We thank Senate Majority Leader Harry Reid for his longtime work and support for the ME/CFS community, and especially for his recent efforts with the Secretary of Health to stress the serious unmet need in the ME/CFS community and the drastic implications of the FDA’s denial of the only medicine in clinical trial for patients.
Secretary of Health Kathleen Sebelius responded to Senator Reid’s inquiries with the letter below. The Secretary’s letter outlines increased coordination by federal health agencies on ME/CFS. The proof of whether federal agencies take ME/CFS more seriously will be reflected in whether they fund more scientific studies, promote clinical trials and approve medicines and treatments for ME/CFS patients in the immediate term.
All eyes are on the FDA scientific and stakeholder workshop in April which will provide the first test of this increased coordination.
How did Sen. Reid contact Sec. Sebelius? If it was through a letter, could you share that? It would be good to know what specifically Sen. Reid asked.
Thanks.
Sen. Reid met with Secretary Sebelius during Bob Miller’s hunger strike.
Robert Miller and all the Ampligen patients are very grateful to Sen. Reid for meeting with Secretary Sebelius during Bob’s hunger strike protesting the FDA’s denial of the first and only treatment in FDA clinical trials for ME/CFS. We remain deeply disturbed at the FDA’s denial of Ampligen, which has been used safely and effectively by many ME/CFS patients for 20 years. Until the first medicine is approved for ME/CFS, there will not be second and third generation medications for our illness.
Unfortunately, the current sequestration will most likely have a substantial impact on the amount of money available to the NIH and the DHHS making it more likely that the abysmal amount of funding currently set aside for research into ME and CFS will remain static for the foreseeable future. Hopefully, it will not decrease.
Our government is jerking us around; the sequestration should not have any impact at all on current spending. Government has more than enough money to fund all services- but it is squandered and not managed at all. The answer in NOT to keep raising taxes until all of us have nothing but crumbs and go through life begging bureaucrats to “do something” about various issues. We could cut waste and excess in numerous areas- including managing the borders and the freebies given to other nations and people groups ( I love the F-16’s to the Muslim Brotherhood- that was charming), but this adminstration ( and all others as well) will NEVER cease funding what needs to be ended. Having said that, do not take the bait that this miniscule attempt at controlling out of control spending is harmful- we are being blackmailed by a creepy bunch of Marxists who are succeeding in driving everyone into government dependence.
If government bureaucrats weren’t so incfredibly involved in all aspects of life, many of our current problems- including those in healthcare- would not exist as they do.
Could not be better stated Nancy. No Sequester in this story out today: “John Kerry releases $250m in US aid to Egypt as reward for political reforms”? If American’s Health Care Came first, and the political health care reforms would not neglect the realistic treatment needs of ME/cfs sufferers, we would not have a revenue vs tax debate. We would all be working to care for our families, Instead we are waiting, for……..our $250m for life sustaining assistance.
Agreed…..
Agreed here too.
Dear Bob ,
It is obvious that you have the attention of top politicians on ME/CFS. There is a unique opportunity at the FDA meeting to mobilize the global ME/CFS community and make your country´s top health officials realize that the global patient community is watching what they do (ref. mail sent to Cort)….
In a time of budget cuts and with the strong prejudice against our disease in the medical community I think it is critical that you make Sebelius and other politicians realize that they have to:
EARMARK funds for patient supported studies, basically overruling or dictating the health officials at NIH and CDC how to spend the limited amount of money available. If they do not, the merry-go-round and inaction will continue.
I would argue that large randomized controlled studies of very tightly defined patient populations (f.ex. CCC) of the most promising drugs; Ampligen, Rituxan, others? is the best and FASTEST way for our community to change the dismal reality we have been in for 30 years. We need one large study with significant results and the tide will turn….
Brgds,
Lars
Numbers don’t lie. The CDC cut $2.45 million off the MECFS spending for 2013, leaving I would calculate $4 million, down one third from 2012 — the greatest cut in the CDC budget, and the whole burden of cutting for the department of Emerging and Zoonotic diseases.
I have not added up the teensy weensy grants that will account for NIH spending, but the direction won’t be up. Spending by the National Institute of Allergic and Infectious Diseases will be zero, as always, due to Dir. Fauci’s prejudice against the disease.
