COVID is still with us. Vaccine resistance is real, and it is dangerous

That there are a lot of people who are vaccine-resistant will be news to no one at this point. I wrote about this on May 17, 2021 (COVID, Vaccine, Racism, and Masks: Changing for better or for worse?), and while many people who were initially resistant have now changed their minds and have gotten (or in many cases, are trying to get) vaccinated, there is a hard-core residual group. There are a variety of reasons that people have, and sometimes articulate, for not getting vaccinated.  These include a lack of knowledge (hard, I know, given the amount of discussion) and a mindset that disbelieves those who are in power (also in some ways understandable; they do lie a lot). This is complicated for some parts of the population, particularly members of minority groups like African-Americans and Native Americans, by the fact that the US history is loaded with stories of exploitation and oppression and infection, from the passing out of measles and smallpox-infested blankets to Indians to the Tuskegee experiments that denied treatment for syphilis to Black men and many other crimes.

But at this point, there are no responsible people at all who are urging folks to not get vaccinated. Virtually all doctors, epidemiologists, and scientists have been (with some effectively evil exceptions, such as Joseph Mercola, DO (The Most Influential Spreader of Coronavirus Misinformation Online). Inversely, I mean anyone who is (which unfortunately includes many politicians, FoxNews personalities, and other “influencers”) is not responsible. COVID is real, it is infectious, the Delta variant is more infectious, it makes people really sick, and it kills people. A lot of people. Irrespective of whether they believe it is “real” or “dangerous” or not. Indeed, most of the people dying now (over 95%) in the US are those who have not been vaccinated. There is definite evidence that people who are vaccinated CAN get infected, and maybe even a few of them will die, but this is also definitely being overplayed by the media. Most of the media does not lie, exactly, but most people don’t go beyond the headlines and a very large number have no concept of relative risk or odds (I would assume, therefore, that poker players have been vaccinated!) You can cross the street very carefully, on a green light, at a corner, looking both ways, and still be hit and killed by a car driven by a lunatic speeding around the corner. But it is pretty unlikely compared to, say, running across a busy 6-lane highway without looking. Most folks can get that kind of relative risk, and it is not really unlike the risk of being vaccinated or not. This graphic illustrates that risk:                                                

Another way to express it, with a more traditional line graph, by county:

A recent article in the NY Times, “Workplace vaccine mandates reveal a divide among workers” describes another way that workers are being divided, not just by whether they are willing to be vaccinated, but by whether their employers are willing to mandate (and pay for) vaccination for them. Apparently, they are for white collar workers who they want back in the office (not clear why) but not necessarily for the blue collar workers, those who actually do work that cannot be ‘phoned (or Zoomed) in’ but requires their physical presence, those people who have often been called essential workers. Walmart, for example, ‘announced mandatory inoculation for employees at its headquarters and for managers who travel domestically. For a sense of scale, about 17,000 of Walmart’s 1.6 million employees are expected to work in new headquarters in Bentonville, Ark.’ The argument for this seems to be that companies like Walmart need lots of workers and don’t want to alienate those who don’t want to be vaccinated by mandating it. But somehow it is ok for office workers. I am not sure that I understand this, but it must have something to do with pay: if you get paid a reasonable living wage you are more likely to be willing to get a mandatory vaccine, and you should anyway. It seems to me that if Walmart and other companies wish to increase the demand for their jobs, the better way to do it is: pay more!

We read that ‘Trump's COVID-19 testing czar warns the unvaccinated: 'You’re going to get the delta variant' (The Daily Kos article’s author notes that they didn’t remember that #TFG had  a testing czar. Neither did I.) Of course, a lot of people regret having not been vaccinated once they end up sick, hospitalized, and on a ventilator, like conservative radio talk show host Phil Valentine and others covered in a recent article in Rolling Stone. The NY Times also had an article titled “They Spurned the Vaccine. Now They Want You to Know They Regret It”. I heard from a friend about a hospital-based health professional (not a physician) they knew who had been vaccinated but ended up on a ventilator, which was very concerning. A few weeks later, we called to follow up. Guess what? Turns out they weren’t vaccinated; they and their whole family were lying. Embarrassed. Reassuring, in one sense, but also very worrying that folks are lying.

I hope that others who have reservations will take their advice and get vaccinated. It is, of course, a bit disingenuous; if they knew they were going to get sick and maybe die they would have gotten vaccinated. If we had known  that the roulette wheel was going to come up black, we would never have bet on red! You can’t be sure what will happen to you, but the important point is that you have to do it because you might, and at least as important, because you can infect others.

But there are many people who steadfastly believe that being vaccinated is not for them, and some who believe that it is not for anyone. They are getting sick, and will continue to get sick, and infect others, and cause others to die. They will not wear masks, and they will not wear signs. When they say that vaccine mandates, or mask mandates, are oppression, they are being, frankly, ridiculous.

