Monday, October 20, 2014

Suggested Protest of the P2P

Note: I posted this in response to a discussion in the Facebook group, US Campaign for ME.


SUGGESTED PROTEST OF THE P2P

(Deadline Oct. 20, 11:59 pm Eastern Standard Time)

This group’s focus from the start has been to oppose the three US government initiatives (including the P2P) to redefine ME and change the direction of research and clinical guidelines. We have been told by the government that P2P is part of the official response to the October 2012 CFSAC recommendation to convene a stakeholder workshop (including experts, patients, and advocates) to reach a consensus for a case definition, starting with the 2003 Canadian Consenus Criteria. We continue to support the experts and the CCC, as updated by the ME ICC.

As founders and administrators, we propose that members consider using the tool AHRQ has given us, a place to comment, in much the same way we used the public comment spaces at the January IOM meeting -- to protest the process rather than comment on the substance of the draft report. 

Videos of those who protested at the IOM are part of a permanent public record on the IOM’s YouTube channel. Similarly, the AHRQ must publish all public comments on its official government website. Thus, those comments (unlike letters sent to NIH Director Collins and others) will be accessible to the public at large and can be easily shared with the press, members of Congress, and others who need to see the truth: 

There is widespread dissent to what the U.S. government is doing to ME! Others are commenting on the substance of the report. We must counter their voices!

A protest comment can be pasted in the "General Comments" section of the AHRQ form, the last blank box toward the bottom of the page. There is no need to enter anything in the other boxes designed for more formal submissions. Comments can be anonymous.

Don't forget your comment must be submitted by 11:59 pm EST on Monday, October 20!

Feel free to copy and paste the sample comment below (don't forget to enter the years you've been sick) or use it for inspiration.

Click here to get to the AHRQ comment website. 


SAMPLE COMMENT:

I am writing to protest the entire P2P process, including the production of this report. I have had ME for ___ years and am outraged at the US Department of Health & Human Services’ (HHS) pretense that P2P is responsive to the Chronic Fatigue Syndrome Advisory Committee (CFSAC) October 2012 recommendation to convene a stakeholder workshop (including experts, patients, and advocates) to reach a consensus for a case definition useful for research, diagnosis, and treatment.

In no way is the P2P process responsive to this recommendation. NIH has not engaged or involved stakeholders in a substantive way. The Workshop panel consists of individuals with no expertise in ME or CFS. It ignores the subsequent letter to HHS by disease experts who have adopted the Canadian Case Definition for research, to be updated as needed. Instead, the focus of the draft report is "medically unexplained fatigue". 

By using evidence-based practice, the very research studies that could move the field forward are ignored. The report itself will unequivocally set back research and treatment and lead to continued harm to patients, quite possible worse than what has already been inflicted on people like me.

For these reasons, I object to the continuance of the P2P process, including publication of this report, its dissemination to the P2P panel, and its use for any other purposes.

Saturday, October 19, 2013

UPDATED ACTION! Tell Congress & the President to Cancel the IOM Contract & Adopt the CCC!



We must keep up the pressure to get the IOM contract cancelled and the CCC officially adopted by the U.S. Department of Health & Human Services.  


We must get our Congressional delegations to contact the key Senators and Representatives with jurisdiction over HHS -- the power to hold investigations, cut funding, and basically make the Department uncomfortable.  We must email the President, Vice President, and the President's science advisors. We must get HHS to listen and to ACT.

Remember, fifty ME/CFS experts stated in a letter to HHS,“[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary...Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.” (Emphasis added)
Our ME/CFS experts have spoken. HHS must follow their lead and adopt the CCC. HHS must cancel the IOM contract as wasteful, unnecessary and harmful. 
For U.S. residents only:  
Please contact your congressional delegation as soon as possible and ask them to contact these congressional leaders to tell HHS to adopt the CCC and cancel the IOM contract. Please ask your family and network to do the same. 
Instructions and a sample letter are below.  

