PB #27 ... Articles About GEAR Program Now Available to Everyone ... 8/31/22

Readers familiar with this site will note that I have already posted several Personal Blog columns about the GEAR program … Blogs # 18, 24, and 26 … a federally funded program designed to improve care for people with Alzheimer’s disease (AD) and other forms of dementia in hospital Emergency Departments (EDs).  Published manuscripts about the research reviews conducted by the GEAR task force in four focus areas … communication, detection, best practices, and transitions … are now available to read.  These articles, as well as additional information about this project, may be accessed in the “Manuscripts and Publications” section of the main GEAR website at https://gearnetwork.org.

In the words of Dr. Chris Carpenter, one of the leaders of this project, “We would like to generate some media interest in this effort so that persons living with dementia and their care partners are aware of this work.  The more folks know the more they can pressure their Congressional leaders to ensure funding for this research. These citizens can also pressure their local emergency departments to begin adapting for more dementia-friendly care.”

If any reader has access to major mass media, it would be wonderful to alert such media to the availability of these manuscripts to generate more interest in improving emergency care for dementia patients and increase general awareness of what must be done.  Following are the verbatim “Conclusions and Implications” sections of the manuscripts dealing with our four areas of focus.  It is hoped that these articles will lead to future research to develop the most effective strategies in each area and eventually lead to substantial improvement in how dementia patients are treated in hospital EDs.

  

Communication … Conclusions and Implications

This scoping review identified sparse published research to guide evidence-based communication strategies in the ED for PLWD and their care partners. Although general themes appear to emerge around rushed communication and inadequate engagement of care partners, these findings are neither quantified nor directly linked to ineffective communication. Strategies to improve ED communication for PLWD do not exist, although educational interventions outside the ED suggest limited effectiveness. GEAR 2.0-ADC stakeholders prioritized the identification of barriers and facilitators to effective ED communication for PLWD.

 

Detection … Conclusion and Implications

We report the results of 2 systematic scoping reviews evaluating diagnostic accuracy and feasibility to detect cognitive impairment and dementia in the ED setting. The GEAR 2.0 Advancing Dementia Care task force, using these results, developed consensus research priorities practice gaps to advance the detection of cognitive impairment and dementia in the ED setting. They include the need for more effective and efficient approaches to recognize persons at risk for cognitive impairment and dementia. These approaches should balance the importance of equitable screening and the goal and the consequences identifying cognitive impairment. These research priorities will be the basis of future GEAR 2.0 research funding opportunities.

 

Best Practices … Conclusions and Implications

The results of this scoping review reveal a wide range of components of both ED care practices and ED care needs for PLWDs. Although many structural and process interventions show positive results, the lack of depth and reproducible results prevent specific recommendations on best practices in ED care for PLWDs. Future research should work to identify improvements in ED care for PLWDs, address gaps in training, identify priority outcomes, address community and identity-based factors, and incorporate economic viability and implementation science

Transitions … Conclusions and Implications

This systematic scoping review found few ED-to-community care transition interventions targeting cognitively impaired older adults and their care partners. Further, there was little data identifying care transition outcomes of importance to these groups. Personalizing care transitions for these ED patients and measuring what matters most during ED-to-community care transitions were identified as the highest priority areas for future ED research involving cognitively impaired older adults and their care partners. As such, research funding agencies, advocacy groups, and researchers should focus their resources and efforts on these domains, thereby developing the science to improve the health of this vulnerable population.

 

Once again, readers are urged to access https://gearnetwork.org to read the entire articles and learn more about this project.

Alzheimer Disease Support Groups

 

JUNE 2022 PRACTICAL NEUROLOGY 45

 Alzheimer Disease Support Groups

A care partner plea for physicians to inform patients and care partners about Alzheimer disease support groups.

