"NIH to patients, 'We are your partners'" by Simon McGrath

[Dolphin]

http://www.meaction.net/2016/03/21/nih-to-patients-we-are-your-partners/

 

[aaron_c]

As the Russians say: Trust, but Verify.

 

[Snow Leopard]

As the Russians say: Trust, but Verify.

Well said!

 

[Forbin]

As the Russians say: Trust, but Verify.

Well said, indeed!

Russian: "Доверяй, но проверяй"

English: "Doveryai, no proveryai"

Pronounced: "Doh-vee-eye, no pro-vee-eye" (at least by Ronald Reagan)

[Actual Russian pronunciation sounds more to me like "Doh-vee-Ray, no pro-vee-Ray" with a sort of soft "ch" sound swallowed at the end of both uses of "Ray."]

[Considered an old Russian proverb or maxim.]

 

[Sasha]

Great article, @Simon - and some very interesting comments on it at #MEAction.

 

[TiredSam]

Vertrauen ist gut, Kontrolle ist besser!

Attributed to Lenin:

https://de.wikipedia.org/wiki/Vertrauen_ist_gut,_Kontrolle_ist_besser!

 

[duncan]

We are not their partners.

 

[jamie]

He also highlighted the key role patients who take part in the study will play, saying the history of medicine shows how doctors can learn from patients.

So who do the patients in the study interact with that will make such a difference? Who is the coordinator or go between with the patients and the higher ups? The "expert" clinicians? I don't see Collins or Koroshetz having chats with them about how they feel after the excersize test. My guess is that Walitt and his friends will be the ones to both interact with and ask patients questions, chose the patients and they will relay what they chose to to their bosses.

And I love how they said they are listening and this call is proof as they put up their study specifics on line just as the call started so they knew nothing said during that call would change anything and give us no time to read it and respond.

If they had any input from patient groups as they said they did in creating this study nobody would have let those controls happen or the reeves criteria or the selecting of patients left to unqualified people. So I think they were lying about that or exaggerating broad discussions as real input.

That call was theater because they did not allow for any followup questions. "I'm not biased" now that's settled next question

Simon, this rant isn't directed at your article, just reading what they say vs what they've done gets me all wound up.

 

[Simon]

NIH to patients, “We are your partners”

The National Institutes of Health’s (NIH’s) ‘New Deal’ for ME/CFS, particularly the intramural study, has had a very mixed reaction from the patient community.

Patients have criticised both specifics of the study, such as using the controversial Reeves diagnostic criteria, and the failure to consult patients from the start. The lack of new cash for new studies so far has also led some patients to doubt the NIH’s commitment.


Francis Collins tells patients “We are your partners

During the recent tele-briefing the NIH was clearly trying to mend fences. Director Francis Collins kicked off the call saying, “We are your partners”, and throughout the call senior NIH staff stressed how keen they were to listen to patients.

Collins emphasised that the NIH wanted to work together with the community to crack ME/CFS. He said, “We want to hear from you, that’s why we’re having this call today. And we’re listening carefully to the comments and suggestions you might have about how best to move this effort forward.”


...The sentiments and plans are all great, and I can’t think of another ME/CFS study or research programme with anything like this level of patient engagement. The NIH deserves a good deal of credit for this work.

Of course, there is a lot of history with the NIH and patient community, where many in the community are angry with the NIH and still distrust it after decades of pitiful funding for ME/CFS. It will take time for trust to build from such a low base

....

full blog

Lots of interesting commments, inc this one from @Jonathan Edwards on bias (and I agree)

Thanks for an informative summary. My impression is that the NIH team are genuinely trying to get this right and I wish them all success – we need it. My only caveat is that if they want to convince other researchers in the field that they are unbiased they are not going to get very far saying ‘there is no bias at the NIH’. Productive collaborative science comes from everyone admitting that they are struggling to minimise the sea of bias that threatens to engulf us every minute. Good scientist joke and apologise about their biases and admit that nobody is better than anyone else from having a name on the doorway. What counts is good study design.

International dialogue in ME/CFS research is now very good and we hope the NIH team will participate in that as soon as they have some data – or even before!

A couple of comments on why the NIH hasn't invited patients to take part as partners, from people who work/have worked in US govt, are interesting about the practicalities of that (and wow, what a lot of bureaucracy).

