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The Call for Opposition: Challenging the P2P and IOM Processes

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. 

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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

Sign the petition to get ME/CFS a research budget of $250 million a year!
There's a US petition and a global solidarity petition here with a long-term target of 50,000 signatures. Time we were on an equal per-patient funding basis with similar diseases!

{ 33 comments… add one }

  • Dreambirdie January 13, 2015, 7:46 pm

    Wow, What a great article! So well articulated and detailed. Thanks for doing such an awesome job, Gabby. I have bookmarked it for future reference.

  • catly January 13, 2015, 8:07 pm

    I agree, just WOW and kudos to @Nielk for such moving piece. Also thanks for the reminder that I have to make my monthly contribution to ME Advocacy.

  • Marylib January 13, 2015, 8:10 pm

    Terrific article! Reallly awesome. Thanks so much!

  • Liz Willow January 13, 2015, 8:12 pm

    Your analogy of POWs who form an attachment to their captors and those within our community who mistake the P2P and IOM initiatives as "not too bad" is very apt. Decades of abuse have made many blind to the fact that government action has not and will not bode well for us. Those who want decent definitions, research, diagnosis, funding, and treatment would do well to stand up and defy the continuing government control over issues that are already (and should be) addressed by medical experts.

  • Ember January 13, 2015, 8:29 pm

    Here's an alternate cautionary tale.;)

  • beaker January 13, 2015, 8:40 pm

    Here! Here !

  • Wildcat January 13, 2015, 9:20 pm

    .
    Thank you for doing that Gabi.

  • Marylib January 13, 2015, 9:44 pm
    Liz Willow

    Your analogy of POWs who form an attachment to their captors and those within our community who mistake the P2P and IOM initiatives as "not too bad" is very apt. Decades of abuse have made many blind to the fact that government action has not and will not bode well for us. Those who want decent definitions, research, diagnosis, funding, and treatment would do well to stand up and defy the continuing government control over issues that are already (and should be) addressed by medical experts.

    Well said Liz Willow. I support resistance, not compliance.

  • RustyJ January 13, 2015, 11:50 pm
    Marylib
    Liz Willow

    Your analogy of POWs who form an attachment to their captors and those within our community who mistake the P2P and IOM initiatives as "not too bad" is very apt. Decades of abuse have made many blind to the fact that government action has not and will not bode well for us. Those who want decent definitions, research, diagnosis, funding, and treatment would do well to stand up and defy the continuing government control over issues that are already (and should be) addressed by medical experts.

    Well said Liz Willow. I support resistance, not compliance.

    Good job Gabby. No Kool-Aid for me thanks.

  • NK17 January 14, 2015, 2:02 am

    Thank you Gabby for this fine article. I stand with you in opposing the amatorial approach of the government to our serious medical condition which should be called ME and should be clinically defined by the CCC and ICC. PWME don't need crumbs, we need strong biomedical research, clear intentions and un-biased support. Either you stand by ME or you're against ME.

  • jimells January 14, 2015, 9:56 am

    It is rather disheartening to see how many folks are willing to believe that NIH has suddenly changed its tune. I really do understand the desire, perhaps the need, to believe the NIH will now help us. Who wants to believe that "their" government officials are lying, all the time, about almost everything? And yet it is an inescapable, well-documented fact.

    In evaluating the honesty of the NIH, one need only ask one question:

    Where is the money for real research?

  • caledonia January 14, 2015, 2:03 pm

    Great article Gabby, and thanks for including MEadvocacy.org.

    I would just like to add that as part of the National PR Campaign for ME, we are suggesting that everyone start using the term ME when you mean true ME as defined by CCC/ICC, and to use CFS when you mean CFS as defined by Fukuda.

    The upcoming WHO ICD-10-CM codes (medical billing codes for the US) as of Oct. 1, 2015 will have separate codes for ME and CFS. In addition, each one excludes the other. So if you're diagnosed with ME, you can't be diagnosed with CFS and vice versa. Fortunately, this reflects exactly what we're asking for in our campaign.