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For everybody - U.S. and international members of the community:
Please contact the President’s science advisors as well as the President and Vice President today and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Directions are below.
Also, if you have not done so, please sign the following two petitions calling on HHS to adopt the CCC and cancel the IOM contract. Ask your family and friends to do the same. 
  1. October 7, 2013 petition calling on HHS to stop the HHS/IOM contract and accept the CCC definition - http://bit.ly/GUedsp 
  2. June 2013 petition calling on HHS to adopt the CCC and stop using the name ‘chronic fatigue syndrome’   http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/
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Instructions to Email or Call Your Congressional Delegation (U.S. only)
  1. Senators and members of the House of Representatives need to hear directly from their constituents. You can get the contact information for your congressional delegation at this website:
Type your zip code into the form and click on “Submit It”. The website will return the names of your two senators and one representative along with their phone numbers and a link to their contact form.    
  1. Click on the link to the web contact form for your senators and representative. This will bring up the web contact form for that legislative leader. 
    1. If you are using the sample letter, copy it into the box provided for your message. 
    2. Use “Stop the IOM Contract to Redefine ME/CFS" as the subject. 
    3. Select a choice dealing with healthcare if needed.
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Sample Message 
To be copied into the web contact form:
I am asking you to contact one or more of the following Senators and Representatives who chair committees with jurisdiction over the Department of Health and Human Services (HHS):  Senators Harkin, Murray, Alexander, Mikulksi, Shelby, Sanders, and Burr; and Representatives Upton, Kingston, Pitts, Pallone, DeLaura, Rogers, and Lowey, on my behalf.  Ask them to contact HHS today and tell Department to follow the lead of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) disease experts. Ask them to tell HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS.
Fifty of the leading ME/CFS researchers and clinicians have written to HHS Secretary Kathleen Sebelius calling for the Canadian Consensus Criteria (CCC) to be used as the sole case definition for ME/CFS. These experts also urged HHS to abandon its plans to contract with the Institute of Medicine (IOM) to use non-experts to create its own definition. On the same day, despite an outpouring of patient opposition, HHS announced that it was going forward with the IOM contract to develop its own clinical diagnostic criteria for ME/CFS, instead of adopting the 2003 Canadian Consensus Criteria (CCC) created and endorsed by ME/CFS experts. 
Regarding the IOM contract, the fifty experts stated,“[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary ... Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”
The use of non-experts is especially concerning because, thanks to the bad definitions that HHS has promoted, the disease is so poorly understood that the medical community at large believes the disease is either not real or is a form of depression or deconditioning. ME/CFS is not deconditioning or depression. It is a devastating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. ME/CFS costs the U.S. economy an estimated $17-23 billion dollars a year in lost productivity and direct medical costs. 
Given the overwhelming opposition to HHS’ plans by both patients and experts, I am asking you to do whatever you can to get HHS  to follow the lead of ME/CFS disease experts. HHS must cancel the contract with IOM.  HHS must  adopt the Canadian Consensus Criteria.
For more information, see the following links or send an email to meactnow@yahoo.com.


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Instructions for Contacting President Obama’s Science Advisors, President Obama, and Vice President Biden:

  1. Copy and paste all but the first paragraph of the sample message below into the body of the content form.  
  2. Substitute "Please order HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS." for the first paragraph.
  3. Send the modified email to the President's science advisors: pcast@ostp.gov (cc meactnow@yahoo.com). 
  4. Some of these emails are bouncing back.  The President has 18 PCAST advisors.  Just in case they are not receiving the message, use  the form at http://www.whitehouse.gov/administration/eop/ostp/contactusScroll down to “PCAST” on the menu and fill out the rest of the required information. Copy and paste the modified message for the body of the content form.
  5. Go to http://www.whitehouse.gov/contact/submit-questions-and-comments, check "Health & Human Services" for the subject,  and copy and paste the modified message to President Obama and Vice President Biden.
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      Background Information (not to be included in the sample letter)  

      Note: For those who are telephoning or meeting with their Congressional delegations, the following also are fodder for talking points.


      On September 23, HHS announced that it had engaged the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. That announcement can be found here: http://bit.ly/18m7XlJ

      The same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) sent an open letter to Health and Human Services (HHS) Secretary Kathleen Sebelius announcing they have reached a consensus on adopting the Canadian Consensus Criteria (CCC), calling on HHS to adopt the CCC as the sole definition for ME/CFS and urging HHS to abandon its plans to develop its own diagnostic criteria. Fifteen additional experts added their signatures to this letter in October. The letter can be found here: http://bit.ly/15npS9B

      General background can be found here http://bit.ly/16qOLY3

      Additional facts about the HHS/IOM contract for ME/CFS can be found here – http://bit.ly/1hIz4ej 

      Ask to join the Facebook group, U.S. Campaign for Myalgic Encephalomyelitis (M.E.), for updates and additional ideas. 

      Saturday, September 28, 2013

      One Heck of an Inspiring anti-IOM Study Letter

      Read this letter.  It spells out  all the issues and connects the dots.  The author has granted permission to share it.  I hope it inspires you as much as it has me. 


      Dear Secretary Sibelius, Dr. Koh,  Dr. Maier, Dr. Unger, Dr. Lee, Dr. Fineberg, and Dr. Behney,

      As a physician, health services researcher, and person affected by myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS), I am writing to you today to request that you consider strongly the letter expert ME/CFS scientists and physicians sent September 23, 2013 and cancel the Department of Health and Human Services’ contract with the Institute of Medicine (IOM) to construct a clinical case definition for ME/CFS. While I am appreciative of DHHS’ continued interest in ME/CFS and recognize the important and influential role the IOM plays in the health of the nation, I believe that the money and resources spent on such a contract might not only be duplicative and better spent on other areas of ME/CFS research  but may end up being harmful to patients in the short-term, by subjecting them to inappropriate treatments, and in the long-term, by obstructing and obscuring research progress.  Patients, patient advocates, clinicians, and researchers understand these issues and thus, rather than greeting the contract with joy and enthusiasm  expected, are instead contacting you with their concerns.

