NIH intramural research program update

[Nielk]

Are you wondering by now why so many NIH doctors have misconceptions about the disease?

They don't have to go far for this type of information. CDC- the US health agency responsible for education for this disease has misinformed countless of doctors over the years and continues to do so today.

Just listen to Dr. Lapp's presentation at the Grand Rounds last week. He was invited by Dr. Unger to misinform thousands more.

Advocates and members of CFSAC have urged Dr. Unger to remove false information from the CDC website as well as from the continuing medical education videos.

They are still there. The damage that this type of wrong information is causing patient is immeasurable and long reaching.

 

[caledonia]

I'm not thrilled with Unger's involvement either. She also has an institutional bias against this disease. Basically a continuation of Reeves, but quieter.

 

[mfairma]

There are a lot of things that frustrate me about this study, from its content and the way it has been planned to the way the community reacts to it. But what frustrates me most, as some others have pointed out, is that we (patients, caregivers, advocates, experts) have been here a long time. We know best how to jump start our disease. If HHS really wanted to make a difference, among other things, they would start by engaging with the community to figure out what studies would most move us forward politically, to help correct this political problem that they created. My fundamental concern with studies like this, especially given all the problems discussed, is that it favors potential unknowns over relative sureties, like validating the CPET work and figuring out what it would take to make Rituxan available once the 2018 Norwegian study comes out. As a community, we get so bogged down in our reaction to the goods and bads of this study that we focus too little on the broader concerns. We have a political problem and what they have announced so far does nothing to address that problem today. I understand that this is not all that NIH plans, but will they really act in a way that will move this disease forward as quickly as they could? Not likely, I think, especially if we continue to focus on the immediate, rather than judging holistically.

 

[searcher]

I just wanted to address one small item--

My fundamental concern with studies like this, especially given all the problems discussed, is that it favors potential unknowns over relative sureties, like validating the CPET work and figuring out what it would take to make Rituxan available once the 2018 Norwegian study comes out.

I don't know the latest status on this, but I wanted to mention that the NIH have said they are working on a Rituximab trial and I believe were speaking with the Norwegian team. I think we should push to get an update from NIH on those plans. Collins mentioned some of the other internal work to Julie at http://www.meaction.net/2015/12/21/nih-considering-ampligen-and-rituximab-trials/.

 

[mfairma]

Thank you, searcher. I was aware of that. I meant that as an example to illustrate the broader point.

 

[BurnA]

There are a lot of things that frustrate me about this study, from its content and the way it has been planned to the way the community reacts to it. But what frustrates me most, as some others have pointed out, is that we (patients, caregivers, advocates, experts) have been here a long time. We know best how to jump start our disease. If HHS really wanted to make a difference, among other things, they would start by engaging with the community to figure out what studies would most move us forward politically, to help correct this political problem that they created. My fundamental concern with studies like this, especially given all the problems discussed, is that it favors potential unknowns over relative sureties, like validating the CPET work and figuring out what it would take to make Rituxan available once the 2018 Norwegian study comes out. As a community, we get so bogged down in our reaction to the goods and bads of this study that we focus too little on the broader concerns. We have a political problem and what they have announced so far does nothing to address that problem today. I understand that this is not all that NIH plans, but will they really act in a way that will move this disease forward as quickly as they could? Not likely, I think, especially if we continue to focus on the immediate, rather than judging holistically.

Regarding favouring unknowns over surities, I think we have to embrace the unknown. So much is unknown about this disease we don't have any choice if we want to learn more. The CPET work is primarily useful for diagnosis and even then it won't suit many patients. The reason it is useful for diagnosis is because we don't have a biomarker. Studies like this one should provide a biomarker which might negate the usefullness of CPET as a diagnosis tool altogether.

Regarding the political problem, it's not easy to fix in one go but this study can help - again a biomarker is very important. If we find a biomarker, all psychobabble is exposed for once and for all. Sure there are other ways, but all I am saying is this study can help.

Sometimes by focusing on the immediate it can lead to improvements all round but you only see that by looking back after the fact.

Sure there is plenty more that can be done but I dont think we should beat ourselves up over not achieving more, this study represents progress. If this gets underway in a manner we are all happy with then we can focus on the other items.

 

[Kati]

Another one from Hillary:

Hillary Johnson
@oslersweb
@NIHDirector NIH/CDC have historically discarded expertise in their limited M.E. research efforts--it's just that you said that was over

 

[viggster]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH. I do think Walitt on the study is problematic, and I don't like that NIH hired him in the first place. I asked a friend at NIH about what Walitt's role as "clinical lead investigator" means, and my friend said this:

A) It is a VERY bureaucratic role with lots of paperwork and shuttling patients around

B) No one takes his institute (Nat’l Institute for Complementary & Integrative Health) seriously

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

 

[ScottTriGuy]

@viggster

Thanks for sharing.

