WASHINGTON, D.C. -- Flouting the "strong recommendations" ofa National Institutes of Health review committee, the Army hasdecided to proceed with a Phase III trial of a single AIDSvaccine, the gp160 vaccine produced by MicroGeneSys Inc.
Last fall, in a move that elicited much anger from thebiomedical community, MicroGeneSys of Meriden, Conn., andthe Walter Reed Army Medical Institute had successfullylobbied for the addition of $20 million to a Defense Departmentappropriations bill for a trial of the biotechnology company'svaccine.
In response, NIH Chief Bernadine Healy convened a "blueribbon" panel to consider the matter. The panel ultimatelycalled for a Phase III trial focusing on multiple vaccines ratherthan just one.
But "the DOD has no choice in this matter," said Marvin Rogul,associate director for research, marketing and policydevelopment at the Walter Reed Institute of Research. "Thecongressional language mandated (the single-vaccine trial)."
Moreover, the cost of a trial of several vaccines would havebeen about $55 million, Rogul said, way beyond theappropriation.
However, Rogul said discussions are going on with NIHregarding possible co-sponsorship of a larger trial.
But if such discussions are taking place, NIH hasn't heard aboutthem. "Healy had said NIH would be happy to provide somefunding, in the neighborhood of $1 to $2 million a year," saidJohanna Schneider, spokeswoman for the NIH. But she said theArmy has not approached NIH on that matter.
In fact, she said, the Army hadn't even told NIH of its decisionto proceed with the single-vaccine trial. "I'm just hearing aboutit through the media," she said.
The NIH is not alone in being left out of the loop. "We have noinformation other than what has been in the press," said FrankVolvowitz, chief executive officer of MicroGeneSys.
Nor had Sam Broder, head of the National Institute of Allergyand Infectious Diseases at NIH, been apprised of the Army'sintent.
"There is nothing that requires giving them formal notification,"said Rogul. "There was no necessity to make a formalannouncement.
Nonetheless, the Army's behavior is perplexing, Schneiderimplied. An Army representative attended every NIH meetingon the subject, she said, "and they never gave any indicationthey didn't want a multi-vaccine trial. We have sent them all ofour formal communications."
She also disputed Rogul's claim that $20 million would not beenough to support a multi-vaccine trial. "Our design teamdesigned a trial that would accommodate multiple products fora $20 million trial," Schneider said.
The single-vaccine trial could have been torpedoed if Healy,FDA Commissioner David Kessler or the Secretary of Defensehad provided opposition in writing within six months of whenthe amendment passed.
Not responding directly to why Healy had not done so,Schneider said Healy wanted to place the multi-vaccine trial "apositive light."
Kessler was not available for comment.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.