Phoenix Rising tells QMUL: release the PACE trial data
Mark Berry, Acting CEO of Phoenix Rising, presents the Board of Directors’ open letter to Queen Mary University of London (QMUL) urging them to release the PACE trial data, and hopes that other non-UK organisations will join British charities in the same request...
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P2P workshop Dec. 9 & 10, 2014

Discussion in 'Action Alerts and Advocacy' started by Nielk, Dec 9, 2014.

  1. Nielk

    Nielk

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    I listened to parts of both days of the workshop. I do not share the optimism that some of you feel.

    This process has been rigged from the beginning. The way the process is designed, the questions that have been produced for the panel to answer as well as each and every panel member who spoke have been very well chosen by NIH. This is a completely controlled process by NIH and the outcome has been predetermined.

    Eventhough some of the panelists gave good presentations, it will not matter in the outcome. For example, I really liked Dr. Snell's presentation but, unfortunately his study will not be included because it does not hold up to the standards of inclusion in the review. This holds true too with Dr. Natelson's study.

    In my opinion the main failure is due to:

    - The use of all 8 diagnostic criteria, as if each one is equally qualified in describing the disease.
    - They admit that the Oxford criteria is inferior and should not be used anymore, yet they allow the studies using the Oxford criteria in the review
    - The main question of removing ME from CFS has not been tackled - they seem to think that ME is simply CFS that is more severe (there is no scientific evidence to back this up)
    - The majority of our studies have been excluded due to the rigid standards (NIH knew this would happen)
    -

    In addition:

    NIH states: P2P workshops are designed for topics that have incomplete or underdeveloped research, difficulty producing a report synthesizing published literature, and are generally not controversial.

    I think that one thing that we can all agree on is that this disease is hugely controversial. Why then do you think this process was chosen for this study?

    I think that these two day have been a play on us. It has been a big charade. They were very condescending to the patients/advocates commenting on both days. They wanted them there to appear as if it matters what we think.

    IT DOESN"T!!!

    I am 100% against this sham of a process and will continue to fight it.
     
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  2. alex3619

    alex3619 Senior Member

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    The presentations are not a key outcome. The report is. That is where we see the degree of failure of this process. Its a degree, not either/or, as just how it was managed was a failure. I also expect huge problems with the report, which we will be commenting on for years to come. This is not an issue that is going to go away soon, and indeed books may be written about this - if I ever get to finish my book I expect to have a chapter on this anyway.

    One thing I hope is that this will lead many to see that ME issues are not just about the science, but about politics and management. Politics and management have a different focus, with different agendas. So far, historically, the politics and management of issues relating to ME have been disastrous. This might change, a little or a lot, but its hard to envisage the P2P report leading the way.
     
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  3. catly

    catly Senior Member

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    I didn't get to watch all of it, there are definately parts I would like to go back to and watch again when the videos are up that I thought were intersting, particularly the Q &A's. And of course I agree the key is the report, which will be out next week.

    I also have to say that I was in a very negative frame-of-mind about the whole thing while I was watching the live broadcast, but having just scanned through the AHRQ report and seeing some fairly substantive changes, mostly for the better (I think), maybe I'm a bit more obtimistic that the final report might not be as bad as originally expected. :jaw-drop:

    Having said that, I want to reiterate a key question that @Valentijn quoted above from a person in the audience who asked "What's the point in recommending these projects, since the NIH has already refused to fund those exact projects in the very recent past?"

    I guess that just gets at a much larger issue with overall funding of medical research in the US--which largely impacts not only MECFS but all underfunded diseases with no approved treatments. It is also one of the issues that the house committee on 21st century cures is trying to address. The way I see it in my overly simplistict view, is there currently is little connection between identified research needs and NIH funding. Researchers basically choose the topics they want to study and apply for grants. The overall NIH grant approaval rate is very low--so they either have to have another strong income stream or have a large research department constantly applying for grants. Those who have gotten funded in the past are likely to get future grant funding. Once funded, they are not typically held to producing research that would typically "pass" the AHRQ "litmus test", case in point--just look Natelson's published studies, much of it funded with NIH money and I don't think any of it made the AHRQ cut. But this is NOT unique to MECFS, the low percentage of studies that passed the AHRQ test is pretty much abysmal in a lot of areas when they apply their evidence review methodology.

    So where does that leave us?

    The NIH staff at the meeting kept saying--submitt the proposals, give us proposals---well who has the time and money to submitt proposals with a accpetance rate of something like <17%? Not many of these small MECFS research centers, I can guarentee that.

