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FDA Workshop on Drug Development for CFS and ME

Discussion in 'General ME/CFS News' started by Ember, Feb 21, 2013.

  1. Simon

    Simon

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    biophile likes this.
  2. Nielk

    Nielk

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    Thank you Simon.

    I'm not sure why they exclude the most severely affected? They will never get a clear picture of this illness of they continue to do that. If one is interested in statistics that are accurate, why eliminate 25% of the patient population?

    I am not sure what the number 12/16 means with post exertion, but both in the CCC and ICC PEM is a required symptom for a diagnoses.
    Simon likes this.
  3. Simon

    Simon

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    Thanks.

    Severely-affected excluded indirectly because they can't attend the outpatient clinics where these studies happen. There's a debate about this over on the blog: First Results of CDC study with top US Clinicians

    12/16 means an average score out of 16 on the CDC's Symptom Inventory scale for post-exertional fatigue. you get points for both severity of symptom and the frequency, a max severity symptom scores 4, 'all the time' scoes 4 giving a max of 4x4=16. Will be interesting to see if those without much post-exertional fatigue form a separate cluster when they do the full analysis.
    Nielk likes this.
  4. Ember

    Ember Senior Member

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    Dr. Unger presented at the IACFS/ME Conference in September 2011 following Dr. Carruthers' introduction of the ME-ICC. Dr. Carruthers ended his presentation with an urgent call for change:
    Within a few weeks, the CDC had discussed their new milti-site study at a CFSAC meeting. Now, almost two years after the publication of the ICC, the CDC is able to report heterogeneity in ME&CFS and to distinguish patients who experience pain from those who do not.

    The ICC was published entirely without sponsorship. How much time (measured in human misery) and how many resources has this CDC study consumed so far? Last June, Dr. Carruthers called again for long-delayed ME research:
    When will the CDC acknowledge the urgent need for change?
  5. JayS

    JayS

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    Here's a quote from a comment of Cort's in that debate:

    "I imagine that at the end of the day Unger will be able to separate out more severely ill patients and see what kinds of unique issues they have."

    Yeah. $5 says she'll find they have the unique issue of ME.

    Me, I'd sidestep the discussion that surrounds the issue of 'test the sicker patients.' How about, 'test patients that can be diagnosed with Ramsay ME or CCC ME/CFS.' The CDC isn't interested in doing that, so I have limited interest in reading about all the questionnaires.

    There are people who often speak of 'ME is not CFS.' I find some of them to be quite tedious even though I've never disagreed with the premise. But I've lost patience; enough is enough already. There's no excuse for the CDC treating ME as some sort of vague, mysterious, fatiguing condition, instead of what it is, and the FDA got an earful of mixed messages they likely don't want anything to do with. Well, they asked for it.

    I know not everyone is comfortable with Mindy's comments or what she wrote on her blog, but the FDA people didn't see the couches around the piano where patients were going because they needed to lie down. And her public comment made a real impression, only to be somewhat blunted a moment later by what I made sure to not include in the youtube video--the 'I want your spit' guy. Good grief. If someone wanted to make a mockery of the whole thing, it couldn't have been scripted better.

    Sort of like the idea that we should view ME as a subset of CFS.
  6. beaker

    beaker CFS/ME 1986

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    When someone high in the power spectrum gets sick . very sick .
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  7. Ember

    Ember Senior Member

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    We surely can't wait for that! Patients were relatively subdued when Ampligen was turned down.

    David France has called AIDS activism a primer: “It really establishes a paradigm for activism.” Watch how AIDS activists responded (11:00 – 13:00 below) when the FDA turned down DHPG:



    Would the AIDS activists have been more quiescent had AIDS started as a predominantly female disease?
  8. akrasia

    akrasia Senior Member

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    One of the ways of looking at what's happening at the FDA and CDC is the performative, a kind of dance where they are demonstrating drawing away from previously held views of the illness.

    During the autumn FDA telephone conference Hillary Johnson asked the obvious question: why is policy changing?

    So much of policy making is occluded. Patients have been starved of information regarding the most basic decisions affecting their everyday lives. And yet.

    We all know why cfs ended up in Women's Health, or why it was kept in the Viral section of the CDC even though the trajectory of research was psychogenic. Bad faith, ambiguity and evasion have defined government's relationship to us.

    So, you have to read the inferences and not the manifest content, although I do believe that the CDC and FDA are in the process of a radical shift in policy. But they are doing it in response to something we can't see at the moment, but which because they are doing it at all implies that marked change in how the illness is seen is imminent.

    Both Mady Hornig and Greg Towers will be speaking of pathogens at the upcoming invest in m.e. conference.
    Valentijn, beaker and JohnnyD like this.
  9. beaker

    beaker CFS/ME 1986

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    I wasn't suggesting that WE do. The question was when will THEY act.

    AIDS predominately struck an already well organized group of individuals ( the gay community) They used their advocacy base that was already in place.
    We don't have that.
    We have people who are too sick to do the major advocacy work and often little support from the world of the well.
    Shell and Ember like this.
  10. Nielk

    Nielk

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    Why is it that when they collect data for ME/CFS like the CDC did here, do they include all these forms to be filled out regarding anxiety and depression? When I suffered from active Crohn's disease for fifteen years and was very tired all the time, no one asked me to fill anything out regarding my mood.
    beaker, Purple and Valentijn like this.
  11. Ember

    Ember Senior Member

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    What strikes me as different too, though, is their attitude.
    beaker likes this.
  12. Ember

    Ember Senior Member

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    Dr. Unger wants to describe a disease continuum. She doesn't much want to discover that patients with mild ME become patients with severe ME as a result of exertion and PENE. That same deterioration won't likely be found in other CFS patients, some of whom may have FM.

