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IOM's response to patients' concerns about panel selection

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Nov 12, 2013.

  1. Roy S

    Roy S former DC ME/CFS lobbyist

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    The belief by some that our best and most experienced physicians can't be trusted because they have seen too many ME/CFS patients is an old one. I've never known that concept to be applied to any other serious physical disease. I consider it one of the psychological sophistry brigade's underhanded tactics to deny reality by dismissing physicians as brainwashed by their patients.
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  2. Nielk

    Nielk

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    I totally agree with you Roy. The 50 'experts' who signed the letter to HHS are top doctors in their specific field of study. They have attended the best medical schools. Some are world renown.

    What HHS and IOM is effectively saying these clinicians and researchers, because they have treated or done studies on ME/CFS patients, are no as well qualified to serve on a committee to study diagnostic criteria than a clinician and/or researcher who has not treated or done studies on ME/CFS patients.

    This thought, on it's own, shows bias and prejudice. There are enough clinicians and researchers from all the medical fields with ME/CFS experience as to enable a composition on a panel of all experts in ME/CFS in defining the disease.
  3. Iquitos

    Iquitos Senior Member

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    Yes, it's part of the disinformation campaign. I recall Bill Reeves saying he didn't accept MECFS docs' patients in his cohort because the clinicians were "contaminated." This from the guy who used random digit dialing to find his cohort -- the Publishers Clearing House method of scientific "research."

    IOM's "experts" will have the same attitude. "Don't confuse us with the facts. Our minds are made up."
  4. WillowJ

    WillowJ Senior Member

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    most likely, none. Most doctors can't be bothered to figure it out, and already are biased with the official view that CFS is a nonserious condition (CDC says it's important but they then contradict themselves by saying don't use medication, don't use tests; they lie and say it's actually been studied extensively and nothing significant found in all this supposedly thorough study throughout the years--doctors and the public can read between the lines) and related to [based on methods errors:] personality disturbances and perverse beliefs and prejudices of the patient (bah!)

    if we get lucky, we get some like Jonathan Edwards and Harvey Alter, who are able to quickly make an accurate assessment and think very clearly, and bring new ideas and new expertise. (I for one would welcome more specialists of various kinds if--and only if--they would be smart and kind like Jonathan Edwards. But that's highly unlikely, especially if the persons approving them are themselves uneducated about the condition and trying to maintain "balance" by covering all perspectives including unscientific and debunked perspectives, and may themselves believe it's psychogenic.)

    My point was not that it was likely going to work out ok (that seems highly unlikely to me) but that the problem could possibly be more stubbornness of protocol than a deliberate slight. In the end it may not matter, because if it fails it doesn't matter whether there was bias, malice, misfeasance, complacence, ignorance, or slavish adherance to protocol whether protocol is advisable or not. A fail will have very serious consequences regardless of the reason.

    In the interim, however, it might help if Meck isn't antagonistic, supposing she has any say in what happens (she might not, though she may have advisory or gatekeeping power?). It may still be possible to explain things clearly to her.
    Last edited: Nov 17, 2013
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  5. WillowJ

    WillowJ Senior Member

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    Nobody knows for sure what will happen, but it's highly possible that the rules IOM will be operating under will exclude much evidence from consideration, particularly the evidence we want considered.

    I think the more doctors we can enlighten the better, but that could be a slow way.

    The most effective way would be to change the official position so DHHS gives out valuable information, and then the doctors would come around much more quickly. The problem is that DHHS is very stubborn and operates under outdated and unscientific (not to mention sexist) assumptions and biases, then wants to use only its own stuff.
    Last edited: Nov 15, 2013
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  6. leela

    leela Slow But Hopeful

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    Not to mention the clear agenda that is apparently already guiding the entire process.
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  7. alex3619

    alex3619 Senior Member

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    Its not just about exclusion of evidence, its about weighting of evidence. Psychobabble does RCTs, with highly subjective and probably highly biased outcomes. RCTs rate higher than physician experience. So they have the most weight. Because there are so many they will get even more weight. That is what evidence based means. Yet the rules will not permit them to examine this psychobabble research with the kind of fine focus that is required. If they could then it would almost all be discarded as junk.

