NEW POST: Holderman and Burmeister Release Sample Letters Opposing HHS's IOM & P2P

[Nielk]

From Eileen Holderman:

Below, is a sample letter to HHS Secretary Burwell in opposition to HHS's IOM and P2P initiatives to redefine ME/CFS. Advocates requested a sample letter, so feel free to use this letter (in part or in its entirety) to show your opposition (not participation or buy-in) to the IOM and P2P. This letter can be sent right away or at any time, as this is an ongoing advocacy protest.

October 21, 2014

Dear Secretary Burwell:

I am writing to state my opposition to the Health and Human Services (HHS) initiatives - the Institute of Medicine (IOM) and the Pathways to Prevention (P2P) - to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Nearly 1 million American men, women, and children, and over 17 million worldwide, suffer from the neuroimmune disease, ME/CFS.

I join multitudes of advocates, patients, caregivers, ME/CFS researchers and clinicians, and other stakeholders, in opposition to IOM and P2P. There are numerous reasons for my/our opposition to these initiatives to redefine this disease, many of which I list as follows:

* We do not need more Government-sponsored clinical and/or research definitions for ME/CFS. Our ME/CFS experts already developed a research and clinical definition called The Canadian Consensus Criteria (CCC). HHS has created numerous erroneous definitions (i.e. Fukuda, Reeve's Empirical, etc.), which include innumerable people in the patient population that do not really have ME/CFS - and this has terribly harmed patients with ME/CFS. HHS's IOM and P2P seek to, yet again, create more definitions for ME/CFS which will further harm patients.

* We do not need HHS bureaucrats who are not ME/CFS experts to redefine this disease. Our 50 ME/CFS expert researchers and clinicians already reached a consensus on a research and clinical definition for ME/CFS - the CCC - which they have been using for 10 years and for which they have agreed to refine as necessary. The 50 ME/CFS experts sent former Secretary Sebelius a letter urging her to refrain from reaching out to groups such as IOM to redefine ME/CFS and urged HHS to adopt the CCC in all Government agencies. Again, IOM and P2P use mostly, and in some circumstances, entirely, non-ME/CFS experts - actions which will harm patients. Please click on the link to read the Expert's Letter to former Secretary Sebelius:

* We do not need another Government-sponsored name for this disease. In 1969, The World Health Organization (WHO) acknowledged and coded the name of the disease - Myalgic Encephalomyelitis (ME) - which is the name used and endorsed by most nations, experts, and patients around the world. In 1988, HHS renamed the disease Chronic Fatigue Syndrome (CFS) knowing that a name already existed for the disease and knowing their new, unscientific name would harm patients. Again, HHS/IOM aims to create yet another name for this disease - possibly Chronic Multi-Symptom Illness (CMI) - the name IOM alluded to for ME/CFS in their earlier VA/IOM report - and a name that will further harm patients.

* We do not need more Government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined. ME/CFS receives only $5 million a year from NIH in research and causes billions annually in lost productivity due to high rates of disability from the disease. ME/CFS experts established research and treatment centers around the country through private and institutional funding that need Federal funding for their research - but don't receive it. Instead, IOM and particularly, P2P, ignore the ME/CFS experts' biomedical research in favor of non-experts' psychosocial research, resulting in recommendations of CBT, GET, and anti-depressants, instead of recommendations of anti-virals, immune modulators, and other biomedical treatments. This tactic will save Government and insurance companies big money! As IOM and P2P bury 30 years of biomedical research and over 5000 peer-reviewed scientific publications on ME/CFS, HHS will save huge sums of money because they will not have to fund biomedical research or pay for long term disability and other Government entitlements for patients with ME/CFS. And Government related health insurance companies will save massive sums when they deny ME/CFS patients the biomedical tests and treatments they need.

