Old People Have a Drug Problem

Blood Moon 2021

There is a new drug problem that affects older people directly, but really also everyone else.   It is the drug that the FDA recently approved, Aducunumab—or Aduhelm, which is its brand name.  It is a drug designed to treat Alzheimer’s disease by reducing the size of one of the pathologies associated with the disease, amyloid plaques.  The problem is—the drug may have only a minimal benefit.

Many of you have probably been following the controversies around Aduhelm.  Two trials by the drug company, Biogen, failed, but then the company conducted a re-analysis and found that one arm of the trial had positive results.  The benefits, however, were fairly minimal—a 4 month period during which cognitive decline of participants slowed and some reduction of the amount of amyloid in the brain.  

There are three problems here.  First is the research is flawed.  As two researchers, Aaron Kesselhelm and Jerry Avorn wrote in The New York Times, this was the worst example of how the FDA has been lowering research standards.  Conducting a re-analysis can be warranted, because benefits might be found in a specific subset of participants or with some other combination of dosage and other variables, but any time you reanalyze data it increases the possibility of a chance finding.  In other words, this type of positive outcome that was found searching through the data needs to be confirmed in a new, independent study, and not used as evidence of efficacy of the drug.   

Second, the benefit of the drug is fairly minimal.  The cognitive benefits—a slowing of decline for a short period of time—are not as good as results of cognitive stimulation studies conducted in the UK and other European countries or the results of the excellent cognitive rehabilitation training study conducted in the UK by Dr. Linda Clare and her colleagues, who showed that both cognition and brain activity increased with training.  As for Aduhelm’s effect on amyloid, other drug trials have shown that reducing the amount of amyloid does not necessarily have clinical benefits for cognition.  In other words, removing amyloid does not change the underlying damage done by the disease.

Third, the drug was tested mainly on persons with mild dementia symptoms, but the FDA approved the medication for use by anyone with dementia.  It is not obvious that persons with more pronounced symptoms will benefit and the risk of harm is likely to be greater.  The medication can result in brain swelling or hemorrhaging.  To monitor those risks, patients need regular MRI scans, which could be difficult for persons with more advanced Alzheimer’s disease.  Treatment, which consists of a monthly infusion, may also be a challenge for anyone, but particularly persons with significant cognitive decline.

So why was the drug approved?  We are sure you have guessed.  Money.  The FDA was heavily lobbied by the drug companies.  According to an analysis in Upshot section of The New York Times, the estimated annual costs for treatment will be $56,000 for the drug alone, plus additional costs for MRIs to monitor for brain swelling.  That works out to somewhere between $5.8 billion and $29 billion in annual costs for Medicare and its enrollees.  It means that everyone on Medicare will likely face substantial increases in their premiums to pay for this overpriced and largely ineffective drug.

Another factor in the approval was lobbying from the Alzheimer Association and other advocates.  The argument they make is that we need to offer hope for people with an Alzheimer diagnosis.  Doctors and other health care providers will argue that they need to have something to offer a patient when the diagnosis of Alzheimer is made.  This was one of the arguments put forward for the previous Alzheimer medications that were approved.  These medications (Aricept, Exelon, and Razadyne) have little or no benefit, other than placebo effects, but at least the side-effects are fairly minimal.  We should have compassion for people with Alzheimer’s and other neurodegenerative diseases, but it is not compassionate to make false promises. Instead of filling the coffers of the drug companies, why don’t we for once follow the research, and make the behavioral and cognitive programs that have been shown to be effective more widely available to persons living with dementia and their family members.

References:

Claire, L., et al. (2018).  Cognitive rehabilitation, self-management, psychotherapeutic and caregiver support interventions in progressive neurodegenerative conditions: A scoping review.  NeuroRehabilitation, DOI:10.3233/NRE-172353.

Katz, J., Kliff, S., & Sanger-Katz, M. New drug could cost the government as much as it spends on NASA.  The New York Times, June 23, 2021.

https://www.nytimes.com/2021/06/22/upshot/alzheimers-aduhelm-medicare-cost.html?searchResultPosition=5.