By Allan S. Vann

 

 

 

   I am a retired public school principal. I started observing my late wife’s symptoms of what would eventually be diagnosed as early or young-onset Alzheimer disease (AD) 15 years ago. There were many frustrations, especially about misdiagnoses for several years. As my wife was treated first for stress, then anxiety, and then depression, I continued seeing her AD symptoms worsen. Another frustration was that we were not informed about available support groups, which led me to become an advo­cate and share my frustrations in written publications.

   In my first article, published in the American Journal of Alzheimer’s Disease and Other Dementias in 2010, I noted the need for doctors to be more helpful in finding sup­port groups for their patients, “Doctors as well as local/ national AD organizations should also be working together to provide patients with ready access to support groups as patients progress through the stages of this fatal dis­ease—and helping to better meet the needs of those who are diagnosed at a young age and/or are in the very early stages of the disease.”¹

 

My Support Group Experience

   At the time of my wife’s diagnosis, I could not find a sin­gle support group on Long Island specifically designed for those with early onset AD. I did find a group for people in early-to-moderate stages of AD, and my wife was accepted into that group. The Long Island Alzheimer’s and Dementia Center also had a support group for spouses of people with AD, but I didn’t think that I needed a support group at the time. I was so focused on my wife’s needs that I hadn’t yet begun to understand what my needs were, or would be, as her disease progressed.

  My wife, however, insisted that she would only join her support group if I attended at least 1 meeting of the spouse’s support group. So, as she went to meet with her group, I went to what I thought would be my only meeting with the spouse’s support group. To my surprise, within minutes, I realized that group was where I needed to be. My wife’s insistence may have been her final gift to me because I don’t know how I would have coped during her illness without assistance from that spouse’s group. I was too naive back then to realize that support groups for AD care partners may be even more important than support groups for those with AD.

  I learned more important practical and helpful informa­tion from members of the support group than from all the doctors we met, all the books I read, and all the internet searches I did. They helped me become a better care part­ner and learn how to deal with my own needs as my wife’s disease progressed.

  Importantly, it was just blind luck that led me to my essential support group because the neurologist caring for my wife never mentioned how support groups might be helpful for either of us. Shortly after I joined the spouse’s support group, I asked everyone how they had learned about our group; out of 15 of us, only 1 had learned about our support group from a neurologist.

  In another article I wrote that was published in 2011, I noted, “Some cities and some states have local and state associations that provide a multitude of support groups for both the patients, their spouses/caregivers and for non-spouse caregivers, often through branches of the Alzheimer’s Association, the Alzheimer’s Foundation, or hospitals. If there are such groups near where your patient and spouse live, please refer them to those groups or organizations. If not, please consider speaking with leaders of your state’s associations to have such groups formed. Also, become aware of the excellent online support groups available that you can recommend.”² Some resources for finding support groups are provided in the Box; you can use the QR code there to access a stand-alone version of this that you can print and share with your patients and their care partners.

Increase in Support Groups, But Not Neurology Referrals

Within 2 years, more support groups were forming on Long Island for people with various stages of AD and for their care partners, and more online groups were becom­ing available. Neurologists, however, were still not rou­tinely discussing the existence and importance of support groups with their patients with AD or those patients’ care partners. In a 2013 article published in the Journal of the American Geriatrics Society, I wrote, “Doctors working with someone who is caring for a spouse, parent, grandparent, friend, or other family member with Alzheimer’s disease should urge them to join a support group. Let them know that they can learn many practical suggestions from those who have ‘been there’ and how important it is to have a place where they can talk openly about their feelings, fears, and concerns while receiving emotional support from oth­ers ‘who get it.’ Caregivers should not have to ‘go it alone’ when a loved one is declining from an incurable disease, but unless doctors inform them of the existence and value of support groups, many who would find emotional and practical help there will lose out on this wonderful source of information and comfort.”³

   The increasing number of AD support groups on Long Island and elsewhere, both for people with AD and their care partners, is a sign of progress. However, neurologists are still not routinely referring patients and care partners to such groups.