The pandemic is not over. Delta is very serious. Get vaccinated. Wear a mask indoors.

I cannot resist including two other posts that make that point: 

  

Drug and device makers: Obscene profits and kickback -- a big part of why our "healthcare" costs so much

 

Drug companies are greedy parasites. This is well-known to everyone. Even the shock troops of the Republican right know about and decry it.

The drug companies start with the capitalist model – sell something at a profit – and take to an extreme: make as much profit  as possible no matter who it hurts (as long as it doesn’t hurt them).

They have a great business plan: people need their medicine, they (or mostly their insurance companies, including government insurers Medicare and Medicaid) are willing to pay for it, even if truculently, and they’ll pay whatever is asked.

While we are all shocked periodically by stories of individual dramatic greed, such as Mylan and its CEO Heather Bresch jacking up the price of EpiPen® to over $600 (Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, Sept 3, 2016) or Martin Shkreli and his company Turing brazenly raising the price of Daraprim® from $13.50 to $750 (Drug prices and corporate greed: there may be limits to our gullibility, Sept 27, 2015), the fact is that this is the standard business model of pharmaceutical companies. Think of colchicine, an anti-gout drug first used by ancient Egyptians at least since 1500BC, having its price jacked up from $4/mo to $5/pill (VISA and colchicine: maybe the banks and Pharma really ARE in it for the money!). 

Or, to get to one of the biggest scandals of all, the price of insulin!  Should there be anyone who does not know, insulin was one of the most important drugs ever discovered. Unlike the newest drugs that I have recently discussed, which sell for thousands (or tens of thousands) of dollars a month, insulin is not for a niche market. It is for diabetes, one of the most common diseases. For people with Type 1 diabetes, who produce no insulin of their own, it is simply an absolute requirement for life. For the larger group of people with Type 2 diabetes, it is often a critical part of controlling their disease. It was discovered by Canadians Banting and Best in the 1920s, who sold the patent to Eli Lilly and Co. for -- $1! (Not sure if that was a US or Canadian dollar.) This drug – the impact of which is HUGE – now is over $100/month for the cheapest generic forms if you have a coupon, and, depending upon the formulation, can be hundreds!

So, we have predatory pricing on products people absolutely need for their lives. Check.

We have outrage among millions of people of all political stripes. Check.

We have the ability to control these prices, starting with the largest payer in the US, Medicare. Check.

We have done what we can, as a government and a society, to address this issue. Um, uncheck. Nope.

In fact when Congress passed the Medicare Drug Plan, (MMA, Part “D”) in 2003, it specifically forbade Medicare from negotiating drug prices. Good deal for the drug companies! Guaranteed payment and no ability for the purchaser to negotiate the price! Where can you or I get that deal? Nowhere, of course. We do not have huge piles of $$ for paying Congressmen. Every time the drug manufacturers suggest that they need their profit to pay for Research and Development (R&D), we need to note how much MORE they spend on Marketing (including lobbying and contributions). It is also worth noting that contrary to their propaganda, MOST drugs are not developed in the US. It is the large plurality, but Japan and Western Europe also contribute a lot. (see, e.g., Light and Lexchin Pharmaceuticals as a market for “lemons”: Theory and practice and Pharmaceutical research and development: what do we get for all that money?, also for another take US Pharmaceutical Innovation in an International Context) More important, perhaps, is that most of the basic (high-cost, high-risk) research is funded by you, the taxpayer, through National Institute of Health (NIH) grants; drug companies most often buy the patents only after the original research shows promise.

Of course, in recent years, there has been a change. In labeling. Some expenditures that used to be included as marketing are now included as R&D. Not that the amount that they spend on lobbying, political contributions, marketing to physicians, and direct marketing to consumers has changed. And of course we have the FDA approving incredibly expensive and profitable drugs against the recommendations of their scientific panels (FDA approves Alzheimer's drug against the recommendation of its scientific panel. Be very concerned, June 21, 2021). This is corruption, this is your government selling you down the river to increase the profits of an industry that everyone, justifiably, hates.

And then, of course, we need to consider the device makers. You know, the companies that make stuff that is stuck into your bodies by surgeons, from artificial hips to cardiac defibrillators. Just to make sure that they do not continue to fly under the radar, getting cover from the excesses of the drug manufacturers. This is important; unlike drugs, if it turns out that your  implant  is not the best choice, or is not working well, or is really inferior, or is harming you, it is not as easy to just stop and put a new one in. That artificial hip? They opened you up, cut out the top part of your thigh bone (femur), and part of where it inserts into the pelvis (ilium) and put in this new hardware. Replacing it is a big deal. So getting the best one available is important. Usually, this decision is left up to the surgeon. So how do you get surgeons to use your device if you are a device manufacturer? Marketing! Telling them how great it is! Showing them testimonials from other surgeons!  Oh, yes, and, of course good old kickbacks, paying them for using your product! This is reported on in a recent piece in Medscape, “Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products”, June 17, 2021. That is how you wanted your surgeon to choose the new part that is going to replace part of your hip, or spine, or knee, right? Bribery?

