8 - The Michigan Daily - Tuesday, December 14, 2004 NEWS A U.S. officials warned of concerns against AIDS drug Health center failed to inform administration of dangers of drug used to fight AIDS in Africa WASHINGTON (AP) - Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned that research on the key drug was flawed and may have underreported severe reactions including deaths, government documents show. The 2002 warnings about the drug, nevirapine, were serious enough to suspend testing for more than a year, let Uganda's government know of the dangers and prompt the drug's maker to pull its request for permission to use the medicine to pro- tect newborns in the United States. But the National Institutes of Health, the gov- ernment's premier health research agency, chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution, according to documents obtained by The Associ- ated Press. "Everyone recognized the enormity that this decision could have on the worldwide use of nev- irapine to interrupt mother-baby transmission," NIH's AIDS research chief, Edmund Tramont, reported March 14, 2002, to his boss, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The documents show Tramont and other NIH officials dismissed the problems with the nevi- rapine research in Uganda as overblown and were slow to report safety concerns to the Food and Drug Administration. NIH's nevirapine research in Uganda was so riddled with sloppy record keeping that NIH investigators couldn't be sure from patient records which mothers got the drug. Instead, they had to use blood samples to confirm doses, the documents show. Less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Health and Human Services Department sent a nine- page letter to Ugandan officials identifying violations of federal patient protection rules by NIH's research. Africa accounts for more than two-thirds of the world's AIDS cases, with 27 million infected. The NIH research "may have represented a failure to minimize risk to the subjects," the Office of Human Research Protections told Ugandan authorities in summer 2002. Nevertheless, NIH officials told AP they remain confident after re-reviewing the Ugan- da study and other research that nevirapine can be used safely in single doses by African moth- ers and children to prevent HIV transmissions during birth. But they acknowledged their Uganda research failed to meet required U.S. standards. As a result, NIH recently asked the National Academy of Sciences to investigate its science in the case, and has spent millions in the last two years improving its safety monitoring and record keeping. "I would say there are many lessons that we have learned from this review that will help us do our clinical research, both domestically and internationally, much better," said H. Clifford Lane, NIH's No. 2 infectious disease official. Senate Finance Committee Chairman Charles Grassley (R-Iowa) has asked the Justice Depart- ment to investigate NIH's conduct. In a letter released yesterday, Grassley said he was com- pelled to do so by "the serious nature of these allegations and the grave implications if the alle- gations have merit." One lesson already derived from a closer review of the Uganda research is that even single doses of nevirapine can create instant resistance, meaning patients may not be able to use the drug or others in its class again when her AIDS wors- ens, Lane said. "It was unexpected, and what it means is nevi- rapine probably shouldn't be a drug of first choice if other options are available," Lane said. Lane said NIH officials were aware in spring 2002 about the impending White House announcement on nevirapine but did not tell presidential aides of the problems because they were confident, even before reviewing the Uganda research, that the underlying science was solid. The White House - though unaware of the NIH concerns - also remains confident in Bush's $500 million plan in 2002 to send nevi- rapine to Africa. Bush approved $2.9 billion for global AIDS fighting next year. "The president's mission is to try to stop the spread of AIDS in Africa and to come at it from a new angle, and that is what this is all about," spokesman Trent Duffy said. Nevirapine is an antiretroviral drug marketed in the United States as Viramune that has been used since the 1990s to treat adult AIDS patients and is known to have potentially lethal effects like liver damage and severe rashes when taken over time. In 1997, NIH began studying in Uganda whether it could be given safely in single doses to stop mother-to-baby transmissions. That research showed it could reduce transmission in as many as half the births. But by early 2002, an NIH auditor, the agen- cy's medical safety experts and the drug's maker all disclosed widespread problems about the U.S.- funded research in Uganda. Boehringer Ingelheim, the Connecticut-based Edmund Tramont, chief of the National institutes of Health AIDS Division, stands in the Natcher Building on the NIH campus during a break at an AIDS symposium in Besthesda, Md. company that makes nevirapine, told NIH it iden- tified at least one "critical compliance issue" that compromised the integrity of the study and more than four dozen issues it described as "serious" and "major." Boehringer and NIH auditors cited concerns such as failing to get patients' consent about changes in the experiment, administering wrong doses and delays and underreporting of "fatal and life threatening" problems. "It appeared likely, in fact, that many adverse events and perhaps a significant number of serious adverse events for both mother and infant may not have been collected or reported in a timely manner," Westat Corp. reported in March 2002. Westat is a professional medical auditing firm hired by NIH to visit and audit the Uganda site. 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REGISTRAR'S BULLETIN BOARD WINTER TERM CLASSES BEGIN JANUARY 5, 2005 WINTER TERM REGISTRATION Registration, drop/add, modify, and swap transactions are available on Wolverine Access (http://wolverineaccess.umich.edu) from your appointment time through midnight on January 25. The wait list option is available through January 4. Please check the main menu for hours of operation. If you need to obtain PERMISSION for a class e Contact the department obtain an electronic permission e Add the class via Wolverine Access Beginning the first day of the term, a late registration fee will be assessed for all initial registrations. 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