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 yesterday.
Dr. Jonathan Fishbein said officials at the National Institutes of Health (NIH) overlooked problems with the way the study was being conducted on the AIDS drug, nevirapine, 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,” Dr. Fishbein said at a hearing before a panel of scientists at the independent Institute of Medicine. The Institute was asked by NIH to review the Uganda study.
Dr. Fishbein did not draw any conclusions about whether nevirapine is a safe or effective drug. Instead, he discussed a number of problems with the practices of the researchers involved in the study. He criticized data collection, record-keeping and quality control.
Because of those concerns, he said, the results of the study could not be trusted. “We can ill-afford to entrust the lives of people to invalid data,” the doctor said.
NIH has acknowledged that the Uganda research failed to meet required U.S. standards. But it maintained that hundreds of thousands of African babies have been saved by using single doses of the drug to block the AIDS virus and that it can be done safely with those single doses.
Nevirapine is an antiretroviral drug used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects, such as 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.
Dr. 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 nevirapine to pregnant women and their babies to prevent HIV transmission.
Dr. 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,” he testified.
The doctor 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 clinics reopened.
Documents show NIH knew of problems with the study in early 2002, but did not tell the White House before President Bush approved a $500 million plan that summer to use nevirapine throughout Africa.
Dr. Fishbein said he is being fired in retaliation for speaking out, but the agency said he is being let go because of poor performance during his probation period.