Saturday, February 15, 2014
Thank you very much,
NJCFSA Advocacy Chair
Dear Patient Community:
We are asking your help to continue to push for treatments for ME/CFS. Our ME/CFS Treatment team will continue to work for meetings between the FDA and pharmaceutical companies with the sole purpose of urging them to develop and approve drugs to treat ME/CFS. People with this disorder must not be forgotten!
While many felt Ampligen did not receive a fair review at the Advisory Committee Meeting in December 2012, the FDA has taken positive steps. The Stakeholder's Meeting and the Voice of the Patient document opened the FDA's eyes to the debilitating effects of ME/CFS, and the FDA responded by stating they consider ME/CFS to be a serious disorder on par with diseases like heart failure and kidney disease.
That was a good beginning, but it's only the start. One drug across the finish line will change the course of this disease forever.
(1) It will for the first time make an approved treatment available for ME/CFS patients everywhere.
(2) It will make the disease "real" in the minds of doctors and the public because there is a drug for it.
(3) A successful drug will encourage pharmaceutical companies to develop other treatments for it
The FDA can do much more to approve Ampligen. It showed how much more it can do when it gave 6000 healthy Princeton students access to the drug Bexsero, unapproved by the FDA, because they might develop meningitis in the future. If Princeton students can get access to a drug for a condition they don't have and may never get, we believe people with ME/CFS should have access to a drug for use today that has been used safely by hundreds of patients, and which the FDA's own panel voted was safe enough, given the needs of the ME/CFS community.
We believe ME/CFS patients have a right to try Ampligen, just as the Princeton students had a right to choose Bexsero. Here are two links to the Bexsaro story:
http://www.nj.com/mercer/index.ssf/2013/11/princeton_university_meningitis_outbreak_prompts_cdc_to_consider_emergency_vaccinations.html. (spaces are underscores)
Please help keep the pressure on the FDA and please send the following letter to the list below. The outpouring of emails and letters from patients last spring was tremendously effective – let's do it again!
Please do send letters to the elected officials and to the FDA names below. Janet Woodcock, M.D., is Director, Center for Drug Evaluation and Research, FDA. Margaret Hamburg, M.D., is Commissioner of the FDA. Monika Volante is Legislative Director for Representative Jos. Pitts, (R-PA); he has been helpful to our cause in the past. Other names are health aides to other legislators who have some influence in health affairs legislation.
Bob Miller, Patient Activist and Advocate
Pat Larosa, NJCFSA President
Billie Moore, NJCFSA Advocacy Chair
Cort Johnson, Founder of Phoenix Rising and Health Rising
Lori Chapo-Kroger, PANDORA.org, President
Nancy McGrory, Providence Mgt. & Comm., Patient Advocate
Patients: Cut and paste and add your own information and comments.
Email To: email@example.com; Margaret.firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; Mitchell.email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; Meghan.email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; Thomas.email@example.com; Elizabeth.firstname.lastname@example.org; email@example.com; firstname.lastname@example.org;
Subject Line: Unequal Treatment
Dear Dr. Woodcock:
Why were 6000 Princeton students given the option to try an FDA-unapproved drug for a disease that struck only seven students when more than a million people with Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are denied access to a drug that ME/CFS expert practitioners whole-heartedly endorse? Ours is a serious disease also! And people are dying from its effects.
Why were these 6000 Princeton students who do not have meningitis but who might get it given more options than people with ME/CFS who have been sick for decades? I am talking, of course, of the unapproved drug Bexsero that the FDA recently allowed to be made available to students at Princeton after seven other students came down with the meningitis.
While healthy students get Bexsero, very sick people with ME/CFS are being denied access to a drug, Ampligen, which has been used safely by hundreds of patients, sometimes for years. The FDA review panel for Ampligen concluded that Ampligen was safe enough to be used by people with ME/CFS. Despite the fact that ME/CFS patients, like the Bexsero patients, have no FDA approved drugs to treat this very serious and life robbing disease, the FDA has not found a way to
give them access to a drug that's been safely used for decades. Unlike the well Princeton students, 61% of ME/CFS patients have reported they are bedbound or housebound on their worst days (and there are far more worst days than best days).
Thankfully the seven students at Princeton will recover. I, however, will not – not unless a treatment option is made available.
Severely ill patients with no other options available to them should be allowed to decide, in consultation with their physician, whether to try Ampligen, under suitably managed conditions! The FDA can find a way to make this happen.
It did it with Bexsero and it can do it Ampligen. Stop keeping people with ME/CFS from treatments! Stop keeping them from having hope of a better life! Give a million people with this disease the same option you're granting to 6000 healthy Princeton students.
I've waited long enough. I have been sick since _________. Day to day my life looks like ____________________. Why is my life not worth that of a Princeton student?
Friday, February 14, 2014
According to the vagus nerve infection hypothesis (VNIH), there is a physiological reason behind post-exertional malaise: Exercise provokes muscle tissue to produce the proinflammatory cytokine IL-6, which would then exacerbate the ongoing local cytokine response within vagus nerve ganglia or paraganglia. That's the hypothesized mechanism behind post-exertional malaise.
