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A Call To Action From the ME/CFS Treatment Team: Approve Ampligen!

  [ 3 votes ]   [ 1 Comment ] • February 9, 2014

A Call To Action From the ME/CFS Treatment Team: Approve Ampligen!
Dear Patient Community:
We are asking your help to continue to push for treatments for ME/CFS.  Our ME/CFS Treatment team will continue to work for meetings between the FDA and pharmaceutical companies with the sole purpose of urging them to develop and approve drugs to treat ME/CFS. People with this disorder must not be forgotten!
While many felt Ampligen did not receive a fair review at the Advisory Committee Meeting in December 2012, the FDA has taken positive steps. The Stakeholder’s Meeting and the Voice of the Patient document opened the FDA’s eyes to the debilitating effects of ME/CFS, and the FDA responded  by stating they consider ME/CFS to be a serious disorder on par with diseases like heart failure and kidney disease.
That was a good beginning, but it’s only the start. One drug across the finish line will change the course of this disease forever.  
(1)   It will for the first time make an approved treatment available for ME/CFS patients everywhere. 
(2)   It will make the disease “real” in the minds of doctors and the public because there is a drug for it.
(3)    A successful drug will encourage pharmaceutical companies to develop other treatments for it.
The FDA can do much more to approve Ampligen. It showed how much more it can do when it gave 6000 healthy Princeton students access to the drug Bexsero, unapproved by the FDA, because they might develop meningitis in the future.   If Princeton students can get access to a drug for a condition they don’t have and may never get, we believe people with ME/CFS should have access to a drug for use today that has been used safely by hundreds of patients, and which the FDA’s own panel voted was safe enough, given the needs of the ME/CFS community.
We believe ME/CFS patients have a right to try Ampligen, just as the Princeton students had a right to choose Bexsero. Here are two links to the Bexsaro story:

Click HERE and HERE.

Please help keep the pressure on the FDA and please send the following letter to the list below.  The outpouring of emails and letters from patients last spring was tremendously effective – let’s do it again!
Please do send letters to the elected officials and to the FDA names below.  Janet Woodcock, M.D., is Director, Center for Drug Evaluation and Research, FDA.  Margaret Hamburg, M.D., is Commissioner of the FDA.  Monika Volante is Legislative Director for Representative Jos. Pitts, (R-PA); he has been helpful to our cause in the past.  Other names are health aides to other legislators who have some influence in health affairs legislation.
Bob Miller, Patient Activist and Advocate
Pat Larosa, NJCFSA President
Billie Moore, NJCFSA Advocacy Chair
Cort Johnson,  Founder of Phoenix Rising and Health Rising
Lori Chapo-Kroger,, President
Nancy McGrory, Providence Mgt. & Communications, Patient Advocate

Patients: Cut and paste and add your own information and comments.
Email To:;;;;;;;;;;;;;;;;
Subject Line:   Unequal Treatment
Dear Dr. Woodcock:
Why were 6000 Princeton students given the option to try an FDA-unapproved drug for a disease that struck only seven students when more than a million people with Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are denied access to a drug that ME/CFS expert practitioners whole-heartedly endorse?  Ours is a serious disease also!  And people are dying from its effects.
Why were these 6000 Princeton students who do not have meningitis but who might get it given more options than people with ME/CFS who have been sick for decades?   I am talking, of course, of the unapproved drug Bexsero that the FDA recently allowed to be made available to students at Princeton after seven other students came down with the meningitis.
While healthy students get Bexsero, very sick people with ME/CFS are being denied access to a drug, Ampligen, which has been used safely by hundreds of patients, sometimes for years. The FDA review panel for Ampligen concluded that Ampligen was safe enough to be used by people with ME/CFS.  Despite the fact that ME/CFS patients, like the Bexsero patients, have no FDA approved drugs to treat this very serious and life robbing disease, the FDA has not found a way to give them access to a drug that's been safely used for decades.  Unlike the well Princeton students, 61% of ME/CFS patients have reported they are bedbound or housebound on their worst days (and there are far more worse days than best days). 
Thankfully the seven students at Princeton will recover.  I, however, will not – not unless a treatment option is made available.
Severely ill patients with no other options available to them should be allowed to decide, in consultation with their physician, whether to try Ampligen, under suitably managed conditions!  The FDA can find a way to make this happen.
It did it with Bexsero and it can do it Ampligen.  Stop keeping people with ME/CFS from treatments!  Stop keeping them from having hope of a better life!  Give a million people with this disease the same option you're granting to 6000 healthy Princeton students.
I've waited long enough.  I have been sick since _________.   Day to day my life looks like ____________________.   Why is my life not worth that of a Princeton student?

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Article Comments Post a Comment

Ampligen, or...
Posted by: me/cfs
Feb 10, 2014
I rated the article five stars because I admire the effort and leadership toward moving the FDA to approve a drug for the treatment of ME/CFS. I would imagine that if I had experienced relief from Ampligen, that is the one I would be pushing for.

However, a sense of realism pushes back at me when I stop and think that the FDA has given Ampligen two hearings and turned it down both times. In addition, Hemishpherx has not done any further research and has pending lawsuits as a result of the 2012 hearing. Perhaps, even though another drug might not hold as much promise as Ampligen, it might be time to try a different route.

In agreement with your statement that one drug approved by the FDA will change the course of the disease forever, I feel we need to help the FDA find the easiest route available to that approval.

I appreciate your efforts and hope you do not see this as criticism.

Reply Reply
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