Elder Law Prof Blog

Visiting in Canada as a 2024-25 Fulbright Fellow at University of Ottawa

I'm catching up on my blogging life after an especially busy summer, which included a horseback riding adventure with a dear friend  from New Mexico, Deborah Walker, along the Ring of Kerry in County Killarney, Ireland.  We enjoyed every moment!

Now I'm in Canada as a visiting 2024-25 Research Chair in Health Law, Policy and Ethics at the University of Ottawa's Center for Health Law.  This is my second career opportunity to "visit away" under the auspices of a Fulbright Fellowship program and it is wonderful to experience new places, new ideas, and new people.

My start on the Fulbright was a little delayed -- because of a late summer horseback riding accident (although, thankfully that accident did NOT take place in Ireland), as I managed to break my arm and bruise a few ribs when my horse fell unexpectedly,  sending us both to the ground from a canter. 

I must admit -- after a lifetime of riding both horses and bicycles for long distances in new places with a few tumbles along the way  -- you would think I "knew" better than to jump at the chance to ride one more "new" horse who had arrived in the barn just a few days before my original planned departure for Canada.  Whoops!  The ER, a  cast, a bit of surgery and lots of physical therapy and I'm back on a good path.  This is my first time blogging with both hands on the keys since the tumble.

I've been fascinated by the University of Ottawa programming I'm witnessing.  I chose Canada -- and specifically Ottawa -- because I wanted to take time to experience the nation's capital, and take a close look at Canada's  health care program and approaches to aging issues.  So far, I've already sat in on presentations on a range of health-related subjects, including a book launch on September 25 of Pandemics, Public Health, and the Regulation of Borders. 

The multi-author approach provided important contrasts on the question of what does it mean to keep vulnerable populations safe in the face of a global health care crisis, while still being "good national citizens" of the world.  Colleen Flood, recent Director of UOttawa's Center for Health Law and now the Dean of  Queen's University Faculty of Law and a co-editor of the Routledge Press (open access) book, led off the discussion that centered on COVID-19, by comparing New Zealand's locked border approach with the attempts of both Canada and the United States to limit travel (and thereby reduce transmission of disease) while still permitting open borders to facilitate economic transactions, including movement of needed supplies.  I was especially interested in the presentation of Kumanan Wilson, a physician and scientific leader with the Bruyère Research Institute, who provided a brief history of the science of "vaccine passports," including the need for stable, reliable sites for digital information.  (Did you lose track of your paper vaccine card(s))?    

Stay tuned!  More reports to come!

Lucidity for Persons Living with Advanced Dementia, from the Perspective of Caregivers

I've been working on an article examining lucidity in persons diagnosed as having some form of dementia.  My analysis has been largely focusing on the implications of lucid intervals for attorneys, including those involved in advising on estate planning and care-related needs.  This has helped me to tap into other ways of thinking about lucidity and most recently I read an article in The Gerontologist, titled "Caregiver Accounts of Lucid Episodes in Persons with Advanced Dementia," published in June 2024, by a research team lead by Jason Karlawish, M.D. at the University of Pennsylvania.  

The article begins with careful look at definitions used in a research study that relied in major part on telephone interviews with caregivers.  For example, threshold questions for the caregivers were whether they had observed or were aware of "any unusually lucid moments" during the most recent four months (or during the final for months of a person's life if they were no longer alive). This approach was to isolate a concept known to the researchers as "paradoxical lucidity."  The working definition for paradoxical lucidity, from a 2019 National Institute on Aging Study, was "unexpected, spontaneous, meaningful, and relevant communication or connectedness in a patient who is assumed to have permanently lost the capacity for coherent verbal or behavioral interaction due to a progressive and pathophysiologic dementing process."  Eventually the study focused on 30 caregivers (and a corresponding 29 individuals with advanced dementia).  All of the final participants were "family caregivers."

There is a lot to unpack in the findings.  Although the length of the lucid moments for a given individual were usually very short -- and the longest was just 45 minutes -- the incidence of such moments across the study population was  frequent.  The findings combined with other empirical studies, lead the researchers to "question the 'paradoxical' in 'paradoxical lucidity.' Here, 'paradoxical' denotes an observation that is inconsistent with disease theory."  The researchers suggested there may be a need to "modify the theory of disease" for "severe-stage dementia."  

The study's caregiver-participants uniformly reported that "witnessing a lucid episode did not influence decisions about medical care."  However, these researchers "found that lucid episodes affected approaches to daily care, shaping, for example how often they brought the person living with dementia into social situations, diet, and sleep schedules."  The article continued:

"Such changes are substantive and important but not framed by caregivers as critical decisions  They are alterations in what might be called the 'ordinary ethics' [citation] of caregiving, evincing shifted understandings of what constitute good care."  

Certainly this study is not being used to talk about legal implications of lucid moments.  That is important too.  

