-Caveat Lector- from: http://www.washingtonpost.com/wp-srv/WPlate/1999-04/05/003l-040599-idx.html <A HREF="http://www.washingtonpost.com/wp-srv/WPlate/1999-04/05/003l-040599-idx.h tml">Research Law Fight: Right to Know, or to Squelc </A> ----- Research Law Fight: Right to Know, or to Squelch? By John Schwartz Washington Post Staff Writer Monday, April 5, 1999; Page A07 It seemed like such a simple idea at first: Make all data from federally funded scientific research more available to the public. How could anyone, especially scientists, be against openness and the public's right to examine or better understand science? But it has turned out to be far from simple. The federal law intended to make that happen has triggered loud and angry opposition from the scientific community. "This is a meat-ax approach to access to data when it's actually a fine scalpel that's required," said Mary Ellen Sheridan of the University of Chicago at a recent forum on the issue held at the American Association for the Advancement of Science. Scientists and the institutions they work for say the law will add to the costs of research, will be used to harass and intimidate researchers whose work angers powerful interest groups and companies, and could expose their work to the prying eyes of potential academic and commercial competitors. They contend that it will even imperil the privacy of people who volunteer for research projects. Sen. Richard C. Shelby (R-Ala.) said he sponsored the bill, passed by Congress at the end of last year, after he was refused access to Harvard School of Public Health studies that the Environmental Protection Agency used to develop controversial new air pollution rules. EPA Administrator Carol M. Browner said she could not release the data because it belonged to Harvard; the university had refused to hand the data over to critical industry groups such as the American Petroleum Institute. The Harvard researchers eventually turned the data over to a third party for review, but Shelby wasn't mollified. "The taxpayers are paying billions of dollars for scientific research that they have a right to have access to," Shelby said. "Any study ought to be able to be defended, if it's worth publishing, if it's worth making policies over. . . . I think that's just common sense." Now some lawmakers are trying to repeal the law, which makes federally funded research subject to the Freedom of Information Act (FOIA). "This is clearly one of those things that becomes more complicated the more we look at it," said Jean Fruci, an aide to Rep. George E. Brown Jr. (D-Calif.), who has introduced a repeal bill. "You spend a little bit of time up here on the Hill, when something looks too good to be true, you know you're in trouble," Fruci said. Brown does not question Shelby's motives in passing the original bill, and Fruci noted that Congress passed the law and President Clinton signed it. "If it's a mistake, it's a bipartisan mistake." But drug companies, too, have expressed reservations about the law. It is "potentially chilling on the conduct of clinical trials--which is certainly not good public policy," said Chuck Ludlam, vice president for government relations at the Biotechnology Industry Association. The Pharmaceutical Research and Manufacturers of America has voiced similar worries about patient confidentiality and trade secrets. The Office of Management and Budget (OMB) has made an initial attempt to draft regulations based on the new law, narrowing its scope to apply only to published research and to research that is used as the basis for making federal policy or rules. But those who oppose the law say it cannot be tinkered into better shape. "FOIA is really a blunt instrument when it comes to striking the right balance" between the need to share data and to protect researchers and their work, said Nils Hasselmo, president of the American Association of University Professors. In a recent letter to the OMB, Hasselmo wrote: "We do not believe it is possible for OMB to allay these concerns given the problems inherent in the underlying statute." Shelby staff members said FOIA has exceptions to protect commercially sensitive information and confidential medical information. Scientists and institutions opposing the new law say their fears that the law will be used to harass are not idle speculation: State open records laws, they say, have already been used to punish researchers whose results anger powerful companies and patient-advocacy groups. Oregon drug researcher Bruce Psaty, for example, contends that his work on the health risks of drugs known as calcium channel blockers was met with harassing investigations by drug companies. "These public records laws that were supposed to protect the public were really subverted in behalf of private interests," he said. Similarly, Paul Fisher, a Georgia-based doctor, said his state's laws helped drive him out of research altogether. He published an influential 1991 article that found that more than half of children between the ages of 3 and 8 recognized R.J. Reynolds Tobacco Co.'s cartoon camel character and identified "Old Joe" with cigarettes. The company vigorously attacked the studies, and R.J. Reynolds lawyers used Georgia's open records acts to demand access to "everything in my office," even the names of the children Fisher interviewed, he said. "Their goal was harassment of me," Fisher said, "and that has nothing to do with science." The open records law, he said, protects companies that want to harass scientists and keep them from doing commercially sensitive research. "What their lawyer said in court was that they were going to knock on the children's doors and ask them if they actually said what I claimed they said in my study" more than two years after the fact, he said. Fisher, who had promised the families confidentiality, refused. His university sided with the company, however, and Fisher left academia for the private practice of medicine. "I didn't feel it was reasonable to continue on as a faculty member" considering the school's position, Fisher said. Guy M. Blynn, a deputy general counsel for R.J. Reynolds, said that "as soon as the objection was raised, everybody recognized that we didn't need and didn't want to bother the parents and these 3- and 6-year-old children." Officials initially simply wanted to confirm that Fisher had actually performed interviews. "This comes down to a very, very simple issue," Blynn said. "If Fisher and other researchers have nothing to hide, then why do they try to hide their data?" Blynn said Fisher's work was deeply flawed because the children were not asked their attitudes about smoking; the company's own research suggests that children with the highest Old Joe recognition disliked smoking most. George Thurston, an associate professor at the New York University School of Medicine, said the threat to patient privacy could have the most far-reaching effects. Patients, he said, may refuse to participate in studies "because they know someone can force us to turn over the data. So what's the result? You don't do the research, which I think is one of the intents of the law." © Copyright 1999 The Washington Post Company ----- Aloha, He'Ping, Om, Shalom, Salaam. Em Hotep, Peace Be, Omnia Bona Bonis, All My Relations. Adieu, Adios, Aloha. Amen. 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