Phoenix Rising tells QMUL: release the PACE trial data
Mark Berry, Acting CEO of Phoenix Rising, presents the Board of Directors’ open letter to Queen Mary University of London (QMUL) urging them to release the PACE trial data, and hopes that other non-UK organisations will join British charities in the same request...
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#MEAction soliciting community input for protest demands

Discussion in 'Action Alerts and Advocacy' started by JaimeS, May 10, 2016.

  1. JaimeS

    JaimeS Senior Member

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    The U.S. demands for the protest were originally intended for the protest in Washington D.C. alone, but over time, #MillionsMissing has grown into an international, multi-city protest. With that in mind, we will have an open meeting on Wed. May 11th, 2 pm EDT to discuss the demands and receive input from the community. We will also be using this time to check in with the satellite protests to ensure that everything is running smoothly. Please make sure you have a representative from the satellite protests present, if at all possible.

    These demands are a living document. After the protests on May 25, the demands will evolve as #MEAction receives input from the community and when we can gauge government response. MEAction.net will be setting up a mechanism for receiving that community input.

    Please read the existing demands first, before making suggestions! (Needless to say?)

    RSVP for the Global Demands Call

    Register for the call by clicking the link above. Thank you for your time and input!
     
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  2. JaimeS

    JaimeS Senior Member

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    To clarify, we're considering discussion regarding the document

    We want input, but won't have the time / bandwidth to alter demands on the fly, before the protest. We're planning on revisiting them in an official capacity after the protest itself is over.

    -J
     
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  3. Esther12

    Esther12 Senior Member

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    Thanks for trying to organise this. Some of the discussions we've had on PR about what shared goals we all have show how difficult it is to get a consensus on anything.

    I'm not going to be able to attend, but had some comments:

    What if they don't find good evidence to support the value of any of these treatments? I worry that this bit sounds like you want lower standards for FDA-approved medications. I thikn that we need higher standards before claims are made about effective treatment, for medications and CBT/GET approaches.

    I have no idea what I'm talking about here, but is there a danger that if this demand is followed, it will make trials much more expensive and complicated, and thus much less likely to take place at all? How would we assess the costs and benefits of this demand?

    I worry that demand 3 focuses too much on the IOM report finding that CFS was not a psychological condition. That in itself does not mean that CBT and GET should not be sold to patients as effective treatments for CFS. It's the poor quality of evidence underpinning the claims of CBT and GET's efficacy that is the problem. I think it would be better to argue that all treatments should be held to the same standards for research, and that nonblinded trials relying on subjective self-report outcomes should not be seen as providing reliable evidence of efficacy for pharmaceutical or behavioral interventions.

    I think that it's likely that some people's view that CFS is best understood as a psychological condition has played a role in encouraging the view that it is okay to mislead patients about treatment efficacy in order to encourage 'positivity'. That shouldn't be the case even if CFS were a psychological illness, but emphasising the importance of honest and accurate information is important.

    I wonder if it would be worth asking for an apology for some of the specific poor quality CFS research we've seen, as well as a commitment to holding researchers to higher standards in the future. This is the sort of thing that those in medical research would probably hate, but I don't think it's unreasonable.
     
  4. JaimeS

    JaimeS Senior Member

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    Is that something in HHS's power to grant?

    I see your point, here. If nothing is working, no one can conjure an effective medication out of thin air. However, all of these currently seem promising... note, too, that the demands lists these as suggested meds.

    This is another really good point. It's well-known that the inclusion of severely-ill patients ups costs and investment of time considerably. However, I think Ron Davis is on the right track: in severely ill patients is where we will see the most profound dysfunction and the most out-of-range results. The question becomes, do we want studies on minor-moderate patients, who may kinda-sorta show results if we get enough subjects, or 18 people who may all show the same, dramatic dysfunction, giving us reasonable paths to follow?

    I'm playing devil's advocate; of course there's no guarantee! However, I do think that there should be studies on the sickest of us, even though that incurs extra cost, because that is where we have the greatest likelihood of discovering dramatic dysfunction.

    Additionally, the funding we are asking for would make this sort of study more feasible.

    Note: none of this is the 'official' party line; I had no hand in creating the demands. The official explanation / rationale people may hear from the crafters of the demands (who were many) may differ.

