Wednesday, July 21, 2021
PHI recently released a new report, Federal Policy Priorities for the Direct Care Workforce. This excerpt from the introduction sets the stage
Throughout the country, millions of direct care workers—home care workers, residential care aides, and nursing assistants—ensure that older adults and people with disabilities have the support they need across care settings. The COVID-19 crisis has reinforced the enormous value of these workers, and government officials have rightfully deemed them “essential” during this period—one of the greatest truisms ever publicly affirmed about this workforce. Unfortunately, the quality of direct care jobs does not reflect their essential contribution. These jobs are often characterized by inadequate compensation, limited training and advancement opportunities, long-standing inequities, and a general lack of recognition and support. As a result, employers struggle to recruit and retain workers during a time when the rapid aging of this country continually drives up demand for these workers— with many workers opting for modestly better jobs in fast food and retail. Without enough workers willing to take these jobs, consumers are forced to go without the services they need, and family caregivers are left without support and respite.
The report focuses on eight categories, providing data, discussion and recommendations for each category. The categories cover financing, compensation, training, workforce interventions, data collection, direct care worker leadership, equity, and public narrative.
The report concludes with a call for action:
Federal leaders across the board can make this vision a reality by prioritizing direct care workers and investing in long-term care financing, compensation, training, workforce interventions, data collection, direct care worker leadership, equity, and the public narrative. We have always believed that quality care is rooted in quality jobs—now is the time for a federal strategy that brings this mission to life.
Tuesday, July 20, 2021
The Washington Post recently published an article about ongoing research into the role of creativity in both longevity and healthy aging, Creativity may be key to healthy aging. Here are ways to stay inspired. "Studies show that participating in activities such as singing, theater performance and visual artistry could support the well-being of older adults, and that creativity, which is related to the personality trait of openness, can lead to greater longevity." However, creativity isn't limited to the arts. Not sure what it means? The article offers some ideas, including travel, daydreaming, being playful (and childlike, but not childish :-)), applying your knowledge, meditating, meeting your challenges, playing brain games, and exercise. So go out and have a little fun!
Monday, July 19, 2021
We have all heard about the shockingly high temperatures out west. The full impact is yet to be determined, but it is a life-threatening event. Most Oregon heat wave victims were elderly, had no central AC gave us some data about this tragedy.
A preliminary report by Oregon’s Multnomah County found that a majority of the deaths reported during the record-breaking heat wave that began late last month were elderly men who lived alone and did not have central air conditioning....In Portland, which is in Multnomah County, from June 25 and June 28 the city reached triple-digits, even hitting a high of 116 degrees...The report examined deaths from June 28 through July 9. The Multnomah County Medical Examiner’s Office suspected hyperthermia in 71 deaths during this time. The report examined 54 cases where deaths were formally ruled as hyperthermia....Of those 54 deaths, 81.5 percent were ages 60 and older and 90 percent were white. The preliminary data states that 63 percent were males and 78 percent lived alone.... No one who died had central air. (emphasis added)
With climate change, this isn't the first environmental tragedy, nor will it be the last.
Loss of Empathy and How Such Changes Affect Caregiving Relationships (and Can Inadvertently Affect Law-Related Matters)
During the pandemic, as our caregiving relationships have probably become more intense because of the physical restrictions on travel, socializing, eating out, etc., I've had time to observe and think more about "empathy." For several years, even before Covid-19 changed social patterns, I've heard friends and family members who are serving as caregivers talk about frustrations they are experiencing with "their" older persons, not just because of increasing physical needs, but because of changes in personality. While a loved one's confusion and memory problems are typically associated with Alzheimer's Disease and other neurocognitive impairments, I also notice how often the caregivers can "forgive" the problems associated with those domains, but are enormously impacted if their loved one no longer is "nice" or no longer seems to be interested in, or cares about others' moods or needs.
Loss of empathy is a documented phenomenon in aging generally, and in neurocognitive impairments specifically. At the same time, loss of empathy seems to be rather weakly studied, or perhaps, more accurately, rather weakly understood.
