by Sasha The FDA may have disapproved Ampligen but Bob Miller isn’t giving up his hunger strike. Visibly weaker in a video clip on his Facebook page, on Day 9 of his hunger strike, Bob moved on to the next, logical target: he wants Secretary of Health Kathleen Sebelius to have the National Institutes of Health conduct a clinical trial
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by Sasha Bob Miller has started a hunger strike to push for FDA approval of Ampligen. He and his wife, Courtney Alexander, who are well-known for drawing President Obama’s attention to the plight of people with ME/CFS, urge us not to do the same. Instead, they’d like us to send the email below, alerting key decision-makers to his strike, to
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by Sasha “There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government.” So said Suzy, in an online comment about the failure of the FDA Advisory Committee on Ampligen to vote in a manner that would have got approval for the drug’s use for patients with ME/CFS. But it’s not too
ContinueTry to leave your calendar open from 8am-5pm EST on the 20th for the FDA’s hearing in Ampligen! Information about the meeting is available at December 20, 2012 Meeting of the Arthritis Drugs Advisory Committee (not mistitled!). The webcast will take place at https://collaboration.fda.gov/aac122012/ and Phoenix Rising will attempt to embed the video locally to make it easier to simultaneously
Continueby Cort Johnson Call to Action for First Drug For ME/CFS: the Ampligen FDA Advisory Hearing URGENT: ME/CFS Patient “A C T I O N” A Call To Impact Our (me/cfs) Nation For All ME/CFS Patients, Families and Friends (U.S. & Non U.S.) Organizer: Robert Miller, Cort Johnson and TEAM Contact: 511bobmiller42@gmail.com For the first time, people with chronic fatigue
Continue Posted by Cort Johnson Moving quickly, Ampligen’s producer, Hemispherx Biopharma, filed its ‘complete response’ to the FDA’s request for data just 53 days after the agency agreed to relax its requirements for review of the drug. Hemispherx’s ‘complete response’ means we will know by the end of January and perhaps sooner whether Ampligen becomes the first FDA approved drug for
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Posted by Cort Johnson After a warm winter the Sierras were experiencing a cold and snowy March. I drove into cold blue skies but within a day it’d started snowing -hard. We got ‘over the hill’ OK the first day, slipping a bit now and then, but got stuck on the highway the second. I hiked back to get some
ContinueFROM PHOENIX RISING Blogs Ampligen on the Clock: Hemispherx’s ‘Complete Response’ Means Ball is in FDA’s Court Now – Hemispherx’s quick response means we will know if Ampligen becomes the first FDA approved drug for ME/CFS by the end of January, 2013. Major Move From FDA Puts Ampligen Back on Track (July 2012) – in a major turnaround the FDA relaxes its
After trying dozens of other treatments Kelvin Lord was on his last legs when he practically crawled in Dr. Lapps office in January 2010 for his first infusion of Ampligen, an immunomodulator under review by the FDA for ME/CFS, which was available to a only few doctors in the US. Chart Kelvin’s progress as he describes, in sometimes side-splitting fashion,
Posted by Cort Johnson Reversing a 2009 decision some commentators felt was potentially crippling to Hemispherx BioPharma, Ampligen’s producer, the FDA today stated they would not, after all, require a expensive 300 person study to assess Ampligen’s effectiveness in chronic fatigue syndrome (ME/CFS). (Safety concerns appear to have been taken care of.) Instead they would allow Hemispherx to use new
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Posted by Cort Johnson The recent blog on Hemispherx’s Ampligen study has been amended to take account of the fact that the study involved an analysis of data from a 1998-2004 study. The blog in its original state suggested that this was a new study done in response to the FDA’s 2009 concerns. That was not true. Hemispherx may have
ContinueAmpligen (AMPlIfied GENetic Activity) is a double-stranded RNA molecule developed in the 1960’s by Merck and Co to reduce tumor formation. Effective in the lab but too toxic for use Ampligen languished until Dr. William Carter, working with other Johns Hopkins University researchers in the 1970s, was able to reduce its toxicity. Ampligen’s reported mode of action – bolstering the