Population Continues to Age

That title sounds like a no-brainer, doesn't it? A recent Washington Post story, U.S. continues to get older and more diverse, new estimates show, is about the recently released Census report.

Since 2000, the national median age has increased by 3.4 years to 38.8, with the largest single-year gain of 0.3 years coming in 2021, the year after the coronavirus pandemic hit, according to the bureau’s new 2021 population estimates, an annual data set that is used to fine-tune and update existing statistics.

The birthrate nationwide has been declining, and decreased immigration levels have accelerated the decline.

Between 2020 and 2021, 47 states and the D.C. saw an increase in median age; only Montana, New Hampshire, and West Virginia had no change in median age.

The Northeast was the oldest region in 2021, with a median age of 40.4, followed by the Midwest (39.0), the South (38.6) and the West, which saw the largest increase, up 0.3 years to 37.7, the bureau said.

The full Census report is available here.

Cognitive Aging, Maturity and Guns

Yesterday I wrote a blog post about gun use that several of my friends correctly characterized as heartfelt.  Of course, legal research is merited, and I find that my view echoes what is written in a key section of a very recent opinion:

Beyond these significant safety concerns, contemporary scientific research increasingly sheds light on the relative immaturity and incomplete cognitive development of young adults. California cites to evidence that young adults are less mature than older adults, which leads them to take more risks and behave more reactively than their elders. Young adults are thus quicker to anger than older adults and more vulnerable to intense mood swings and to making instinctive, rather than considered, decisions. This cognitive immaturity makes young adults more likely to use firearms in situations of significant emotional arousal or perceived threat, or other situations that require rapid, complex information processing. Other Circuits have credited similar evidence to uphold regulations on firearms affecting 18 to 20-year-olds. NRA, 700 F.3d at 208; Horsley v. Trame, 808 F.3d. 1126, 1133 (7th Cir. 2015). The semiautomatic rifle regulation helps to “ensure that access to these weapons is restricted to mature individuals who have successfully completed safety training,” such as members of law enforcement and the military, “furthering the public safety objectives and ensuring that the Founding Era balancing of Second Amendment rights with safety concerns continues today.” Jones, 498 F. Supp. 3d at 1328.

Unfortunately, this is from the dissenting opinion in Jones v. Bonta, decided by the 9th Circuit with an opinion issued less than two weeks before the shooting in Uvalde, Texas.  Sigh.  

Or, as the always astute Professor Naomi Cahn observes, "The irony of the timing of such a ruling is beyond distressing." 

When It Comes to Guns, Age Matters

I suspect I'm not alone in thinking about guns this morning in the wake of the Texas shooting at a grade school in Uvalde Texas.  This post reflects matters I've been thinking about for a long time.  Indeed, thirty years ago I considered making gun violence a core academic research topic, until I realized how potent is the lobby supporting gun sales, and therefore gun ownership.

First, this morning I listened to a young man, David Hogg, speaking to an NPR interviewer about his own frustrations in opposing gun violence.  He urged legislators at state and national levels to do at least "one thing" to move forward on gun safety legislation.  My first reaction was "one thing?"  How is that going to help?  

Second, I heard a bit more about the background of the 18 year old shooter in Texas, as well as the background of the similarly-aged shooter in Buffalo New York.   More memories.  In one of my previous lives, I volunteered for a neighborhood tutoring program in New Mexico.  My first two students, in high school, had been sent to the program by judges trying to help youths in crime-related incidents.  One young man attended once -- and then disappeared.

I managed to have a good session with the other student, a junior in high school, who at my request wrote a short essay about what he saw as his future.  The 500 word piece was quite well written, and gave us something we could definitely use to gently work to improve his reading and writing skills.  The focus, however, proved to be a window into the bleak outlook of a young man who was involved in a so-called gang.  To put it simply, he saw no future for himself after high school.  He said with utter confidence that his high school "had" to graduate him regardless of whether he did any more work, as long as he merely attended class.  I didn't want to believe that, but he had plenty of evidence to support his hypothesis. He didn't have any post graduation plans.  He had equal confidence that he probably wasn't going to make it to age 21.  The following week during our tutoring session, he was creative in his resistance to my role as a tutor.  He turned in his next essay, but it was written entirely in what was some sort of "tagger's script," the stylized script he used when spray-painting his messages on public building.  Tagging was his only crime at that moment.  

I eventually decided to volunteer for younger students, and in fact I had a two-year working student-tutor relationship with a grade school boy who was in the program at his mother's insistence.  Actually, I got to know the whole family, including his parents and a sister who also sometimes attended our reading sessions (and she helped turn reading into a competitive adventure).  To mark the success of his "graduation" from the program, we went to a Phoenix Suns basketball game, because the opposing team that day had a player much admired by my student.  At his comparatively "youthful" age, he had written about his plans for the future, including somehow, against all genetic odds, planning to "grow" tall enough to be a professional basketball player, like his idol, Nate Archibald.  We talked about coaching as an alternative -- just in case.