Kesselhim, A., & Avorn, J.  The FDA has reached a new low.  The New York Times, June 15, 2021.

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html?searchResultPosition=4.

Woods, B., Aguirre, E., Spector, A. E., & Orrell, M. (2012, Feb).  Cognitive

stimulation to improve functioning in people with dementia.  Cochrane Database Systematic Review, DOI: 10.1002/14651858.CD005562.

Finding Small Comforts

Whether we are old or not so old, the pandemic has probably led us to think about our mortality.  Adding to the stress of the pandemic has been the daily vitriol of the election and its aftermath. The news headlines have frayed our nerves and left us worrying about whether our democratic form of government will survive a would-be dictator and his band of sycophants. 

Much has been written about pandemic baking, and we have joined that group.  Sometimes there is comfort in making something sweet or familiar.  Certainly the focus that is required to bake from scratch is a welcome distraction from the world around us.  The holidays have given us an additional excuse to bake familiar cookies for family members.  The grandkids that we can see came over last week to bake Steve’s family recipe for poppyseed cookies for Hanukkah.  Then Steve baked two more batches to send to two of our children, one in Chicago and one in Nashville.  We’d already sent the traditional box of See’s candy custom selected for each family (the milk chocolate butter is probably the most asked for, although the chocolate covered peanut brittle comes close) .  We can’t all be together, but we can still have some familiar food memories together that we can talk about when we have our family Zoom on Saturday.

We’ve also become huge fans of Goldbelly, the website that ships restaurant and bakery goods from around the country.  We’ve enjoyed the Momofuku Bo Ssam dinner, Marcus Samuelsson’s  hot honey chicken & cornbread waffles, Xi’an Famous Foods’ hand-ripped noodles, and Hattie B’s hot fried chicken, to name a few.  The first three are from New York, and Hattie B's is from Nashville, which we tried in person last year.  The hand-ripped noodles from Xi’an were particularly enjoyable because you got to pull and tear the noodles yourself, and then whack them against the counter top.  The ingredients were incredibly fresh and delicious, too.  We’ve had so much fun with it that we gave all of the kids gift certificates to Goldbelly for their Christmas present this year.  What could be better than a restaurant meal at home in these times?  

We have found that indulging in good food is a way to assuage the feeling of deprivation from not being able to travel to see our children and grandchildren.  By sharing the good food we can at least evoke memories of meals together. 

At this point some of you must be thinking that this is not healthy.  We have all been conditioned to worry about what we eat.  There is, of course, some truth to being careful about what and how much we eat.  Obesity is a major problem in our country.  It is not healthy to overdo pastries and ice cream or anything else.  But it is healthy to thoroughly enjoy a good meal or desert without guilt.  Good tasting food is good for our mood and it is satisfying.  Not skimping on ingredients is important.  We use good quality butter and good chocolate in baking, because the final product tastes better.  Food that tastes good is really satisfying.  We end up eating less, but feeling better. Eating good foods is often equated with eating too much.  But it is easier to control how much we eat when we feel satisfied.

One of the harder things to do during the pandemic is to engage in activities that we enjoy.  Like good food, enjoyable activities are important for our daily mood.  Almost everyone is interacting less in person with other people, and it is much harder or not possible to do things we used to enjoy—going to a movie or restaurant, shopping, even walking through a park.  When we begin to feel the walls closing in on us, it has been helpful to start planning activities that we enjoy.  It can be something simple, like finding a movie on demand that we want to see, or arranging a phone or video call with a friend.  The key is having something enjoyable to look forward to on most days.

We also know how fortunate we are to be able to afford to indulge our food desires.  So we have been supporting both the Greater Pittsburgh Area Food Bank and the Free Store in Braddock during the pandemic and plan to continue for the foreseeable future. And we continue to support local restaurants.

The photo shows Steve’s Poppy Seed Cookies.  You may notice one is missing from the cookie sheet.  Someone couldn't wait to try one of the cookies.