The CBT practitioners in the infamous PACE study were focused on avoidance/fear of activity because they began with the assumption that CFS is psychological. They think the fear of activity itself is the cause of CFS; I'd say that fear of activity is justified
- See more at: http://simmaronresearch.com/2014/02/michael-vanelzakker-ph-d-talks-vagus-nerve-infection-hypothesis-chronic-fatigue-syndrome-mecfs/#sthash.tyuWTJH1.dpuf
Read more here: http://www.sacbee.com/2014/02/12/6149139/inside-medicine-15-percent-of.html#storylink=cpy
Read more here: http://www.sacbee.com/2014/02/12/6149139/inside-medicine-15-percent-of.html#storylink=cpy
Thursday, February 13, 2014
Tuesday, February 11, 2014
Monday, February 10, 2014
Interview: Ian Lipkin's Million Dollar Appeal for Microbiome Study
February 10, 2014
Lipkin believes that immune activation may be responsible for driving
the symptoms associated with ME/CFS. And that the immune activation
and could itself be triggered by bugs, not in the blood, but found in
the vast ecosystem of bacteria, viruses and fungi, that constitute the
However, he doesn't have the funds to pursue this research and so he's
appealing to the patient community for the one million dollars he
needs to get the work done. The payoff? A better understanding of the
illness and the possibility of new treatments.
The smoking gun
The immune activation he's found could explain fatigue – it's almost a
universal symptom of infections like flu, and is actually a
consequence of immune activation rather than caused by pathogens
The same could be true of other ME/CFS symptoms including disturbed
sleep and brain dysfunction which again are typical symptoms of immune
Lipkin is eager to build on this work. He believes the immune
activation is a smoking gun and now wants to track down who or what
pulled the trigger.
... his attention is particularly focused on the microbiome, the
large ecosystem of bugs that live on our skin and within our 'inner
tube' that leads from mouth to bottom.
... The potential to treat disease by restoring the microbiome is one
reason this area of research is attracting so much attention.
Lipkin's proposed study will look at all three trees of life:
bacteria, fungi and viruses in the microbiome of 100 patients and 100
controls recruited for a previous NIH study. It will cost a cool
1. Sample collection: $150,000
2. Faecal Microbiome sequencing and Analysis: $317,000
3. Development of highly-accurate real-time PCR assays to confirm
findings and levels of microbes: $328,000
4. Cytokine analysis: $86,000
5. Development of antibody tests for important bugs identified by the
microbiome work: $249,000
... NIH is not in such a hurry as it has declined to fund the study at this time.
But then the NIH has only ever committed relatively small amounts of funding to ME/CFS – around $5 million a year, compared with around $115 million annually for MS and $284 million for Asthma.
Its funding record firmly suggests the NIH's priorities lie elsewhere.
Dr Lipkin has now appealed to patients to fund his latest study that
aims to hunt in the gut microbiome for the 'trigger' of the immune
activation his study found in ME/CFS. And he needs a cool million
dollars to pay for the study outlined above.
Actually, the study comes to a bit over a million dollars (see above)
- $1.13 million, to which another $140,000 of costs for maintaining
the high-tech equipment used and general lab costs making $1.27
million in total. However, the initial target has been set at $1
In his CDC telecast to patients last September, Lipkin explained the
microbiome project was being held up by this lack of funds, and urged
patients to contact their representatives in Congress.
He also appealed directly to patients who could afford to do so, to
invest in research:
"it may not be appropriate to pass the hat, but that is exactly what I am doing"
How long will it take for the results? "Within a year", said Lipkin
Donate to the the ME/CFS microbiome study
... I have just donated and hope many other patients will do too. Just
click on the button below and follow the instructions. The option is
to donate to CFS research, but in the next page you can add 'special
instructions' such as 'for the microbiome study'.
We need only for every US patient to donate $1. Or one in ten patients to donate $10.
If people want to do more to help – and this is a big target – they
can help to promote this crowdsourcing initiative at this new group,
or email Vanessa Li. I will give her the last word:
"The CDC says there are more than one million ME/CFS patients today in
the US alone. There is no reason why, if every patient were made aware
of Dr. Lipkin's appeal and donated $1, that we should fail to raise
the $1 million. An esteemed researcher doing high-caliber work is
taking a serious interest in finding out the cause of our desperately
under-researched illness. Now is the time to act!"
"There is no question in my mind that this is a physical disorder. The fact that we haven't been smart enough or invested enough in it to sort that, doesn't mean that this is anything else."
Sunday, February 9, 2014
I also wanted to let you know that I found a link on your site that doesn't seem to be working. It's a link to http://www.healthreform.gov/ (found on this page: http://www.cfsfacts.org/2009_04_19_archive.html), which was archived when the Affordable Care Act became law. This page has replaced it: https://www.healthcare.gov/, which I thought would be helpful to you in case you'd like to update the broken link.
I've also found a few other resources that I thought you may want to link to. These have been really useful to me, so I'm passing them on in hopes you'll agree they would be useful and helpful to others via your site:
Affordable Care Act: Obamacare & Health Reform Facts: http://healthreform.kaiserpermanente.org/
Understanding the Impact of Obamacare on Medicare: http://blog.ehealthmedicare.com/media-center/infographics/?pid=11
What does Marketplace health insurance cover?
Affordable Care Act: State-by-State Impact: http://www.hhs.gov/healthcare/facts/bystate/statebystate.html
The Lifestyle Revolutionaries Guide to Addiction Intervention: http://www.lakeviewhealth.com/InterventionGuide.pdf
I hope you're able to use these on your site!
If you are looking for more info, I'd be happy to show you my guide when I've finished it! I'm hoping it will be very useful. Or if you know of any other resources that might help, I'm open to suggestions.
Thanks so much! Hope you're able to use these resources. All my best,
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