Wow…that’s incredible. How did you find this out?
Excellent! I’d be happy with no money being spent at the CDC. The sooner we stop thinking the government will come to the rescue the better.
After 25 years they can’t even properly define the disease – in fact the government definitions have gotten worse over time. This alone should indicate the government has no motivation to make progress. And it certainly could be inferred that the government may have motivation NOT to make progress for whatever reason.
Floydguy,
I think you are maybe right about the health officials at CDC and NIH, they have been/are? squarely in the hands of the health insurance and psychosomatic lobby, finding it convenient to write off about 1 million people as a mental health problem….but you do have to distinguish between these people and politicians like Harry Reid and others who are sincere. We have to make them earmark funds for patient supported studies! FDA meeting is such an opportunity, giving up is not an option!
Yes, Floydguy the CDC doesn’t have a great (or good or even middling) past with definitions but they are actually right now probably doing more than anyone else (with the exception of Lenny Jason), believe it or not, to redefine this disorder with their 7 site study involving many of the top practitioners in the field (Peterson, Kogelnik, Lapp, Bateman, Klimas, etc.).
These are obviously very well characterized patients – if these people can’t identify them I don’t know who can – and if everything goes right they should be able to tease out different types of patients. The study could eventually lead to a break up of this disorder…who knows..maybe into infectious, immune damaged patients an central sensitized patients…
I don’t know, although Dr. Unger says it was on the books, that a Reeves CDC group would have done this study…
The study was just greatly expanded; its now a five year study with biological samples included….
It’s good stuff!
Cort,
I really hope you are right about this, maybe at some point you could describe this more in a blog….maybe with commentary from the clinicians participating…I think the community needs to hear that they think CDC is actually doing a good study…are they actually trying to define patients in a proper way ? after 30 years of turning their back on patients…
I also hope you’re right, Cort, but study or no study, Unger seems pretty committed to keeping the Reeves Disease patients misdiagnosed as CFS regardless. My guess is that with this info she will stratify “chronic unwellness” to include Reeves Disease plus the mild and mild-moderate patients in the 7-center study.
Where we can go from there, scientifically, is beyond me.
Hopefully the Lipkin, Horning, et al. study will yield something more helpful and we’ll actually get something with diagnostic usefulness, and then we might be able to try to re-diagnose people who fail the test(s) coming out of that. (If we end up with some left over, we can then study those as a new group.)
Janelle
While I am glad to see that Harry Reid and the Secretary discussed ME/CFS, and the Secretary wrote a comprehensive letter, I am not understanding what specifically the HHS is doing differently after the hunger strike then it was doing before.
Please don’t misunderstand, I am grateful every time ME/CFS is discussed in the upper echelons of goverment, and the more often it comes up the better, but am I missing something that they are going to do for us now?
I was not pleased to read a couple things in the Secretary’s letter –
– 1st paragraph: ” I assure you that HHS is committed to fostering the development of drugs to treat the symptoms of ME/CFS and to otherwise alleviate the experience of patients…..”
Why wouldn’t she not mention drugs that could be a cure? Yes, drugs to treat symptoms would be nice, but is merely Step 1 in a process.
– 7th paragraph: “The Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration are hosting webinars to educate providers in their network……”
OK, I don’t speak “bureacratic red tape”, but why is the Mental Health Services Administation involved??
– I also second much of Billie Moore’s letter above.
I wish Harry Reid would ask her further questions since he as been invitied to do so, and say – “Thank you for allowing the Chronic Fatigue Advisory Committee to continue with it’s work. Can you explain why most of the Committee recommendations get turned down? In the furture, would you publish clear answers to each recommendation and explain the specific reason why it is being turned down. For instance – “no budget”, “bad idea”, etc. Otherwise, we are you spending over $100,000 of the taxpayers money on this Committee?
I noticed symptom part as well – that was kind of strange and I agree completely about the toothlessness of the CFSAC panel..and yes, lets have some reasons why the fed govt can’t take on any of major recommendations of the panel…
I did speak with someone in the federal govt whom I trust who said a huge change in how the federal govt views ME/CFS has occurred in the past three years but she acknowledged that we can’t seem much evidence of it yet..Hopefully she’s right and we’ll see some positive actions in the future. There are some good things are happening – but the big good things are not happening…
I appreciate that Sen. Reid met face to face with Secretary Sebelius to discuss ME/CFS and I was told that meeting with DHHS employers with ME/CFS was an emotional olne.
