Publishers wary of NIH plan

Publishers, patient advocates and fiscal conservatives are balking at a government transparency plan on healthcare research, claiming it would put publications out of business, hamper medical research and waste taxpayer money.

The public-comment period closed this week on a National Institutes of Health (NIH) proposal that would create a database that includes all NIH-funded research studies. These data would have to be made available no later than six months after their publication.

The NIH said the plan would make research funded through taxpayer money available “in a timely fashion to other scientists, healthcare providers, students, teachers, and the many millions of Americans searching the web to obtain credible health-related information.”

But some publishers warn that this could put niche publications out of business and harm the public good. While the opponents of the proposal say they support more public access, they feel the NIH approach could also “have a chilling effect on research output.”

Publishing houses such as Wiley and Elsevier say they are already spending millions to give broader access to information but making NIH-backed research available after only six months could mean the end for niche publications that recoup the cost of editing and the peer-review process through subscriptions.

Colette Bean, executive editor of Wiley, pointed out that, while the NIH is funding the research, it does not pay for the final product. She also lamented that no open hearings were held on the issue and said there was not enough dialogue between the affected parties. Bean and other publishers, such as Brian Nairn, CEO of the health-science division of Elsevier, said the policy, which is intended to give more people access to information, could result in less information being put out.

In an editorial, the New England Journal of Medicine, one of the most prominent of the research publications, supported the NIH proposal. The publication is already making all of its research articles available at no cost on the Internet six months after their publication.

But the journal’s vice president for publishing, Chris Lynch, pointed out that other publishers have “legitimate concerns” about being able to recoup their expenses.

“You can’t look at one journal and draw conclusions across the scene,” Lynch said.

Language supporting the creation of the NIH database has been included in the pending House labor, health and education appropriations bill. But in a letter to appropriators, Council for Citizens Against Government Waste (CCAGW) President Thomas Schatz urged that the language be struck.

He criticized Congress for adding a provision that “may sound reasonable” at first glance without congressional hearings, adequate outreach “to obtain information or evaluate possible consequences of this proposal” and no cost estimate.

The CCAGW sees the NIH proposal as a government program that is trying to compete with the private sector. Schatz predicts that some journals will decide not to publish peer-reviewed articles that have been funded, in part or fully, with NIH money. That, Schatz said, “could force researchers” that accepted federal funds “to turn to the NIH for peer review instead. Ultimately, costs to taxpayers will rise.”

“The process will invite censorship or politicization of science and medical research,” Schatz said, adding, “Even worse, some publishing firms or professional associations may simply cease to exist, limiting the amount of information available to the public in a timely manner.”

Patient advocacy groups also said the plan could backfire. In a comment to NIH, the American Cancer Society, the American Diabetes Association and the American Heart Association asked the agency to ensure that the plan does not “inadvertently detract from the goal of conducting and promoting quality research that ultimately promotes patient health.”

Specifically, the groups said that the NIH must make certain that the proposal does not jeopardize the peer-review process and that the database does not drain funding from research.

Peter Banks, a publisher with the American Diabetes Association, said that while the NIH estimates the cost of the proposal to be less than $5 million, he envisions that the cost could spiral tenfold. Others said the program could be even more expensive.

In addition, the patient-advocacy groups said that, to be a valuable tool, the planned repository must be accessible and easily searchable. They suggested that articles should appear in context of existing information on the issues they cover.

An NIH spokesperson declined to comment on the issue before the end of the comment period but said all input would be reviewed carefully before formulating a policy.

on a National Institutes of Health (NIH) proposal that would create a database

Any time I see Health and Database in the same sentence I get concerned.

Sen. Hillary Clinton (D-N.Y.) urged NIH Director Elias Zerhouni in a letter last month to weigh carefully all comments on the new policy to “avoid any unintended consequences that might undermine the goals of open access and the journals and nonprofit societies that are the backbone of the current research literature infrastructure.”

Sen. Hillary is still an idiot, there are clauses in each grant or contract for NIH studies or any other federal agreement, that guarantee that the results remain within the Federal Government, they can use it any way they choose. The contractor or grantee can also use the research as they choose. Look at the FAR or the OMB Circulars, the government owns what they pay for. Besides what is the "research literature infrastructure"?????

Ok, I'm a moron. Could you explain your position(s) a bit more? Always good to meet a freeper that knows what he/she is talking about. Is patient privacy an issue here?

Look at the FAR or the OMB Circulars, the government owns what they pay for.

Great rant. Good or bad?

HIPAA laws cover patient privacy and data security issues.

There are 2 concerns on the new policy:

1) It may greatly increase the cost of doing research by adding a whole new layer of bureaucracy. There will be strict rules applied as to when the study results must be posted.

2) There is some concern that it may interfere and undermine the normal peer-review process through journals.

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