      Duplicative efforts will waste time, resources, and money

      1) Over the decades, a number of different clinical case definitions from different countries have been proposed for ME/CFS. Expert clinicians and researchers have reviewed all of them, found many to be unsatisfactory in describing patients, and, thus, came up with two different consensus-based definitions in the last decade, the Canadian Consensus Criteria (CCC, 2003) and the Myalgic Encephalomyelitis - International Consensus Criteria (ME-ICC, 2011). The experts recognize that both the CCC and ME-ICC need further validation and refinement but agree that these definitions are adequate enough to be used NOW both for clinical and research purposes. Indeed, use of the CCC has already yielded a possible treatment, rituximab, for some patients via a successful small trial in Norway. 

      2) DHHS’ own CFS Advisory Committee (CFSAC), recommended in October 2012 that “at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates) workshop  in consultation with CFSAC members [be convened] 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.” CFSAC did not ask for separate meetings to construct separate clinical and research definitions but for meetings to construct a case definition useful for multiple purposes. 

      3) Several studies, including the Centers for Disease Control and Prevention’s Multi-Site Clinical Assessment Study, and a meeting, an Evidence-based Methodology Workshop, are already being planned by the National Institutes of Health to address the issue of case definitions. It is unclear how IOM involvement would add value to the processes already underway. Instead too many cooks may spoil the broth. 

      4) Whenever patients, clinicians, researchers, advocates, or CFSAC have asked for increased funds for ME/CFS research and care, like for a Request for Applications (RFA) or for a Center of Excellence, they are told that there is no money. Yet, DHHS has money now to spend on a meeting rather than these repeated worthwhile requests? 

      Separate research/ clinical case definitions are harmful to patients, obstructive/ destructive to research efforts

      The last 3 decades have demonstrated that the separation of clinical care and research has resulted in suboptimal, even harmful care, of patients and little progress in our understanding of the cause(s) of and treatment for ME/CFS.

      As shown recently by the US Food and Drug Administration’s excellent final report from their ME/CFS Drug Development Workshop (The Voice of the Patient), post-exertional malaise (PEM),  exacerbation of all ME/CFS symptoms (including pain, exhaustion, sore throat, insomnia, cognitive problems, etc.) with mild physical/ cognitive activity, is a key feature and disabling symptom of ME/CFS. PEM, not chronic fatigue, is why patients are bedridden, homebound, unemployed, and unable to walk a block. Clinicians from around the globe who see and take care of thousands of ME/CFS patients regularly are well aware of this symptom and thus chose it as a required symptom when constructing both the CCC and ME-ICC.  The management of PEM is also different from chronic fatigue; rather than push patients to ignore PEM and to continue to engage in mental or physical activity, which could result in not only temporary but prolonged disability, experienced clinicians tell patients to balance their activity with rest to decrease the onset or severity of PEM. 

      In contrast, the emphasis on fatigue by the 1994 Fukuda and other case definitions promote the image of ME/CFS as a benign illness that can be overcome merely by a positive attitude, increased exercise, healthy diet, and enough sleep. This is reinforced by  European-based clinical trials of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) that claim to substantially improve the health of or even cure ME/CFS patients. These are double-blind randomized placebo-controlled clinical trials so they must be the best and last word in care, right? This treatment information is distributed widely in usually trusted resources such as the online medical database UpToDate.  Yet a careful reading of those trials shows that frequently, subjects were selected primarily because of chronic fatigue and that a common primary outcome measure was fatigue reduction. PEM was neither required for subject selection nor measured as an outcome. (Aside from the fact that none of the trials report objective increases in activity, for example, via actigraphy.) 

      Consequently, when the results of those trials are applied in practice to patients with symptoms beyond only chronic fatigue,  over  50% of thousands of patients surveyed over the last decade have stated that those treatments made them worse, not better. Patients who follow their physicians’ directions faithfully have ended up bedridden, some for days, others for years. The most recent IOM contract announcement mentions the 2007 NICE Guidelines for CFS/ME from the United Kingdom, where CBT and GET are mainstays of treatment.  The NICE guidelines were not deemed to be “nice” but rather “unfit for purpose” by the ME Association and UK patients, who asked for a  judicial review of that document. When the majority of people receiving a treatment are not getting better or even getting worse, we should ask WHY, not cling to the results of trials and doubt the words and experiences of patients. 

      Because most physicians are not educated about PEM and the limits of GET/ CBT trials, patients who do not improve substantially with or defer CBT or GET are either blamed for non-compliance or viewed as depressed, malingerers, or hypochondriacs.  In 2011,  the Centers for Disease Control and Prevention reported that 85% of clinicians still viewed ME/CFS as a wholly (14%) or partially psychiatric disorder (71%).  A quarter of clinicians recommended referral to a psychologist as an initial treatment. This perception, coupled with lack of knowledge, is why hundreds of thousands of patients all over the United States cannot find a single knowledgeable and sympathetic physician to take care of them. It doesn’t matter if the patient visits Dr. “Average” at a rural private practice clinic or Dr. “Expert” at a metropolitan internationally respected university medical center. The attitude displayed and advice given is rarely different; when choosing “experts”, even those selected for their methodological/ analytic rather than clinical/ basic science skills, will DHHS or IOM consider screening for knowledge about or attitudes towards ME/CFS? Will those who view it as a primarily psychological or psychiatric illness be screened out? I understand  that the current IOM Gulf War Illness panel is currently facing criticism from Gulf War veterans and even from the chairman of the GWI advisory committee, Jim Binns, that the panel includes members who don't think GWI is a physical illness. Will any ME/CFS IOM committee have the same problem?

