RSV(P)

Respiratory syncytial virus (RSV) is a virus you may never have heard about, but you’ve probably had. It affects the upper airways with cold like symptoms, but it can cause a severe pneumonia, particularly in infants, older adults, and those with lung disease, or who are immunocompromised. By two years old almost all children have been infected. It causes roughly 2/3 of the number of hospitalizations and deaths as that cause by influenza (the flu). It tends to peak around the same time as influenza and COVID-19, constituting a triple threat.

There is a monoclonal antibody for infants and young children, but this year for the first time adults 60 and older can get a vaccine for RSV.

There are currently two vaccines approved, Abrysvo from Pfizer,and Arexvy from Glaxo Smith Kline’s (GSK). Abrysvo is also approved for women who are 32 to 36 weeks pregnant during September through January (to cover when RSV is typically active). Full disclosure – I was a primary research investigator for one of the Pfizer’s studies, but I make no money from sales of the product.

In one study with Arexvy and influenza vaccines there were two cases of acute disseminated encephalomyelitis (ADEM), and one case of Guillain-Barré syndrome, serious neurologic side effect seen with some other vaccines, and sometimes for no apparent reason. It’s not clear if it was due to the RSV vaccine component, the influenza component, the combination, or unrelated. There were 3 reported cases of Guillain-Barré in the Abrysvo studies.

Although there were few reported cases of Guillain-Barré in the RSV studies, given the severity of the side effect one needs to consider risk versus benefit. For those at high risk, I think the benefit outweighs the risk. It’s harder to know what to do for those who are approved to get the vaccine, but are otherwise at low risk, such as those in their 60’s who are generally healthy. Currently for those patients I’m not encouraging them to get vaccinated, and if they ask, I say they may want to consider skipping it this season. By next season we should have a much better idea of the true risk. If you’re 60-years-old or older, you should discuss with your physician/provider.

It’s not yet known how long the vaccine provides adequate protection, but probably for 2 years or longer. In fact when the companies realized the vaccines would last more than one year, they raised their prices as their original profit calculations assumed people would need yearly vaccinations.

Shaky Business

Early in the pandemic I avoided seeing my patients for a while, except with virtual visits. After returning to the office I tried to maximize the distance, and minimize the duration of contact to lessen both our risks.

As the pandemic has progressed, both my patients and myself have gradually become more relaxed. I think this is from a combination of vaccinations, having effective treatments, and just habituating to the situation. Initially I had stopped shaking hands, and my patients stopped trying to shake mine. But eventually some did, with either a fist or elbow bump, or sometimes a full hand shake. Some would follow my lead but remark about how they guess we are no longer shaking hands.

A few months ago a plumber came out my house to replace a sprinkler valve system that sprung a leak after an earlier freeze. When he arrived he stuck his hand out to shake. Not wanting to be rude I shook his hand, then was careful to make sure I didn’t touch my face before washing my hands.

Not longer after, someone came out to pump our septic tank. The same thing occurred. No offense to those in the sanitation field, but if you’re a germaphobe, rationally or not, shaking hands with someone who empties tanks with human waste does not sound like a good idea! But again, I didn’t want to be rude, so I did so.

After those encounters, I pondered what I should do with my patients. Having seen plenty of guys in public bathrooms walk out without washing their hands, or with just a cursory rinse, and knowing that most people, myself included, often touch their faces unconsciously, which is how diseases often spread, I’m a little leery of shaking anyone’s hands. Pre-pandemic I overrode those concerns and did so anyway, for the social bonding benefit, but now it’s more socially acceptable to not shake hands.

In the office we wash our hands often, even pre-pandemic. We’re taught to gel in, gel out. That means you use alcohol gel to wash your hands when you walk in to see a patient, then again as you leave the room. Even with that I usually put the gel in one hand, open the door with the other (who knows who touched that door handle last), then rub my hands together as I walk into the room (which also demonstrates to the patient that I washed my hands). If I then shake their hand (and anyone else they came with), then I feel compelled to wash them again lest I touch my face during the visit, or just to avoid potentially contaminating the keyboard (though my nurse does wipe it down often). That can easily add up to washing my hands over 50 times a day. Certainly the alcohol is a lot faster than using soap and water, but is more drying on the skin.

So where does that leave things? Basically I shake hands when my patients offer it, and occasionally other times, as I continue to weigh the pros and cons. I suspect after the current wave of infections declines I’ll relax more and be able to shake off the feeling of impending doom.