Of course, it is not listed as bribery on the companies’ balance sheets, and I’m sure that the individual surgeons do not report it on their income tax under “kickbacks”. Back in 2012, surgeon and writer Atul Gawande, in an article in the New Yorker called “Big Med” (discussed by me in Quality and price for everyone: Bigger may be better in some ways, but not all, Aug 24, 2012) reported on an effort in a Harvard-affiliated hospital to standardize the hardware used by orthopedic surgeons. Rather than having each surgeon pick their own favorite and having the hospital have to stock several – or sometimes more than 10 – versions of, say, an artificial hip, a committee researched the quality and the hospital stocked 1 or 2 of the best, and each surgeon had to use them. This improved outcomes. There was no suggestion that the surgeons were, at that time, getting kickbacks, but it is certain that the manufacturers whose products were not chosen were not happy about it.

It is not hard to see why the American people distrust the healthcare system, and the hugely profitable drug and device industries that supply it, and the healthcare “providers” – hospitals – that deliver it, and, sadly with news like these kickbacks, even the doctors and other clinicians caring for them. And I haven’t even gotten into  (today) the insurance companies! As in so much else, it often appears that both our major political parties are the parties of Corporate America, although one is at least making some efforts to limit those corporations. The other is, like the drug companies, totally shameless.

It is not hard, but it is sad. And worse, destructive to our health, as individuals and as a society. 

FDA approves Alzheimer's drug against the recommendation of its scientific panel. Be very concerned.

Early in June, an article in the NY Times discussed the possible approval of aducanumab, a recombinant DNA (the “-ab” is always clue!) drug intended to treat Alzheimer’s disease. The FDA approved the drug a few days later, going against the recommendations of its advisory committee of scientific experts, and generating this “Quotation of the Day” in the Times from one of its members, G. Caleb Alexander: “There’s no way to recover the opportunity to understand whether or not the product really works in the post-approval setting.” Almost immediately, three members of the advisory committee, Joel Perlmutter of Mayo, David Knopman of Washington University in St. Louis, and Aaron Kesselheim of Harvard, resigned in protest of the decision. Dr. Kesselman, along with his colleague, Dr. Jerry Avorn, presents a strong indictment of the FDA in an Op-Ed guest essay in the Times, and they are not alone. Most neurologists, including those that I know who are experts on and leading researchers in Alzheimer’s, echo these concerns.

This is pretty unusual. Not just the resignations, but the reason for them – the decision by the FDA to approve a new drug based on evidence of effectiveness so weak that the scientific advisory panel recommended against it. It raises a number of questions, the foremost one of which is “why?” Also: Is this a precedent, and will it happen again, or more regularly? What was the reason that the advisory committee recommended against approval? Who were the people at the FDA who overruled them, and what were their reasons?

First let’s start with cui bono? – who benefits. This is certainly Biogen, the company that developed aducanumab and will market it, under the tradename Aduhelm. It is estimated that it will cost $56,000 a year. This is not a record; there are other recombinant DNA drugs – including several for neurologic conditions – that cost even more. In fact, as indicated in recent study by the American Academy of Neurology, “Medicare paid 50% more for neurology drugs over 5 years while claims rose only 8%”. Still, it is a tidy chunk of change, and since Alzheimer’s is a far more common disease than most of the rare one that are ostensibly treated by more expensive drugs, Biogen expects to make a bundle. And, because only the very very rich could afford this much, most of it will be paid by you. That is, by insurance companies that collect your premiums, and especially by Medicare, the insurer for the majority of Alzheimer’s patients, which is funded by your tax dollars. This is described in another article, with the subhead: ‘Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.’  If people are not insured, or rich, they can forget it. Which, in this case, might be just as well.

Making a lot of money, as much as they possibly can wring out of patients and insurers, is the core business of pharmaceutical companies (and most companies, although pharmaceutical companies have been particularly good at making outrageous profits, always ranking as the #1 industry for profit). It is not, despite their ads (and they spend much more on marketing than on research and development) about improving your health.  You are just the coincident vehicle for generating their profits. Their drugs do not have to actually help you get better; as long as they don’t harm you too much – and, of course, as long as the FDA approves them – they are golden. This is why they spend so much on marketing, and lobbying, and specifically lobbying the FDA. Indeed, the “golden parachute” of many FDA staffers is to retire from the agency and get a job lobbying for a drug company. Sigh. So that one is obvious. Corrupt and despicable, yes, worthy of complete anger and condemnation, yes. But obvious. Not, heretofore, however, predictable.

