1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
The ePatient Revolution
Ryan Prior shares his experience and his thoughts from attending the Stanford Medicine X Conference as he contemplates the rising of the ePatient Revolution ...
Discuss the article on the Forums.

UK: House of Lords to debate PACE study, Weds 6 Feb 2013

Discussion in 'General ME/CFS News' started by Sasha, Jan 31, 2013.

  1. Mark

    Mark Acting CEO

    Messages:
    4,527
    Likes:
    2,004
    Sofa, UK
    Gutted for you WillowJ. Maybe the Lazarus plugin wouldn't have helped in this case? I haven't come across the technical hitch you describe, but sounds worth looking into in the Technical Support forum to see if there's a way to stop it happening again. I'd start by mentioning what browser and version it happens in.

    Those speeches in response to Mar are stuffed full of logical fallacies, misleading arguments, and I think also some statements of fact about the trial that are just plan untrue, though whether it would make any difference to go through rigorously and list them all I don't know. After reading that debate, and after the way Mar's public conversation with Wessely was cut off as soon as she got down to the facts which exposed his position, I just despair of reasoned and evidenced argument as a way forward here. They're just not listening.
    SOC, Dolphin, WillowJ and 4 others like this.
  2. biophile

    biophile Places I'd rather be.

    Messages:
    1,387
    Likes:
    4,586
    Lady Mar's 15% figure is correct. It is the general net response rate for many pre-defined oops I mean post-hoc defined outcomes, such as "recovery" (*cough* which bordered with or even overlapped with criteria for disabling CFS), the minimal low threshold for "clinically useful difference", and feeling "much better" on the CGI. As long as the appropriate caveats are included (i.e. generalizability issues, some measures improved but not others, non-blinded trial with different levels of encouragement/optimism between groups), then the 15% net response rate should not be denied by anyone, but it is also within range of a small placebo-response for changes in questionnaire-answering behaviour.

    Wessely co-authored a systematic review which examined placebo response rates in CFS, and reported that the pooled response was 19.6% (95% CI 15.4-23.7) as opposed to the often cited 1/3 for illness in general. The examined studies were also grouped according to the expected response rate, so studies based on "psychological/psychiatric assumptions" were placed in the "low [placebo] response" group because "some sufferers reject psychological causation and with it psychological treatments". Despite this grouping, the pooled placebo response was still 14.0% (95% CI 8.0 to 19.9).

    That said, it is worth looking further into how these latter studies (many involving CBT and GET) defined and measured the placebo response. I do not think it is as simple as subtracting 14% from 15%. PACE had no adequate placebo-control. APT was not meant to be a placebo-control and nor would it be appropriate to treat it as one. Even if CBT and GET can genuinely help a slim minority of broadly-defined CFS patients, it would be strange to completely ignore or dismiss the complications of a placebo-response, a possibility taken seriously in drug research. There may be people who would argue that a placebo response or effect and genuine improvement in CFS are all synonymous.

    Again, 15% net response rate for some measures and basically no response for others, is that an "awful lot"?
    Dolphin, Bob, user9876 and 1 other person like this.
  3. alex3619

    alex3619 Senior Member

    Messages:
    7,230
    Likes:
    11,368
    Logan, Queensland, Australia
    Yes, its politics not reason or science. It doesn't have to be rational, it doesn't have to cite or fit facts, it just has to be convincing rhetoric to those who don't know a lot on the topic.
    peggy-sue and Jarod like this.
  4. alex3619

    alex3619 Senior Member

    Messages:
    7,230
    Likes:
    11,368
    Logan, Queensland, Australia
    I don't know how you would get a placebo group with this kind of treatment. Its not a drug. The SMC group is probably as close as they can get. The only other option is no care, which would give them a timeline comparison of no care whatsoever. However I think this might run into ethical considerations.

    A Cochrane collaboration re-analysis is cited, but I wonder what that really is? If they do not have full data, and its clear they should not if the problems with patient privacy apply (absurd as that argument is), then how can they do a proper analysis? What recovery definitions will they use? Will they be happy with a mildly ill 30 year old regaining physical function of a 65-85 year old and then claiming thats recovery?

    Someone also asserted that PACE demonstrated the treatments are safe. Based upon the known pathophysiology this is itself a very unsafe remark. I don't recall the exact figure but were there not many hundreds/thousands of claims of harm, but nearly all failed to make the arbitrarily strict definition of harm used?
    WillowJ, taniaaust1 and Valentijn like this.
  5. Stukindawski

    Stukindawski

    Messages:
    79
    Likes:
    160
    ME advocacy is in a crisis of public legitimacy, for this very reason.

