Month: July 2021

Alice Herb, 88, an intrepid New Yorker, is used to walking miles around Manhattan. But after this year of being shut inside, trying to avoid covid-19, she’s noticed a big difference in how she feels.

“Physically, I’m out of shape,” she told me. “The other day I took the subway for the first time, and I was out of breath climbing two flights of stairs to the street. That’s just not me.”

Emotionally, Herb, a retired lawyer and journalist, is unusually hesitant about resuming activities even though she’s fully vaccinated. “You wonder: What if something happens? Maybe I shouldn’t be doing that. Maybe that’s dangerous,” she said.

Millions of older Americans are similarly struggling with physical, emotional and cognitive challenges following a year of being cooped up inside, stopping usual activities and seeing few, if any, people.

If they don’t address issues that have arisen during the pandemic — muscle weakness, poor nutrition, disrupted sleep, anxiety, social isolation and more — these older adults face the prospect of poorer health and increased frailty, experts warn.

What should people do to address challenges of this kind? Several experts shared advice:

Reconnect with your physician. Large numbers of older adults have delayed medical care for fear of covid. Now that most seniors have been vaccinated, they should schedule visits with primary care physicians and preventive care screenings, such as mammograms, dental cleanings, eye exams and hearing checks, said Dr. Robert MacArthur, chief medical officer of the Commonwealth Care Alliance in Massachusetts.

Have your functioning assessed. Primary care visits should include a basic assessment of how older patients are functioning physically, according to Dr. Jonathan Bean, an expert in geriatric rehabilitation and director of the New England Geriatric Research, Education and Clinical Center at the Veterans Affairs Boston Healthcare System.

At a minimum, doctors should ask, “Are you having difficulty walking a quarter-mile or climbing a flight of stairs? Have you changed the way you perform ordinary tasks such as getting dressed?” Bean suggested.

Get a referral to therapy. If you’re having trouble moving around or doing things you used to do, get a referral to a physical or occupational therapist.

A physical therapist can work with you on strength, balance, range of motion and stamina. An occupational therapist can help you change the way you perform various tasks, evaluate your home for safety and identify needed improvements, such as installing a second railing on a staircase.

Don’t wait for your doctor to take the initiative; too often this doesn’t happen. “Speak up and say: Please, can you write me a referral? I think a skilled evaluation would be helpful,” said James Nussbaum, clinical and research director at ProHealth & Fitness in New York City, a therapy provider.

Start slow and build steadily. Be realistic about your current abilities. “From my experience, older adults are eager to get out of the house and do what they did a year ago. And guess what. After being inactive for more than a year, they can’t,” said Dr. John Batsis, associate professor of geriatrics at the University of North Carolina-Chapel Hill.

“I’m a fan of start low, go slow,” Batsis continued. “Be honest with yourself as to what you feel capable of doing and what you are afraid of doing. Identify your limitations. It’s probably going to take some time and adjustments along the way.”

Nina DePaola, vice president of post-acute services for Northwell Health, the largest health care system in New York, cautioned that getting back in shape may take time. “Pace yourself. Listen to your body. Don’t do anything that causes discomfort or pain. Introduce yourself to new environments in a thoughtful and a measured fashion,” she said.

Be physically active. Engaging regularly in physical activity of some kind — a walk in the park, chair exercises at home, video fitness programs — is the experts’ top recommendation. The Go4Life program, sponsored by the National Institute on Aging, is a valuable resource for those getting started and you can find videos of some sample exercise routines on YouTube. The YMCA has put exercise classes online, as have many senior centers. For veterans, the VA has Gerofit, a virtual group exercise program that’s worth checking out.

Bienvenido Manzano, 70, of Boston, who retired from the Coast Guard after 24 years and has significant lower back pain, attends Gerofit classes three times a week. “This program, it strengthens your muscles and involves every part of your body, and it’s a big help,” he told me.

Have realistic expectations. If you’re afraid of getting started, try a bit of activity and see how you feel. Then try a little bit more and see if that’s OK. “This kind of repeated exposure is a good way to deal with residual fear and hesitation,” said Rachel Botkin, a physical therapist in Columbus, Ohio.

“Understand that this has been a time of psychological trauma for many people and it’s impacted the way we behave,” said Dr. Thomas Cudjoe, a geriatrician and assistant professor at Johns Hopkins Medicine in Baltimore. “We’re not going to go back to pre-pandemic activity and engagement like turning on a light switch. We need to respect what people’s limits are.”

Eat well. Make sure you’re eating a well-balanced diet that includes a good amount of protein. Adequate protein consumption is even more important for older adults during times of stress or when they’re sedentary and not getting much activity, noted a recent study on health aging during covid-19. For more information, see my column about how much protein older adults should consume.

Reestablish routines. “Having a structure to the day that involves social interactions, whether virtual or in person, and various activities, including some time outside when the weather is good, is important to older adults,” said Dr. Lauren Beth Gerlach, a geriatric psychiatrist and assistant professor of psychiatry at the University of Michigan.