 

[duncan]

So they didn't mean the bit about being our partners? Then why say it?

I suppose saying nice stuff has its place.

It might be hard to feel the love, though, if someone is stiff-arming you while sweet-talking.

What might be better? Removing that psych gateway to the study. Reducing the controls to one by eliminating the Lyme control. Not allowing any clinician to populate the study if they regularly endorse GET to their ME/CFS patients.

 

[Sasha]

So they didn't mean the bit about being our partners? Then why say it?

I think they're saying they want to be our partners but that federal regulations prevent them from consulting patients before a study design has been put forward - if I've understood this correctly. That is, we can only contribute in the dark before this point - and only fully once an initial design has been put forward, at which point we can start partnering.

This is unsatisfactory but if there are issues that can be worked out there, it's well worth doing it for future studies.

For now, we're in the position of having been invited to be partners at this point in time, so we can use that to try to fix problems with this proposed design. We need to move forward on this, and we certainly shouldn't be recommending that they ditch it all and start again, IMO: its 80% there.

 

[Sasha]

There really are some excellent comments on the bureaucracy issue (which we need to understand), like this one:

http://www.meaction.net/2016/03/21/nih-to-patients-we-are-your-partners/#comment-2551

Well done, @Simon - you've not only written a great article but have pulled in some excellent and helpful commentary.

 

[duncan]

It could be 99% there, but if the 1% remaining happens to have teeth and venom, it still could be dangerous.

Again, most would prefer they simply fix this stinker, not trash it totally. But I don't see them fixing much after the FMD correction.

 

[jimells]

So they didn't mean the bit about being our partners? Then why say it?

Because it is what the "communications" people tell them to say.

 

[jimells]

It could be 99% there, but if the 1% remaining happens to have teeth and venom, it still could be dangerous.

It's like accepting a ride on the back of a crocodile who promises not to eat his passenger.

 

[jimells]

NIH to patients, “We are your partners”

Tell that to Jeanette Burmeister, Dr Collins. She has a $140,000 legal bill created by HHS intransigence, hostility, and perjury, just because she filed a FOIA request. They did finally pay up, as ordered by the federal judge, but Jeanette received no compensation for the many personal hours she spent on the litigation, and certainly received no compensation for the damage to her health caused by these "partners".

http://thoughtsaboutme.com/2015/09/...unrelenting-and-unrepentant-legal-violations/

I successfully sued HHS and NIH in federal court for violating FOIA and the Judge found the agencies’ conduct to be unreasonable to a degree that led him to order both agencies to pay all of my attorneys’ fees, more than $139,000. The award of attorneys’ fees is by no means a given in FOIA cases; it requires a high level of unreasonableness on the government’s part.

If Dr Collins really wants to be "partners" he could start by apologizing to Ms. Burmeister and implementing the CFSAC recommendations. All the NIH blah-blah about "we don't know how to communicate with patients, and besides, it's too complicated" is bullshit, pure and simple.

There is already a two-way communication mechanism - it's called the "Chronic Fatigue Syndrome Advisory Committee". It's only been around since 2003. Perhaps someone should tell Dr Collins about it.

 

[alex3619]

There is already a two-way communication mechanism - it's called the "Chronic Fatigue Syndrome Advisory Committee". It's only been around since 2003. Perhaps someone should tell Dr Collins about it.

What ever happened to the investigation into the claim that CFSAC reports were being altered between being approved and being delivered to NIH?

 

[cmt12]

As it currently relates to ME/CFS, patient input is only minimally beneficial. Patients tend to be right about what's wrong, but wrong about what's right.

 

[jimells]

What ever happened to the investigation into the claim that CFSAC reports were being altered between being approved and being delivered to NIH?

Good question. I can't even remember if it was Jeanette Burmeister or Jennie Spotila who worked on that issue. I'll have to search their websites to see.

 

[Asa]

@jimells I wanna say it was Spotila (bless her (!)) who wrestled with that...
http://web.archive.org/web/20160326...pycfs.com/2014/11/24/another-cfsac-violation/

There's a good deal of info/history in the above link, but I don't believe a resolution (if one yet exists) is included there.