      This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?

      We now have two  case definitions, CCC and ME-ICC,  vetted by experienced clinicians that are already being used in both practice and research. I see no need to waste further time, money, or energy on another consensus-based meeting when those resources could be better used to validate/ refine these definitions or find biomarkers, diagnostic tests, or treatments. Patients’ lives are passing by each minute, never to be regained;  don’t make us to wait another 3 decades!

      Thank you for your attention, 
      Lily Chu, MD, MSHS, 
      Burlingame, CA

      (bolded text by the author)

      Wednesday, September 25, 2013

      Support and Thank Our Experts! Adopt the CCC & Cancel the IOM Contract.

      Our ME/CFS experts have spoken. We need to support them and call on HHS to follow their leadAdopt the CCC. Cancel the IOM contract as wasteful, unnecessary and harmful.


      On September 23, HHS announced that it will begin working on the initiative with the Institute of Medicine (IOM) to begin work to develop “clinical diagnostic criteria” for ME/CFS. That announcement can be found here: http://bit.ly/18m7XlJ


      The same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) sent an open letter to Health and Human Services Secretary Kathleen Sebelius announcing they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

      The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here: http://bit.ly/15npS9B

      Let's support these experts by signing and sharing this petition!  


      Each of the experts will receive the following thank you message with all signatures and comments attached:


      Thank you for your letter to the Department of Health & Human Services (HHS) stating your consensus on the use of the Canadian Consensus Criteria as the sole definition for ME/CFS, for calling on HHS to adopt CCC for all its activities, and for urging HHS to abandon its Institute of Medicine (IOM) study to develop it's own clinical diagnostic criteria for ME/CFS. 



      For decades, the stunning lack of clarity on the nature of ME/CFS has severely impeded research, perverted clinical care, stigmatized patients and left our country with a huge economic burden. We applaud you for showing exactly the kind of leadership and courage that is needed to change the future for ME/CFS patients and their families. We stand ready to support you and follow your leadership in achieving this. We call on HHS to do the same, starting with immediate adoption of the Canadian Consensus Criteria and abandonment of HHS’ plans to create its own criteria.  

      (Thanks to Mary Dimmock for pulling everyone's thoughts together to create this petition.)


      October 5, 2013 Update: Due to the U.S. federal government shutdown, Congressional staff are not being paid and are unlikely to be at work answering the phones or emails.  Thus, please direct your attention to supporting the petition above until further notice.  


      For U.S. residents: Please contact your congressional leaders and the President’s science advisor today and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Please ask your family and network to do the same.

      Instructions and a sample letter are below.

      Additional background can be found here: http://bit.ly/16qOLY3
      Answers to frequently asked questions (FAQ) can be found here: http://bit.ly/1eHuMGO 

      Join this Facebook event page for updates and a sense of community: https://www.facebook.com/events/705280782832088

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      Instructions for Emailing or Calling Your Congressional Leader (U.S. only)

      1. Senators and members of the House of Representatives need to hear directly from their constituents. You can get the contact information for your congressional leaders at this website:

                                  http://www.congressmerge.com/onlinedb/index.htm


      1. Type your zip code into the form and click on “Submit It”. The website will return the names of your two senators and one representative along with their phone numbers and a link to their contact form.   
      2. If you are calling, ask to speak to the legislative aide that deals with healthcare issues. You can use the sample letter as talking points.
      3. If you are sending an email, click on the link to the web contact form for your senators and representative. This will bring up the web contact form for that legislative leader. 
      4. If you are using the sample letter, copy it into the box provided for your message. 
      5. Use “Stop the IOM Contract to Redefine ME/CFS" as the subject. 
      6. If the online form indicates that you need to choose the nature of the issue, select a choice dealing with healthcare. 
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      Instructions for Contacting President Obama’s Science Advisors

      1. Go to http://www.whitehouse.gov/administration/eop/ostp/contactus
      2. Scroll down to “PCAST” on the menu and fill out the rest of the required information.
      3. Copy and paste the sample message into the body of the content form.
      4. Add your name to the end of the message.
      ===============================================================

      Sample Message 

      To be copied into the web contact form and/or used for phone calls:

      I am asking you to contact the Department of Health & Human Service (HHS) today and tell them to follow the lead of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) disease experts. Tell HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS.


      On September 23, HHS announced that it has contracted with the IOM to develop clinical diagnostic criteria for ME/CFS, rejecting the use of criteria created by ME/CFS experts, including the 2003 Canadian Consensus Criteria (CCC). HHS pursued the contract unilaterally with virtually no if any involvement of ME/CFS experts or patients. Further, HHS has stated that it intends to use people with no expertise in ME/CFS to redefine ME/CFS. Adding to the concerns, the IOM’s only other effort to define a disease has been harshly criticized by Gulf War Illness (GWI) advocates for using non-experts, emphasizing psychiatric issues over evidence of chemical injuries and moving it toward a broadly defined symptom-based syndrome. For all these reasons, ME/CFS patients have been protesting the IOM contract for weeks but HHS went ahead with the contract anyway.