    The term ME/CFS is confusing. And there is no billing code for it. It doesn't actually officially exist, even though the NIH has picked up on using it (apparently because we patients are?). We suggest that people discontinue the use of this term. To this end, we have gone through both our websites and gotten rid of all references to ME/CFS (except as necessary, for example, it's used in the name of the P2P Workshop). I have personally started doing this in all my online conversations.

    I have written a blog article explaining this further.
    http://www.meadvocacy.org/if_you_mean_m_e_just_say_m_e

    I would love to see Phoenix Rising, both officially, and the site members as individuals start doing this.

    And of course, please donate so that the public relations firm can continue to assist us in fighting against the HHS and their corruption.

  • OneWaySurvival January 14, 2015, 3:33 pm

    SAMPLE P2P Opposition RESPONSE:

    Feel free to copy/paste or modify, and re-send to the govt. email addresses listed at the bottom of my letter.

    My response is a compilation/blend of several advocates who have written amazing responses already…Gabby Klein, Jeannette Burmeister, Eileen Holderman, Jarrold Spinhirne, and Jim Ellsworth (who stands out as having the MOST CONCISE yet powerful comment I've read yet).

    I have decided not to submit via the official Public Comment because I do not want it to count as buy-in. I am boycotting the P2P/IOM, but I still want my voice to be heard, so I have emailed the following letter to US Health Secretary Sylvia Burwell and CC’d several other govt. officials listed after the letter:

    Subject Title: Response to P2P for M.E.

    January 14, 2015

    Dear Secretary Burwell,

    My name is ___________ (Tom Jarrett) and I have been sick and disabled by Myalgic Encephalomyelitis (M.E.) for ______ (8) long and difficult years.

    I am a real person. Please keep that in mind.

    I am writing to state my complete opposition to the Health and Human Services (HHS) initiatives involving the Institute of Medicine (IOM) and Pathways to Prevention (P2P) to redefine the disease properly known as M.E. but that HHS has begun improperly referring to as ME/CFS.

    I join multitudes of M.E. advocates, patients, caregivers, researchers and clinicians, and other stakeholders, in total opposition to the IOM and P2P initiatives.

    Together we are united in stating the following:

    We do not need HHS bureaucrats who are not M.E. 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.

    Here is what we DO need and what we DO demand:

    1) Adopt the CCC now, with an open mind toward the ICC
    2) Widely Distribute the 2012 ME IC Primer to Doctors
    3) Increase funding for biomedical M.E. research to match diseases of similar cost and disability burdens

    Here are my supporting arguments for what is needed, and my reasons for opposing the entire P2P process for M.E.:

    M.E. experts have already reached consensus on the definition question. By pursuing a different way (P2P/IOM), and judging by the anti-patient manner in which they are pursuing it, HHS is revealing a harmful ulterior motive.

    HHS/NIH should listen to the more than 50 M.E. expert researchers and clinicians who sent an open letter on Sept. 23, 2013 to then U.S. Health Secretary Kathleen Sebelius, stating in part:
    "adopt the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.

    We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

    The expert biomedical community will continue to refine and update the case definition as
    scientific knowledge advances; for example, this may include consideration of the 2011 ME
    International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As
    leading researchers and clinicians in the field, however, we are in agreement that there is
    sufficient evidence and experience to adopt the CCC now for research and clinical purposes,
    and that failure to do so will significantly impede research and harm patient care." (emphasis added)

    View the full letter, signed by more than 50 M.E. experts, endorsed by over 170 leading patient advocates, and backed by nearly 10,000 petition signatures.

    But the HHS refused to follow the experts' advice and foolishly/selfishly/secretly embarked on a million dollar Institute of Medicine (IOM) contract and a separate Pathways to Prevention (P2P) process to redefine M.E. to their own liking. They defended the plan to use the IOM by misrepresenting a recommendation from the HHS’s Chronic Fatigue Syndrome Advisory Committee (CFSAC).

    In short, HHS hijacked the CFSAC recommendation.

    The real recommendation was "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."

