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.

Leaving Against Medical Advice

When a patient leaves the hospital against the recommendation of their doctor, whether it’s to return home, or to go out for a smoke, it’s called leaving against medical advice, or AMA.

Yesterday President Trump left the hospital briefly so he could see his supporters on the streets near Walter Reed Hospital, where he has been hospitalized for COVID-19. In my book, he left AMA.

Not only did he needlessly put at risk the Secret Service agents who drove him around, but he put his own health at risk. If he is sick enough to get put on remdesivir, which is only approved by the FDA for emergency use, an experimental antibody cocktail that has only been approved for experimental use and was authorized on a compassionate basis, and the steroid dexamethasone, which was only found to be beneficial in those requiring mechanical ventilation or oxygen, then he is sick enough to remain in the hospital until he is ready to leave.

I attended the Uniformed Services University of the Health Sciences (USUHS) medical school, where part of my training was at Walter Reed National Military Medical Center. One of the things taught us was that contrary to what you might expect, generals often get worse care. The example given was a doctor skipping the prostate exam he would otherwise do so as not to embarrass the colonel, potentially missing a prostate cancer. Although nowadays the value of a routine prostate check is debatable, the lesson was correct. It applies more so to this president, who may be at risk of being overly treated, and those around him not insisting strongly enough that he follow doctor’s orders.

First Thoughts on Coronavirus From a Primary Care Physician

Young girl wetting hands in fountain in Stockholm, Sweden.

The coronavirus infection COVID-19 has spread from Wuhan, China to my backyard in the Seattle area. I experienced firsthand the impact of this infection while on vacation in Hawaii over two weeks ago. The day after arriving in Honolulu, and just before traveling to Hawaii, a report came out that a Japanese tourist had been in Maui, then felt ill after arriving in Honolulu, then was diagnosed after returning to Japan. I started to see people wear masks, and friends who live there wanted to meet in a park for a picnic rather than go to a restaurant as a result.

To date 6 people in Washington State have died from COVID-19, which makes people, including healthcare workers, more nervous. We’ve already had several meetings to discuss how we will manage things. Things are still being worked out, and there are still a lot of unknowns.

As healthcare workers we are concerned about patients infecting us (and if we get sick, who will care for the patients?), or other patients. It’s a balance between asking patients not to come in if sick, and not wanting to miss other causes. It’s still flu season, and someone with a cough and fever is still more likely to have influenza then COVID-19. There are also other viruses, as well as bacterial infections that can cause pneumonia and need to be treated.

As the CDC says, the most important thing is hand washing. It’s important to not touch your face, which we tend to do often, myself included. I’ve started applying moisturizer lotion each morning as dry skin tends to itch more, which leads to touching the face more often.

I just saw a patient for hypertension and needed to start him on a medication. There are lots of choices, but for various reasons I usually start with an ACE inhibitor, such as lisinopril. That’s what I ended up prescribing, but I had second thoughts as the most common side effect is cough and I worried that people might think he had coronavirus if he developed a cough. I consider an angiotensin renin blocker, such as losartan or valsartan, but there have been frequent shortages of that class lately due to chemical contamination issues leading to recalls.

There will be lots of other things to consider as things progress. In the meantime, don’t panic, but wash your hands often. Don’t wear a mask if you’re not sick or around someone who is (it probably doesn’t help, and we need to make sure we don’t run out for those who really need it), and don’t touch your face!

Aspirin – Questioning Established Wisdom

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Bayer began selling aspirin (acetylsalicylic acid) in 1899, and the similar salicylic acid, derived from willow bark and other sources, has been used medicinally for thousands of years.  Since the 1960’s it has often been used for heart attacks and strokes. Studies showed that in patients who have had heart attacks, daily aspirin prevents another one. This is know as secondary prevention.

Doctors have assumed that it would also be good to prevent the first heart attack in patients at higher risk. This is know as primary prevention. The problem is that’s much harder to prove.  Even patients at higher risk might never have one, or maybe not for many years, so a research study can take many thousands of patients followed for many years, thus costing many millions of dollars, to tell if there is a benefit. Rare side effects can take many years to figure out. There have been studies done over the years, with inconclusive and sometimes with inconsistent results.

