Recently, once again, Ampligen was NOT approved by the Food and Drug Administration for treatment of Chronic Fatigue Syndrome or ME/CFS. Many people consider this a travesty; others think it was the right thing to do.
This seems to be quite an emotional issue. Desperate CFS patients are seeking anything to help them. Even so, if it’s not the one drug to help all ME/CFS folks, maybe there is more to learn here. Maybe there is a larger lesson that we haven’t stumbled upon…yet.
And that’s why I think it’s wise to re-post the letter of one lady who tried Ampligen as an investigational drug or trial (she didn’t say), but did not do well with it. Her letter was sent to federal officials at the agency and I must assume the information was considered. You have to wonder “why” Ampligen performed so poorly for her and yet some people claim they got their life back by taking it.
The FDA absolutely should NOT approve Ampligen with the current data. Although failure to do so leaves us with no FDA-approved options to treat this disease, that is still better than allowing desperate patients to consume a drug that might very well make them grossly sicker, simply because there are no alternatives.
(Health Matters Show podcast today is 6 minutes 54 seconds.)
ME is a serious and life-threatening disease, and without treatment, patients and their families are indeed left to suffer. I am completely bedbound except for medical appointments, and Ampligen helped me get this sick, but you will not find my data in what was submitted to you for approval. I am in constant pain and suffering.
For us, even small improvements have a very significant impact on our quality of life. It is evident that Ampligen has provided benefit to *some* patients, but since the manufacturer has no interest in patients for whom the drug is either ineffective or deleterious, no evidence is available regarding WHICH patients are good candidates for treatment with Ampligen.
Patient testimony and patient and clinician experience provide evidence that this drug works in some patients. Differing experiences are more difficult to find, since other patients frequently are not well enough to represent themselves, others resent the sharing of non-positive outcomes, and the manufacturer has threatened to sue patients–or even journalists–who attempt to share their negative experiences with Ampligen.
Thank you for understanding the difficult plight of ME patients.
I share this information with you because you need to know it. This is a publicly available letter. Let none of us ever be afraid of the truth or unwilling to explore what is really going on. If Ampligen can help a certain class of ME/CFS folks or people exhibiting certain symptoms, then that truth will be important in the long run to everyone seeking treatment for Chronic Fatigue Syndrome.
The facts are that we need to understand the whole panorama of ME/CFS and its voluminous symptoms so much better than we do now. Based on definitive science, we need answers that work. For now a universal treatment for Chronic Fatigue Syndrome (ME/CFS) will have to wait.
Host of the Health Matters Show