Transcript & audio of Nov. 28 NIH telebriefing now available

[Mary]

https://www.nih.gov/mecfs/events

 

[ErdemX]

Thank you, I was waiting for that to fully listen to Derya Unutmaz's presentation.

 

[Ember]

Rebecca Taurog argues, “You’re saying the science drives it and we’re not getting enough good grants to fund in ME/CFS, but we all know that there are grants that are not being funded that are by top scientists (54:30 – 54:45).” Amid the obfuscation, this telebriefing highlights some disheartening issues.

1. Slow Pace:

Where is the sense of urgency among “team tired” at the NIH? They plan to study 80 patients. Dr. Nath reports that their study has the capacity to handle, at best, only one individual a week (30:00). “So it’s going to be a while.”

2. No Definition:

Dr. Nath says, “If you don’t study the right patients, you’re going to...garbage in, garbage out (27:47).” But Dr. Koroshetz maintains that, without an agreed-upon research definition, the NIH is simply leaving the definition question up to the scientists to decide:

What we’d like to do is have the science drive these kind of questions as opposed to coming up with a convention, which is I think important that the definitions be standardized so that people know what they’re talking about, but not necessarily coming down on one definition and saying you can only study this one patient group. Because I think that may prevent us from seeing things that are really important in this condition. So I agree with the point, but I think that for the research we, NIH generally, in all cases, is not really in the position to be prescriptive and say, ‘This is what you have to do.’ We really leave it up to the scientists. But we are in this instance pushing them to do this in a collaborative fashion to avoid what’s happened in the past which is one definition for one study, another definition for another study, and then you really can’t combine the data. (39:25 – 40:31).

Several years ago, the NIH P2P report recommended that for needed progress to occur the ME/CFS community should agree on a single case definition (even if it is not perfect). Remember this:

To accelerate the progress of ME/CFS treatment, we recommend the following overarching research strategies:

1. Define disease parameters. Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS. A national and international research network should be developed to clarify the case definition and to advance the field. NIH Institutes and Centers not presently represented in the Trans-NIH ME/CFS Working Group should be incorporated to capitalize on the tremendous opportunities to learn from other disciplines and diseases (e.g., Gulf War Syndrome, Lyme disease, fibromyalgia, multiple sclerosis, and Parkinson’s disease) (pp. 9-10).

Where’s our stakeholder-driven consensus definition for research? Apparently, the NIH ignores its own recommendations.

3. Token Funding:

Despite his claim to the contrary, Dr. Koroshetz dodges the question about the paltry level of funding for ME/CFS (56:00 - 57:15). Why was only seven million dollars allocated to support the research centres this year? And why is that funding projected to remain at the same low level over the next five years? Dr. Lipkin alludes to this problem:

If in fact, more money had been allocated to support these centres.... There was a lot of good science that was left on the table that could have been picked up. There were applications out of Stanford; there were applications elsewhere. None of that, you know.... And hopefully we’re going to see that there’s going to be an expansion of the program.

Dr. Koroshetz himself alludes to this problem when he speaks of “putting particular money, not really to solve the...we don't think that this amount of money is going to solve the problem:”

We hope that this seven million, seven million a year for five years, so 35 million...but the key thing is that we think if we can start these consortia, that is seeding the research landscape, and the hope is that this will bring in more people from the centres and from outside the centres.... This is going to take real hard work, and a stroke of genius and a lot of luck, I think.

Dr. Koroshetz says repeatedly during the telebriefing that “this is just a beginning (46:23).” But he claims that NIH can't do more:

The multiple sclerosis field, which was quite small when it started in the 70s, is now what we want the ME/CFS field to be at. But the only way we can do that is to get really good scientists interested in it. As you know, with a payline of 12 percentile, you need to submit eight grants to get one. And that’s...we’re resource limited in this country. And I think a lot of really good science does not happen. But there’s not much you can do about it without more resources (56:37 - 57:16).”

The NIH must be familiar with this telling graphic. It's been used to argue for a 25-fold increase in ME/CFS funding to bring it in line with NIH allocations for MS and other diseases:

Apparently, the NIH can spare only enough to double our token funding.

4. Systemic Bias:

Dr. Koroshetz offers patients some advice. Lobby scientists: "But I think, for you, your passion, you have to make that infectious. Be persistent and get other people in your camp doing the science and competing for grants. That will guarantee that ME/CFS research will advance at the pace you want (57:23 – 57:40)."

