Dear Friends,
We, as a community, accomplished some very important things during the last few weeks, and so I am ending my hunger strike tonight. I am committed to working with our federal health agencies to bring a stronger focus and program to bear on ME/CFS for all of us. The most important thing patients did in recent days was come together. When we commit to each other in the way we all did these last two weeks, we can make great strides toward treatments and understanding of ME/CFS.
I believe we have made the following accomplishments:
- Dr. Wanda Jones, who I trust and respect, in the Assistant Secretary of Health’s office has engaged with the Secretary of Health over the past days on the need for a serious commitment to address our unmet needs.
- Dr. Jones committed to me that the Secretary’s office will be engaged in the FDA Stakeholder Meeting this Spring to make it a successful meeting in promoting the need and path forward toward evidence-based treatments.
- For the first time, Secretary Kathleen Sebelius met with a few ME/CFS patients from her universe to understand directly the complexity, unmet need, and frustration of patients.
- Senate Majority Leader Harry Reid, my senator, advocated for ME/CFS patients at the highest level this week, and I am deeply grateful. He and Senator Kay Hagan were instrumental in raising the seriousness of patients’ unmet need and elevating the importance of a strong FDA Stakeholders Meeting for our future. I know many other Senators and Congresspeople engaged, and that is important to our future efforts.
There are two things we need to do now.
- .Stop doing mass emails to the federal agencies, and
- Now turn our efforts toward making a thoughtful contribution to the FDA Stakeholders Meeting, so that we can advance treatments with a smart, strong push from the patient community.
I want to stress that it is important that patients work with those in our federal health agencies who will work with our community seriously. I always will. Thank everyone you know for helping to make this action successful, and we especially thank Dr. Wanda Jones for her leadership.
Thank you all for being some of my strength and supporting my family in these challenging days.
Robert Miller
Thank you, Robert Miller, for leading this sucessful community effort, putting your own health at even greater stake. I am so glad you are ending your strike.
A thousand thanks to you and Courtney for all you have accomplished in the last few years.
Thanks, Bob, for your sacrifices during the hunger strike. You should be very proud of the accomplishments that your advocacy efforts made possible.
Bob, why focus on the FDA when the authority for defining this disease is the CDC? As long as the CDC denies us authenticity, how can any government agency go against them (as shown in the FDA Ampligen vote)? I think we should be uniformly targeting the CDC and any other target is a waste of time.
Bob G.
We have the attention of the Secretary of Health’s office, which is over CDC. We have a planned StakeHolder meeting that we must focus on and come to the table very well prepared. CDC has started to alter not just it’s view of CFS, but it is acting on it by doing a multi-site study at 7 of the top ME/CFS expert clinical sites in the U.S. and funding it. That is Huge.
Kindly,
Bob Miller
Dear Bob,
good to read, that you stopped your hunger strike and congrats to your success.
I thought very often about your hard fight, I supported whenever and whereever I can.
One question:
“… is acting on it by doing a multi-site study at 7 of the top ME/CFS expert clinical sites in the U.S. and funding it. That is Huge.”
What that means?
The government will support a Ampligen study at 7 sites?
Good health and good luck for you and your family!
Best wishes from Germany
Thanks, Bob, to you, Courtney and your family.
I hope you recover well and get your strength back very soon.
I’m relieved you stopped when you did – I agree, these are great accomplishments.
First, Thank you All for your support. I am in recovery mode, but wanted to make a response to you all today. As always our achievement was because this patient community was United, it is the only reason I was able to do the HungerStrike, because I had support, support on my wife, my twin boys (12 yrs. old) and this entire patient community. We now shift gears from getting the attention of the highest levels at our Federal Health agencies(specifically HHS who is over NIH,CDC & FDA) to working with those who are willing to work with us. We need to prepare for the upcoming StakeHolders meeting. I would ask everyone to stop all emails and phone calls to the Health agencies as we now want their attention on the StakeHolder meeting and you have all done such a great job of slamming them, they have been unable to do anything else but focus on our Action. If needed we can always resume Plan A… Cort, if you could set up a place for patients to submitt requests and ideas for the StakeHolders meeting , that would be great. I would ask all patients who can, to do some homework on, who and what we should have at the meeting. Such as the expert clinicians in the world of ME/CFS, Pharma companies(we can select a few and begin writing to them to attend) Insurance Co’s. and more. We as patients need to be prepared and educated for the best possible meeting. So please take a rest and then begin doing the Homework. Cort, Thanks for keeping everyone up to speed.
And again my humble thank you to the patients for All your support.Now lets be United and create the best StakeHolder meeting ever.
Kindly,
Bob Miller
Bob,
So grateful for your sacrifice and leadership during the last few weeks. Was overwhelmed to hear the Dr. Wanda Jones interceded on our behalf and the Sebelious met with a few ME/CFS patients!!
