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Will the IOM field test their definition?

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Andrew, Nov 6, 2013.

  1. Andrew

    Andrew Senior Member

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    I sent the following question with comments to the IOM. I was going to wait for an answer before posting this. But the automated response said they do not reply to every email. So I'm posting now.

     
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  2. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Great point, Andrew.
     
  3. alex3619

    alex3619 Senior Member

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    The contract cannot, I think, include any field testing. There is neither enough money nor time.

    There is also the problem about how to test - what benchmark are they going to test against?

    Field testing will require a further contract. Most likely they will just release it without testing. Theyz be smartz, dun need no testing here. Yet the one lesson that is central to Evidence Based Medicine is that only high quality testing in large cohorts with well developed studies and good methodology count. The rest is not quality evidence based, or class 1 evidence as described in EBM. Its definitely not Gold Standard quality.

    The concept of Gold Standard is based on the notion that there is a best practice standard to compare to. The problem in ME and CFS is that we have no such accepted standard. We might have if we could get the CCC accepted. Then everything can be compared to that, including the ICC.

    The closest we come to a Gold Standard, which is more like a Bronze Standard, is the Fukuda Definition. Its the most widely used for the longest time, but it doesn't stand up well to close scrutiny when compared to the evidence.

    Worse, we have the Lead Standard, malleable, dull, poisonous: the Oxford Definition.
     
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  4. Andrew

    Andrew Senior Member

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    I have a follow up letter in mind. The thing is, because patients are excluded from the decision making, I have to sit here on the outside trying to lob thoughts over the wall surrounding their ivory tower. Even if I testified directly to them as part of stakeholder feedback, it is not the same as being part of the decision making process. As part of the decision making process, one can attempt to inform on any step of the process. But in testimony, all one can do is make general suggestions from the audience.

    The fact is, I think what I brought up is unarguable. If they have any scientific and humanitarian integrity at all, there is no way they can recommend that an untested criteria be let loose on sick people. And IMO, ethics require them to prove what they come up with is better than CCC. The CCC is the one that has been consensually validated by American experts based on direct experience. And the instructions state that this is to be developed with American use taking priority.

    OTOH, I'm not counting on ethics here. The HHS contract ties their hands. And my big fear is this will drive us back into Fukudaland, because that's where most of the literature comes from.

    @alex3619 You might want to send them your thoughts too based on your way of saying this. I think two emails are better than one, and it would be good to have this light shined clearly into their faces.
     
  5. alex3619

    alex3619 Senior Member

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    I will think about this Andrew. Ethical issues are very important in medicine, and one possible avenue we have not explored is to raise it with the American Medical Association. Letters regarding ethics however should be broadly targeted. Don't just swat the big fly, swat all the flies.

    Ethical issues are planned to be part of my book, but I have yet to do much research into this.
     
  6. alex3619

    alex3619 Senior Member

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    Question: who is worth target on ethical issues? Has anyone investigated this?

    Question: how do we want to present the ethical violations? How do we structure the argument? What should be considered?

    If anyone has a background in ethics on this site then you might consider looking into these issues.
     
  7. Andrew

    Andrew Senior Member

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    I'm trying to appeal to their sense of ethics and responsibility and put some perspective on the relative values of criteria. I don't think any formal review body gives a hoot about this kind of thing. Just look at our history.
     
  8. alex3619

    alex3619 Senior Member

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    A review committee often doesn't need ethics approval. For some reason its unethical to do all sorts of things in clinical studies, but its entirely ethical to foist unproven studies or reviews on the public, doing who knows how much damage. The standard counter-argument is often that these are only guidelines, not rules. However when government and health care insurers start using such guidelines they might not treat them as provisional or suggestive. Such reviews can become prescriptive in too many cases. Just look at the DSM and how insurers treat those diagnostics.

    My point about who to target is based on this principle: most of the people in a panel will probably be doctors, and so are covered by medical ethical practices. Every country has their own watchdog on medical ethics, and there are often organizations that have a view on medical ethics. They can all be contacted and made aware of these issues, but for the US for example, who are they? The AMA obviously. Who else?

    What range of ethical considerations do we want to consider? I think this is worth exploring a little more than we have. We have made a start, but this is a whole new angle to pursue.
     
  9. Andrew

    Andrew Senior Member

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    The AMA is a professional organization to support and lobby for doctors. I think ethical violations are taken care of at the State level.
     
  10. alex3619

    alex3619 Senior Member

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    That is different to Australia and the UK then, though in the UK the disciplinary body is the GMC. If this is state based, then every state needs to be advised of possible ethical violations.
     

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