Brief excerpts from a review of some recent literature on loss of empathy:
- "Early loss of empathy is one of the core symptoms of behavioral-variant frontotemporal dementia (bvFTD), which is often diagnosed when people are in their 50s. In contrast, empathy remains relatively intact in people with Alzheimer's disease (AD). People with bvFTD are often unaware of the impact of their behavior on others, causing strain in close relationships. The  study conducted by NeuRA researcher Dr Muireann Irish, found that both the ability to understand other people's emotions (cognitive empathy) and to share in other people's feelings (affective empathy) were decreased in people with bvFTD. People diagnosed with Alzheimer's however, retained the capacity for affective empathy." (from a 2016 report by NeuRA, an independent, not-for-profit research institute based in Sydney, Australia).
- "The question of how aging impacts empathy has important implications for public health because reduced empathy has been associated with greater loneliness, depression, and poorer relationship satisfaction. Socioemotional selectivity theory ... highlights the importance of emotional meaning for older adults, and this typically takes the form of spending time with close others. Thus, if older adults experience decreases in empathy, this could have a significant, negative impact on their well-being." (from Preliminary Conclusions: State of the Research on Empathy in Aging, in Janelle Beadle and Christine E. de la Vega's article on "Impact of Aging on Empathy: Review of Psychological and Neural Mechanisms" published 2019 in Front Psychiatry).
How do changes in empathy impact decision-making, including decisions about pre-death gifts and post-death bequests? If differences in the ability to empathize with others are associated with a disease process, should that mean that any corresponding change in gifting could (or should) be legally impacted? Is loss of empathy a component of reduced legal competency or legal capacity?
Thursday, July 15, 2021
The Center for Medicare Advocacy recently released a new report, Nursing Home Industry is Heavily Taxpayer-Subsidized.
I offer you this opening paragraph as a teaser to the 6 page report:
It is well-known that Government health care programs, Medicare and Medicaid, are the primary payers for nursing home care. The two federal programs paid facilities tens of billions of dollars for providing care to residents and were the primary payer for nearly 80% of residents. Far less known is that, in addition to receiving these direct payments, the nursing home industry also benefits from the extensive subsidies, through income-related public benefit programs – Medicaid, food assistance, housing assistance, heating assistance, cash payments, tax credits, and more – that help support its underpaid staff. The Government subsidizes the nursing home industry by billions of dollars each year by providing needs-based public benefits and earned income tax credits to its many low-wage nursing home workers. (citations omitted in this quote).
The article discusses the facilities, the employees, salaries and public benefit programs, and issues this call to action: "Change is beginning to happen in wages for low-wage workers, but until all nursing home workers’ wages are raised to (at least) living wages and until all workers receive health benefits and paid time off, the Government will continue to subsidize nursing homes by billions of dollars by providing needs-based public benefits and earned income tax credits to the nursing home industry’s low-paid workers. ..." (citations omitted in this quote).
In the interest of full disclosure, I am on the board for the Center for Medicare Advocacy.
Tuesday, July 13, 2021
Kaiser Health News ran this story last month, Desperate for Home Care, Seniors Often Wait Months With Workers in Short Supply. Using Maine as an example, the article explains
The Maine home-based care program, which helps Shackett and more than 800 others in the state, has a waitlist 925 people long; those applicants sometimes lack help for months or years, according to officials in Maine, which has the country’s oldest population. This leaves many people at an increased risk of falls or not getting medical care and other dangers.
The problem is simple: Here and in much of the rest of the country there are too few workers. Yet, the solution is anything but easy.
The article reminds us that the President had included funding for home and community-based care in the infrastructure bill ("human infrastructure") and that this shortage was not unexpected. "For at least 20 years, national experts have warned about the dire consequences of a shortage of nursing assistants and home aides as tens of millions of baby boomers hit their senior years."
And here we are. The article emphasizes money--the lack of it, the low wages and more.
Friday, July 9, 2021
During the first part of my summer, I wrote a review on Senator Amy Klobuchar's April 2021 book, Antitrust: Taking On Monopoly Power From the Gilded Age to the Digital Age. That turned out to be a very enjoyable, stimulating task and my article will be published late summer or early fall. This gave me the incentive to rethink how antitrust law, as a form of pro-consumer-protection "competition" rules might affect long-term care, including the concentration of ownership and operation of nursing homes and other types of "senior living." The student editor for the Law Review, Claudia Bernstein (Dickinson Law, Class of 2022), also has been captured by the topic, and she sent me an article today from the New York Times that furthered this inquiry. A key passage:
[In the U.S.] Fewer new businesses are starting. Existing businesses have slowed the pace at which they hire new workers . . . . Workers are less likely to switch jobs or move to a new city. Companies are investing in new buildings and equipment at a lower rate. And small businesses make up a shrinking share of the economy.
