In our second article on how to react to the publication of the draft P2P report, Gabby Klein provides her view of why she and a large group of advocates and patients are continuing their protest of the government’s ongoing control and manipulation of our disease via their processes of the P2P and IOM.
In yesterday’s piece, Clark Ellis critiqued and praised elements in the draft report. Given the controversial nature of the report, Phoenix Rising is presenting both views in the interests of balance and representing the whole community…
“We are not crumbs! We must not accept crumbs!” – Larry Kramer
When I first read the draft report created by the panel for the P2P for ME/CFS, my first reaction was: They are throwing us crumbs — this is dangerous.
Let me explain.
I have been watching the series “Prisoners of War” on television this past couple of weeks. (I recommend it highly.) It depicts the experiences of three Israeli soldiers who were captured in Syria and kept as prisoners for 17 years. They were tortured daily in extremely sadistic ways.
They were kept in complete isolation. The only people they saw were their captors who treated them as if they were wild animals. Two of the soldiers were eventually freed in exchange for Arab detainees. The third one was thought to be dead for the past five years.
It turns out that he wasn’t really dead. He had turned. Within five years, he became totally transformed — indistinguishable from the Arab fighting group he had chosen to join.
When the Mossad (Israel intelligence agency) heard of what happened to this third soldier, they enlisted the help of the biggest expert in experiments of prisoners held captive in the country. She explained the psychology of people in captivity.
The aim of the captors is to exert complete control over the captive. The prisoner becomes totally dependent on the captor in order to stay alive. The captor is the one who tortures him daily, but he is also the one who provides needed nourishment and, therefore, life.
The prisoner starts to form an attachment to the captor. The captor is his only connection to the world and life itself. But, says the expert, it is when the captor decides to give any sign of tenderness, whether it is just a smile, a pat on the back or a kind word, that the scope of control is complete.
It is that small sign of civility that hooks the prisoner and thereby accomplishes the turning point of having complete control over him. From this point on, the captor can influence him any way that he wishes.
This is the reason that when I finished reading the draft report, I became scared. I knew that this was probably the point of no return for some advocates and patients. This was the signal of civility that would influence and change the mindset.
Like prisoners of war, we, the ME/CFS patient population, have been abused by the U.S. Department of Health and Human Services. For the past 30 years, we have been maligned, mistreated, and taken advantage of. The HHS has attempted to bury the severity and grave effect of this disease. Proper care, disability and certain treatments have been denied us.
We have been forced to suffer in isolation. Many have been bound to their bed, lying still in their darkened rooms with no hope of recovery. For many of us, this has become our life for years and decades. The maltreatment of the government health agencies toward this disease has become the norm.
The expectations of most people were that the P2P report would be devastating. In actuality, there are some elements that are “not so bad”. It does acknowledge that patients are maligned and suffering. It does provide for the possibility that the etiology might be biological.
These are crumbs.
In effect, this report is a confusing list of conflicting information gathered and written up in a rush. It does not recognize the hallmark symptom of post-exertional malaise/ post-exertional neuroimmune exhaustion (PEM/PENE) as is mandatory in the CCC and ICC criteria.
It repeatedly and incorrectly stresses depression as a co-morbidity. It recommends behavior modalities as treatments, as well as exercise.
They list recommendations for further research without specifying priorities, nor where the funding will be coming from.
The idea that this report will be “good for us” is a mistake in perception. It will not advance the understanding of the true disease of ME nor will it magically produce the funding needed for the many studies that it recommends. Yet, many are willing to accept these crumbs and jump for joy.
We deserve better and we should demand better!
It is not the government, but the expert medical professionals who are responsible to create criteria for disease.
Dr. Nancy Lee (OWH) is on record stating that Secretary Sebelius told her that the government is not in the business of setting criteria for diseases. Case definitions are a clinical decision that have to come from the clinical community.
Dr. Beth Unger (CDC), stated in 2011, “Opinions of advocates, clinicians and researchers remain divided about whether CFS and ME are the same or different entities. However, we are following the discussions with interest and would consider any consensus that is reached by patient groups and the scientific community going forward.”