    In this letter, I will focus on the problem of NIH's Pathways to Prevention (P2P) initiative and its resulting flawed P2P draft report, which I fully oppose.

    NIH inexplicably decided on using the P2P process for the controversial disease "ME/CFS". However, the P2P process, as per its website is not to be used for “controversial topics.” That is a blatant violation by itself, but is only the beginning of a fatally flawed process.

    Trans-NIH ME/CFS Research Working Group Chair Susan Maier described the P2P workshop as based on the “jury model” that requires the exclusion of any clinician or researcher who has any experience with M.E.

    Fellow M.E. patient and advocate Jeannette Burmeister called it "the jury model stood on its head" and went on to say:
    "Experts and government officials with varying points of view will present their views at the workshop…Then the P2P panel, made up—by design—of those with no expertise or prior research or opinions on [M.E.] AT ALL, will take the evidence report and the comments of the presenters—the “prosecution” and the “defense”— and deliberate and issue their recommendations in writing within [a week]…I find it hard to capture in words the absurdity of this approach."

    When NIH stubbornly moved forward with P2P, a protest with wide community support was held to oppose the NIH's Dec. 9 and 10 P2P workshop.

    This absurd P2P process culminated in a Draft Executive Summary report released to the public on December 18, 2014.

    This P2P draft report is a crumb, and I will not accept it. Instead, give me the 2012 IC Primer. The IC Primer language (written by actual M.E. experts more than 2 years ago!) is far superior to this P2P report regarding descriptions of M.E. and the manner in which it outlines the needs for future research and funding. NIH could have and should have avoided the monumental waste of time, energy, and tax dollars used to produce the bogus and inferior P2P report.

    HHS/NIH are playing games with us, and our suffering grows.

    Between P2P and IOM, the NIH is forcing a process on us that is more costly, more draining on patients, and with a much longer wait for valid research than if they simply put their full weight and effort into expediting the recommendations from our experts to use the CCC now for diagnostic and research purposes, to widely disseminate the IC Primer to properly educate doctors on the disease M.E., and to dramatically increase funding into biomedical M.E. research to bring it to a commensurate level with MS and other diseases with similar cost and disability burdens to patients and the U.S. economy.

    In addition to rejecting the P2P draft report and the contrived process used to create it, fellow patient Jim Ellsworth makes a powerful and eloquent argument for increased funding into legitimate M.E. research, "We do not need more government reports, conferences, or 'stakeholder meetings.' We need cash for research. That's all that's needed. Everything else is just re-arranging deck chairs on the Titanic."

    To help conclude my argument for opposing P2P/IOM, I offer the following excerpts from fellow M.E. patient Jerrold Spinhirne's public comment for the January 13, 2015 CFSAC Meeting.

    His essay stunningly illustrates the numerous problems with the P2P process, while helpfully pointing to a beneficial alternative in widely disseminating the 2012 IC Primer to healthcare professionals.

    "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]

    The unknowledgeable P2P panel from outside the field seems to be unaware that
    most of the problems the panel has "discovered" have already been addressed by
    the 2011 ICC and 2012 IC Primer. HHS can begin correcting these problems by
    recognizing ME as the distinct neurological disease that it is and removing ME
    from the broader inappropriate CFS category, as called for by the ICC. HHS needs
    to assume an ancillary role and begin disseminating the IC Primer to doctors
    so they can make the differential diagnosis of ME, instead of continuing to
    place ME patients at risk by misdiagnosing them with CFS or some new "ME/
    CFS" pseudo-diagnosis.

