Sunday, January 6, 2013

Ampligen Call to Action


This is it, folks. This letter shown below is the action that can cause the medical community, the government,the public, and big pharma to believe believing ME/CFS is real. We need to write letters to all those listedin the email below protesting the failure of the Food and Drug Administrationto approve the only drug for ME/CFS that has gone through numerous clinicaltrials – Ampligen.

On December 20th the FDA's Arthitis AdvisoryCommittee found the data supporting Ampligen not to be as convincing for"efficacy" as they would have liked, although the majority of the votingcommittee believed it to be safe. Theirturn down is not final, however. Higherlevel people in the FDA will have until February 2nd to make a finaldecision. Lyrica, for instance, wasinitially turned down for approval but was approved in the time between thefirst vote on it and its final decision date.

Here is what is at stake -- it's not just about Ampligen!

A drug, Ampligen, known to work for many ME/CFS patients, can get approved for us by the federal government (FDA). This will make the drug available nationwide at many locations, and likely to eligible for having insurance companies and Medicare pay for it. Hundreds of thousands of patients might well be improved somewhat or very greatly. Maybe you!

The medical community tends to believe in diseases if there are drugs approved for those diseases. It is a major reason why ME/CFS is so disrespected – "no drug, must not be real." The public will come to respect ME/CFS for the same reason.

The pharmaceutical companies will see that the size of the suffering patient population can be a moneymaker if they can develop other drugs for ME/CFS. If Ampligen is not approved, big pharma will lose interest in our disease for years, if not decades.

The National Institutes of Health (NIH), the Centers for Disease Control (CDC) and other funding arms of the federal government will be much more likely to give money to ME/CFS clinical trials since "it is a real disease," i.e., it has a drug already approved to treat it. Right now there are many doctors who would like to test medications and other treatments for ME/CFS who simply cannot get funding. $6 million for CFS in the NIH budget in 2011. $3 billion for HIV/AIDS. About the same number of patients!!

PLEASE WRITE to those peoplelisted in the sample email below. Sendthe same email, or write your own, telling your own story. Please do this quickly, as the FDA can make adecision anytime before February 2nd. They are not obligated to wait until then todecide. Please write daily – numbers ofletters matter!


To: Secretary KatherineSebelius
CommissionerMargaret Hamburg
DirectorJanet Woodcock
DeputyDirector Sandra Kweder

CC: SenatorRichard Blumenthal
SenatorRobert Casey
Senator KayHagen
CongressmanJoseph Pitts

Email addresses:



The FDA shouldapprove Ampligen by Feb 2, 2013. Patients and our physicians musthave the opportunity to access a treatment that has shown such promise forME/CFS patients. Failure to do so leavesus with no FDA-approved options to treat this disease.

The FDA has stated that ME/CFS is a serious and lifethreatening disease. Yet, withouttreatment, patients and their families are left to suffer. Many of us are bedbound or homebound. We are in constant pain and suffering,abandoned to bodies that torture us every day and demands that we parse out ouractivities like a single piece of bread that must last for a month. According to one retrospective study, patientsare more likely to die prematurely from cancer, heart failure or suicide. Thisis the long-term reality of living, untreated, with ME/CFS. Imagine living with an untreatable disease soterrible that you would choose suicide to escape from it.

Over 700 written and over 30 in-person patient testimonies,including that from the AAC patient representative, conveyed how profoundlythis devastating disease impacts our lives and the risk we are willing to takefor the opportunity to escape from this terrible physical burden and get backeven a piece of our lives.

For us, even small improvements have a very significantimpact on our quality of life. It isevident that Ampligen has provided benefit to patients, with the testimony anddata pointing to meaningful change in our ability to function and care forourselves.

The true nature of this disease and the plight of patients havebeen ignored for too long. Remember that the disease itself has a collateralimpact that creates its own serious risks for patients. Risk/benefit may be thecurrent standard, but there is a third factor – the risk of no approved treatment.
Patient testimony and patient and clinician experienceprovide evidence that this drug works in patients. A number of AAC membersagreed that Ampligen helps, and other members noted that they saw an indicationof effectiveness in patients. ApproveAmpligen and let patients and their doctors decide whether to take thisopportunity for patients to find some relief from the living death that istheir reality today.

The advisorycommittee voted that Ampligen's safety profile is adequate for approval. Approve Ampligen by Feb 2, 2013. Anything less is condemning one millionAmericans to years of continued suffering without any hope of relief.
Thank you.

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