   For the past 2 years I have been a member of the Geriatric Emergency Care Applied Research Network 2.0 (GEAR 2.0) Task Force. GEAR is “a National Institutes of Health funded program working to advance the science supporting emer­gency care for people with dementia.”⁴

  During many zoom meetings and online exchanges, care partners and people in early stages of AD have told me that their neurologists have not discussed support groups with them.

  I have also had many interactions with AD care partners and people with early onset AD as a member of several AD research panels sponsored by the Center for Information and Study on Clinical Research Participation (CISCRP).⁵

 Through this work, I have again been told many times by people with AD and care partners that neurologists are not routinely discussing the importance of support groups, let alone where to find such groups.

BOX.   How To Find Alzheimer Disease and Other Dementia Support Groups

Call the Alzheimer Association 24/7 Helpline 1-800-272-3900 Provides information about in-person and virtual support groups in your area

Visit the Alzheimer Association Online Community alzconnected.org An online community with multiple message boards where patients and caregivers can ask questions and find answers and support from peers

Community Resource Finder communityresourcefinder.org from the American Association of Retired Persons and the Alzheimer Association Allows individuals to search for support groups and other resources by zip code

Lewy Body Dementia Association lbda.org/local-support-groups Offers interactive support group finder for both patients and care partners

The Association for Frontotemporal Degeneration Helpline 1-866-507-7222 Provides information about in-person and virtual support groups in your area

The Association for Frontotemporal Degeneration Support Group Finder theaftd.org/living-with-ftd/aftd-support-groups/ Offers interactive support group finder for both patients and care partners

                                                                                          (Continued on page 55) 

(Continued from page 46)

 Research Supports Referral to Support Groups

   Last summer, citing a 2015 study reported in the International Journal of Geriatric Psychiatry, medical writer Sherry Christiansen wrote: “Support group members often give each other tips on how to manage the various chal­lenges that arise. Not only can Alzheimer’s support groups provide information, but studies have shown that they can help reduce depression and improve the quality of life and self-esteem for people with AD who have mild cognitive impairment (early Alzheimer’s), as well as those in the later stages of the disease (ie, Alzheimer’s dementia).”^6,7

   According to the online “Caregiver’s Corner” section of the Fisher Center at Rockefeller University website, “Research shows that when family members and caregivers are educated about the disease and involved in the per­son’s care, the person who has Alzheimer’s benefits. When the family and caregiver of a person with Alzheimer’s understand the disease and learn how to communicate and interact with the person in ways appropriate to the disease stage, they are better able to reduce behavioral problems and improve the quality of life for all involved.”⁸

Conclusion

   Support groups for patients with AD and their care partners can improve their quality of life, but many neu­rologists are not referring to support groups. This leaves patients and care partners without an essential part of treatment. I urge all neurologists to find out about support groups in their area and inform their patients not only of these groups’ existence, but also of how such groups can be helpful to their treatment. To do otherwise is to pro­vide less than the best care.

 

1. Vann A. Alzheimer’s and baby boomers. Am J Alzheimers Dis Other Demen. 2010;25(6):477-478.

2. Vann AS. 10 things you should do when the diagnosis is Alzheimer’s. Am J Alzheimers Dis Other Demen. 2011;26(2):93-96.

3. Vann AS. Caregiver support groups. J Am Geriatr Soc. 2013;61(8):1413.

4. Geriatric Emergency Care applied Research website. https://gearnetwork.org/about-gear-2/. Accessed May 19, 2022.

5. Center for Information and Study on Clinical Research Participation website. http://www.ciscrp.org. Accessed May 19, 2022.

6. Christiansen S. Alzheimer’s disease support groups. Verywell Health. https://www.verywellhealth.com/best-alzheim­ers-disease-support-groups-4844290 Updated on August 31, 2021. Accessed May 19, 2022.

