Thursday, December 29, 2005
Registering clinical trials aims to outline a new drug's risks and benefits.
Associated Press
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 & amp; 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 AG 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.
"We're getting a lot of trials being registered," including many that American drug companies are doing in foreign countries, she said.
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 such as cancer.
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.
Reason for 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 analysis covers May 20 to Oct. 11. Entries rose from 13,153 to 22,714 in that time, spiking around Sept. 13 when the medical journals' new policy took effect.
Dr. Zarin focused on whether company listings revealed two things: 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; 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 percent of its total registry entries lack specific drug names.
Worst to best
Merck used to be the worst but amended its entries over the summer and now has the best record, listing the drug 99 percent of the time. However, it did very poorly on the second measure in the analysis, listing what outcome was being measured only 20 percent of the time.
Novartis was even worse. It registered more studies than any other company in the analysis -- 239 -- but gave the outcome measure for a mere 3 percent.
Glaxo spokesman Rick Koenig said his company supports disclosure. Besides listing on the registry studies it is launching, Glaxo also gives detailed results of ones it has completed at www.gsk.com.
"We are unaware that any corporate, academic, or governmental institution is making a more comprehensive, more widely accessible report of the results of its clinical work," he said.
A Merck spokeswoman said the company was happy the journal acknowledged its progress toward listing names. But she said Merck considers information about the precise outcome it is testing to be private information that would damage its competitive position in most early-stage studies, which it lists voluntarily in the registry.
Efforts to reach representatives of Pfizer and Novartis were unsuccessful.
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."
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