    I think what they (NIH) are hoping will happen is an evolution of research where "interest groups", meaning clinicians, researchers, patient advocay groups, charitable foundations and biotech companies form collaboratives or even better "consortia" (that's the new buzz word) where they agree to work together, pooling resources, sharing information and reducing competition for grants and other funding. For any of you who watched the workshop, I think the example of a collaborative might be the MAPP program for chronic pelvic pain presented by Dr. Clauw. I also think a lot has been done recently in the area of rare diseases.

    I personally think that the ability to do that for MECFS is going to be key to "advancing the research for ME/CFS". So in a long about way--maybe the purpose behind the P2P process, assuming the final report supports the research needs, is to set the foundation for someone to step up and take the lead on developing stronger MECFS collaboratives/consortia...where smaller "discovery" studies lead to larger replications studies and then treatment studies, with the likely hood of NIH funding and then biotech funding increasing along the way. But I don't think NIH is going to take the lead on setting this up...so the big question is who, if anyone will...?

    Of course, this is my intepretation of trying to understand the "bigger picture". I could be completely wrong and therefore reserve the right to reverse my opinion on this at any time and can easily be convinced otherwise--just saying. (OK where's the dodging bullets emotive?):)
     
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  4. alex3619

    alex3619 Senior Member

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    My current view is that initiative will have to come from all the stakeholders, operating in parallel, until it merges into something useful. Charities, organizations, advocates, patients, researchers, doctors ... we need ways to get these groups together. This is not the thread to discuss that though.

    There are several existing collaboratives though. Many of our researchers not only are aware of the need to do this, they have started down this path.
     
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  5. Wally

    Wally Senior Member

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    @Anne,

    I also watched both days of this meeting and my impression is very similar to what Nielk has set forth above. I am not feeling very well this evening, so it is difficult for me to write and add more to what Nielk has already articulated. However, perhaps the videos I have attached below will add some additional insight into my overall impression of the meeting and the P2P/IOM review process.

    Wally

    The musical tunes that came into my mind while I watched the meeting.



    This is why I believe the selection of a P2P/IOM
    review process by the HHS could not possibly result
    in an improvement in the perception, understanding
    and funding of a complex illness like ME/CFS.
     
    Last edited: Dec 12, 2014
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  6. Ember

    Ember Senior Member

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  7. Hope123

    Hope123 Senior Member

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    Yes, do write in. As Alex said in another comment, although the AHRQ report has influence, the final report is more than the AHRQ and includes information from the presentation as well as ideas drawn from public comments.

    I also find that if you like something saying you agree with it and then putting in your own point helps. It's the art of negotiation where you want the person across the table agreeing with you, saying "Yes, yes, yes........" before you get to what you want.

    So, write in that you agree with AHRQ's assessment that Oxford should be retired and, no matter that AHRQ included the trials in their report, we can ask that the Oxford trials be set aside in evaluating treatment. Another way of doing this is asking for a "sensitivity analyses" -- this is a research technique whereby you throw out trials that could bias the conclusions (e.g. GET and CBT work) one way and see what happens when they are left out. (e.g. what happens when people with more symptoms than only fatigue are subjected to GET/ CBT).

    As a side note, the use of Fukuda in the original PACE paper -- the 30% or so of Oxford patients also fitting Fukuda -- was incorrect; the PACE authors admitted this in the recovery paper where they noted that they only asked about Fukuda "minor" symptoms over a short period (1 or 2 weeks I don't remember exactly) and not the 6 month duration that Fukuda minor symptoms are required to be present. So someone who had fatigue for six months but minor symptoms (e.g. sore throat, muscle aches, etc.) for only 1-2 weeks qualified as Fukuda per the PACE authors. Therefore, the original PACE paper, where they asserted GET/CBT was effective for Fukuda is incorrect.
     
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  8. Valentijn

    Valentijn Senior Member

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    One possibility for the discrepancy between using the Oxford research while recommending the retirement of it might be due to the requirements placed on the panel reviewing the research. They had strict criteria to follow which resulted in Oxford being included and may not have been given the discretion to throw out any research which met those criteria, even with glaring and fundamental flaws in the methodology of those research papers.

    Hence it's possible that the panel sees these problems, and believes that they are problems, but lacks the power to toss them out of the report. Which would indicate that the P2P and/or AHRQ process itself is fundamentally flawed, regardless of the intentions of the researchers and/or panel members.

    At least the recommendation to retire Oxford does indicate good intentions, and should seriously undermine any aspects of the report which substantially rely on Oxford trials. And one presenter did point out that one large trial (presumably PACE) was contributing a lot of weight to the calculations of the effectiveness of CBT/GET versus controls. The types of treatments which crossed the threshold for being clinically useful did so by small margins, so in the absence of Oxford and PACE being used in those calculations, those treatments would show up as not being useful.