    The tools for educating medical professionals about ME already exists in the ICC
    and IC Primer. The problem is HHS does not want to devote the necessary
    resources to educating doctors and healthcare professionals on how to
    recognize, diagnose, and properly treat ME. HHS prefers, instead, to accept
    the increased disability in the US population and increased yearly cost to
    the economy caused by medically neglecting and mistreating ME. The HHS
    leadership has chosen to support the bureaucrats at the CDC's inept CFS program,
    and their negligent CFS Toolkit collection of dangerous medical misinformation,
    over the public interest. [CDC, undated]

    Why would HHS ever implement any of the grand proposals of the P2P draft
    report when HHS stubbornly refuses to take even the low-cost, simple step
    of removing the harmful, inaccurate CFS Toolkit from the CDC website and
    disseminating the excellent IC Primer to healthcare professionals? Doctors now
    are unaware of the possible permanent harm to their ME patients posed by exercise
    and overexertion. ME must be recognized and diagnosed early so the patient can
    be advised to take total rest to limit the risk of permanent severe disability caused
    by the disease.

    Doctors have been left totally uninformed about ME by the continued misconduct
    of HHS bureaucrats. Instead of conducting seminars educating doctors about ME
    with information that is now readily available, HHS is squandering public money
    on the obfuscating P2P Workshop and its report.

    Further reasons for disseminating the 2012 International Consensus Primer now
    to healthcare personnel (and the medical risks to [M.E.] patients posed by continued misdiagnosis
    with chronic fatigue syndrome) are given in my December 17, 2014 article: 'Why There Is an Urgent Need to Widely Distribute the Myalgic Encephalomyelitis International Consensus Primer to Doctors.'"

    End Public Comment from Jerrold Spinhirne, S.E.

    My opposition to IOM and P2P is a complete rejection of these initiatives to redefine M.E.
    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,

    _______________(Thomas W. Jarrett)
    M.E. Patient and Advocate
    US Citizen

    To:Sylvia.Burwell@hhs.gov (HHS Secretary)

    cc:Francis.Collins@nih.hhs.gov (NIH Director)
    Tomfrieden@cdc.gov (CDC Director)

    Other key government employees involved with the P2P:
    Susan.Maier@nih.hhs.gov (Chair, Trans-NIH ME/CFS Research Working Group)
    David.Murray2@nih.hhs.gov (Director, Office of Disease Prevention)
    Wanda.Jones@hhs.gov (Deputy Assistant Secretary for Health)

    Note:
    The above letter includes hyperlinks to other articles. Some email accounts may not support hyperlinks, in which case you can copy and paste the version without hyperlinks that I posted in the comment section at MEadvocacy.org. See http://www.meadvocacy.org/post_your_p2p_comments_here

  • Sing January 14, 2015, 4:45 pm

    I object to the sarcastic description of those who have anything positive to say about P2P, as "jumping for joy", and comparable to a prisoner of war who has turned coat and is now fighting for the enemy. In my view, the approach suggested here of protesting the whole P2P and IOM process all together is a fine, and so is what those of us who painstakingly gave many hours trying to analyze and respond to P2P and sent their commentary to CFSAC and P2P. I feel that the approach of protest above is well articulated and is one useful way, but do not believe that using a divisive language and tone makes a constructive contribution to us as a whole or to how we can be strong in pursuing our common goals. In the end what matters most is that as many who can do participate in some way. Beyond just talking to ourselves, in whatever way makes sense to us, we seriously need to voice the direction we are wanting.

  • Nielk January 14, 2015, 4:56 pm

    My purpose was not to insult anyone and I'm sorry if you feel that way.

    I do not criticize people who choose to comment to the P2P. I actually have respect for many who have been working hard to give very intelligent and constructive comments.

    I do not share the opinion of those who feel that this will have a very positive effect for us.

    My problem is not patients or advocates with differing opinions, but with the Government.

    I do feel that the government has hi-jacked this disease and has been holding us hostage.

    I feel that we deserve the same care as patients suffering with other serious diseases like MS, Parkinson's and Cancer.

    We deserve hundreds of millions in funding. We deserve for the Government to respect our medical experts who know what this disease looks like.

    I feel like we should not accept crumbs.
    I certainly did not mean to insult any patient or advocate.

  • Marylib January 14, 2015, 5:30 pm

    I found your comparison very powerful, Nielk. And I certainly know that you have not meant to insult anyone. It is just a matter of personal choice and some of us have chosen to participate in the ways Nielk has described, rather than through the channels requested by the govt. agencies.