But as Bob noted…time will tell.
Thanks Cort, I am glad to hear that a change in government views seems to be happening. And yes, sometimes that takes awhile to translate into real action. I do have renewed hope in CFSAC now that three patient advocates will be added to it.
I am thankful for Bob and Courtney’s work in creating conditions for Sen Reid and the Secretary to meet. Also, it’s nice to hear that her meeting with the DHHS employees was emotional and hopefully impactful. Yes, that was a good outcome of the hunger strike.
I think we are all disgusted with the continued lip service, hope to see real action at the upcoming FDA and CFSAC meetings.
While I also worry about adequate funds for future successful studies, I am becoming angry. We, as patients, should not be the ones to come up with money, or figure out how. We are owed money, a great deal. It is difficult to have watched the sequence of events over the last 20-25 years, and NOT remember the damage done. Yet, the major issue is to get our government involved in education, the Ampligen approved, and the appropriate respect for the patient community. The Ampligen helped me so greatly, and I can’t believe it was considered dangerous. Perhaps it their misunderstanding of M.E./CFS that is at the root of these disapprovals.I am so encouraged to have read these communications between Sebelius and Reid, but still wait for the truth beyond these. Thank you, Bob and Courtney Miller!
Odd that the Secretary of Health didn’t mention the paltry amount of money spent on CFS/ME that they’re so “concerned about.” Wonder how we could let him know that our disease gets 6 million while AIDS get something like 6 Billion! Anyone that understands research knows with so little money it’s no wonder nothing has been found in the last 30 years. Without more money it’ll just be 30 more years if psychological BS -blaming the patient for being lazy, depressed, hypochondriac, fill in the blank.
I agree that spending 4-6 million dollars/year and expecting answers is crazy. I’m sure she and Harry Reid are very well aware of the low funding rates. I can understand why they probably can’t be changed now; every program, I think, is getting equal cuts…but why the NIH won’t pump more money into this disorder is worth a couple of blogs. Part of it has to do with the way ME/CFS is funded; our funding structure is essentially a recipe for disaster and it’s been that way for about the last ten years.
Why Sebelius can’t just say double the funding or why if she can say that she won’t I don’t know.
Taking the advice of the advisory council and then not mentioning the weight given to the advocates who were there leaves us in the dark. Remember it was only a -7 vote that the drug was not approved. It did have a 8-5 margin on safety too market. his is a spinning cycle that seems to never stop. No answers forthcoming for either Hemispherex or the FDA what can and should be done to ressurect this only drug that works. How do these people sleep at night. Robbie Goldstrein
“The Centers for Disease Control and Prevention (CDC) is in the final stages of a seven-site study of the clinical characteristics of ME/CFS. This study was launched in September 2011 to collect standardized data from clinical practices of clinicians with expertise in ME/CFS. The data will be used to evaluate variation in the illness among clinics, to characterise all domains of illness in ME/CFS patients, and to provide data that could be used in evaluation of a research case definition and diagnostic criteria.”
Call me naive, but I’m optimistic that this will be a major step forwards for the international ME/CFS patient community. Possibly even game changing.
My reply to FDA
Dear Mary Kremzner,
me and the other ME/CFS patients believe that you, the bureaucrats of public health, you do not have fully understood how much is unbearable for us and our family this terrible disease.
I’m not saying that Ampligen is the best drug for CFS, but we currently have no better and you should know that even a slight benefit for us is a great improvement in the quality of our lives. Is demonstrated by the many testimonies of patients who use Ampligen that there are clear improvements in
their quality of life.
In addition, the panel on 20 decembre 2012 voted in favor of the safety profile of Ampligen.
Believe me there are diseases such as ME/CFS where we are willing to accept any risk in exchange for a small benefit even for a single minute of our life desperate.
Please find a solution a.s.a.p to have free access to the use of Ampligen not take away this hope!!!!!
Our life is made every day of terrible suffering for us and our families and now we have taken away the hope with your decision to reject Ampligen.
