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Check out Geoff’s narration

The GIST

The Blog

 

Vicky Whittemore

VIcky Whittemore has been at the heart of the ME/CFS program at the NIH since 2015.

Vicky Whittemore is our go-to person for chronic fatigue syndrome (ME/CFS) at the National Institutes of Health (NIH). Besides overseeing the ME/CFS grants (study) portfolio since 2013, she and Joe Breen (NIAID) and the Trans-NIH Working Group are involved in virtually everything of consequence happening with ME/CFS at the NIH.

With several major events, efforts, and studies occurring, it’s a heady time for the ME/CFS field. The publication of the CDC study that dramatically upped ME/CFS prevalence, the recent NIH ME/CFS conference, the publication of the Intramural study, and the completion of the RoadMap effort all suggested that the stars might be aligning for ME/CFS at the NIH – and we might be ready to move forward in a big way.

Now was a good time to talk to Vicky. You can see the talk in the video below and/or read the overview below which cuts some things and adds others.

The Talk

Vicky talked about how she got started with ME/CFS (she started out small), how she supports the grant administration process, and how the removal of ME/CFS from the Center for Research on Women’s Health threw the Trans-NIH Working Group into her and Dr. Koroshetz’s laps. At that point, she got involved in strategic planning.

THE GIST

  • Check out the video interview with Vicky and Geoff’s narration of the GIST on the blog.
  • Vicky Whittemore is our go-to person for chronic fatigue syndrome (ME/CFS) at the National Institutes of Health (NIH). Besides overseeing the ME/CFS grants (study) portfolio since 2013, she is involved in virtually everything of consequence happening with ME/CFS at the NIH.
  • With the publication of the CDC study that dramatically upped ME/CFS prevalence, the recent NIH ME/CFS conference, the publication of the Intramural study, and the completion of the RoadMap effort all suggested that the stars might be aligning for ME/CFS at the NIH – and we might be ready to move forward in a big way.
  • I wanted to hear about that from Vicky. She believes there are probably more grant applications coming in than usual, and from people not involved in the field.
  • Vicky noted that above all we need to get to clinical trials and reported something novel for this field – the possibility of NIH-funded clinical trials. She’s talked to several groups that have submitted applications, or are about to submit applications, for clinical trials for ME/CFS including small businesses that are attempting to get small business grants. “That’s exciting!” she said.
  • Next we moved onto the former NIH Director Francis Collins. Vicky felt that Collins played a key role in getting many of the Institute directors to support the small research centers. The new NIH Director, Monica Bertagnolli is “very aware” of ME/CFS, perhaps more importantly, perhaps, Vicky said the new director of NIAID, Jeanne Marazzo, is very, very aware of ME/CFS and is very interested in this disease. Nice!
  • The Research RoadMap is designed to move ME/CFS forward at the NIH. It’s an exhaustive effort to provide recommendations on how to move forward with the intent of producing clinical trials.
  • Vicky discussed creating working groups, consortium’s, and roundtables to put the put the Roadmaps recommendations to effect. What about new funding for ME/CFS? Was the NIH going to finally put some real money to work for this disease?
  • Not a chance. Citing currently budgetary problems Vicky essentially said the NIH will not provide funding for initiatives to move ME/CFS forward. If ME/CFS is going to move forward it will move forward organically.
  • The NIH, in the end, is still broken with regard to ME/CFS, fibromyalgia and other diseases. It purports to be concerned with the health of all Americans and then neglects the health of tens of millions of people.
  • The NIH is not immutable. People created the NIH and they can change it. The question is whether they will.
  • While ME/CFS’s time at the NIH has clearly not finally come, the news for ME/CFS in general is encouraging. Interest in it and post-viral diseases is up significantly. Vicky feels the field has grown enormously since 2015, and I agree. By bringing together consortiums and think tanks together, Vicky Whittemore is doing what she can with what she has.
  • The great question for Vicky and all of us, though, is when this increased interest will show up in the bottom line – increased funding. There is only one sure pathway to dramatic and rapid change for ME/CFS at the NIH, and that’s Congress and Vicky actually called for ME/CFS patients to go to their representatives and advocate for more funding for ME/CFS and the NIH as a whole.
  • The RoadMap will be presented to the NINDS Council meeting by Vicky, Maureen Hanson and Lucinda Bateman during an hour-long session from 1:30 to 2:30 pm EST on April 15th. They did a tremendous amount of work on this effort, and you can watch them make their case for more ME/CFS research in a televised session here.