According to a trio of recent articles (Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly, Effect of Aspirin on All-Cause Mortality in the Healthy Elderly, and Effect of Aspirin on Disability-free Survival in the Healthy Elderly), aspirin use may cause more harm than benefit for primary prevention. They looked at patients >= 70-year-old (>= 65-year-old for blacks/hispanics in the US). A low proportion of participants regularly took low-dose aspirin before entering the trial, which did not directly address whether healthy older persons who have been using aspirin for primary prevention should continue or discontinue its use. Now 2019 guidelines from the American College of Cardiology and the American Heart Association recommend low dose aspirin for primary prevention only in limited patient populations at higher risk.

When it comes to medical treatments, it’s pretty much always a question of balancing benefit versus risk and cost. For aspirin, cost is pretty much not an issue. Although studies may look at thousands of patients, people are not homogenous, and any particular study may not apply to a particular patient. The guidelines listed above state that aspirin might be considered for primary prevention in adults age 40 to 70 at higher heart risk but who do not have a higher bleeding risk. They do not recommend it for routine use for those over 70-years-old. Note that it still may be warranted in some because of higher risk, and it’s still recommended for most older patient if they have known heart disease.

I think these new recommendations will eventually lead to less patients taking aspirin to prevent a first heart attack. This will lead to less bleeding, but it may increase other problems For example, aspirin may decrease the risk of colon and other cancers. It may help prevent deep venous thrombosis (DVT) blood clots in the legs, which could lead to a more serious pulmonary embolism (PE), so long distance air travelers may be at higher risk of a clot if they stop taking their aspirin. They could just take it before a trip, but will they remember? The FDA just added a block box warning for Uloric (febuxostat), a medicine used for gout, because of recently appreciated increased risk of cardiovascular disease. Surely there will be patients on that medication on aspirin for primary prevention who will stop aspirin, as a result of reading in the media that they should, but will then go on to have a heart attack because either they didn’t discuss it with their physician, or they did but their doctor didn’t know or appreciate the increased heart attack risk with Uloric. That medicine, by the way, should also be judged on benefits versus risks and alternatives, and is still appropriate for some patients, though not as many people as the drug reps would have had doctors believe. They’ve stopped promoting it as it’s almost generic, but that’s another story.

Wasting Resources – A Day in the Life of Yours Truly

I’ve written before about some of the things that waste physicians time, and how trying to be a good steward of resources can be frustrating. As the saying goes, no good deed goes unpunished. So here are three such things I dealt with the day after April Fool’s Day.

I prescribed the diabetic medication alogliptin, the generic of Nesina, for one of my patients on a Medicare Advantage plan. I was told it wasn’t covered, but they would cover substitutes, including Januvia (sitagliptin). The cash price is a little over 4 times as much for Januvia! I don’t mind using Januvia from an efficacy point of view, but it was a waste of my time having to make the change, and tax payers are wasting money buying a more expensive drug. After any negotiated deals it may not be 4 times as expensive for the plan, but it’s hard to imagine it would be a cheaper option than what I prescribed.

I ordered a head MRI for one of my patients. A week ago I called Molina insurance after receiving a message that they required a peer to peer phone conversation with another physician. After 10 minutes on hold I left a message explaining why I had ordered the MRI (which I had already explained in my note and on the MRI request). As they still hadn’t approved it, I called back again today. I spent 3 minutes on hold, then 8 minutes talking to a staff member before she transferred me to a physician, then 3 minutes with him as he gathered the basic information then approved it. I did not give him any more information than I had provided in the first place. He said he didn’t have any information on why I had ordered the test or he would have approved it right away.

And the third thing? I can’t remember. No fooling!

As If I Have Nothing Better To Do

Ask most primary care physicians and they will probably tell you they waste a lot of time getting medications approved for their patients. I just dealt with this for one of my patients. He had been on it for four years, but they wanted some information from me. It seems they didn’t trust my judgement and wanted recent lab work to confirm he wasn’t taking too much, even though I had him on the lowest dose. The patient has insurance with Regence, and OptumRx manages the prescription benefit.

