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Call to Action: Include Ampligen in the 21st Century Cures Legislation!

  [ 16 votes ]   [ Discuss This Article ]
By Billie Moore • • September 25, 2014

Call to Action: Include Ampligen in the 21st Century Cures Legislation!
By Billie Moore
The announcement below is from Fred Upton, Chairman of the Energy and Commerce Committee, U.S. Congress, and explains the urgency of this reply. Following that is the form email. You can send it or modify it as you wish. But please send something. 

Congress is working on something that has promise of having a good effect on getting Ampligen approved - legislation through the 21st Century Cures initiative. If Ampligen is approved, even conditionally, other drug companies will take note; ME/CFS automatically becomes a "real disease"; physician and public respect follows. Ampligen helps people. Let's work to help many others receive it. It's not a panacea, but it's a very good start. It's the only thing out there likely to get FDA approval in the next 10 years. The email stresses, however, that these three requests for inclusion in the legislation are appropriate for many other under-valued, underfunded diseases. 

Billie Moore
Patient Advocate

More Valuable Ideas Shared on the #Path2Cures

21st Century Cures continued today with another blockbuster roundtable discussion to review the ideas that have been shared with the committee over the past several months and discuss next steps for the initiative. The President and CEO of the Biotechnology Industry Organization, Jim Greenwood, recently took to The Hill to share some of his ideas for accelerating the pace of cures and treatments, noting specifically the impact that Alzheimers has on our nation. Greenwood explains how accelerating this process will not only provide hope for patients and families but also will have an enormous economic impact.

As Energy and Commerce Committee Chairman Fred Upton (R-MI) noted at this morning’s event, 
“We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress. If you want your idea considered, please send it to as soon as possible. The more specific the idea, the better.”


The following is to be sent to
Subject line: Please include Ampligen in the 21st Century Cures Legislation

To Members of the 21st Century Cures,
On behalf of the more than 1 million Americans suffering and dying from Myalgic Encephalomyelitis (sometimes referred to as Chronic Fatigue Syndrome but preferably as ME/CFS by government agencies and patient groups) we ask that the following be included in your 21st Century Cures Legislation.

1) The 2015 NIH budget should be commensurate with the size of the disease and/or the cost to the nation. For example, Multiple Sclerosis (MS), a disease the FDA states is similar in seriousness to Chronic Fatigue Syndrome but with only 400,000 patients - receives a $115 million per year in NIH funding - and there are already nine existing drugs for MS. People with ME/CFS have NO approved treatments yet more than 1 million people are sick (versus 400,000 for MS), and it receives only $5 million from the NIH. That is only $5.00 per patient! This is a ridiculously small amount. Yet CDC studies estimate it costs the nation $22 billion per year. Other funding levels for 2014:

~ Anthrax $72 million (who gets anthrax?)
~ Attention Deficit Disorder $50 million (not life threatening)
~ Smallpox $31 million (no one gets smallpox anymore)

2) One drug – Ampligen - has shown promising results against ME/CFS. There were significant improvements in approximately 40% of the patients on Ampligen! Many patients in the trials have been safely on this drug for years. Yet the FDA continues to drag its heels in approving it. We request that the legislation reflect that if a drug shows promise and the top experts in the disease believe the drug should be on the market, then FDA should use its existing regulatory authority to approve the drug, and in collaboration with the experts and the sponsors develop the appropriate follow-up studies and REMS program. The expert physicians that work with the patients and the drug have the expertise and knowledge needed to provide sound judgment. This will allow for a large proportion of new ME/CFS patients’ lives (and those with other similarly ignored diseases) to improve. Leaving patients without treatment is NOT in the best interests of public health; ME/CFS patients die early deaths from cancers, heart disease, suicides (because there are no drugs and no hope). 

3) FDA should be required to provide the same type of flexible approach to chronic illnesses with few or no FDA-approved treatments that it does to those considered fatal (able to cause "imminent death"), to rare disorders, or to disorders that produce epidemics. ME/CFS falls between the two as do many chronic illness, yet cost families and the nation greatly. The fact that 1,000,000 people with ME/CFS have suffered for decades without a single FDA-approved drug requires the FDA recognize that a new approach with more flexibility is called for in this disease and other diseases which the FDA has failed to support. After DECADES of inaction, IT IS TIME. 

Thank you for your attention.

(your signature and date)

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