NIH To Ease Restrictions in Proposal To Make Public Results of Federally Funded Clinical Trials
NIH has decided to ease restrictions on its plan to provide results of federally funded research to the public, the Washington Post reports. The decision was made "under pressure from scientific publishers," who said that no-cost access to research would lower their profits and reduce their ability to financially support research, the Post reports (Weiss, Washington Post, 1/18).
NIH in September 2004 announced a plan 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 have required federally funded researchers to submit papers to the agency six months after they have been accepted for publication and edited by a journal (California Healthline, 1/10).
In the final version of the plan, the deadline for posting trial results has been extended to one year after publication, the Post reports. According to the Post, the revised plan was scheduled to be announced last week but was "abruptly canceled" by HHS purportedly to "keep it off the federal agenda until after [Tuesday's] confirmation hearings" of HHS Secretary nominee Mike Leavitt.
NIH Director Elias Zerhouni said, "I could not prove that a six-month deadline would not harm a significant part of the industry. The new policy continues to call for release of information as soon as possible after publication, but it really leaves it in the hands of the scientists to decide when."
Some experts said the scaled-back plan could be perceived as "another instance of [NIH] failing to stand up to moneyed interests -- in this case scientific publishers," the Post reports. Rick Johnson, director of the Scholarly Publishing and Academic Resources Coalition, said few subscribers would have cancelled their subscriptions because research represents only a portion of journal content. Some public access advocates said even a voluntary plan could be beneficial, "if the NIH makes clear to its grantees that it is serious about wanting them to participate."
Michael Eisen, co-founder of the Public Library of Science, said, "The next year will tell if [the plan] is working" (Washington Post, 1/18).
The British Medicines and Healthcare Products Regulatory Agency has announced a plan to publish data on side effects collected from patients, the Wall Street Journal reports. MHRA will collect data both online and with printed forms to be distributed in medical offices, and all "basic data" on adverse reactions will be published online, the Journal reports.
Additional information will be available to researchers who maintain ethical and scientifically sound guidelines and agree to protect patient confidentiality. The plan will enable patients "to play their part in making medicines safer and help the experts better monitor drug safety," Undersecretary of Health Lord Warner said.
The British program "appears to be the first effort to publish side-effect data on the Internet," the Journal reports (Whalen, Wall Street Journal, 1/18).