List of Comments
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PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.
M.K. Beers | 5-10-2022
I am privileged to be speaking with you today.
I am here today because my mother Amalia was diagnosed with Frontotemporal Degeneration--or FTD--in 2016, and passed away in December of 2020 at the age of 56.
In 2020, my friend and I created a podcast called Remember Me to tell the stories of FTD, and provide valuable resources that are otherwise almost impossible to find.
We have produced over 70 episodes and told stories of families from all over the country and are well versed on the challenges faced on the FTD journey.
One of the key themes of Remember Me is the harrowing road to diagnosis.
The majority of stories include visits to multiple primary care physicians, psychiatrists, counselors and neurologists before finally arriving at the diagnosis of FTD.
Many that we interview recall their loved ones being placed on an excessive amount of medications while psychiatric professionals try to figure out how to treat them.
We’ve heard many recall doctors saying “well, they’re just depressed”, while their loved ones are desperately searching for answers as to why their loved one is not acting like themself.
In the most recent season of our podcast, a 40-year-old mother of two spent the majority of the last 6 months of her life in a Psychiatric hospital until her family insisted on receiving an MRI. She received the FTD diagnosis and passed months later.
Another mother, 30-years-old spent months in a psychiatric hospital with a diagnosis of severe postpartum, until her mother traveled across the country to find answers from a top neurologist.
My call for action today is focused on the field of mental health and psychiatry. How do we educate across medical specialties on the symptoms of FTD?
I'm asking today that the committee partner with its colleagues in the field of psychology to educate them on the terrible disease that took away my mother Lia, her father Frank, and countless other mothers, fathers, siblings, spouses and children in the prime of their lives.
M. Sharp | 5-10-2022
Hello. I am Advocacy Manager for The Association for Frontotemporal Degeneration. I have a couple comments regarding the importance of biomarkers for FTD, but first I want to say thank you for splitting this meeting into 2 days. Trying to fit a whole agenda into a single half day was too much and there was simply not enough time to cover everything the council needed to.
Yesterday’s panel discussion on the advances in biomarkers for Alzheimer’s was fascinating and offered great hope for progress in biomarkers for FTD and the related dementias. Being able to diagnose Alzheimer’s disease with a blood test is a revolutionary prospect that would change the landscape for all forms of dementia and based on the presentations yesterday it seems like that is a real possibility in the not too distant future.
A similar test is desperately needed for FTD and could help avoid the years of confusion and turmoil so many families go through while trying to find a reliable diagnosis. FTD is too often the diagnosis of last resort and only arrived at after numerous mis-diagnosis and inappropriate treatments. Personality disorders, Major depression, Schizophrenia and bi-polar disorder are just some of the diagnoses people in the early stages of FTD may be lableled with. And that is only for those who do not accept dismissive explanations like “it is only a mid-life crisis” and who have the time and resources to seek medical attention and advocate for the additional evaluations and diagnostic tests needed to rule out all the more likely but wrong diagnoses that clinicians must start with.
I also appreciated Dr. Mims challenge to the panelists yesterday and the ensuing discussion on the practical benefits of a definitive Alzheimer’s diagnosis but am struck by how different that discussion could be from the perspective of FTD. When considering whether or not to pursue a biomarker test for Alzheimer’s the question is obviously “is this Alzheimer’s disease?”. In FTD the question is often asked in situations where Alzheimer’s or even dementia is not being considered. In FTD the question a diagnosis would answer could be something like “how did my faithful partner of 30 years suddenly become a serial adulterer” or “why did my financially cautious father spend my college tuition on a new car?” In these cases the answers a definitive diagnosis could provide are far from academic and in extreme cases could change the outcome from a criminal charge to medical care and a plan for support.
The progress that has been made in Alzheimer’s biomarkers is truly revolutionary but that similar advances are still needed for FTD and the related dementias because Alzheimer’s disease is not always the right answer. There is also a lot of information on our website about the FTD-Biomarkers initiative and other funding opportunities for biomarker research in FTD.
W. Mobley | 5-4-2022
I'm a Neurologist and Associate Dean for Neuroscience Initiatives at the University of California San Diego School of Medicine. I direct the Down Syndrome Center for Research and Treatment and Chair the National Down Syndrome Society Scientific and Clinical Advisory Board.
I want to thank you for the opportunity to speak. First, let me say that what I wish to say resonates strongly with other comments during this meeting that speak to justice and the care of the underserved. In the case that I address, I speak of the justice evidenced by the medical community’s willingness, eagerness and, really, obligation to care for people who are often overlooked, misunderstood, underestimated, and undervalued - people with intellectual disabilities including Down syndrome.
