National Alzheimer's Project Act: Public Comments on Advisory Council Meeting, July 2019

07/29/2019

ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES

Public Comments on Advisory Council Meeting, July 2019

List of Comments

   

Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.

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. Hogan  |  07-23-2019

Good morning. I am glad to be in attendance this quarter and sorry that I missed the meeting dedicated to Person Centered Planning, a topic near and dear to my heart. I listened to the April meeting on line in prep for today’s comments. My personal experience with PCP is that it is often misunderstood and inconsistently applied. It is often static rather than dynamic. Perhaps the efforts of this Council and CMS will facilitate change.

Today I bring to you the print form of the Alzheimer’s Disease and Down Syndrome A Practical Guidebook for Caregivers[1]. This publication was funded by the National Down Syndrome Society, written by lead author Dr. Julie Moran, a practicing geriatrician and member of the NTG, with input and assistance from several NTG members. We also benefitted from input offered by the Alzheimer’s Association. It took almost two years to nurse the publication from concept to print form. Many are greatly relieved to know that the Caregiver Guidebook is now accessible in print form in both English and Spanish.

The Caregiver Guidebook is also available electronically in English, Spanish and will soon be posted in French. Plans are approved and underway for a Dutch translation facilitated by an international colleague who also translated Aging and Down Syndrome into Dutch.

Since release of the electronic and print publications, the feedback has been positive from both families and professionals. I hope you will take time to read it carefully, appreciate the richness of the text while viewing the many photos that have been included of people with DS. The photos communicate the human suffering that often accompanies AD and they are profoundly touching. The images convey the journey that unfolded for many individuals and their families. Their reality has been respectfully offered and honorably conveyed.

On the cover of the Guidebook is Irma Fella who was born in Detroit, Michigan in 1945. When Irma was born, the life expectancy of babies with Down syndrome was about 13. She passed away at age 74 on July 16th of this year in San Diego, CA.

After the death of their Mother In 1992, Irma, age 47, moved to San Diego, California to be near her sister Evelyn. Evelyn became Irma’s advocate and champion. For many years after her move, Irma thrived. She became more independent, enjoyed her life in her group home, attended a sheltered workshop, formed many new friendships and remained very active.

Neither Evelyn nor I can remember how we found one another, but we came together to share our experiences after Irma began to decline at or about age 60. She faced many challenges including transitions in her care setting. I visited them in San Diego and we continued to remain in contact these last several years. I have remained aware of the significant challenges that both Irma and Evelyn have faced and I am grateful for all that they have shared with me and other families.

Irma’s story is pertinent today as a follow up to last quarters discussion of Person Centered Planning. Like most individuals with ID and their families who face a diagnosis of ADRD, Irma and Evelyn were primarily left to their own devices as Irma declined. There was no person centered planning facilitation, no point of contact for a care team or care manager, no quality delivery system, quality measures or continuous learning opportunities for caregivers. Dementia Care, based on best practices, was only a dream, never a reality. Shawn Terrell noted during the April 2019 meeting that PCP was a concept familiar in the disability community. In my experience and that of many families, PCP has not been consistently applied to older individuals with ID and complex care needs even in advance of a diagnosis of ADRD. If there was planning, it lacked consistency, was not a dynamic and had no practice standards. The reality is that most of our older family members in the ID community have not had access to PCP with standards for implementation.

Over the course of Irma’s decline she sometimes experienced undiagnosed complications like UTI’s and skin infections complicated by diagnostic overshadowing. Evelyn continuously sought to advocate for timely, appropriate medical care for Irma and stressed positive functional outcomes for her.

For a long period of time Evelyn personally hired extra staff to be available to Irma in her care facility, especially during mealtime to ensure that Irma had ample time to access nutrition. These devoted caregivers saw to it that Irma had reason to smile even in the final years of her life. Irma’s roommate vigilantly watched over her for the past seven years and was often the most accurate contact person for Evelyn. She was in many ways, Irma’s lifeline.

The story of Evelyn and Irma remains all too familiar as families and caregivers strive to provide support to their family member with ID and ADRD. It is our hope that one day we can come to expect that Person Centered Care can become the lived experience for all people with complex care needs such as ADRD. We are hopeful that the focus on planning will include not only the medical needs but also the social, behavioral, environmental, spiritual and relational needs of our family members. We want those who shape policy and practice to recognize that people with ID have preferences and values that should guide all aspects of their future healthcare. They, too, should have access to a dynamic care team that will create and effectively implement a person centered care plan that will ensure quality of life until the end of life.

You are free, Irma. You have lived an inspirational life and for that we are eternally grateful.

NOTES:

  1. National Down Syndrome Society. (2019). Alzheimer’s Disease and Down Syndrome: A Practical Guidebook for Caregivers. Washington, DC: NDSS. https://www.ndss.org/wp-content/uploads/2018/12/NDSS_Guidebook_FINAL.pdf.