Vicky said the decrease in funding reflected a gap in the funding of the Centers because of delay in the production of the RFA that funds the center. She believes there are probably more grant applications coming in, and from people not involved in the field, which she called exciting.

The next round of ME/CFS research centers has been decided and funded, and as soon as the Institutional Review Board (IRB) signs off on them, they will announce which investigators will get the funding. (Maureen Hanson, Derya Unutmaz, and Ian Lipkin led the last series of research centers).

Intramural Study – There was the intent to bring people back and enroll new study participants, but it didn’t turn out to be feasible. Vicky highlighted the functional MRI findings and T-cell exhaustion findings that replicated past findings. She emphasized – noting the T-cell exhaustion – that we really need to get to clinical trials, and getting to that point was the focus of the Research RoadMap.

NIH-Funded ME/CFS Clinical Trials?

Vicky then reported on something novel for this field – the possibility of NIH-funded clinical trials. She’s talked to several groups that have submitted applications, or are about to submit applications, for clinical trials for ME/CFS including small businesses that are attempting to get small business grants. “That’s exciting!”, said Vicky, and it is – my jaw pretty much dropped at that idea. (I know of only one NIH-funded clinical trial – Shungu’s NAC study – in the history of ME/CFS.) Time will tell if they will get funded – the funding environment is very tight right now – but it was good to hear that this is happening.

The Collins Effect and the New NIH and NIAID Directors

The Institute of Medicine report on ME/CFS came out in the mid-2010s. Around that time, investigators and advocates got NIH Director Francis Collins’s ear and he started looking into what the NIH was doing for the disease. NINDS Director Koroshetz got interested around the same time. All this resulted in ME/CFS moving from the Office of Women’s Health to getting taken under the NINDS wing (a bit). Seeking to move the field forward, the Trans-NIH Working Group came up with the idea of funding ME/CFS research centers.

Jeanne Marzzo

Vicky reported that the new director of the immune institute NIAID, Jeanne Marrazzo, is very interested in ME/CFS.

Vicky felt that Collins played a key role in getting many of the Institute directors to support the small research centers. (Most of them provided quite small amounts, but it did add up. Once Collins left, several Institutes stopped providing even minimal funding.)

What about the new NIH Director, Monica Bertagnolli? Vicky stated that she is very aware of ME/CFS – and particularly so of long COVID. More importantly, perhaps, Vicky said the new director of NIAID is very, very aware of ME/CFS and is very interested in this disease.

That’s Dr. Jeanne Marrazzo. Dr. Marrazzo was formerly Director of the Division of Infectious Diseases at the University of Alabama at Birmingham. Dr. Marrazzo came to some parts of the recent Symposium.

Vicky asserted that where we are now, compared to 2015, is like night and day. We know so much more about the biology, there’s the long-COVID angle, and there’s a lot of cross-Institute discussion regarding broader initiatives on post-viral issues. Awareness is way up but funding… that is another story.

The RoadMap

The Research RoadMap has been an effort by NIH representatives, ME/CFS researchers, patients, and advocates to take an exhaustive look at ME/CFS biology and provide recommendations on how to move forward with this disease with the intent of producing clinical trials. Led by Vicky, Maureen Hanson and Lucinda Bateman, the RoadMap produced 8 day-long webinars in what was surely an exhausting endeavor as well.

The Roadmap

The massive Roadmap effort produced a strategic plan to help ME/CFS move forward at the NIH.

Assuming that the NINDS Council approves the RoadMap, it will fall to a group of Institute representatives called the Trans-NIH Working Group to find ways to implement the its recommendations. Vicky discussed creating working groups, consortium’s roundtables. Vicky thought, for instance, that creating genetics consortiums to pull together all that genetics information could lead to clinical trials. If the group found that a gene controlling some part of the immune system was defective in ME/CFS, the group would look for treatments that could bolster that part of the immune system.