7. Leung P, Orrell M, Orgeta V. Social support group interventions in people with dementia and mild cognitive impair­ment: a systematic review of the literature. Int J Geriatr Psychiatry. 2015;30(1):1-9.

8. The Fisher Center for Alzheimer’s Research Foundation. Caregiver’s Corner. https://www.alzinfo.org/treatment-care/ caregivers-corner/. Published 2022. Accessed May 20, 2022.

 

 

Allan S. Vann, EdD

Care Partner & Patient Advocate

Commack, NY

allansvann.blogspot.com

 

Disclosures

ASV reports no disclosures

Published in Practical Neurology, June 1922, Vol. 21, No. 5, beginning on p. 45.   Access at: https://practicalneurology.com/articles/2022-june/alzheimer-disease-support-groups

 (Unable to reproduce the QR download code for box ... sorry!!)

PB # 26 … Update on GEAR 2.0 Federal Grant Project re Care of Dementia Patients in Hospital Emergency Departments … 3/22/22

This project, described in PB #18, is well underway.  The mission of the Geriatric Emergency care Applied Research (GEAR) network is to improve the emergency care of older adults and those with dementia and other cognitive impairments.” ¹

Meeting frequently during the past 2 years via zoom, GEAR 2.0 participants have worked in 4 domain groups to identify priorities in Emergency Department (ED) settings. These 4 domain groups are:

• Best practices and the delivery of emergency care for persons with dementia in the ED setting.
• Care transitions for persons with dementia in the ED setting.
• Communication and shared decision making for persons with dementia in the ED setting.
• Detection and recognition of dementia and cognitive impairment in the ED setting. ²

Each domain group identified priorities that led to key research questions for further investigation.  An example of domain questions deemed most important to investigate further are …

In the Best Practices domain …What components of emergency department care improve patient-centered outcomes for persons with dementia? 

In the Transitions domain … What measures of quality ED discharge transitions are important to varying groups of ED patients with impaired cognition and their care partners?     

In the Communication domain … How does “communication and decision making” differ for persons with dementia compared to persons without dementia?

In the Detection domain … How can the ED best identify cognitive impairment?  Are there differences by race or ethnicity?

The current phase of this project involves awarding competitive grants supporting research to find answers to these and our other priority questions that will lead to improved care of people with dementia in hospital Emergency Department settings. ³

Four articles, one coordinated by the chair of each domain group, are now undergoing a peer reviewed medical journal submission process to “get the word out,” so to speak, on these important questions.  We want to encourage the specific research necessary to help find answers to these important questions so the ED experience can be a more effective and more positive experience for those with dementia.

Readers who wish to become more familiar with the aims and objectives of this NIH/NIA funded GEAR grant project, to eventually read these articles when published, or to learn more about the grant application process, should consult the gear network website. 

1.  Access at gearnetwork.org

2.  Access at https://gearnetwork.org/2021/07/21/cognitive-impairment-dementia/

3.  Access at https://gearnetwork.org/about-gear-2/

Another Voice: NFL should do its part to raise Alzheimer’s awareness

 

With a new football season underway, NFL broadcasters and advertisers are expected to reach a very wide TV audience. Of the 50 most watched TV broadcasts last year, 33 were NFL games.

In October, as it has done each year since 2009, the NFL is promoting cancer awareness with its "Crucial Catch" campaign during its broadcasts. Players in past seasons wore special uniforms to show support for those diagnosed with cancer and to stimulate greater disease awareness. In the past 12 years, the NFL has raised more than $18.5 million for the American Cancer Society, and I applaud the NFL for taking this leadership role.

Another leadership role well suited for the NFL would be to have players wearing purple on their uniforms in November to raise awareness of Alzheimer’s disease and other forms of dementia. Alzheimer’s and other forms of dementia kill more people than breast cancer and prostate cancer combined.

