International ME/CFS and FM Awareness Day Is On May 12, 2018
Thomas Hennessy, Jr., selected May 12th to be our international awareness day back in 1992. He knew that May 12th had also been the birthday of Florence Nightingale. She was the English army nurse who helped to found the Red Cross as well as the first school of nursing in the world.
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The P2P Draft report is out

Discussion in 'Action Alerts and Advocacy' started by CBS, Dec 18, 2014.

  1. Bob

    Bob

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    If anyone would like to get involved but is finding it overwhelming, I think it would be helpful to send in positive feedback for the sections of the report that need praising or reinforcing.

    If that's involves too much brain energy, then if helpful for anyone, we could start a new thread in which we quote sections of the text that we consider to be positive.
     
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  2. Bob

    Bob

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    Someone pointed out to me that the report doesn't say anything about pacing.
    Perhaps there's not much research evidence on pacing?
    And so perhaps this is something that patients need to tell them about, from first-hand experience.

    The only evidence that comes to my mind is from UK patient surveys, as follows:

    Action for ME patient survey 2008:
    http://www.actionforme.org.uk/get-i...ch-treatments-have-other-people-found-helpful

    Pacing:
    Helpful: 82%
    No change: 15%
    Made worse: 3%

    ME Association patient survey 2008:
    http://www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res10.pdf

    Pacing:
    Helpful: 71.2%
    No change: 24.1%
    Made worse: 4.7%

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

    Note that these surveys also include data for CBT and GET, but Tom Kindlon's paper is a great citation if you want to discuss harm from GET and CBT...

    Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bull IACFS/ME 2011;19:59–111.

    http://iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx
    PDF: http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk=

    Results:

    Table 2. (Page 110.)

    Pooled Data of Harms from GET, CBT and Pacing reported in Surveys

    51% of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health
    20% of survey respondents (range 7-38%, n=1808, 5 surveys) reported that CBT worsened their health.

    (Includes any degree of harm. e.g. "somewhat worse" and "a lot worse".)
     
    Last edited: Jan 11, 2015
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  3. Ember

    Ember Senior Member

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    I dreamed last night of a government program that takes a large quantity of dead matter and buries it under the sea without allowing it to disintegrate or disperse. Every so often a small quantity of dead matter gets released with no apparent usefulness.

    Then I dreamed of Nielk's newborn infant, David. I first noticed that he wasn't sucking and then that he had a full set of teeth. But when I tried to post (apologies to Nielk) that I'd never seen a full set of unused teeth before, my keyboard was too heavy for me to use.

    An enormity of deliberate government waste is lined up against our infant MEAdvocacy.org.:depressed: It's David and Goliath!
     
    Last edited: Jan 11, 2015
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  4. Ember

    Ember Senior Member

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    Post Your P2P Comments Here
    Posted by Mary A. Kindel · January 09, 2015 4:47 PM
     
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  5. Bob

    Bob

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  6. jimells

    jimells Senior Member

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    prevention@mail.nih.gov

    Public Comment on the ME/CFS "P2P" Draft Report

    I have been suffering with this illness for over ten years. I have spent thousands of hours trying to understand the illness and why there has been so little progress in the past thirty years.

    My conclusion is that the NIH and CDC do not want to help us, and will not fund the research needed to find real answers. Therefore I completely reject the P2P draft report and the contrived process used to create it.

    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. This illness is a solvable puzzle. We have highly intelligent and well experienced researchers that know how to solve this puzzle, and would like to do so, but they have to eat, too. And buy stuff for their labs.

    This situation goes well beyond simple benign neglect. Federal agencies that were created to improve public health are actively working against us, even to the point of openly violating well-established federal laws and agency policies. I urge the authors of the draft report to carefully consider the history of agency actions regarding this illness before signing off on a report that will, at worst, be used against patients, or, at best, be ignored and put on a shelf.

    Perhaps the report's authors are familiar with the federal law known as "Freedom of
    Information Act", or FOIA. On October 30, 2013, patient and advocate Jeannette Burmeister submitted a FOIA request to HHS regarding the IOM contract to redefine ME/CFS. After being rebuffed and ignored for months, Ms. Burmeister was forced to file a suit in federal court on January 9, 2014. Please note that the law normally requires the documents to be provided within twenty days.

    In the words of the judge who found in Ms Burmeister's favor (eight months later), "the government has ‘improperly withheld agency records’ in violation of FOIA.” The judge also noted, "the government’s conduct throughout its dispute with Ms. Burmeister was unreasonable." In fact, the government's behavoir went well beyond unreasonable. They have fought tooth-and-claw to avoid compliance, to raise the cost of litigation as high as possible, and to damage Ms Burmeister's already fragile health.