    Most of our studies showing physiological abnormalities are unreplicated, or poorly replicated, or only done on small cohorts. They may well be dismissed in their entirety. The fact that the are so very many of these studies showing pathophysiology will not matter. The fact that some use Gold Standard testing (e.g. 2 day CPET) will be ignored, as the studies themselves don't use a "Gold" standard methodology. The misuse of Gold Standard will likely work against us. Maybe I should write a blog on this, and what Gold Standard really means, as I see the term used liberally, and most of that is misuse.

    This is about form over substance. They IOM may claim they did it with the latest and most vigorous methodology. In other areas of government etc. this is called a white-wash. They will argue its evidence based, how can we dispute the evidence? Yet the evidence from psychobabble is highly distorted, and full of formal fallacies, statistical error, redefinition and spin.

    The rules of evidence are far more important than the experts. All our experts could do, with integrity, is resign as a group.

    Now if the experts are chosen properly, for a scientific selection, and choose their own evidence ratings, this would be very different. Don't count on this happening. Also don't forget that most doctors are not scientists.
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  8. aimossy

    aimossy Senior Member

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    "unreplicated, or poorly replicated, or only done on small cohorts"
    that's the shizzle right there!
    I get the feeling that this is what is being worked on at the moment, with research beginning to piggy back and institutes communicating with each other with this goal in mind.
  9. Wally

    Wally Senior Member

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    I had missed this thread until today due to feeling like crap from the effects of this illness. However, upon reading patient and advocates responses to the IOM's response, I felt compelled to add in my own two cents about this contract.

    [​IMG]

    :ill::ill::ill::eek::eek::eek::eek::aghhh::aghhh::aghhh::lol::lol::lol::lol:
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  10. Chris

    Chris Senior Member

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    This might be a good moment at which to remember the story that Hillary Johnson tells in "Osler’s Web" of Paul Cheney’s meeting with some committee (CDC? FDA? could not locate it in the index, sorry) –he had taken the trouble to prepare a video showing some seriously ill patients, and was accompanied by a seriously ill but beautiful young woman. The committee literally walked out on him, and told Hillary later that they thought Cheney was "depressed" (he doubtless was by their response, as well as angry), and that the woman was "hysterical." She was dead two years later.
    One would hope that an IOM committee would be less blatant, but.... Chris
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  11. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Why don't the rules let them examine the studies closely enough?

    Where are these rules found? ecoclimber mentions they can be found in texts of previous reports.

    Yes, more explication on the gold standard testing v. methodology, etc. would be great.

    So, I assume EBM doesn't take into account whether the study used an invalid definition or bad method (other than not being double blinded RCTs with large cohorts)?

    I guess we could argue they have to look at the quality of the definition since they think the redefinition of ME is so important, you can only look at EBM to inform it, then you clearly need to look at whether the definitions used in the studies you are considering were themselves formed on the basis of good evidence. And obviously, common sense dictates that the case definition is the foundation of the study and if the definition is invalid, the study is invalid regardless of whether it was a RCT or not.

    We discussed before if there was literature on these questions and you said not really. I think it would be really useful if you could write an article for say PR explaining why EBM will fail in this instance, hopefully fully cited to the literature if at all possible. Then we could have your article to refer to and cite in our arguments.
  12. alex3619

    alex3619 Senior Member

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    @justinreilly , I would like to write such an article as well. I am not sure if I am still up to it though. My cognitive capacity has been declining since February, so I stopped writing all blogs/articles, even my book. I can try though. It will take weeks to months though, as hunting through references and documentation takes oodles of time and concentration for me. I was planning to do this anyway, as part of research for my book, but everything takes so long for me to do now that it verges on the ridiculous.

    I am basing my argument on what I know of EBM in general, not of whatever version IOM will use. We don't know what they use, or have used, or will use, though it is possible it is buried in their documentation. EBM varies a fair bit through the literature.

    EBM gives a best guess via rating documentation. It is not a scientifically validated process. The best way to think of it is that it is a management tool, aimed at creating a convenient guide by translating and condensing the scientific material into clinical terms. It can do this really well. It can do this abysmally.

    So they can take, for example, CBT/GET and rate the papers in CBT/GET. Then they can do a metastudy on the best papers, and comment on the result. In a metastudy they amalgamate the results, and comment on the outcome on the new larger group. This has been done at least once on CBT/GET, and I think another is in process, iirc.

