FDA Just Says “No” To Salk Immunogen.
The illustrious Dr. Jonas Salk and officials of his Immune Response Corp. appeared before an FDA advisory committee on 26 January seeking approval for large-scale Phase III efficacy trials of its envelope depleted HIV (Zairean strain) as a possible therapeutic vaccine. (The design was originally intended to be “whole-killed,” but the envelope was accidentally depleted in the attenuation process, thus the current concept.) To their credit, the advisory panel judged the efficacy data to be extremely weak, and agreed that the Salk Immunogen failed to show enough promise to warrant Phase III studies.
Heralding the Naked Emperor, Part II.
During the Q&A following UC-San Diego virologist Douglas Richman’s NNRTI presentation at January’s National Retrovirus Meeting in Washington, Boston virologist Clyde Crumpacker apparently “leapt to his feet to denounce the vogue of giving combinations of drug to patinets in the hope that one mutation will cancel out another” (source: Laurie Garrett, NYN). “I’m skeptical it ever will be possible,” Crumpacker is reported to have said. “That may conceivably be true,” Richman conceded. “But then we shouldn’t even be bothering. That’s too pessimistic for me.”
OAR’s Dr. Paul Speaks.
In a 4-page editorial in Science magazine (3 February 1995: 633-36), Office of AIDS Research director William E. Paul blasts current research efforts against AIDS, explaining that the $1.3B program failes to encourage necessary research. Noting that the lion’s share of existing monies are tied up in expensive, long-term clinical trials, Paul observed that precious little is left to fund late-breaking leads in research and to encourage innovative approaches. Dr. Paul said he plans to reassess the entire governmental strategy.
Varmus Selects New Director for Office of Alternative Medicine.
Lt. Colonel Wayne Jonas, of the Walter Reed Army Institute of Research, will replace out-going director Joseph Jacobs (who resigned last September) at the NIH’s OAM effective July 1, 1995. Jonas has been a consultant on several OAM projects and has studied homeopathy, acupuncture, nutritional and megavitamin therapy and NMR spectroscopy. The Office of Alternative Medicine was created by Congress in 1992.