Recently the Centers for Medicare & Medicaid Services removed exclusionary language that prevented individuals with Down syndrome from participating in trials that would provide coverage for monoclonal antibodies directed against amyloid peptides for the treatment of Alzheimer's disease. This is a great step forward, but we need an important next step. That next step would be to ensure that people with Down syndrome have the same access to treatments as the general community with respect to trials evaluating the safety and efficacy of treatments against Alzheimer's disease. While trials in people with Down syndrome may merit special considerations with respect to trial design, the inclusion of these individuals in well-designed trials is to be championed by the Alzheimer's disease and Down syndrome communities. I am confident that it is so championed.
The FDA also recently indicated that Alzheimer's disease in typical individuals and individuals with Down syndrome are the same disease and the research literature and my research strongly supports this conclusion. There are many similarities if not identities in neuropathological findings, changes in biomarkers and even in changes in brain proteins that are the source of biomarkers, including those that characterize synaptic function and structure. So, yes, Alzheimer’s disease in people with Down syndrome very closely mirrors the disease in the typical population.
In summary, individuals with Down syndrome deserve equitable access for treatments for Alzheimer’s disease. Absent evidence of insurmountable concerns, people with Down syndrome must be included in current and future trials assessing safety and efficacy of treatment interventions that target Alzheimer’s disease. Justice demands that individuals with Down syndrome merit the same access to such trials as the rest of us. I ask for that and call for that.
M. Japha | 5-4-2022
Eli Lilly and Company (Lilly) is excited that meaningful change for people living with Alzheimer’s disease is now upon us. However, the potential benefits of amyloid plaque-reducing therapies, including those yet to be approved, can become reality only if patients have timely and equitable access to both therapies and diagnostics.
Without further and timely action, we are deeply concerned that the Centers for Medicare & Medicaid Services’ (CMS’) National Coverage Determination (NCD) for amyloid plaque-reducing therapies will undermine the National Alzheimer’s Project Act (NAPA) and the National Plan to Address Alzheimer’s Disease (National Plan).
NAPA seeks to accelerate the development of treatments that would prevent, halt, or reverse the course of Alzheimer’s disease (AD)1. With this decision, CMS has seemingly negated the FDA’s use of accelerated approval in Alzheimer’s Disease and is, in fact, making patient access to potential Alzheimer’s treatments more restrictive and slower than in any other disease state. This not only undermines the intent of the accelerated approval pathway, but also the goals of NAPA and the National Plan.
Furthermore, as written, the NCD undermines Goal 1 of the National Plan, which is to “prevent and effectively treat Alzheimer’s Disease and Related Dementias by 2025.” Lilly appreciates that effective treatments should be the touchstone for satisfying that goal. However, the NCD does not outline how a drug that has demonstrated clinically meaningful change in cognition and function will move beyond Coverage with Evidence Development (CED) to outright coverage so that patients can be better served.
We believe that the NAPA Advisory Council should urge CMS to expand Medicare coverage where positive confirmatory data is available and to recommend that CMS immediately reconsider the applicability of the NCD for such products.
Time is of the essence for patients living with Alzheimer’s disease. We therefore urge the Advisory Council to ensure that CMS articulates a clear, timely, and transparent reconsideration process for drugs that produce positive confirmatory data. Given the devastating nature of this disease, AD patients deserve unrestricted access to therapies that demonstrate clinically meaningful change in cognition and function.
- Pub. L. No. 111-375, § 2(c) (Jan. 4, 2011).
R. Katz | 5-3-2022
I serve as the Manager of Federal Government Relations at the National Down Syndrome Society, the leading human rights organization for all individuals with Down syndrome. On behalf of NDSS and the Down syndrome community, I want to thank the Council for the opportunity to speak today. During our last meeting, a few of my colleagues addressed the Council to share why it is critical for this body to address the needs of our community, and they recommended actions that could help you do so. I would like to follow up on those recommendations today.
In October, and again in January, we recommended that this council establish a special subcommittee to focus on how HHS can improve the diagnostic and clinical supports available to individuals with Intellectual and Developmental Disabilities, including Down syndrome. Today I wish to reiterate that request because the need for the subcommittee has only become more pressing in the past few months.