Routines are especially true for older adults with cognitive impairment, who tend to do best when their days have a dependable structure and they know what to expect, she noted.

End-of-day routines are also useful in addressing sleep problems, which have become more common during the pandemic. According to a University of Michigan poll, administered in January, 19% of adults ages 50 to 80 report sleeping worse than they did before the pandemic.

Reconnect socially. Mental health problems have also worsened for a segment of older adults, according to the University of Michigan poll: 19% reported experiencing more sadness or depression while 28% reported being more anxious or worried.

Social isolation and loneliness may be contributing and it’s a good idea to start “shoring up social support” and seeing other people in person if seniors are vaccinated, Gerlach said.

Families have an important role to play in re-engaging loved ones with the world around them, Batsis suggested. “You’ve had 15 months or so of only a few face-to-face interactions: Make it up now by visiting more often. Make the effort.”

Laura Collins, 58, has been spending a lot of time this past month with her mother, Jane Collins, 92, since restrictions on visitation at Jane’s nursing home in Black Mountain, North Carolina, eased and both women were vaccinated. Over the past year, Jane’s dementia progressed rapidly and she became depressed, sobbing often to Laura on the phone.

“She loves getting outside and that has been wonderful,” Laura said. “Her mood immediately shifts when she gets out of the building: She’s just happy, almost childlike, like a kid going out for ice cream. And, in fact, that’s what we do — go out for ice cream.”

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug’s mixed results in studies — the FDA’s own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid.

But lost in this discussion is the underlying problem with using the FDA’s “accelerated” pathway to approve drugs for conditions such as Alzheimer’s, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.

The accelerated approval process, begun in 1992, is an outgrowth of the HIV/AIDS crisis. The process was designed to approve for sale — temporarily — drugs that studies had shown might be promising but that had not yet met the agency’s gold standard of “safe and effective,” in situations where the drug offered potential benefit and where there was no other option.

Unfortunately, the process has too often amounted to a commercial end run around the agency.

The FDA explained its controversial decision to greenlight the Biogen pharmaceutical company’s latest product: Families are desperate, and there is no other Alzheimer’s treatment. Also, importantly, when drugs receive this type of fast-track approval, manufacturers are required to do further controlled studies “to verify the drug’s clinical benefit.” If those studies fail “to verify clinical benefit, the FDA may” — may — withdraw them.

But those subsequent studies have often taken years to complete, if they are finished at all. That’s in part because of the FDA’s notoriously lax follow-up and in part because drugmakers tend to drag their feet. When the drug is in use and profits are good, why would a manufacturer want to find out that a lucrative blockbuster is a failure?

Historically, so far, most of the new drugs that have received accelerated approval treat serious malignancies.

And follow-up studies are far easier to complete when the disease is cancer, not a neurodegenerative disease such as Alzheimer’s. In cancer, “no benefit” means tumor progression and death. The mental decline of Alzheimer’s often takes years and is much harder to measure. So years, possibly decades, later, Aduhelm studies might not yield a clear answer, even if Biogen manages to enroll a significant number of patients in follow-up trials.

Now that Aduhelm is shipping into the marketplace, enrollment in the required follow-up trials is likely to be difficult, if not impossible. If your loved one has Alzheimer’s, with its relentless diminution of mental function, you would want the drug treatment to start right now. How likely would you be to enroll and risk placement in a placebo group?

The FDA gave Biogen nine years for follow-up studies but acknowledged that the timeline was “conservative.”

Even when the required additional studies are performed, the FDA historically has been slow to respond to disappointing results.

In a 2015 study of 36 cancer drugs approved by the FDA, only five ultimately showed evidence of extending life. But making that determination took more than four years, and over that time the drugs had been sold, at a handsome profit, to treat countless patients. Few drugs are removed.

It took 17 years after initial approval via the accelerated process for Mylotarg, a drug to treat a form of leukemia, to be removed from the market after subsequent trials failed to show clinical benefit and suggested possible harm. (The FDA permitted the drug to be sold at a lower dose, with less toxicity.)

Avastin received fast-track approval as a breast cancer treatment in 2008, but three years later the FDA revoked the approval after studies showed the drug did more harm than good in that use. (It is still approved for other, generally less common cancers.)

In April, the FDA said it would be a better policeman of cancer drugs that had come to markets via accelerated approval. But time — as in delays — means money to drug manufacturers.

A few years ago, when I was writing a book about the business of U.S. medicine, a consultant who had worked with pharmaceutical companies on marketing drug treatments for hemophilia told me the industry referred to that serious bleeding disorder as a “high-value disease state,” since the medicines to treat it can top $1 million a year for a single patient.

Aduhelm, at $56,000 a year, is a relative bargain — but hemophilia is a rare disease, and Alzheimer’s is terrifyingly common. Drugs to combat it will be sold and taken. The crucial studies that will define their true benefit will take many years or may never be successfully completed. And from a business perspective, that doesn’t really matter.