Monday, January 15, 2024

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.

Prescription for Bankruptcy. Buy the book on Amazon

Sunday, January 7, 2024

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.

Prescription for Bankruptcy. Buy the book on Amazon

Monday, January 1, 2024

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.

Prescription for Bankruptcy. Buy the book on Amazon