You can find the recipe in Judy’s food and baking blog, Tasty Treats, at 

https://jzcooks.blogspot.com/search?q=poppy+seed+cookies

There are two minor additions to the recipe: 

1.Put the butter and shortening in the freezer for about 10 minutes before cutting them into the dry ingredients. 

2.  When the cookies are on the cookie sheet and ready to go into the oven, put them in the freezer first for about 40 minutes.  

Keeping the butter and shortening as cold as possible will lead to lighter and tastier cookies.  Of course, they are even more addictive then.

Is Biden Too Old or Have Other Presidents Been Too Young?

There is a column in today’s New York Times by Jennifer Senior that makes the case that President-elect Biden’s age could really be an advantage.  She points out the positive things that can happen as we age.  Like experience and expertise.  Many people have pointed out that Joe Biden knows how Washington works and can draw on that experience to get things done.  Of course, some critics have suggested that his knowledge of Washington is obsolete, that the Republican Party and its soulless leader in the Senate will not cooperate or compromise to pass important legislation.  But is there a better idea than trying to reach across the aisle to make things happen, or a better person than Mr. Biden to try to make that work?  

 

Senior notes another quality that Biden brings to the Presidency--wisdom.  We often say that older people are wise, but then we don't treat them as wise.  Of course, not all older people are wise, and age alone does not lead to wisdom.

 

What actually constitutes wisdom was a long-standing issue in Gerontology, but a program of research conducted by Paul Baltes and his colleagues has provided a compelling framework for understanding wisdom.  One aspect of wisdom is drawn from experience—factual and procedural knowledge.  That is, a wise person has access to a lot of facts in a domain as well as knowledge about how things work and how problems get solved in that domain.  One implication is that wisdom is not a general characteristic.  Rather, people can act wisely in domains where they have expertise, but may not give “wise” counsel in other domains.

 

Expertise, however, is not enough.  Another aspect of wisdom is what Baltes and colleagues called “excellence in mind and virtue.”  Here, they mean that the wise person strives toward excellence and the common good.  The wise person is not focused on themselves.  They are not saying, “I did it this way, and so that’s what you should do.”  They are instead applying knowledge about a specific situation that takes into account both the situation and the people involved.  Another way to say this is the wise person has empathy, which is another finding in the research conducted by Baltes and colleagues.  

You can see in this definition of wisdom a major difference between the 74 year old outgoing President and the 78 year old President-elect. Or as Senior wrote, the voters “decided to replace a savage clown and chaos-sowing novice with a man defined by decency and nearly half a century of public service.”

 

Aging, of course, has its perils.  The older we get, the more likely something bad will happen.  But Biden’s knowledge and temperament and his concern about other people, all of which have been honed over the course of his life, indicate he is up to the tasks ahead.  

 

 

Link to “Stop Worrying About Biden’s Age” by Jennifer Senior

https://www.nytimes.com/2020/11/12/opinion/biden-age-president.html?referringSource=articleShare

 

To read more about wisdom:  Baltes, P. B., & Smith, J. (2008).  The fascination of wisdom:  Its nature, ontogeny and function,  Perspectives on Psychological Science. 3, 56-64.  doi: 10.1111/j.1745-6916.2008.00062.x

Photo:  Elephant on a stairway in Lisbon.

 

The Silly Science Around Alzheimer’s Continues

A week hardly goes by without a new claim about causes of Alzheimer’s disease or cognitive impairment.  The New York Times Health Correspondent, Jane Brody, has never missed an opportunity to hype a potential cause or cure, no matter how suspect the evidence is.  This past week she wrote about vision and hearing loss as possible causes.

This is an idea that has been around for awhile.  And while some scientists make a plausible argument that reduced sensory input might lead to lower cognitive abilities, that is a far step from causing plaques, tangles, strokes, or other dementia-related pathologies.  We have yet to hear a plausible explanation for the biological mechanism the connects hearing loss, which occurs within the ear, or vision loss, which occurs in the eye, to dementia, which occurs in the brain.  Hearing loss and vision loss definitely limit and distort the quality of information a person is able to take in, but they do not cause brain cells to progressively deteriorate the way we know they do in dementia. 

