Call for Congressional Hearing on Treatment for ME/CFS

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The following announcement comes from the FDA Treatment Team, a group of people dedicated to securing FDA approval for Ampligen. For readers who are unfamiliar with Ampligen, it is a drug that modulates the immune system. It has been used successfully for many years by ME/CFS specialists to treat severely ill patients. The makers of Ampligen have conducted a number of clinical trials proving the safety and efficacy of Ampligen, but, so far, FDA has not approved it.

The team has drafted a letter requesting a congressional hearing on Ampligen. You can support their effort by sending your own letter (see template below). 

The team has provided email addresses on their template letter. In addition, it is recommended that you send the letter to your own representatives as well via their web forms. Representatives always pay attention to letters sent by their constituents. You can find your representatives HERE simply by typing in your zip code.
New Opportunities to Create FDA Action on ME/CFS Treatments
Currently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) have spearheaded a bipartisan initiative called “21st Century Cures” to increase the pace of medical breakthroughs. This initiative gives us fertile ground to press Congress and the FDA to provide an environment that attracts drug companies to ME/CFS research and for the FDA to give conditional approval of Ampligen. Remember, if we get one drug across the line, many more will follow.
We are asking you to help us continue to push the FDA to foster and approve treatments for ME/CFS. It is important that ME/CFS stay high on the FDA’s agenda. Please cut and paste the following message and send it to the email addresses below.
~From The FDA Treatment Team
Cort Johnson, Bob Miller, Billie Moore, Pat LaRosa, Dr. Janet Smith, Anita Patton, and Lori Chapo-Kroger

Send your email to:;;;
Subject line:
FDA fails to approve drug for ME/CFS – Time for a congressional hearing
In the body of the email:
Recently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) spearheaded a bipartisan initiative called “21st Century Cures” to increase the pace of medical breakthroughs. This initiative provides opportunities to help speed approval for treatments that affect underserved populations – such as those who are severely ill with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome).
To date, the FDA has failed to approve a drug considered safe for ME/CFS, leaving chronically ill patients to take untested, off-label medications. ME/CFS costs the United States economy approximately $20 billion annually and affects one million Americans. It has left many families in ruins.
The FDA says it will approve drugs with serious adverse side effects that they believe are effective for ME/CFS, but they won’t approve Ampligen, a drug that they acknowledge is safe.
Where is the data on efficacy and safety of the drugs currently being used off-label to treat ME/CFS?
ME/CFS Expert Dr. Charles Lapp, who has treated thousands of ME/CFS patients and has used Ampligen for more than 25 years, said, “Even if Ampligen doesn’t improve a patient, it does no harm.”
The experts have said it works, and the FDA Advisory Committee has said it’s clear that patients are experiencing benefit. More than 700 patients provided testimony at the FDA Advisory Meeting in December 2012 requesting approval of Ampligen, and more than 4,000 signed a petition after FDA denied the approval in February 2013.
In April of 2013 – four months after the FDA denied approval for Ampligen – the FDA admitted they did not have a complete understanding of ME/CFS. We believe that if the FDA had understood the unique needs of ME/CFS patients prior to the Ampligen approval hearing, the drug would have received conditional approval, leading to a functional improvement in many severely ill patients.
The FDA is to be commended for acknowledging the seriousness of ME/CFS. However, more needs to be done. The FDA needs to recognize the special circumstances and desperation of the ME/CFS community and act accordingly by assisting drug companies in bringing their products to market.
A group of patient advocates has demanded a congressional hearing, and I support them. The FDA must live up to its commitment and help those with chronic illnesses. We have a right to treatment; our voices and our experts need to be heard.
[your name]
[your city and state]
[years you have been sick]

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3 thoughts on “Call for Congressional Hearing on Treatment for ME/CFS”

  1. anomar says:

    More than that, I HAVE to testify. If I do not do something to publically express the tragedy of this disease and how it has limited my professional and personal, I conspire in my destruction, I join the ranks who feel we are expendable.

  2. ehodges says:

    I agree with “anomar”‘s statement. I wish I lived close to Washington to do something or could afford to fly to Washington to fight for us. Something needs to be done for us who suffer, who can no longer work, think, function, and are in chronic pain, sleep their lives away, etc. I never in a million years dreamed that my life would turn out this way. Social Security released an SSR on April 3rd or 4th of 2014, ruling how CFS should be addressed. Unfortunately, it is still not listed as a “listed impairment or disease”. Doesn’t make any sense to me. I am losing everything and am financial destitute now because of this disease. I have to wait 3 years before my case will be reviewed by the Social Security Appeals Counsel. Well let me tell you, I won’t make it. I cannot continue to live this way and all that I need to complete the end to my suffering is my will, which I am working on, although I do not have much left to “will” to others. I have no burial policy so hopefully my family that disowns me now, maybe they will finally get the picture and understand once I am gone. I know if something does not change in the next 6 months to a year, I will no longer be able to bear the physical, mental and financial suffering anymore! I pray that God will understand and you will also. Thank you for listening!

  3. anomar says:

    Please try to hold on. I have found that UVI treatments help me. Of course, they are not covered by insurance if you still have insurance. Know that you are not alone.

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