    -J
     
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  5. A.B.

    A.B. Senior Member

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    Agreed with the need to greatly increase funding. It needs to explicitly say "biologically oriented reseach" though. One can never be cautiousd enough.



    I think it's a mistake to focus on clinical trials so much. We do need trials on severely ill, but it's not practical to demand that every trial include this patient group.

    An important point is that if the biological basis was understood, there may be no need to distinguish between severe and mildly affected. I think this distinction is made because there is the suspicion that there may be different diseases.

    We need to sort this uncertainty out and focus more on actually understanding the disease process and finding biomarkers. Without a biomarker it will be hard to make progress, unless we are very lucky and by sheer luck stumble across a medication that works well enough in a large enough number of patients (Rituximab might be this medication).

    Yet another symptom of our nearly total lack of understanding is the endless debate about definition and the name. This would end quickly if the biological basis was understood.

    Besides clinical trials we also need to understand the disease better! If it was understood, many of the problems in this area would just go away.

    Consider taking ideas from The biological challenge of myalgic encephalomyelitis/chronic fatigue syndrome: a solvable problem.

    So to sum it up, clinical trials yes, if there are promising medications to test. Otherwise focus on understanding the disease.


    Also going to agree that a smarter way to argue for the removal of CBT and GET from educational material is that the evidence for their use comes from p-hacked trials without placebo controls and little to no improvement on objective outcomes. Demolishing the pseudoscience on a scientific level is more effective than insisting that it's wrong - it could make us look like science deniers in the eyes of people without special knowledge on the topic (which is pretty much everyone).
     
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  6. JaimeS

    JaimeS Senior Member

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    I understand, and I did read the paper you referenced. ;)

    In the words of that same paper, people are desperate for something to improve their QOL, hence this focus. The point is in approving these meds for ME/CFS so that people's insurance will have to pay for them (at least in the U.S.; I'm not sure how it works, elsewhere.) This is a small step in the grand scheme of things, since the clinical trial for Rituximab (Phase III) is already underway, and it will (or won't) show that there is improvement in our condition. Once this trial is over, if it shows positive results and the study is examined with due diligence, I hope the paperwork saying Rituximab is approved for ME/CFS moves through the system so fast it catches on fire.

    IF the Phase III looks successful -- IF the study genuinely reports its findings (hey, if you're reading this, open data PLEASE, so nothing is kept in the dark) -- IF there aren't a significant number of adverse events -- then and only then do I hope that the US government greases the wheels of bureaucracy so that we can get a medication that can significantly better our lives.

    That isn't something that is costly in terms of time or energy, though, in the case of Rituximab: it's a pre-existing, already FDA-approved drug and a currently-underway study... there's nothing huge to fund, just a request to ensure it is approved swiftly by the FDA for our illness, should the research support that.

    110% agreed. It's not just that it's harmful, insulting, degrading and patronizing. It ALSO doesn't work, and the researchers tried to fudge things so that it looks like it does work; and that's where the emphasis should be. Logic > emotion when it comes to this sort of thing.

    -J
     
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  7. duncan

    duncan Senior Member

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    Sorry, I called in for the conference call, but had to hang up before comments/suggestions.

    If I had spoken, I would have something along the line of, as I see it, two of the greatest hurdles confronting the ME/CFS patient community are:

    1) Potential researchers and clinicians not appreciating the need for new research, because not enough researcher understand the severity and prevalence of ME/CFS;

    2) A misplaced belief that there is a psychological basis to ME/CFS.

    HHS is in a position to remove or lower both of those hurdles. With these problems resolved, funding, trials, education,etc should follow more easily. I do appreciate the catch-22 quality here.

    I also appreciate that both of these issues are addressed in the body of the complaints. My observation is where they are embedded; rather, that perhaps they would be better positioned up-front and center since they act as a pivot point for the other issues so well articulated in the demands.
     
    Last edited: May 11, 2016
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  8. BurnA

    BurnA Senior Member

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    But what happens if they concede to all the demands on the 25th ?
     
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  9. BurnA

    BurnA Senior Member

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    Ok serious reply this time, I like the demands apart from the clinical trial section.

    I don't like the idea of specifiing a quantity of trials.
    I am not sure how relevant the FDA are to clinical trials taking place. They approve trials but I doubt they are the bottleneck. Probably worth getting proper advice on this matter.