There is another stakeholder group involved, Alzheimer’s advocacy groups. The FDA still has an acting chief, Janet Woodcock, and another article notes these groups supported her becoming permanent. It says “Woodcock’s nomination back in February when the application for the drug, aducanumab by Biogen, was pending, its approval was a sign that they backed the right candidate.” Wow. Shouldn’t we be paying them attention? After all, they are not the drug manufacturers who will be making a mint. And Alzheimer’s is a terrible disease, and we need effective treatments, right?

Not so fast. Yes, Alzheimer’s is a terrible disease. Those who have it suffer greatly, at least until it is so advanced they no longer recognize what is going on. And their loved ones continue to suffer, more and more. A drug that would cure it, or mitigate it, or make it progress more slowly would be wonderful (although it shouldn’t cost $56,000 a year!). But is aducanumab that drug? Not according to the scientific panel, who know. But the advocacy groups are pushing for it anyway. Why? Well, they make not be making most of the money, but they have to justify their existence. And they almost certainly are getting donations from those drug makers. And maybe, even, they care so deeply about the disease that their hope and optimism overcomes appropriate caution. It wouldn’t be the first time that this has happened (e.g., the continued promotion by breast cancer advocacy groups for decreasing the age and increasing the frequency of screening even when science showed the opposite).

It also wouldn’t be the first time that those advocating for victims of terrible disease pushed strongly for approval before studies were completed. One meaningful and important example is the efforts of groups such as ACT-UP to get early approval for anti-retroviral drugs, as people were dying in droves from AIDS.  But there are differences. One is the disease; Alzheimer’s is not killing people quickly as did AIDS, and no one is claiming that aducanumab or any other drug will change its eventual downhill course. Another is health equity. In the political and social landscape of the 1980s, AIDS was a disease primarily affecting gay men and IV drug users, definitely not the mainstream. Leaders such as Ronald Reagan refused to offer support. And, perhaps most importantly, the anti-retrovirals were showing a definite positive effect in studies, and the calls were to speed up the approval process. In the current case, the trials are complete and the evidence showing a positive effect is not sufficient.

This is in no small part due to the fact that the “positive effect” studies show involves changes in biomarkers, not changes in people’s lives. That is, they look at lab tests rather than whether people die less soon or suffer less. Yes, there is evidence, as there is evidence in many diseases, that these intermediate markers are related to long-term outcomes, but the problem is that the further out they get the more it becomes like a game of “telephone” (well, our drug affects A, and A is related to B, and B may be related to long-term outcomes). We need studies that look at patient-oriented not disease-oriented or laboratory-test-oriented effects.

Sometimes an intermediate marker improves but the patient does not, or gets worse. It could be from a side effect of the drug (drug safety) but it can also be from the desired positve effect of the drug!  For a time diabetes groups pushed to lower the target hemoglobin A1c (HbA1c) -- a measure of long term glucose level, to be 5 rather than 6, because people with diabetes with lower HbA1c levels had lower levels of diabetes complications. Makes sense. But when the average blood sugar over several months is lower, it increases the risk of significant hypoglycemia (low blood sugar), which can be more dangerous than higher sugar. Indeed, if you pass out from low blood sugar, fall and break your hip, and die, the lower rate of complications from your diabetes in the long term is irrelevant. There is an old medical joke about Harvard doctors being very insistent that their residents keep patients’ lab values in the normal range, so that even when the patient died, they died in “perfect Harvard balance”.

This is not what we want. We want diseases to be cured, or ameliorated; for lives to be lengthened and improved in quality. We certainly do not want drug companies to make billions off of people’s suffering. When the FDA approves a drug over the recommendations of its scientific panel, it should be of great concern to all of us. 

And don't forget cui bono?

Culture and Medical Culture: Understanding to increase benefit and reduce harm

Culture is often understood, at least by that culture that is in a majority in a given place, as a characteristic of others. That is, we are “regular”, they have a culture. The greater the disproportion between the dominant group and others in terms of numbers, the less diverse a community is, the more this – incorrect – assumption prevails. In the 19^th century, before the work of Bronislaw Malinowski and Margaret Mead, who actually spent time in the places and cultures they were studying,  cultural analysis of the world by anthropologists was often done “offline” by what have become known as “armchair anthropologists”. All European, they ranked cultures from least to most civilized, and guess what: European, and especially Western European, cultures were always at the top!

