Clinical Trial Data on Few Prescription Drugs Published by Pharmaceutical Companies in Voluntary Registries
A voluntary commitment by pharmaceutical companies in July 2004 to make unpublished clinical drug trial results public "has produced limited disclosures," with unpublished data for only five drugs posted, according to a Boston Globe review of various Web sites (Rowland, Boston Globe, 1/10).
The pharmaceutical industry has come under criticism in the past year for voluntarily publicizing positive trials while placing less emphasis on or concealing negative data. New York State Attorney General Eliot Spitzer (D) last year filed suit against GlaxoSmithKline for alleged concealment of negative trial results for Paxil, and trial attorneys allege that Merck concealed negative results for the COX-2 inhibitor Vioxx, which the company voluntarily withdrew from the market last September.
Under current law, pharmaceutical companies must post data on ClinicalTrials.gov only for trials that involve treatments for life-threatening diseases or conditions (California Healthline, 1/7). Drug companies must inform FDA of all clinical trials performed in the United States, but they only have to make public the date if they are part of an FDA application for approval, the Globe reports (Boston Globe, 1/10).
In response to growing concerns, the 11 members of the International Committee of Medical Journal Editors in September 2004 announced that they would publish completed studies only if they have been publicly disclosed at the trials' outset (California Healthline, 1/7).
NIH also in September 2004 announced that the agency planned to make available at no cost to the public the results of all NIH-funded research six months after the work is published in a scientific journal. The proposal would require federally funded researchers to submit their papers to the agency after they have been accepted for publication and edited by a journal (California Healthline, 9/28/04).
Most recently, the Pharmaceutical Research and Manufacturers of America, in conjunction with three other large pharmaceutical industry trade groups in Europe and Japan, on Thursday in a joint statement announced that their members plan to voluntarily post on a Web site more clinic trial results. Under the plan, scheduled to take effect July 1, member pharmaceutical companies will post data on the Web site when clinical trials begin and within one year of when medications are approved or trials end. The companies will post trial results on a publicly accessible database operated by the federal government, a company or a trade group.
PhRMA said that some pharmaceutical companies will exclude some trial data, as well as the results of Phase I trials, which test the safety of medications (California Healthline, 1/7).
PhRMA has posted results of 26 clinical trials -- out of more than 10,800 prescription medications sold in the United States -- on an industry Web site clinicalstudyresults.org. Of the 26 drugs listed, five contain previously unpublished data, according to the Globe. Out of the 29 drugs the company markets in the United States, Pfizer disclosed unpublished study results only for its antidepressant Zoloft.
According to the Globe, Merck posted a link to the label of Vioxx and listed two previously published studies, but not the full text of the studies. In addition, Merck did not post information on an unpublished clinical trial conducted in 2000 that showed an increased cardiovascular risk for those taking Vioxx, the Globe reports.
According to the Globe, industry experts maintain that "estimating the amount of unpublished data from clinical trials [is] difficult if not impossible." Officials for GSK, Novartis, Eli Lilly and Bristol-Myers Squibb said they plan to publish information about more than 90 drugs during 2005; however, officials for most drug companies last week said they did not know how many drugs they would post on the government Web site. Industry representatives noted that converting "raw data" from unpublished studies into an "internationally recognized uniform format" is a lengthy process, the Globe reports.
Alan Goldhammer, PhRMA's associate vice president for regulatory affairs, said, "The progress has been fine. We gave people a full year to post things, and the companies are taking that very seriously."
Merck spokesperson Chris Loder said, "Given the voluminous nature, we did not go back and post trials completed prior to '02."
Sens. Edward Kennedy (D-Mass.), Christopher Dodd (D-Conn.), Tim Johnson (D-S.D.) and Ron Wyden (D-Ore.) have sponsored a bill, and Reps. Edward Markey (D-Mass.) and Henry Waxman (D-Calif.) sponsored a companion bill (HR 5252) in the House that would make the disclosure of all clinical trial results mandatory.
Senate Finance Committee Chair Chuck Grassley (R-Iowa) also is "considering" legislation, the Globe reports.
Journal of the American Medical Association Associate Editor Drummond Rennie called the industry's efforts to date to post unpublished information "pathetic." He added, "They get all the publicity from saying they will do it, and then they don't."
New England Journal of Medicine editor in chief Jeffrey Drazen called the slow start "not at all surprising," saying that drug companies' "past behavior suggests that would be a legitimate reason for what's going on right now." He noted that the unpublished information does not "fit into a template" and "[e]veryone's kind of putting stuff in their own way."
Markey said that the voluntary disclosure system is "set up like a poker game. The less information you give, the more money you are likely to make."
Sidney Wolfe, director of Public Citizen's Health Research Group, said, "These sporadic, inconsistent, partial responses by a few companies have to be viewed as thinly disguised public relations efforts" (Boston Globe, 1/10).