As we all know, the IOM and P2P reports, and the Hornig/Lipkin cytokine paper, give us weapons with which to press for funding, treatment, and respect for our long-neglected disease.
On Health Rising, Bob Miller has made the first call to action off the back of these important events. He's calling for mass action to pressure the government on Ampligen. This is an advocacy action that has been in the pipeline for a while and is now ready to go.
Bob says that another advocacy campaign - to pressure the NIH for more research funding off the back of these important events - will begin soon.
Here are details of how to take part in the Ampligen campaign. I've impertinently given Bob's instructions a light edit and have broken up the text for ease of reading.
On Health Rising, Bob Miller has made the first call to action off the back of these important events. He's calling for mass action to pressure the government on Ampligen. This is an advocacy action that has been in the pipeline for a while and is now ready to go.
Bob says that another advocacy campaign - to pressure the NIH for more research funding off the back of these important events - will begin soon.
Here are details of how to take part in the Ampligen campaign. I've impertinently given Bob's instructions a light edit and have broken up the text for ease of reading.
Bob Miller on Health Rising said:To all ME/CFS/SEID patients, family and friends,
As most patients know, the IOM and NIH P2P have released some positive findings in our disease. While there is debate about the new name, SEID, there is no debate at all that we need treatments.
(From the recent Hornig et al. study: “If replicated in longitudinal studies, these data may provide a basis for early immuno-modulatory intervention to prevent long-term, recalcitrant illness”. In fact we already have an immuno-modulatory drug that’s proven to help with ME/CFS: it’s called Ampligen.)
The FDA admitted prior to and during the Advisory Committee meeting for the approval of Ampligen, that they did not fully understand this disease. They have agreed that it is a serious disease – but they’re not treating it like one.
Consider:
(1) that the FDA Advisory Committee voted 8 to 5 that Ampligen is safe for this patient population;
(2) that the FDA has stated it has no safety concerns regarding Ampligen;
(3) that the FDA has stated ME/CFS is a serious disease and that ME/CFS patients urgently need treatment options;
(4) that two recent federally funded reports (IOM and P2P) underscore the immense need for treatment options for the million Americans with this disease; and
(5) that the FDA has done nothing to alleviate the suffering of people with ME/CFS … but it could.
It’s clear that Ampligen presents minimal risks and large potential rewards for a large, drastically underserved community.
The recent IOM Report from the National Academy of Sciences and the NIH’s P2P findings give us our best opportunity yet to push for FDA approval of Ampligen. That‘s why we are asking patients, family and friends to email the below request to our representatives in Washington DC and at the Department of Health and Human Services (DHHS).
This is step one of many to finally get a treatment approved for ME/CFS. With approval will come insurance coverage for all, and more treatments as other companies see the potential for profits.
There is a template email below to follow if needed and you can copy and paste for ease. It is only a template or guide; use your own voice and let your voice be heard. Please send in your email ASAP.
Thank you for taking action for yourself and for those unable to do so.
Kindly,
The FDA Action Team
Instructions
Please cut and paste these addresses (for staff of Congress members, and for Dr. Woodcock at the FDA and Dr. Lee at the HHS) into your email "TO" box: 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 ; janet.woodcock@fda.hhs.gov; Nancy.Lee@hhs.gov
Cut and paste into the SUBJECT LINE: Hearing request for treatment denial
Cut and paste into the EMAIL MESSAGE:
To: The Honorable Congressman Joseph Pitts Chairman, Energy and Commerce, Subcommittee on Health
To: Representatives Reid, Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
Cc: Janet Woodcock, Director, Center for Drug Evaluation and Research, Nancy Lee HHS
REQUEST: A hearing/adjudication to examine the failure to provide treatment that has the potential to positively impact 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) which stated that Chronic Fatigue Syndrome is a legitimate disease that needs diagnosis and treatment.
We have been calling on the government for decades to support ME/CFS. While we are grateful for the IOM report, until the spirit of the report is acted on – and approved treatments exist – the report is simply more words to a community that has been hearing nothing but words for decades. Until approved treatments for ME/CFS exist, the million people with ME/CFS will continue to suffer – many of them needlessly.
We, therefore, 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 see improvement and without a doubt it would open the gate for greatly needed biomedical research and innovation.
Your oversight powers enable you to ensure that drugs receive a just and fair review based on an appropriate risk-benefit assessment. We don’t believe this has happened with Ampligen and we’re not surprised, given the FDA’s public statement that they do not understand this disease.
We therefore ask that you bring experts in who do understand this disorder, in order to conduct an open and objective hearing on the pro’s and cons of Ampligen approval for ME/CFS.
Cost Estimates: Using ME/CFS prevalence data of 0.42% and indirect cost estimates from Reynolds et al. (2004), the direct and indirect cost of ME/CFS to society in the US is estimated to be $18,677,912,000 for the community sample and $23,972,300,000 for the tertiary sample. These findings indicate that ME/CFS imposes substantial economic costs to the US economy, that many are suffering and all deserve to have valid treatment options.
NIH currently spends $5 million annually on a disease that costs the US economy over 20 billion dollars a year.
Sincerely,
Your name HERE
Number of years of life lost to CFS HERE