Sincerely
Well said…I wish they had taken the panels vote on safety into account. I remember the moderator looking absolutely stricken when that vote came down…..
That said, Hemispherx is appealing and we’ll see what their plans are after that. Hopefully there is a way forward.
Thank you Sen Reid for the care and concern you have shown our community over many years. It’s much appreciated.
I’m sorry but I am having a hard time seeing the words in this letter. Can someone help me? All I can see is “Blah, Blah, Blah. Now go away and leave me to my job of doing nothing for these whiners”.
Thanks Cort but all I see again in the letter is “Blah, Blah, Blah….” Unfortunately that is all we will ever see from her.
I agree, Jeff. More lip service.
Thank you, Bob and Courtney for making the meeting come about!
I hope everyone can contact Senator Reid and let him know that HHS’ response is inadequate and disingenuous!
As for the pursuit of the “alleviation of symptoms”. This in every HHS letter I can remember reading and obviously highlights how lightly they regard, or disregard, “CFS.”
Thank you Bob for your many endeavors to raise awareness. It appears Secretary Sebelious did at least do her homework before responding to Senator Reid, which is more than I can say when the HHS responds to me.
Thank you Cort for sharing. Like you say, or someone did, the proof will be in the pudding.
Oh yes, thank you Bob for the hunger strike you went through. I am sorry you went through it, but I am glad you did.
The big danger is that senator Reid now thinks that his mission to help us is accomplished.
I think we need to send senator Reid a letter saying that the response by the HHS just proves that nothing will change.
The approval of Ampligen was the one thing that would have proved that something is changing. In this letter it says that many factors were taken into account, including data and the advice of the AC. Unfortunately the opinion of the patients is not listed! Unless Ampligen is approved it is clear that CFS patients have not been and will not be taken seriously. How can the HHS deny patients the only treatment.
CFS is a bullshit diag. ME is more correct in that is IS a debilitating brain inflammation. You all need to contact a ILADS Dr or “Turn the Corner” physician who will treat this as the intracellular bacterial infection/viral reactivation of latent Herpes viruses (HHV6, EBV, HSV1, Cytomegalovirus) and fungal synergetic chronicillness.
Your immune system is a wonderful thing and can hold MANY pathogens/viruses at bay UNTIL your immune system is overwhelmed by a fungal infection that tollerizes through the TLR2 pathway. When the TLR2 pathway is compromised, the immune system pretty much shuts down. Borrelia, Chlamydia Pneumonea, Mycoplasma Pnemonea and malarial “like” infections bear OspA “like” fungal antigens. These fungal antigens reactivate latent herpes family viruses and cause Lymphoma and B cell cancers. It is WELL known that HHV6 is implicated in MS. Research the HHV6 Foundation for more info on that.
The Mycoplasma is a ancient bacteria the size of a virus. It has fungal properties as well. It destroys the cells Mitochondria, causes the Lipids to fall out and damages the DNA and RNA of the cell. Once it has killed the affected cell, it cloaks itself with the cell that just died outer surface protein, effectively “hiding” itself from the immune system. It TRULY is a “Stealth Pathogen”. You need to go to IMMED.ORG to get more info on CFS/Gulf War Illness/Autoimmune illness/Neurodegenerative Diseases like MS, Lupus, ALS, etc.
You can be cured by altering diet to eliminate these INTRACELLULAR pathogens food source. Carbs, Sugars and Sterols. Eliminate their food source, they weaken. Yo also need to boost immune function. Lastly, You need to take lonmg term Antibiotics of the Macrolide class. Doxy, Azithromyacin, Omnicef, Minocyn, etc. These ABX work by inhibiting the bacterias ability to replicate.
I was like you all but I knew Pharma makes a killing off of new drugs to modulate your symptoms instead of CURING the ROOT CAUSE. The root cause is bacterial (will never show up on standard tests as the bacteria is INSIDE where an immune response is impossible), viral (reactivated Herpes viruses) and fungal (these bacterias MAKE a fungal lippopeptide that suppresses the immune system). Listen to me and get better. DO YOUR RESEARCH, DO NOT ACCEPT BIG PHARMAS MONOPOLY ON YOUR HEALTH.