Over the past 14 months, AIDS treatment
activists, many of whom are members of The HIV Immune Based Therapy Working
Group have placed pressure on the Food and Drug Administration regarding the
FDA process, procedures and review of immune based therapies for the treatment
of HIV disease. In a surprise turn of events by the FDA Antiviral Committee,
a meeting took place yesterday to discuss these issues.
The pressure placed on the FDA by AIDS treatment activists over the past 14 months about the review process of immune based therapies including IL-2, made by Chrion, and Ampligen, made by Hemispherx Biopharma came to a head at a controversial meeting, held in Washington DC. The meeting was open to the public, and convened to discuss how the Antiretroviral committee should
proceed in its review of these therapeutic options for people with AIDS.
"The FDA has been slow to acknowledge that there is a lack of meritorious
review procedures in place to ensure scientifically valid consideration of
these clinical options," said Jeannie Gibbs of the IBT Working Group.
The FDA posted a notice (with limited distribution) about the proposed
contents of the meeting.
It was hoped by the AIDS treatment activists that the FDA would use the
opportunity to begin to catch up with the rest of the clinical community
involved in HIV research and allow for some strong determining results that
encourage the development of valid clinical research on immune
restoration for HIV disease.
Researchers interested in what took place at yesterday's meetings can contact: Nancy Chamberlin, or
Beverly O'Neil, Center for Drug Evaluation and Research (HDF-21), Food and
Drug Administration, 5600 Fishers Lane, (for express delivery) 5630 Fishers
Lane Rm. 1093) Rockville, MD 20857, or by e-mail: CHAMBERLINN@CDER.FDA.GOV.