#MEAction petition: "NIH: Put ME/CFS patients at heart of research design process

[Sasha]

Off we go!

http://my.meaction.net/petitions/nih-put-me-cfs-patients-at-heart-of-research-design-process

The asks:

Therefore we, the undersigned, ask the NIH to:

• include patient representatives in the design process of this and future NIH ME/CFS studies at the earliest possible stage;

• set up a transparent and participatory process for the selection of those representatives; and

• not move forward with this study until input from the patient representatives has been incorporated.

...and there's reference to the ref-flag issues such as the FMD group (though it's up-to-date about that) and Walitt (though not by name).

Let's get some signatures on this thing in time for tomorrow's meeting!

 

[ScottTriGuy]

signed and facebooked.

 

[Scarecrow]

Thanks to everyone who contributed to getting this petition off the ground.

 

[BurnA]

I don't want to put a dampener on things but my first reaction is ...another petition ? And why now ?
Would it have made more sense to wait until they had a chance to respond to the list of questions ?

Nath has previously said he welcomes patient involvement so why do we need a petition ?

I'm all for patient involvement but we all know the flaws - Walitt and patient numbers/ control groups.
They are probably the few things we all agree on to some extent.
If we get into any more detail than that we'll all be arguing like cats and dogs soon I imagine.

Maybe I'm just frustrated by the whole thing so apologies if I have missed something obvious. I'd like to think we can move on from petitions and have useful engagement.

 

[Simon]

I support this petition, and have signed - but it's not as a pop at the NIH, who I think are making very encouraging noises on engagment.

I strongly believe that involving patients as partners in research leads to better, more valuable research. And that would apply to all other mecfs studies by other researchers, as well as medical research on other illnesses.

The NIH do look like they are ready to engage, and I very much hope they will take patients on board as partners.

This is good from the UK "Involve" intiative

INVOLVE defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.

This includes, for example, working with research funders to prioritise research, offering advice as members of a project steering group, commenting on and developing research materials, undertaking interviews with research participants.

Set up by the NIHR, which seem to play lip service to this in practice, but the principles remain sound

 

[Sasha]

Would it have made more sense to wait until they had a chance to respond to the list of questions? Nath has previously said he welcomes patient involvement so why do we need a petition ?

I'm all for patient involvement but we all know the flaws - Walitt and patient numbers/ control groups.
They are probably the few things we all agree on to some extent.
If we get into any more detail than that we'll all be arguing like cats and dogs soon I imagine.

Maybe I'm just frustrated by the whole thing so apologies if I have missed something obvious. I'd like to think we can move on from petitions and have useful engagement.

Regardless of what Nath says in response to the specific questions over Walitt, etc., this petition ask for the NIH to include us right at the beginning of the design process in all future NIH ME/CFS projects, as they should have with this one. The petition isn't about the specifics of this study, it's about the process of patient involvement and it's crucial.

They should never have got as far in study design without us as they did - and by failing to include us from the beginning, they've caused enormous suspicion and anger. Their process needs fixing, and that's what this is about.

Definitely worth signing. I'd love to see this one get a ton of signatures. We're with the NIH for the long haul, and we've got to make them see we won't be left out like this again.

We've got to show them we're watching. And if Nath is under pressure from within the organisation to have stupid bolt-ons like the (now defunct) FMD group, a petition by 10,000 patients will help him resist that pressure.

 

[Sasha]

101 signatures! The petition has earned its first

Sign the petition, tell your family and friends, put it out on Twitter and FB...

 

[A.B.]

I think more than a petition we need a concrete plan on how to realize the goal of including patients in study design and research directions.

There is a downside to this as well. By including patients into the process, more people need to be consulted. Potentially more work has to do be done before arriving at a consensus.

And how does one arrive at a reasonable panel of patient advisors to the NIH?

It's worth thinking about these things and maybe propose a more detailed plan at a later point.

A good starting point would be looking at some other disease whose patient community was able to realize this goal.

 

[Sasha]

I think more than a petition we need a concrete plan on how to realize the goal of including patients in study design and research directions.

I think the two go together. The petition calls on the NIH to "set up a transparent and participatory process for the selection of those representatives". We need both the plan and the political force - demonstrated by numbers signing a petition - to get it implemented.

 

[BurnA]

Regardless of what Nath says in response to the specific questions over Walitt, etc., this petition ask for the NIH to include us right at the beginning of the design process in all future NIH ME/CFS projects, as they should have with this one. The petition isn't about the specifics of this study, it's about the process of patient involvement and it's crucial.

They should never have got as far in study design without us as they did - and by failing to include us from the beginning, they've caused enormous suspicion and anger. Their process needs fixing, and that's what this is about.

Definitely worth signing. I'd love to see this one get a ton of signatures. We're with the NIH for the long haul, and we've got to make them see we won't be left out like this again.

We've got to show them we're watching. And if Nath is under pressure from within the organisation to have stupid bolt-ons like the (now defunct) FMD group, a petition by 10,000 patients will help him resist that pressure.

I am all for patient involvement and I agree with everything you have said but I'm confident that the NIH or Collins has got or is getting the message.
And if not, I'm confident that further engagement will further enforce the message.

Sometimes its a good idea to let the dust settle and see where we are.
They have already showed signs of listening by removing the FMD group. Why do we need a petition right now ?
I think after tomorrow we will have a lot more information. What happens if we don't like what we hear tomorrow ? Another petition ? Why not wait and see what happens next before using up more ammo ? The ball is in their court, lets see how they play it before we take our turn.

Just to be clear, I am not against this petition in what it is requesting, I am questioning the timing of it. It is either a week too late or possibly a day too early.

