U.S. Screwed the Pooch on AIDS Study

A U.S.-funded study on an AIDS drug was so poorly conducted that it potentially put the lives of hundreds of mothers and babies in Uganda at risk, a government whistleblower said Tuesday.

Dr. Jonathan Fishbein said officials at the National Institutes of Health overlooked problems with the way the study was conducted on the drug, nevirapine, which was being used to protect babies in Africa from HIV infection during birth.

Fishbein testified before a panel of scientists at the independent Institute of Medicine. NIH, which maintains that the drug is safe in single doses, asked the institute to conduct the review.

In his testimony, Fishbein accused NIH of a double standard, saying the project in Uganda would not have passed muster with federal health officials in the United States.

“The actions of the NIH reveal a callous indifference to the fate of Africans,” Fishbein said. “African life, it would appear, is not to be valued as highly as American life.”

NIH’s No. 2 infectious disease official, Dr. H. Clifford Lane, acknowledged there were record-keeping problems with the study. Even so, he said, the drug is saving lives in Africa.

“The overall conclusions remain valid that single doses of nevirapine given to the mother during labor and given to the child shortly after birth were safe and could reduce the spread of HIV disease from mother to baby,” Lane said in an interview with The Associated Press.

Fishbein did not draw any conclusions about whether nevirapine is a safe or effective drug. Instead, he cited shoddy data collection, careless record-keeping and quality-control issues as some of the problems with the study.

Because of those problems, he said, the results of the study could not be trusted.

“They (NIH) rushed to defend the study without really looking closely at what the problems were, the egregious problems in the study. And they kept defending it and digging themselves deeper and deeper into a hole they couldn’t get out of,” he said.

Nevirapine is an antiretroviral drug 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.

Concerns surfaced more recently that nevirapine also might cause long-term resistance to further AIDS treatments. It is marketed in the United States as Viramune.

The hearing marked Fishbein’s first public testimony since a series of articles by the AP 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. He was hired by NIH to improve agency research practices.

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 clinics 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.