March 23, 2007

Journal to shed light on more drug studies

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C. Michael Stein, M.D., is editing an online journal that will feature the results of drug studies which otherwise might not be published. (photo by Susan Urmy)

Journal to shed light on more drug studies

Vanderbilt's C. Michael Stein, M.D., has been named editor of a new online journal that will report the results of drug studies which otherwise might not be available to scientists or the public.

Archives of Drug Information, a free, open-access, peer-reviewed journal, will publish the results of drug studies, including inconclusive or negative clinical trials, as well as routine drug-interaction and other drug-development studies that usually don't make it into the mainline science journals.

“The pharmaceutical industry is under a lot of pressure to publish information about the studies they perform,” said Stein, professor of Medicine and Pharmacology, and associate director of the Division of Clinical Pharmacology.

“But it's actually very difficult for them to do so because most scientific journals select the highest impact articles for publication, and many of the studies performed in drug development do not have a high scientific priority for medical journals.”

As a result, “whenever there are problems with a drug later on, there are often allegations that information was in some way hidden,” he said.

Archives of Drug Information will provide a scientific home for information that might otherwise languish “on file” in a pharmaceutical company.

The journal also will help protect scientists from unknowingly going down “blind alleys,” or repeating the mistakes of their predecessors, Stein added.

“A company can develop a compound … (and) find it doesn't work or even find toxicity in a small number of people,” he said.

Currently, “that information may never see the light of day if the compound doesn't progress in development.

“So, a few years later another company can easily repeat the same mistakes with a similar compound because the results of that first study are not generally accessible.”

Stein, immediate past editor of Clinical Pharmacology & Therapeutics, a leading medical journal, said he asked Blackwell Publishing Ltd., acquired last year by John Wiley & Sons, to launch a journal that would provide this information free to the public. The company, now known as Wiley-Blackwell, agreed.

In late spring or early summer, the journal will begin publishing studies that have been peer-reviewed to ensure that the methods were valid and the results not biased.

The journal will be free, in that readers and subscribers will not pay, but the authors — usually pharmaceutical companies — will pay a publication fee.

Stein, whose research involves the genetic variability of drug responses, inflammation and atherosclerosis, said that he has collaborated with pharmaceutical companies in scientific studies, but none of his salary support comes from industry.

That, he said, will help ensure the journal's scientific independence.