Monday, April 19, 1993
MicroGeneSys quandary: Stay or go?
By Kris Herbst
WASHINGTON - MicroGeneSys Inc., no longer the exclusive beneficiary of a $20 million appropriation to test its AIDS vaccine and unhappy with the probable conditions of an NIH-run comparison trial of several competing products, now has to decide whether it wants to participate.
The Department of Defense last week finally agreed to transfer the $20 million from the Army, once earmarked for an exclusive trial of MicroGeneSys' gp160 therapeutic vaccine, to the National Institute of Allergy and Infectious Diseases, the NIH organization which conducts AIDS research.
The inter-agency agreement may have resolved a fractious dispute over the funds, which were appropriated by Congress after a high-level lobbying effort on behalf of the company last fall. Health and Human Services, the NIH and FDA considered the appropriation an end-run around established scienctific and agency procedures.
Mary Jane Walker, a NIAID spokesperson, could not estimate when the trial will begin. But she said NIAID "clearly needs to see evidence from our ACTG 209 trial, which will probably be available in about six months." The trial involves Genentech Inc.'s gp120 vaccine.
NIAID has not decided which specific vaccines will be used. But it plans to use a protocol recommended unanimously by an NIH gp160 review panel that was convened in February by NIH Director Bernadine Healy, Walker said.