A key military researcher working on an experimental AIDS vaccine engaged in "a systematic pattern of data manipulation, inappropriate statistical analyses and misleading data presentation," a consumer health organization charged yesterday.
Sidney M. Wolfe, director of Public Citizen's Health Research Group, released a letter to Rep. Henry A. Waxman (D-Calif.) calling for hearings on the research by Lt. Col. Robert Redfield, chief of the department of retroviral research for the Walter Reed Army Institute of Research. In his letter to Waxman, Wolfe cited Army documents that he said indicated that Redfield had repeatedly put a misleadingly positive spin on his research results. Waxman announced that he would reopen an investigation into the vaccine, gp160, the researchers and the manufacturer, Connecticut-based MicroGeneSys.
Redfield did not return calls seeking comment. But he has previously denied having committed any scientific misconduct. Redfield has acknowledged that analysis of his AIDS vaccine data was faulty. An Army investigation into Redfield's research concluded in August 1993 that "Evidence does not support the allegations of scientific misconduct."
An Army spokesman said a corrected version of the data will be published in a peer-reviewed scientific journal in coming weeks.
Wolfe cited a report by two Air Force medical researchers saying Redfield's data analysis of the results of his work on gp160 was "sloppy or, possibly, deceptive" and "creates false hope and could result in premature deployment of the vaccine." Wolfe called the Army report clearing Redfield a "whitewash."
The gp160 vaccine has been controversial from the start. Large-scale testing of the vaccine was initially rejected by public health officials as premature, but in 1992 Congress mandated a $20 million clinical trial of the vaccine after an intense lobbying effort by the manufacturer, which hired former senator Russell B. Long (D-La.) to bolster its cause. Scientists and activists criticized the legislative guidance as an example of money and politics corrupting scientific research.
The Defense Department, with its huge network of medical facilities, has long played a major role in AIDS drug research, including civilian trials. But choosing which drugs to test traditionally has been the role of the National Institutes of Health. Last January the Defense Department announced it was scrapping the $20 million MicroGeneSys-only trial.