According to a report due to appear in Friday's issue of Science,the Army has launched an investigation of Lt. Col. RobertRedfield and his lab about data from trials of gp160, atherapeutic AIDS vaccine under development by MicroGeneSys.
The concern is that Redfield, one of the Army's prominent AIDSresearchers, may have overstated the significance of clinicaldata he reported in July at the international AIDS conference inAmsterdam.
Redfield told the meeting that "the vaccine reduced the levelsof HIV in the bloodstream of infected people," according to anarticle in last week's New Scientist.
This week's story in Science suggests that the allegationsagainst Redfield stemmed from colleagues who were"uncomfortable" with the data he presented at the meeting andconcerned that "Redfield failed to share his analysis of the datawith key members of his research team before presenting it."
Further, according to the New Scientist article, an internalmemo from Bill McCarthy, director of the department ofbiostatistics at the Henry M. Jackson Foundation in Washington,D.C., disputed Redfield's findings.
The memo, leaked several weeks after the Amsterdammeeting, concluded that "the level of the virus was not affectedby the vaccine."
Franklin Volvovitz, president and chief executive officer ofMicroGeneSys of Meriden, Conn., told BioWorld that Redfield'sfindings have been "invariably confirmed" in other studies atmultiple sites.
"Redfield has generally been a good deal ahead of otherresearchers and probably has insights that come from hisexperience," Volvovitz said.
The Army's investigation may be connected to controversyarising from legislation passed by Congress after an intenseeffort by "high-powered lobbyists" to award $20 million to theArmy to conduct large-scale studies of MicroGeneSys' gp160vaccine.
"At least two forces have been unleashed on the Army by thelegislation singling out MicroGeneSys' gp160," including theNavy and the Air Force, which are disturbed that all militaryAIDS research money goes to the Army before beingdistributed elsewhere, according to Science.
Members of the health care industry and industryrepresentatives are also perturbed.
"If we're going to have legislators determining what drugs wetest in people, we're potentially facing as large a moraldilemma as we have ever faced in medical science," BernadineHealy, head of the National Institutes of Health (NIH), toldScience.
A panel led by Healy is scheduled to meet Thursday to discussthe $20 million appropriation.
"It's hard to know what all the fuss is about," Volvovitz said."The funding is for the Army, not us."
Volvovitz said his company has allowed investigators topresent data freely since it entered clinicals. "We have yet tosee any substantial therapeutic data from any other products,"he said.
-- Michelle Slade Associate Editor
(c) 1997 American Health Consultants. All rights reserved.