      Its important to note that on the same day that HHS announced that IOM would begin work, thirty-five of the leading ME/CFS researchers and clinicians wrote to Health and Human Services Secretary Kathleen Sebelius calling for the Canadian Consensus Criteria (CCC) to be used as the sole case definition for ME/CFS. The ME/CFS experts also urged HHS to abandon its plans to contract with the Institute of Medicine to create its own definition.

      This is an unprecedented statement by our top experts and indicates researchers and clinicians are able and willing to the use the CCC now and improve on it as science develops. As the letter states, “[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

      I have been personally affected by ME/CFS. It is a debilitating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. ME/CFS costs the U.S. economy an estimated $17-23 billion dollars a year in lost productivity and direct medical costs. Due to the overly broad ‘case definition’ (criteria) used for this disease by HHS since 1994, patients with ME/CFS are lumped together with patients with depression, deconditioning and unspecified chronic fatigue. The use of these overly broad criteria has impeded ME/CFS research and severely impaired medical care for patients like me.

      Given the overwhelming opposition to HHS’ plans by both patients and experts, I am asking you to contact HHS today and tell them to follow the lead of ME/CFS disease experts. Tell HHS to adopt the Canadian Consensus Criteria. Tell HHS to cancel the contract with IOM.

      -Link to the September 23 announcement from HHS on the IOM contract: http://bit.ly/18m7XlJ
      -Link to the September 23 letter to Secretary Sebelius from the 35 ME/CFS experts: http://bit.ly/15npS9B
      -Link to additional background: http://bit.ly/16qOLY3
      This Action Alert was put together by a group of ME advocates, including me.

      Monday, September 23, 2013

      HHS Signs IOM Contract


      The CFSAC Listserv sent out the following announcement this evening:


      We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month.  This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.”  Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them.  The NIH is convening an Evidence-based Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.

      The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC.  A group of voting and non-voting members of the committee participated in the development of the Statement of Work.

      The IOM has agreed to perform the following tasks over the next 18 months:
      ·         Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
      ·         Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
      ·         Recommend whether new terminology for ME/CFS should be adopted;
      ·         Develop an outreach strategy to disseminate the definition nationwide to health professionals.

      To accomplish these tasks, the IOM has also agreed that:
      ·         the IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions.  The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee.
      ·         the IOM, in addition to the committee meetings, will sponsor open meetings to enlist the comments and concerns of patients, family members and other caretakers, health educators, health care professionals, and advocacy groups.  During these meetings, an open phone line and email address will be available to those who cannot attend in person.
      ·         as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC multi-site clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.
      ·         the committee will distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.

      HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email.  It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS. 

      ________________________________________________________
      The CFSAC Support Team

      I wanted to get this distributed as soon as possible.  It will take us all some time to digest the news.  Please note that all those emails to HHS and Congress were not for nothing.  It appears, at first glance, that the ME community's concerns are reflected in part in this summary.  In addition, the emails to Congress have built awareness not only of ME but also of the problems our community is having with the lack of transparency from HHS.

      Monday, September 16, 2013

      TELL CONGRESS & THE PRESIDENT "NO" TO THE IOM CONTRACT


      Totally disregarding the strong outpouring of patient opposition to HHS’ August 27 announcement to contract with the Institute of Medicine (IOM) to “develop clinical diagnostic criteria for ME/CFS”, HHS announced on September 12 that it intends to go forward with its contract with IOM! This is after telling the ME community it was withdrawing from this solicitation.  What a blatant lie!  And HHS has said that it will provide additional information only after the contract is completed -- which it expects will be September 30!

      THIS IS WAR.  IT’S TIME TO CHANGE TACTICS.  LET’S CONTACT CONGRESS & THE PRESIDENT!

      HHS is speaking loudly and clearly. The Department does not want to hear what we have to say about our disease. It has every intention of pursuing its plans to redefine ME, unilaterally and in secret. 

      It’s time to change our tactics.  Rather than emailing HHS, let’s bring this to the attention of our Congressional delegations.   They  need to know about HHS’ outrageous actions . Let’s ask THEM to go to bat for us!  And while we’re at it, let’s send the same message to the President’s Council of Advisors on Science and Technology (PCAST).  And let's do this DAILY.

      DIRECTIONS FOR CONTACTING YOUR CONGRESSIONAL DELEGATION:

      1. Copy the sample message provided below.
      3. This will bring up contact forms for your Representative and your two Senators.
      4. If you have to choose a subject area from a scroll-down menu, look for "federal agency" or "health".
      5. Paste the sample message into the body of the contact form. If you wish to personalize it, add a sentence or two at the beginning of the text. 
      6. Add your name to the end of the message.


      DIRECTIONS FOR CONTACTING PRESIDENT OBAMA’S SCIENCE ADVISORS:

      1.Go to http://www.whitehouse.gov/administration/eop/ostp/contactus
      2. Scroll down to “PCAST” on the menu and fill out the rest of the required information.
      3. Copy and paste the sample message for the body of the content form.
      4. Add your name to the end of the message.


      SAMPLE MESSAGE  (to be copied into the contact form)

      Dear _________,

      HHS has stated it intends to sign a contract with IOM to redefine my disease by September 30!  Please tell the Department not to do this -- as soon as possible.