Together, these trends suggest that the economy suffers from a lack of fair competition, many economists believe. Large corporations are often able to increase profits not by providing better products than their rivals but instead by being so big that they exercise power over workers and consumers. The government also plays a role, through policies that protect existing companies at the expense of start-ups and new entrants into an industry.
The technical term for excess profits from a lack of competition is “monopoly rents.” Just think about how frustrated you may have been by the customer service from an airline, cable-television provider or health insurer. And then imagine how frustrating it may be to work there. Despite the problems at these companies, consumers and workers don’t always have good alternatives.
In my local area, there is a variation on this problem. As I have written about recently, county officials are proposing to close the county's "nursing home," which in my experience has been well run and served as a viable alternative for necessary services, including memory care. The likely purchaser will be a for-profit company (a modest-size, relatively new tri-state regional player). The county hopes to cease "having to subside the facility with general tax money." But, without those "subsidies," consumers' payment for care will have to increase, affecting residents unlikely to have the ability to pay more. As one article on the history of Pennsylvania's county nursing home conversions concludes:
County-owned homes, once ubiquitous, are becoming less common in Pennsylvania. Facilities that have been privatized generally have lower ratings on common metrics; a York Dispatch study in 2018 found that 15 formerly county-owned facilities sold since 2005 had an average rating of 1.9 stars out of five on the common scale used by the Centers for Medicare and Medicaid Services, while the state’s 21 county-owned homes averaged 3.1 stars [out of a possible 5 stars].
Tuesday, July 6, 2021
- Choose a trusted financial advocate
- Organize your financial information
- Start a conversation with your financial advocate
- Explain your future money management needs and what you expect from your advocate
- Officially appoint your advocate as your agent under a financial power of attorney
- Shift money management to your advocate when the time is right
Thursday, July 1, 2021
As Covid-19 Eases, Is Germany Again Seeking "Filial Support" (Elternunterhalt) Payments from Children?
It has been a while since I've written a "Filial Friday" post. After more than a year of no calls or requests for information about "Elternunterhalt" payments in Germany, in the last 45 days I've heard from three sets of American citizens who recently received requests for financial contributions to the care of an aging parent in Germany. In each of the instances, the adult children had never heard of Germany's parental maintenance laws before receiving the demand.
First, Germany adopted a threshold annual income for a potentially obligated child of at least 100,000 Euros, effective for claims after January 1, 2020.
Second, it appears that Germany has also clarified that only the adult child's income is considered in determining the amount of the potential support obligation. In the past, the German authorities would routinely ask for "all" income and asset information for the child and any spouse or partner.
For more on this, see this article and another article, from Germany, describing these changes as "reforms." Germany's renewed use of filial support laws began with a ruling by the Federal Court on June 23, 2002. "The legal basis is mainly Section 1601 and 1602 Paragraph 1 BGB," according to a third article.
While I've often seen "claim letters" submitted to adult children living in the U.S., I've never seen a formal administrative proceeding or court proceeding to enforce such a claim if not paid voluntarily. In some instances, I've seen German authorities agree to drop the claim, usually because there is strong evidence that the now needy-parent neglected or mistreated the child while the child was a minor. I have also sometimes seen a voluntary settlement between the U.S. child and the German authorities. But, have any of our readers seen a litigated outcome in a cross-border claim? Do we have any attorneys reading this blog with experience with cross-border claims between the U.S. and Germany?
You may recall that the President proposed an increase in home care funding. But, Biden's pledge to boost home caregiver funding excluded from infrastructure deal.
Because the federal government does not require states to provide these benefits for all those who qualify, nearly 820,000 older or disabled Americans were on state waitlists for Medicaid’s home- and community-based services in 2018, according to a Kaiser Family Foundation study published last year. Many rely on family members for their most basic needs, including bathing, getting dressed and taking medication. Without outside help, their family members often struggle to balance caregiving with work and face the enormous challenge of keeping their loved ones safe.
Amid the growing need, President Joe Biden vowed to eliminate these waiting lists during his campaign and originally proposed to inject $400 billion into these programs through the massive infrastructure bill currently under debate in Congress. Republicans, however, have blasted the effort to include “human infrastructure” in the bill, and Democratic leaders excluded the funding from the deal that the White House struck on Thursday with a bipartisan group of senators. Biden has pledged to pursue money for caregiving in a separate, far larger bill that could potentially pass with Democratic votes alone, but that is far from guaranteed.