Do we know who these patients were, how were they choosen, or what was discussed?
Focusing our attention now on the upcoming stakeholders meeting is a great idea. I also think tthat we should develop strategies for the upcoming CFSAC and in choosing our patient representatives to be added to the Committee.
Very happy now you can eat, rest and recover.
All the best as we press forward,
Kristina
Bob, you have done a tremendous job. Thank you very much.
The FDA Stakeholders Meeting is definitely a very important next step. But will it really be so different to the outcomes of the many CFS Advisory Committee meetings. My fear is that it will only be used to calm us down.
The FDA stakeholder teleconference on Sep 13 also gave us big hope when the FDA talked about the accelerated approval process which could be applied to CFS that this will be used to approve Ampligen. And the outcome is that Ampligen was rejected because the FDA still requires the highest standards on results. And now we drop our request that Ampligen needs to be approved and focus only on the upcoming FDA Stakeholders Meeting. Even if there will be a good discussion and the understanding about CFS of the FDA will be increased it still means no approved drug for the next 5 years.
We heard in the Arthrithis Advisory Committee meeting on Dec 20 when they discussed the post-hoc analysis that every analysis is considered to first generate a hypothesis which then needs to be confirmed in a placebo-controlled trial. But not only one trial but two trials. And the trials need to be of sufficient size. So in the trials many patients receive placebo and do not even get the drug. And we can never be sure that the results are good enough because of the complexity of the disease and then we will be in 2018 still not knowing whether we will have an approved drug.
I am not sure whether the CDC has altered it’s view. Fact is that Dr. Unger voted against Ampligen approval.
Bob,
I just want to say a very big thank you to you and your family for your commitment and personal sacrifice over the past few weeks. I am in Canada, and as limited as treatment options are in the US, they seem to be non-existent here. Every step forward that the US makes will help all of us.
I am very relieved that you have chosen to end your hunger strike, and will pray that you will regain your strength again soon.
Sincerely,
Christine
Bob,
You are a hero!
I do hope you will include Rituxan/Rituximab in your lobby efforts in the US. 2/3 of patients in Norway have clear response to this drug, some with complete recovery. Its long and established safety record for other diseases, like RA, is very important to the FDA.
I hope we can now stand united globally and finally turn the tide!
All the best from Norway,
Lars
Dear Bob,
I’m realizing that I don’t know anything about the upcoming stakeholder’s meeting. Where is it, who is going, how long is it, what do we hope to accomplish–any information would be appreciated, as the more I know, the better I will be able to focus my energy on the next step.
Laurel
Hi Laurel,
I am working with our Team who initiated this stakeholder meeting several months ago, for now we only have the basics in place, but we are working to ensure we have the most productive meeting possible. More details will be coming and I will post them as they become available. I suggest everyone to just google FDA stakeholder meetings and educate yourself, so you can help our team with your input. I ask for all patients to please do this.
Thank you,
Bob
Here is a link to a letter FDA presented as the intro for the meeting.
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM319213.pdf
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf
I just wanted to thank you for your commitment and outstanding advocacy for the M.E community and how very pleased I am that you have now been able to stop the hunger strike. I hope and pray you will get no long term payback from it.
I’m from the UK and the government’s attitude to M.e is still woeful. I am though feeling great hope from what is happening in your country and I am indebted to all who work so hard to move forward understanding and support for this devastating illness. Finally, there feels some light at the end of a very dark tunnel. Thank you.
Ps as I’m sure people are aware the psychs in the U.K still wield much power and maintain a stranglehold on medical doctrine about this illness
I think of the UK patient group often (sincerely), and my heart goes out to you. It’s still really hard here, but there is a million times worse.
I will keep my fingers crossed for all of you that if a definitive biomarker or reliable treatment is found, that they will no longer be able to incorrectly classify patients that way. I think that’s what it may take, but the rest of the medical community is sure to take notice when that time comes. The tide is starting slowly to shift for us, it’s just much slower at the centre of their power. 🙁
Thank you so much for such a wonderful and difficult action Bob! It seems like if we could only figure out more civil actions to bring our cause to the public, and to the Legislature, perhaps we could get more funding and more done towards finding a cure for this miserable disease. I wish you the best for a steady recovery.
I have the same question as ‘charly’ from Germany in his e-mail above.
He wrote: “One question:
‘… is acting on it by doing a multi-site study at 7 of the top ME/CFS expert clinical sites in the U.S. and funding it. That is Huge.’
What does that mean? ”
And now I write:
ie a) where are, and who runs these so-called ‘7 of the top ME/CFS expert clinical sites in the U.S’?
I had no idea there WERE any ME/CFS expert clinical sites, let alone 7. What physicians are associated with them?