Speaking Truth to Power

On 4/18/22, a federal judge in Florida struck down the CDC requirement of wearing masks on trains, planes on domestic flights, and other public transportation. This came less than a week after the Centers for Disease Control extended the mask mandate through 5/3/22. Immediately a number of airlines, including Delta and Alaska, announced that they were removing the requirement.

She made this ruling before a hearing was held, and nationalized the ruling rather than limiting it to the plaintiffs who had filed the case. In addition the mandate was probably going to go away in 2 weeks in any case.

Who was this federal judge? It was Kathryn Kimball Mizelle, appointed for a lifetime position at the age of 33 by President Trump, despite that she had never tried a case, and the American Bar Association rated her as, “Not Qualified.”

Just because she had the power to make this ruling, doesn’t mean she’s right. Of course when it comes to the law, I’m even less qualified than this judge, but from a medical point of view, we’re still in a pandemic. I, for one, will continue to wear a mask in an airplane, at least for a while, even if it’s just to avoid the common cold.

Omicron OMG!

Just when it looked like it was going to get safe to get back into the water, now we have a new COVID-19 variant with which we have to contend. Named after the Greek letter Omicron.

We don’t have enough information yet to know how serious of a threat this is, and whether it will significantly change what we do, but at best it’s tiresome news, and at worst it may cause significantly more cases.

For now, continue to wash your hands frequently and wear a mask in crowded places. If you’re fully vaccinated then there are a number of considerations about which situations it’s safe to not wear a mask. It includes the number of cases where you live, the chances of being exposed to those not wearing masks, and you personal risk.

Getting a booster is now a much simpler process. According to the CDC, if you’re 18-years or older and it has been 6 months since you last Pfizer-BioNTech or Moderna vaccine, get a booster. If it has been at least 2 months since a Johnson & Johnson vaccine, get a booster.

You may mix and match boosters. If you had a Johnson & Johnson vaccine, you will probably get a better response from having a Pfizer-BioNTech or Moderna vaccine booster compared with another Johnson & Johnson booster.

Stay tuned!

A is for Aspirin

You probably recently read in the news something about aspirin recently, and maybe you’re wondering if you should stop taking it, or you went ahead and already did. I know lots of my patients have been asking me.

The article by the U.S. Preventive Services Task Force talks about the use of aspirin to prevent heart attacks and strokes. They said for primary prevention (meaning to prevent a first heart attack) they recommended shared (between patient and their doctor/provider) decision making for starting aspirin in 40 to 59-years-olds with a 10% or greater risk of having a major heart event (such as a heart attack) in the next 10 years who do not have increased bleeding risk. They recommended not starting aspirin in those 60 and older who have less than a 20% risk.

There are a number of key points.

  • This is a draft recommendation. There is a public comment period and changes will be made before it’s finally published, probably in 6 or more months.
  • The recommendations only apply to starting aspirin.
  • The recommendations do not apply to people who have previously had a heart attack or stroke.
  • They make no recommendations about stopping aspirin other than considering stopping at 75 years old for primary prevention.

For patients who have had a heart attack, stroke, or peripheral artery disease (blocked artery to one’s arms or legs), the benefits of aspirin generally outweigh the risk of bleeding.

The decision to use any medication is always a balance of the benefits versus the risks (and sometimes the cost). Why the change in recommendations? Well in part we generally get progressively better as we accumulate more scientific information. But probably in this case it’s more due to treatment changes. When the original recommendations came out to use aspirin for primary prevention we did not have very good treatment for the conditions that cause heart disease, particularly cholesterol. With improved treatment, there is less incremental benefit from aspirin, yet the bleeding risk remains. That may shift who we should treat.

For now, I’m not recommending any changes before the final recommendations come out. Aspirin was first recommended for primary prevention over a century ago! If taking aspirin was that risky we’d have known there was a problem long ago. I don’t think there is any reason to make any rushed decisions unless someone is having a problem with aspirin.

So you if you are already on aspirin and doing fine on it, and your next appointment to see your doctor will be within 9 months or so, I suggest considering not even asking your doctor until your next appointment. That gives time for the final report to be published, and time for your doctor to consider the information. That’s better than making a decision based on a headline.

Vaccinations and FUD

Driving home earlier this month I saw a bunch of people on an overpass over the highway with a large sign that said, “COVID VACCINE MAKERS ARE EXEMPT FROM LIABILITY.” This is something activists have done in all fifty states.

