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Added benefit of subset analysis insufficient for keeping safe drug from patients with no alternative

An FDA "no" to Ampligen would significantly slow down investment in chronic diseases in general. They voted it safe. They're not contesting its effectiveness per se, they mainly insist on knowing which subset is affected more than others. We're not saying this doesn't belong in an efficacy profile, we're saying its added benefit doesn't outweigh the tremendous human and financial cost. It's an insufficient justification for keeping a potentially life-saving drug from bed-ridden patients with no alternative. Authorities in Canada and Brussels approved it 2 decades ago. Do you really think they're less diligent? Respect our right to decide with our doctors and provide incentive for sponsors to give drug companies the means to get those subsets refined. We already know the subset that matters most. They're called ME/CFS patients.

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We need your help!

I've been contacted by several advocacy groups and there's a handful of campaigns starting up to promote the petition. Robert Miller will personally be handing over the signature list to the FDA (and a Congress Rep. if we have the numbers) and is coordinating with Cort Johnson on how best to proceed. It looks like we're gaining traction, but the petition will need an all-out effort to reach the kind of numbers required for media exposure. The ultimate goal would be Congress -- but we need your help! Some Twitter and Facebook activity can go a long way. Ask people to retweet your calls to sign the petition. Reply to sceptics that Ampligen was voted safe. Ask your Facebook friends what they would want. You *can* make this a success...

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A comment by anonymous for the New Year

Responsible evidence-based decision-making acknowledges the possibility that it is sometimes the evidence, and not always the subject, that is lacking. Even the most conclusive studies are still statistical arguments – concluding what is *likely* to be repeated in *most* cases, not what is unequivocally true. When you base your decisions on a lack of evidence, you are in even deeper theoretical territory. I'm sure you are familiar with the adage that "absence of evidence is not evidence of absence." Unfortunately, while you have the luxury of arguing these finer points of scientific epistemology, sufferers of this disease live very real, very empirically awful lives. And yet you are withholding their *only* treatment option? Can you find the humility to consider that inconclusive research is not the same as an identified threat, and give the sick the option to find out for themselves if they can be helped by this drug? Sufferers of this disease are...

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This is our chance to make something happen

I've been amazed at the incredible response so far and would like to thank everyone who's been getting involved! Special thanks go to Robert Miller, Myra, Donna Pearson, Cort Johnson and Phoenixrising. It's still early days though. We need many more signatures to make sure the FDA pays attention to us on February 2nd. You too can make a difference! Exposure on Facebook and Twitter can go a long way. Spread the word far and wide -- and if you feel you can help out in any other way, feel free to send me a message. It's not just about Ampligen. Imagine a safe and potentially life-saving drug being kept from your loved one, even though it's been available in places like Canada and Brussels for 17 years. It's about all of us.

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Goal: 8,000 signatures

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Links

ME/CFS Facts

Center for Disease Control on CFS

Wikipedia on Rintatolimod

A patient who was at the 20 dec FDA Arthritis Advisory Committee meeting about the approval of Ampligen

Audio recording of above meeting

Alternative names for CFS

FDA on postmarket REMS programs



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