According to a study reported earlier this year by researchers at Penn State University, “a single head injury could lead to dementia later in life. This risk further increases as the number of head injuries sustained by an individual increases.” 

In 2014, a successful lawsuit filed by retired players against the NFL concluded that “former players between 50 and 59 years old develop Alzheimer's disease and dementia at rates 14 to 23 times higher than the general population of the same age … and … rates for players between 60-64 are as much as 35 times the rate of the general population.”

The NFL knows it has a problem and has taken measures to try to prevent and lessen the effects of concussions. Unfortunately, even though concussions were reduced about 5% in 2020, Jeff Miller, NFL executive vice president, had to bluntly admit, “This is progress. This is not success.”

In 1985, President Ronald Reagan proclaimed November as National Alzheimer’s Disease Month, asking people in the United States “to observe that month with appropriate observances and activities.” That year, 2 million Americans had Alzheimer’s.

Today more than 6 million Americans have Alzheimer’s, the only disease among the top 10 causes of death in this country with no effective means of prevention, treatment, or cure.

With players wearing purple on their uniforms, NFL broadcasters and advertisers can educate people each November about Alzheimer’s disease and other forms of dementia, while also helping to raise money for research.

NFL Commissioner Roger Goodell once cited a principled stand taken by his father, former U.S. Sen. Charles Goodell, when the senator explained why he spoke up in opposition to the Vietnam War. Charles Goodell said, “It’s not easy to know what is right, but when you do know what is right, you have to have the courage to do it.”

Commissioner Goodell surely knows that it is right for the NFL to help promote Alzheimer’s awareness and research each November. The only question is, does he have his father’s courage to do what is right?

Allan S. Vann is a freelance writer and former caregiver to a spouse with Alzheimer’s.

Published in The Buffalo News on 10/16/21.  Access at: https://buffalonews.com/opinion/another-voice-nfl-should-do-its-part-to-raise-alzheimer-s-awareness/article_22c1edd6-2cf1-11ec-b2c0-eb7a546cd015.html

Personal Blog #25 … Tips from Michael Ellenbogen … a Person Living With Dementia and fellow member of the GEAR 2.0 Task Force ... 10/2/21

This Personal Blog (PB) is very different from previous PBs I have posted on this site.  I have already written PBs about GEAR 2.0, the NIH/NIA grant program seeking to improve hospital emergency room treatment for people with Alzheimer’s disease (AD) and other forms of dementia.  One of my fellow task force members is Michael Ellenbogen, a person living with dementia (PLWD).  When Michael was 49, he was diagnosed with early-stage AD … but that was only after Michael spent 10 years trying to receive a diagnosis for what was happening to him.  Doctors now believe he may have Frontotemporal Dementia (FTD) instead of young or early onset AD.  Regardless, Michael is now 63 and he continues to share his experiences to help improve life for those with all forms of dementia.  

I asked Michael to write about some of the things he thought were most important to share with both PLWDs and their caregivers so I could post these items in a Personal Blog.  I selected 4 items from Michael’s list to share in this column.  I will print Michael’s words in bold print, followed by my perspective as a former AD spouse caregiver.

1.  This disease is far worse than you can imagine. Just imagine that you are going in reverse from an adult to a child but you still have the knowledge of how things should be done but you are no longer capable of doing it.  For PLWD who are aware of what is happening to them, it is so very frustrating because they know that they are screwing up but can’t do much about it.   From my caregiver’s perspective, AD is even much worse than this description.  As this disease progresses from early to moderate to advanced stages and the PLWD continues “going in reverse,” the PLWD will also lose the knowledge of how things are done, not just the capability of how to do things.  Caregivers of those who are aware of their decline … not all PLWD are aware of how much they have declined … must also prepare for increasing frustration knowing there is nothing they can do to prevent this decline of their loved ones.  Both the PLWD and the caregiver must prepare to accept this reality.