      I have been personally touched by the devastating disease, Myalgic Encephalomyelitis (ME).  ME has been classified as a neurological disease by the World Health Organization (WHO) since 1969 (WHO ICD code 93.3).  However, in the US, the Department of Health and Human Services (HHS) promotes an excessively broad view of the disease and conflates it with “Chronic Fatigue Syndrome” (“CFS”).   “CFS” is a social construct created by a government committee in 1988 based on a cursory investigation of an outbreak of ME in Lake Tahoe, Nevada, by the Centers for Disease Control and Prevention (CDC).  According to the physicians and patients who were affected by this outbreak, patients were not examined and abnormal test results were ignored.  This has confounded ME with depression, deconditioning and nonspecific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

      Now HHS is intent on redefining ME again using the Institute of Medicine (IOM), an organization whose former President, Dr. Kenneth Shine, has stated it is highly unusual for  the IOM to be asked to  define a disease.  The first time IOM was contracted to do this was earlier this year -- to define Gulf War Illness (GWI).  The GWI IOM study group includes people with well-known biases as well as members unfamiliar with the disease. (IOM's study procedures are aimed at including non-experts.) It is harshly criticized by GWI advocates as a previous IOM report referred to GWI as “Chronic Multi-Symptom Illness”, a symptom based syndrome defined so broadly that half the US population could be diagnosed with it.  

      HHS has repeatedly stated its intent to similarly use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community.   It is also inexplicable given that researchers and clinicians with years of experience in studying and treating this disease have already created two peer-reviewed case definitions, the 2011 ME International Consensus Criteria (ME-ICC)and the 2003 Canadian Consensus Criteria (CCC). Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. 

      In defiance of President Obama’s Open Government Initiative, HHS is pursuing the IOM contract unilaterally and with disregard for the overwhelming opposition to it from the ME community and advice from its own “Chronic Fatigue Syndrome” Advisory Committee (CFSAC). I have been emailing HHS daily ever since I found out about the IOM contract solicitation to ask the Department to stop it.  

      I thought I was heard when, at one point, the contract solicitation was modified to read, “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request”, followed shortly thereafter by the statement, “This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”  But on September 12, the ME community was informed (via a listserv) that HHS will “continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.  When the contract is completed, we will provide additional information via the CFSAC listserv and website.  This topic will be included as an agenda item for the November (CFSAC) webinar." Since then, HHS has informed the ME community it expects to finalize the IOM contract by September 30.

      I beg you to intervene and stop HHS from pursuing the IOM contract to redefine my disease.  Ask HHS to use this money instead to set aside funds for research based on the criteria ME experts have already created.  This would drive the sorely-needed aggressive campaign to validate biomarkers, understand the pathophysiology of the disease, and identify treatment approaches.

      Sincerely, 
      <Your Name>

      ------------------------------------------------------------------------------


      For those who want to email HHS again, I suggest a brief message:

      Stop your work on the IOM contract to “develop consensus clinical diagnostic criteria for ME/CFS." IOM's study group selection procedures work against limiting such a panel to disease experts.  If you don't abandon this contract, you will  be putting my fate in the hands of a "diverse" group of people, including some who know nothing about my disease or may have preconceived biases. Faulty criteria will affect diagnosis and treatment for years. Instead, accept and follow the criteria created by ME experts.

      Sincerely,
      <Your Name>

      ADDRESSES:
      TO: Kathleen.Sebelius@hhs.gov
      CC: howard.koh@hhs.gov, txf2@cdc.gov, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov, collinsf@mail.nih.gov, richard.kronick@hhs.gov, MEACTNOW@yahoo.com

      =========================================
      NOTE:  If you are on Facebook, you can participate in this campaign through this Facebook Event Page.  Get updates, show your support, invite your friends!

      =========================================
      BACKGROUND (For your information; not to be included in the letter.)

      On August 27, the US Department of Health & Human Services (DHHS) announced their intent to award a sole-source contract with the Institute of Medicine to develop new clinical diagnostic criteria for "ME/CFS". In response to an outpouring of concern from patients, HHS cancelled this announcement on September 4. The cancellation notice stated that HHS “will continue to explore mechanisms to accomplish this work.” 

      Despite the demands of the ME patient community that HHS not go forward with the IOM contract, HHS announced, on September 12, that it intends to continue its plans to contract with IOM to develop clinical disease criteria for ME. HHS has said that it will provide additional information after the contract is finalized. We now know that HHS expects to sign the IOM contract by September 30.

      Could there possibly be any clearer indications that HHS does not care what the community thinks? 

      HHS actions are concerning on so many levels:

      HHS has rejected expertly defined ME definitions like the Canadian Consensus Criteria (CCC) and the ME International Consensus Criteria (ME-ICC) that require hallmark symptoms like post-exertional malaise (PEM). CDC has questioned whether PEM should be mandatory for a diagnosis of “CFS” and has declined to incorporate the one test proven to objectively demonstrate PEM, the two day Stevens Protocol, into its multi-site study. Instead of accepting our experts view of the disease, HHS promotes an excessively broad view of the disease that encompasses depression, deconditioning and various nonspecific causes of chronic fatigue. In fact, HHS has even reclassified “CFS” to be a subcategory of “chronic fatigue” in direct opposition to standards set by the World Health Organization, which has classified it as a neurological disease.