* We do not need more Government misinformation about ME/CFS disseminated to physicians, health insurance carriers, the public, and the press. Our ME/CFS researchers and clinicians have published a case definition - the CCC, 2 Diagnostic and Treatment Primers, over 5000 scientific papers, video lectures, PowerPoints, books, and resource guides about the disease. National and State patient advocacy organizations have published materials online and in hard copy with reliable information for patients and their caregivers. Yet, IOM and P2P are charged with publishing their reports which HHS will use to "educate" doctors, nurses, insurance companies, the public, and members of the press. HHS's dissemination of the erroneous information from IOM and P2P will gravely harm patients.

My letter of opposition to HHS's IOM and P2P is part of the ongoing protest which includes:
CFS Advisory Committee (CFSAC) recommendation urging the use of the CCC, ME/CFS Experts' Letter calling for the CCC, Advocates' Letter calling for the CCC, petition signed by over 6000 stakeholders calling for the cancellation of the IOM Contract and calling for adoption of the CCC, Facebook, Twitter, Thunderclap, letter, email, and phone campaigns calling for the CCC and condemning IOM and P2P, meetings with Congressmen, protests and demonstrations, media coverage, collaborations with Gulf War Illness patients, Freedom of Information Act (FOIA) requests, and even a lawsuit filed against HHS and NIH for non-compliance with an IOM FOIA, resulting in a Federal-Court finding of the Government's violation of Federal law.

My opposition to IOM and P2P is a complete rejection of these initiatives to redefine ME/CFS. HHS should not consider my letter of opposition as participation or buy-in - because it is not. This is a letter of opposition for the public record.

Thank you for your attention.

Eileen Holderman
ME Advocate
US citizen

cc: Francis Collins (NIH), Thomas Frieden (CDC)

Sylvia.Burwell@hhs.gov (Secretary of HHS)

Francis.Collins@nih.hhs.gov (Director of NIH)

Tomfrieden@cdc.gov (Director of CDC)

From Jeannette Burmeister:

P2P: “Pleased to Participate?” Not. Count me out!

Here is my open protest letter to Secretary Burwell (with carbon copies to Dr. Collins and Dr. Frieden) regarding the ME/CFS P2P program. As you will note, I am not engaging substantively at all. Instead, I am protesting the process all the way. Anybody should feel free to borrow the language in this letter in whole or in part for their own letter in this ongoing protest campaign, which can be sent to the email addresses listed at the end of this post.

Dear Secretary Burwell,

AHRQ has asked for public comments on the draft “evidence review” report prepared for the agency as part of the NIH-driven ME/CFS Pathways to Prevention (“P2P”) program. I am one of many patients who refuse to participate in the commenting process. Count me out!

In other words, let me stress, for the avoidance of any doubt, that this open letter is in no way to be construed as participation in, or engagement with, the ME/CFS P2P program. Instead, I protest this ludicrous and dangerously unscientific process in the strongest way possible.

As an ME patient and advocate, I will not participate in this kangaroo court the outcome of which is preordained to set back ME/CFS research for decades and which is so unalterably contrived, ill-intentioned and scientifically unsound as to invite only condemnation, not participation or cooperation.

The "evidence review" report prepared for AHRQ by non-ME/CFS experts is only part of this Kafka-esque charade of a process, the ME/CFS P2P, which will conclude with a two-day "workshop" of individuals who are not experts in the field and a "jury" deliberation of those non-ME/CFS experts who will have all of 24 hours to write the final report. You or anybody with a scientific background—or with any common sense, for that matter—cannot, in all honesty, believe that this process will result in any scientifically valid outcome. A jury model is about as incompatible with science as one can imagine. Remember Galileo Galilei and how well a jury of non-experts worked for him? Is that how HHS, NIH and AHRQ see their role: in the same vein as the Roman Catholic Church of the 17th century conducting inquisitions and witchcraft trials?

The insincere call for public comments on a rigged game is a contemptible farce. I will not—by giving substantive comments—provide HHS with the opportunity to claim that patients were heard and that their input was considered when any public comments are guaranteed to be ignored, as they were with respect to the IOM panel where comments were also feigned to be sought.

