Drug companies making more study data public

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, stung by allegations that it hid information on Vioxx's dangers, gets somewhat better marks in the new analysis -- covering May 20 to Oct. 11 -- than it did in an earlier one. However, Pfizer, GlaxoSmithKline and Novartis are lagging, according to the report in today's New England Journal of Medicine.
Run by the National Library of Medicine, the registry, www.clinicaltrials.gov, 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.
But it didn't get wide participation from industry or many voluntary listings until September 2004, when editors of leading medical journals said they would no longer publish results of any studies that were not first listed in a public registry.
The idea was to make it easier for scientists, regulators and the public to cross-check what studies were being done on a drug and get the big picture of risks and benefits. The registry includes studies by universities, governments and industry, but concerns about openness center on industry.
The new analysis focused on whether company listings revealed the name of the drug or device being tested and the main outcome being measured, such as death or cancer recurrence within five years.
Pfizer was worst on giving names, and Glaxo named the drug in all but one of its new listings; Merck now has the best record of naming drugs but did poorly on listing the outcome being measured.
Novartis gave the outcome measure for a mere 3 percent of its registered studies.
A Merck spokeswoman said the company considers information about the precise outcome it is testing to be private information that would damage its competitive position.