 

M. Sterling  |  07-23-2019

For those who don’t know me, Alzheimer’s and other forms of dementia have had a profound impact on my family. My husband and I have 3-out-of-4 parents who have struggled with three different forms of dementia.

My father-in-law, the only one definitively diagnosed with Alzheimer’s, passed away on June 22nd, bringing a long, painful era to an end. For my husband’s family, it meant the sad loss of its patriarch. For me, there’s a much more profound meaning. This is the first time since I was a teenager that I don’t have a parent or parent-in-law with dementia. I’m 52.

All these years after the start of this journey, the world has changed dramatically. The information age and technology have changed how we interface with the world.

But some things have not changed.

Emergency room visits, hospital stays, nursing home and end-of-life care are all provided by people who have no idea how to provide care for someone who has Alzheimer’s or interact with their family.

Adequate support for family caregivers remains elusive. We are gathered in Facebook groups trying to gather “tribal knowledge” from other caregivers, unable to find resources in our own communities.

Women are disproportionately impacted. An entire generation of women will lose their jobs, financial security, physical and emotional health because of caregiving responsibilities.

The duration of dementia caregiving is seldom discussed and another devastating blow to families. The inability to obtain affordable, dependable, knowledgeable home healthcare is depressing.

The Medicaid eligibility process is painfully complex, and families often just give up and drain their own finances trying to manage on their own. This has repercussions that I can’t even begin to address.

The incorporation of patient and family caregiver voices in research is agonizingly slow. Despite several bright spots, the research community largely remains skeptical and slow to adopt new practices, including the transformation of clinical trials to accommodate those with Alzheimer’s and their caregivers, who often cannot leave their homes and travel to distant academic medical centers in order to participate.

Despite these observations, I remain hopeful -- thanks to relentless advocates and new avenues of research. But dramatic change will only come when those who have lived with dementia and their families are included at every table -- and collaborating with every researcher, policy maker, and healthcare delivery professional both here and around the world.


 

C. Alcorn  |  07-22-2019

As reported by the Alzheimer's Impact Movement, the Alzheimer's and related dementia research funding at NIH has increased steadily from $448 million in 2011 to $2.3 billion in 2019 (AIM, 2019). The impact of the increased spending is multifaceted and has permitted the development of new research tools and techniques as well as diverse hypotheses as to the causes of neurodegenerative diseases and targets for intervention. Yet, review of the Alzheimer's disease drug development pipeline shows Alzheimer's research productivity may be in decline.

A simple, objective metric for Alzheimer's research is the number of drugs in Phase 3 clinical trials. Analyses of the Alzheimer's drug pipeline show the number of disease-modifying drugs in Phase 3 clinical trials declined 14% in 2018 and declined another 11% in 2019. The number of drugs in prevention trials also declined by 14% in 2019 while unchanged in 2018 (UsAgainstAlzheimer's, 2018; UsAgainstAlzheimer's, 2019). This trend is disturbing as these trials are necessary to validate or disprove research hypotheses by assessing whether resulting treatments produce clinically meaningful benefits. Absent these trials, there will be no treatment.

Another Alzheimer's metric might be the total research investment. A compilation of both public and private investment would strengthen reporting as solely looking at public investment may yield an incorrect perception, particularly if public sector spending is rising as private sector investment is declining (Rowland, 2019; Weild IV & Pickett, 2019). Unfortunately, a source for timely and accurate information regarding private investment is not known to the undersigned apart from the implementation of a survey of sponsors of Alzheimer's research.

The Advisory Council should evaluate Alzheimer's research performance metrics to be reported and explained. The impetus for this suggestion is a concern that the product development pipeline appears to be clogged as evidenced by the declining rate of Phase 3 clinical trials. Further information may better define actions (beyond increased funding at NIH) that are needed to permit the pipeline to flow.

References

AIM. (2019, July 18). ALZHEIMER'S AND DEMENTIA RESEARCH. Retrieved from Alzheimer's Impact Movement: https://alzimpact.org/priorities/research

Rowland,C. (2019, July 5). Alzheimer's research is getting a reboot at small companies focused on the immune system. The Washington Post. Retrieved from https://www.tulsaworld.com/news/trending/alzheimer-s-research-is-getting-a-reboot-at-smaII­companies/article_58574e35-ee07-Sfba-9d82-2eba98b3b343.html

UsAgainstAlzheimer's. (2018, July). The Current State of Alzheimer's Drug Development 2018 Alzheimer's Drug Pipeline. Retrieved from USAgainstAlzheimer's: https://www.usagainstalzheimers.org/sites/default/files/2018_Alzheimers_Drug_Pipeline_The_Current_State_Of_Alzheimers_Drug_Development.pdf

UsAgainstAlzheimer's. (2019, July). The Current State of Alzheimer's Drug Development 2019Alzheimer's Drug Pipeline. Retrieved from UsAgainstAlzheimer's: https://www.usagainstalzheimers.org/sites/default/files/2019-07/RAAPages_FlNAL.pdf