The critical link between Down syndrome and Alzheimer’s disease is genetic. Because the amyloid precursor protein that is the basis for Alzheimer’s disease to occur is present on chromosome 21, people with Down syndrome, who have three copies of chromosome 21 instead of two, are at a higher risk for developing Alzheimer’s disease. Although there is still more work to be done, we are grateful to see that the Centers for Medicare & Medicaid Services (CMS) removed the exclusionary language of the coverage of this class of drug. It is important, due to this genetic link, that CMS not set a precedent in which individuals with Down syndrome do not receive the same coverage as the general public. We continue to ask that the Council be more intentional with their inclusion of individuals with Down syndrome and would like to work alongside the Council to address these issues.
Thank you again for the opportunity to speak today. All of us at NDSS are eager to collaborate with you to promote positive outcomes for our community and stand ready to assist however we can.
W. Smith | 4-28-2022
Thank you Chair Carlsson and members of the National Alzheimer’s Project for the opportunity to speak to you today and for your leadership in addressing the needs of families with Dementia.
Many in my family have been diagnosed with a neurodegenerative dementia caused by the under-production of the protein progranulin. We do not “fit” in the current language of how dementia is discussed. We are often mischaracterized. Sometimes we are lumped into the one size fits all bucket of Alzheimer’s disease of which we are not, we have no plaques or tangles. Some professionals associate us with related dementia which is inaccurate as we are not related to dementia, we are dementia. Sometimes we are referred to as the “other” dementias which minimizes the tragedy that we face in coping with a dreadful disease. How would you feel being referred to as “other?”
Tripping over the language with clinicians and health care professionals is frustrating and confusing, I would like to encourage you and the Advisory council to help bring clarity on how we talk about the neurodegenerative diseases and provide greater inclusivity for all families with dementia.
L. Okwaro | 4-18-2022
I am a graduate student and graduate research assistant from Georgia State University in the Gerontology program. I am writing a comment on what I would like to be considered on the Advisory Council on Alzheimer's Research, Care and Services.
Recommendation on how to improve health care on Alzheimer’s disease.
Alzheimer’s damages the brain by damaging the brain cells. Brain health is rarely discussed and recently I was able to attend a workshop with one of our professors whereby she took us through how brain health is important. Staying physically active, having enough sleep, better nutrition and engaging the brain were some of the things discussed.
- I would like to recommend that we have centers which provide services to the older adults that help promote and make aware of brain health and its importance. These centers should encourage older adults to attend to talks and learn more about the importance of exercise and its long-term benefits to the brain. This will help to preserve the brain integrity.
- In addition to the brain health, I suggest having talks with older adults living with dementia and those who don’t have dementia about why sleep is important. Sleep is associated with Alzheimer’s disease and enough sleep helps to clear toxins that causes Alzheimer’s. brain health is a lifelong process and we should begin early.
S. Choe | 4-17-2022
First, I would like to thank you for your consistent and passionate efforts in addressing challenges and improving the well-being of individuals with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) and their families.
My mother is a first-generation Korean immigrant and was diagnosed with Younger Onset Alzheimer's in 2016 at the age of 56. In existing racial and ethnic health care disparities in the U.S., racial and ethnic minority populations are at higher risk for Alzheimer's disease and face more challenges in accessing dementia care and assessment due to cultural and linguistic barriers. Here, I would like to share some experiences as a primary caregiver of an immigrant mom with Younger Onset Alzheimer's to provide recommendations for developing the National Alzheimer's Project Act (NAPA).
Cross-cultural assessment of AD/ADRD: Cross-cultural assessment of AD/ADRD: One recent study shows that older immigrants have 70% greater odds of having dementia and 119% higher odds of being undiagnosed compared to the U.S.-born.1 The diagnosis of dementia in immigrant populations can be challenging for a number of cultural and linguistic barriers. Another study finds that many clinicians in particular experienced difficulties assessing dementia among older immigrants due to language barriers and challenges related to the family's involvement or an interpreter. An unfamiliarity with test situations among those being evaluated and a lack of knowledge regarding appropriate diagnostic tools among health professionals are becoming challenging.2 My family can deeply relate to this experience. My mother received assistance from an interpreter during the initial assessment and regular visits. However, there was another layer of difficulties in detecting and treating her conditions in an unfamiliar setting and a lack of communication directly between the clinician and the patient. Such challenges may be improved with cross-cultural competencies. Training in communication skills and cross-cultural assessment tools may help build competence and confidence when assessing and caring for people with different cultural and linguistic backgrounds. In addition to culturally and linguistically appropriate education, training, and support materials about AD/ADRD, which are increasingly available to caregivers and families with different cultural backgrounds, cross-cultural assessment and screening programs for dementia can improve the timely diagnosis of AD/ADRD among immigrant populations with limited English proficiency.