The most plausible explanation is that the findings are an artifact. Think about how cognitive functioning is assessed.  We show someone visual images and/or present verbal information that they are to repeat or remember.  If you can’t see or hear well, you are more prone to make mistakes on tests.  That is a fundamental premise of neuropsychological testing.  Whenever Judy saw someone for testing who had hearing loss her first priority was to be sure that conditions were optimal for hearing (quiet room, speaking in a low register and projecting her voice directly to the person), and when that wasn’t sufficient, using written materials to supplement verbal instructions.

Imagine dear old Uncle Bill, who is hard of hearing, being asked a standard dementia screening question:  “What’s today’s date?”  And Bill answers, “I haven’t been on a date in years.”  How might that answer be interpreted?  Before jumping to the conclusion that he has dementia, it’s important to consider he didn’t hear the question correctly.  Or maybe he’s just a wiseass.  Either way, it may not be dementia.

Many of the studies that have reported correlations between hearing loss and cognitive function have been conducted over the phone.  It’s hardly an optimal way to assess someone with hearing loss.  But even clinical studies may confound hearing loss and cognitive problems, if the person conducting the tests is not well-trained.  The studies are also largely correlational, and don’t show decline in cognition over time.  Brody cites two large studies, one with 3,000 people, and one with 30,000 people, that present correlations of cognition and hearing loss, but a large sample is not necessarily better.  It’s easier to find statistical significance with a large sample, but what is called “effect size,” that is, the size of the association, may be quite small. 

We would all like to know that there is something that we could do that might prevent dementia.  And if we have hearing loss that affects daily life, it would be a good idea to get evaluated for hearing aids or other hearing devices, because that could make things easier at least in some situations.  But that’s a far cry from advising someone to get hearing aids in order to prevent the development of dementia.

How Are You Doing?

 

How are you doing?  We are getting along well.  We are not seeing our grandkids as much as we’d like or traveling or doing other things we enjoy.  But we are doing all right.

 

It’s the country we are worried about.  This is the most important election in our lives.  We have had presidents in the past who lied (Nixon about Watergate, Johnson about Vietnam), but we have never had a president who lies constantly and threatens to destroy our democracy.

 

We urge you to vote, if you have not done so already.  And get your friends and relatives to vote, too.  

 

If you are still undecided, or know someone who is undecided, take a look at the excellent column by Nicholas Kristof (link is below).

 

At the beginning of the primaries, we wrote a blog suggesting that Biden (and Trump, too) were too old to be president.  Joe has shown us to be wrong during the campaign.  Instead of trying to match Trump in vitriol, he has presented a vision of what this country could become by bringing people together.  He speaks powerfully from his experiences.  He knows that more anger and bitterness will not get us anywhere.  Our country has lots of problems.  Joe promises to get to work on them, with our support.  That’s wisdom that comes with age.

 

We hope to tune back in next week to celebrate the end of this long nightmare.

 

 

Link to Nicholas Kristof’s column:

 

https://www.nytimes.com/2020/10/30/opinion/donald-trump-polarization.html?campaign_id=45&emc=edit_nk_20201030&instance_id=23642&nl=nicholas-kristof&regi_id=60761850&segment_id=42887&te=1&user_id=98f3fcf260219e79a11053d8948e41ec

 

Photo:  Fall colors. Frick Park, Pittsburgh

The Vote is in!

                                                                    

Not that vote.  But an important vote in our family.  As a diversion from the corona virus, election and other upsetting stories in the daily news, we have been finding wonderful food that can be ordered on-line.  A few weeks ago we ordered babkas from Zabar’s in New York for ourselves and our kids.  They were wonderful.  Even our grandkids were thrilled.  We had tasted Zabar’s babka in the past, but it has been awhile, and we had forgotten how good they could be.