    While the importance of continued work on supporting research remains ever important, I have to admit that the content of this debate leads me to believe that, ME/CFS in the UK has been all but utterly defeated on a media level in the UK.

    The time for a rational professional patient lobby group with stated aims who will play the PR game beyond any personal pride may well be upon us.

    We need to step up and we need as much unity as possible, with a focus on what we agree upon as opposed to what we do not.
    Mark, Bob, Valentijn and 1 other person like this.
  6. user9876

    user9876 Senior Member

    Messages:
    759
    Likes:
    1,825
    I would have thought that a placebo control group would need to be a treatment rather than a management strategy. As I understand it SMC and APT were never intended as cures hence they do not control for the effect of being given a treatment that cures patients.

    At one level they get away with this because they are seen to be comparing different possible treatments however as an experiment they have failed to control for a treatment vs management strategy variable.
    WillowJ likes this.
  7. user9876

    user9876 Senior Member

    Messages:
    759
    Likes:
    1,825
    For those who don't know Lord Winston was a professor of reproductive health at Imperial College. He also made some TV documentaries and is a labour peer. I would describe him as being at the heart of the british medical establishment,

    Hence I find his views interesting. Basically I suspect for this debate he has skimmed the papers and taken them at face value because they come from "very prestigious departments of medicine". This is the attitude that we are basically fighting against, that is that good universities do good well formed research. Others in the medical establishment are not questioning enough and see no reason to be. They are happy of course to question big pharma as they see a nasty profit motive here and they forget that the same "very prestigious departments of medicine" are often the ones doing the trials that don't get or get selectively published.

    What we need to some kind of shock to push the medical establishment from their comfort zone. A widely accepted biomedical cause could be such a shock.
    Roseblossom, SOC, Dolphin and 3 others like this.
  8. alex3619

    alex3619 Senior Member

    Messages:
    7,230
    Likes:
    11,368
    Logan, Queensland, Australia
    My nightmare scenario is that the shock will occur with a major ME outbreak, something so big it cannot be ignored. Its better to get things moving before something like that happens.

    In my opinion, any major biomedical finding as to cause will be subjected to intense scrutiny for years, then denied vehemently or be otherwise reinterpreted for years more. Unless its very very convincing I expect it will take 5-10 years to have an impact.

    The imminent publication of DSM-V is going to change the game for everyone. It will be used to discredit biomedical findings but its also going to create huge opposition to unsubstantiated hypothetic psychiatric diagnoses. With 7% of healthy people diagnosable with SSD, and up to 25% of people sick with a purely physical disorder also at risk of a highly unreliable diagnosis, there may be new opportunities for advocacy.

    See for example:
    http://www.psychologytoday.com/blog.../why-did-dsm-5-botch-somatic-symptom-disorder
    snowathlete and Valentijn like this.
  9. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,338
    Likes:
    9,102
    Amersfoort, Netherlands
    The link in the article indicates the DSM-V will be rolled out in May, which is also when our ME/CFS day is. Maybe some protests would be a good thing to plan for around that time.
    snowathlete, taniaaust1 and alex3619 like this.
  10. Stukindawski

    Stukindawski

    Messages:
    79
    Likes:
    160
    Prof Winston's parry to a perfectly literal question on Twitter is quite telling:-

    It's like he's been briefed on how to derail legitimate enquiry.
    Valentijn likes this.
  11. taniaaust1

    taniaaust1 Senior Member

    Messages:
    7,989
    Likes:
    4,967
    Sth Australia
    When that DSM-V is rolled out. I think ME/CFS patients are in danger everywhere of things possibly becoming like the English situation.. The psychs will then have a new recognised mental health catagory to throw us all in.. and then say that proves that ME/CFS is a mental illness.

    Watch out for a big new wave of Wessely studies etc.. showing how many ME/CFS people fit the new mental health diagnosis. I do not doubt at all that will happen (golden NEW study opportunity for him and others like him..their other stuff is all like getting too old and people must be starting to get bored with all that old stuff).

    It sucks..that will happen while all the while..things like Ampligen probably wont get more studied. The ME/CFS community NEEDS to work out efficient fund raising strategies like the heart foundation, diabetes foundation and other illnesses have (with that they also do good advocacy for their illnesses).. so we can start getting some good money in to go towards the studies we need to be happening. We possibly are in a worst situation then we've previously been in.