The idea is to spark interest and in that vein, Vicky mentioned Paul Hwang an NHLBI researcher outside the field who stumbled upon a balky gene variant associated with the mitochondria, linked it to ME/CFS, ended up producing a potentially important paper on ME/CFS, and is now attempting to get a clinical trial underway. The key, Vicky said, is validating that variant. Many times if you find a gene variant, you’ll find a group of researchers studying that variant.

That happened for her with tuberous sclerosis where two genes involved in a cancer-related pathway opened the door to cancer labs, which quickly resulted in clinical trials and an approved drug.

Dashed Hopes

That was all good, and yet the news was not all good. When Francis Collins announced the creation of the Intramural study, he said the NIH was looking for solid evidence it could act on. That was why the study went to incredible lengths to make sure they had ME/CFS and only ME/CFS patients in the study. The NIH said it needed solid data to move forward – now the NIH – not a group of outside researchers but NIH researchers – have provided it.

I took that to mean that once the intramural study was done, the NIH would provide funded grant opportunities called RFAs to explore those areas that draw researchers to them to like bees to honey. They are what a struggling field like ME/CFS needs to build momentum. Absent something like that, it’s hard to see how the ME/CFS springs forward at the NIH.

They are not going to happen, though. If there ever was a plan to use the Intramural study findings to support significant new funding for ME/CFS, it’s long gone.

ME/CFS Non-Profits Asked Again to Help Move the Field Forward

When I asked explicitly what will happen after the RoadMap, my heart sank when Vicky first turned to an old theme: having ME/CFS non-profits use the RoadMap to help move the field forward.

The NIH has been asking the tiny, tiny ME/CFS non-profits to move this massive and complex field forward for decades. It’s remarkable to see a $48 billion institution ask our little non-profits to move the field forward, but that’s what it’s done almost from day I. Our non-profits can’t begin to fill the enormous gap between what’s wanted and needed, and what we have now.

It’s not as simple as another rejection of ME/CFS hopes. NINDS – the Institute Vicky works for – is in the midst of a budget situation.

Bad Budget Situation

Budget

Reduced funding means fewer grant opportunities and fewer initiatives. (Congressional action resulted in a nice boost for Azheimer’s research, though.)

As for the NIH directly supporting ME/CFS, Vicky referred to the challenging budget situation NINDS is facing in 2024 and probably 2025. The overall budget for the NIH remained flat in 2024, and NINDS received a small increase – which was not enough to account for inflation – resulting in an overall drop in funding. Plus, the big Brain Initiative received a major funding cut.

At the end of April of this year, NINDS Director Walter Koroshetz alluded to the “difficult decisions” that needed to be made given the “challenging budgetary landscape” and the lower-than-usual 11% payline (only 11% of best-scored grants get funded) that had to be instituted. Fewer grants will be funded this year and some already funded grants will see (probably modest) reductions in funding.

While the NIH website states that funding levels for most diseases are expected to largely stay static or increase slightly, the Brain Initiative received a whopping 40% cut, which hurt NINDS in particular. The funding cut resulted from the strange funding mechanism created in the 2016 21st Century Cures Act which provided fluctuating levels of support from year to year. This year, funding for the Initiative from 21st Century was due to drop dramatically. In the past, Congress stepped in to backfill the shortfall, but the budget caps agreed to last spring made that impossible, so funding was cut.)

For me, though, the budgetary argument fell a bit on deaf ears. While the opportunities for funding are clearly harder to come by in this budgetary environment, I’ve seen ME/CFS funding drop dramatically drastically during times when the NIH was flush. NINDS funding, for instance, has grown by $1.2 billion over the past ten years and is now at $2.8 billion. 

The NIH-Funded ME/CFS Research Centers

The NIH spends about 80% of its funding on investigator-initiated grants; i.e. grant applications that come from outside the NIH, leaving 20% for initiatives that come from within the NIH. The ME/CFS research centers, for instance, came from that 20%.

When asked about using some of that 20% for ME/CFS, Vicky noted the difficulty creating new initiatives now but not to stop thinking about longer-term initiatives that could be possible in the future. She noted again how encouraged she was about the interest small businesses are showing in this disease. Being creative with what we have was a theme.