The final report produced by the non-experts will guide future NIH-funded research, which has been at a paltry $5 million a year—an inexcusably and unconscionably pitiful amount for a debilitating and complex disease such as ME/CFS, which, of course, has lead to an irremediably flawed “evidence” base. That in turn, makes the P2P process just about as unfit for this disease as one can imagine. The community is in agreement that a catastrophic result of the P2P process seems to be HHS's intention.

Otherwise, HHS would abandon it immediately before the agency causes more harm to patients by forcing them to continue fighting the P2P at tremendous cost to their health and by ensuring a disastrous outcome for patients delivered at the hands of non-experts.

For your information, I am attaching an analysis of the P2P “jury model” that I wrote after this stroke of genius was initially announced to the public during the first ME/CFS IOM meeting in January.

Sincerely,

Jeannette K. Burmeister
Patient, Patient Advocate and Attorney at Law

cc:
Dr. Francis Collins, NIH
Dr. Tom Frieden, CDC
Attachment:
P2P: “Patients to Purgatory” or the Jury Model Stood on its Head, February 7, 2014
Sylvia.Burwell@hhs.gov
cc:
Francis.Collins@nih.hhs.gov
Tomfrieden@cdc.gov

For Holderman’s and Burmeister’s prior letters in opposition to the IOM and P2P, please click on this .​

 

[Valentijn]

Both excellent letters

 

[Andrew]

In case it helps, here is part of the last letter I sent regarding IOM. I only included the core part because the opening and closing paragraphs were tailored to the receiver. Obviously you cannot simply copy and paste this for your use, because some of it is in first person references to my testimony. But you could reword that part.

In September 2013 the Department of Health and Human Services (HHS) announced a contract with the Institute of Medicine (IOM) to develop new clinical and research criteria for ME/CFS. This happened despite the fact that ME/CFS experts in the United States had already developed expert criteria in cooperation with Canadian experts. Informally known as “Canadian Consensus Criteria,” these criteria have been recognized by the leading experts for many years, but the HHS has refused to acknowledge them. (The actual “Canadian Consensus” can be found beginning on page 7 of the following journal: http://www.mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf.)

Most of the U.S. ME/CFS experts sent a joint letter to HHS Secretary Kathleen Sebelius, asking her to adopt the Canadian Consensus Criteria (CCC) and abandon the IOM project. The letter can be seen here: https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter final 10-25-13.pdf

But the HHS refused to do this. And they defended the plan to use the IOM by misrepresenting a recommendation from the HHS’s Chronic Fatigue Syndrome Advisory Committee (CFSAC). What the real recommendation called for was at least one stakeholder’s workshop consisting of ME/CFS experts, patients, and advocates, in consultation with CFSAC members. The real recommendation can be seen at the top of the list here: http://www.hhs.gov/advcomcfs/recommendations/10032012.html

But instead of this, the HHS entered into a $1 million contract with IOM that removed patients and advocates from the process, and gave them only a brief time to speak from the audience. They also relegated experts to a minority representation on the panel, thus removing the possibility of this being a real expert committee. The HHS also claimed the contract could not be cancelled, which is not even true. Government regulations require a clause in this type of contract to allow termination at the convenience of the government. http://www.name-us.org/AdvocacyPages/OtherActions.htm#Simplified_Explanation

Furthermore, the HHS ignored testimony about the IOM’s terrible track record with ME/CFS research. One example of this is the IOM guide called “Gulf War and Health: Treatment for Chronic Multisymptom Illness,” which includes a section about the treatment of chronic fatigue syndrome. For example, in the report they recommend graded exercise, and to support this they reference two journal articles that do not study whether exercise helps people with CFS.

On two occasions I gave testimony about the IOM’s bad research practices directly to HHS representative Dr. Nancy Lee, and to the CFSAC. You can read copies of the two presentations that are now on record at the HHS website: http://www.hhs.gov/advcomcfs/meetings/presentations/0614-andrew-bokelman.pdf and at http://www.hhs.gov/advcomcfs/meetings/presentations/bokelman-andrew121113.pdf. Yet despite this, the HHS continues to use the IOM (instead of a consensus of leading experts) to shape the future of thousands of seriously ill patients.