    I think incentivising is a good idea but again I dont like specifiing a quantity of drugs.
    I only want trials performed and drugs approved if they are worthwhile, specific numbers can't really be brought into it. One blockbuster might work or 10 drugs might be required, I don't see the relevance of at least 2 drugs. This could put the focus on approving 2 fairly inadequate drugs, versus approving 1 proper drug.

    Also would be hesitant to say 'must' include severe patients.
    Why must a clinical trial include severe patients ? If Olav Mella was held to this demand the rituxme trial would not be going ahead right now. We dont want to tie ourselves up unnecessarily.

    For funding, what is the difference between RFAs and extramural research ? My impression is the figures are way too low in the RFA section but I'm not 100% clear on their meaning.

    All in all I think these demands are a great idea and a very good first attempt. But some more thought needs to go into the specifics.

    Absolute words ( or numbers ), especially need to be carefully considered for their appropriateness.
     
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  10. JaimeS

    JaimeS Senior Member

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    We dance wildly about a celebratory campfire until we all collapse with PEM!
     
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  11. JaimeS

    JaimeS Senior Member

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    OMG I had a long reply to you, @BurnA and then my computer crashed. :eek::mad::mad::mad:

    Okay, to summarize:

    -- Being specific is important because otherwise we (and they) won't know what meeting the demands looks like.
    -- These numbers were well-researched before inclusion. The 250 million is from disease burden; the RFAs are from similar data from other once-ignored illnesses, and how they turned things around; even the numbers of clinical trials are based off of knowledge of how fast it takes to get one underway. We have had a lot of great input from the AIDS/HIV organizers, which is where some of this information has come from.

    Additionally, if you would like to learn more about RFAs, please refer to the thread where I announced the protest demands; they were explained at length. ;)

    -J
     
  12. BurnA

    BurnA Senior Member

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    Sorry to hear your computer crashed !

    I agree totally about being specific in terms of $ amounts. It's an easy measurable way to determine if a goal is met. And, it's the most important requirement overall.

    My main comments were relating to the clinical trial section. I don't see how being so specific here is a such good thing. If it was worded in such a way that clinical trials have to happen then I would have less of an issue but to specify that drugs need to be approved is something that is beyond control.

    Generally I would think, if the $ figures are met then drugs and trials will follow. They aren't mutually exclusive and for me, better research will lead to better trials and drugs.

    Thanks for the pointing me to the other thread - maybe put a link to it somewhere in your original post ?
     
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  13. Mark

    Mark Former CEO

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    When you compose a post on PR, there should be a draft that is saved periodically: I think we have a plugin that's supposed to do that. So even after your computer crashed, you should have found your half-written post still there when you came back to the thread. Sometimes you might have to reload the page once or twice to get the draft to come up. I think there may also be a 'drafts' button somewhere, but if so, I can't remember where it is right now...perhaps somebody else (@Kina?) can clarify how the drafts feature works? So...it's just possible that your post is still there, somewhere...it may now be too late though, because you've already replied again on this thread and that may have overwritten the previous draft.

    The other thing you can do to make sure this sort of thing never happens to you again is to install the Lazarus add-on; I have this installed on Firefox, and it saves drafts of everything you type into web forms so that you can go back if you ever get interrupted mid-post. I strongly recommend this; if you ever do need it, you'll be very glad you installed it.
     
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  14. Kina

    Kina

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    Drafts are saved every sixty seconds and stored for 24 hours. If you have composed a post and a draft has been saved and then close your browser by accident, if you go back to the thread you were composing your post on, the draft will be there for 24 hours.

    I often compose posts on my iPad and then get fed up. I go to the same thread on my laptop and the draft is there. You can also manually save a draft by clicking on the 'Drafts' button:

    Untitled.png
     
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  15. JaimeS

    JaimeS Senior Member

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    Usually, yes, Kina and Mark! I typically find my message in the box, even if I accidentally navigate away. That did not happen this time for some reason.

    @Mark -- that add-on sounds useful! I will find it.

    -J
     
  16. Justin30

    Justin30 Senior Member

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    They had severe patients in the trial. 5/100, 10, 100 those in my eyes are severe......

