Monday, January 7, 2008

Ampligen and Politics

For those who wonder why there is no treatment for CFS:
 
For 20 years, FDA has been promising us that Ampligen is 18 months from approval.  It is still "18 months from approval".  Although (like any prescription medication) there are side effects, most of the patients also reported miraculous recovery.
 
 
Ampligen, a drug undergoing clinical trials in AIDS sufferers. Ampligen's creators claimed the drug stimulated natural killer cells, but it reputedly had additional immune-stimulating properties as well. In 1987 a paper appeared in Lancet touting the results of the first AIDS clinical trials using the drug.

*William Carter et al., "Chronic Enterovirus Infection in Patients with Postviral Fatigue Syndrome," Lancet 1 (8578) (Jan. 23, 1988): 146-50

 
Ampligen(r), an experimental therapeutic, as a new class of toll-like receptor 3 agonist drugs that would, if licensed, be the first pharmaceutical treatment for CFS.
 
 
Aside from Ampligen's apparent clinical safety, Peterson noted that the test subjects who fared best were those who had yet to advance to full-blown AIDS -- the AIDS-related complex sufferers -- whose clinical symptoms were virtually indistinguishable from those of chronic fatigue syndrome sufferers.
 
Paul Cheney noted, "The FDA is really in a bind. If the agency approves the treatment IND application, they will, in one swoop, destroy the credibility of two government agencies."
 
"There's not a chance the Food and Drug Administration is going to approve this drug," Peterson said over dinner the night of Carter's presentation. "How can they approve a drug for a disease the NIH says doesn't exist?"


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