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Larger companies still withholding trials info, says study

US medical journal attacks companies for obscuring basic information on clinical trials

The New England Journal of Medicine (NEJM) has fired a broadside on the pharma industry, alleging that several major companies are withholding important details about clinical drug trials in published studies.

In this week's edition of the US journal, a study by researchers at the National Library of Medicine, which runs a federal clinical trials registry, said companies including Merck, Pfizer and GlaxoSmithKline, are obscuring basic information on trials of drugs to treat serious diseases.

The registry, www.clinicaltrials.gov, was created in 2000 to beef up US Food and Drug Administration monitoring but did not get wide participation until September 2004, when editors of leading medical journals said they would refuse to publish results of any studies that were not first listed in a public registry.

In an accompanying editorial, NEJM editor in chief Dr Jeffrey Drazen called for investigators and patients to avoid participating in drug trials where companies are not forthcoming with information.

ìWhen patients put themselves at risk to participate in clinical trials, they do so with tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor,î he wrote.

While the study said most drug companies had made progress to make public more information about their trials, it said several large companies are providing information that is incomplete or vague and in some cases are not even disclosing the names of the drugs they are studying, using terms such as ìinvestigational drugî to describe them.

The study also found that some companies provided scant information about what results their clinical trials are measuring. For example, Novartis reported details about outcomes it was measuring in reports on only eight of 239 trials, while Merck reported outcome details in only nine of 46 trials.

In a statement, Merck said it was reluctant to provide details on outcome data in early stage research trials because such information is ìhighly proprietaryî.

Several of the larger companies said they were meeting all federal requirements for disclosing of clinical trial data, but were wary of giving out too much information because of competitive concerns.

However, Dr Drazen described the companies' concerns as ìa smoke screenî and said that other drug makers managed to provide full and detailed information on their trials.

He also said that by not requiring companies to name drugs being tested, the federal requirements had a loophole: ìCompanies are meeting the letter but not the spirit of the law.î

30th September 2008

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