I remember the difference in these individuals as I listen to the troubled histories of the two "boys" who bought guns as part of their 18th birthday celebrations.  I don't know what happened to most of the other the students involved in the tutoring program.  The second student dropped out of the program for reasons I never learned, but I later saw his name in the newspaper when he was accused of being the driver in a car-jacking where his "friend" shot the woman who resisted having her car taken.  Sadly, that student's essay was prophetic, as any true dreams for a future may have ended with that crime.

So, if we are going to do at least "one thing," could we -- should we -- focus on raising the threshold age for gun ownership?  Should we give young people in their late teens more  time to grow older (and "taller" or more mature) and thus to reach a point where the future seems brighter?  I'm not suggesting they cannot participate in shooting sports, hunting, and the military, where we hope their use and skill building would be supervised by knowledgeable people. I am suggesting making it unlawful for them to "own" or at least to purchase guns until they are older. Research suggests that substantially more crimes of gun violence against others are committed by individuals between the ages of 17 and 21.  There is research to support restricting gun ownership (and therefore gun sales) to individuals over 21 as one step forward in terms of safety. 

For example, in June 1999, a "collaborative report" under the auspices of the U.S. Department of Justice noted in part:

In 1996, 26,040 people in the United States were killed with guns.  In 1997, offenders age 18, 19, and 20 ranked first, second, and third in the number of gun homicides committed.  Of all gun homicides where an offender was identified, 24 percent were committed by this age group, which is consistent with the historical pattern of gun homicides over the past 10 years.  

Other statistics suggest that gun-related suicide death rates are highest for females age 45 to 64 and for males age 75 and older, statistics that point to another form of age-specific gun tragedies. Age matters.

That first boy who "disappeared" after the first tutoring session?  I later learned he had been killed in a neighborhood shooting.  Would younger adults support delayed lawful-ownership as one form of protection against gun violence?   Certainly, more is needed on so many other levels including mental health supports. But could "one thing" -- at least -- include blocking gun sales to people who are still in the process of learning to plan for the future, for their futures?  

 

Researcher Explains: Misuse of Data Can Lead to "Pariah-Tizing" the Elderly While Failing to Provide Key Information for All Ages

In September 2021, I listened to a great set of speakers at the Aging, Health, Equity and the Law Conference hosted by Touro College in New York.  One session in particular captured my attention.  Barbara Pfeffer Billauer, JD, MA (Occ. Health), PhD, who is currently Professor of Law and Bioethics at the University of Porto and Research Professor at the Institute of World Politics in Washington DC. spoke about the misuse of statistics regarding COVID-19 on an international scale.  We exchanged emails, and it was clear she was deep into the emerging data from countries around the world.

Dr. Billauer's most recent analysis has received its first publication on May 19, 2022 by the American Council on Science and Health at ACSH.org, with the appropriate yet provocative title of Pariah-Tizing the Elderly: Another Casualty of COVID.

Here she takes on recent news media coverage, including the Washington Post, as well as some scientific community publications, to raise the significant concern that exaggerating the risk of COVID-19 stigmatizes one group -- here the elderly -- while failing to fully inform all age groups about the efficacy of vaccination.  She opens with this explanation:

I call a mistaken, targeted focus and overemphasis on any population group “pariahtization.” As recent evidence demonstrates, this "pariah-tized” focus on the elderly regarding COVID-19 is certainly misplaced. It also has resulted in untoward policies that caused more deaths in both the younger segments of the population. . . .  

 

Contrary to popular opinion . . . COVID is not a disease of the elderly—like dementia, or cataracts, or osteoarthritis. Indeed, older people are less likely to die of COVID than heart disease or cancer. This is not so for the younger cohort, for whom during several months last year COVID was the leading cause of death.

 

For six months of 2021—half the year, COVID was the leading cause of death in those 45-54. In three months of the year, COVID was the leading cause of deaths forages 55-64, but only in two months was it the leading cause of death for those 65-74, the same as for those 35-44; and only in one month was COVID the leading cause of death for those over 75. . . .

 

The misplaced focus [of the media] on the aged being especially vulnerable has led younger people to unwisely eschew vaccination on the grounds that the disease is not generous to them.

Dr. Billhauer clearly has a way with words and she makes effective use of data and charts to explain important data concerns.  The implications of her findings go beyond the problem of the current crisis.  

