Advocacy Month Details Waiting on Broken Budget

Our advocacy is expanding. We have more advocates every year. We’re reaching more people, recruiting more allies to our side every year – so it makes sense that Advocacy Week is no longer Advocacy Week but that the entire month of May is now Advocacy Month. That means our advocacy days are going to be more spread out – giving our precious ME/CFS advocates more time to rest and recover between sessions. It’s a win for everyone.

So, what is surely going to be in the biggest Advocacy Month to date? We don’t know yet. Emily Taylor – the leader of Solve M.E.’s legislative advocacy effort – explained that the budget process is extraordinarily confused right now. (She called it a “hot mess”.) We’re not going to be able to decide on our ask until the Biden administration provides its 2023 budget, which has been delayed while it’s been waiting for Congress to meet its obligations for the 2022 budget (yes, that’s the 2022 budget) – probably in March 2023.

To me – that’s the bad and good news. The bad – that Congress continues to redefine what the term “broken” means. The good news, though, is that we have a professional advocate with her ear to the ground who’s taking a strategic approach to advocacy. Solve M.E. is not going to simply ask that ME/CFS gets “x” dollars – it’s going to see what opportunities the President’s budget request provides and then determine the best targets in them. That’s smart advocacy.

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The budget isn’t the only thing in play, though. In fact, there’s some really good news. The abandonment of the Build Back Better legislation has left a lot of legislative balls in the air, several of which could benefit us enormously.

Opportunity Knocks in Major Bills

It’s been said many times: if you want to make really major change in these diseases, Congress is the place to do it. We saw what a dramatic difference Congressional advocacy can make when Congress gave the NIH over a billion dollars to study long COVID.

Emily estimates we have about 6-8 months while the COVID-19/long-COVID iron, so to speak, is hot, to create seminal and long-lasting changes in how ME/CFS and long COVID are treated.

This year there are plenty of opportunities to do that.

21^st Century Cures for Long COVID and ME/CFS

21^st Century Cures 2.0 – The original 21st Century Cures bill passed in 2016 focused on, among other things, finding ways to speed treatments through the onerous FDA approval process. We tried but failed to get support for ME/CFS included in that bill.

Now the bill’s original authors are back with 21^st Century Cures 2.0, and we’re back as well, but five years of working at the federal level have put us in much better shape. The bill prominently includes support for long COVID – in fact, it’s the first topic mentioned.

Emily reported that Solve M.E. and Congressmen Jack Bergman and Don Beyer have successfully gotten provisions from H.R. 2754, a 2021 bill that explicitly supported both long COVID and crucially, post-viral illnesses (i.e. ME/CFS) folded into the bill. Plus, Representatives DeGette and Upton supported our efforts to get key provisions about medical and public education folded into the Cures 2.0 bill as well.

New Agency – New Mandate – New Opportunity for ME/CFS

Another scintillating opportunity comes from Congresswoman Anna Eschoo – one of our strongest ME/CFS and long-COVID supporters. Rep. Eschoo has gotten the ARPA-H bill (see Solve M.E. action item) absorbed into the Cures 2.0 bill.

ARPA-H (Advanced Research Projects Agency for Health) creates a medical research institution that may, depending on which model is embraced, sit outside the NIH. APRA-H is designed to “promote high-risk, high-reward innovation to develop high-need cures”.

In “A new agency to accelerate biomedical science can succeed, under the right conditions”, two commentators asserted that for ARPA-H to succeed it’s essential that it be housed outside the NIH, and Eschoo’s version does that.

When the NIH will not fund clinical trials for ME/CFS because it doesn’t know enough about the disease (but won’t provide the funding opportunities needed to learn about it), you can see how desperately something like ARPA-H is needed. Ditto with low dose naltrexone and dextro-naltrexone – two potentially cheap and effective pain relievers – which, in the midst of an opioid crisis that the NIH has been tasked to fix – the NIH refuses to fund.

As Ron Davis has pointed out many times, the NIH is reluctant to fund explorations into new technologies, yet new technologies are exactly what ARPA-H is intended to accelerate.

