Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Associated Press (12.30.04) - Thursday, December 30, 2004
In the lawsuit, Joyce Ann Hafford's mother and sister allege that doctors continued giving Hafford the AIDS drugs - intended to protect her baby from HIV - despite signs of liver failure, and that the patient was not warned of the trial's dangers. Hafford's family seeks $10 million in damages.
Officials at the National Institutes of Health quickly suspected Hafford's drug regimen because it contained nevirapine, which is known to cause liver problems. But ever since Hafford's death in August 2003, her family believed her death resulted from AIDS complications. They said they learned only this month - after AP obtained copies of Hafford's case file - that NIH had concluded the drug therapy likely caused her death. The federal government halted its nevirapine research program after Hafford died.
In spring 2003, when she became pregnant, Hafford learned she was HIV-positive. Soon after, hoping to avoid mother-to-baby transmission of HIV, she started the NIH-funded clinical trial of Combivir and nevirapine (Viramune). Her baby boy, who was delivered prematurely by Caesarean section less than 72 hours before Hafford died, is HIV-negative.
Defendants named in the lawsuit include several doctors and nurses who treated Hafford, Regional Medical Center in Memphis where the drugs were administered, and drug makers SmithKline Beecham Corp. and Boehringer Ingelheim Pharmaceuticals.
Documents obtained by AP show that information about Hafford's treatment reached Dr. Edmund Tramont, chief of NIH's AIDS Division. "Ouch! Not much [we] can do about [dumb] docs," Tramont wrote in an e-mail after his staff reported that physicians continued giving the drugs to Hafford despite signs of liver failure.
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