“There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government.”
So said Suzy, in an online comment about the failure of the FDA Advisory Committee on Ampligen to vote in a manner that would have got approval for the drug’s use for patients with ME/CFS.
But it’s not too late. The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier. So we have to act now to have a chance of getting Ampligen approved.
Cort Johnson and Bob Miller have put out a call for patients, families and friends to email the FDA, now and every day until we hear the final decision, to apply pressure to get Ampligen for patients.
There is still room for hope. The panel voted that Ampligen’s safety profile was adequate for approval. The vote on whether Ampligen’s safety and efficacy data supported approval went 8 to 5 against: two votes the other way would have made it 7 to 6 in favour.
We have to push, push now, push hard and keep pushing. Bob and team have produced a template email for us to use, reproduced below, which makes this an easy action. 750 of us emailed the FDA last time: let’s do it again. Please email, and do it now.
Would we like to have better data on Ampligen at this stage? Of course. But it’s an imperfect world and this is our chance. Having Ampligen approved would put the decision about risk and benefit in the hands of you, the patient. And it would validate ME/CFS as an immune disease – the knock-on benefits of that would be enormous, way beyond Ampligen itself.
To close with the rest of Suzy’s post:
“There comes a time when being alive does not equal living a life. Numerous cancer patients willingly suffer side effects of chemotherapy and radiation for a chance to live. CFIDS patients have been given a different kind of life sentence but are also fighting for their lives — give us a chance.”
Click here to create your email automatically from the template, and copy in the suggested text below, or write your own message.
The addressees (already in the template) are:
HHS Secretary Katherine Sebelius, FDA Commissioner Margaret Hamburg, Director Janet Woodcock, Deputy Director Sandra Kweder, Senator Richard Blumenthal, Senator Kay Hagen, and Congressman Joseph Pitts.
To: Kathleen.Sebelius@hhs.gov, firstname.lastname@example.org, email@example.com, Sandra.Kweder@fda.hhs.gov, Monica.firstname.lastname@example.org
CC: Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, email@example.com
Subject: Approve Ampligen now
From: PLACE YOUR NAME HERE
The FDA should approve Ampligen by Feb 2, 2013. The advisory committee voted that Ampligen’s safety profile is adequate for approval. Patients and our physicians must have the opportunity to access a treatment that has shown such promise for ME/CFS patients. Failure to do so will leave us with no FDA approved options to treat this disease.
The FDA has stated that ME/CFS is a serious and life threatening disease. Yet, without treatment, 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 our activities like a single piece of bread that must last for a month. According to a DePaul study, patients are more likely to die prematurely from cancer, heart failure or suicide. This is the long-term reality of living, untreated, with ME/CFS. Imagine living with an untreatable disease so terrible that you would choose suicide to escape it.
750 written and over 30 in-person patient testimonies, including that of the AAC patient representative, conveyed how this devastating disease impacts our lives and the imperative of weighing the opportunity to benefit against the risk of no treatment to escape from this terrible physical burden and get back even a piece of our lives.
For us, even small improvements have a very significant impact on our quality of life, which were dismissed by FDA statisticians. It’s evident that Ampligen has provided benefit to patients, with the testimony and data pointing to meaningful change in our ability to function and care for ourselves.
The true nature of this disease and the plight of patients have been ignored for too long. Patient testimony and patient and clinician experience provide evidence that this drug works in many patients. A number of AAC members agreed that Ampligen helps and other members noted that they saw an indication of effectiveness in some patients.
Let patients and their doctors decide whether the only treatment in FDA clinical trials for ME/CFS is the right medicine to provide relief from the living death that is our reality today. Remember that the disease itself has a collateral impact that creates its own serious risks for patients.
The advisory committee voted that Ampligen’s safety profile is adequate for approval.
Approve Ampligen by Feb 2, 2013. Anything less is condemning ME/CFS patients to years more of continued suffering without any hope of relief.