The need is great and the wait is long, according to the article.
Without greater support, the number of vulnerable Americans who can’t access paid care at home will continue to rise, experts and advocates say, given the aging population, pandemic-fueled fears of nursing homes, and a growing shortage of workers, deterred by Medicaid’s low pay rates and tough working conditions. That means more families could be left scrambling to patch together care for their loved ones at home, not knowing if their number on the waiting list will come up or if they will be able to receive care when it does.
Add into the mix worker shortages and we are facing a critical situation. Although not included in the infrastructure bill, Democrats on Thursday introduced a bill "to expand eligibility and access to Medicaid home- and community-based services, helping states reduce waitlists and increasing pay and benefits for home health workers. Democrats can pass certain spending bills without Republican votes, but would need support from every member of their razor-thin Senate majority, and 10 Democratic senators have yet to sign on to the new home care bill."
Wednesday, June 30, 2021
A number of years ago, I had an email correspondence going with Dr. Jason Karlawish, Professor of Medicine, Medical Ethics and Health Policy, and Neurology at the University of Pennsylvania. He was writing and speaking in intelligent, understandable ways about complex issues in degenerative neurocognitive disorders.
My sister brought him back to my attention, as she had just heard Brené Brown's podcast interview with Dr. Karlawish. Dr. Karlawish recently published an important book on The Problem of Alzheimer's. I immediately ordered the book and I'm still reading, but I can tell this is -- and should be -- an important resource for anyone trying to understand or explain the Alzheimer's or other progressive impairments in cognition. Frankly, that means all of us. He is taking on an essential question: "What's a good life when you're losing your ability to determine that life for yourself?" The subtitle of the book helps explain the scope: "How science, culture, and politics turned a rare disease into a crisis and what we can do about it."
I'm sure I'll write more hear about this book as I plunge ever deeper into the clear prose, organized in logical chunks, where I'm finding "gold" embedded on every page. It is not a soothing read, but that is exactly why it is so important.
June 30, 2021 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Elder Abuse/Guardianship/Conservatorship, Ethical Issues, Health Care/Long Term Care, Statistics | Permalink | Comments (0)
Tuesday, June 29, 2021
We all have heard the stories about the number of SNF residents dying during the pandemic. The Inspector General for HHS recently issued a report looking at the number of Medicare beneficiaries who died in SNFs during the pandemic, COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.
The executive summary explains:
Nursing home residents have been particularly affected by COVID-19, as they are predominately elderly, tend to have underlying conditions, and live in close quarters. However, data on the number of nursing home residents who were diagnosed with COVID-19 or likely COVID-19 have not been readily available, particularly for early in the pandemic. Nursing homes are not required to report cases and deaths that occurred before May 8, 2020.
This data snapshot provides objective, standardized data based on Medicare claims for all Medicare beneficiaries in nursing homes throughout the country. This data snapshot is the first in a three-part series. Subsequent work will address the characteristics of the hardest hit nursing homes and strategies used by nursing homes to confront the challenges of the COVID-19 pandemic.
WHAT WE FOUND
- Two in five Medicare beneficiaries in nursing homes were diagnosed with either COVID-19 or likely COVID-19 in 2020.
- Almost 1,000 more beneficiaries died per day in April 2020 than in April 2019.
- Overall mortality in nursing homes increased to 22 percent in 2020 from 17 percent in 2019.
- About half of Black, Hispanic, and Asian beneficiaries in nursing homes had or likely had COVID-19, and 41 percent of White beneficiaries did.
- Understanding the pandemic's effects on nursing home residents is necessary if tragedies like this are to be averted.
Note that this is the first of 3 reports on the topic. The full report is available here.
Monday, June 28, 2021
We have read stories about the efforts in various states to encourage folks to get vaccinated. Bloomberg Law ran a story last week that looks at the impact on SNF residents when staffers are not vaccinated. ‘Flat-Out Resistant’ Staffers Imperil Nursing Home Vaccine Goal gives this data:
An industry effort to vaccinate 75% of nursing home staff against Covid-19 by July 1 appears to be faltering as continued employee hesitancy, declining infection and death rates, and general pandemic fatigue are making it tough to sustain the urgency necessary to meet the lofty goal.