With regard to the proposed Office for Postviral Diseases, Vicky noted that the Office could help coordinate research but that the funding would still come from the Institutes (of which neither ME/CFS or long COVID is a part of). Noting the strong interest being shown by Institutes across the NIH, being able to coordinate research across the many Institutes that are now interested in post-viral diseases would be a big win.

Broken Institution

The NIH is clearly broken. Any institution that purports to have as its goal enhancing the health of the nation, yet which deigns to provide sufficient funding for tens of millions of people (ME/CFS, fibromyalgia, IBS, POTS, etc.) in that nation is broken. The problem is how the NIH is broken. If it was broken for a major disease, the problem would be fixed, but it’s broken for diseases like ME/CFS and fibromyalgia that don’t have the clout to fight back – so they’re stuck.

If the NIH was committed to significantly increasing funding at the NIH it would keep at it until it found something that works. Maybe the Roadmap and the intramural study will spark something – let’s hope so. The ME/CFS Research Centers were supposed to increase researcher funding, but funding for ME/CFS, if it hasn’t dropped, has been as flat as a pancake since they were announced.

The NIH may now have a strategic plan to fill the many research holes in ME/CFS, but does it have a long-range strategic plan to boost ME/CFS funding? Something like, the NIH is committed to boosting funding for ME/CFS by 30% by year X – and if it doesn’t happen, it retrenches, figures out why, and moves forward again. Absent that kind of a commitment, we see a stab here and a stab there (they tend to occur about every ten years) and little progress is made.

For reasons that we still don’t fully know, the NIH is structured in such a way as to make it very difficult for diseases like ME/CFS or fibromyalgia to make headway. (In the 2014 Mangan interview, I noted that Lipkin and others stated that both Collins and Koroshetz’s hands were tied when it came to ME/CFS).

Like any other organization, though, the NIH is not immutable. The way the NIH is was not handed down from heaven on tablets of stone. The NIH is what the people in the NIH say it is. If it’s not working, they can change it. I would suggest they’re at least obligated to the millions of people with chronic, debilitating post-viral illnesses to try.

Whatever the justifications for keeping the status quo (e.g. “It’s impossible”, “it’s just the way things are”, or “look at how well we’re doing in other areas”), the bottom line is that the NIH has shortchanged a generation of millions of people with chronic illnesses and everyone working at the NIH has to deal with the fact that they’re part of that.

Congress

“We need patient advocates to be out there saying Congress we need more money for ME/CFS research and NIH funding overall.” Vicky Whittemore

While ME/CFS’s time at the NIH has clearly not finally come, the news for ME/CFS in general is encouraging. Interest in it and post-viral diseases is up significantly. Vicky feels the field has grown enormously since 2015, and I agree. By bringing together consortiums and think tanks together, Vicky Whittemore is doing what she can with what she has. The great question for Vicky and all of us, though, is when this increased interest will show up in the bottom line – increased funding.

There is only one sure pathway to dramatic and rapid change for ME/CFS at the NIH, and that’s Congress. That’s what Ian Lipkin – who knows the NIH well – said ten years ago and that’s what he repeated at the recent Symposium on the Intramural study.

Vicky believes so as well. Noting that the budget situation may be even worse in 2025, Vicky said, “We need patient advocates to be out there saying Congress we need more money for ME/CFS research and NIH funding overall.”

A couple of weeks ago, Lipkin said we need “better advocacy” at the congressional level, and we do. During the last Advocacy week, I was the only person present at the five meetings I had with Congressional staffers. Advocacy Week – now run solely by the Solve ME/CFS Initiative – is our one big opportunity to make progress where it counts the most – at the federal level.  That’s simply where the money is. Even in this difficult budget environment, Alzheimer’s disease got a nice boost in funding – thanks to Congress. The NIH’s 47-billion-dollar budget dwarfs – as in, its not even close – any other medical research funder. It’s a nut we must crack at some point.

Lastly, Vicky said that working closely with the ME/CFS community over the past year has been one of the most rewarding and meaningful experiences of her working life. She said she read every one of the thousands of comments provided.

The RoadMap Presentation

The RoadMap will be presented to the NINDS Council meeting by Vicky, Maureen Hanson and Lucinda Bateman during an hour-long session from 1:30 to 2:30 pm EST on May 15th. They did a tremendous amount of work on this effort, and you can watch them make their case for more ME/CFS research in a televised session here.

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