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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

FDA Study of Imreg is Apparently Tied to Data Submitted on New AIDS Drug




 

Wall Street Journal (07/28/88), P. 11

Imreg Inc., maker of the AIDS drug Imreg-1, is now being investigated by the Food and Drug Administration (FDA) for possible "irregularities in data" it submitted on tests of the drug. A congressional panel is already investigating whether the firm broke FDA rules on pre-approval promotion of the drug. Dr. Arthur Gottlieb, who runs Imreg Inc. with his wife Marise Gottleib, said the investigation was a routine examination tied in with the new FDA priority on speeding access to AIDS drugs. The company claims the drug caused a fivefold reduction in progression from ARC to AIDS among patients in a trial. Questions other researchers have raised about the data include whether patients were improperly grouped according to the relative strengths of their immune systems.



 


Copyright © 1988 -CDC Prevention News Update, Publisher. All rights reserved to Information, Inc., Bethesda, MD. The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles.



Information in this article was accurate in July 28, 1988. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.