UNITED STATES: AP Exclusive: Woman Died During AIDS Study

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

UNITED STATES: AP Exclusive: Woman Died During AIDS Study

Associated Press (12.16.04) - Thursday, December 16, 2004
John Solomon; Randy Herschaft

Joyce Ann Hafford - who was 33, pregnant, and HIV-positive - enrolled in a federally funded research project in hopes of preventing her newborn from becoming infected. She died last year after doctors continued to administer an experimental drug regimen despite signs of liver failure, government memos say. Family members said they were never told the National Institutes of Health had concluded that the therapy likely caused her death; they learned this from documents recently obtained by the Associated Press.

In July 2003, the Tennessee woman was hospitalized and on a respirator, and top government scientists were monitoring reports of her worsening condition. NIH officials suspected the drug regimen was the cause as it contained nevirapine. Since at least 2000, the government has warned that nevirapine could cause lethal liver damage or rashes when taken in multiple doses over time.

"Ouch! Not much [we] can do about [dumb] docs," Dr. Edmund Tramont, chief of NIH's AIDS Division, wrote in an e-mail after his staff reported that physicians continued giving Hafford nevirapine and Combivir despite signs of liver failure.

NIH officials acknowledge that experimental drugs - probably nevirapine - caused Hafford's death, and that keeping this information from her family was inappropriate, but said they usually leave such disclosures to the treating physicians. Results of the study in which Hafford was enrolled led researchers to conclude that "continuous nevirapine may be associated with increased toxicity among HIV-1 infected pregnant women" with certain liver cell counts.

Dr. H. Clifford Lane, the second-ranking infectious-disease specialist at NIH, said Hafford should have signed an NIH- approved consent form at the outset. The warning about the possibility of liver failure appears on the sixth page of the 15-page document, which is filled with complex medical terminology.

Hafford's infant, Sterling, was delivered prematurely by Caesarean section. Hafford died less than 72 hours later, on Aug. 1, 2003. The baby was not HIV-infected. He and Hafford's older son are being reared by Hafford's mother, Rubbie Malone.

NIH's official review said Regional Medical Center in Memphis, where Hafford died, failed to react to lab tests showing she was experiencing liver failure well before her death. Jim Kyle, attorney for the hospital, declined comment due to the family's pending litigation.

In response to Hafford's death, NIH ordered changes in the rules its researchers follow in nevirapine studies to ensure early detection of liver problems, according to memos. Dr. Jonathan Fishbein, NIH's chief of good research practices, is seeking federal whistleblower protection after raising concerns about NIH's practices.
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