 

[viggster]

I am not against this petition in what it is requesting, I am questioning the timing of it. It is either a week too late or possibly a day too early.

I agree here. Koroshetz, Whittemore, Collins, and Nath have all repeatedly heard - and acknowledged hearing - that patients want a seat at all the tables for the new ME research program. I don't see the point it throwing another petition at them that repeats what we have repeatedly told them over the past few months. What's wrong with waiting for a response to these already-made requests and then deciding what actions to take? Also, at Nath's CDC presentation, he said there will be a patient advisory committee. So you are petitioning the NIH for something that it has already said it will do.

 

[Comet]

I am all for patient involvement and I agree with everything you have said but I'm confident that the NIH or Collins has got or is getting the message.
And if not, I'm confident that further engagement will further enforce the message.

Sometimes its a good idea to let the dust settle and see where we are.
They have already showed signs of listening by removing the FMD group.

I have mixed feelings about this petition. I am all for patient involvement in the research process. I think most of us would agree that after decades of neglect this is imperative so that research stays relevant to our disease and to our symptoms.

But I am also still enjoying the small victory of us being heard and responded to with the removal of the FMD group from the study. Just my opinion, but I think sometimes you have to pick your battles.

 

[Simon]

On reflection, maybe this is a little premature and we should wait til we see what happens in today's call with the NIH (10am ET, 3pm GMT) before making any further moves.

By dropping the FMD control group the NIH have shown they are willing to respond to issues raised by patients (which is they central issue here) and hopefully a more formal role for patient input will follow soon.

 

[Sasha]

On reflection, maybe this is a little premature and we should wait til we see what happens in today's call with the NIH (10am ET, 3pm GMT) before making any further moves.

Not much longer to wait...

Looking forward to seeing how that call goes. I'm hoping it will be all good news.

 

[aaron_c]

There is part of the petition that I did not understand. Perhaps I should have asked the question here before I flagged it for them, but here was what I wrote to them:

I still do not understand the "controversy" surrounding Post-Lyme condition, specifically whether you are referring to the lack of sensitivity in testing for Lyme's Disease or something else. And although I take your point about the lack of research into Lyme's Disease possible connection with ME/CFS, I am not sure that research done using Fukuda is enough of a bedrock to build this tower upon.​

I am willing to be convinced otherwise, but at this time I feel that combining important objections to elements of the study or study authorship that might contribute to the furthering of the psychogenic school of thought with less important objections to the Post-Lyme control group weakens our position where it matters most.​

I understand that allies in any fight will not always agree on tactics, and I hope that you do not take my objection as a personal attack in any way. I appreciate all yall do for those of us with ME/CFS.
​

In short: Does anyone understand the whole Lyme's Disease control objection and why it gets a place alongside what I can see are important issues?

 

[Sasha]

In short: Does anyone understand the whole Lyme's Disease control objection and why it gets a place alongside what I can see are important issues?

There's an explanation on the supplementary page to the petition (linked to from the petition's front page).

http://www.meaction.net/patients-concerns-about-the-study-design/

 

[aaron_c]

There's an explanation on the supplementary page to the petition (linked to from the petition's front page).

I saw that, and what I posted was more or less a reply to that blurb. It didn't answer my question about what controversy they were referring to in regards to Lyme's Disease diagnosis. It also doesn't explain to me (and I see now that this forum is probably the better place to ask) why a post-EBV control group, for instance, would be that much better than a post-Lyme control group.

For the record, Valentjin had to explain to me why it was important to remove the FMD control group--so I am not coming to this from a place of deep understanding. Just curiosity.

 

[duncan]

@aaron_c , for one thing, many believe that no one can say that anyone is definitively post-Lyme or not.

Another issue is ticks often don't just infect with Lyme; when they bite, they deliver other pathogens like Bartonella and Babesia. When this happens, there is often a lag between the bite and an active infection. Compound that with really poor testing - some say worse than Lyme testing. The end result with this proposed healthy control could be individuals with many silent infections.

Lyme is just as controversial in many regards as ME/CFS. It is the proverbial hot potato. Why on Earth would the NIH advocate using such a hotly contested control in the already controversial area of ME/CFS?

 

[Bob]

In short: Does anyone understand the whole Lyme's Disease control objection and why it gets a place alongside what I can see are important issues?

I had the same questions as you, and struggled to find convincing answers, but @Valentijn posted some very helpful thoughts, here:
http://forums.phoenixrising.me/index.php?threads/details-on-nih-study.43076/page-29#post-704721

 

[aaron_c]

Thanks @Bob and @Valentjin, that was exactly what I was looking for. The parts I particularly like:

My main objection is that they weaken the statistical power of the study. A few of the dodgier investigators have engaged in such behavior before, using multiple control groups. The result is that there needs to be a huge difference in a lab result between the patients and a control group for it to have statistic significance. Anything more nuanced or representing a subgroup is completely lost. And depending on the ethics of those investigators, they will gloss over the lack of power and present the study as a straight-forward null result. I do not want them to have the opportunity to do that again.

When comparing ME to something, it should be compared to something which is very well understood. Otherwise, we don't know what we're comparing it to, or what the similarities and differences mean. Generally I would not be opposed to that happening, but it should not be happening in a preliminary exploratory study, especially when the results could impact on Stage II and Stage III of that study, or on prospects for further studies.

[emphasis added]

This is the nuance that I was looking for. Because I can't see a scientific comparison between Lyme's Disease and ME/CFS as a terrible thing...but I can see now how it could harm further understanding when placed within the limits of this study.