Drug Companies Lagging on Openness

Jan. 9--Six months after the drug industry vowed to make its clinical trials more transparent, 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a common website to give the public "unprecedented access" to studies both good and bad, drug companies have posted unpublished trial results on the site for just five drugs.

Pfizer Inc., the world's largest drug manufacturer with $40 billion in revenues in 2003, voluntarily disclosed unpublished study results on only one of the 29 prescription brand-name drugs it actively markets in the United States, the antidepressant Zoloft.

Merck & Co.... 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. ... Vioxx performed in 2000 that showed a six-fold increase in cardiovascular risk. ... ignored risks of Vioxx years ago. ... similar to Vioxx, such as Pfizer Inc.'s Celebrex and Bextra. Pfizer has not posted any information on Celebrex or Bextra. ... "It's pathetic," said Dr. Drummond Rennie, associate editor of the Journal of the American Medical Association ... ... Of the 26 drugs listed, just five contain data that have been previously unpublished, according to the Globe review. ... ... information to the public about potentially life-threatening side effects hidden in America's drug supply. ... "The drug companies just hide the negative results and hope the public can't seek them out," said US Representative Edward J. Markey, a Massachusetts Democrat ... "It's set up a like a poker game. The less information you give, the more likely you are to make money," he said. ... "These sporadic, inconsistent, partial responses by a few companies have to be viewed as thinly disguised public relations efforts," said Dr. Sidney Wolfe, director of the health research group Public Citizen, a Washington consumer group that has joined the call for mandatory disclosure of trial results.

Companies generally keep the existence of unpublished studies secret. ... Drug companies said they were taking so long to publicly post information because they are taking raw data from unpublished studies and placing them into an internationally recognized, uniform format. ... Academics and physicians for several years had been pushing for more clinical trial disclosures before the issue 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 2004 without admitting wrongdoing. ... The New England Journal of Medicine and other prominent medical journals, meanwhile, said they will require that drug companies disclose the launch of all drug studies as a condition of publication of the eventual results. The requirement, to take effect in July, will allow physicians and the public to at least be aware of every study being conducted. ...

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."