    But since the process itself seems (deliberately?) flawed to include those results, I think it's inevitable that HHS will be heavily pushing them.
     
    Last edited: Dec 12, 2014
  9. alex3619

    alex3619 Senior Member

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    This is what the chapter in my book would be on. Its about a failed application of evidence based medicine. As I have said many times now, EBM is mostly a good idea, how its usually applied is typically flawed. Further it appears that many claiming to practice EBM do not even understand what its about, but are able to recite catch phrases and slogans about it.

    PS I suspect, but cannot prove, that what is stopping the flawed EBM processes from collapsing under its own ineptitude is there are still enough doctors able to think for themselves, with the right training, that the profession can still operate within an EBM setting.
     
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  10. Ember

    Ember Senior Member

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    Jerrold Spinhirne says:
    December 12, 2014 at 8:49 am
     
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  11. melamine

    melamine Senior Member

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    It seems a simple enough test. Perhaps too reliable, as they say.

    “The dysfunctional activity/rest control system and loss of homeostasis result in impaired aerobic energy production and an inability to produce sufficient energy on demand. A test-retest cardiopulmonary exercise study revealed a drop of 22% in peak VO2 and 27% in VO2 at AT on the second day evaluation. [39] Both submaximal and self-paced exercise resulted in PENE. [40] These impairments and the loss of invigorating effects distinguish ME from depression.”
     
  12. alex3619

    alex3619 Senior Member

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    This is not quite how the current science shows it. Usually, if I recall correctly, and please someone comment if you read the papers again or you recall differently, the main thing is the anaerobic threshold change.
     
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  13. lnester7

    lnester7 Seven

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  14. Denise

    Denise Senior Member

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  15. Denise

    Denise Senior Member

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  16. Hope123

    Hope123 Senior Member

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    Number of viewers from this page:

    http://videocast.nih.gov/PastEvents.asp



    Day 1 - 293 total viewers with 275 live and 18 that have seen the archived version as of today
    Day 2 - 273 live and 4 archived

    That's pretty good, compared to the other talks on Monday -- except for the Advisory Committee to the Director which had 400+ viewers on Dec 11. (Speaking of which, it would have been interesting to contibute to that Committee as advocates have been trying to get Dr. Collins to prioritize ME/CFS.) At the high point of CFSAC -- the XMRV episode back in 2009-2011, the highest number of viewers was 800.

    As I understand, the videos will be up for a while. The more people watch, the better as it shows the gov't that people are interested in this topic.
     
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  17. catly

    catly Senior Member

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    Thanks everyone for posting the links to the videos. I watched maybe 60% of the live presentations and definitely want to go back and re-watch some of it- particularly the Q&As.
     
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  18. Dolphin

    Dolphin Senior Member

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    Anne, NK17, Sing and 10 others like this.
  19. Denise

    Denise Senior Member

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  20. Ember

    Ember Senior Member

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    “MY NAME IS SUSAN MAIER, I'M DEPUTY DIRECTOR OFFICE OF RESEARCH ON WOMEN'S HEALTH. SO MY TASK TODAY IS GIVE AN OVERVIEW OF THE TOPIC....

    MY JOB I THOUGHT TODAY WOULD BE TO GIVE YOU MY OVERVIEW OF MY IMPRESSION OF PERHAPS A NEEDS ASSESSMENT....

    THE ME/CFS PUBLICATIONS INCREASED DRAMATICALLY THE PAST FEW YEARS, THERE'S A NUMBER OF PEOPLE SCIENTISTS CLINICIANS PUBLISHING ON THIS. SHOWING THE RESULTS OF THE STUDIES. BUT FINDINGS ARE OFTEN INCONSISTENT. COULD IT BE THIS IS BECAUSE WE DON'T UNDERSTAND THE POPULATION OF PEOPLE BEING STUDIED? ARE THEY HETEROGENEOUS? IS THIS ONE DISORDER OR MULTIPLE DISORDERS?”

    Hint to Panel: ME≠CFS

    Remove patients who satisfy the ICC from the broader category of CFS:

    “The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.”

    Research ME:

    “Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.”
    - International Consensus Panel (2012)

    Collectively, the members of the panel have:
    diagnosed and/or treated more than 50,000 patients who have ME;
    more than 500 years of clinical experience;
    approximately 500 years of teaching experience;
    authored hundreds of peer-reviewed publications, as well as written chapters and medical books; and
    several members have co-authored previous criteria.
     
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