    The motivation is that people were dying, and unsound science was driving medical treatments that did not work. It was supposed to fix this, or at least make a start at fixing this. The estimate of how many died on one class of drugs alone, in the USA, is millions.

    Now to start with, I am not aware of any psychiatric study using psychotherapy or behavioural therapy etc. that uses the most favoured methodology - double blinded random controlled trials. This is because it is obvious to both patient and therapist which group the patient is in. So there is always bias. The primary outcome measures used are from questionairres, which are subjective and based upon how people think, and CBT alters how people think, so the outcome measures are subject to major bias.

    Then there is the diagnostic criteria. Typically they use the Oxford criteria, though sometimes Fukuda, and they also used a modified London ME criteria in the PACE trial that was modified by them to suit their trial. Oxford criteria produce a highly heterogeneous group, Fukuda is a bit better but not even close to right, and the modified London criteria were highly problematic as they have never been properly investigated in this form.

    More in a bit, in my next post.
    Last edited: Nov 16, 2013
  13. alex3619

    alex3619 Senior Member

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    Generally psychogenic criteria have major failings, which in part is unique to psychogenic medicine, and in part is related to psychiatry in general.

    Psychiatric diagnoses, such as those in the DSM, have no validated scientific basis. They are not science. I have been looking into this for the last two years, and I have a long long way to go, but essentially all psychiatric diagnoses used in the DSM are derived by a consensus process. They use the existing evidence base. Hmmmmm...... what does that tell us?

    Psychogenic medicine has been resoundingly criticized since at least 1922, and I think it goes back to the 19th century though I lack documentation on this. It has defied all evidence and reason though, and operates more like a cult than science. Either you are a believer or you are not. This why it has been variously called nonscience, pseudoscience and psychobabble. It runs afoul of multiple logical fallacies, and it is planned to be a big part of my book writing about this, though that is not expected to be done in the medium term but the long term. My best guess is I am still a full decade from completing that, though I was hoping to get some version out in maybe 2015 or so, but this is now on indefinite hold until I get more cognitive capacity back.

    Essentially the Gold Standard is the benchmark in treatment. It is the prior but existing best treatment. In other words, its what EBM has determined to be the best in the past. Now its often used to rubber stamp the current favoured treatment, even if that is not evidence based.

    In theory EBM should take into account methodology etc in rating papers. Often this does not happen, especially in psychiatry. The Cochrane review on CBT/GET for CFS did not look at flaws in the methodology. They mainly focused on amalgating data and trying to get more reliable results .In other words, its post processing without validating the input. Its often presumed that peer reviewed published papers are acceptable, just statistically unreliable due to size and bias. To some extent its presumed bias is study by study specific. They do not take into account systemic bias in the whole field of study.

    Now a review committee, which is what the IOM panel will be, do not have time, resources or mandate to tease the various studies apart, come to conclusions, then run trials testing their conclusions. They will instead have to take studies on face value. There is simply not the time or resources to do otherwise. There is too much material to cover, and too many entrenched problems in psychiatry and psychogenic psychiatry in particular.

    The IOM process is not scientifically validated, just as EBM is not. In doing something like creating evidence based definitions on problematic areas with limited research, I think they should have focused on doing maybe a decade worth of well funded research on how to best do such diagnostic criteria. Instead we face them leaping in and learning on the job. They already stuffed up GWI, sorry I mean CMI. No, actually, I don't.

    So the IOM is an attempt to use a consensus process (not science) to create a definition that will not be extensively tested before they pass it out to the public. Of course they will argue that is all Holmes, Fukuda, CCC and ICC are. That is another argument for another post.

    This is what should happen. Its not what I am so far seeing in EBM. If this approach were taken to any part of psycho-psychiatry, it would all be dismissed as low grade evidence.

    Which brings up another point. EBM does not made final conclusions. It rates evidence. It amalgamates evidence. It translates scientific evidence, and I would argue nonscientific evidence, into clinical practice, by making recommendations. So evidence can be upgraded or downgraded based on assessment of strength, risk, outcomes etc. Once this gets transitioned into medical management however, the tentative medical conclusions often become management dogma. Insurance companies often use EBM results to determine what is and what is not allowed.

    The more I think about it, the more I think this article will take years to write to an academic standard. Its not simple, and there are large numbers of papers to take into account. I am working on this anyway, but super slowly, and I will release more detailed and referenced articles when I am able, as stepping stones to something with more careful analysis and investigation.