    In the end, the federal court awarded $139,000 in attorneys fees to Ms Burmeister, money that could have been spent on helping patients instead of stonewalling them.

    I have seen the emails released as a result of Ms Burmeister's efforts on behalf of all patients. They reveal, in black and white, the government's disdain for the patient community, as well as general incompetence throughout the NIH bureaucracy. But now the shoe is on the other foot, and we are fighting back. After all, we have nothing to lose, since it's either fight for help or be sick until death.

    In the now-infamous words of Susan Maier,
    "Fasten your seatbelts [sic] and return your tray tables to the upright position because its’ going to be a bumpy ride :)"

    At the current pace of research, I will be dead and buried long before the answers are found. The most likely causes of death for me will be cardiac arrest, cancer, or by my own hand. Even so, privately funded research is moving ahead in spite of NIH intransigence. Our researchers and clinicians are making real progress, progress that was excluded from the AHRQ Evidence Review, and therefore the draft report. I have every reason to believe that answers will be found, even if I don't live to see them.

    I can not stop the P2P report. I can not stop the authors from signing the report. But with this letter, the authors can not claim that they are completely ignorant of NIH actions and policies that harm patients, or their own role in promoting those harmful polices.

    The NIH tells us everyday, in every way, that we are a bunch of lazy whiners. The patients I know do not ask, "Why me?". But they do want to know, "Why won't the NIH help us?"

    Jim Ellsworth
    Littleton, Maine
     
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  7. Nielk

    Nielk

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    I wish you better dreams tonight, Ember.o_O
     
  8. jimells

    jimells Senior Member

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    I'm going to look into submitting a FOIA request for the public comments. That'll throw a wrench into their plan to dump the comments into the bit bucket. It's a simple process to initiate, but will be hard for me to pursue into the federal court. A long time ago I submitted a bunch of FOIA requests to the NLRB, back in the olden days when I was a labor agitator. The NLRB was easy to deal with. Some offices wanted a small fee, while the rest were free. Same agency, different rules, as usual...
     
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  9. Ember

    Ember Senior Member

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    Thanks! I'm concerned now about the nightmare that February 10 may bring.:nervous:
     
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  10. Nielk

    Nielk

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    Jeannette Burmeister just posted this:http://forums.phoenixrising.me/inde...working-group-p2p-document.34896/#post-544827

    Just wanted to share this email that I sent to Barbara James (CFSAC’s DFO) at Barbara.James@hhs.gov regarding a potentially serious concern with respect to CFSAC’s official P2P submission. Hopefully, we’ll get an answer before the meeting on Tuesday.

     
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  11. Anne

    Anne Senior Member

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    For anyone including in their P2P comment the need for RFAs, this might be useful.

    Here’s what I found on the various times it has been recommended that NIH issue RFAs:

    The CFS Advisory Committee (CFSAC), which provides advice and recommendations to the Secretary of Health and Human Services (HHS) on issues related to ME/CFS, has made this recommendation on numerous occasions, including:

    - Nov 2011:
    “CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Applications (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).”
    https://wayback.archive-it.org/3919/20140324192811/http://www.hhs.gov/advcomcfs/recommendations/11092011.html

    - October 2012:
    “CFSAC recommends:
    […] - Instructing the NIH to issue an RFA (funded at the $7-10 million range) for projects to establish outcomes measures for ME/CFS diagnosis, prognosis and treatment which would include but not be limited to biomarker discovery and validation in patients with ME/CFS.”
    http://www.hhs.gov/advcomcfs/recommendations/10032012.html

    - June 2014:
    “CFSAC recommends that the NIH issue a Request for Applications (RFA) for ME/CFS by November 1st, 2014, or as soon as feasible, to address the gaps in ME/CFS knowledge and research. The RFA should consider current known gaps in knowledge for the following areas:

    - Provocation designs where symptoms are triggered through standardized challenges involving exercise, cognitive tasks, and mental stressors. These designs appear to be more likely to identify symptom to biology relationships in comparison to assessments done in resting states.

    - Ambulatory monitoring of symptoms, activities, behaviors, and physiological states that identify associations between biological and behavioral measures, e.g., daily fatigue ratings and cytokine fluctuations.

    - Network analysis of dysregulation of multiple bodily systems, such as the neuroendocrine system, the central nervous system, the autonomic nervous system and the immune system.

