COVID - forgotten but not gone

Understandably, most of us have developed “Covid fatigue.” After what seems like years of warnings and behavior changes, we want to put it all behind us. Unfortunately, while we are tired of the virus, the virus is not tired of us.

The latest variant to appear, JN.1, is much more transmissible that its predecessor even though it has only a minor genetic change. It has rapidly become the dominant strain hitting the U.S. and much of the world. Fortunately, the last vaccine, aimed at an earlier variant, seems to be very protective against severe illness and death, even if not that good at preventing infection.

While not nearly as dramatic as the situation of 2-3 years ago, both case counts and deaths have been trending up. For the last period for which we have complete data, some 1500 Americans are dying of Covid every week – most, but not all, older and/or with severe underlying illnesses, and most not up to date on their vaccines.

Only 19% of adults 18 and older and 8% of children have received the current vaccine. Of those 65 and older, at highest risk of severe disease, only 38% have been fully vaccinated.

What should we do?

First and most important, get your booster! Vaccines only work when you get them.

Second, wear a well-fitted mask when you are indoors with lots of people. Think concerts, bridge games, indoor sporting events. While not a panacea, masks do cut down transmission of both Covid and other respiratory viruses such as colds and flu.

Finally, if you are sick, stay home. You do not want to be the one who recovers but finds out that you gave the virus to your elderly aunt who died. There will always be another event.

For those who do get sick, treatments are available that help. Paxlovid is under-used. In the older population, it cuts hospitalization and death by more than half. If you are very high risk, IV antibody treatments are even more effective.

We do not want or need to go back to the days of school closures and shuttered restaurants, but we can and should do these simple things that protect us all.



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Is the FDA protecting us adequately?

The high point of the FDA (Food and Drug Administration) showing its worth came in 1960, when Dr. Frances Kelsey refused to let thalidomide be marketed in the U.S. She prevented the U.S. from experiencing the epidemic of babies born with deformed limbs to mothers who were prescribed the drug for morning sickness in Europe.

Do we still have similar guardians? Recent years have seen a raft of drugs and devices of dubious value approved by the FDA.

Example: Zurzuvae was approved in August 2023 to treat postpartum depression. This is a major depressive disorder that begins during pregnancy or within 4 weeks after delivery. Standard recommended care is psychotherapy or the well-studied group of antidepressants called SSRIs (selective serotonin reuptake inhibitors). Zurzuvae works on the same brain receptors as benzodiazepines (think Valium, Xanax) and barbiturates, and so not surprisingly causes sedation, sleepiness and dizziness, and most people who take it for over a week suffer withdrawal symptoms when they stop.

Two studies of Z were done in women with severe postpartum depression, and in both it was compared to placebo, not SSRIs. It was superior, but the placebo group saw about 75% of the improvement seen in active drug users. The real test would have been comparison with a safer SSRI, not a placebo.

Moreover, even though only patients with severe depression were studied, the drug was approved for all patients with the disorder. I’d avoid it.

Example: In Dec 2019, the FDA approved the oral drug Olaparib for treatment of pancreatic cancer. This drug is priced at $12,000 PER MONTH. The study leading to approval showed a very modest improvement in survival: 18.9 months vs. 18.4, with no quality-of-life benefit. Statistically significant perhaps, but clinically? I’d also question using placebo rather than existing approved drugs as the comparison.

In addition to drugs, I could describe many devices of dubious value, but will only mention one in the interest of brevity.

In 2023 the FDA approved two devices that destroy nerves to the kidney to treat high blood pressure without medication. Two studies have been done. One showed no benefit and one showed statistical lowering, but by an average of 3 mm – less than the usual variation I would see between two measurements in the same visit. Is that worth the estimated $6000 that using the device will cost? Do we have data showing long-term benefit? (No!)

We should require that the pharmaceutical and medical device industries fund studies that clearly define which patients will benefit from new drugs and devices. We should then also require our regulators to protect the public by forcing new innovations to pass a proper bar before being allowed on the market. “Might help some people,” at high cost and with potential side effects is not a high-enough bar, not when lives are at stake.

Let the FDA know they need more Dr. Kelseys and fewer rubber stamps.



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Who makes the decisions about your health care?