It should be needless to say that this was wrong. In addition to all the examples that can be given of other non-European cultures were far more advanced (think the Arab world for mathematics and science, China for all kinds of things), all cultures are different. They do not just have “strengths” and “weaknesses”, or areas in which one is “better”, but differences which have developed to serve the needs that existed where they lived. Weather, for a start, makes a difference in the types of crops grown or how housing is designed. In addition, of course, different cultures share many similarities. This allows for, for example, religious ecumenism, in which folks of different religions can come together based upon the values that they share. In the US today, we have seen great advances in understanding not only that differences between cultures do not mean one is better than another, but also that similarities between people usually exceed differences. Recently, we are seeing great strides against racism, sexism, jingoism, and all the other “isms” that promote hatred instead of understanding. Unfortunately, however, we also see a backlash from people who feel threatened by the idea that other people, whom they have disparaged and discounted, are indeed their equals. This has gone beyond attitudes; it has led not only to violence, but to legislation enshrining prejudice, hatred, and discrimination. I hope this will get better, but it might get worse first.

One way that we have on tried to address this issue in medical education has been discussions between small groups of students about how they see common phenomena in the world, in their communities, in families, and relationships. The more diverse a class is, the richer these discussions become and the more the students learn that what they think of as “regular” is in fact just as much a cultural belief as that of other people. Of course, this also can reveal assumptions that they may make about what is “normal” that are not normal for others, particularly regarding financial and socioeconomic issues. Or, for instance, whether the police are seen as your protectors or your persecutors.

This becomes an important entry point for examining medical culture, which certainly exists and carries its own beliefs and prejudices, as do most professions. These beliefs are no more, or less, “true” than sociocultural beliefs. Because medicine involves not only extensive interaction with other people who are not immersed in the culture but, even more, extensive power over the lives and health of those people, coming to grips with what you (and your teachers) believe because, well, we all believe it, rather than what is based in evidence, is important. This is more difficult because a big part of the socialization to a profession such as medicine is for a novice who is from outside that culture to learn the jargon, way of thinking, and indeed prejudices that characterize it, and this can have negative as well as positive results.

For example, our medical students usually enter perfectly capable of speaking English (and perhaps other languages) and conversing with others and communicating ideas and information. As part of becoming doctors, they learn new language, new terms, new acronyms, new meanings, and eagerly repeat them as evidence of their acculturation. Unfortunately, this can become an obstacle to communication with their patients, who do not speak this language. One example: a couple of sentences ago, I used “positive” and “negative” in their usual English senses of “good” and “bad”. However, when doing medical tests (lab, imaging, biopsies) a positive result is usually bad, and a negative result is good. But when a doctor, or student, informs a patient that their results are negative, it is common for the patient to react with fear, since this sounds like a bad thing. We urge them to say “normal”. Whew, that’s a relief!

Some other issues of medical culture are address in an Op-Ed by Robert Pearl in the Los Angeles Times of May 16, 2021, “How doctor culture sinks US health care”. A big part of Dr. Pearl’s critique in the distinct bias, not only in physician attitudes but in medical journal articles, towards intervention and procedures rather than prevention. This, he notes correctly, is very much tied to money, since physicians and hospitals and health systems (which are increasingly the physicians’ employers) stand to make much more money from them. Medical journals are more likely to print articles with positive (there is that word again!) results, demonstrating that a procedure had benefit, than negative results, demonstrating that, actually, compared to something – or nothing – else, something (or nothing) that was easier, cheaper, less interventive, and less dangerous, it had no better outcomes. Of course, anyone can see that knowing this information, that doing something is not worthwhile, is at least as important as knowing that something works well.

However, the inclination (or perhaps prejudice) among most physicians is to do something, to intervene; aside from making money, it makes them feel that they have skills, are justified, are important. Unfortunately, this is also an attitude quite prevalent among their patients, who want something done to help their problem – to cure their disease, or increase their lifespan, or improve the quality of that life, and in particular to ease their pain. But doing something does not always improve things, and can definitely increase the risk of harm. We need to know what works (and what doesn’t), and in what circumstances, and what the dangers are, and what the alternatives are, and their potential benefits and risks, and then have discussions together about what, in the specific circumstance a specific person is in, what would be the best choice for them.

This effort is likely to overlap with more traditional sociocultural and religious beliefs, which can have an influence on what a person thinks would be best for them. Communication around this requires care, and a real effort on the part of the medical professional to understand and to make their own thoughts clear and clearly expressed. This is even more complicated when, as is the case, physicians are from a pretty narrow slice of the American population, racially, culturally, and economically (and, again, a good argument for increasing its diversity). As in all situations where there is a power differential (and in medical care, the greater power lies with the physicians and health systems) it is incumbent on those with greater power to make the effort to understand those with less. And, at least as important, to not make decisions for and about people based on only your understanding – or worse, assumptions – about what they want, or are because of race, religion, gender, national origin, etc. Doctors, even when they are well-meaning (and all of them are not always) too often allow themselves to fall victim to the ecological fallacy, and confuse “condition X is more common in population Y” with “the patient is a member of group Y so probably has condition X”.

It is, of course, also very important to recognize that all interventions and procedures are not a bad idea; indeed, they are often the best treatment. And, also, that not everything sold as “preventive” is really so; plenty of tests and treatments called preventive are not proven to prevent anything. It is not easy to overcome prejudices and beliefs.