A New Map of Life

The Stanford Center on Longevity has released a new report, The New Map of Life. Looking at the 100 year life,  "make a clear distinction between aging, the biological process, and longevity, the measure
of long life. The Center’s goal is not to advocate for longer life—a phenomenon that is well underway—rather, it is to identify ways to enhance the quality of those century-long lives, so that people experience a sense of belonging, purpose, and worth at all ages and stages." One focus is looking forward, "on the economic potential of a more age-diverse population in which older adults contribute in increasingly significant and measurable ways to the social good and to GDP, so that opportunities for healthy longevity are shared across races, geographical regions, and socioeconomic status." (citations omitted).

The report addresses the following: Age diversity is a net positive, investment in centenarians to gain big returns, realignment of health spans to life spans, be amazed by the future of aging, work to an older age courtesy of flexibility in working, lifelong learning, invest in longevity communities, and look at life transitions as a positive.  In preparing to take this new road on the new map of life, the authors note that "[m]eeting the challenges of longevity is not the sole responsibility of government, employers, healthcare providers, or insurance companies; it is an all-hands, all-sector undertaking, requiring the best ideas from the private sector, government, medicine, academia, and philanthropy."

Be sure to read this report!

Breakthrough in Alzheimer's Research?

My dear friend and colleague, Professor Feeley, sent me a link to this recent article, Likely cause of Alzheimer’s identified in new study.

Here's a brief bit of info about the study

[S]cientists in Australia have recently discovered an additional factor that may be responsible for the development of this neurodegenerative condition.

Lead study author Dr. John Mamo, Ph.D. — distinguished professor and director of the Curtin Health Innovation Research Institute at Curtin University in Perth, Australia — explained to Medical News Today the conclusion from the new research...

“This study,” he added, “shows that exaggerated abundance in blood of potentially toxic fat-protein complexes can damage microscopic brain blood vessels called capillaries and, thereafter, leak into the brain, causing inflammation and brain cell death.”

The findings were published here. This is the abstract from the article

Several lines of study suggest that peripheral metabolism of amyloid beta (Aß) is associated with risk for Alzheimer disease (AD). In blood, greater than 90% of Aß is complexed as an apolipoprotein, raising the possibility of a lipoprotein-mediated axis for AD risk. In this study, we report that genetic modification of C57BL/6J mice engineered to synthesise human Aß only in liver (hepatocyte-specific human amyloid (HSHA) strain) has marked neurodegeneration concomitant with capillary dysfunction, parenchymal extravasation of lipoprotein-Aß, and neurovascular inflammation. Moreover, the HSHA mice showed impaired performance in the passive avoidance test, suggesting impairment in hippocampal-dependent learning. Transmission electron microscopy shows marked neurovascular disruption in HSHA mice. This study provides causal evidence of a lipoprotein-Aß /capillary axis for onset and progression of a neurodegenerative process.

COVID 19 Impact on Older Adults

A couple of weeks ago, the Commonwealth Fund released a report,  The Impact of COVID-19 on Older Adults: Findings from the 2021 International Health Policy Survey of Older Adults. Here are the survey highlights:

• Compared to their counterparts in the other survey countries, older adults in the U.S. have suffered the most economically from the COVID-19 pandemic, with more losing a job or using up all or most of their savings.

• Latino/Hispanic and Black older adults in the U.S. have been far more likely than white older adults to experience significant negative economic consequences.

• COVID vaccination rates for older adults were highest in countries where vaccines were most widely available when the survey was fielded. In the United Kingdom, nearly all older adults (97%) had already been vaccinated. The U.S. had the largest percentage of older adults who were not planning to get vaccinated.

The conclusion includes several steps for going forward "to reduce this burden on older Americans and to ensure that their health care needs are met":

Reducing care barriers... affordable access to care is increasingly a priority for policymakers and care delivery systems. Timely access to primary care is particularly important for older adults with multiple chronic conditions, because effective treatment requires coordination and follow-up plans....

Role of telemedicine...  countries clearly have an opportunity to improve care delivery to older adults through the expansion of virtual care services for those unable or resistant to receiving care in a clinician’s office....

Expanding vaccination ...  "[f]or older adults who said they were not planning to get vaccinated, limited trust in government to ensure vaccine safety and concerns with side effects were the most cited reasons. To increase uptake in this population, messaging campaigns should address their apprehension by engaging a wide range of voices, from clinicians and scientists to community members and local, state, and federal government agencies, to get the word out....

The full report is available here and the charts, here.

Why Monoclonal Antibodies Might Be Used in Assisted Living

Recently a friend noted with concern that she'd been advised that an elderly relative would be receiving "antibodies" in her assisted living community. The confusion was "if she has been fully vaccinated, and hasn't tested positive herself, why would she need "antibodies?"  Turns out there were new incidences of COVID-19 in her wing of older adults, many of them with multiple risks factors, and the staff was being proactive.   More than likely, what she was receiving was "monoclonal antibodies."  The question arose before the question of authorization of "booster" shots had been addressed by the FDA.