If you have commercial health insurance or are one of the over half of Medicare enrollees who have a “Medicare Advantage” plan, decisions about your health care are not decided solely by you and your doctor(s). There is a third party in the room: your insurer, whose interests are financial rather than health.

As medicine became more complex and much more expensive, one response of health insurance companies was to try to decrease the use of expensive tests and treatments. They developed lists of tests, medications and procedures that could in some cases be substituted by older cheaper tests and treatments. When a doctor wished to order an expensive new approach, they had to justify why this was necessary.

If done properly, this was fair and reasonable. Every expensive new drug is not always better than a cheap old one. Every patient with back pain does not need a CT scan or MRI. The problem is that insurers went overboard.

The process works like this: your doctor sends a prescription to your pharmacy or asks their staff to schedule you for an imaging test. They then hear from the pharmacy or the radiology department that your insurance company requires “prior authorization.” The cost will not be paid until the insurance company agrees it is needed. The doctor’s office calls the insurer and are questioned by a clerk with no medical background using a checklist. Sometimes miracles happen, every box is checked and you get approval.

More often, your doctor is told that the request does not meet their criteria for necessity and will not be paid. There are now three choices: do it anyway and have you, the patient, pay the bill; forget about it and try a different approach; request an appeal of the decision.

For all but the very wealthy, paying out of pocket is very difficult. If there indeed is a good cheaper alternative the system has worked as intended. Most of the time the request is necessary for the best outcome and the doctor must appeal.

A survey found that the average doctor’s office devoted 14 person-hours a week to prior authorizations – time that costs the doctor money and takes away resources that could be better spent on care. Clearly the insurers hope that if they deny needed care, the doctor may sometimes decide it is not worth the time and effort to appeal.

Recent investigations by ProPublica and others have found that many insurance companies rely on biased algorithms to deny needed care. They have also documented that insurance company medical directors review 10,000 cases/year or more, and often make decisions without even looking at the patients’ charts. Moreover, many companies employ as medical directors doctors who have been driven out of practice by disciplinary action or numerous malpractice suits.

If your doctor’s suggestion is denied by your insurance company, what can you do? If you and your doctor agree that the denied service is truly best for you, insist on appealing. While the doctor’s office has to take the lead, you can add your voice to the process. Get the HR office at work to intercede on your behalf. Threaten to – and do if necessary – contact the state office of consumer affairs.

It is their money – but it is your life and health.



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All Fall Down

As children, we played Ring Around the Rosie, ending with “ashes, ashes, we all fall down.”

When small children fall down, it is fun. When older adults fall down, it is anything but fun. Over the course of my career, I saw many frail but independent elders fall, breaking a hip, and ending up in nursing homes for the rest of their lives.

The leading cause of injury and injury deaths among adults 65 and older is falls. At the last census, 14 million older adults – 28% of those 65 and older – reported falling during the prior year. In 2021, 38,742 older adults died due to falls.

How can you avoid adding to these dismal statistics? There are many things you can and should do!

You can do things to your body. Work on balance. An excellent way to do this is to sign up at the Y or your local Senior Center for Tai Chi – an exercise program focused on balance. At home you can do simple exercises on your own, such as standing on one leg – just Google “balance exercises.”

Increase your muscle strength with resistance exercises, including squats. This will both improve your leg strength, which reduces falls, and strengthen your bones, so you are less likely to sustain a fracture if you do fall.

Speaking of bones, do you know your T-score? Women in particular, but older men as well, should be checked for osteoporosis at least once. If your bones are very thin, your fracture risk is higher and you can discuss options with your doctor for improving this.

Beware of medication! Some medications can make you unsteady either by lowering your blood pressure too much or by directly impacting your brain. Sleeping pills and sedatives are a major culprit. A “med review” to look for any that can be stopped should be a regular event with your doctor.

Many simple things can reduce your risk of falls. When going up or down stairs, hold on to the banisters. Have adequate lighting, particularly at the bottom of stairs. If your vision is less than perfect, put bright tape on the last step so you do not miss it.

Be sure that any small rugs have non-skid bottoms or a non-skid pad under them.