  • beaker January 15, 2015, 4:31 am
    Sing

    I object to the sarcastic description of those who have anything positive to say about P2P, as "jumping for joy", and comparable to a prisoner of war who has turned coat and is now fighting for the enemy. In my view, the approach suggested here of protesting the whole P2P and IOM process all together is a fine, and so is what those of us who painstakingly gave many hours trying to analyze and respond to P2P and sent their commentary to CFSAC and P2P. I feel that the approach of protest above is well articulated and is one useful way, but do not believe that using a divisive language and tone makes a constructive contribution to us as a whole or to how we can be strong in pursuing our common goals. In the end what matters most is that as many who can do participate in some way. Beyond just talking to ourselves, in whatever way makes sense to us, we seriously need to voice the direction we are wanting.

    I support both those protesting the absurdness of the P2P AND those who choose to respond.
    Covering all bases seems most prudent.

  • Nielk January 15, 2015, 7:55 am
    beaker

    I support both those protesting the absurdness of the P2P AND those who choose to respond.
    Covering all bases seems most prudent.

    The difference being that those of us who choose no to participate with the P2P will not send in their comment to the P2P directly. We have choose instead to send letters to Secretary Burwell and other Government HHS representatives:

    * P2P mailbox is exclusively for comments about P2P and which count as participation with the P2P process and reportedly will not be retained for the official record.

    * Letters of protest sent to Secretary Burwell or other Federal Officials (personal email addresses) are retained for the official record and do not count as participation/buy-in to the P2P process.

  • Bob January 15, 2015, 10:03 am
    beaker

    I support both those protesting the absurdness of the P2P AND those who choose to respond.

    Me too. I'm making submissions to try to get the report improved, but I absolutely support those who have decided to protest. Personally, I don't think there is any correct way to carry out advocacy. Bureaucratic change is messy and happens slowly, and it comes about because of persistent pressure brought to bear from all types of citizens, advocating in a variety of ways, over a long period of time. I think it's the combined community effort that makes the difference.

  • Sing January 15, 2015, 10:09 am

    @Nielk Thanks, Gabby, for your very respectful response–post #16–and clear explanation of your thinking. I agree with these goals, and feel that it can be useful for us to respond both ways, through the strategy of "covering all bases", as beaker said.

  • Sing January 15, 2015, 10:15 am
    Bob

    Me too. I'm making submissions to try to get the report improved, but I absolutely support those who have decided to protest. Personally, I don't think there is any correct way to carry out advocacy. Bureaucratic change is messy and happens slowly, and it comes about because of persistent pressure brought to bear from all types of citizens, advocating in a variety of ways, over a long period of time. I think it's the combined community effort that makes the difference.

    The main thing is pressure and persistance in a community effort, I agree!

  • Hope123 January 16, 2015, 4:02 am
    Sing

    I object to the sarcastic description of those who have anything positive to say about P2P, as "jumping for joy", and comparable to a prisoner of war who has turned coat and is now fighting for the enemy. In my view, the approach suggested here of protesting the whole P2P and IOM process all together is a fine, and so is what those of us who painstakingly gave many hours trying to analyze and respond to P2P and sent their commentary to CFSAC and P2P. I feel that the approach of protest above is well articulated and is one useful way, but do not believe that using a divisive language and tone makes a constructive contribution to us as a whole or to how we can be strong in pursuing our common goals. In the end what matters most is that as many who can do participate in some way. Beyond just talking to ourselves, in whatever way makes sense to us, we seriously need to voice the direction we are wanting.

    I agree with Sing. Some of the comments here make presumptions about people who are working hard to submit comments or do other things behind the scenes to engage with the government. We're not the enemy and we are not naive. In fact, some of us have a better understanding of whom we are facing and the issues at hand because we engage.

    It would be easy for me to just throw in the towel and do nothing; in fact, it would be better for my health and my family but IMO, to not engage is an error.

