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Drug Companies Lag on Voluntary Disclosure
Six months after the drug industry vowed to make its clinical trials more available, and three months after launching a common website to give the public "unprecedented access" to studies both good and bad, drug companies have posted unpublished trial results on the site for just five drugs.
Pfizer Inc. voluntarily disclosed unpublished study results on only one of the 29 prescription brand-name drugs it actively markets in the U.S.
Merck & Co. posted a listing for its withdrawn painkiller Vioxx®, but clicking on the link reveals nothing but another link to the product’s label and a list of two previously published studies, but not the studies themselves.
The lack of information comes amid heightened public concern about drugs similar to Vioxx®, such as Pfizer’s Celebrex® and Bextra®. Pfizer has not posted any information on Celebrex® or Bextra®. A spokeswoman declined to say when the company would post past studies or if unpublished data on the heavily prescribed drugs even exist.
"It's pathetic," said Dr. Drummond Rennie, associate editor of The Journal of the American Medical Association and an advocate for mandatory disclosure of all clinical trial results. "They get all the publicity from saying they will do it, and then they don’t."
Some legislators, physicians, editors of academic medical journals, and consumer groups said the snail’s pace of voluntary disclosure is all the more reason Congress this session should make laws to require that companies disclose all information to the public about potentially life-threatening side effects. "The drug companies just hide the negative results and hope the public can’t seek them out," said U.S. Representative Edward J. Markey, a Massachusetts democrat and sponsor of one of several initiatives in Congress that would make disclosures of clinical trial data mandatory.
Last week, the industry launched an initiative for an international disclosure database and pledged to list the launch of more clinical trials on a National Institutes of Health website. The announcements were the latest of at least four announcements since last June about increasing the volume of voluntary disclosures.
Companies generally keep the existence of unpublished studies secret. Companies notify the FDA if a trial is performed in the U.S., but the data generally only have to be made public if they are part of the FDA application for an approved drug. Such rules make estimating the amount of unpublished data from clinical trials difficult if not impossible, said editors of some medical journals and consulting firms. Rennie estimated in a July 2003 study that 1 million late-stage, controlled clinical trials had been conducted since 1948, and that only half the results were published, although many have been presented as a poster or paper at scientific conferences.
Academics and physicians for several years had been pushing for more clinical trial disclosures before the issued gained momentum in 2004 when New York Attorney General Eliot Spitzer sued GlaxoSmithKline. Spitzer alleged that the British drug giant suppressed safety concerns about the effects of its antidepressant Paxil® in children and adolescents. GlaxoSmithKline settled for $2.5 million in August of 2004 without admitting wrongdoing.
The New England Journal of Medicine and other prominent medical journals said they will require that drug companies disclose the launch of all drug studies as a condition of publication of the eventual results. he requirement, to take effect in July 2005, will allow physicians and the public to at least be aware of every study being conducted.
Members of Congress, including Markey in the House and Senators Edward M. Kennedy of Massachusetts and Chris Dodd of Connecticut, introduced legislation to make trial disclosures mandatory. Charles Grassley of Iowa, chairman of the Senate Finance Committee, is considering similar legislation.
The presentation of individual drugs on a common website falls short of industry promises for a central, easy-to-use location to find critical health information, said Dr. Jeffrey Drazen, the editor in chief of the New England Journal of Medicine.
"It’s not like they fit into a template," he said. "Everyone’s kind of putting stuff in their own way. You don’t know where to look, and you might miss something."
The industry’s performance thus far, he added, "is not at all surprising. Their past behavior suggests that would be a legitimate reason for what’s going on right now."
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