    More in part 3 soon. I hope. I need a break for a few hours, and some more sleep.
    Last edited: Nov 15, 2013
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  14. usedtobeperkytina

    usedtobeperkytina Senior Member

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    When we met with IOM person when we happened to be in DC for other reasons, we expressed to lady who will not oversee the study and Kate who will work to handle much of the legwork that we would like to see 50% ME//CFS clinical experts, 25% ME/CFS experts and the last 25% be representatives from medical professional organizations, such as the AAN (neurology) and others. It was explained to us that there will definitely be ME/CFS clinical experts. But the non experts being there, but knowing that type of science, means they can challenge the position of the experts to prove it with the research. So, that is why their reports carry more credibility than a bunch of people who are of same experience and coming in similar opinions. It's a type of internal peer review process. Also, remember that the committee's report must go through an external peer review process.
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  15. Ember

    Ember Senior Member

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    The experience of the IOM in developing clinical diagnostic criteria hasn't yet earned them “more credibility than a bunch of people who are of the same experience and coming in similar opinions.” The “bunch of people” to whom you refer is generally known as a panel of experts.
  16. Mark

    Mark Acting CEO

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    Anything that has to go through this filter of having to be 'proved' by research, given the state of ME/CFS research and the low level of funding for it, is surely going to give a far inferior result for a case definition than research plus the collective expertise of clinicians who have been seeing and treating patients for decades, no? Won't this 'evidence-based' process imply discarding much of the clinical experience of experts regarding aspects where they have relevant insights but where appropriately high quality (ie expensive) studies have not been done? Are the 50 experts wrong to oppose this process?

    More credibility maybe, but it seems to me that such a process will inevitably produce a 'lowest common denominator', discard important insights, and produce a lower quality of case definition than a consensus of experts like CCC or ICC. And will the panel look deep enough to discard the conclusions of pseudoscientific research like the PACE trial, or will it be like the IOM's GWI panel and take that sort of rubbish at face value? The IOM's history, particularly with GWI, strongly suggests the latter.

    The 'official' evidence base is systematically skewed and corrupted, so why would an evidence-based approach to case definition be a good idea? The IOM's reports may carry more credibility for some, but I've read enough of their work on GWI for them to carry zero credibility with me: that work does not look remotely unbiased or independent to me.
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  17. alex3619

    alex3619 Senior Member

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    The single biggest reason to be against the IOM process is this: 50 of our experts are against it. If it were such a good process, in an undeveloped research field like CFS, why would they want the CCC accepted and the IOM stopped? They know a lot more about the process than we do. We should trust their position. I have more to say later.
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  18. WillowJ

    WillowJ Senior Member

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    @alex3619 I'm glad you explained the EMB problem more clearly. If you do write the article, I hope you publish it somewhere very noticeable to those outside our community.
    Last edited: Nov 16, 2013
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  19. WillowJ

    WillowJ Senior Member

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    They do not write cancer studies with 75% cancer experts and 25% non-oncologists. Again, there is no reason we should accept more than 1 non-expert (e.g. a statistician) on the task force. This is simply not customary--it is not done at all (except in very badly disrespected diseases and it is a sign of disrespect)--and we do not have to put up with it.

    The problem is not that we need to bring on other experts to try to gain credibility--using inappropriate methods to examine currently-available information. The problem is that we need DHHS to start taking the biomedical model seriously, beginning with removing information based on rubbish inclusions, and funding for replication and discovery of biomarkers, and taking the advice of the actual experts in the field about how to do this.

    Then and only then should DHHS be involved with publishing info to the wider community, writing training manuals/ doing education, and recruiting non-expert doctors.
    Last edited: Nov 16, 2013
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  20. WillowJ

    WillowJ Senior Member

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    I agree with Ember

    Plus, the experience and opinions differ. It's mostly reactivating CMV/EBV/HHV-6. It's mostly enterovirus. It's an immune response to a past infection, no present or reactivating infections in most patients. It's probably an autoimmune disease. It's mold in some patients. Few of these patients actually have ME, which requires measurable neurological damage. etc.

    If those opinions are not dissimilar enough, then they must be actively looking for: It's psychosomatic; it could be triggered by a virus but it's sustained by bad beliefs and bad management. ??
    Last edited: Nov 16, 2013
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