    However, you will not see me disparaging those who choose other avenues of protest. In fact, I have supported them with $$$ in the past. History shows that most movements succeed through a variety of tactics and personalities. Think of it as a financial investment portfolio, would you put all you money in only one type of stock? Diversify!

  • jamie January 16, 2015, 5:04 am

    Why not add letters to President Obama. He seems like he is in a place where he has no power in congress for the next two years and is wanting to make a difference though government agencies. Give him the basic story of a wrong that has a simple right. To tell the Secretary to stop this process, except the experts disease definition and make the funds available to this disease comparable to other diseases with the same profile.

    Then give him a link to this letter.

    It's a hail mary but why not? They say he is given 10 letters a day to read.

  • Nielk January 16, 2015, 11:32 am
    Hope123

    I agree with Sing. Some of the comments here make presumptions about people who are working hard to submit comments or do other things behind the scenes to engage with the government. We're not the enemy and we are not naive. In fact, some of us have a better understanding of whom we are facing and the issues at hand because we engage.

    It would be easy for me to just throw in the towel and do nothing; in fact, it would be better for my health and my family but IMO, to not engage is an error.

    However, you will not see me disparaging those who choose other avenues of protest. In fact, I have supported them with $$$ in the past. History shows that most movements succeed through a variety of tactics and personalities. Think of it as a financial investment portfolio, would you put all you money in only one type of stock? Diversify!

    I think that there might be a misunderstanding.

    There are those who are submitting comments to the P2P in order to improve the resulting final report. Clark Ellis has written an article about it HERE.

    Others have chosen not to send comments directly with the P2P as they feel that would be considered participation. Instead, they have chosen to send comments to key US officials.

    All the efforts by patients and advocates with the aim of improving the plight of the patients are appreciated. The difference being that we have chosen different tactics.

  • Nielk January 16, 2015, 3:35 pm
    Hope123

    It would be easy for me to just throw in the towel and do nothing; in fact, it would be better for my health and my family but IMO, to not engage is an error.

    Just a reminder that protesting does not mean throwing in the towel and doing nothing. From my article:

    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

  • denlander January 19, 2015, 8:24 am

    I reiterate my support for Gabby's super letter. The remarks are pinpoint on target. Gabby quoted me correctly in saying that the Government was wasting precious funds with a scheme to minimize the devastating effects of this disease and sidetrack patients into ineffective treatment.
    Derek Enlander MD ,
    New York

  • jimells January 24, 2015, 8:54 am
    jamie

    Why not add letters to President Obama.

    See this front page story from Aug 2012

    From Bob and Courtney Miller

    "In an unprecedented step, President Obama has asked the National Institutes of Health and the Department of Health and Human Services to elevate Chronic Fatigue Syndrome in priority, assigning his Deputy Chief of Staff to follow their efforts. When President Obama promised Courtney Miller to “see if they could do more” for CFS research at a Reno Town Hall meeting last year, he was the first U.S. President to say the words Chronic Fatigue Syndrome. Now he has lived up to his promise, becoming the first President ever to ask the nation’s health agencies to elevate the priority of CFS! Thank you, President Obama!

    So has there been an increase in research in the last 2 1/2 years?

    Instead of research we got P2P and IOM. My version of the story is:

    Obama to staff: "Take care of this"
    Staff: "Sure Boss, we'll cure the illness by re-defining it out of existence. "

  • Izola February 4, 2015, 9:41 pm

    Maybe we should start inundating the congress and president with letters. Years of challenging the HHS, CDC & NIH does not seem to get us anything but grief and crumbs.

    Nielk, you piece was great. I am sorry I have run out of the ability to talk. You rock. I pledge my dead body to be deposited on the steps of HHS or CDC.

    I skipped some of the posts above. I went back and saw the Obama comments. At least he listened. Now it is up to us to keep his attention. It appears that he believed us long before most every one else in power.

    I'll come back to this if I can. iz

  • leela March 1, 2015, 6:24 pm

    @Nielk I'm only just seeing this outstanding article now.

    What an incredible gift to the community. Truly stellar–thank you so much.