Finally – A Disease Burden Institute?

Developing new technologies is all for the good, but there’s one provision of the bill that should get everyone out of their chair. Along with other factors, the bill states ARPA-H will take into account “the effect on disease burden, including unmet patient needs” and “health equity” in its funding decisions.

That’s worth repeating. Embedded in the language creating ARPA-H is a provision that requires the new agency to take into account “disease burden”, “unmet patient needs” and “potential opportunities to advance health equity.” You couldn’t have written a sentence that more targets ME/CFS than that. ME/CFS is the poster child for unmet patient needs, for unacknowledged disease burden, and for a lack of health equity.

It’s the NIH’s inability, or unwillingness, to bring disease burden or unmet needs into its funding equations that has kept large, common, but poorly funded, diseases like ME/CFS and fibromyalgia from getting the support they deserve. Without those factors figured in, it’s been impossible to get past the anti-ME/CFS bias, and the chokehold the big diseases have on funding.

That was demonstrated in spades when we actually lost support at the NIH during a pandemic that created millions of ME/CFS-like cases in the U.S. That bears repeating as well. Even in the midst of a tsunami of long-COVID (er, ME/CFS) cases hitting our medical system, the number of Institutes that were willing to provide even a small amount of money for the ME/CFS research dropped dramatically. Somehow, we lost ground.

In the ARPA-H bill, we have a potential antidote for that and the possibility for recognition and funding.

The Care for Long COVID Act

“I tell people it feels like all my nerves have had like five cups of coffee,” Senator Tim Kaine on having long COVID

The title is a bit misleading. S.3726, the Comprehensive Access to Resources and Education (CARE) for Long COVID Act, doesn’t just cover long COVID, it also covers post-infectious illnesses. Senator Tim Kaine (D-VA) – who still has long COVID; longtime ME/CFS champion, Senator Ed Markey (D-MA); and Senator Tammy Duckworth (D-IL) unveiled the act about ten days ago.

In case someone didn’t get it, the act explicitly states that ME/CFS, fibromyalgia, postural orthostatic tachycardia syndrome (POTS), other forms of dysautonomia, and autoimmune diseases fit the definition of a post-infectious disease. Note key phrases in the bill will.

• Accelerate research by centralizing data regarding Long Covid and related post-viral illness patient experiences;
• Increase understanding of treatment efficacy and disparities by expanding research to provide recommendations to improve the health care system’s responses to Long Covid and related post-viral illnesses;
• Educate the public and medical providers by working with the CDC to develop and provide the public with information on common symptoms, treatment, and other related illnesses, specifically ME/CFS.

You can support this bill, which Solve M.E., long-Covid families, and other advocates were involved in from the beginning, right now.

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Pandemic Preparedness Package Potentially Provides Centers of Excellence for ME/CFS and Long COVID

Recently named the PREVENT Act, Emily reported that the package creates Centers of Excellence that support both long COVID and potentially other post-infection research and treatment, which would be a huge win for our communities that desperately need access to good doctors. Legislation supporting COEs didn’t make it through last year but has been absorbed into a “Pandemic Preparedness Package.”

The Long-COVID / ME/CFS Gap

Money has been falling from the sky for long-COVID researchers, but ME/CFS is still being funded at the same old petty pace. There’s simply no way at its current level of funding that the ME/CFS field can, within a reasonable amount of time, apply the breakthroughs that are sure to come in long COVID.

The NIH’s decision not to allow even 500 ME/CFS patients into its 17,000 person long-COVID cohorts, its decision not to increase funding for three small research centers, and the 7-month gap in funding for the research centers means that the ME/CFS field continues to starve in the midst of plenty. I asked Emily, what, if anything, can be done about this situation?

Her answers were illuminating. For one, a few vocal and apparently influential long-COVID leaders have been working to block the NIH combining its long-COVID work with work on any other post-infectious illnesses. Of course, it’s entirely predictable that when faced with a threat, some people will become self-centered, rigid, and uncaring. It’s particularly jarring to hear, though, when a disease like long COVID has been given such enormous funding.