But understanding that we all have culture, and trying to not be bound by it and doing our best to understand that of others, is a good start.

COVID, Vaccine, Racism, and Masks: Changing for better or for worse?

We are not yet out of the COVID pandemic. Not in the world, where hot spots linked to both bad luck and irresponsible arrogant governments continue to rage in such places as Brazil and India, as well as in some countries in Europe and in other parts of the world. Not in the US, despite the CDC indicating that it is now ok for those who are vaccinated to stop wearing masks. People are still dying in large numbers, people are still being infected, and this map of the US does not show all light-colored, low-risk counties (the gray counties, and state of Alabama, have to do with nonreporting).

But things are getting better. We no longer have an ignorant, evildoer in the White House who is intent on ensuring that as many Americans die as possible (while he himself got every a

vailable treatment when he was sick, and indeed got vaccinated), but there are still plenty of Americans who are loyal and faithful to him (or to the myth of him), and to the wacko conspiracy theorists on the dark part of the web. Many of these folks are vaccine-hesitant or vaccine-resistant.

A lot of the coverage of these attitudes has been in minority, and particularly Black, communities. There is definitely resistance there, and to a large degree it is based on the experiences of those communities with the health care system. Some of this may be, in fact, the oft-cited historical examples of exploitation and experimentation on Black people in this racist nation. These include (probably most famous) the Tuskegee study of the “natural history” of syphilis in Black men that continued even after a cure (penicillin) was discovered; they were not treated. They also include the work of the “father of gynecology”, Dr. J. Marian Sims, whose discoveries were based on non-consented (of course) surgery on Black slave women, for a foretaste of Nazi doctors. They include, more recently, the fact that the HeLa cell line, derived from a cancer in a Black woman, Henrietta Lacks, has been basis of many discoveries to treat cancer, but she was not cured and neither she or her family received recognition (or money, despite much going to researchers) for it.

Many Black Americans know these stories, and it is probably true that, to some degree, they influence the reluctance of some people to put their fates in the hand of the healthcare system and to trust the government, including the CDC. But I would posit that a larger reason is not these near-mythical (although very real) abuses, but the more mundane, everyday abuses that people, especially poor and minority people, have experienced at the hands of that system. It is no fun to be sick, no pleasure to need treatment, and the arrogance of much of our health-system culture to its patients is very often confusing, frustrating, unpleasant, and demeaning to even well-insured and well-to-do White people. How much greater are all of these indignities – and too often abuses – if you are not insured or poorly-insured? If the massive health care institutions that have been built in pursuit of profit do not really want to care for you, or offer you their special magic bullets available to those with more money? How much greater than even that is it when you are Black, and endure the overwhelming manifestations of American structural racism as delivered by the healthcare system? When the presumption is you are more likely to be the cause of your own problems, because of your behaviors, or your self-abuse, when the presumption is that you are guilty of not-always-clearly-stated malfeasances, that you are stupid and ignorant and not to be trusted?

Sure, Tuskegee and Sims and HeLa came from the same racism, but you don’t need to even know about them at all to know that the health system is stacked against your, and your family, and your friends, and your community, and not always to be trusted. So maybe you’re not sure about getting that vaccine. And many Black Americans, and other minorities are not sure. But they aren’t the majority of the “vaccine skeptical”, despite getting more attention. The “traditional” anti-vax community is largely White, educated, upper-income and centered on the coasts, especially the West Coast. It is represented by a legion of celebrities and other famous people, including Robert Kennedy, Jr., Jennie McCarthy, Mayim Bialik, even (until recently) Oprah Winfrey. In the COVID pandemic, they have been joined by another much larger cohort, overall less educated and wealthy but just as White – the Trumpers. Following the incorrect and dangerous information that continues to spew from their leader, they now believe that the vaccine is ineffective, probably bad for you, and likely a result of a conspiracy of foreigners. You can look into the Dark Web, or QAnon to find this information, or just turn your dial to FoxNews. And while there are organized efforts by Black leaders, including celebrities, to urge folks to receive the vaccine, there is no comparable campaign among by the heroes of the White right.

Many articles have appeared documenting the degree to which our emergence from the COVID shutdown is going to depend upon adequate numbers of people receiving the immunizations. Health authorities, nationally and in state after state, have dropped the age criteria for being immunized, so that at this point in many jurisdictions, only infants are ineligible. And folks are still being immunized; while the rate of immunization has decreased from the peak, it is still being actively pursued by many people. But what is scary is that there are so many who will not receive it. And they won’t wear signs.