  • shastamax March 22, 2015, 11:55 am

    Beg to differ, but the IOM report is the best thing to happen in my 20 years of having this illness. I'm not brainwashed. I'm as mad as the rest of you about the lack of progress. But consider that the IOM report has generated a highly prestigious place to refer doctors and others who still believe this is not a real and serious illness. It has generated a number of well done media pieces (NPR, NY Times, The New Yorker). I am a biomedical researcher, so maybe can lend some insight. It has recently become a common and very fruitful approach in biomedical research to get outsiders involved. The outsiders in this instance became very well educated about our illness by working on this report for a year and going through all the literature published in the last 60 years. Ellen Wright Clayton (chair of the IOM ME/CFS report group) has become quite the advocate for our cause. She is on our side! Let's support her and work to see that the IOM report call for much more funding gets translated into action.

  • Nielk March 22, 2015, 12:09 pm
    shastamax

    Beg to differ, but the IOM report is the best thing to happen in my 20 years of having this illness. I'm not brainwashed. I'm as mad as the rest of you about the lack of progress. But consider that the IOM report has generated a highly prestigious place to refer doctors and others who still believe this is not a real and serious illness. It has generated a number of well done media pieces (NPR, NY Times, The New Yorker). I am a biomedical researcher, so maybe can lend some insight. It has recently become a common and very fruitful approach in biomedical research to get outsiders involved. The outsiders in this instance became very well educated about our illness by working on this report for a year and going through all the literature published in the last 60 years. Ellen Wright Clayton (chair of the IOM ME/CFS report group) has become quite the advocate for our cause. She is on our side! Let's support her and work to see that the IOM report call for much more funding gets translated into action.

    As a biomedical researcher, how often have you seen HHS contract with a medical institute to redefine a disease that has already been defined by the private expert medical clinicians and researchers?

  • out2lunch June 13, 2015, 4:39 pm
    Nielk

    As a biomedical researcher, how often have you seen HHS contract with a medical institute to redefine a disease that has already been defined by the private expert medical clinicians and researchers?

    BINGO! :thumbsup:

    Redefining our disease seems to serve the interests of those outside the patient community for the most part. And as @Nielk correctly posted, the actions of HHS to rely on an outside "medical institute" to pull this bait-n-switch with the very definition of what we're suffering from, is more than beyond the pale. It's unprecedented.

    Instead of striving towards gains with regard to understanding this disease and how best to treat it, HHS takes a giant step backward in doing anything remotely effective with regards to stimulating research for physiological etiology and not just psychiatric. Simply entertaining the validity of GET/CBT throws cold water on the whole process, IMHO. How can we be expected to take these so-called professionals seriously, when they don't take the decades of peer-reviewed research seriously?

    The conspiracy theorist in me continues to rage on, believing that this whole HHS/IOM/SEID nonsense is more about throwing SSDI a lifeline than working to support our community in all areas of our daily lives, especially being able to meet our basic survival needs.

    I believe that HHS is paralyzed with overwhelming fear about the SSA fiscal consequences of fully acknowledging the permanently debilitating nature of our disease, and has proactively taken steps to tamp down any and all efforts to help our community receive disability payments, literally holding us hostage, to borrow this wonderful metaphor, to the whims of the ignorant and intolerant folks throughout the disability bureaucratic food chain, who routinely deny us SSDI and SSI out of that ignorance and intolerance.

    Until HHS can get behind the researchers who have proven the destructive nature of GET/CBT in treating our illness, nothing substantial is ever going to be accomplished through the agency. It's obvious to me and a huge swathe of our community, that these recent actions by HHS are just another form of lip service designed to keep us in our place and foolishly believing that they're on our side. :cautious:

  • caledonia June 13, 2015, 5:53 pm

    Since this post was started, MEadvocacy has gone above HHS and targeted Congress.

    It's not too late to send a message regarding Appropriations – you can still sign the One Click letter asking Congress to fund research for ME for $250 million here:
    http://www.meadvocacy.org/tell_congress_to_increase_funding_for_me_research