As explained in this WebMD Health News article, titled Monoclonal Antibodies vs. Vaccines vs. COVID-19, from August 2021, families with loved ones in communal settings may want to discuss monoclonal antibodies with the health care team: 

Can I help relatives in assisted living get it?

If you believe that a relative in a residential facility -- like a nursing home, assisted living facility, long-term care home, or prison -- has COVID-19 or has been exposed, the first thing you should do is have a conversation with the medical leadership at the facility.

 

[Michigan Department of Health and Human Services Division of EMS and Trauma Director, Dr. William Fales] has partnered Michigan-based paramedics with several nursing homes in the state to have monoclonal antibodies delivered to these facilities when there’s an outbreak. It’s also possible for long-term care pharmacies to get monoclonal antibodies to administer in-house. If the medical leadership doesn’t appear to be aware of the treatment, you can use the same websites to find the nearest infusion center and begin coordinating treatment with it.

 

It's a good idea, Fales says, to find out where monoclonal antibodies are offered in your area, and perhaps talk with your doctor or a high-risk loved one’s doctor about how to get them, to be prepared. The faster you can get the treatment, the more likely it will help.

Friday's Public Hearing re Approval for Third Dose Covid-19 Boosters Can Be Viewed Online

The U.S. Food and Drug Administration hearing on Friday, September 17, 2021 to address the question of approval for "booster" doses of Covid-19 vaccines is scheduled to be "open" to the public through online portals.  The hearing begins at 8:30 a.m. Eastern time.

The FDA's website helpfully links to the submissions from the drug companies and other interested parties as well to the hearing portal.  In contrast to The Lancet article published earlier this week which takes the position that a booster vaccine dose is not "currently" indicated for most members of the public, Pfizer and Moderna each submitted materials to the FDA this week in support of administering third shots beginning six months after an individual's second shot. Pfizer is recommending a full-strength dose for its booster shot, while Moderna is recommending a dose that is 1/3 the level of its original doses.  It appears both companies are citing observational studies, clinical trials, and antibody tests in support of their recommendations, including studies in the U.S., Israel, and South Africa, and discuss histories of reactogenicity, adverse events, and risk/benefit assessments.  

Here's the useful FDA vaccine hearing webpage and links:  https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement#event-materials

The Challenges of Federal Oversight for Medications or Food Supplements Targeting an Aging Public

I'm finding myself spending a lot of time reading and thinking about the Food and Drug Administration (FDA) and Federal Trade Commission (FTC).  Of course, public concerns about the efficacy of Covid-10 vaccines dominate the attention of many of us working on health-related legal concerns that affect older adults.  For example, I've been researching questions about the potential for FDA approved antibody tests for Covid-19 vaccines.  

But also intriguing is a report that a slow-moving FTC suit against developers and marketers of the dietary supplement known as Prevagen may be getting closer to a possible trial date in the Southern District of New York.  A dismissal of the 2017 law suit filed jointly by the FTC and the New York Attorney General was overturned in 2019 by the Second Circuit in a summary order, concluding that the "FTC and New York have made plausible allegations that Defendants] marketing campaign for Prevagen contained deceptive representations."  For more on this and other Prevagen-related suits, see the Washington Post's recent article Does the Supplement Prevagen Improve Memory? A Court Case is Asking that Question.

Plus, there are significant questions arising in the wake of the FDA's June 7, 2021  announcement of its "accelerated" approval of aducanumab for treatment of Alzheimer's Disease.  See e.g., Recently Approved Alzheimer Drug Raises Questions that May Never Be Answered (JAMA Network, July 21, 2021).

As noted in Dr. Jason Karlawish's important new book, The Problem of Alzheimer's: How Science, Culture, and Politics Turned a Rare Disease into a Crisis and What We Can Do About It, the number of Alzheimer's patients in the U.S. will rise to an estimated 13.8 million by 2025.  The caregiver market alone is searching desperately for answers, and it can be very hard to make individual decisions about risks and benefits without trustworthy information.  This is a tough time for what we might call a pandemic crisis about "trust."   

Highlights from Touro Conference on Aging, Health, Equity, and the Law (9.13.21)

Touro College's Jacob Fuschberg Law Center hosted a fabulous half-day, interdisciplinary program on Aging, Health, Equity and the Law.  Among the highlights:

• A perfect kickoff with opening remarks on the theme of the conference from Syracuse Law Professor Nina Kohn, who outlined the civil rights of older persons, reminding us of existing laws and the potential for legal reforms;
•  A unique "property law" perspective on the importance of careful planning about ownership or rights of use, in order to maximize the safety and goals of the older person, provided by Professor Lior Strahilevitz from University of Chicago Law School;  
• Several sessions formed the heart of the conference by taking on enormously difficult topics arising in the context of Covid-19 about access to health care, including what I found to be a fascinating perspective from Professor Barbara Pfeffer Billauer  from her recent work in Israel. She started with an interesting introduction of three specific pandemic responses she's identified in her research. She then focused on how "Policy Pariah-itizing" has had a negative effect on health care for older adults, with examples from Israel, Italy, and China.  I was also deeply impressed by the candid presentations of several direct care providers, including nursing care professionals Esperanza Sanchez and Nelda Godfrey, about the ethical issues and practical pressures they are experiencing; 
• Illinois Law Professor Dick Kaplan offered  timely perspectives on incorporating cultural sensitivity in Elder Law Courses.  His slides had great context, drawing in part from an article he published about ten years ago at 40 Stetson Law Review 15;
• Real world examples about tough end-of-life decisions involving family members and/or formally appointed surrogates, with Deirdre Lock and Tristan Sullivan-Wilson from the Weinberg Center for Elder Justice leading breakout groups for discussions.

I know I'm failing to mention other great sessions (there were simultaneous tracks and I was playing a bit of leap-frog).  But the good news is we can keep our eyes out for the Touro Law Review compilation of the articles from this conference, scheduled for Spring 2022 publication.  I know it was a big lift to pull off the conference in the middle of the fall semester.  Thank you!

Front Page on the Sunday NY Times: "Phony Diagnoses" Used in Drugging at Nursing Homes

In a front-page Sunday article, Phony Diagnoses Hide High Rates of Drugging at Nursing Homes, The New York Times adds a subtle but important focus in providing its latest reports of a well known issue, the use of chemical restraints, including antipsychotic medications, to control behavior for people in long-term care settings.  The patients have been getting "new" diagnoses of schizophrenia, thus attempting to justify the sedation associated with major antipsychotic medications, such as Haldol, despite the fact that such medications are contraindicated for dementia patients. From the article:

In 2005, the Food and Drug Administration required manufacturers to put a label on the drugs warning that they increased the risk of death for patients with dementia.

 

Seven years later, with antipsychotics still widely used, nursing homes were required to report to Medicare how many residents were getting the drugs. That data is posted online and becomes part of a facility’s “quality of resident care” score, one of three major categories that contribute to a home’s star rating.

 

The only catch: Antipsychotic prescriptions for residents with any of three uncommon conditions — schizophrenia, Tourette’s syndrome and Huntington’s disease — would not be included in a facility’s public tally. The theory was that since the drugs were approved to treat patients with those conditions, nursing homes shouldn’t be penalized.

 

The loophole was opened. Since 2012, the share of residents classified as having schizophrenia has gone up to 11 percent from less than 7 percent, records show.

 

The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.

As the news article reports, the challenges of caring for individuals with dementia are enormous, and lack of adequate staffing is certainly a reason why families and facilities use and misuse drugs to control -- restrain -- them.  But, at the same time, as I have written about on this Blog several times (see here, for example), the problem is not "just" about staffing ratios.    

Special thanks to Laurel Terry, Dickinson Law Professor Emerita, for ensuring I saw this latest article.  

NPR Morning Edition: "Antibody Tests Should Not Be Your Go-To for Checking COVID Immunity

Apparently I'm not the only person asking about the proper role of antibody tests in determining safety protocols during this current phase of COVID-19 infections.  This morning on NPR's Morning Edition program, a strongly expressed piece discounted the value of current antibody tests.  At the heart of the story was the following:  

[Washington University School of Medicine Immunologist] Ali Ellebedy says that having detectable antibodies from a blood test six months after vaccination "only means that your immune system mounted a successful response then and that you have immune memory."

 

While scientists have generated a "ton of data" on which antibodies are best at neutralizing the virus, Ellebedy says, the available antibody tests are not designed to specifically pick up whether you have enough of these protective antibodies, especially in the face of evolving variants.

 

And don't forget the immune system is more than just antibodies, so even with low detectable levels in your blood, you're not defenseless. "Antibody tests — it's really probing just one part of your immune system," says Elitza Theel, who directs the Infectious Diseases Serology Laboratory at the Mayo Clinic.

The NPR piece poses the question of whether a person can "learn anything" from antibody testing.  The piece says "Yes, as long as you don't expect it to give you a straightforward answer for how well-protected you are from catching the virus."  

For more, I recommend reading or listening (3 minutes) to the NPR segment entitled "Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity."  The segment suggests that "the identity of a blood test that can eventually give consumers a reliable indication of their immunity is not far-fetched."  Okay.  But as I suggest in my previous post on this topic, are there communities available for antibody testing to further the identification of "correlates of protection" that aren't being tapped currently?  Could college and university communities and long-term care communities become part of the development of a reliable tool?  

 

United Kingdom to Begin Offering Home-Finger-Prick Tests for Covid-19 Antibodies

Yesterday, I wrote here about what I'm hearing about use of antibody testing in some long-term care facilities in Pennsylvania.  The more I read about antibody testing for COVID-19, the more I'm surprised by the state of the science and the level of apparent uncertainty about appropriate uses for such tests. 