Be cautious with ladders. Do not climb any higher than you would feel safe falling. DO use small ladders rather than chairs to get something down from a high shelf – ladders are designed to stay upright when you stand on them; chairs are not. Keep things used often on lower shelves.

Add grab bars to the shower. Closing your eyes to keep soap out of them can make you unsteady.

Both at home and in hotels, have a night light to help you safely navigate from bed to bathroom.

Be proactive! Do not be a statistic!



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Cannabis: panacea or poison?

First, some vocabulary. Cannabis is synonymous with marijuana, and refers to a plant, the chemicals in the plant and products derived from the plant. THC, tetrahydrocannabinol, is the primary psychoactive compound in cannabis. Cannabidiol (CBD) is also psychoactive but does not have the euphoric effect of THC. CBD sold is usually derived directly from the hemp plant, a cousin of marijuana, or manufactured in a laboratory. The cannabis plant contains more than 500 chemicals, many not well understood.

Cannabis use has increased dramatically over the past decade. Once illegal throughout the U.S., cannabis is now legal for medical use in 38 states and the District of Columbia and for recreational use in 24 states and D.C. A Gallup poll in 2019 found that 14% of adults had used cannabis during the preceding year and a 2021 survey found this had increased to 21%.

Seniors are the group who are increasing their use most rapidly. In 2007, only about 0.4% of people age 65 and older in the United States reported using cannabis in the past year. That number rose to almost 3% by 2016 and in 2022 it was over 8%.

Another group who use cannabis heavily are those with cancer. A recent survey of cancer survivors found that almost half were current or past users.

What are the benefits of cannabis? Because cannabis is still classed at the federal level as “Class 1” – a drug with no currently accepted medical use and a high potential for abuse (along with heroin and LSD) – it is hard to do research into its medical benefits. Much of what we know comes from observations rather than controlled trials.

Granting that the evidence is soft, cannabis seems to help reduce chemotherapy-induced nausea. It also has antiseizure effects and has been used in patients with epilepsy not responding well to traditional drugs. It can be useful in reducing pain in chronic pain sufferers, and may be a welcome alternative to narcotics. Patients with multiple sclerosis report less spasticity and pain. Finally, patients with inflammatory bowel diseases report better quality of life with cannabis use. It may be useful in treating insomnia.

The downsides are numerous. Inhaled cannabis, the most common way it is used, has adverse effects on the lungs similar to the effects of tobacco smoking. While THC acutely dilates airways, chronic use makes asthma worse. Several asthma deaths have been linked to inhalation of marijuana. Inhaled cannabis increases the risk of lung cancer.

Recent reports at a national cardiology conference found increased risk of heart attacks, strokes and congestive heart failure in regular cannabis users. Women who use cannabis during pregnancy have a 25% increased risk of adverse pregnancy outcomes.

Some regular cannabis users develop severe vomiting requiring hospitalization and IV fluids.

Cannabis impairs driving ability and is clearly linked to increased motor vehicle accidents, though it is not nearly as bad as alcohol in this regard.

While many or most users are looking for the relaxation effect of cannabis, psychiatric side-effects including panic attacks and psychosis are common. Psychiatric problems are particularly common in adolescents, and there is good evidence that cannabis use by young people interferes with brain development.

Bottom line: if you have a problem that is not responding to traditional medication, cannabis may help but its use comes with risk. Adolescents and young adults should not use cannabis, nor should pregnant women. No one should use cannabis before driving or doing other risky things requiring alertness.



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Suicide

The holidays, Christmas, Hanukah, Kwanza or just “the holiday season,” are for most of us a time for family get-togethers, singalongs, gifts and joy. For people living alone, or struggling with depression, the expectation that they should be happy simply adds to their pain. This season is thus for some a time of increased risk of suicide.

Last year the U.S. experienced a new high in “deaths of despair,” including suicides. In 2022, almost 50,000 people lost their lives to suicide. While all age groups are affected, the highest suicide rate was in men 75 and older. Also striking is that over half of these deaths were carried out by guns.

How can we reduce these horrible events?

If you are contemplating suicide, please reach out. No matter how it may seem, you are not alone. In Massachusetts, you can call 833-773-2445. Most states have a chapter of The Samaritans. From anywhere in the U.S., you can call 988. All of these services are anonymous, free and available 24/7.