The government passed a law to protect vaccine makers from liability in order to encourage them to develop vaccines in the face of a dangerous pandemic. So the sign is correct, but it’s misleading. It’s sowing FUD – fear, uncertainty, and doubt.

Many people decide not to get vaccinated because they conclude that their risk of dying is less than 1%. Although that’s true, it’s not an extremely rare event. Would you do something if you were told there was only a tenth of 1% chance of dying? What if I phrased that as out of one thousand of your friends and family, one person would die as a result of doing that activity? Would you decide that was a sacrifice worth doing, or conclude it wasn’t worth the risk? If not, why would you accept a risk ten times higher?

Even if you don’t die or get very sick as a result of getting infected, you have a high chance of developing Long Covid, with multiple symptoms that may last a year or more and be debilitating.

A majority of the misleading disinformation and hoaxes on social media has been spread by a dozen anti-vaxxers, according to the Center for Countering Digital Hate. Unfortunately they don’t have the redeeming qualities of the movie The Dirty Dozen. If you value your health make sure you’re following the advice of reputable sources, not influencers with their own agenda. If you haven’t been vaccinated yet, do so today.

Vaccination Vacillation

Now that COVID-19 vaccinations are available to anyone in the United States who is 16-years or older, some people are having to come up with more excuses of why they are not getting vaccinated.

A number of my patients say they’re just waiting and don’t want to be, “a guinea pig.” Sure, technically so far the FDA only approved them for emergency use, but over 200 million doses have been administered in our country alone, and almost 1 billion doses of all COVID vaccines have been given world wide. So you’d hardly be the one experimented on. I hear people say they just want to wait and see. If you saw a fire in one room of your house, would you wait to see if it would spread before calling the fire department?

Many people are worried about side effects, particularly after the recent hold on the Johnson & Johnson vaccine. Yes, the rare blood clots are concerning, however they are rare (less than one in a million) and seem to be mainly in younger women. Although those clots are little different, and possibly similar to the kind we sometimes see with the blood thinner heparin, the overall risk of blood clots if you get infected with COVID-19 or take birth control pills is far higher.

People tell me they don’t feel the need to get vaccinated since they don’t get out much and they take precautions. That’s all well and good, but besides that you can’t completely eliminate the risk, is that how you want to spend the rest of your life?

Ninety-nine percent of people survive, so why get vaccinated, some people say. Besides that many of those surviving people can get pretty sick and have symptoms that last a long time, and may possibly be permanent, a 1% risk of dying is still high. Imagine that 99 of your friends and family were going to join you for a get together at a tropical resort for a vacation. Would you go if you knew that one person would die in a plane crash as a result of taking that trip?

If I haven’t convinced you that COVID-19 is a serious disease, perhaps you’d like to take a trip to Brazil, where recently they had an average of 177 people per hour die of the disease. Prefer not to travel overseas? How about Michigan? They may have just passed their peak, but they recently have had over 4000 cases a day and 61 people dying on Sunday and Monday, and a case fatality rate of 2.1%.

Most everyone should get vaccinated, not only for themselves, but for others. As long as there are a lot of cases in the world, due to natural selection, it will tend to mutate to become more infectious, and potentially more dangerous. The faster we reach herd immunity, the sooner things can go back to closer to how they were before the pandemic. It’s better to be part of the herd from having been vaccinated, rather than just infected.

What to Do After You’re Vaccinated for COVID-19

I recently received my second of two COVID-19 vaccinations, which happened to be from Pfizer/BioNTech. Although it’s a big relief, and I’m much better protected now, it doesn’t mean it will change much that I do for a while. Let me explain why.

Vaccines don’t act right away. The way they work is to prepare your immune system to recognize something that is bad for you, so if it arrives your body is ready to attack it. But it takes time to do this. Imagine you’re running a race and someone is trying to chase you down before you can cross the finish line to safety. The faster they are, the more head start you need. What makes a bacteria or virus faster, besides the basic nature of it, is how much of a head start it has, which is basically how much of it you’re exposed to. It’s an over simplification, but supposed the virus doubles every 6 hours and you initially breath in 10,000 virus particles. After 5 days you’d have about 10 billion of them. After one more day you’d have close to 168 billion, a massive increase. So you have to have enough of a head start that the virus can’t grow to the point of overwhelming you. Every day after your initial vaccination is that much more of a head start.