Only 1,133 nursing homes—less than 10% of the roughly 15,000 Medicaid- and Medicare-certified facilities—had reached or surpassed the 75% staff vaccination threshold by the end of May, new federal data shows. And only 50% of staff have been inoculated at nursing homes that have provided the recently required vaccination data.
We all know how the pandemic ravaged many of the SNFs, and the article offers this: "Nursing homes and other long-term care facilities have been the epicenter of the Covid-19 outbreak, accounting for nearly 184,000 deaths and more than 1.4 million infections as of May 10, according to the Kaiser Family Foundation. Infected staffers are believed to be the cause of much of the carnage."
Facilities are taking various measures to increase the vaccination rates amongst staff. Some are doing one on one counseling, others are opting to require vaccination as a condition of employment. What are the barriers to vaccination? "Along with concerns about the vaccines’ rapid development and potential side effects, [staff] reluctance to get the shots reflects a combination of misinformation, cultural distrust of the medical profession, and a growing anti-vaccine sentiment that’s taken hold across the country.... [with such] hesitancy [continuing] even though more than 1,900 nursing home workers have died from Covid-19, while nearly 585,000 have been infected, federal data shows." Some facilities are offering incentives. One helpful resource, "[t]he Agency for Healthcare Research and Quality has produced a how-to, best practices guide to building vaccine confidence among CNAs."
Friday, June 25, 2021
Yesterday, the Tampa Bay Times ran this story, DeSantis signs controversial bill to boost staffing at nursing homes. According to the article, "HB 485, which Gov. Ron DeSantis signed ..., allows a type of worker known as a “personal care attendant” to count towards the staffing requirements for nurse assistants, though they have less training and a more restricted role in the type of assistance they can provide." Notice that this category of employee counts toward the staffing numbers. The article notes that previously this was "intended as a tourniquet to help mitigate staffing shortages at nursing homes during the pandemic, [and now the] new law will make permanent a program that allows facilities to hire less experienced employees to supplement the work of nursing assistants, who are able to provide more complex care for seniors." The article discusses the long standing staffing requirements in Florida and how that was impacted by the pandemic.
In March 2020, as more staffers became infected with the virus or quit due to health concerns, the state implemented an emergency program that allowed nursing homes to temporarily hire personal care attendants to help amid the deficit.
Personal care attendants assist with daily living activities. After 16 hours of training, they’re able to begin caring for residents and, through hands on experience, are meant to continue learning on the job. They can do so for up to four months — at this point, they must take the exam to become a certified nursing assistant if they wish to continue working at a facility.
The article notes objections by those concerned at the impact of the new law. "By allowing personal attendant care to be counted as if it was time a licensed nurse assistant spent caring for a resident, critics fear the law will be used to hire fewer nurse assistants, who are paid higher salaries and cost nursing homes more, in favor of less-qualified staff." Proponents offered that this new position can serve as a training opportunity for those who want to become CNAs. The article offers that no Florida "agency appears to be tracking the program’s success in creating future nurse assistants. Florida’s Agency for Health Care Administration, the Department of Elder Affairs and the Department of Health all said they do not collect data related to this information."
We will have to wait to see if this new position becomes a recruitment tool for more CNAs.
Tuesday, June 22, 2021
Richard Kaplan, elite elder law professor and friend, sent me the link to this recent article from the Wall Street Journal, One Family’s Lessons Learned From a Decade of Caregiving.
As do many families, the spouse committed to caring for his spouse with dementia.
The family learned much along their decade-long caregiving journey, about setting up trusts, getting help in the home and respecting each other’s decisions. They think about a few things they would have done differently. And they found that caregiving, while relentless and heartbreaking at times, can also be rewarding.
Being a family caregiver is one of the most difficult jobs and one that nearly everyone will have at some point. An estimated 42 million people in the U.S. provide unpaid care to those 50 and older, a 14% increase since 2015, according to the Caregiving in the U.S. 2020 report by the National Alliance for Caregiving and AARP.
Each family is different, and what works for one family may not work for another, says ... [the] chief executive of the National Alliance for Caregiving. Family members don’t always agree about when to call in hospice or sell a house, but it’s important to be supportive, she says. “The hardest thing to say is, ‘It’s not the choice I would make, but I want to honor their choice.’ ”
The story is heartfelt, and compelling. The caregiver spouse offers this advice as to what changes he would have made.