I've read published articles suggesting multiple explanations for why such tests have not been widely used as part of the response to COVID-19 and variant infections including:

• Lack of availability of commercially-based testing products 
• Lack of reliable testing products
• Lack of FDA protocols to establish reliable tests
• Disagreements (or lack of clarity) over what level of antibodies should be considered "protective"
• Concern that any test results could be misused 
• Lack of easily administered tests, especially tests that would not require medically-trained persons for blood draws

See, for example, these two articles by John Hopkins Center researchers:  Rachel M. West et al, Antibody (Serology) Tests for COVID-19: A Case Study (May 2021); Rachel West, et al, COVID-19 Antibody Tests: A Valuable Public Health Tool with Limited Relevance to Individuals (November 2020). 

As a non-scientist I can understand some of these concerns for the first half of this pandemic, where the issue was whether and to what extent actual infection would provide protection against reinfection. But, with almost 9 months of publicly administered vaccines, it is troubling to think that there could still be concerns about reliability of antibody testing following those vaccinations. Can an illness be called a "breakthrough" infection if the level of immunity wasn't being tested?  Or rather, if the immunity status couldn't be reliably detected?  

In any event, as I dig deeper, it seems that the U.K. is moving forward this month (August 2021) to "begin offering COVID-19 antibody testing to the general public...for the first time" via a home-administered finger-prick test.  From a Reuters report that leans on other media sources:

The government's new programme is intended to produce data on antibody protections for people following infection by different coronavirus variants, according to details of the programme published by multiple media outlets, including Sky News and BBC.

 

From Tuesday, anyone aged 18 or over in England, Wales, Northern Ireland and Scotland, will be able to opt in to the programme when receiving a PCR test, Sky News reported.

 

Participants, on testing positive for COVID-19, will be sent two finger-prick tests to complete at home to inform the UK Health Security Agency of the antibody response to different coronavirus variants, BBC reported.

Again, I find it odd that the U.K. goal -- at least so far as this report -- is to determine level of antibody protections following "infections" rather than "immunizations." Why not both? Why not especially the latter?   I'd still like to think that the U.S. can better prioritize the need for any and all protective actions, including booster shots, through intelligent use of antibody testing. 

 

One of my new (and exciting) colleagues, Penn State Dickinson Law Assistant Professor Sara Gerke, is the lead author on an article discussing appropriate safeguards for implementation of employment-based antibody testing.  See Covid-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations, published Summer 2021 in The Journal of Law, Medicine & Ethics. The analysis begins with a series of important research-assumptions.  The authors "assume that there is an antibody test for COVID-19 on the market that is accurate and reliable with high specificity and sensitivity." They acknowledge "FDA authorized tests meeting a reasonable threshold of accuracy and reliability" are essential to establish an ethical basis for their use.  

 

So much of COVID-19 testing is happening in an unusually public context, with new information generated every day. The intensity of a pandemic response certainly affects research and treatment priorities.  Nonetheless, the fact that some facilities are using antibody tests to facilitate care decisions seems significant.  Could certain residential institutions offer -- encourage? -- voluntary testing for COVID-19 antibodies, especially after the administration of the first doses, and  both before and after any booster doses?  Could colleges and universities, assisted living centers and nursing homes, all places where people are likely to live, work, and play together in close quarters around the clock, be uniquely good platforms for important data generation?   Could these locations be making better priority-based decisions about protective measures that both help their customers stay safe and provide better information for the public at large? 

Are LTC Residents "Telling" Us that Antibody Testing is Important for Covid-19 Prioritization for Boosters?

In recent weeks, I've spoken to or read about residents of long-term care facilities being tested for Covid-19 antibodies.  Some residents, without being ill, are showing low (or even "no") levels of antibodies, despite having been fully inoculated in the spring of 2021.  This doesn't mean there was anything wrong with the original vaccinations, but it does suggest that at least for older persons, the immunity reduces over time.   As a result of these test results, the facilities are recommending that families support getting booster shots for their loved ones. That strikes me as using scientific data appropriately, to help prioritize next steps in fighting the troublesome developments with Covid-19. 

Why aren't other institutions, including universities, seeking similar information about antibodies or lack thereof?   Does it "matter" that a faculty member -- or a student -- or an administrator -- or a staff member -- was "fully vaccinated" in, for example, February 2021, if they aren't still "protected" in September 2021?  