Another way to look at it is to imagine you body is a village and a company of hostile enemy soldiers shows up. They would quickly overrun and capture the place. But suppose these soldiers were not not yet nearby but you knew they might attack. You’d have time to enlist people to provide more security, train them what the enemy looks like, and set up additional lines of defense. Then if they were to attack it’s likely you’d successfully fend off the attack, though you might be a little worse for wear as a result. But if they attacked with a larger force, such as a battalion, they could still overwhelm you.

So you can think of getting a vaccine as giving you a greater head start, or having more bodyguards. That should protect you from most situations, but you still wouldn’t want to run the risk of getting a massive exposure, or perhaps being someone who didn’t develop a good response to the vaccine. So wearing a mask, maintaining distance, etc. all minimize the risk. We don’t know yet how much exposure it would take to actually get someone sick if they have been vaccinated with sufficient time to be fully effective, so my concern now is just theoretical, but there are other reasons to remain cautious, particularly until the number of cases in one’s community falls significantly.

For one thing, the vaccine was 95% effective in the studies. That’s impressive, but it still means 1 out of 20 were infected sufficiently to have symptoms. For another, we don’t know if vaccinated people can subsequently get infected and not have symptoms, but be capable of spreading it to others. Finally, people who have not yet been vaccinated may feel anxious, or resentful, seeing people who are not wearing masks.

Some of my patients have told me they are concerned about the vaccine, and some of have even decided they just won’t get it. Let me address some of the concerns. One worry is the vaccine was rushed and they don’t know if they can trust it. Although it was rushed, it was mainly from everyone working longer hours than usual, companies prioritizing the research and production, and governments willing to promise to buy vaccine before before approved, with the risk that they could have spent billions on something that would never be used. The FDA did approve it before having longer term studies than usual, but given the risk of not being vaccinated, it was the right thing to do.

Although sore arms and flu like symptoms are relatively common, particularly after the second dose, serious reactions are very rare. You shouldn’t look at the risk without considering the context. Without a vaccine you have a high chance of getting infected. Those infected have a relatively high risk of serious complications, including death, particularly if older, or have various medical conditions. Those at the lowest risk of getting COVID-19 or getting significantly sick, will be the last to get it the vaccine, which means they will have the benefit of there being more experience with it. Even if you are not worried for your yourself, getting vaccinated is good for the community. We need to get a high proportion of the country vaccinated to reach herd immunity so the virus can no longer take off. Unfortunately there have been a lot of misinformation spread about the coronavirus pandemic, and politicization about it, but that doesn’t mean that these are not excellent vaccines.

I’ll have to see what happens, but between having been vaccinated, and the pandemic probably being much better controlled, I hope that I’ll finally be able to take a real vacation by this fall.

COVID-19 Vaccine – A Missed Opportunity

Under Operation Warp Speed, the government agreed to pay vaccine makers to produce vaccines ahead of approval to remove some of the financial risk, and get the vaccine produced as quickly as possible. It included a contract with Pfizer and its German partner, BioNTech, to produce 100 million doses of vaccine. Since each person requires two doses, that would be enough to vaccinate 50 million people.

As just reported by the New York Times, the Trump administration passed up the opportunity to buy additional doses late this summer, preferring to rely on other vaccines, having made 6 contracts to hedge their bet.

On 11/11/20 the European Union announced a deal to purchase 200 million doses from Pfizer/BioNTech, and the option to buy an additional 100 million doses. They said they may not be able to produce more for the United States until June as they now have other contracts. President Trump just issued an executive order prioritizing distribution to Americans, but I don’t think that is likely to have the force of law behind it.

Moderna has also applied for emergency approval of their vaccine. They said they expect to produce 85 to 100 million doses for the United States in the first quarter of next year. That would be enough for up to 50 million people.

So far that would get us enough to vaccinate up to 100 million people in this country by the end of March, assuming the companies are able to produce it at that rate. To put that in perspective, that’s only about 1/3 of the population. In addition, producing enough vaccine is only half the story. It then has to be distributed, and injected into people’s arms, which is a difficult challenge.

The Trump administration said that they turned down the option to purchase more vaccine because they are counting on other vaccines. Although they may come through, it seems like it was a big missed opportunity. The worse case scenario would have been we had more vaccine than we needed (well the worst would be that it turned out that the vaccine was either not effective or not safe). Think of the good will we could have earned by donating millions of doses, at a cost of only $39 to give two doses to each person. That’s a small price to pay to prevent a lot of illness, death, and damage to the economy.

Open Notes – Do they Clarify or Muddy the Water?

Wai-O-Tapu Thermal Wonderland in New Zealand

Big changes are coming to patients ability to see their medical information.