He would have gone to an elder-law attorney earlier to make sure their assets were in a trust that would better protect them from having to be spent down to qualify, if needed, for Medicaid’s coverage of long-term care costs.
And he would have bought a single-story patio home within walking distance of their church and shopping center when [his spouse] suggested it 20 years ago. “It was what [she] wanted to do, but I wanted the yard. My own little domain. I wish I would have,” he says. “Here I am now with this big house, by myself. I’ll probably reach a point where I can’t take care of it.”
Knowing how hard it is to provide hands-on care, and not wanting to be a burden, he recently told his daughters, “Just put me in a nice place. You don’t have to do what I did for mom. You don’t have to take me into your house. I don’t want that.”
I'm assigning this reading to my students. Thanks Professor Kaplan!
June 22, 2021 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Estates and Trusts, Federal Statutes/Regulations, Health Care/Long Term Care, Housing, Medicaid | Permalink | Comments (0)
Tuesday, June 15, 2021
The New York Times recently ran an article examining polypharmacy problems in elders, Looking to Tackle Prescription Overload. "[P]olypharmacy refers to an increasing overload of drugs that may not benefit the patient or interact well with one another, and that may cause harm including falls, cognitive impairment, hospitalization and death. It has sparked interest in “deprescribing”: the practice in which doctors and patients regularly review medication regimens to prune away risky or unnecessary drugs."
One solution, the focus of this article, is deprescribing. For example, "the Drive to Deprescribe campaign, [was] launched last month by the Society for Post-Acute and Long-Term Care Medicine, known as AMDA, which represents medical directors and administrators of long-term care facilities, where polypharmacy is particularly prevalent."
Bloomberg recently published an opinion regarding the Uniform Definition of Brain Death, A Scary Plan to Revise the Definition of Death. "People may be less willing to agree to be organ donors if they believe the quest for organs changes how patients are treated."
According to the article, the Uniform Law Commission has a study committee, looking at "the need for and feasibility of updating the Uniform Determination of Death Act (1980), which has been enacted in 44 states. Issues to be considered include lack of uniformity in the medical standards used to determine death by neurologic criteria, the relevance of hormonal functions, and whether notice should be provided before a determination of death."
The Bloomberg article mentions an opinion piece published last year in the Annals of Internal Medicine which the Bloomberg article suggests is concerning. The Bloomberg article examines the elements of the proposal and reviews the advantages of it, but also notes opposition to it. "Despite all the arguments in favor of the revisions, more than 100 experts in medicine, law, philosophy and bioethics have signed a statement of opposition...."
The article discusses the objections and how the proposal might reduce the amount of organ donations. The article is very interesting and if you could End of Life planning in your classes, this article gives you some thoughtful background.
Thursday, June 10, 2021
The CEO for Biogen, the publicly-traded biotechnology company that developed Aduhelm, issued a statement about the company's policies and plans for the new drug in conjunction with the FDA's announcement of its accelerated approval of the drug for patients with Alzheimer's Disease. He writes in part:
The approval of ADUHELM represents a crucial inflection point in our collective battle against Alzheimer’s disease. By addressing a defining pathology of the disease, this novel therapy has the potential to help fundamentally change the way patients are diagnosed and treated.
I have hoped for years that we would reach a moment like this. We all know the staggering numbers: there have been at least 100 drug development programs discontinued since 2003—the last time a new Alzheimer’s drug was approved. What it tells us is that the path for innovation is not straightforward, especially for something as complex as Alzheimer’s research. The journey during Biogen’s many years of research and development has been humbling, but we have learned from industry’s past research efforts and been determined to follow the science, always driven to address patients’ unmet needs.
ADUHELM is a first-in-class approved therapy: I believe it will be the catalyst to a new era of innovation for Alzheimer’s disease, and the first of many new treatments available to patients. More resources will be drawn into research that can help patients through the disease continuum, explore new pathways, and find potential therapy combinations.
The use of this drug involves some important questions about patient consent, precisely because the drug will most likely be used with people who have "confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease, consistent with Stage 3 and Stage 4 Alzheimer’s disease," the group of patients who took part in the pre-approval clinical trials. What is the process for obtaining such consent with cognitively-impaired patients?
