February 2, 2000

Federal scientific data often flawed when not reviewed
Shelby Amendment improves the quality of federally funded research

Independent review of federally funded research is crucial both for good science and for good public policy, write the authors of a Cato Institute study released today.

Michael Gough and Steven Milloy argue that Public Law 105-277, known as the Shelby Amendment and enacted by Congress in October 1998, is the best way to ensure that regulatory law is based upon sound science. The authors write that federally funded research has frequently been tainted by poor methodology, dubious analysis, faulty data, politicized conclusions and even borderline cases of fraud. The law, which has been under attack, guarantees, through the provisions of the Freedom of Information Act, public access to grantee-collected data that are used in support of rules or regulations.

"The concern that flawed scientific research-immune from independent review-may be used to justify misguided and costly regulations is well grounded in fact. Without independent review of scientific data and methodological practices, policy mistakes are inevitable. The history of public review of federally collected data and analyses reveals the importance of such review in correcting errors made by government officials," the authors write.

The study highlights several important cases in which third-party review revealed shoddy science that the government relied on to justify rules and regulations, including EPA-funded research on airborne asbestos, the National Cancer Institute's research on the herbicide 2, 4-D, the FDA's and the government's campaign against fen-phen and the American Lung Association's research on particulate matter.

"In many of those cases, third-party review served to correct or prevent costly regulatory mistakes. In some cases, however, independent review of federally funded science occurred too late to prevent significant economic and consumer harm. Requiring the government 'to show its work' opens up the regulatory process," conclude Gough, a former staff member at the National Institutes of Health and, Milloy, author of Science without Sense: The Risky Business of Public Health Research.

The Case for Public Access to Federally Funded Research Data