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NIH Revises Plan for Quick, Free Access to Study Results

By Rick Weiss
Washington Post Staff Writer
Tuesday, January 18, 2005; Page A15

An ambitious proposal to make the results of federally funded medical research available to the public quickly and for free has been scaled back by the National Institutes of Health under pressure from scientific publishers, who argued that the plan would eat into their profits and harm the scientific enterprise they support.

The initial plan, encouraged by Congress and hailed by patient advocacy groups, called for the results of NIH-funded research to be posted on a publicly accessible Web site within six months after they are published in a scientific journal. Most research results now are available only by subscription to the journal -- at a cost that often reaches into the thousands of dollars -- or on a pay-per-article basis that can cost $100 or more for two or three articles.

NIH Director Elias A. Zerhouni denied that the agency had buckled under industry pressure.

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It was not until the early 20th century that the Senate enacted rules allowing members to end filibusters and unlimited debate. How many votes were required to invoke cloture when the Senate first adopted the rule in 1917?

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In the final version of the plan, however, the recommended six-month deadline for posting results has been stretched to a year. That change has angered many advocates of public access, who have argued it isn't fair that taxpayers must either wait or ante up to see the results of research they have already paid for.

A scheduled announcement of the policy was abruptly canceled last week by the Department of Health and Human Services, of which NIH is a part. Two sources within the department, speaking on the condition of anonymity because they are not authorized to speak for the department, said the announcement was delayed in order to keep it off the federal agenda until after today's confirmation hearings for Michael Leavitt, President Bush's nominee to become HHS secretary.

Sensitivities about the relationship between NIH and private industry are especially high these days. The agency has been pilloried in the past year by Congress and others for allowing many of its scientists to collaborate with drug and biotech companies in lucrative deals that raise conflict-of-interest issues. Several NIH-watchers said one reason for canceling the rollout of the new plan might have been to avoid calling attention to what could be perceived as another instance of the agency failing to stand up to moneyed interests -- in this case scientific publishers, the largest of which have enjoyed skyrocketing profit margins of 30 percent or more in recent years.

"There's been so much embarrassment flying around about transparency and the public interest at NIH, it's just coming to a head," said Bob Witeck, a spokesman for the Alliance for Taxpayer Access, a coalition of groups favoring easier access to publicly funded scientific findings.

Several business coalitions -- including the Association of American Publishers, whose president is Patricia Schroeder, a former congresswoman from Colorado -- had lobbied strenuously against the initial proposal, which they said would jeopardize many journals' existence by undercutting their paid subscriber base.

"The publishers were crawling all over the place," said Rick Johnson, director of the Scholarly Publishing and Academic Resources Coalition, an alliance of academic and research libraries trying to change the current system. He and others have argued that few scientists or libraries would cancel their subscriptions just because NIH-funded content was available free elsewhere, because such research represents only a fraction of the content of most journals.

Johnson also noted that the revised policy of asking scientists to post their results within 12 months of publication was a minimal request, because many journals already make their content freely available on the Internet after a year. (The policy has focused on getting scientists to post their results on a centralized, government Web site rather than trying to force journals to make their pages public, which raises copyright and other issues.)

NIH Director Elias A. Zerhouni denied that the agency had buckled under industry pressure. Zerhouni said in a telephone interview that there are so many different kinds of publishers -- including many nonprofit publishers run by scientific societies, which reinvest their profits in scientific and educational endeavors -- that it did not make sense to demand a six-month release deadline for all.

"I could not prove that a six-month deadline would not harm a significant part of the industry," Zerhouni said. "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. What's important is that we're creating a precedent in which the agency that funds medical research is establishing a public database containing all its scientific output. I am certain that over time people will see this as a win-win."

Some advocates for public access agreed that even a voluntary policy encouraging release within 12 months could result in more access than is available today, if the NIH makes clear to its grantees that it is serious about wanting them to participate.

"The next year will tell if it's working. If a lot of people do it, it won't matter what the language is," said Michael Eisen, co-founder of the Public Library of Science, which publishes scientific journals freely accessible to the public. "What's important is for NIH to convincingly say they're behind it."

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