If you have guns at home, be a responsible gun owner – keep them locked up.

If you are worried about a friend or loved one, reach out. Talking about suicide does NOT “put the idea in their head.” Talking, and more important, listening, is incredibly helpful. Initiating the conversation is not easy. Make sure they feel safe in being open. Start with something like “You have seemed very down recently. I am worried about you. Would you like to talk?” When it seems appropriate, it is OK to ask “are you considering suicide?”

If they are open to discussing their feelings, be prepared to listen deeply: maintain eye contact, reflect back their words and acknowledge their feelings. Don’t interrupt and/or try to talk them out of their feelings. While you may feel things are not that bad, they do.

Suggest they get professional help or call one of the hot-lines. If they are not ready to do this, tell them you will be available to talk more. Ask them to promise you they will not act on their impulses without more talking.

If they do not want to talk, tell them you will be available when they are. Share your concerns with others in their support network; there may be someone else with whom they feel more comfortable.

Finally, if you feel the risk is very high and they refuse to seek help, reach out to emergency services on their behalf.

Weight loss drugs - are they for me?

Last year, Denmark published statistics on its Gross Domestic Product with and without Novo Nordisk, the giant Danish pharmaceutical company that markets Wegovy – that is how much money is rolling in to the manufacturer of the wildly successful obesity drug.

Why are Wegovy and friends such a hit? What should you know about these drugs?

America is suffering an epidemic of overweight and obesity – some 70% of us are either overweight (BMI>27) or obese (>30). Excess weight contributes to the development of hypertension, diabetes and heart disease and losing 5% or more of body weight has been demonstrated to lower the risk of cardiovascular disease.

The problem is that losing weight is hard. For most of us it goes well beyond “will power.” The determinants of weight are complex, and include genetics, environment and habits. The food industry with its high fructose additives and advertising are also culprits.

Enter the holy grail – the search for a safe and effective drug that will help people lose weight.

Drugs for weight loss have been around for a while, and include phentermine, orlistat and Contrave.

Phentermine is an amphetamine that has been shown to produce about 6% of body weight loss after 6 months of use, but has the expected side effects of anxiety, racing heart and insomnia. Orlistat decreases the body’s absorption of fat and leads to about a 5% weight loss; it has a number of bowel side effects including leaking of stool, though is otherwise safe. Contrave combines naltrexone, an opioid blocker, and bupropion, an antidepressant. About half of those using it lose at least 5% of body weight after a year. Side effects include seizures, behavior changes and suicidal thoughts.

So, modest weight loss and serious or annoying side effects with these older agents.

The new kids on the block are GLP-1 agonists – drugs that mimic the effects of glucagon-like-peptide-1. They send a signal to the brain that you are full and also slow the stomach emptying. These drugs have been used to treat diabetes since 2005. Because they must be injected, they never captured much of the diabetes market.

What has turned the GLP-1 agonists into blockbusters is their dramatic effects on weight. In different trials with different products, subjects lost 12-20% of their body weight after a year. Most recently, a trial of semaglutide in very high-risk patients – in their 60’s with established cardiovascular disease – showed that those on the drug had 20% fewer events (heart attack, stroke or cardiovascular death).

There are now three products on the market: Wegovy (semaglutide), Saxenda (liraglutide) and Zepbound (tirzepatide – a GLP-1 agonist plus another). Given the vast market potential, more will follow.

What is the downside? First is cost. Wegovy retails for $1349/4 weeks; Zepbound for $1060/4 weeks; Saxenda about $1300/4 weeks. And note that these drugs must be taken indefinitely! In trials, those who stopped the drug after a year regained most of the weight they had lost by a year after stopping.

Nuisance side effects including nausea, diarrhea and constipation are common. More serious side effects including inflammation of the pancreas or gallbladder, kidney injury and suicidal thoughts have been reported in less that 1% of people taking them.

Are they for you? If you are seriously overweight and have other conditions such as diabetes, high blood pressure and/or heart disease, and if you have made your best effort at losing weight without medication, definitely discuss their use with your doctor.

Remember that weight is a life-long issue, and commit to using dietary changes and exercise as part of your life.



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