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NIH Whistleblower says U.S. bungled AIDS study Research was aimed at protecting babies in Africa

The Associated Press
Jan. 2005

WASHINGTON - 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.

FACT FILE:
What is neviarpine?

The AIDS drug nevirapine, pronounced Nee-VERA-peen, is made by Boehringer Ingelheim Corp. and is marketed under the brand name Viramune. There are two generic versions, Nevimune, made by Cipla, and Nevirex, made by Aurobindo Pharma.

“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.