(This is unusual…the ME/CFS community has been so good at supporting  advocacy efforts that it’s shocking when it doesn’t happen. Last December, for instance, the ME/CFS Community so swamped the FDA during the Ampligen Advisory hearing that they broke the FDA’s servers.  Now, the patient input section deadline (April 8th) is fast approaching with few submissions thus far.  Remember this is a different group of FDA officials; they need to be educated all over again and above all they need to feel our passion.  Bob provides an easy to use template below. …Cort)

:Let's light a fire under the FDA; let them know

Light a fire under the FDA, let them know, why ME/CFS needs more drug options

FDA Drug Development Workshop needs your comments, and they’re due by April 8th. I provide the link below, docket #FDA-2012-N-0962-0004. The comment form is for everyone, not just those attending the meeting. Few comments have been submitted, and if we don’t flood them this week, nothing will change in the drug approval process to speed treatments for ME/CFS patients.

There’s a template below, but as always, add your personal information if you are up to it. I think it is really important to include what biological measures are abnormal for you, if you know that. The FDA would like to know how your symptoms affect your life and how effective the medications you’ve tried have been, but they should also learn about the biological and immunological markers that accompany those symptoms.

My Personal Results – For me, my Natural Killer Cell function and T cells are very Low, HHV6, Epstein-Barr Virus, CMV titers are high or active, RNASE L and cytokines elevated, low VO2 max.

Please tell the FDA what you know of your diagnostic tests along with the most debilitating of your symptoms and how you have improved (or not improved) on any medication. For me, when on Ampligen, I am no longer bedbound. I can function on getting 10 to 12 hours of sleep vs staying in bed for days at a time. I must still monitor my energy output but pain levels improve, gut imbalance improves, so I am able to eat with less pain. My cognitive ability improves, so I can drive and remember how to return home.  I’m not nearly well but I’m better.  That’s what I’ll be telling the FDA.

Equally important is telling the FDA about ineffective your medications have been. This Workshop wouldn’t be taking place if we had effective medications, so please tell the FDA about what medications you’ve tried, and how effective they’ve been or haven’t been.  (See the end of this blog for the FDA’s specific questions.)  If you use the template below you can give the FDA a nice nudge to get moving on ways they can support drug development in this disorder.

Please go to the webpage and enter your comments in the space provided or attach a letter with your comments. There is a limit of 2,000 characters for the comment section on the form or you can upload a document or letter which isn’t limited in length. You need to fill in your name and basic information.


Dear FDA Commissioner Hamburg,

I have been ill with ME/CFS for ____years now. There still are no FDA-approved treatments for me and the other One Million Americans suffering daily from ME/CFS. We need a stated path to drug approval for ME/CFS, with special evaluation criteria to fill the profound unmet need and the empty pipeline, just like you announced for treating Alzheimer’s, “FDA to Ease Alzheimer’s Drug approval”.

The FDA Workshop should lead to a proposal including these points:

1. ME/CFS clinicians with the most experience conducting clinical trials in ME/CFS will be consulted to produce a compendium of biological outcome measurements that correlate with patient improvement.
2. Enrichment studies will be acceptable to demonstrate efficacy for approval for ME/CFS, conditioned on selection criteria for use and continued Phase IV studies.
3. FDA request CDC and NIH study the responders to Ampligen, Valcyte, Vistide, Valtrex and other medicinal treatments to learn what works and how to design studies around appropriate subsets (NIH did that with MS drug – daclizumab, and implicated a unique cell in that disease)
4. FDA request NIH to spearhead clinical trials for ME/CFS where the outcome measures are set through collaboration with the most experienced treating clinicians, just like AZT

My ME/CFS symptoms are

(example – put yours here: Susceptible to opportunistic infections(EBV, HSV, HHV-6, CMV, Coxsackie, H. Pylori) cognitive decline(unable to read a newspaper article), inability to concentrate( only one person can speak at a time), bedridden ( I require 20 hrs. of sleep and rest daily) , muscle pain (unable to use legs, arms and back due to increased pain) headaches (severe migraine like), fevers ( low grade), night-sweats)

My abnormal test results include (put yours in place of mine below):

a. low natural killer cell function, which improves when I am treated with Ampligen
b. Low T-cell count
c. High Epstein-Barr virus titers and HHV6 or Active infection
d. Low VO2max
e. Elevated Cytokines

Thirty years is too long for any illness to go without a single FDA-approved treatment. As long as safety is demonstrated, patients must have access to medicines in order to alleviate our tremendous suffering and to advance our scientific understanding of ME/CFS. Who a treatment works for is more important that whether it works for everyone. We need FDA to start somewhere.

Here are the questions the FDA has asked for answers on.

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

  1. What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
  2. What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)
    1. How does the condition affect your daily life on the best days and worst days?
    2. What changes have you had to make in your life because of your condition?

Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME

  1. What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
    1. What specific symptoms do your treatments address?
    2. How has your treatment regimen changed over time and why?
  2. How well does your current treatment regimen treat the most significant symptoms of your disease?
    1. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
    2. How well have these treatments worked for you as your condition has changed over time?
    3. What are the most significant downsides of these treatments (for example, specific side effects)?
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