December 17, 2004
Another Human-Research Imbroglio
As reported by the Associated Press (courtesy of Yahoo!News), "[a] pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say":
Family members of Joyce Ann Hafford say the 33-year-old HIV-positive woman died without ever holding her newborn boy. They also said they never were told the National Institutes of Health (news - web sites) concluded the drug therapy likely caused her death.
The family first learned of NIH's conclusions when The Associated Press obtained copies of the case file this month. For the past year, they say they were left to believe Hafford, of Memphis, Tenn., died from AIDS complications but began pursuing litigation to learn more.
One recurring theme in this story is the utter ineffectualness of informed consent in research settings:
[Dr. H. Clifford] Lane [NIH's No. 2 infectious-desease expert] said Hafford should have signed a 15-page, NIH-approved consent form at the start of the experiment specifically warning her of the risks of liver failure. The family says Hafford seemed unaware of the liver risks. They even kept the bottle of nevirapine showing it had no safety warnings.
"My daughter didn't know any of the warning signs," said Rubbie Malone, Hafford's mother and now caretaker of Hafford's new baby and older son. "She never got to hold her baby."
Lane confirmed the nevirapine bottle Hafford received likely wouldn't have had safety warnings because the experiment's rules called for the patient to be unaware of the exact drug effects to avoid patient influence on the test results. That means the consent form would have been her lone warning about potential liver problems, he said.
That 15-page, single-spaced consent form is chock full of complex medical terms like "hypersensitivity reactions" and "pharmacokinetic test." The warning about potential liver problems shows up on the sixth page, where it said liver inflammation was possible and "rarely may lead to severe and life threatening liver damage and death."
The story also raises questions about the quality of care in Hafford's case: "NIH's documents suggest Hafford's life might also have been spared if the drug had been stopped when the first liver problems showed up in her blood work two weeks before death":
"Ouch! Not much wwe (we) can do about dumd (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.
December 17, 2004 | Permalink