From Emily:

“a few vocal minority voices (from the long COVID community) have put the NIH in a difficult position”

 

“Both Congress and the Executive branch could take simple and immediate action to prioritize and distribute funding differently, and provide policy guidance to key leaders to include other post-infection diseases like ME/CFS in long-COVID programs. However, there are two big barriers to that happening.”

 

“The first: there is pressure from the long-COVID community against being associated with or studied with other post-infectious existing illnesses. This position does not represent the majority of long-COVID community leaders, but a few vocal minority voices have put the NIH in a difficult position regarding merging existing programs and the new RECOVER Initiative. There are some in the long-COVID community who oppose such collaboration and cross-pollination with ME/CFS experts. The NIH is working with these community members also.”

 

Emily added this to clarify:

 

“Some Long COVID patients are wary of existing illnesses and voice their opinions against comparing Long COVID to other post-viral conditions like ME/CFS, or POTS. I feel that these folks have not taken advantage of the robust resources available from these communities or lack the potential educators around them to explain the overlaps and the clear scientific connection to Long COVID. But, we are fortunate because the vast majority of the patient-led organizations in the Long COVID community understand these connections and that we are stronger when we work we together. You can see evidence of that success through our collaborative efforts in Congress.

 

However, the RECOVER Initiative and other research advisory councils include varied participation and not all of these representatives recognize the link between Long COVID and existing post-viral illnesses. That is why Solve M.E. and our Long COVID partners are currently working on launching a new training program to educate, empower and elevate patient leaders in key roles on research advisory committees.”

 

Many thanks!

The Budget Issue

The second factor – the budget impasse – indicates that the NIH itself is in a squeeze and suggests that maybe we should – at least temporarily – give it something of a break. The NIH can obviously shift money around – that happened when 4 of the Institutes decided not to fund the ME/CFS research centers this time around ,but it does have some financial shackles imposed on it. We’ll know more when the 2023 budget is set.

From Emily:

“I completely understand why NIH is unable to offer additional resources currently.” 

 

“Second, I cannot emphasize enough what a powerful factor budget uncertainty is. I completely understand why NIH is unable to offer additional resources currently. Simply put: Congress prevented any funding increases at this time. This is happening because the NIH does not have a budget. Without a budget, it cannot promise money it doesn’t have. The only budget the NIH has at their disposal right now is identical to last year. Therefore, the only money the NIH can commit is the exact same funding as last year. Any hope for a funding increase this year was dashed by Congress’s inability to pass a budget on time.”

“The good news is this is an area where we can make an impact. Solve M.E. recently drafted a letter to Congress calling attention to these funding gaps and impacts because of the federal budget situation. By calling attention to these needs, we establish a history regarding the damage caused by the budget delay, and urge them to prioritize funding for programs harmed by the budget delays (like the ME/CFS centers).”

Conclusion

A broken budget process dating back to last year is holding things up at the NIH, and a few long-COVID advocates are trying to exclude ME/CFS and other post-infectious diseases from directly benefitting from the Congressionally funded long-COVID research at the NIH.

Three big bills already underway demonstrate, once again, how incredibly effective advocacy at the Congressional level can be.

Advocates on the Hill have allied with Congressmen and women to insert key provisions which include post-viral illnesses in the 21st Century Cures 2.0 bill. Among the most exciting of those are the creation of a new organization, ARPA-H, (hopefully outside of the NIH), that is dedicated to accelerating innovation, and which includes taking into account disease burden, patients’ unmet needs, and health inequities in its funding decisions.

The Pandemic Preparedness or PREVENT package also includes language that creates Centers of Excellence for long COVID and post-viral illnesses.

Plus, the recently introduced “Care for Long COVID Act” also contains language explicitly including ME/CFS, fibromyalgia, and POTS, in its plans to create a centralized database, expand research into treatments, get doctors better informed about these diseases and others. You can support this bill now.

We’ll be tracking these bills as they move through Congress.