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Dr Mary Fletcher suggests IOM report deliberately altered

Discussion in 'General ME/CFS News' started by RustyJ, Sep 11, 2015.

  1. RustyJ

    RustyJ Contaminated Cell Line 'RustyJ'

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    Staggering claims by Dr Mary Fletcher. Her presentation starts at 15.05 mins. It is one thing for patients to be suspicious about the IOM report, quite another for a respected researcher to point out such glaring errors and suggest that they may indicate deliberate interference.

    The immune dysfunctions in me/cfs are perhaps the most critical for indicating the future of research and treatment. Was this defining research deliberately buried in the IOM report.

     
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  2. alex3619

    alex3619 Senior Member

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    This hinges on misquoting and mis-characterizing papers on cytokines in ME and CFS. It is very unlikely to have been from the panels, as members of the panel were some of the authors of these papers. So its very likely it was changed later, by parties unknown.

    It looks like there are important NK function and cytokine signatures that were overlooked by the IOM report, and newer studies that reinforce this, and might lead to a diagnostic test.
     
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  3. TiredSam

    TiredSam The wise nematode hibernates

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    She really needs to go on a course on how to give a presentation.
     
  4. Valentijn

    Valentijn Senior Member

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    Personally I'd prefer that she continues to spend her time on the science aspect :p
     
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  5. jimells

    jimells Senior Member

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    Has anyone seen a transcript yet? I'm unable to view video over a dialup internet connection...

    I was quite surprised to here her allegations during the meeting. And even more surprised that nobody responded to her report or asked questions about it. To me, this is a very serious allegation to make in the context of a public meeting - I can well imagine she might have new difficulties in obtaining grants.

    Somebody at the meeting (I don't know who) also reported that Malcolm Hooper was informed by an insider that the IOM panel was specifically told that naming the illness "ME" was not an option - another serious allegation that was promptly forgotten, apparently.
     
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  6. A.B.

    A.B. Senior Member

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    I find this difficult to follow, can anyone sum it up?
     
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  7. alex3619

    alex3619 Senior Member

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    I am not sure I would categorize this as allegations. She pointed out errors, errors that were very unlikely to be in the report initially, and there was a discussion on publishing errata. That the section was flawed, and had inappropriate references, is stronger than mere allegation.

    There has clearly been either error or deliberate tampering. However she referred to it as technical error (iirc). We do not know what actually happened. For all we know a section was omitted, or garbled, during formatting for release.

    We are more willing to discuss this as deliberate, but everyone at CFSAC was more careful in what they said.

    The more disturbing thing is if this section had major error, and she only read this one section, how much of the rest of the report has major errors? This was briefly commented on in the talk.
     
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  8. Tammy

    Tammy Senior Member

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    I hope the issues that Dr. Mary Fletcher brought up regarding bio-markers.........cytokines, NK numbers etc. are not swept under the rug because the information I feel is extremely important.........imo she is spot on in this area and it really should be emphasized.
     
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  9. alex3619

    alex3619 Senior Member

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    Most of the evidence relating to biomarkers would have been excluded according to the rules of evidence. I don't think many appreciate the issues with evidence based medicine, or why I considered the IOM report premature by some years. In the video Nancy Klimas said the evidence at the time would not have changed their conclusions. She also said that current evidence might have.

    Evidence based approaches are good when excessive bias is minimized, and when a field of research is mature. CFS research is not mature - lack of funding, lack of replication studies, widespread denial of grants, these prevent the research published from reaching "evidence based" standards. Yet that is in itself a denial of the principles of evidence based medicine. Evidence based medicine is about use the best available evidence. Its not about using a truncated set of evidence, though ranking of evidence occurs. If the best evidence that exists is just a few case studies, that is what you have.

    This idea that "RCTs good, everthing else bad" distorts how the information is being processed. Even RCTs are often wrong, and the error rate may be much higher than most expect. Similarly meta-studies risk amalgamating poor studies into larger analyses, reinforcing systematic bias. On the other hand even case series studies have good value if the effect sizes and outcomes are very clear.

    There is a well established principle that good studies with large effect sizes can have their evidence ranking upgraded. Similarly a study can have its evidence ranking downgraded, and this may mean that particular RCTs are considered to be far less then the gold standard. Sadly in typical reviews and metastudies this adjustment of ranking does not occur. Nobody has the time or the resources.

    To be clear, for clinical trials (and not other types of studies) an RCT is not gold standard either. To be ideal it must be both double blinded and placebo controlled, not merely having a comparison group. It should have other sources of bias minimized, the effect sizes should be large, and the primary data should be on objective observations.

    For the record, the RCTs used in psychogenic theorizing about CFS, that is the use of CBT/GET, are not double blinded. They are not placebo controlled. They are from an insular group that ignores other data. The effect sizes are tiny. The primary outcome measure are subjective. When you look at studies that try to become more rigorous from using objective measures then typically the results are much worse, and can even look like CBT/GET is detrimental to patients. It is NOT gold standard. As I described in one of my blogs, the best label might be "lead standard", and then they pretend to turn lead into gold. Modern day alchemy.

    In five or ten years a report like that done for the IOM might be appropriate if research continues to make the gains we are seeing, or even bigger gains. I think this is why the panel put such an emphasis on revisiting the topic in not more than five years.

    A diagnostic biomarker panel, cytokine or otherwise, will change the research done in CFS and ME forever. Its a huge next step.
     
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  10. Sean

    Sean Senior Member

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    It's a mixed bag.

    I agree that strictly speaking, from a technical view, it was premature, & also imperfectly done (just like the AHRQ & P2P reports).

    On the other hand, as political keys or even sometimes battering rams, to start opening up debate on the technical, political, and ethical issues, these reports are a big help, IMHO. If we can work them well.
     
    Last edited: Sep 12, 2015
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  11. alex3619

    alex3619 Senior Member

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    I don't disagree. We use what we have, and what we have is still the most authoritative review on ME and CFS ever done. My point is that we cannot have reasonably expected the report to have got it completely right, nor did it. The next report will be better, and the one after that even better, unless we wind up with a badly selected panel.

    There are lots of medico-political gems in this report. We can still use them.
     
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  12. jimells

    jimells Senior Member

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    Yes, everybody was very diplomatic in their words, but it's not hard to read between the lines, which is where one usually finds the real story.
     
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