Ken's Caucus

{Note: this letter was written by me and Andrea Lytle Peet, and co-signed by over 50 people with ALS and their caregivers in NC, to petition for higher priority access to COVID vaccines for people with ALS and others with high-risk medical conditions.}

February 5, 2021

Dear Members of the NC COVID-19 Vaccine Advisory Committee,

We write to you as a group of NC citizens in a high-risk medical category, to petition you to press the NC DHHS to reconsider its prioritization plan for access to the COVID-19 vaccine. Though we represent only one rare disease — all of us are living with the neurological disease ALS (or are caregivers) – we advance an argument that speaks to the urgent needs of many other North Carolinians living with other serious medical conditions.

At present, the portion of the NC population most at risk of dying or developing severe complications from COVID (“Adults at High Risk of Exposure and Increased Risk of Severe Illness”) are (unless a health care worker, resident or staff in a long-term care setting, over the age of 64, or an essential frontline worker) relegated to category 4, only one level above the general population, and below a number of other categories.[1]

We are, moreover, disappointed to learn that the current prioritization plan is the result of a change made in January 2021 that demoted people with high-risk medical conditions from category 2.2 to category 4.[2] The earlier plan had placed people with high-risk medical conditions ahead of (non-frontline) essential workers.[3] 

The new NC prioritization protocol is at variance with the spirit of CDC guidelines[4], which places people at high risk in the same category (1c) as “other essential workers” and the general population age 65 and over.   Those same CDC guidelines list as one of three goals  to “decrease death and serious disease as much as possible,” which clearly signals the ethical imperative to prioritize people with serious preexisting health conditions. 

We do not see the logic in prioritizing healthy 65 year olds or the broad category (as North Carolina has defined it) of  “essential workers” over the portion of the population living with high- risk medical conditions. For a patient group like ours, with weakened respiratory functions, exposure to COVID-19 puts us at enormous risk.[5]  Though we are sure that the NC DHHS did not intend to send a message that it puts less value on our lives than those of the healthy population, it is hard not to interpret the revised NC guidelines any other way.[6]

We note as well that some other states have placed their medically high-risk populations nearer to the top of priority groupings, rather than near the bottom. In its ongoing assessment of how states are prioritizing groups, the Kaiser Family Foundation found that 19 states include younger adults with high-risk medical conditions in phase 1a or 1b, including six states that have updated their priority groups since mid-January.[7] 

Our understanding is that the prioritization guidelines each state is adopting are living documents and are frequently updated,  as government authorities respond and adapt to new circumstances and knowledge.  We hope that flexibility can facilitate a revision of the NC guidelines in a way that levels the playing field for people living with serious medical conditions.       

We thank you for your service to the community in providing guidance to DHHS on the difficult decisions related to vaccine access. We are grateful for your time and consideration of this request, which is made not just for those of us with ALS, but for all NC residents suffering from high-risk medical conditions.   We hope to hear back from you at your earliest convenience. Our points of contact are Dr. Ken Menkhaus, at  kemenkhaus@davidson.edu, and Andrea Lytle Peet, at  andreapeet@yahoo.com.

Sincerely,

Ken Menkhaus 

Andrea Lytle Peet  

Larry Falivena 

David Lloyd

Ed Rapp 

Dana Baker

Jeanne Luther, and caregiver John Luther

Michael S. Bereman, PhD, and caregiver Meagan Bereman    

Chris Heal, and caregiver Laura Heal

Kristin McCoy

Coral Thorpe

Willie Mae Oldham, and caregivers  Dalton Neal Olham, Christopher Neal Oldham and

