FDA denies drug for Chronic Fatigue Syndrome

Reported by: Alyx Sacks
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Updated: 2/05/2013 8:03 am

RENO, Nev. (KRNV & MyNews4.com) -- A drug some patients say they rely on to combat a debilitating disease has been denied by the U.S. Food and Drug Administration.

Robert Miller of Reno has battled Chronic Fatigue Syndrome for over 20 years and he says Ampligen has changed his life. Ampligen made by Hemispherx Biopharma, Inc. has been going through clinical trials for about 20 years and has recently been denied by the FDA.

Miller has been on Ampligen since 1999, and moved his family twice in 14 years to access the clinical trial.

“Now the 100 or so patients on Ampligen like me risk losing the only treatment that clearly works for us. Ampligen transforms me from bedridden to being able to care for my twin boys,” Miller says.

The following is a statement released by Hemispherx, "Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company” or "Hemispherx”), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA”) declining to approve its new drug application ("NDA”) for Ampligen® for Chronic Fatigue Syndrome ("CFS”).  The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analysis."

CFS is a disorder according to the National Institute of Health that causes extreme fatigue, but not the kind of tired feeling that goes away after you rest instead it lasts for long periods of time and limits ordinary activity. At least one million Americans are effected by CFS. Miller says it also causes extreme chronic pain in joints and throughout a patient's body.

In the release Hemispherx says the FDA made recommendations, "the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues.  The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen® for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. "

Miller is asking Secretary of Health Kathleen Sebelius to conduct clinical trials of Ampligen at the National Institutes of Health.

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leigh - 2/6/2013 1:52 PM
0 Votes
Thank you for your coverage on this story! It is because of your coverage and hopefully others that Robert Miller's heroic effort to call attention to the FDA's denial of Ampligen for patients may be heard. It is so important as it also helps expose the horrible neglect of this patient population.

Walking Dead - 2/6/2013 7:54 AM
0 Votes
How could the FDA not approve the only drug in the pipeline fot the VICTIMS of ME/CFS, they don't care, they are going to push it back as long as they can. I have been looking at history, and its grim what our government has done, the veterans that served in Vietnam that handeled Agent Orange in 1960-1970's had illnesses like MS, Parkinsons, Lympomas, and others. Over 26,000 Veterans were denied disability until 2009, 40 + years after exsposure. Even though they proved that they caused the Verterans illness they still classified the illness as "PRESUMED". Robert Miller I think your on the right track, its time to go GANDHI on them. Thanks for the ONLY coverage were getting.

Pittsburgh Pa - 2/5/2013 9:14 PM
1 Vote
People stuck on their couches all over the world are rooting for you, Bob.20 years is a long time to be sick with 'The Living Death'.

ampligenworks - 2/5/2013 6:03 PM
1 Vote
We the invisible losers in this battle really appreciate your coverage of the FDA denial of thre only current treatment, Ampligen. It's been a huge battle by a few patients to try and make this treatment available for all CFS/ME patients. CFS is a primary chronic immune deficiency illness with very serious and lasting effects. We need s treatment that

Noreen - 2/5/2013 4:59 PM
0 Votes
THank you for covering this story. Robert Miller is now on Day 8 of his HUNGER STRIKE. It's disgraceful that the FDA did not approve Ampligen to treat M.E. (CFS in the U.S.) patients. If they had to live for one day with this illness, I guarantee you it would have been approved. They could have conditionally approved it, they've done that before with other drugs. But no, not for M.E. they won't. They've also approved drugs with serious side effects and less efficacy than Ampligen. The FDA itself admitted in December it was safe. The name was changed to CFS (Chronic Fatigue Syndrome) to denigrate the illness. Sadly, the bottom line is that nobody cares about M.E. patients. What has been done to M.E. patients will go down in history alongside the other ABUSES perpetrated against people by governments and their agencies. SHAME on them all. We wish Robert well, are keeping him in our thoughts and are very fearful for him.

Noreen - 2/5/2013 3:59 PM
0 Votes
THank you for covering this story. Robert Miller is now on Day 8 of his HUNGER STRIKE. It's disgraceful that the FDA did not approve Ampligen to treat M.E. (CFS in the U.S.) patients. If they had to live for one day with this illness, I guarantee you it would have been approved. They could have conditionally approved it, they've done that before with other drugs. But no, not for M.E. they won't. They've also approved drugs with serious side effects and less efficacy than Ampligen. The FDA itself admitted in December it was safe. The name was changed to CFS (Chronic Fatigue Syndrome) to denigrate the illness. Sadly, the bottom line is that nobody cares about M.E. patients. What has been done to M.E. patients will go down in history alongside the other ABUSES perpetrated against people by governments and their agencies. SHAME on them all. We wish Robert well, are keeping him in our thoughts and are very fearful for him.

Noreen - 2/5/2013 3:58 PM
0 Votes
THank you for covering this story. Robert Miller is now on Day 8 of his HUNGER STRIKE. It's disgraceful that the FDA did not approve Ampligen to treat M.E. (CFS in the U.S.) patients. If they had to live for one day with this illness, I guarantee you it would have been approved. They could have conditionally approved it, they've done that before with other drugs. But no, not for M.E. they won't. They've also approved drugs with serious side effects and less efficacy than Ampligen. The FDA itself admitted in December it was safe. The name was changed to CFS (Chronic Fatigue Syndrome) to denigrate the illness. Sadly, the bottom line is that nobody cares about M.E. patients. What has been done to M.E. patients will go down in history alongside the other ABUSES perpetrated against people by governments and their agencies. SHAME on them all. We wish Robert well, are keeping him in our thoughts and are very fearful for him.

htracy - 2/5/2013 2:55 PM
1 Vote
Thank you for the continued coverage of this story. Please if you are moved or inspired by this family's attempt to move through the barriers of our government and help patients out, join us in support. Write to your reps, congress, NIH, FDA. The ME/CFS currently only receives @ $6.00/patient/year to study from our government agencies. Private funding is also extremely low. One of the lowest funded diseases studied. The burden on society is @ 20 billion/year in direct and indirect cost. Disgraceful!

StandsWithFist - 2/5/2013 9:06 AM
1 Vote
Money paves the way when it comes to the FDA's mighty power of approval to do business in this country. As many drugs as we have on the market approved by the FDA that have far worse life threatening side effects then the products intended use, yet, we are going to deny a product that has been tested for 20 years with no deaths? I'd say their are two reason's for denial...#1 $$$ expedites the approval process, #2 wait long enough, big pharma can patient their own version of the drug and get it approved, leaving the little guy in the dust calling theirs the "Generic Version! If they allow you to follow behind and sell it that is!
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