 

But then the question came up—is the chocolate babka better than the cinnamon babka?  You may remember the Seinfeld episode about babkas.  Jerry and Elaine were standing in line, waiting to buy a chocolate babka as hostess gift for the dinner party they were going to.  But the couple a head of them buy the last chocolate babka.  The baker offers to sell them a cinnamon babka, which Elaine calls “the lesser babka.”

 

We thought a taste test of our own was appropriate.  Jerry and Elaine went to Royale Bakery for a babka, but it has closed.  A New York friend of ours said the place to go when you are bringing a babka as a gift is Green’s Bakery in Brooklyn.  So we placed our order.

 

The vote is in.  The winner is (drum roll)  -- the cinnamon babka from Zabar’s.  The consensus was that Green’s chocolate babka was better than Zabar’s, but Zabar’s cinnamon babka was the best overall.  Not the lesser babka at all.

 

FYI.  The Seinfeld episode, “The Dinner Party,” is Season 5, Episode 13, and is available on Prime Video.

  

What’s in a Name? Could COVID-19 Be too Mild a Name to Gain Compliance with Preventive Approaches?

Why has it been so hard to get people to comply with simple protective approaches that reduce the spread of the COVID-19 virus?  It is a simple matter to wear a mask outdoors and in shops.  It is simple to maintain a safe distance.  Yet go almost anywhere and you see someone with the mask below the nose or hanging below the chin.  Or someone who gets far too close to you.  People complain bitterly that these restrictions are trampling on their freedom. Freedom to infect others?

 

Part of the problem, of course, is due to the politicians, starting at the top, who have minimized risks from the beginning and encouraged people not to take any precautions.  But maybe the problem is partly due to the name, COVID-19 Pandemic.  The word “COVID” does not sound threatening.  It doesn’t carry any meaning.  Would a different name be more motivating for people to take precautions?

 

Looking back in history, plagues had more evocative names.  The Great Plague, also called the Black Death or Bubonic Plague, swept across Europe and Asia several times.  In the 14^th century, the Great Plague wiped out between two thirds and three quarters of the population in parts of Europe.  Those names carry some heft to them.  Likewise, other illnesses that led to widespread infection and death had names that conveyed threat:  Small pox, typhus, typhoid, cholera, malaria.  Or more recent names—Ebola and Zika.  And of course, Human Immunodeficiency Virus (HIV/AIDS).  They sound ominous.  Even “Spanish flu” sounds more serious than just ordinary influenza or H1N1 flu.  

 

And why call it a pandemic?  Plague is more dramatic.  It’s something people react to.  The term “plague” calls to mind all those apocalyptic paintings of victims from the 14^th century and later plague outbreaks.  New York Times columnist Roger Cohen recently quoted Camus, who wrote that the plague “never goes away. It is waiting to exploit stupidity.”  That fits our response. 

 

What, then, should we call it that would better get attention?  President Trump started calling it the China Virus, which everyone saw as just another attempt to divert attention from his incompetence in letting the virus spread in the US, even as much of the world was implementing shutdowns and other efforts to control the virus. Such as wearing masks.

 

But it is not just that COVID-19 originated in China.  Viruses have regularly been making the jump from animals to humans in China.  The source is believed largely to be markets where wild animals are sold for food.  For years, the US and other countries have been talking with China about closing these markets, and there is some indication that they may be willing to do so. That would be an important step that could reduce the annual flu epidemic and prevent other novel viruses such as COVID-19.

 

To further that goal, we thought that COVID-19 should be re-named for one of its animal hosts, bats.  Bats are ugly.  We use their images for decorations for Halloween.  But Bat Virus is not strong enough.  Bats play an important role in eating mosquitoes in this country, and, after all, they are not responsible for the virus.  So we propose instead that COVID-19 be renamed the Bat Shit Plague.  There’s nothing nice or comfortable about that.  The bat isn’t being blamed directly.  And the name conveys how terrible the virus has been.  Maybe people unwilling to take precautions for COVID-19 will take steps to avoid the Bat Shit Plague. It’s a thought.