Drug companies are making public more information about medical studies they are conducting, but some still withhold key details, a new analysis of a federal registry finds.
Merck & Co., stung by allegations that it hid information on Vioxx's dangers, gets somewhat better marks in the new analysis than it did in an earlier one. However, Pfizer Inc., GlaxoSmithKline PLC and Novartis are lagging, according to the report in Thursday's New England Journal of Medicine.
In May, the journal's editor-in-chief accused Merck, Pfizer and Glaxo of making a mockery of efforts to increase the transparency of such experiments, called clinical trials.
The new report shows some progress, said its chief author, Dr. Deborah Zarin of the National Library of Medicine, which runs the registry.
"We're getting a lot of trials being registered," including many that American drug companies are doing in foreign countries, she said.
The registry was created in 2000 as part of an overhaul of Food and Drug Administration monitoring. It requires certain types of studies to be listed, such as late-stage experiments involving life-threatening illnesses like cancer.
But it didn't get wide participation from industry or many voluntary listings until September 2004, when editors of leading medical journalssaid they would no longer publish results of any studies that were not first listed in a public registry....In an editorial, journal editor-in-chief Dr. Jeffrey Drazen and Dr. Alastair J.J. Wood, a Vanderbilt University drug expert who has served on many FDA advisory panels, call for complete compliance with the registry, saying it "makes moral sense."
"When patients put themselves at risk to participate in clinical trials, they do so with the tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor," they wrote.
They also urged scientists and patients to refuse to participate unless studies are fully registered.
Posted by
Peter Suber at 12/29/2005 10:22:00 AM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