2. Don’t argue about things that are not true or are remembered incorrectly, and sundowning makes it even more difficult.  Just trying to pay attention takes so much energy as the day progresses from morning to afternoon to night.  Just thinking about what to do takes up so much energy, I feel burnt out.  As my wife progressed from early to moderate stages of AD, I learned about something called “confabulation.”  Confabulation is a symptom of memory disorders often experienced by people suffering from dementia, traumatic brain injury, and a variety of other conditions. My wife would often “remember” events or activities that had never actually happened.  Even if presented with evidence to the contrary, she could not be convinced that her memory was faulty.  But she wasn’t lying to me when she confabulated … she genuinely believed that what she said was true.  Caregivers of PLWD should take Michael’s words to heart … don’t let yourself become involved in an argument you will not win, and be aware of the effects of sundowning.

3.  If you are going to have an angry face or tone, expect it 10 times worse from your PLWD.  I can vouch from personal experience that when I let my frustrations get the better of me, not only did I forget that my wife’s frustrations and feelings of anger were much greater than mine, but I also forgot how my reactions were affecting her.  Caregivers must not allow their frustrations or anger to show in their voice, facial expressions, or actions.  As with all situations when dealing with a PLWD, caregivers must always try to remember that their actions and reactions will have a great effect on their loved one’s actions and reactions.  So, in the words of one of my former teachers who posted only 2 words as her classroom rule each year: Be nice!

4.  This disease is like a curvy road and you need to be prepared for what is ahead to stay on track, and it will not be easy.  When I attended my first support group with fellow spouse caregivers, I was told that if you know one person with AD, then you know one person with AD.  All PLWD will eventually go through “stages” as this disease worsens.  However, some people advance rapidly through stages, some advance rapidly only through some stages, some advance slowly through all stages, and some advance slowly only through some stages.  Some go back and forth between stages because not all PLWD advance through stages in a completely linear fashion.  Some lose specific abilities forever as they advance to the next stage, while some regain those abilities for a limited period of time, only to then lose them forever.  And not every PLWD experiences the characteristics of a particular stage in the same way. 

As Michael said, “this disease is like a curvy road.”  Progression from early to moderate to severe stages of AD is a bumpy one, but you can learn about what lies ahead to avoid being surprised and to allow yourself to “stay on track.”  No one can predict exactly when or how quickly or slowly one will progress through stages of any form of dementia.  However, knowing what is coming … even if unable to know exactly when … will provide you time to plan for the future.

 

Personal Blog #24 … Personal Statement to GEAR 2.0 Task Force ... 8/16/21

The GEAR project … Geriatric Emergency care Applied Research … is winding down its year of having task force domain groups focus on four major areas affecting people with dementia or cognitive impairment in hospital Emergency Departments (EDs).  Groups focused on the best way to detect cognitive impairment/dementia in patients in the ED, the best practices to treat such patients, best ways to communicate with such patients and how to involve care partners in shared decision making, and best ways to facilitate transitions between the ED and home or to other facilities.  Groups worked on preparing questions to research in each area, prioritized questions, and conducted reviews of the literature.  Further discussion and voting will take place at upcoming “consensus conferences in September.  After these top priorities are selected, pilot grants will then be issued to, hopefully, provide some answers.  As stated on their new website, “The mission of the Geriatric Emergency care Applied Research (GEAR) network is to improve the emergency care of older adults and those with dementia and other cognitive impairments.  GEAR looks to identify research gaps in geriatric care and support research and evaluation of these areas”  https://gearnetwork.org/

As a former caregiver who participated in each of the four domain groups … zoom meetings for each domain were held monthly for the past year … I was given the opportunity to prepare a brief personal statement to be shared with participants at the consensus meetings in September.  I viewed this as an opportunity to share what I thought should be the two highest priorities of our group … the two areas needing most change to try to make ED experiences more effective for people with dementia.  Based upon my own experiences with my late wife in EDs, and the experiences of other caregivers who provided me feedback, here is what I prepared for that video statement. 