I appreciate the difficult position you find yourself in. It is a challenge to be one of the few straddling both worlds.

 

[viggster]

@viggster

Thanks for sharing.

I appreciate the difficult position you find yourself in. It is a challenge to be one of the few straddling both worlds.

Oh thanks. I don't feel like I'm in a difficult position. I just want to figure out how to smooth out communications between the patient community and the people at NIH who can help us.

 

[Sasha]

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

Thanks for posting - interesting! But if they wanted to punish this guy, it's a pity they put him in a highly visible role in a trial for patients who have been misrepresented as having a psychosomatic disease for decades.

And if it didn't come from him or one of the other co-researchers who favour a psychosomatic model, where did that FMD control group come from? Someone in a position to influence the study design managed to get that in there.

 

[viggster]

Here's an official response from Vicky Whittemore to initial questions about Walitt's role:

"As the Lead Associate Investigator, Brain Walitt will assist Dr. Nath with the oversight of the day-to-day clinical operations of the protocol. Dr. Walitt will work with the CDC and the NIH ME/CFS executive committee to coordinate screening of potential participants for the study. He will ensure that participants are provided with clear details of the research study prior to enrollment as part of the NIH informed consent process and will coordinate participants’ care with the local medical providers. He will also help integrate the work of the team of experts who are collaborating in this complex undertaking and will provide clinical oversight for the study participants during their time at the NIH Clinical Center."

http://www.meaction.net/2016/02/23/nihs-initial-response-to-article-and-comments-on-walitt/

 

[BurnA]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH. I do think Walitt on the study is problematic, and I don't like that NIH hired him in the first place. I asked a friend at NIH about what Walitt's role as "clinical lead investigator" means, and my friend said this:

A) It is a VERY bureaucratic role with lots of paperwork and shuttling patients around

Would it be possible to compare / contrast this to Naths role ?
Are there definitions anywhere or can the NIH provide clarity ?
Thanks

 

[Comet]

B) No one takes his institute (Nat’l Institute for Complementary & Integrative Health) seriously

Then why is he the lead investigator of a serious research study?

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

Punishment is having to work with the ME/CFS patients? What?! Please don't think I am directing anger at you, @viggster, but this is infuriating to me. I realize this is complete speculation as you are posting anecdotal information, but it's like hearing the powers that be at the NIH think he's a jack ass, so they threw him over to the loony tunes.

 

[searcher]

And if it didn't come from him or one of the other co-researchers who favour a psychosomatic model, where did that FMD control group come from? Someone in a position to influence the study design managed to get that in there.

My best guess is it came from http://me-pedia.org/wiki/Mark_Hallett as he is supposed to be an expert in FMD, but I genuinely don't for sure.

NIH wrote back to our initial email over the weekend about Walitt. I expect there to be more responses forthcoming and I think there should be another update today. As we mention in the article, we are trying to finalize a petition although multiple petitions are welcome.

http://www.meaction.net/2016/02/23/nihs-initial-response-to-article-and-comments-on-walitt/

 

[searcher]

Then why is he the lead investigator of a serious research study?

Punishment is having to work with the ME/CFS patients? What?! Please don't think I am directing anger at you, @viggster, but this is infuriating to me. I realize this is complete speculation as you are posting anecdotal information, but it's like hearing the powers that be at the NIH think he's a jack ass, so they threw him over to the loony tunes.

I think being a lead clinical investigator is not a prestigious role as you don't have much control. Being the PI is much more prestigious and powerful. (edit: this was somehow misconstrued as me thinking he should be in this role. As I've said many times, I don't think he should be in this role, nor should any of the other psychologizers, and I don't agree with the control groups.)

 

[Sasha]

Punishment is having to work with the ME/CFS patients?

No:

She says it’s possible he’s being punished by having to do the job of clinical investigator

That is, he's been given a lowly admin role rather than a research role.

 

[JAH]

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

Is it punishment to work on CFS, or is the job of clinical investigator just a shit job?

I appreciate your posts. I think you must cringe at reading this thread, and think it's appalling that some people, like Julie Rehmeyer are being attacked for her investigation of this study.

And I know you know this - but the NIH/CDC has screwed us, deliberately siphoned funds away from CFS, etc. I read this stuff, and am happy for you and the other young people with CFS, but this disease has taken my life. It is too late for me, my life is over. I just want my suffering to end. So I cannot apologize my skepticism.

JAH

P.s. At least Walitt isn't a dentist. The old timers will get that one...

 

[viggster]

No:



That is, he's been given a lowly admin role rather than a research role.

Yes, that is what my friend was implying. I have no idea if it's true.

 

[jimells]

The universe has a message for me.

Yup. I have received the message loud and clear...

Life Sucks Then You Die.