Weild IV, D., & Pickett, H.V. (2019, Feb 22). Opinion: With News of Another Failed Trial, a Cure for Alzheimer's May Have More To Do With Corporate Finance Than Science. Being Patient. Retrieved from https://www.beingpatient.com/alzheimers-search-for-a-cure-common-need­investment/


 

D. Blackwelder  |  07-20-2019

Hello and thank you again for the opportunity to speak to you again about my lived experience with Younger Onset Alzheimer’s. Today, I have some disturbing news to report but feel the more that are made aware, the more likely action will be taken to stop a disturbing practice of physically restraining the elderly and people living with dementia including by family caregivers. As a point of reference the World Health Organization has published a brief stipulating the importance of “…ensuring that those responsible for protecting the human rights of people living with dementia should be held accountable for any human rights violations. In addition, there should be increased education about dementia to change attitudes of society and reduce stigma. Lastly, people living with dementia should be empowered to participate in decision making processes and to maintain their legal capacity…”

Unfortunately, Amazon in the US, Canada and UK is advertising a variety of physical restraints with titles and descriptions of being for “the elderly” or persons with “dementia” or “senile dementia”. See below screen captures with photos of the restraint devices. While it is not illegal to sell restraints, it is in violation of our human rights as people living with dementia to be restrained merely because we have a diagnosis of dementia. I hope each of you are as sickened as I am when viewing these ads by Amazon and will take every action in your power to change this. To date, Amazon UK has promised to cease with these ads but have failed to do so and Amazon U.S. and Canada has been silent. Amazon knowingly and egregiously perpetuates the stigma based practice of physically restraining persons merely because of age of dementia diagnosis in direct violation of our human rights. Having these kinds of ads on a popular shopping site like Amazon not only perpetuates the stigmas but creates an environment where family and other non-professional caregivers may believe this is an appropriate way to treat us.

https://www.who.int/mental_health/neurology/dementia/dementia_thematicbrief_human_rights.pdf

----- ----- ----- ----- -----

July 6, 2019 and again on July 20, 2019 -- Reported incorrect product information on multiple ads directly to Amazon with no response received to date.

Violation of human rights as “elderly” or “senile dementia” dx does not warrant restraint, per World Health Organization this is a violation of human rights.

https://www.amazon.com/YxnGu-Knee-Legs-Feet-Bound/dp/B07RZQ2KBJ/ref=sr_1_117?keywords=dementia+restraints&qid=1562437818&s=gateway&sr=8-117

Image of GFYWZ Patient Restraint Bundled Clothing.
Image of YxnGu Medical Adjustable Patients Constraint Band. Image of Patient Restraint Upper Garment. Image of Patient Restraint Upper Garment.
Image of YxnGu Knee Legs and Feet Bound Band.

 

C. Danesi  |  07-17-2019

Two minutes may not seem very long for most but for me they must be worth a lifetime. As many of you know, my mom has had this wretched illness for many years. Projected by all of her doctors and specialists to live at the very most one year from the point of diagnosis--she’s lived more than twenty and is still here as you can see today. If anyone should be called a survivor it should be her, myself and my family. Having endured and overcome struggles, challenges and obstacles that most people will be fortunate enough to never have to go through in their lifetimes, we know the unimaginable suffering that comes with this brutal disease. We also know that to survive it you must think outside of the box. As you may know, I have been advocating for change in the Alzheimer’s world for many years. The compound that I truly believe can be a game changer in the trajectory of this illness, after many years of trying has finally made it to phase one human trials as of February this year. Although I have to be patient as data is collected and things progress, I am confident that J147 is going to do extremely well and not only will have the ability to help treat the illness throughout various stages-I also believe it will have preventative capabilities if taken early enough. I do not proclaim to be a researcher or a medical professional. What I do proclaim to be is a daughter-a daughter who’s life and family was destroyed when we were given my beloved mother’s diagnosis so many years ago. Desperate, alone and afraid I did the only thing that I could do and that was to fight back. I fought to reach my mom-to get into her world-the world that this brutal disease had pulled her into and pull her back for myself, my father and my family. So here we are in the present and my mom will be turning 74 years old in September. Where do mom and I go from here? Some people say if J147 makes it-it won’t help your mother-it’s too late. My response to them is how do you know? And so now as we embark on what may be our final journey in our story, Mom and I have one imperative message for everyone: Acceleration-5 to 10 years for a new and better compound like J147 to come to accessibility is an unacceptable amount of time while millions of Americans and their families across the nation are suffering. If J147 proves that it can do what I feel in my gut it can do, I ask that you join me in making sure that J147 comes to fruition Fast so that millions can be helped and the future trajectory of this illness, where before held only despair will now hold true hope in my mother’s honor and for all those who have been forever affected. I will close my comment with this: Mom I thank God every day for the time we have together and no matter what happens I love you so much more than words can describe. Thank you.

At that time, at the council’s discretion, I respectfully request a brief moment for anyone present that would like to ask questions of me regarding mom and the proactive path we chose for her. My answers would of course be polite, kind and informative.


 


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