Were you worried about a third wave of COVID? Or is it now fourth? I forget. Anyway, good idea to worry. The CDC has indicated that those people who are fully vaccinated can now not wear masks in public. There is actually good scientific evidence for this, and it would certainly help people to feel like a corner has been turned. Except – they won’t wear signs. As reported by the Associated Press on May 15, 2021, while many small businesses are embracing the new opening and taking down their signs requiring masks, not wanting to “have to play police” any more, many large chains are continuing their mask policies.

‘As many business owners pointed out, there is no easy way to determine who has been vaccinated and who hasn't.’ 

‘And the new guidelines, issued Thursday by the Centers for Disease Control and Prevention, essentially work on the honor system, leaving it up to people to do the right thing.’

Right. The honor system. The folks who stormed the US Capitol, who stood with guns outside the Michigan State Capitol to oppose masking (in the state which now has the highest COVID rates in the US), who believe that COVID is a hoax, that Trump won the election, that Nancy Pelosi is the devil, and that Jews have space lasers, will be honorable enough to wear masks when they haven’t been vaccinated.

Good luck with that.

We need more primary care to serve our people: Why do the medical schools lie?

Every year the nation’s medical schools graduate thousands of people with MD and DO degrees. But this is just the start of becoming a practicing physician; they now need to complete residency programs in a specialty area, ranging from 3 to as many as 8 years, to become family physicians, surgeons, radiologists, dermatologists, orthopedists, etc. Indeed, for many physicians this “postgraduate” training (meaning post-medical school, since medical school itself is post-graduate, requiring a bachelor’s degree for entrance) can have two components as well. First there is the primary residency program, say an internal medicine residency of 3 years, and then there is subspecialty training, usually called “fellowship”, where that internist becomes a cardiologist, or endocrinologist, or pulmonary medicine physician. While the internist who completes 3-year residency may practice general internal medicine and thus become a primary care physician for adults, those subspecialists do not. A similar process exists for pediatrics. Family physicians completing their 3 year residencies can also do fellowships in a limited number of areas, and some limit their practices to sports medicine or geriatrics or adolescent medicine, but most add these skills to their primary care practice. And, of course, geriatrics and adolescent medicine are, like general internal medicine or general pediatrics, primary care for a particular population.

This is important. Primary care doctors provide care for their patients that is comprehensive and unrestricted, other than by age for pediatrics, internal medicine, and geriatrics. They meet the World Health Organization (WHO) criteria for primary care, providing continuous, comprehensive, community-and-family-centered care. Distilled down, this means that primary care physicians see their patients for everything, whatever concerns them, referring when needed. They are the doctors for their people, not for a particular disease or set of diseases. The lack of sufficient numbers of primary care doctors has significant negative impact on the health of our people. Of course, it falls hardest on those who are always most disadvantaged – the poor, members of minority groups, and rural residents. But it also has negative impact upon the health of privileged people who see lots of subspecialists, in two ways. One is that the specialist may be expert in their field, but miss appropriate treatments, and especially preventive measures, outside it. The other is that many specialties and subspecialties rely on and extensively use care that is very high-tech and expensive, which can lead to people getting tests and treatments that are not only costly but may not be of any benefit, and indeed may lead to harm.

 

So, when a medical school claims that it is good at producing primary care physicians, this is serious, and should be accurate. But it usually is not, because schools want to look as good as possible so establish criteria that make them look good, counting a wide variety of specialties that their graduates might enter as “primary care”. The biggest “offender” in this regard is counting all graduates entering internal medicine residency programs as entering primary care. As described above, some of these end up doing fellowships to become subspecialists and do not practice primary care; indeed, “some” is an understatement as it is about 80%. In addition, about half the rest end up practicing as “hospitalists”, taking care of hospitalized patients only, rather than practicing primary care. So an approximation would be to assume about 10% of those entering internal medicine residencies will practice primary care. In pediatrics, continuing as a general pediatrician is much more common; the appropriate multiplier is probably 60%, and for family medicine as much as 95%. There are also residency programs in a combination of medicine and pediatrics (Med/Peds) which can produce primary care doctors, and whose graduates are less likely to pursue subspecialty training; however, they are very likely to choose only one of those areas (adult medicine or pediatrics) and also to become hospitalists.

In addition, some (or many) schools include in the primary care numbers specialties that are simply not primary care at all. Most commonly, they include emergency medicine and obstetrics/gynecology. Emergency medicine does indeed provide first-contact care, but it does not provide continuity. Obstetrics/gynecology can provide some aspects of primary care (and indeed OBGyns may be the only doctors some young women see) but it is limited in that it is not comprehensive; women are more than their reproductive tracts, and they can have a variety of conditions OBGYN does not care for (diabetes, hypertension, heart disease, depression, arthritis, asthma and other lung problems, substance abuse, etc., to name a few). Perhaps the most egregious abuse is counting all students who enter internal medicine “transitional” or “preliminary” years. Such one-year programs, which have replaced the old “rotating internships”, are required for many specialties such as neurology, anesthesiology, radiology, ophthalmology, dermatology, and others, whose practitioners do not do primary care at all.