And if these doctors exist, why can’t I ( and others) access them? Can my physician contact them? Oh yeah, we are desperate out here.
See here for the CDC site selection: http://www.cdc.gov/cfs/programs/clinical-assessment/index.html
The doctors involved are Dr’s Klimas (Fl), Peterson(Nev), Natelson (NY), Kogelnik (CA), Bateman (Utah), Lapp (PA) and Podell (NJ.) So these are all very well known in ME/CFS research and treating circles.
It’s a very good US based group…:)
Cheers,
Tony…:)
Bob,
Thanks so much for you and your family’s sacrifice. I am a fairly new me/cfs patient (2009) and need to be educated on how my input can move us forward in terms of the stakeholder’s meeting. I have spent the last week raising awareness on my facebook page and writing to the FDA, NIH and one of my senator’s.
Sincerely,
Katherine
in Houston.
This information was already prepared for the Stakeholders meeting:
http://phoenixrising.me/federal-drug-administration/fda-stakeholders-meeting-for-chronic-fatigue-syndrome-goals-and-objectives
I’m not sure who came up with it. Is this thrown out now, or something we want to continue with?
Dear Bob:
Thanks for your effort — at the very least, it got some attention! Are you aware
of the Whittemore-Petersen Institute at UNR, Reno?
They had some scandal when a researcher bailed with a good deal of data, and
I don’t know how that affects their status now. But they are local, they were built because a man with some wealth got so frustrated at the lack of treatment for his daughter, he pledged several million dollars if the state would come up with
matching funds. They did, and the new institute was built. Whittemore is the man who came up with the money, for a while the Institute was associated with
Dr Daniel Petersen of Incline Village at Tahoe, after the outbreak there in 1985.
I became ill in 1981, and got a lot of the usual nothing but “It’s all in your head’ and ‘by the way, you should see my friend, the shrink” — for 4.5 years before I
was finally diagnosed.
It was about 1996 when the CDC DID acknowledge that our illness was ‘real.’
The AMA didn’t get on board until after the year 2000.
Both of my adult children came down with it, at a time we were still being told it
was ‘not genetic.’ My daughter later also came down with MS! I don’t think it
can get more real than that.
Best wishes, Penny McCracken.
I’ll have an interview with Annette Whittemore and Vincent Lombardi of the WPI coming up shortly, by the way.
Cort,
By the way, you need a hit counter on your blog. Will be motivating and good for business.
Lars
Thanks Lars for the idea. The hits have been pretty good. I will put finding a way to get page views up there on my list 🙂
Explain ‘genetic’. Anyone. Are we talking a genetic susceptibility or a direct genetic abnormality that causes one to be ill from birth? Confused here.
And whatever came of Ken Wilber’s R.E.D.D. aka Rnase-L Enzyme Dysfunction Disease?
Does CFIDS run in families?
Forgive me for asking quesitons that are perhaps dated. I read a lot but it seens to me that the so called ‘facts’ VARY.
ie What is real?
We are talking about a genetic susceptibility of some sort. There does appear to be increased risk of CFS and FM in families; much higher than usual in diseases – based on a few studies. RNase L appears to be dead in the water so far as current research is going but it could be resurrected.
Ampligen
there are two viable options still open to get Ampligen legalised and designated for CFIDS / ME.
1. Hemispherx is unlikely to win its appeal to the FDA, though it is still worth a try. There is a high probability of them losing the appeal. To counteract this injustice, many CFIDS / ME organisations throughout America and Europe and Australasia could make an agreement to jointly fund a legal case to the US Federal court or the US Supreme court demanding that Ampligen be legalised and designated for subgroups of CFIDS patients, as efficacy has been proven in a certain percentage of patients (the subgroups), on the legal grounds of medical necessity including life and death issues, and on the grounds of human rights. Some law firms may take this case on at a reduced or lowered fee and if someone has family or friends who are partners in law firms then one could get the case for free. There are some conscientious lawyers still around. If we could set a legal precedent for this in the US Supreme court we could over-turn and over-ride the corruption in the FDA now and in the future, which would work for the benefit of CFIDS and other neglected disabilities. We must remember that the government and its agencies are there to serve the people, including respecting their Constitutional rights and human rights.