Should readers have any comments regarding this statement, or comments regarding any of my posted articles and personal blogs, please forward those comments to me at acvann@optonline.net.

Task Force Statement … Allan S. Vann

I am a former Alzheimer’s spouse caregiver.  When in moderate to severe stages, my late wife was brought to a hospital ED on several occasions.  The one common denominator of these ED visits was poor treatment.  I attribute that poor treatment to two overriding reasons … lack of training by ED staff, and the refusal of ED staff to see her as a higher triage priority.

One should expect better outcomes if ED staff are properly trained to diagnose and treat people with dementia, especially those in advanced stages.  Properly trained staff would know, for example, to use non-verbal communication and diagnostic techniques if the dementia patient is unable to understand questions or respond accurately.  If brought to the ED in pain after a fall, for example, it is futile to ask where the pain is or ask on a scale of 1-10 how much it hurts.  A knowledgeable physician might slowly apply pressure to different parts of the patient’s body to note reactions that would often indicate where and how severe the pain is.  Well-trained staff would also understand the value of asking caregivers, if present, for helpful information.

If dementia patients were a higher triage priority, issues in EDs that can unnecessarily cause increased discomfort and pain, let alone complicate diagnosis and treatment, could be lessened dramatically.  Issues such as increased anxiety, sundowning, restlessness, disorientation, and heightened confusion due to long waits for examination and diagnostic testing followed by longer waits for results of such testing, IV needles in arms for many hours, sensory overload due to bright overhead lighting, sounds of machines beeping and strangers and staff talking, lying on uncomfortable gurneys, effects of delays in taking daily medications which may specifically help lessen anxiety, increasing fatigue due to not eating until all testing is complete, and the list  goes on … all of these issues can be lessened to a great extent if people with dementia were a higher triage priority.  Inattention to these matters can also mask or exacerbate the very issues that led to the ED visit, or even cause new health issues, so ED staff must also recognize that it is extremely important to reach decisions to admit or discharge as quickly as possible.  

Many other spouse caregivers have shared similar ED experiences with me.  ED staff responsible for treating people with dementia need more and better education and training, and dementia patients must be given a higher triage priority.

Personal Blog #23 ... Letter to Acting FDA Commissioner re Aduhelm ... 6/11/21

 

On 6/7/21, the FDA approved the drug Aduhelm, Biogen’s aducanumab medication, an intravenous infusion to be administered monthly for people with Alzheimer’s disease.  Despite not one member of the FDA’s Advisory panel voting to approve this med, FDA approved its use anyway.  FDA determined that since Aduhelm helped clear some amyloid protein from the brain, it may be “expected to help slow dementia.”  However, Biogen’s own data do not support such a claim, and readers can read my Personal Blogs #11 and #12 to learn more about results of clinical trials with this drug. 

Aduhelm will also be a very costly drug.  It is priced at $56,000 a year.   As noted in Newsday on 6/10/21 (Lane Filler, page A25), “If 10% of American Alzheimer’s sufferers began using aducanumab, the tab would be $33.6 billion annually billed to Medicare for the still-solvent sufferers and Medicaid for those bankrupted by the disease.”  That is money that could be better spent elsewhere. 

Earlier today I sent the following letter via email to Janet Woodcock, acting FDA Commissioner, at Janet.Woodcock@fda.hhs.gov  re FDA approval of AD med, Aduhelm:

As a former Alzheimer's disease (AD) caregiver ... my wife died after her AD struggle in 2016 ... I want to register my strong objections to the FDA's decision to approve yet another "bottle of hope" for people with AD.  Having been a member of an AD spouse support group for many years, having briefly facilitated spouse support groups for the Alzheimer's Association, and having had more than 100  articles published about AD (www.allansvann.blogspot.com), I can attest to the serious negative consequences approval of Aduhelm will have for many surviving spouses.  

