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Whistleblower says U.S. bungled AIDS study

/ Source: The Associated Press

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 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,” 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.

NIH’s No. 2 infectious disease official, Dr. H. Clifford Lane, said there were record keeping problems with the study and that it failed to meet some required U.S. standards. But, he said, using single doses of the drug is safe and is saving lives in Africa.

“While some of the technical aspects of reporting could have been better, 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.

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 cited shoddy data collection, record-keeping and quality control issues.

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,” Fishbein 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.

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.

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 nevirapine to pregnant women and their babies to prevent HIV transmission.

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.

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.