    Severe patients represent 1/4th of ME patients.

    It is the fault of the government for letting it get so out of hand.

    The most severely ill need the most help so why would you ignore them? Let them suffer more than the 75% combined?

    Look at Whitney and 100,000 of thousands of others like him in the US and Canada Alone....

    I dont understand what you mean by "tie ourselves up unneccessarily" can you please elaborate?

    If it wasnt for the most severe bed bound patients Ampligen would never had been tried on an ME patient. Petterson talks about this first approval of Ampligen and it started to get used.....

    May I also mention @BurnA that it was determined that only I believe 13% of people with ME work full time...as per Leonard Jason so what does that say for the majority of the people with the illness....?

    We overall have the lowest QOL Scores of any disease on the planet and if the government doesnt represent all of us and investigate all of us the bedridden will be left to Rot and Die like many have been since the first outbreaks in the 50's.

    Everyone needs to be studied and subsetted bottom line
     
  17. taniaaust1

    taniaaust1 Senior Member

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    "The clinical trials must include severely ill, homebound patients, and must be overseen by an advisory team of ME/CFS specialists and researchers who best know the needs of this patient population."

    I personally think that last part of this should be left out as it could put off some studies being done if that was a requirement.. what is some researchers cant find an advisory team of ME/CFS specialists and researchers? Not only that just cause a group may be seen as being ME/CFS advisers who are specialists/researchers, it doesnt mean they are good.

    What if the Wessely schooler researchers/specialists went and set up an ME/CFS advisory team to offer themselves as this to all the researchers out there wanting to do ME/cfs studies due to new rules which get put into place due to what is being asked here?

    We could end up in a far far worst place then we are right now. (it may end up having worst impact then the media centre in the UK has had on the ME/CFS field.. they give advice and approve things and look where that got things over there). So I think this idea while they are out there and generally accepted by the medical profession as being specialists in this, is a very very bad idea.

    Please dont push that last idea, I can see it as being disasterous to us and a play right into the psych schools hands.

    I personally do believe studies should include the severe group but for some studies it may not be suitable to include this group eg a 2 day exercise stress test study, well one couldnt put a severe ME person from the 25% group throu that.

    Maybe it would be better to push that any study not including this group show a strong clear disclaimer saying the study may not be represent many who have ME/CFS so may not be representive to all of us esp the severe group
     
    Last edited: May 18, 2016
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  18. BurnA

    BurnA Senior Member

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    Sure, let me try to explain.
    First I was certainly not suggesting to ignore anybody. The more studies done on the severe patients the better imo. But if we want more studies on severe patients then let's demand that - why not incentivise or allocate funds specifically deidicated for studiing and performing trials on severe patients. This would seem straightforward and measurable and a good idea.

    By tie ourselves up unnecessarily I mean we should be careful about imposing requirments where it could impede research.

    The example I gave about Fluge and Mella not including severe patients was the basis on my point - they chose not to include severe patients for the reasons they gave. If the demand was worded incorrectly this could potentially cause a study to be jeprodised - that was my point.

    I'd like to stress my point was about careful wording in terms of specifics, not about wanting to exclude or include anybody for the sake of it.

    I think a good way to come up with demands is to identify the needs one by one and then word the demands appropriatly.

    In the case of clinical trials, for me the need is more of them in general and more of them on severe patients. But if we combine the two needs into one demand it doesn't necessarily gain anything.

    I am open to all suggestions and really want the best solution. I think it requires careful thinking that's all I was saying but let me know if you want more clarification.
     
  19. BurnA

    BurnA Senior Member

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    I just re-read the demands again and to me it's fairly explicit that the clinical trials must include severely ill patients.
    They also explicitly mentions rituximab.

    This would seem at odds with what Fluge and Mella are doing.

    Of course, I believe clinical trials should include severe patients but must every trial include them or what is the intention ?

    Would be good to get other peoples interpretations of this demand.
     
  20. JaimeS

    JaimeS Senior Member

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    I'm not sure how tough that will be.

    ...but that is a very good point.

    Regarding everyone's comments, we are setting up some infrastructure to hear comments from the patient community after the protest. These are important ideas, and I think you all should convey them there. As previously stated, we are not shifting them on the fly, but will revisit them after the protest on May 25.

    -J
     

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