In 2013 I wrote about FDA-approved AD meds in one of my articles.  Quoting from that article, "Despite there being no research to support the effectiveness of these AD medications beyond a few months, at best, many doctors continue prescribing these medications for years and years. Not only can these AD medications no longer be helping their patients, but they may actually be causing some harm. Maintaining patients on these medications long term may provide false hope to patients and their caregivers. I refer to these medications as “bottles of hope” because as I watch my wife decline, I know that the medications cannot possibly be helping anymore, if they ever did at all.  For many patients and caregivers, the high costs of AD medications present an economic hardship. Money spent on AD medications is money that might otherwise be spent on day care programs, companions, home health aides, or other services that would actually improve the quality of their lives."

I witnessed AD spouse caregivers having to spend life savings on AD meds.  Some had to sell their homes when placing spouses in assisted living or to cover costs of home health care aides.  Now even more will have to do so because of money needlessly spent on this latest bottle of hope you have approved.  Based upon data I have seen ... a difference of 0.39 on an 18 point scale of cognitive and functional ability ... I can understand why not one member of your 11 member Advisory panel of experts that evaluated the data for FDA voted for approval.

I am SO sorry that FDA has approved yet another costly "bottle of hope" that will now financially ruin the lives of more AD spouse survivors with virtually zero benefit to their loved ones.  This is just not fair to people with AD, and not fair to their eventually surviving spouses.

After writing this email to Dr. Woodcock at FDA this morning, we entered into a series of email exchanges during the day.  Here is what we wrote to each other, beginning with her response to my email:

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

I’m very sorry to hear of your loss.  Thank you for writing. This new drug, unlike the previous ones, is intended to slow the course of the disease rather than simply help with symptoms.  Janet Woodcock

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Thank you for your prompt reply, but good intentions do not help loved ones nor do they help pay for aides and other needs of loved ones. If you were a member of a spouse support group ... and I hope you NEVER have that experience ... you would understand the severe negative consequences these meds have on loved ones with AD and their spouses. With all due respect, I think this is not just the wrong decision, but worse another decision that will make life an even greater hardship for those who survive. In fact, I just posted a column opposing this decision on my site.

I hope you reconsider your decision asap.

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

I am sorry you feel this way.  I have had a close family member die of Alzheimer’s disease and am well aware of the trauma to all involved.  Slowing the rate of cognitive decline is an important goal.  Janet Woodcock

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I agree 100% that slowing the rate of cognitive decline is a very important goal. My gripe is that there is no clear evidence that this med will actually slow cognitive decline in a meaningful way. Unless and until Biogen can produce clear evidence that their medication does slow cognitive decline to a significant extent, it remains only an expensive bottle of hope. The costs to Medicare and the thousands of dollars patients will be facing with deductibles will cause much more harm than good.

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I won’t continue writing to you on this topic because it seems we will just have to agree to disagree.  However, I just read that a 3^rd member of your 11 member Advisory Panel has now resigned as a result of this FDA approval.  To quote from CNBC …Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.“  

At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”  “This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he said.  

Dr. Woodcock … I thank you for allowing me, a former AD spouse caregiver, to have access to you in sharing my feelings and concerns.  We both want the same thing, Dr. Woodcock. Now 74, I will remain an AD patient and caregiver advocate for life.  I continue writing for publication and posting personal blogs to help further AD awareness, to try to bring about change in the medical profession, and to help other caregivers.  I want so much to see a new medication that will truly slow down the progression of the disease to allow a longer period of quality of life.  I want so much to see development of a new medication that will successfully treat if not cure AD.  But this new medication is just not the one that FDA should be lowering their standards for, not the one to create false hope among those suffering with AD and not the one to create such financial stress for caregivers.  When an Advisory FDA panel has 11 experts and not even one of those experts votes to approve this medication, one has to wonder how something like this could happen.  But, again, thank you for allowing me to express my concerns.