Please sign this urgent Ampligen petition.
As many of you know, the FDA is about to make a decision on whether or not to approve Ampligen, the drug that has improved my quality of life dramatically with very little side effects. Other patients have had similar experiences. The deadline for the decision is February 2, 2013, but since that is a Saturday, I expect the FDA to act sooner than that. Therefore, time is of the essence. The FDA advisory committee meeting on the issue held in December 2012 didn’t go very well. The bias of the FDA against the disease and the drug was blatant and poorly disguised.
Other patients, those who don’t have access to the drug in the absence of FDA approval, urgently need this effective treatment and I need to continue my treatment because I will relapse off the drug, potentially very quickly. If the FDA doesn’t approve the drug, it will most likely become unavailable to me and everybody who is currently receiving it as part of a self-pay trial. There are no other treatments for ME and if Ampligen doesn’t get approved, there won’t be any treatment for at least a decade because there is nothing else in the pipeline.
We need everybody’s support by signing the petition linked to above. It literally takes less than a minute to sign. Please use your full name because that carries a lot more weight than just using your first name or “Anonymous.” If you could also ask friends, family, neighbors, (former) colleagues to sign, that would be extremely helpful. Imagine the domino effect if everybody gets just 5 other people to sign.
Dr. Nancy Klimas, leading ME researcher and specialist, makes the argument for the approval of Ampligen very poignantly. Dr. Klimas makes the point that the only reason not to approve Ampligen is the FDA bias against the disease. She does so by stressing the efficacy of the drug in a sub-group of patients proven in several trials over more than two decades and then saying:
“Yet, that’s not enough evidence for the FDA advisory committee to approve because they would like to see a conclusive biomarker. As a physician, I could live with this decision if I had other effective therapies to treat my CFS/ME patients. But I do not. Moreover, it defies common logic in used in drug approval for other complex immune mediated diseases.
Take for example, MS: Its earliest approved treatments had opposite immune effects. One interferon increased immune activity and a second interferon quieted immune activity. In the studies that led to approval, MS drugs, like Ampligen, had about a 40 percent success rate.
Clinical research for these early MS drugs produced no biomarkers other than a patient’s successful response to therapy, such as the case of Ampligen. The biomarker the FDA relied on for approval of MS — seeing if the lesions in a patient’s brain decreased — had no correlation to the patient’s improvement.
Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.”
Even though Science Daily doesn’t normally run op-ed pieces, they picked up Dr. Klimas’ comments as an adapted version because of the critical importance of the issue.