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Call to Action: Congressional Hearing on Ampligen

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By FDA Action Team • www.ProHealth.com • March 5, 2015


Call to Action: Congressional Hearing on Ampligen
By FDA Action Team

To all ME/CFS –S.E.I.D. Patients, Family and Friends: 

As most patients know, the IOM and NIH P2P have released some very positive findings on our disease.

While there is debate re: the new name S.E.I.D., there is no debate that we need treatments. FDA continues to ignore the severity of our disease, even though they admitted on the record that prior to and during the Advisory Committee for the approval of Ampligen, that they did not fully understand this disease.

We now have the chance to use the recent IOM Report from the National Academy of Sciences and the NIH P2P findings to gain approval for the only treatment ever to be in an FDA-approved clinical trial, one which the FDA Advisory Committee voted 8 to 5 was safe for this patient population.

The opinion and data reported by IOM and P2P should make it clear to FDA and others that Ampligen’s risk is minimal and the reward potential is great for those suffering with this most devastating disease. That‘s why we are asking patients, family and friends to email the request below to those who represent us in Washington D.C. and at HHS agencies.

This will be step one of many to get a treatment approved for suffering patients. With approval will come insurance coverage, then more treatments as other companies see the potential for profits, thus leading to more research dollars.

Below is a template email. You can copy and paste it, or you can modify it to include anything further you have to say.

Let Your Voice Be Heard! 

Thank you for taking action for yourself and for those unable to do so.

Kindly,

The FDA Action Team

Please cut and paste the addresses below into your address bar. (These are email addresses for Congressional staffers.)


TO:


monica.volante@mail.house.gov ; sarah.curtis@mail.house.gov; Elizabeth.brown@mail.house.gov;  dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.paluskiewicz@mail.house.gov; scott.dziengelski@mail.house.gov; thomas.power@mail.house.gov ; 
 
CC: janet.woodcock@fda.hhs.gov
 
SUBJECT LINE: Hearing Request for Treatment Denial

[Body of email]

To: The Honorable Congressman Joseph Pitts, Chairman, Energy and Commerce, Subcommittee on Health; Representatives Reid, Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
 
Cc: Janet Woodcock, Director, Center for Drug Evaluation and Research

REQUEST: A Hearing/Adjudication to Examine the Failure to Provide Treatment that has the potential to improve the lives of 40% of the population living with ME/CFS.

You may have recently seen the report issued by the Institute of Medicine, “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness,” 2015. It stated that “… The primary message of this report is that ME/CFS is a serious, chronic, complex, multisystem disease that frequently and dramatically limits the activities of affected patients. In its most severe form, this disease can consume the lives of those whom it afflicts. It is ‘real.’” 

We have been calling on the government for decades and while grateful for the IOM report – it’s just words. What happens when someone gets diagnosed, and there are no treatments? We suffer.

ME/CFS patients request that you call a hearing to examine a treatment that has shown promise for 20 years. Experts agree that between 20-40% of patients would see improvement, and without a doubt it would open the gate for biomedical research and innovation.

It is FDA’s job to approve drug treatments and it’s your job to ensure that the regulatory process allows for fair and just review which must be based on the true facts of benefit risk. The FDA does not understand this disease based on their own admission and we ask that you bring the experts in and provide an open hearing for the facts. The FDA appeals process is flawed. It is a self-review that takes years and many thousands of dollars.

A 2004 study by Reynolds et al. has estimated the direct and indirect cost of ME/CFS in the United States is between $18,677,912,000 and $23,972,300,00 annually (http://www.dynamic-med.com/content/7/1/6). These findings indicate that ME/CFS imposes enormous economic costs to the U.S. economy. This burden could be substantially reduced by the approval of Ampligen.

We need your help to get help for ourselves and so many others.

Sincerely,
 
[Your Name]
[Years of Life Lost to ME/CFS]  



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