I called OptumRx and they first asked if I was a member or calling from a provider’s office. Well if they had separate numbers for each they wouldn’t have to waste time asking that question. Next they asked for my name and title. Then they asked for my NPI number. Once I gave it to them they looked up my name, so they could have skipped the question of my name and merely confirmed it after they had obtained it from the NPI number. Actually they should have already had my NPI number as it was attached to the prescription, that they paid for, and I’m sure is in their records already as they get that information when physicians apply to see (and bill) their patients.

Next they asked for the patient’s member ID number. I told them I didn’t have it, but I did have the reference number they gave when they asked for me to call. I was told they couldn’t use that information, so they asked for the patient’s name and date of birth. I gave it but the person couldn’t find the patient in their system. So she then asked for that reference number. After a while she said that patient wasn’t in the group she managed and she would have to pass me on to someone else.

The next person again asked some identifying information then wanted to know a test result the patient had, as well as the normal range for that test. I gave the three numbers and she said they would be in contact. Less than 30 minutes later it was approved, but that whole call took 9 minutes! That’s an incredible waste of my time just to give 3 numbers. They could have just asked my nurse to give the lab results to them over the phone or fax it to them and not have wasted my time at all. Besides the time I spent, there was also the time spent by a couple of staff members to get the message to me, and the subsequent fax confirming that it had been approved. We deal with lots of these things every day. If physicians were their paying customers, they’d be out of business with service like that.

Let’s be Clear on ClariSpray

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Bayer, the maker of Claritin, has a new product, ClariSpray. This is a good product, but with a confusing name. It has nothing to do with Claritin, other than they are both used for allergies (allergic rhinitis).

It’s actually fluticasone nasal spray, the same ingredient as Flonase, a prescription product, but now available over-the-counter.

Their website does takes pains to explain this, but there are some things things they don’t mention. They don’t say how it compares with Flonase or Nasacort. Although there are slight differences, and some people may prefer one over the other, they are basically similar, and just a matter of personal preference. Bayer’s website also doesn’t tell you that you shouldn’t take ClariSpray if you are taking Flonase or Nasocort, or one of the other nasal steroid sprays only available by prescription.

Gluteus Maximus

I ordered atorvastatin (generic Lipitor) for one of my patients with high cholesterol and Medicare Part D coverage. It was denied. We then appealed it (prior authorization). A fax from Maximus Federal Services said their decision was, “UNFAVORABLE.” They said the patient had not tried and failed one of the preferred generic statins (lovastatin or simvastatin). They did note that we could appeal to an Administrative Law Judge.

In fact the person had tried simvastatin, which I had noted on the prior authorization. However the cost savings is minor. According to Goodrx, a 90 day supply of atorvastatin is as low as $19.25 around where I work.  For the equivalent dose of simvastatin it’s $10.06.

Yes, it’s almost half the price, but it’s still a pretty small amount, especially in my patient who had already had a heart attack, and the difference will only get smaller as Lipitor has not been generic for all that long. Contrast that with the staff time wasted dealing with this on both ends. Dealing with this is a pain in the Gluteus Maximus!

How to Get Rich – A Guide for Pharmaceutical Companies

The Changling Ming Dynasty Tomb of the Yongle Emperor
The Changling Ming Dynasty Tomb of the Yongle Emperor – copyright 2012 Daniel Ginsberg Photography

Thanks to Congress, Medicare is not allowed to negotiate for the cost of medications. The bill was shepherded through by congressman Tauzin, the chairman of the House Energy and Commerce Committee that regulates the industry, who subsequently stepped down then took a job as the President and CEO of the Pharmaceutical Research and Manufacturers of America. This is a lobbyist group for pharmaceutical companies.

Here’s a suggestion to pharmaceutical companies; the next time you come out with a new first in class medication, for which there are no other medications that can be substituted, price it at 10 billion dollars a month. After the first prescription gets filled, it may move Congress to act, but by then you will be set and it won’t matter if you don’t sell another pill.