2. Hemispherx may not be able to afford more detailed clinical trials with large populations. So in addition to the above legal case, get the NIH involved in a full scale Ampligen trial. Get them to run very detailed tests of Ampligen on those CFIDS subgroups which are benefitting or have benefitted from Ampligen. This would include full recoveries and those people who improved 70 – 100% of normal function. This trial would include deciphering the biological pathways and mechanisms involved and gene changes and expressions involved in the Ampligen responders. Some of these biomarkers are catalogued on http://www.cfs-ireland.com
And differentiating these CFIDS subgroups from other subgroups which don’t respond to Ampligen. This precision analysis by the NIH would then enable the Ampligen responders to be identified from CFIDS populations and subgroups before Ampligen is even administered. Thus treatment with Ampligen would be 100% effective in the identified subgroups, and both efficacy and safety proved beyond reasonable doubt. This NIH trial could be concluded within 6 months. The NIH findings would force the FDA to legalise and designate Ampligen for CFIDS. A similar NIH trial could be undertaken for Rituximab and similar type drugs. And again if successful the FDA could be forced to comply and legalise and designate these drugs also.
Where will Ampligen fit into the stakeholder meeting I wonder ?
I don’t sense any federal agency is interested in helping to move this drug forward. Bringing new pharma to the table sounds a lot like a very long wait for treatments…
Dear Bob,
I don’t understand what you mean when you say Sec. Sibelius met with a few MECFS stakeholders from her universe. What is her universe? Do you mean Kansas? Do you mean Trinity alumnae? What do you mean?
How did these stakeholders get to her?
What commitments did Sibelius make to them?
Thank you.
Deborah Waroff
There have been requests for more details about what Secretary Sebelius and HHS will be doing for ME/CFS patients. I posted why I halted my HungerStrike and I will repost it again here below, it was based on a committment from the HHS Sec. of Health. I have not given any details as I was not there, I was contacted with the committment from the HHS office . Once I have something in writing I will share it with the patient community.
Here is the repost of my contact with HHS and ending my HungerStrike:
Dear Friends,
We, as a community, accomplished some very important things during the last few weeks, and so I am ending my hunger strike tonight. I am committed to working with our federal health agencies to bring a stronger focus and program to bear on ME/CFS for all of us. The most important thing patients did in recent days was come together. When we commit to each other in the way we all did these last two weeks, we can make great strides toward treatments and understanding of ME/CFS.
I believe we have made the following accomplishments:
Dr. Wanda Jones, who I trust and respect, in the Assistant Secretary of Health’s office has engaged with the Secretary of Health over the past days on the need for a serious commitment to address our unmet needs.
Dr. Jones committed to me that the Secretary’s office will be engaged in the FDA Stakeholder Meeting this Spring to make it a successful meeting in promoting the need and path forward toward evidence-based treatments.
For the first time, Secretary Kathleen Sebelius met with a few ME/CFS patients from her universe to understand directly the complexity, unmet need, and frustration of patients.
Senate Majority Leader Harry Reid, my senator, advocated for ME/CFS patients at the highest level this week, and I am deeply grateful. He and Senator Kay Hagan were instrumental in raising the seriousness of patients’ unmet need and elevating the importance of a strong FDA Stakeholders Meeting for our future. I know many other Senators and Congresspeople engaged, and that is important to our future efforts.
There are two things we need to do now. 1. Stop doing mass emails to the federal agencies, and 2. Now turn our efforts toward making a thoughtful contribution to the FDA Stakeholders Meeting, so that we can advance treatments with a smart, strong push from the patient community.
I want to stress that it is important that patients work with those in our federal health agencies who will work with our community seriously. I always will. Thank everyone you know for helping to make this action successful, and we especially thank Dr. Wanda Jones for her leadership.
Thank you all for being some of my strength and supporting my family in these challenging days.
Kindly,
Robert Miller
Dear Bob,
the FDA has a brand new program.
Maybe this could be an option :
http://www.fiercebiotech.com/story/fda-breakthrough-designation-allows-drug-approval-phi-data/2013-02-12
One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for “breakthrough” drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock, the influential director of the FDA’s Center for Drug Evaluation and Research, started outlining how the program will work–indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.
According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency. “We expect many of these would come available very quickly with Phase I data,” she said.
Sincerely
charly
Robert Miller @bobmiller42
Tomorrow Pres. #Obama will answer questions posted on the link below. I would ask that #MECFS patients go to the… http://fb.me/CGcWY7zQ
use the twitter link above to vote for my question to be answered by Pres. Obama
My Facebook Page request:
Tomorrow Pres. #Obama will answer questions posted on the link below. I would ask that #MECFS patients go to the link and scroll down the page half way and on the right side you will see a search box. Type in: Robert Miller , and my question should come up. You can then vote on the question, just click on the Thumbs up…Hopefully we can get enough people to vote, so he addresses the question.
Thank you,
#RobertMiller
#BobMiller
http://www.youtube.com/api/moderator/g/ytmod/view#52/e=206d30&g=robert+miller&tt=6
Thank you Bob!! I am very happy that Dr. Jones met with Ms. Sebelius! I expect more BS from HHS on ME, but hopefully these recent efforts and events have made some difference.