 

[*GG*]

So is this something that they want us to do also? Would it be of any value?

GG

 

[Nielk]

So is this something that they want us to do also? Would it be of any value?

GG

I think there is a value in each one of us sending in our letter of opposition. Massive letter writing will give the correct message that the majority of stakeholders are against these invalid government induced processes.

 

[Nielk]

Sample letter from Gabby Klein

Dear Secretary Burwell,


I am a patient suffering from Myalgic Encphalomyelitis and I would like to challenge the validity of the NIH’s Pathway to Prevention (P2P); Advancing the research for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).


I am writing to you as a citizen of the United States who believes that the actions of HHS have and are hindering proper and equal care as promised by HHS’ charge of protecting the health of Americans and providing essential human services, especially for those who are least able to help themselves.


At the Lake Tahoe outbreak of Myalgic Encephalomyelitis (ME) in the 80’s, CDC made a decision to highjack this serious neuroimmune disease and to derogate it by renaming it with the vague, undignified name “Chronic Fatigue Syndrome” (CFS). Since then, the NIH and the CDC have continuously and stubbornly made certain that this disease remains buried as a vague “fatiguing syndrome”. By their action, they have ensured that progress will be impeded and that the future of this disease remains under strict Government control. This is in contrast from other diseases, where it is the medical expert community that creates criteria.


NIH has historically denied proper funding for good scientific research that is based on the biology of the disease. The majority of the meager funding allotted is mostly for studies with a psychological slant to the disease. The CDC has created a vague criteria stressing “fatigue” as the main and only mandatory symptom, in their 1994 Fukuda Criteria. Since then, they have stubbornly held on to it regardless of the production of newer, more accurately descriptive criteria by the medical ME/CFS experts such as the Canadian Consensus Criteria of 2003 (CCC) and the International Consensus Criteria of 2011 (ICC).


Today, nearly 1 million American men, women, and children, and over 17 million worldwide, suffer from the neuroimmune disease, ME/CFS. The cost to the American economy has been estimated to be in the billions, yet NIH has been spending a mere 5 million dollars a year for researching the disease. This amount does not come close to the amount of funding granted to other equally serious diseases.


The Canadian Consensus Criteria (CCC) of 2003, created by international medical professionals with experience treating and researching the disease, was very well accepted by the international medical community. For the past ten years, much pressure was put on the CDC by ME/CFS stakeholders, specialists, advocates and patients to adopt the new CCC and to reflect the change on their website. To date, the criteria that appears on the CDC’s website and toolkit remains the 1994 Fukuda criteria.



In October 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), made a recommendation to the Secretary of the Department of Health and Human Services (HHS); CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian ConsensusDefinition for discussion purposes.


The Secretary did not heed the advice of HHS’ own appointed federal advisory committee members. Instead, HHS chose to spend close to 2 million dollars for two separate ventures: The HHS/IOM contract for clinical criteria and the NIH’s P2P for research purposes. These two processes were to employ “unbiased”= non-expert panel members in order to guarantee the perpetuation of Government control of the process.


It is interesting to note that the majority of the ME/CFS community; clinicians, researchers, advocates and patients were in agreement with CFSAC’s recommendation of adopting the Canadian Consensus Criteria (CCC) now, and working on improving it. This is evidenced by the letter to the Secretary of HHS that 50 ME/CFS expert clinicians and researchers signed, informing her that they have in consensus, adopted the CCC and were urging HHS to do so as well. This letter was later endorsed by over 170 patient advocates.


Nearly 10,000 signatures on two petitions have called for stopping these processes and adopting the CCC now. Advocates have demonstrated in San Francisco and in Washington, DC to protest the HHS contract with IOM and the process of the P2P which have attracted the media and resulting in press coverage. A vigorous twitter campaign has been ongoing highlighting the protest of the IOM and P2P.


