Drug Firms Disclosing More Data

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 data on Vioxx’s dangers, gets somewhat better marks in the new analysis than it did in an earlier one. However, Pfizer Inc., GlaxoSmithKline and Novartis are lagging, according to the report in today’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.

The registry, www.clinicaltrials.gov, was created in 2000 as part of an overhaul of Food and Drug Administration monitoring. But it didn’t get wide participation 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.

The analysis covers May 20 to Oct. 11. Entries rose from 13,153 to 22,714 in that time.

Zarin focused on whether listings revealed the name of the drug being tested and the main outcome being measured.

Pfizer was worst on giving names; 14 of its 224 new listings lacked this information. Glaxo named the drug in all but one of its 128 new listings but has the worst overall record: 21% of its total registry entries lack specific drug names.

Merck used to be the worst but amended its entries and now has the best record, listing the drug 99% of the time.

Novartis gave the outcome measure for 3% of its 239 studies.