Woman died during AIDS government-funded study

Joyce Ann Hafford died without ever holding the son she had tried to save from AIDS by taking an experimental drug regimen administered by government-funded researchers during her pregnancy. But even before her stunned family could grieve, the death of the 33-year-old Memphis, Tenn., woman was reverberating among the government's top scientists in Washington. They quickly realized the drugs she was taking likely caused the liver failure that killed her. Reports of her declining health were being monitored in late July 2003 at the National Institutes of Health as she lay on a respirator, and the case eventually reached the nation's chief AIDS researcher, according to documents obtained by the Associated Press. "Ouch! Not much we can do about dumb docs," Dr. Edmund Tramont, NIH's AIDS Division chief, responded in an e-mail after his staff reported that doctors continued to administer the drugs nevirapine and Combivir to Hafford despite signs of liver failure. Nevirapine is an antiretroviral AIDS drug used since the mid-1990s, and the government has warned since at least 2000 that it could cause lethal liver problems or rashes when taken in multiple doses over time. Hafford's family says they were never told NIH had concluded that the experimental drug regimen likely caused her death until AP gave them copies of NIH's internal case documents this month. They were left to believe Hafford had died from AIDS complications but began pursuing litigation to learn more. "They tried to make it sound like she was just sick. They never connected it to the drug," said Rubbie King, Hafford's sister. "If it were the disease, solely the disease, and the complications associated with the disease, that would be more readily acceptable than her being administered medication that came with warnings that the medical community failed to get ... to her." NIH officials acknowledge that experimental drugs, most likely nevirapine, caused her death, and that keeping the family in the dark was inappropriate. But NIH usually leaves disclosures like that to the doctors who treated her. [more]