By inspiring scientists, our infectious passion will somehow "guarantee" the end of thirty long years of systemic bias. Meanwhile, “team tired” sincerely and publicly apologizes for its offensive slide (27:20 – 27:48), being terribly sorry and understanding “the sensitivity between the issue of fatigue and malaise and the importance of studying the right patients.” Dr. Koroshetz says, “We’ll learn from that, I think” (43:28). And he closes, pretending to the moral high ground of fair competition among diseases:

All the diseases that we take care of are terrible. So it’s not like you can say that one is worse than the other.... The solution is to keep growing the science pool so they’re competing against other diseases. Now I would also say that we have at NINDS about 400 different diseases, many of them are fatal disorders...diseases, and none of them get the money that is equivalent to the burden of disease (53:10 – 54:06).

In assessing our situation, Dr. Koroshetz dismisses the relevance of NIH data on burden of disease. We’re supposed to believe that systemic bias at the NIH doesn’t exist.

 

[RYO]

I was at the NIH in March. Progress seems to be painfully slow. My perception is that there are limited beds on NINDS unit. It is extremely frustrating.

However, it is hard to miss other very sick patients (including children) that are also there when the nurses wheeled me around the facility to and from testing areas.

I know the Undiagnosed Disease Program is opening other centers around the country. It would be nice if there were other hospitals that could help with the intramural study but I am not sure they would have similar technical capacity such as metabolic chamber. Hopefully, they are learning from their intake and interview process so that perhaps in the future they can streamline and achieve greater efficiency.

I am still hoping that I'll have the stamina to complete phase II. As I get closer, I realize it may be beneficial for them to obtain second round of data while I am going through severe relapse (debilitating brain fog, dizziness, tinnitus and other neuro symptoms). Having undergone first lumbar puncture in phase I, I am not looking forward to 2nd LP after exercise challenge.

I appreciated the comment from patient who asked about tapping the expertise of autonomic specialists at Mayo and Vanderbilt.

I also wish that they could collaborate with experts who study muscle disorders/pain. There are silos in every organization. Perhaps the NIH will appreciate the need for greater collaboration while studying a complex disorder such as ME/CFS.

The sad reality is that as more time goes by, what little optimism I have dwindles further.

 

[Vassie]

Dr. Koroshetz offers patients some advice. Lobby scientists: "But I think, for you, your passion, you have to make that infectious. Be persistent and get other people in your camp doing the science and competing for grants. That will guarantee that ME/CFS research will advance at the pace you want (57:23 – 57:40)."

I really can’t believe this!

Getting the good scientists in our camp. Great idea. Like at Stanford, right. We get the Nobel laureates in and the NIH says: Sorry, no money for you.

Competing for grants. Which grants would that be? Don’t make me laugh (or cry).

 

[dreampop]

The sad reality is that as more time goes by, what little optimism I have dwindles further.

Do you mean with the NIH in general or the intramural study or just in general? I've taken a few steps back recently and, it looks to me like it could be a long, long time before we get to understanding and treatments. The Ritux thing really shocked me tbh and I have reservations about the NIH intramural study, but I won't even know if those are warranted for years. Very frustrating right now.

 

[RYO]

Do you mean with the NIH in general or the intramural study or just in general? I've taken a few steps back recently and, it looks to me like it could be a long, long time before we get to understanding and treatments. The Ritux thing really shocked me tbh and I have reservations about the NIH intramural study, but I won't even know if those are warranted for years. Very frustrating right now.

I am referring to the entire state of ME/CFS knowledge and research including the NIH Intramural study. It may easily take until 2020 before useful data emerges from intramural study. I share the observation that the first rung of the ladder is to find objective biomarkers that the average doctor can use to diagnose this disease. The lack of a biomarker also severely hampers any study because selecting the right patient population is critical.

We are begging for funding from a public institution whose budget is determined by lawmakers/politicians. I think if you ask journalists who follow science, they will tell you the NIH / basic science research has been chronically underfunded for decades. Yet as a nation we spent over a trillion dollars on fighting wars. It is also possible that more funds are devoted to saving an obscure sea snail than those suffering from ME/CFS. (no offense to sea snails)

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