Several articles have explored this topic outside of the specific drug in question:
In England, the nonprofit organization Physiopedia, offers a detailed protocol for informed consent in the context of cognitive impairment. For example, it suggests assessment of competence involves paying attention to four main abilities:
The person must have sufficient capacity to understand the information. If the study involves a considerable degree of risk, more information must be provided, particularly about possible risks and benefits, and the potential participant must be able to understand such information.
The person must be able to retain, use and weigh up such information long enough to be able to make a decision. In addition, they must also be able to understand what the decision is about, why they are being asked to make it, and what the consequences of making or not making that decision might be.
Possible benefits, risks and inconvenience linked to participating in research must be understood and weighed against the person’s own values and goals, which means that the person must understand how participating might affect him/her personally (High, 1992 and Stanley et al., 1984 in Olde Rikkert et al., 1997).
The person must have the ability to communicate his/her decision.
See also: "Informed Consent in Two Alzheimer's Disease Research Centers: Insights from Research Coordinators," by Christin M. Suver, and others, published April-June 2020, and announcing the plan to use the research to assist in development of "an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process."
Tuesday, June 8, 2021
I used to follow (and regularly blog about) new drugs in the pipeline for Alzheimer's treatment. Then I realized that the drugs weren't making it to the market place. While attending medical programs about R & D, I learned that it was going to be tough to find any magic treatments, much less "cures."
To it was interesting to read this week that for the first time in some 18 years, the FDA has approved use of a new drug, with the marketing name Aduhelm and the generic name Aducanumab (kind of sounds like abracadabra, doesn't it?), manufactured by Biogen.
Aduhelm is described by the FDA as an "amyloid beta-directed antibody," which was approved under an "accelerated approval pathway," to give "patients suffering from a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit of the drug."
But there is a lot of sobering news accompanying this announcement:
First, the mechanism of delivery: monthly intravenous infusions, which means a clinical visit lasting at least an hour per infusion.
Second, Biogen's own predictions about cost: a "list price" predicted to average $56,000 per year per patient! Yikes.
Third, the critical response from a range of experts in relevant research, pharmacy and health fields about the approval process to date, indicating a history of interruptions in the clinical trials when preliminary results showed little to no evidence of clinical benefit.
Fourth: the need for assessment before the first infusion with an MRI, plus recommended follow up MRIs prior to the 7th and 12th infusions, to assess the potential for ARIA-H, which are amyloid-related abnormalities, also potentially associated with edema in the brain.
Here are some links (and I'll try to keep this list up-to-date as new info comes in):
STAT's commentary, dated June 7, 2021 on FAQs: What You Need to Know about the Alzheimer's Drug Aduhelm
New York Times, dated June 8, 2021: FDA Approves Alzheimer's Drug Despite Fierce Debate Over Whether it Works
June 8, 2021 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Ethical Issues, Federal Statutes/Regulations, Health Care/Long Term Care, Medicare, Science, Statistics | Permalink | Comments (0)
Register now for this June 18 (3 eastern) webinar, NORC Webinar: Resuming In-Person Visits During COVID-19: Tips for Identifying Trauma, Potential Abuse, and Supporting Residents
In recognition of World Elder Abuse Awareness Day (WEAAD) join us to learn how to identify and respond to signs of trauma and potential abuse or neglect and support residents as Ombudsman programs resume in-person visits during the COVID-19 pandemic.
Dr. Laura Mosqueda, a national and international expert on elder abuse and neglect, will provide tips for Ombudsman programs conducting in-person visits, such as signs of trauma in response to isolation and loss during the pandemic and potential signs of abuse and neglect. She will also share recommendations for supporting residents and available resources. As an accomplished physician and researcher, Dr. Mosqueda has testified in front of Congress and has been invited to the White House several times to discuss elder justice initiatives. She has taken the lead on landmark studies to identify forensic markers of abuse and neglect and serves as a volunteer representative for the California Long-Term Care Ombudsman program.
Attendees will also hear from two Ombudsman program representatives as they share their experience resuming in-person visits and highlight what they observed upon reentry, how they supported residents, tips for visits, lessons learned, and successful practices.
Click here to register.
June 8, 2021 in Consumer Information, Crimes, Current Affairs, Elder Abuse/Guardianship/Conservatorship, Federal Statutes/Regulations, Health Care/Long Term Care, Programs/CLEs, State Statutes/Regulations, Webinars | Permalink | Comments (0)