      HHS has repeatedly stated its intent to use individuals who are not familiar with ME to establish the criteria for ME. For patients who face constant disbelief from the general medical and research community and whose illness is too often assumed to be a psychiatric illness, this is very concerning.

      The Institute of Medicine (IOM), the organization selected by HHS to develop the clinical criteria, is a prestigious organization. But unfortunately, IOM’s one effort to define a disease has received harsh criticism from GWI advocates for using non-experts, for too much of a focus on psychiatric issues and for rebranding the disease as chronic multisymptom illness, a redefinition so broad “as to include nearly any human health condition” according to Anthony Hardie, GWI advocate. Doing this in ME could set back research and clinical care for years. Further, the January 2013 IOM report on Gulf War treatments also included a section on “CFS” that did not represent ME accurately and which recommended CBT and GET as treatments, treatments that our experts have said can be harmful. 

      HHS is wasting money redefining what our experts have already created. Meanwhile, researchers struggle to get the money to do the studies desperately needed to validate the biomarkers, further understand the pathophysiology or identify promising treatment approaches. At a recent presentation, Dr. Lipkin, world renowned researcher, described the extreme difficulties with getting money for ME/CFS research. Why?

      HHS is acting unilaterally and in secret. The IOM proposal, in the works for months, caught patients and experts alike by surprise. It was not discussed at the May CFS Advisory Committee (CFSAC) and HHS staff resisted attempts by CFSAC members to discuss the case definition issue at all. HHS staff also resisted requests by CFSAC members to have input on who would be involved in the NIH Evidence Based Methodology Workshop, which will be used to inform a research definition.

      HHS is choking off all input from the ME community. Dr. Koh has stated that CFSAC is our mechanism for input to HHS. But at the May 2013 CFSAC meeting, some members alleged they were threatened with eviction from CFSAC by HHS staff for speaking their minds. Almost 4 months later, we still do not have a response from HHS on the investigation of those allegations. And now, the fall CFSAC meeting, long a face-to-face meeting, is suddenly a webinar!

      HHS claims it is responding to the CFSAC recommendation but it is not. The 2012 CFSAC recommendation specifically called for a meeting of experts, for those experts to discuss a case definition useful for research, diagnosis and treatment and for the discussion to start with the 2003 Canadian Consensus Criteria. 

      HHS needs to adopt what our experts have already created and use that definition to reeducate the medical community and to drive an aggressive and fully funded ME research campaign to validate biomarkers, understand the pathophysiology and identify treatment approaches.

      ====================================
      ADDITIONAL RESOURCES:

      HHS Original Announcement of the Intent to Sole Source with the Institute of Medicine for the “Study for Diagnostic Criteria for ME/CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1

      IOM on Study Committee selection process
      http://nationalacademies.org/studyprocess/index.html#st2

      Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/ 

      USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013 http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745/  

      March 13, 2013 testimony by Anthony Hardie, Gulf War vet and member of the VA Gulf War Research Steering Committee, before the House Committee on Veterans Affairs, http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0 ; Video at http://www.youtube.com/watch?v=OuNJbPMfrYo

      IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546 

      CFSAC May 2013 Meeting Minutes. Discussion of the NIH Evidence Based Metholodolgy and the allegations of intimidation of CFSAC members by HHS staff. Starting at page 48. http://www.hhs.gov/advcomcfs/meetings/minutes/cfsacmay23_final_508.pdf 

      Saturday, September 7, 2013

      TELL DHHS TO STOP ALL ATTEMPTS TO REDEFINE ME

      Congratulations! The email campaign to stop the US Department of Health & Human Services (HHS) from contracting with the Institute of Medicine (IOM) to develop "clinical diagnostic criteria for ME/CFS" was successful!  An update posted on September 4th on the contract solicitation notice read: “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”


      BUT WE CANNOT STOP EMAILING NOW!  HHS later that day added to this same notice, “...HHS will continue to explore mechanisms to accomplish this work.”  No one knows what these “mechanisms” are and it is not at all clear what HHS intends to do.  Everything Department officials have said and done points toward simply finding another means of redefining ME (and quite possibly folding it into "Chronic Multi-Symptom Illness").  HHS has repeatedly and publicly stated their intent to use non-experts to define our disease at CFS Advisory Committee (CFSAC) meetings. HHS has even questioned whether post-exertional malaise or post-exertional neuro-immune exhaustion is really required. And most of all, HHS is recreating what experts have already done.

      Having non-experts (who most probably at best know of the CDC’s representations of our disease) create yet another definition is dangerous and could set back ME research and clinical care for years. It is also a waste of precious time and dollars that should be spent validating biomarkers and studying treatments.

      Therefore, it is vitally important to continue emailing DHHS with a slightly different message.  Note that this is a DAILY email campaign until further notice.  The sample provided reflects that there no longer is a solicitation for a contract with IOM to develop a definition, but  that DHHS is seeking another "mechanism" to do this.

      INSTRUCTIONS FOR EMAILING HHS (daily):

      1.If you are using the sample email provided below, copy the sample email into the body of an email message.

