"The studies are connected to drugs being developed by Eli Lilly & Co., an Indianapolis pharmaceutical firm with close ties to the university..." ---------------------------------------------------------------------------- Science and Health ---------------------------------------------------------------------------- NIH Probes Indiana Researchers ASSOCIATED PRESS WASHINGTON (AP) -- Federal officials have sent a letter to Indiana University seeking more information on allegations that medical researchers there are using homeless people as test subjects. Gary B. Ellis of the office of Protection from Research Risk at the National Institutes of Health said Friday that the letter was prompted by media reports that homeless and alcoholic people were being recruited for clinical studies at a hospital affiliated with Indiana University. Use of such "vulnerable people" is restricted by federal regulations. Inquiry letters like that sent to Indiana are usually the first step in an investigation by the NIH agency, Ellis said. He noted, however, that only a small percentage of such letters results in follow-up investigations. The issue at Indiana University, said Ellis, is whether or not proper informed consent has been obtained from test subjects recruited for Phase I drug tests conducted at Wishard Memorial Hospital at the Indiana University medical school. The studies are connected to drugs being developed by Eli Lilly & Co., an Indianapolis pharmaceutical firm with close ties to the university. Under federal regulations, Ellis said, informed consent is only possible if there is no undue influence or coercion of test subjects. The regulations specifically warn against influencing "certain vulnerable populations," that include the economically disadvantaged, such as homeless people, he said. Ellis said no investigation is under way and the agency is awaiting an answer from the university to a series of questions in the letter. "This letter is part of an ongoing evaluation," he said. Before a pharmaceutical company can start human drug tests, it has to receive approval from the federal government. A part of the process is an evaluation of the proposed experiment by an independent board of scientists. The committee giving approval to tests of Lilly drugs often is the Indiana University Institutional Review Board. For that reason, Ellis said, the letter of inquiry was sent to Indiana University instead of to Lilly. Calls for comment from two offices at the Indiana University medical school were not returned on Friday. On Nov. 14, The Wall Street Journal reported that Eli Lilly routinely uses homeless people to test drugs in the Lilly Clinic at Wishard Memorial. The newspaper said Lilly has been rebuked by the Food and Drug Administration for using alcoholics in a study testing a liver drug. The study design specifically excluded people with alcohol abuse problems. An official of Eli Lilly denied that the company uses homeless people to test drugs, noting that 94 percent of the test participants have residential addresses. ---------------------------------------------------------------------------- Previous: AIDS Keeps Spreading in India 23 Dec. 09:33:04 Next: Journal Highlights Research 19 Dec. 15:47:42 Index: Science and Health headlines ---------------------------------------------------------------------------- Questions or problems? Click here. All contents copyright 1996 Las Vegas SUN, Inc. Portions copyright 1996 Associated Press. This page last modified Friday, December 20, 1996 15:43:36
