA is trying to put a lid on what it has to deal with," he said.

An FDA insider said the agency prefers to present data that has been published in scientific journals.

The US health and human services secretary, Mike Leavitt, said that people wanted more oversight and transparency from the FDA. "They want to know what we know, what we do with information, and why we do it," he said. There would be "a new culture of openness and enhanced independence".

The safety board will consist of FDA officials and members of other government health agencies. It will consult outside medical experts and consumer groups, and will run a website to give health workers and the public any new information.

Public confidence in the drugs industry and the FDA's role in ensuring its safety has suffered a number of blows in the past year. For example, the FDA was criticised for being slow to respond to disclosures that most anti-depressants could be dangerous when taken by children and teenagers, even after British authorities had already issued warnings.

The agency was left looking flat-footed when the New York attorney general, Eliot Spitzer, filed charges against GlaxoSmithKline, accusing the company of suppressing data from trials that showed an increased incidence of suicidal behaviour among children taking its drug Paxil.

There have also been wider questions asked about the FDA's method for approving drugs in the wake of the Vioxx scare.