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.

The Coronavirus Pandemic Came and Atlas Shrugged

No, I’m not talking about Ayn Rand’s novel, though there are parallels.

The United States is now heading into its third wave of SARS-CoV-2 coronavirus cases, which is the cause of COVID-19. With over 8 million cases diagnosed, increasing by over 56,000 per day, and over 220,000 deaths, our top scientists are being silenced and bad mouthed by President Trump and his administration.

So whose advice is President Trump listening to? That would be Dr. Scott Atlas, who has said that masks don’t work, and that quickly spreading the disease to develop herd immunity would be a good thing, shrugging off the idea that herd immunity that did not come from a vaccine would come at the cost of potentially millions of deaths.

At a town hall Savanah Guthrie pointed out that Dr. Atlas is not an infectious disease expert (or an epidemiologist for that matter) but Trump said, “Look, he’s an expert. He’s one of the great experts of the world.” He’s a neuroradiologist, so I’ll grant him expertise in MRI images of the neck, but he should not be influencing how we deal with this pandemic. I wouldn’t want Dr. Fauci or Dr. Birx to be responsible to interpret an MRI, and we shouldn’t want Dr. Atlas affecting how we manage this pandemic.

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.

Covid Calculations – It’s Tough

Given the COVID-19 pandemic it’s difficult to know what one should do about so many things, including what activities are safe, what precautions one should take to avoid getting infected, what to do with investments, and whether one should send their kids to school.

As a physician I often give advice to my patients regarding coronavirus. Unfortunately the current administration has politicized the coronavirus pandemic and provided inaccurate and inconsistent messages. They denied it was a problem for a long time, and even now discourage a large number of people from wearing masks.

Besides giving out false information from the very top, they’ve had a corrupting influence on our institutions that deal with this pandemic, affecting our ability to deal with it.

For example, with very short notice hospitals were directed to stop sending hospitalization information to the CDC, and instead send it to the Department of Health and Human Services, only to later reverse course because the data was not being processed correctly.

The Centers of Disease Control (CDC) is world renowned has has trained scientists around the world. They now have to run pandemic related news through the White House and have made many changes and removed documents off their web site due to political considerations. Recently they changed their recommendation to stop testing asymptomatic patents, prompting two scientists, one of which had won a Nobel Prize and was director of the National Institute of Health, to say that we should ignore that advice.

A week after President Trump publicly pressured the FDA to approve a vaccine, the head of the FDA said he might approve a vaccine, in certain circumstances, before Phase 3 research was done. These are the experiments that show that something is safe and effective. The name of the federal government’s program to develop a vaccine, Operation Warp Speed, and the frequent predictions by government officials that we would have a vaccine this year, suggests that they may be willing to cut corners. We should proceed as fast as possible, but it should be based on solid scientific principals and consensus. Even if the decision is made to give up some safety and assurance of a vaccine working because of concerns about the economy, it should be a conscious decision and not pretending the science is something it’s not. We already have a big problem with people distrusting vaccines in general. If an approved vaccine has unexpected problems, it could keep people getting many vaccines for a long time.

President Trump has touted other treatments, including hydroxychloroquine, bleach, and plasma. The FDA just approved emergency use of plasma, despite not having good evidence yet. That will make it harder to recruit patients into research studies, where they might get a placebo, making it all the harder to find out if it’s really effective. Although some of things might have merit, these are things that should be done based on science, and a leader with no medical or scientific background has no business touting unproven treatments.

Recently Dr. Scott Atlas has the ear of the president. He has questioned the use of masks and suggested we encourage infections to get herd immunity. We’re not even sure yet if being infected confers long term immunity, but even if it does, assuming it takes 65% of the population to become infected, and 1% of those infected dies, that means we’d have over 2 million deaths in this country. Dr. Atlas is not an infectious disease specialist or epidemiologist. He is a radiologist who specializes in MRIs. But his qualification, from the White House perspective, is that he has appeared on Fox News multiple times, and it resonates with what they want to hear.

My patients trust usually trust my advice, but if I have to question what the FDA, CDC, and other government bodies tell us, it’s harder for me to give good advice.

Health Injustice

In spite of the COVID-19 pandemic, we’re now seeing large protests daily across the United States, and indeed in many places across the world, sparked by the unfortunate death of George Floyd by policeman in Minneapolis. The Black Lives Matter movement tries to address how blacks are unfairly treated, particularly by police.

This is a complex issue that dates back to when slavery was legal in the United States. I’ll leave the political and legal issues to others to discuss and will focus on health issues.

In the US the life expectancy for blacks is roughly 3 1/2 years less than for non-Hispanic whites as of 2014 according to the CDC. Why is that? It’s largely because they have more chronic medical problems, such as hypertension, diabetes, asthma, emphysema, obesity, and kidney disease. Why is that? Mostly because on average they are poorer, which leads to a worse diet, housing, working conditions, and access to health care. Why are they poorer? In part from racial injustice.

Even when blacks have access to good health care, they may be less likely to take their medications due to social norms, including distrust of the health care system.

With COVID-19 we’ve seen that black and some other minorities are at higher risk of getting infected, and are at greater risk of dying. So while participating in Black Lives Matters protests, they may be statistically at a higher risk of dying than from being killed due to racial injustice. Of course protests often carry risk, and for some it may be worth dying for. But do consider the risk of spreading it to others who may not want to die over it, and take reasonable precautions, particularly wearing a face mask, frequent hand washing, and maintaining social distancing as much as possible.