Christain Curtis

Nancy Meres

Corinne Crownover, and caregiver Christopher Eckert  

Linda M. Kubis

Randy Floyd 

Margaret Broadwell

Ben Matthews, and caregiver Deborah Matthews

John Chamblin, and caregiver Beth Chamblin

Emily and David Milliot, caregivers to Kathryn Stocum  

Sally Weber

Rubi and Darvin Cante Lemus, caregivers to Jose Flores Cante

Jeff Farlow, and caregiver Elizabeth Farlow  

William Crocker

Pat and Nancy Bowes

Bruce Oberhardt and caregiver Mindy Oberhardt 

Stephen Poe

Roger Faulkner

Roz Skidmore and caregiver Tommy Skidmore

Gary Cole and caregiver Mary Lou Cole  

David M. Williams, Jr, and caregiver Jeanette M. Williams

Lawrence Cepuran  

Thomas Corbett, and caregiver Doris Corbett  

Amy R. Peacock, caregiver

Edith E. Eichler

Marie-France Eloi

Donald W. Wilson, and caregiver Becky Wilson

Roger Friedensen

Gail Hardy, caregiver

James D. Baker, and caregiver Nancy Baker

Kenneth Moffitt

Debra James, and caregiver William James

Randall Keen

Seth Hicks, and caregiver Kimberly Hicks

Napoleon Wallace, and caregiver Edna Wallace

Robert Kubis

Jonathan David Rodden, and caregiver Debby Rogan Rodden

Sebrina Hernandez

---

[1] Based on the NC DHHS “Find My Vaccine Group” website: https://findmygroup.nc.gov/

[2] Lexi Wilson, “As North Carolina Expands Who Can Get the COVID-19 Vaccine, Some Are Being Bumped Down the List” WCNC  (January 16 2021)  https://www.wcnc.com/article/news/health/coronavirus/covid-vaccine-priority-list-north-carolina-chronic-illness-high-risk/275-55809e67-0b81-4453-b56c-0bf7886f7e52

[3] “NCDHHS  Shares Updated Rollout Plan for COVID-19 Vaccinations” (December 30, 2020)  https://www.ncdhhs.gov/news/press-releases/ncdhhs-shares-updated-rollout-plan-covid-19-vaccinations

[4] CDC, “When Vaccine is Limited, Who Should Get Vaccinated First?” (January 21, 2021) https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations.html

[5] The ALS Association has just sent a letter to CDC  reporting new data from the Veterans Administration confirming that veterans with ALS who contract COVID-19 are three times more likely to die than veterans with COVID-19 who do not have ALS.   https://www.als.org/navigating-als/living-with-als/covid-vaccines

[6] We note that other people with disabilities and high-risk medical conditions have objected to vaccine prioritization plans that appear to enshrine discrimination against high-risk populations. See for instance Elliot Kuklas, “Where’s the Vaccine for Ableism?” New York Times (February 4 2021)  https://www.nytimes.com/2021/02/04/opinion/covid-vaccine-ableism.html?searchResultPosition=7

[7], Jennifer Tolbert, Jennifer Kates, and Josh Michaud, “The COVID-19 Vaccine Priority Line Continues to Change as States Make Further Updates” (Kaiser Family Foundation, January 21, 2021)  https://www.kff.org/policy-watch/the-covid-19-vaccine-priority-line-continues-to-change-as-states-make-further-updates/

In December 2020, I was part of a group of people living with ALS who took part in the 31^st International Symposium on ALS/MND, the largest annual gathering of researchers working on ALS or ALS-related diseases.  Because of COVID-19, this year’s symposium was virtual.

Below, I share a few personal take-aways from the opportunity to listen to three intensive days of research presentations.

What role can we usefully play in ALS research design and practice?