Access to Medicare and caregiving services for Younger Onset AD/ADRD: Upon diagnosing Younger Onset Alzheimer’s, my mom worked as a caregiver. As her symptoms progressed, she had to leave her job. With the premature loss of income and higher out-of-pocket expenditures for prescription drugs, our family faced financial burdens as well as emotional and mental hardship. After a long wait, my mom is now receiving Social Security Disability Insurance (SSDI) and Medicare coverage. Like my mother, many individuals living with Younger Onset AD/ADRD encounter practical, physical, and psychological challenges. Their prime years are taken away from this painful disease without much time to prepare. One of the ways to help these individuals maintain their level of functioning and delay the progression of the disease is to provide appropriate and timely care and treatment. Here, I am also highlighting the recommendations proposed by many community members and professionals: eliminating the two-year waiting period for Medicare coverage of those under age 65 who’ve qualified for SSDI and expanding funded services such as in-home and community caregiving to accommodate these individuals.
Expand the coverage for AD/ADRD medications: In April 2022, the federal government affirmed its plan to limit coverage for a costly new medication for Alzheimer’s disease, restricting it to Medicare patients enrolled in clinical trials. Aduhelm is the first Alzheimer’s treatment intended to slow cognitive decline. However, with the federal government’s decision, this new medication will remain unavailable to some of the nation’s 6.2 million people with Alzheimer’s who had hoped to try it for mild cognitive impairment or dementia that results from the disease.3 For individuals living with AD/ADRD, time is precious, and delaying cognitive decline is a sliver of hope in this frightening journey of forgetting. While individuals living with AD/ADRD are experiencing multiple difficulties in every aspect of their life, the government should not limit their opportunity to access the treatment and put more financial burden on them. Instead, the federal government and Centers for Medicare & Medicaid Services (CMS) should allow every needed individual to have coverage and access to this new medication, so they deserve the right to live their time.
AD/ADRD has been declared one of the significant public health challenges of the century, and the number of Americans with AD/ADRD will increase significantly as the population ages. And as the population becomes more diversified, we should consider how AD/ADRD impacts the marginalized and underrepresented people and what other care and assessment of the disease are needed. In doing so, we can better understand issues around AD/ADRD, therefore achieving a “culture-change” in Alzheimer’s care and services.
- Franco, Yujin, and Eun Young Choi. 2020. “The Relationship Between Immigrant Status and Undiagnosed Dementia: The Role of Limited English Proficiency.” Journal of Immigrant and Minority Health 22:914-922.
- Sagbakken, Mette, Ragnhild Storstein Spilker, and T Rune Nielsen. 2018. “Dementia and Immigrant Groups: A Qualitative Study of Challenges Related to Identifying, Assessing, and Diagnosing Dementia.” Multicenter Study 18(1):910.
- Belluck, Pam. “Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials.” The New York Times, April 7, 2020, https://www.nytimes.com/2022/04/07/health/aduhelm-medicare-alzheimers.html.
A. Reeves | 4-14-2022
Hello, I am a master’s student in the gerontology department at Georgia State University. I have two suggestions for you to consider at your next meeting. First and foremost, we must consider how the destructive COVID-19 pandemic has detrimentally affected people and older adults living with Alzheimer’s disease and related dementias (AD/ADRD). In my opinion, the first step in uncovering this information is by asking people living with AD/ADRD first-hand about their experiences. Although they experience some cognitive impairments, they are still human beings who can report their own perceptions and who deserve to have their voices heard. Funding needs to be provided for council members (or relevant researchers) to collect data from people living with AD/ADRD about their experiences during the pandemic.
Deke Cateau, the C.E.O. of A.G. Rhodes, a group of nursing homes in and around Atlanta, wrote a book called Brush Fire: COVID-19 and Our Nursing Homes (2021) where he lists in detail how the pandemic has rampaged through nursing homes across the country and the media has blamed them for a lot of side effects of the pandemic that were completely out of their control. He also mentions how especially difficult the pandemic has been for people living with AD/ADRD because their routine that has been essential to their well-being was completely disrupted for months (Cateau, 2021). Caregivers they recognized became strangers due to the required PPE and they had to endure invasive COVID-19 tests that were difficult for not only the residents, but also for the caregivers. They were more susceptible to social isolation and oftentimes unaware if their friends were alive or dead (Cateau, 2021). The emotional distress is immeasurable, not to mention the detrimental effects that came from restricting visitation from family and friends. We must immediately investigate further and more in-depth across our nation, gathering first-hand information from both people living with AD/ADRD and the frontline heroes, as Cateau (2021) refers to them, about their experiences and how we can try to reverse some of the damage that has been done.
