WASHINGTON -- Sen. Richard Shelby complained loudly when he couldn't get the scientific data behind a federal clean-air proposal. Now it is the scientific community that is screaming foul.
The Alabama Republican inserted a provision in last year's sprawling budget law that the nation's top scientists worry will cripple a broad range of research efforts by knocking down privacy protections. The provision provides the public with unprecedented access to research data developed with federal grants at universities, hospitals and other nonprofit institutions.
Sen. Shelby added the requirement after being frustrated by his inability to gain access to research data developed by Harvard University involving the connection between air pollution and health. The Environmental Protection Agency cited the study two years ago as part of its justification for significantly tightening the nation's air-pollution standards.
Specifically, the senator's provision makes all research -- potentially including raw material such as laboratory journals, field notebooks and computer tapes -- subject to the Freedom of Information Act, a federal law designed to give people access to government's internal documents.
"This measure was long overdue, and it represents a first step in ensuring that the public has access to all studies used by the federal government to develop federal policy," Sen. Shelby said.
'A Meat-Ax Approach'
The potential impact of the obscure provision, largely overlooked by the research community until recently, is now hitting home. "This is a meat-ax approach to access to data when it's actually a fine scalpel that's required," Mary Ellen Sheridan, assistant vice president for research at the University of Chicago, said at a jammed-packed forum on the issue Friday at the American Association for the Advancement of Science.
Bruce Alberts, president of the National Academy of Sciences, agrees, calling the legislation "a completely thoughtless way of trying to solve a problem that requires careful thought." At a recent congressional hearing, Harold Varmus, director of the National Institutes of Health, also expressed dismay.
In response to such concerns, the White House Office of Management and Budget, which must carry out the law, is trying to narrow its scope. In a proposed rule, it seeks to limit the material to that which is used as a basis for federal rules and is related "to published research findings."
But most scientists and research groups aren't mollified, saying no amount of OMB tinkering will fix what they contend is a bad statute. Critics ranging from the Society for the Advancement of Women's Health Research to the University of Minnesota are calling for outright repeal.
Junking the Shelby legislation may be difficult, however, considering that its backers include Senate Majority Leader Trent Lott, a Mississippi Republican. He has described it as a "critical step forward" in increasing public understanding of the science used by federal policy makers.
The contretemps is forcing a close look at an issue that even some scientists say needs re-examination: Who owns and should have access to data produced by taxpayer-financed research?
Prior to the new law, only material contained in federal agency files was covered by the Freedom of Information Act. That hardly ever included underlying scientific data; most agencies rely on research published in peer-reviewed scientific journals. The new law changes that, directing the government to reach into scientists' laboratories and offices and retrieve the requested information. Then, the agency decides which material must be released -- and which is exempt.
George Thurston, associate professor of environmental medicine at the New York University School of Medicine, says the situation is ripe for abuse by vested interests. For example, he says, state FOIA laws sometimes have been used as a weapon to try to discredit scientists conducting tobacco research. "I think this certainly could be used as an intimidation tactic," says David Korn, a senior vice president at the American Association of American Medical Colleges.
But some scientists say that the research community has only itself to blame because it hasn't been conscientious enough in sharing the fruits of its federally-funded work with the public. Federal funding, says Roger McClellan, president of the Chemical Industry Institute of Toxicology, "is a two-way street" -- especially when the research produced is used for major, potentially costly decisions.
The Harvard School of Public Health's air-pollution studies, which tracked the health of 8,000 people in six cities for two decades, have been a particular target of industry criticism. At a hearing in the spring of 1997, Sen. Shelby asked EPA Administrator Carol Browner to release the data so that other scientists could reanalyze the data to see if they reached similar conclusions. She declined, saying the material belonged to Harvard.
The university also refused to hand over the information, though eventually a compromise was struck: The data went to an independent institute funded both by the automobile industry and the EPA.
Business Support
Business groups that view federal regulators -- especially the EPA -- as overzealous staunchly support Shelby's approach and will battle the provision's repeal. They include the American Petroleum Institute and the Small Business Survival Committee. Karen Kerrigan, president of the small-business advocacy group, calls the legislation an antidote to "junk science" and "politically driven science."
The biotechnology and drug industries have a different take on the issue, however. They often collaborate with university researchers funded by federal grants, and are worried that a premature disclosure of data could render a hefty private investment worthless. Such concerns recently prompted the Biotechnology Industry Organization, which represents 800 biotech companies and suppliers, to endorse a bill by Democratic Rep. George Brown of California to repeal the Shelby provision.
The Pharmaceutical Research and Manufacturers Association, which represents the brand-name drug manufacturers, also is worried about the legislation, which, according to one official, raises "big problems" in terms of patient confidentiality and proprietary information.
Nonsense, says Shelby spokeswoman Andrea Andrews, who notes that the FOIA law has several exemptions that would prevent the disclosure of confidential medical and proprietary information. Kathy Casey, another Shelby aide, adds that the pending OMB rule can impose additional safeguards so that sensitive information isn't released.
Scientists say that, in any case, the issue isn't going away and must be addressed. "I don't want to be in the position of saying that public accountability isn't appropriate," says Samuel Thier, chief executive officer of Partners Healthcare, the parent of Massachusetts General Hospital and Brigham & Women's Hospital in Boston.
His preferred solution: Have the National Academy of Sciences conduct a study to figure out how to provide better public access for critical research data. He asks, "Why not have the academy figure out an ethical standard for sharing data developed with federal funds?"
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