Starting this month, federal rules will require that all laboratory tests, including pathology reports, imaging, and progress notes be immediately released to patients, with rare exceptions. In March of 2020 the Office of the National Coordinator for Health Information Technology published the “21st Century Cures Act” final rule that requires providers and others to not engage in, “information blocking” by interfering with the use of electronic health information. The idea of patients being able to readily see their charts is known as Open Notes.

Traditionally doctors (and nurse practitioners) notes were considered to be their property. They were paper charts, and if they sold their practice, the chart would go with it. Although they would send copies to other treating physicians, they wouldn’t necessarily give patients a copy if they requested, and they might charge copying costs.

Although ownership status legally varies by state, and is ambiguous and debated in a number of places, in practice nowadays, usually the actual chart, whether it’s paper or electronic, is considered to belong to the physician/practice, but the information belongs to the patient. That information is not always readily available to patients, particularly notes. In the case of test results, even when available through patient portals, there is often a delay. For better or worse, this will be mostly going away.

On the positive side, overlooked abnormal tests are more likely to be caught by patients, they will be able to see their results sooner, and they may better understand their condition and expectations by reading the notes about their visits.

On the negative side, there are all kinds of things that can go wrong. Let’s start with test results. At my institution we’ve had a delay set for tests, with different delays depending on the test. Over time we’ve shorted the time on many of them as we became comfortable with the process. For example, things such as blood counts and chemistry tests (kidney function, cholesterol, etc) would get released shortly after midnight. Other tests, such as pathology tests, have been delayed 14 days. That gives the person who ordered it a chance to contact the patient before they see the results online.

As a patient, would you prefer to find out that you have cancer by having your physician or nurse practitioner call you, or talk to you when you come in for an appointment, or to find out online without putting the information in context (“You’ve got mail!”)?

In some cases physicians can warn patients to get them prepared, such as informing them that although they think a breast lump is probably benign, it may turn out to be cancer, and tell them what will happen if that’s the case. But besides that they may not have time to always do this, some times the results are unexpected. For example, someone may have no symptoms but they get a routine chest x-ray to make sure it’s alright before they undergo certain surgical procedures. It could show signs indicating probable metastatic cancer, and the report that comes back to them electronically may be how they find out.

As a physician I worry about getting overwhelmed by patient requests for information regarding tests they’ve seen online. Already many ask about abnormalities that are not clinically significant, such as a low LDL cholesterol or a high HDL (both of which are generally good). I often say that abnormal doesn’t mean good or bad, just that it’s outside the normal range. I’ve had several patients starting taking calcium as a results of misinterpreting a report when they saw a low “LDL (calc)” not realizing that “calc” is just an abbreviation of calculated, and not calcium.

Patients being able to read progress notes causes even more anxiety. Even though patients already can request copies of their records, in most cases they don’t. If we do get a request we have a chance to contact them if we’re concerned about something they may read.

Besides the concern that questions will generate more work for me, I worry more about patients misinterpreting the notes. When someone comes in with various symptoms, physicians come up with a differential diagnosis, meaning the different things that might cause those symptoms. For example, if someone has a cough, it could be bronchitis, pneumonia, asthma, reactive airway disease due to reflux (heartburn), or lung cancer, among other possibilities. Those possibilities are often included in the note for several reasons. It helps the writer organize their thoughts, and reminds them what they were thinking if they (or someone else) later looks back at the note. It also provides protection against malpractice lawsuits. It’s less egregious to treat lung cancer with an antibiotic if you write that you think it’s unlikely that the patient has cancer and more likely it’s just bronchitis. Many things we may include on our differential are rare, but patients may worry if they read them.

Another concern I have about notes is information that patients may find embarrassing or otherwise uncomfortable. It may include information pertaining to domestic violence, drug use, or sexual function. Although the new law allows one to not release a particular note, it’s expected that it will be used minimally, and there are significant penalties for doing so unless you can justify that it would cause significant patient harm. I think this will lead people to modify how they write their notes, sometimes resulting in notes that are less useful for those writing them. Doctors and other providers can learn to write notes in ways that patients will better accept, but it will take practice, and won’t always be possible. Unfortunately it’s not clear if the law is retroactive, so even notes written 20 years ago may be available to be read, though currently my institution won’t do that, though the legal advice went back and forth on it (thanks, Congress, for making that perfectly clear!).

Many physicians and other medical providers who have already voluntarily gone to automatically sharing their notes have said that most people find out that despite their fears, in practice it has not been an issue. I hope that’s the case.