Yet, HHS has by its actions consistently controlled every aspect of this disease.
*In 1988, the CDC switched the name from the original myalgic encephalomyelitis (ME) to chronic fatigue syndrome (CFS).
*In 1994, the CDC created the watered-down, vague “fatiguing” Fukuda Criteria.
*The CDC refused to change their official criteria in light of newer, more accurate definitions: the 2003 CCC Criteria and the 2011 ICC criteria. These newer criteria recognize the hallmark symptom of PEM/PENE for diagnosing the disease, and require neurological dysfunction.
*The CDC included GET/CBT in their toolkit as favorable treatments for the disease and repeatedly refused to change it regardless of the recommendations by the CFSAC to do so and the urgings by experts, advocates and patients.
*The HHS has consistently ignored or refused the many recommendations by CFSAC that would have improved the science and the quality of patient care.
*CFSAC voting members who asked questions about the workings of the methodology workshop were intimidated and threatened by the DFO, Nancy Lee.
*The NIH repeatedly denied proper funding for the disease. It allocated a minimal yearly amount with an emphasis on psychological/ behavioral research. Because of this, there are only small-scale studies that are not evidence-based, and important biological studies like Dr. Lipkin’s microbiome were denied.
*The HHS refused to heed a letter signed by 50 ME/CFS experts urging HHS to stop their contract with the IOM, as well as to adopt the Canadian Consensus Criteria (CCC) now. They also rejected the follow-up letter signed by more than 170 patient advocates.
*The HHS has delayed and refused the Freedom of Information Act (FOIA) requests by patient advocates. This has resulted in a lawsuit against the HHS and was won by attorney/patient/advocate, Jeannette Burmeister.
The best predictor of future behavior is past behavior.
Now, the HHS wants to continue their complete control of the disease by their two processes: IOM and P2P
I have sent the following letter to Secretary Sylvia Burwell (Secretary of HHS), outlining the points of why I and many others in the community are continuing our resistance to the government’s continued control of our disease by their ill-devised processes of the IOM and P2P:
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 Consensus Definition 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.
The call for resistance and the ME Advocacy group
All the civil rights that we enjoy today were gained by direct action, whether it was the fight for civil rights for African Americans, or the suffragette movement for the right to vote. In the arena of disability rights, every major piece of disability legislation or rules was gained by direct action by grassroots groups and movements.
The “Let’s get ME back” movement is growing and gaining momentum. It calls for no further government control and manipulation of the disease through their processes of P2P and IOM. It calls for ME as defined by CCC and ICC. It calls for expert ME doctors to care for patients.
The ME Advocacy organization has been in existence just a few months yet, has already accomplished a lot. It currently has close to 700 members and an email reach of 4,438 people.
Their goal is to get myalgic encephalomyelitis adopted as its own distinct disease along with true ME definitions, and greatly increase federal funding for research. They are challenging the IOM and P2P government processes.
They have been successful in hiring a professional public relations firm to assist with demonstrations, and getting the message out to the media, and to policy makers in Washington, DC. They have currently raised enough funds for the first month and started the campaign as of January 1, 2015.
They have several ME patient advocates lined up as spokespeople, along with some smaller media outlets to start with, so you should be seeing some national media soon. They were present at the Congressional Inauguration on Jan. 3, 2015, seeking new Congress people who might want to become a champion for ME.
They are currently running a $1,000 “matching challenge”. Please take the time to donate HERE for this important venture.
What can you do?
*You can support ME Advocacy by volunteering and/or donating the much needed funds. HERE
*You can write letters to Sylvia Burwell recording your opposition to P2P and IOM. Sample letters HERE
*You can join the twitter campaign in opposition. HERE
*You can join the Facebook group U.S. Campaign for Myalgic Encephalomyelitis (M.E.). This is a closed group of about 400 patients and advocates who refuse to embrace the government’s processes of the IOM and P2P. HERE