    - Natural history studies aimed at identifying the genetic triggers and causal factors of ME/CFS.

    - Treatment trials that address both clinical and biologic outcomes.

    This RFA may also be informed by the gaps identified in the 2011 NIH State of the Knowledge Workshop, the Pathways to Prevention Program for ME/CFS research panel report or any relevant source, including but not limited to, the IACFS meeting summary.”
    http://www.hhs.gov/advcomcfs/recommendations/06142014.html

    The calls for RFAs have been echoed by several parties.

    In March, 2014, eleven members of Congress wrote NIH Director Dr. Francis Collins, saying:
    ”We applaud your efforts […] in hosting the ME/CFS Research Workshop in April 2011. The Workshop concluded that there continues to be a need for additional interdisciplinary research, coordination of research, centralized data sharing, and recruitment of additional qualified investigators. These suggestions are in line with the recommendations of the HHS CFS Advisory Committee, including an NIH RFA in the range of $7-10 million.

    We encourage you to act decisively on these recommendations. We also ask that you provide us with the current status of the effort to meet the need in ME/CFS research, as well as plans for moving forward with a strong and fully supported research program.”
    https://dl.dropboxusercontent.com/u/57025850/Congressional letter - Dr. Collins - March 2014.pdf

    In April, 2014, the professional organization for clinicians and researchers, International Association of CFS/ME (IACFS/ME) wrote an open letter to Dr. Francis Collins:

    “We call on you and Directors of key Institutes at NIH to collectively work together to issue a Request for Applications (RFA) calling for R01 and R21 projects related to ME/CFS. At a level of $7-10 million annually for five years, an RFA would double current funding and bring talented investigators into the field for the first time. The ME/CFS RFA would also dovetail nicely with ongoing NIH initiatives including those related to the brain, big data and transformative research.

    We realize the substantial reductions in the NIH budget over the past decade have made it hard to issue RFAs. This is even more reason that we must focus our support on specific targets that are poised to make significant progress in the near future. With ME/CFS related to so many other medical diseases and conditions, support for research on ME/CFS will add to, for instance, our understanding of chronic pain, viral/ bacterial infections, sleep disorders, fatigue, autoimmunity, and cancer. In this regard, ME/CFS research already has aided knowledge of Gulf War Illness, fibromyalgia, retroviruses, and Lyme disease.

    The Trans-NIH ME/CFS Research Working Group members have been helpful in coordinating awareness of the disease at the NIH. However, without financial support, their efforts to enhance applications to study ME/CFS are limited to oral encouragement. We all know that is not enough. The State of the Knowledge Workshop on ME/CFS in 2011 concluded that there is a need for interdisciplinary research, coordination of research, centralized data sharing, and recruitment of additional qualified investigators. The ME/CFS RFA could address those needs as well as the longstanding CFS Advisory Committee appeal for such an RFA.”
    http://www.iacfsme.org/LinkClick.aspx?fileticket=tnCp3meyVmU=&tabid=36
     
    Last edited: Jan 12, 2015
  12. Ember

    Ember Senior Member

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    Public comment on the Draft Evidence Report resulted in a sea change from its original ME=CFS position:

    Draft Evidence Report
    Evidence Report
    Does concern over a sea change to ME≠CFS in the Final Report account for the editing and/or non-retention of public comment on the current Draft Report?
     
    Last edited: Jan 12, 2015
  13. Wally

    Wally Senior Member

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    Here is the current status of my request to the HHS/NIH/ODP regarding Public Comments submitted in response to the ME/CFS P2P Draft Report and P2P Workshop.
     
    Last edited: Jan 13, 2015
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  14. Wally

    Wally Senior Member

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    I received the following message in response to the e-mail I sent to Paris Watson - ODP/NIH this morning (1/13/2015).
    I am currently listening to the CFSAC meeting, so I am unavailable today (1/13/2015) at 1:30 pm (EST) for a phone call with the ODP/NIH. The only time I am available tomorrow (1/14/2015) during the time period (1:00 -3:00 pm EST) Ms. Cross has provided for this phone call is 2:30 pm (EST). If there are other advocates who would like to join me in this phone call tomorrow at 2:30 pm, please PM or e-mail me at WallaceAlvinCleaver@gmail.com and I will see if a conference call can be set up for the phone call with Ms. Cross.

    Wally (Susan Kreutzer)
     
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  15. OneWaySurvival

    OneWaySurvival Senior Member

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    @jimells Congratulations on a superbly written, concise letter. I am sending this out to family and friends because it takes a very complicated issue and boils it down to such a clear idea of the problem with P2P and what is at stake for us.

