Federal officials involved in a U.S.-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices, a government whistleblower said Tuesday.
Dr. Jonathan Fishbein said officials at the National Institutes of Health overlooked safety problems with the drug, which was being used to protect babies in Africa from HIV infection during birth.
The consequences of their failure "have grave and sometimes fatal implications for the lives of real patients," Fishbein said at a hearing before a panel of scientists from the independent Institute of Medicine.
The hearing marked Fishbein's first public testimony since a series of articles by The Associated Press detailing problems with the project.
Fishbein, who is fighting a decision by NIH to fire him, is one of several employees at the government's premier health research agency to question the Uganda study. It involved giving the AIDS drug, nevirapine (search), to pregnant women to prevent HIV transmission to their babies.
NIH has acknowledged that the Uganda research failed to meet required U.S. standards. But it maintains hundreds of thousands of African babies have been saved by using single doses of the drug to block the AIDS virus.
Nevirapine is an antiretroviral drug (search) used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects like liver damage when taken in multiple doses over time.
New concerns have surfaced more recently that nevirapine also may cause long-term resistance in patients to further AIDS treatments. It is marketed in the United States as Viramune (search).
Fishbein, an expert hired by NIH to improve agency research practices, said top officials at NIH became "so heavily invested in the (Uganda) trial's outcome" that they could not be objective.
"The old adage 'garbage in, garbage out' is apt," Fishbein said.
Fishbein cited shoddy data collection, record-keeping and quality control issues. "We can ill afford to entrust the lives of people to invalid data," he said.
Fishbein told NIH's AIDS research chief in 2003 that the Uganda study should not be resumed. The agency had stopped the research for 15 months after auditors, medical experts and others disclosed problems with the project.
The concerns were dismissed, and the clinic reopened.
Documents show NIH knew of problems with the study in early 2002, but did not tell the White House before President Bush launched a $500 million plan that summer to use nevirapine throughout Africa.
Fishbein says he's being fired as retaliation for speaking out, but the agency says he's being terminated because of poor performance during his probation period.