    Unless we can do what the other orgs do to get good fundraising money in (with then includes more studies done and advocacy).. things are going to go very very downhill I think and that could happen quite quickly.
    Dolphin, Jarod and Valentijn like this.
  12. snowathlete

    snowathlete

    Messages:
    2,155
    Likes:
    2,513
    UK
    "I'm an ME patient, get me out of here!" Man, I wish I could leave the UK. It's a joke.
    Wildcat, Min and pollycbr125 like this.
  13. Jarod

    Jarod Senior Member

    Messages:
    764
    Likes:
    431
    planet earth
    In the Unites States there is a huge push right now around "mental illness" and "mental health" by the media.

    The discussion revolves mostly around Gun Control, and more government funded "mental health services" as a result.

    It's interesting how the media debate flops back and forth between "mental illness" and "mental health". The terminology changes depending on whether the debate is about limiting access to firearms, or advocating for more mental health services.
    Valentijn likes this.
  14. peggy-sue

    peggy-sue

    Messages:
    2,494
    Likes:
    2,872
    Scotland
    Alex, the placebo effect does not have to be in response to a drug - it is a response to what the person believes is a treatment - so "psychic surgery" - where the person gets their tummy manipulated and pummelled and pounded with a lot of animal blood and clots being thrown around will induce the placebo effect in those susceptible to it.
    It's why folk respond to acupuncture - it's a treatment. Recent research has proved that it actually doesn't matter where the needles are put!

    So controlling for placebo effect is absolutely relevant and essential to a study on CBT and/or GET.

    And for a large population of subjects who get absolutely no help or even basic SMC? - come to Scotland.
    We all fit that category here.:p
    (apart from perhaps a few who do have a human being for a gp who might be trying to help a wee bit)
    Dolphin likes this.
  15. maryb

    maryb iherb code TAK122

    Messages:
    2,816
    Likes:
    1,921
    UK
    Robert Winston is a man who epitomises the medical profession in this country, its a closed shop, he revers his peers (the likes of Wessley White etc) he won't have done any in depth research himself, all he will know is the same as most GP's are taught. Its not his area of expertise but that doesn't stop thim pontificating about stuff he knows nothing about. The arrogance is astounding.
    They truly are told, go out, act as god and heal the world when they leave medical school.
    I have not a shred of respect for them.
    Shell likes this.
  16. alex3619

    alex3619 Senior Member

    Messages:
    7,230
    Likes:
    11,368
    Logan, Queensland, Australia
    The placebo effect in studies is based on the idea of a sham treatment. With drugs thats easy ... give an inert pill, presuming it does not cause issues as sugar pills might. How do you do that with a psychiatric talk treatment? Or exercise? You can give sham treatments that are not drugs, but the practitioner or whoever also needs to be unaware in an indeal situation. How do you do that with a psych intervention? I don't think its possible.
    WillowJ likes this.
  17. user9876

    user9876 Senior Member

    Messages:
    759
    Likes:
    1,825

    I thought Alex was saying it is hard to get a control group for a placebo effect in a non drug trial not that the placebo effect doesn't work. The point is in a drug trial you can give someone a tablet with or without an active ingredient hence this controls for all the other variables bar the active ingrediant. Much harder with a non drug intervention where the 'active ingredient' is obvious to the patient.

    Perhaps it would have been more interesting to have used a tablet as a control group telling people they were antivirals or something like that.
  18. alex3619

    alex3619 Senior Member

    Messages:
    7,230
    Likes:
    11,368
    Logan, Queensland, Australia
    Hmmm, use a sham drug as a placebo control for a CBT/GET intervention? Interesting. You could only do it once though, and hope they don't use the internet. You would also have to fool the people handing out the drug.
  19. pollycbr125

    pollycbr125 Senior Member

    Messages:
    353
    Likes:
    180
    yorkshire

    yep me too and I don't care where tbh theres nothing great about great britain anymore unless you happen to be in the top 1% and if your in the sick/disabled/unemployed bracket your totally screwed . I know many over the last 5 years who have emigrated to places like new zealand and canada and they are all having a great life compared to here . Ive heard even eastern europeans are making tracks back home in their droves too .
    Valentijn, Shell, Wildcat and 2 others like this.
  20. user9876

    user9876 Senior Member

    Messages:
    759
    Likes:
    1,825

    Thats why I thought an antiviral or even immune system modulator story might work. I just think the use of standard medical care or pacing (which I assume patients are doing anyway) offers no real control at all so they needed to be a bit more creative. But you are right that it would be hard to repeat.

See more popular forum discussions.

Share This Page