    I notice that “additional measures of cognition and exercise capacity are planned in a subset of this study population.” Why not investigate cognition and exercise capacity in the whole study population?

    ME needs to be removed from CFS so that it can be treated and studied separately. We would then expect to find additional subsets in both CFS and ME.
    ukxmrv likes this.
  13. Ember

    Ember Senior Member

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  14. Dolphin

    Dolphin Senior Member

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  15. Snow Leopard

    Snow Leopard Senior Member

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    If she wants a disease continum, then she has to include fatigue associated with other diseases (post-cancer, autoimmune, MS, HIV-AIDS etc). The fatigue in these illnesses is not "explained" either, their exclusions from the CFS criteria is just as arbitrary. Those people deserve research and treatment too.
    Firestormm likes this.
  16. Firestormm

    Firestormm Guest

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    But this gets to the 'nub' of the issue, doesn't it Snowy-one :) 'Fatigue' had previously been considered part-and-parcel of either a) a serious medical condition, or b) the result of drug therapy e.g. chemo; or c) being a bit run-down.

    What is now being touted (or has been for a while) is that 'Chronic Fatigue' might be caused or influenced by X i.e. 'it' or more generally the medically defined pure 'fatigue' is caused by something specific.

    It could be that across multiple chronic conditions the same 'chemicals' are affecting/influencing ability to function leading to the symptom expressed and interpreted as 'fatigue'. But that in our condition this is more prevalent - leading to possibly a more disabling experience as a result.

    I was thinking of that MRC funding afforded to the err... Sjorgen's Disease comparative study. And there was another one also looking for - if memory serves - 'fatigue' markers with that chap at Newcastle whose name was umm... Nu or something.

    Oh dear. Time for another dose of caffeine :)
  17. Firestormm

    Firestormm Guest

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    Ok. So it was Pariante (London) and Ng (Newcastle) who were tasked with looking at 'fatigue' and biological underpinnings focusing on the immune system. I was also thinking about the conference presentation upon which this thread was based (think there's another thread running about it as well?).

    The results from CFIDS and Biovista highlighted these monoamine neurotransmitters - serotonin and what-not. Well we've never really considered the impact problems stemming from let's say for argument's sake - a viral infection and resulting bodily stress - has on these babies.

    I don't know what the two drugs CFIDS are looking at for this Trial they are working on; but let's say they relate to Seratonin. Now previously we've all be prescribed I'm sure: anti-depressants; drugs that mess about with these neurotransmitters.

    Maybe, depending on research results, we (as a community) will need to stop thinking in terms of anti-depressants and consider more carefully what these kind of drugs are supposed to be doing. If this research uncovers evidence that supports the notion that neurotransmitters are directly influencing 'fatigue' then we might have to reappraise this area of treatment.

    Of course that all depends on quite a lot. But this drug repurposing does bother me a bit. Of course we don't know what these drugs are that they're looking at - but if I were to search the literature I bet more of these kind of drugs crop up than any other!

    And I have personally been on just about every anti-depressant known to man over 14 years. I swear every doctor I have seen has his favourite and yet here I still am - plodding on... Not recovered sufficiently to work :)

    Ah. Here's the other thread: http://forums.phoenixrising.me/inde...y-candidate-drug-for-repurposing.23534/unread
  18. Valentijn

    Valentijn Activity Level: 3

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    We don't really give a damn how drugs are classified. I take an ADHD drug - doesn't mean I think (or care) that people might label me as having ADHD.

    The problem with SSRIs is that they don't help a lot of patients, and make them feel worse. It's a huge case of "been there, tried that, didn't work".
    heapsreal and Firestormm like this.
  19. Firestormm

    Firestormm Guest

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    Yep. Hey Val, did you pick up on this 'Central Fatigue Hypothesis'? Also mentioned during this part of the talk from Vernon. I need to look a bit more into it. Thought it was new but it's been around a while.
  20. Snow Leopard

    Snow Leopard Senior Member

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    The implication wasn't SSRIs, it was for drugs that control or limit amounts of monoamines (quite different).

    The activity of the serotonin pathways was investigated by three research groups back in the 90s (including well known UK psychiatrists who each took part in two of the studies). They found elevated activity and the papers hypothesised that this may be a causative factor in the experience of fatigue.

    Similarly, no SSRI has ever demonstrated a benefit for depression in CFS patients in double blinded RCTs at reasonable follow up intervals. (but the broader targeting MAOIs are effective)

    The Japanese tried to do a bunch of gene expression stuff, but their studies were flawed as their patients had taken antidepressants long-term before hand, so the finding of lowered Serotonin receptor expression was not a specific finding as the same finding is found in the general population who have taken antidepressants long term. Yes, taking antidepressants long term leads to permanent brain chemistry changes - something that your doctor probably didn't tell you.

    In the 2000s, well known UK psychatrists W and S tried to explain away their results in light of the Japanese research, ignoring the flaw

    Serotonin etc all play important roles in immune response. http://www.ncbi.nlm.nih.gov/pubmed/10080856 and many other reviews.

    I think the measurements of the neurotransmitters is a symptom, not a cause. Drugs that target these neurotransmitters, eg neuroleptics or other classes that have other effects will just cause more problems than they will solve. The reason why they are still being considered is that scientists still don't have a clue when it comes to understanding fatigue. Drugs that prevent damage are a different question. I would also predict that if any of these drugs do magically work, it will be due to reasons (eg protective effects) other than what is currently understood about that drug.
    Firestormm, Bob and Valentijn like this.

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