Ever since I decided to engage on ALS advocacy after my diagnosis, I have struggled with this question: what is the appropriate role for people diagnosed with ALS in discussions and debates over ALS-related research? On the one hand, the movement for patient voice and patient-centrism  across all disease groups has grown rapidly in recent years and has shown us that increasing patient engagement at all level of therapy development has real potential. On the other hand, people with ALS are a challenging group to integrate into some deliberations, in part because we generally have such a short life expectancy after symptom onset. Most of us just don’t have the time or energy left to educate ourselves on the many complexities of ALS research and policy, and then play the kind of sustained role needed to have an impact.  Those of us who do are in the “slow progression” sub-group of pALS, and often possess specific professional backgrounds in medicine, public health, academic research, statistics, and other fields that equip us to follow at least some of the complex scientific issues at play. That is a small subset of the total population of people living with ALS.

After listening to sessions devoted to basic scientific research on aspects of the disease, and assessments of clinical trial results, I reached the following conclusions:

• pALS cannot and should not attempt to master the complexities of lab research, unless they happen to already possess an advanced degree in a field such as cellular biology, bio-chemistry, genomics, etc. The research is simply too complex and advanced to master through a quick self-education. We need to leave that work to the experts.
• pALS do have potentially useful roles providing input on the structure and best practices of clinical trials. We play a central role in this research; we have ample experience in clinical trials; and most of the issues and debates surrounding the structure of clinical trials (enrollment criteria; bio-markers; placebo groups; challenges of heterogeneity in disease progression on trial results; open-label extensions and expanded access options; platform trials; etc.) are, with a bit of reading and time, relatively accessible and understandable to generalists.
• pALS need to be very careful about jumping into debates about the statistical results of research.  Much depends on the level of statistics at issue. If the discussion involves relatively straightforward discussions about a statistically significant correlation, yes, those of us with some basic stats background can contribute. But advanced statistical analysis requires advanced statistical knowledge, or else we risk making serious errors.

Respect the science

There is a lot of easy chatter on social media criticizing research on ALS. Some of the criticism is warranted. Some of it is misinformed, disrespectful, even arrogant. Lately, a lot of it is driven by our observations of how the world was able to mobilize massive resources and research efforts to develop vaccines for COVID-19 within a year of the pandemic outbreak. Why can’t that be done for ALS, some ask.  

My overall takeaway from the proceedings is that contemporary research on ALS is well-conceived, sophisticated, and promising. It deserves our respect. Researchers have to work within some very challenging parameters. These include a disease the causes of which we do not know; a lack of reliable bio-markers; sizable heterogeneity in disease progression; and the sheer complexity of neuroscience and the human neurological system. We get understandably frustrated over the lack of progress in development of effective therapies to slow, stop, or reverse ALS. And we see weaknesses in clinical trial design that can be exasperating.  But we have to remind ourselves that most other neurological diseases, including some that garner much larger amounts of research funding, have encountered the same slow progress in development of effective therapies. Alzheimer’s, Parkinson’s, Huntington’s, and MS are among the many other neurological and neuromuscular diseases which have defied the best efforts of the scientific community to date.  We’re hardly alone.    

The breakthroughs will come, hopefully soon, but the medical researchers working on ALS are grappling with some of the most complex and poorly understood aspects of human physiology. And unlike COVID-19, we don’t even know what causes ALS. Without that knowledge, effective therapies are going to be harder to develop.

Impact of ALS on the brain

Many of us in the pALS group attending the symposium were struck by the research linking ALS to greater risk of  cognitive, emotional, and executive function impairment. This is a sensitive topic in the ALS community, but one we need to openly acknowledge and discuss. How do we self-monitor for changes in cognition or empathy, especially for those of us who continue to work full-time? What does this mean for our aspirations to play more of an active, lead role in ALS organizations?  

A space for thoughtful discussion and exchange of ideas

Our group of pALS met via zoom at the end of each day to discuss the proceedings. It was very useful. It was clear to me that we need to make that kind of space for thoughtful, extended discussion and debate among pALS more widely available.  Social media is not the right environment for us. I hope we can find a way to develop electronic platforms that can support and build on this sort of serious exchange of ideas among pALS. We have a lot of smart, thoughtful people among us, and we need to make sure their knowledge and insights are given plenty of exposure.