Here's what I know so far:

• My own health insurance company requires a "doctor's order" to permit an antibody test to be covered for reimbursement.
• My local pharmacy advertised last spring that its onsite clinic would be offering antibody tests.  I learned recently, however, that it never actually set up that program.  The pharmacist I talked with didn't know why that decision was reversed.
• My regular physician said I could sign up for a booster shot approximately 9 months from my last of the two-shot original vaccination, and said that therefore I didn't need an antibody test.
• My insurance company asked whether I had a known exposure to Covid-19, implying that if the answer was yes, they would cover testing for a breakthrough-Covid infection, but not for antibody testing unless I had a doctor's order.

I realize one personal anecdote isn't evidence of much of anything.  But, is nursing home data already being generated that suggests antibody testing can supply relevant facts, perhaps facts that are "more" relevant than simply a history of immunization?     

 

Nurse Robots?

There have been stories of late about shortages of nurses, for various reasons. For example, NPR reported, Hospitals Face A Shortage Of Nurses As COVID Cases Soar. So, then a dear friend and colleague of mine today sent me a link to this story: Meet Grace, the ultra-lifelike nurse robot.  Grace, developed by a robotic company in Hong Kong, is "a humanoid robot it hopes will revolutionize healthcare.... Designed as an assistant for doctors, Grace is equipped with sensors, including a thermal camera to detect a patient's temperature and pulse, to help doctors diagnose illness and deliver treatments....The android is a companion for patients, too. Specializing in senior care, Grace speaks three languages -- English, Mandarin, and Cantonese -- and can socialize and conduct talk therapy."  The company expects to start large scale production of this robot and another robot by year's end. The article notes that this robot is attended to assist, not supplant, health care providers.  There's an accompanying video, which includes a brief clip of the robot showing Tai Chi moves to the reporter.  The robot at one point responds that her specialization is in "senior care." I don't know what the cost will be of such a robot and what patient load it can handle. Plus, I'm not sure about the lack of human connections in caregiving.  We'll have to wait to see whether the robot is at least a partial solution to the caregiving and nursing shortages.

 

When Do You Start To Get "Old"?

There was a bit of a buzz last week with the publication of a new study about metabolism.  What We Think We Know About Metabolism May Be Wrong explains the recent study: "[u]sing data from nearly 6,500 people, ranging in age from 8 days to 95 years, researchers discovered that there are four distinct periods of life, as far as metabolism goes. They also found that there are no real differences between the metabolic rates of men and women after controlling for other factors."

We probably only think about our metabolisms when we are trying to lose weight. But as the article explains, the implications are far beyond weight gain and loss.

Central to [the researchers'] findings was that metabolism differs for all people across four distinct stages of life.

• There’s infancy, up until age 1, when calorie burning is at its peak, accelerating until it is 50 percent above the adult rate.

• Then, from age 1 to about age 20, metabolism gradually slows by about 3 percent a year.

• From age 20 to 60, it holds steady.

• And, after age 60, it declines by about 0.7 percent a year.

For us in elder law, here  is the point: "And around age 60, no matter how young people look, they are changing in a fundamental way...'There is a myth of retaining youth, [one expert said] That’s not what the biology says. In and around age 60, things start to change. ... There is a time point when things are no longer as they used to be.'"

Thanks to Professor Naomi Cahn for sending the link to the article.

 

Nursing Homes & Covid: Here We Go Again?

Another surge, another rise in COVID in SNFS? According to a recent article in the New York Times, Nursing Homes Confront New Covid Outbreaks Amid Calls for Staff Vaccination Mandates, the cases are rising.  Featuring one company, the article notes

The case count has ticked up again: It’s still below 100 among residents and staff, the company said, but includes many breakthrough cases of vaccinated residents testing positive. Then last week, two vaccinated residents died with Covid .... The company said it had pinpointed the cause of the spread there and at other of its facilities: The breakthroughs had happened in the same homes where unvaccinated staff were testing positive, seemingly carrying the virus into the home from the community.

The company recently announced it was requiring all staff to be vaccinated, the article notes.  As we all know, vaccine mandates are controversial.

Growing calls for vaccine mandates among health care workers have gained urgency but also met resistance in the nursing home industry, where some homes say it will cost them staff members in an industry already plagued with high turnover. Only about 60 percent of nursing home staff members are vaccinated, and some states report an even lower rate, with less than half inoculated, according to the most recent government data.

Staff immunization has been an issue in many states, especially as the highly contagious Delta variant races through regions with low vaccination rates. Some states and cities, not waiting for the nursing home industry, are imposing their own mandates for vaccinations on long-term care employees or operators may face penalties or additional testing requirements for unvaccinated staff.... 

Some states have reinstated visitation restrictions and the CDC is monitoring the number of cases. The article goes on to discuss in depth the issues surrounding a vaccine mandate, with some states requiring frequent testing in lieu of adopting a mandate.  Looks like we are going to be dealing with this through the end of 2021. I go over with my students a list of questions regarding choosing a nursing home. I'm adding "how many of your staff and residents are vaccinated again COVID" to the list.