December 15, 2004
Regula wants answers in drug-trial flap
By Paul M. Krawzak
Copley News Service
WASHINGTON — A federal health agency’s failure to follow its own rules while testing an anti-AIDS treatment has Rep. Ralph Regula concerned. Regula, R-Bethlehem Township, is seeking more information before deciding whether to launch a congressional inquiry.
Regula responded Tuesday to stories distributed by the Associated Press, which reported that the National Institutes of Health violated its own patient protection rules while testing the drug nevirapine in Uganda. The medicine is used to prevent the transmission of HIV from infected mothers to their children.
“This is a pretty serious charge,” said Regula, whose position as chairman of a House appropriations subcommittee gives him oversight authority over the NIH.
NIH acknowledged in a statement Tuesday that there were “procedural flaws” in the drug trials, which began in 1997.
But the agency maintains that multiple reviews of the trials have concluded that the drug is safe and effective when administered in single doses to mother and child.
NIH said the drug reduces the risk of mother-to-child HIV transmission by 50 percent.
“The simple and cost-effective nevirapine regimen has been used in developing countries to prevent HIV infection in thousands of infants,” the agency said. “It represents a major public health advance and is one of the true success stories in HIV prevention.”
The U.S. Department of Health and Human Services warned Ugandan officials that the NIH research “may have represented a failure to minimize risk to the subjects” of the trials, the AP story said.
Reviews of the trials discovered failures to get patients’ consent to changes in the experiment, the administration of wrong doses and underreporting of “fatal and life-threatening” problems.
The story also said the agency never told the White House about the problems before President Bush announced a $500 million plan to distribute the medicine across Africa.
“I’m waiting for more facts,” Regula said. “I’m not sure where the fault lies, whether they were not diligent in insuring that this drug was OK or whether Uganda was delinquent in the way they used the medicine.”
Regula said the agency was responsible for providing safe medicine.
“You can’t really expect Uganda to police the quality of the vaccine that we send them,” he said. “They have to be able to rely on the NIH ... We have a duty if we’re going to promote this program to make sure that we send them good material.”
Late last week, Senate Finance Committee Chairman Charles Grassley, R-Iowa, asked the inspector general at the Department of Health and Human Services to investigate allegations that NIH employees “may have concealed serious deficiencies in the ... study.” He also referred the matter to the Justice Department.