Advocates contacted the media and press and participated in numerous radio, TV, and online interviews and articles about the IOM and P2P issues. Numerous articles and blogs have been written outlining the problems with the two processes and why the majority of stakeholders are protesting both actions. The above mentioned initiatives by advocates, patients, and ME/CFS experts have been and continue to be important to protect the best interests of a million Americans, and 17 million worldwide, who suffer from ME/CFS and to move research and treatment forward.


Yet, HHS refused to heed the entire ME/CFS community’s voice and forged ahead with the IOM and P2P processes.


ME expert Dr. Byron Hyde wisely observed in a paper presented in New South Wales in 1998:


Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described. It is thus important that those that attempt to define any disease or illness to have long term clinical experience with patients with this illness. There is simply no place for the bureaucrat in defining illness. All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients. For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. [Hyde, 1998. Emphasis added]



Historically, diagnostic criteria for diseases are created by the expert medical community, not the Government.


Dr. Derek Enlander, an expert ME/CFS clinician in NYC, stated in his letter presented at the IOM meeting:


At present, the Canadian Consensus Criteria are used by a majority of experts who diagnose and treat this disease; they adhere to the concepts defined by Dr. Melvin Ramsay, who helped pioneer research in this disease, in contemporary clinical settings. Were discussion and debate even necessary, one million dollars could still have been saved--a not insignificant percentage of NIH research funding dollars in this area. Given the paucity of funds allowed for research and study of what we know as Chronic Fatigue Syndrome, it seems, with all due respect, to be a shameful waste of money.



It leaves me with the conclusion that HHS’ move has been a political one at the expense of the wellbeing of the patient.HHS actions show that they have something to gain in keeping this disease in the shadows. They prefer to hold on to an outdated set of criteria which ignores the most important hallmark symptom of the disease; PEM/PENE, post exertional exhaustion. PEM/PENE is the mandatory symptom of the CCC and ICC, thereby distinguishing ME patients from other “fatiguing” illnesses.



NIH decided on using the P2P process for ME/CFS research purposes. The P2P process, as per its website is not to be used for “controversial topics”. Since its inception, ME/CFS has been complex and controversial, yet NIH ignored that fact. By using the P2P process for ME/CFS and setting the parameters which they have, the results were doomed for failure. In addition, NIH decided to lump every single criteria ever created for ME/CFS (8) no matter how wrong into the mix, as if they all have the same value. This lumping together has ensured that the results will be meaningless.


To make matters even worse, the p2P was charged with using an “evidence based search” for their report. Dr. Enlander stated: it seems inevitable that any preference given to the "Evidence Base," may produce a set of loose criteria. In this area, where the 'evidence' has long been grossly distorted, and to date has produced a flawed, inaccurate model of this very serious physical disease, such criteria may well describe other conditions or disease models that are, simply put, not the disease described by Ramsay.


In addition, the choice of a “jury model” unbiased-inexperienced panel writing the final report has ensured that the result will be at best of very low quality. It is impossible for a panel of non-experts to read an evidence based report, listen in to a 1 ½ day workshop and produce a comprehensive report in 24 hours. This “circus act “is not acceptable to me and to the majority of ME/CFS stakeholders, advocates and patients. My future and the future of 17 million patients worldwide will depend on the nefarious actions of the NIH.


I join multitudes of advocates, patients, caregivers, ME/CFS researchers and clinicians, and other stakeholders, in stating the following:


We do not need HHS bureaucrats who are not ME/CFS experts to redefine this disease.


We do not need more Government-sponsored clinical and/or research definitions for ME/CFS


We do not need more Government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined.


We do not need more Government misinformation about ME/CFS disseminated to physicians, health insurance carriers, the public, and the press.


My opposition to IOM and P2P is a complete rejection of these initiatives to redefine ME/CFS. HHS should not consider my letter of opposition as participation or buy-in - because it is not. This is a letter of opposition for the public record.



Sincerely Yours,


Gabby Klein

Flushing, NY




cc: Francis Collins (NIH), Thomas Frieden (CDC)