    I compiled and sent a more detailed letter to HHS, in which I refer to your letter. I have also suggested to friends and family that they join me in writing a letter of protest to HHS, and pointed to your letter as Exhibit A for how to send a brief email to the government, and my letter is Exhibit B for those who want to send a more detailed version. See my SAMPLE letter here: http://forums.phoenixrising.me/inde...-the-p2p-and-iom-processes.34929/#post-545962
     
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  16. Nielk

    Nielk

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  17. Wally

    Wally Senior Member

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    Retention of Public Comments for the ME/CFS P2P Draft Executive Summary Report/Draft Report.

    Per my conversation yesterday (1/14/2015) with Wilma Peterman Cross, Deputy Director at the ODP/NIH, Public Comments submitted in response to the Draft Report will be retained and subject to a FOIA (Freedom of Information Act) request. I was told that the ODP had not planned to release the comments due to concerns that the comments might contain personal identifying information. To address this privacy concern, if these comments are requested to be reviewed by the public, a FOIA coordinator will review the comments and be responsible for claiming any exemption from release and/or will redact the comments to address these privacy concerns prior to release of these documents.

    The individual at the NIH who will handle any FOIA request for these comments is Suzanne Freeman, who is the designated FOIA Coordinator for the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI). Note, the e-mail address for Suzanne Freeman is care off the NIH Blood and Lung Division, but this is the correct address for Suzanne Freeman in her capacity as the FOIA coordinator for any NIH/ODP/P2P document requests. See, http://www.nih.gov/icd/od/foia/coord.htm

    I was able to talk to Ms. Freeman yesterday to understand how the FOIA request will be handled. By specifying in the request that the documents requested are the Public Comments to the NIH/ODP ME/CFS P2P Draft Executive Summary/Draft Report, it will allow the location of the comments to be readily identifiable. In addition, if the request includes a statement that redacted copies of these documents will be acceptable then this will allow the request to be completed more quickly. Otherwise, exemption notification will first need to be sent out if there is personal identifying information within the comments that needs to be protected prior to release of the documents.

    Since there is usually a cost involved in obtaining copies of documents under a FOIA request, you can specify in your request a maximum dollar amount that you would be willing to pay to retrieve/copy these documents. By Monday, January 19, 2015 (following the close of the Public Comment period on 1/16/2015) the NIH/ODP may also be able to provide an estimate of the number of Public Comments that were received as part of this process.

    My plan will be to make a FOIA request for these documents on Monday, January 19th. My request will state that I will accept redacted copies of these documents. Ms. Freeman will be out of the office from Wednesday, January 21st through the end of January, so I want to be able to coordinate this request with her prior to her being out of the office. Notwithstanding that Ms. Freeman will be out of the office during the last part of January, she said that she will be monitoring e-mail and she will forward any requests that are received during this period to her staff.

    While, there is no guarantee that these documents will be received before the final P2P report is released or before February 10, 2015 (date of the release of the IOM Report), it is more likely that by allowing for redacted copies of the comments, the request can be expedited. Once the redacted copies are reviewed, you can still do another follow-up FOIA request that does not agree to the receipt of redacted copies. This would allow for identification of the exemptions (or exclusions) used to redact the comment(s) and an appeal could be made if you disagree with these decisions.

    Once I receive copies of the Public Comments, I will coordinate with MEAdvocacy.org to try to get this information posted on their website for viewing. I will be requesting that the documents be sent to me in electronic form rather than with paper copies.

    If you are interested in understanding more about filing a FOIA request with the NIH, as well as the general requirements for any FOIA request, here are the links that explains this process in more detail - http://www.nih.gov/icd/od/foia/index.htm#requests and http://www.foia.gov/how-to.html

    I also plan to file a FOIA request for public comments/questions that were submitted as part of the 2 day ME/CFS P2P Workshop that took place in December. However, I plan to file this request separately from the request for the Public Comments to the Draft Report.
     
    Last edited: Jan 15, 2015
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  18. Nielk

    Nielk

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    Thank you @Wally for all this work.
     
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  19. Nielk

    Nielk

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    Do we know when the final P2P report is due?
     
  20. Wally

    Wally Senior Member

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    I have asked the ODP if they have an anticipated time frame for when the report is planned to be released (i.e before the IOM Report release on Feb. 10th, at the same time as the IOM Report or sometime after Feb. 10th). I will post an update when I receive a response from the ODP.
     
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