Additionally, Perone and colleagues (2020) have reported that older adults among the LGBTQ+ community are especially triggered during this time as they have already survived the HIV/AIDS epidemic. I cannot imagine what it is like to experience a second pandemic in one’s lifetime. Perone and colleagues don’t mention any reports about how this must be especially difficult for people living with AD/ADRD. My suggestion is that we find a way to identify people living with AD/ADRD who identify with the LGBTQ+ community to investigate what their reports and perceptions are of what they have endured since 2020. Has surviving the pandemic been especially harder for them, and in what ways? How does their experience surviving the HIV/AIDS epidemic affect their experience and survival tactics now? How can we prioritize their mental health and well-being, along with their physical health as older adults are more likely to die from COVID-19? People of all ages living with AD/ADRD are more likely to suffer more/die from COVID-19, and some of them have already survived one pandemic and possibly lost their entire social support network during the first tragedy. It is imminent that we pursue this investigation with all hands on deck to improve the lives of all people living with AD/ADRD.
Cateau, D. (2021). Brush fire: Covid-19 and our nursing homes. Fulton Books.
Perone, A. K., Watkins-Dukhie, K., & Lewis, J. (2020). LGBTQ+ Aging during COVID-19. QED: A Journal in GLBTQ Worldmaking, 7(3), 117-124. doi.org/10.14321/qed.7.3.0117.
A. Gee, Jr. | 3-15-2022
We are writing to add our voice to the call for inclusive Alzheimer’s Disease and Related Dementias (ADRD) research. We are the Black Leaders for Brain Health (BLBH), based in Madison, Wisconsin. Since our committee was established in May of 2019, the BLBH have advised the local ADRD research efforts, in order to make the principal investigators, their research processes, and researchers’ hiring and reporting practices more responsive to the needs of Black people. In short, we function as advocates for change in how research is done, moving toward research that is conducted with communities and not on communities. When research is approached in this manner, it will serve the community and promote health equity.
Conversely, when research studies fail to include a diversity of participants, those most affected by the disease are left wondering if new treatments are safe and effective for people who look like them. An egregious example of this type of flawed research are the recent trials conducted by Biogen for the anti-amyloid therapy, aducanumab. As you know, in 2021 these data were presented to the FDA, and served as the basis for the FDA’s approval of this drug to treat Alzheimer’s disease dementia. Interestingly, the racial and ethnic characteristics of the 3285 participants in Biogen’s EMERGE and ENGAGE trial are reported in a supplement to the scientific paper, and not integrated into the body of the paper. The studies were conducted at 348 sites in 20 countries--all of which are wealthy, and most of which are predominantly white nations. Three Asian nations were included. As you know, Black people in the U.S. are suffering the consequences of ADRD more than any other racialized group. A total of 19 individuals in the study self-identified as Black/African Americans--that is, 0.6% of the sample were people who were most likely to share our ancestry, cultural experiences, and associated biological sequelae of the interaction. The gross underrepresentation of Black/African Americans in the clinical trials undermines our trust in science and medicine, and compounds health disparities. Furthermore, it violates the ethical principle of justice, i.e. equitable selection of research participants so that all may benefit from the research.
This is an urgent matter. Other groups disproportionally affected by this disease are also being left out of the research. The Aducanumab trials included 1 person who identified as American Indian/Alaska Native, and 1 person identifying as Native Hawaiian or Pacific Islander The underinclusion of minoritized groups in such vital research is unethical and it must stop.
The value for diversity in research and the willingness of the research community to make the efforts and investments needed to achieve representativeness in their research is not occurring--in large part because there are no consequences when studies fail to achieve this. We call on the Advisory Committee to push for enforcement of existing mandates (i.e., The NIH Revitalization Act of 1993) for inclusive study design and enrollment. Further, we suggest the following:
- The NIH should support concrete measures to diversify the work force. Ideally, research with communities of color should be led by members of those communities. This may entail providing greater education and training opportunities for community members.
- Require research teams receive training on cultural competence and respectful community-engaged research practices.
- Mandate formation of an engagement with community advisory groups/boards.
- Mandate the evaluation of Inclusion and Retention plans as part of the scientific score for funding proposals.
We feel compelled to speak up because we have seen the suffering associated with ADRD firsthand. The BLBH committee is composed of people who have (or had) loved ones with memory loss or who personally know community members who have been diagnosed with some form of dementia. We use our collective expertise and influence to educate, inform and above all advocate on behalf of those who cannot do so for themselves.
Thank you for your attention to these pressing concerns.