      2. Add your name to the end of the letter.

      3. Add the Subject Line “Stop Your Attempts at Redefining ME".
      Feel free to change the subject line from time to time to avoid spam filters. Another tip: If you have more than one email account, use one on one day and the other on another.

      4. Copy the following addresses into the ‘TO” and “CC” boxes
      TO: Kathleen.Sebelius@hhs.gov
      CC: howard.koh@hhs.gov, txf2@cdc.gov, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov, collinsf@mail.nih.gov, richard.kronick@hhs.gov, MEACTNOW@yahoo.com

      The CC includes addresses for the following: HHS Assistant Secretary Howard Koh, AHRQ Director Richard Kronick, CDC Director Thomas Frieden, CMS Administrator Marilyn Tavenner, FDA Director Margaret Hamburg, HRSA Director Mary K. Wakefield, NIH Director Francis  Collins.  The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.

      SAMPLE EMAIL - To be copied into the body of an email message.

      Dear Secretary Sebelius,

      I understand that HHS has cancelled the IOM contract but will “continue to explore mechanisms to accomplish this work”. While I appreciate that the Department has responded to the public by cancelling this contract, I object to the Department continuing to explore other mechanisms to define criteria for "myalgic encephalomyelitis/chronic fatigue syndrome”. The experts have already defined this disease.

      I am a member of the ME community and have witnessed firsthand the devastation of this disease.  Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

      Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. Both are accompanied by clinical guidelines for medical practitioners and are well regarded by patients, ME doctors, and ME researchers.  The CCC has been used both clinically and in research. Given that expertly defined and accepted consensus clinical criteria already exist, anything other than officially adopting one of these definitions wastes scarce taxpayer dollars and is unnecessary.

      HHS has inexplicably refused to accept what ME experts have produced and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease and conflated it with “CFS”.  This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

      Instead of secretly and unilaterally exploring mechanisms to to redefine a disease that ME experts have already defined, why not use the funds set aside for the proposed IOM contract for meetings of ME experts to build on and refine the consensus definitions, as recommended by the CFS Advisory Committee?  This would allow them (free of interference from government bureaucrats) to agree on biomarkers, testing and treatment -- all of which those affected by ME sorely need NOW.

      It’s time to do the right thing. Stop defying President Obama’s Open Government Initiative and set up transparent communications with the ME community. Give ME experts the resources to do their job.  Stop redefining my disease and instead follow the lead of our top ME experts on the disease definition.

      Sincerely,
      <Add your name here>

      ========================================================
      BACKGROUND
      (For your information; not to be included in the letter.)

      On August 27, the US Department of Health & Human Services (DHHS) announced its intent to award a sole-source contract with the Institute of Medicine (IOM) to develop new clinical diagnostic criteria for "ME/CFS". An email campaign appears to have stopped this, as there was an update posted the morning of September 4th on the contract solicitation notice which read: “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request."  On the afternoon of the same day, the notice was revised to state, “This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”

      Stopping the IOM contract last week is not enough. We all need to be very concerned with what HHS is now planning. Here’s why:

      HHS has repeatedly stated their intent to use non-expert researchers and clinicians  to create case definitions for ME/CFS. Consider how non-experts view our disease – with disbelief, as laziness, depression, or deconditioning. If they have not heard of it, they will most certainly come across the CDC’s biased website information.  How are they in a position to create a better case definition than the definitions that our experts have created?

      HHS has repeatedly ignored hallmark symptoms like post-exertional malaise (PEM) and post-exertional neuro-immune exhaustion (PENE) and questioned whether these should even be required. Instead, they have promoted an overly broad view of the disease that encompasses non-specific causes of chronic fatigue. In fact, HHS has reclassified “CFS” to be a subcategory of “chronic fatigue” even though the World Health Organization has classified it as a neurological disease. Dr. Unger, in charge of the CDC’s CFS program, has gone so far as to link us with neurasthenia and other vague “syndromes”.

      HHS claims it is responding to the CFS Advisory Committee (CFSAC) recommendation, but this is not the case. The CFSAC recommendation called specifically for a meeting of experts. Additionally, they called for those experts to discuss a case definition useful for research, diagnosis and treatment and for that discussion to *start* with the 2003 Canadian Consensus Criteria.

      HHS Secretary Sebelius personally believes government bureaucrats should not be involved in defining diseases.  Dr. Nancy Lee, Designated Federal Officer for the CFSAC stated,  “In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X”   definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community...I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She [HHS Secretary Sebelius] basically said that this has to be coming from the medical community.”  (CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.)

      HHS is acting unilaterally and secretly to advance its objectives. The IOM proposal, in the works for months, caught all of us, including our experts, by surprise. It was not discussed at the May CFSAC.  In fact, HHS staff  refused to discuss the case definition at all when asked to so by other CFSAC members. HHS staff also resisted requests by CFSAC members to have input on who would be involved in the NIH Evidence Based Methodology, another HHS definition effort. There are numerous other examples, even beyond the definition issue, where HHS has refused to provide information or to engage the ME community as the key stakeholders.

      =========================================================
      Additional Resources:

      HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1.