New Dietary Guidelines Ignore Science

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The federal government has issued dietary guidelines every 5 years since 1980. They are the ones that came out with the food pyramid, and most recently gave limits for sugar, saturated fat, and sodium (salt). These guidelines affect many things, including what children get served for lunch at school.

For the first time ever, the Department of Health and Human Services and the Department of Agriculture, under the direction of the Trump administration, is limiting the scope of the committee. They gave them a list of 80 questions, and said they are not to consider anything outside that list. Those questions do not include health risks such as too much salt, red meat, and processed foods.

The nature of science is that with ongoing research things change. Most of you can probably recall getting conflicting diet recommendations over the years. We were told to avoid fats, as we subsequently got collectively heavier, then ketogenic diets said the opposite. Alcohol can decrease heart disease, then studies showed it can increase breast cancer. That’s why it’s important to periodically review the literature and adjust recommendations if warranted.

Why would the Trump administration want to limit the committee? For one thing, they have generally been anti-science in many areas, such as global warming. For another, as they say, follow the money. Thirteen out of 20 of the committee members have food industry ties. This compares with two of 12 members in 2015. You can read more details in a Washington Post article.

Health care costs have been going up at a rate higher than inflation for many years. Although there are many reasons for this, part of it is because people are getting more obese. This leads to such health issues as diabetes, hypertension, heart disease, and arthritis. The new rules effectively says that corporate interests trump human health. So that corporations can profit more, we will pay the price in our health, and in our future medical bills.

The statute (Public Law 101-445, 7 U.S.C. 5341 et seq.) that required the guidelines specifically says that the Dietary Guidelines be based on the preponderance of current scientific and medical knowledge. As that wouldn’t be the case, unless the restrictions are removed, I expect that from 2020 to 2025 I’ll be advising my patients to follow the 2015 guidelines.

Medical Pricing Transparency via Non-Transparent Rule

copyright 2015 Daniel Ginsberg PhotographyHidden in a 700-page draft regulation to improve patient’s access to their electronic medical records is a proposal to require doctors, hospitals, and other healthcare providers to publicly reveal the prices they have negotiated with insurers. This rule, tied to the 21st Century Cures Act, would set the stage for eventually making prices publicly available. Although price transparency may be a good way to help lower medical costs, it’s ironic that there is a lack of transparency when it comes to the proposed rule. I challenge you to read the Title, Summary, or Actions section and realize that it includes such a major change (hint – in the PDF document it’s on page 7513 of the Federal Register under Price Information).

On the face of it, making prices readily available sounds like a no-brainer, but I think it’s more complicated than that, and there may be unforeseen consequences. The rule is long and complex, and I don’t have the few days it would probably take me to really understand it, but let me play devil’s advocate. Some of the comments posted say that medicine is the only industry that hides the cost. To a certain extent that’s true, but this rule could go beyond just saying the price consumers pay. If you go to a restaurant they won’t reveal how much they paid for the the ingredients. If you book through a 3rd party website, they don’t tell you how much, if any, they pay them for the referral. When you buy a car the dealer usually doesn’t tell you if the automobile manufacturer is giving them a rebate. From the point of view of a business, the consumer shouldn’t get to know their internal costs as that’s secret competitive information.

What mitigates that argument is that the price of healthcare has gotten out of control. Despite being better educated about the matter than most, when it comes to getting healthcare for their own family I suspect most physicians struggle to understand their bills just like everyone else.

When it comes to pay, doctors are a commodity. For a given surgical procedure or office visit of a certain complexity, they are paid the same amount as mandated by Medicare or Medicaid, as negotiated with insurance companies, or their list price for the unfortunate cash patient. Just like any profession, some doctors are better than others. If you want to hire a top lawyer or an A list actor, you have to pay top dollar.  But that’s not so with much of healthcare. The price doesn’t necessarily reflect the quality of the care.

Hospital systems mitigate that somewhat. They can negotiate higher prices with insurance companies and with large employers by demonstrating that they provide higher quality care and/or lower cost care, or because patient perceive them as providing superior care and they demand that that can get care from them. What will happen if the rule goes into affect and patients can easily compare prices? I don’t know, but potentially they might choose the lowest cost without regard to quality. That could lead to systems competing on price, cutting corners to do so, and ultimately lowering quality.

The lowest price might actually not be the path to cost savings. Imagine two surgeons. One of them charges $5,000 for a knee replacement, and operates on 60% of the patients seen for knee arthritis, treating the rest successfully with injections and physical therapy, which on average costs $1,000. The other charges $7,000, and operates on 50% of the patients seen and treats the rest successfully with the same conservative measures. Besides the physician fee, the hospital system charges $10,000 for the surgery. In this example, treating 100 patients would cost $940,000 for the first surgeon, and $900,000 for second. So even though the second surgeon charges 40% more than the first, on average the doctor ends up being cheaper when it comes to managing knee arthritis.

I’m inclined to support more transparency in healthcare pricing, but I don’t know how much of an impact it will have, and there may be unintended consequences.

Don’t expect to see published prices anytime soon. Even if the proposal goes forward, following a public comment period that ends May 3, it’s likely to be tied up in legal challenges for quite a while.