If we want to know how well a school is doing in graduating students who actually practice primary care at the end of their residency and fellowship training, these inflated numbers do not inform us. Fortunately, one of the most popular sources of information on medical (and other) schools, US News, has worked with the Robert Graham Center, the policy center of the American Academy of Family Physicians (AAFP) to develop and publish a metric that does show which schools actually produce primary care physicians, available at https://www.usnews.com/best-graduate-schools/top-medical-schools/graduates-practicing-primary-care-rankings. The top of this list is dominated by schools of osteopathic medicine, which consistently graduate higher numbers of primary care physicians, and, among the allopathic schools, the mainly public schools who have been doing well in this area for a long time. The private, largely northeastern, schools that usually top rank lists are nowhere to be found.

It is important to look at this list, not the list of “Top Primary Care Schools”, to get accurate data on production of primary care physicians. The metric on percent of students going into primary care has also been fixed in the “Top Primary Care” rankings, so it is better, but it still only accounts for 40% of that ranking. “Peer Assessment” (subjective rankings) account for 30%, half from medical school deans and other leaders, and half from residency directors. The other 30% is half “faculty resources” (largely faculty ratio) which may be skewed to the advantage of research-intensive schools, because it includes faculty who are mostly in laboratories and not teaching, and half “student selectivity” (based on student grades and MCAT scores), which is actually negatively associated with entry into primary care. This doesn’t mean the students that enter primary care are not as smart; it means that the cachet of attending a research-intensive school makes the competition greater. Unsurprisingly, adding these other criteria does affect the rankings; Harvard, for example, is now #8 in “best primary care schools”, although it ranks #141 of 159 schools in percent of graduates practicing primary care. (In contrast, the University of Kansas, which ranks #9 in primary care, below Harvard, ranks #17 in graduates practicing primary care, at 37.8%). Reputation affects peer assessments in at least 3 ways. One is spillover effect -- well, it’s Harvard, and good in everything so it must be good in primary care. A second is the ignorance of non-primary care deans and residency directors about what kinds of doctors the school produces. Finally, the fact that “good in primary care” can mean things other than what specialties the graduates enter can have an effect; there are schools in which the family medicine and other primary care faculty are well-known for their research and leadership in national organizations, but which do not graduate very many students into primary care disciplines.

The fact remains, though, that the US very short of the primary care doctors it needs to provide quality health care to the American people. The way to begin to change that is to stop deceiving ourselves. Then we can start the process of producing a higher percentage, in every school.

"Values" based care: Public Health, Primary Care, and Medicare for All

Recently, a class of undergraduate freshmen I teach debated the issue “Health Care is a Human Right”. Although we later determined that most of them personally supported that statement, the “no” team did a good job marshalling the arguments of opponents, often citing those of libertarian think tanks such as the CATO Institute (originally founded as the Charles Koch Institute, in case that helps), which identifies itself as promoting "free markets and individual liberty”. This includes identifying health care as a “commodity” and opposition to health care as a right (and thus to universal health coverage) as an infringement upon individual liberty. Essentially these two concepts boil down to the idea that the individual is free to decide what kind of health care they want, or don’t want, and what kind of insurance coverage they want, or don’t want, and can use their money (or not) to purchase this commodity (health care) as opposed to another (I don’t know, say a bass boat).

The hole in this argument is wide enough, though, to drive a bass boat through. It is that not everyone has such a large amount of disposable income that they have the financial options to make such decisions. An old point about commodities having to do with cars, when most Americans bought American brand cars, is that some folks can buy Cadillacs and others Chevrolets. But of course, even if we update this to Beemers and Kias, there are a huge number of people who are buying used cars – often old “junkers” – to try to get to work and shopping. And there are those who can’t afford to buy, insure, and run any car at all and are reliant on public transportation. If there is any public transportation where they live. People without a lot of money (often despite working multiple jobs, even those making quite a bit more than the federal minimum wage of $7.25/hour -- last raised in 2009 when $7.25 was equivalent to about $9 today) make regular trade-offs on what they will spend their money on. Rent? Food? Clothes for the kids? Heat? Electric bill? Gas for the car to get to work, if they have a car? Health and medical care are rarely right up there at the top unless they are actively ill. Indeed, often even chronic diseases don’t get adequately managed, with medications for common conditions such as diabetes and hypertension stretched out. This family – and to a greater or lesser extent, this is probably true of the majority of families – is trying to figure out how to juggle absolute necessities, not luxury goods. The students arguing the “anti” position gamely tried to respond to such concerns, but learned that, outside the walls of conservative think tanks, Congress, state legislatures, and country clubs, there is a limit to the effectiveness of continually repeating “individual liberty” and “commodities”.

Paying for the cost of health care is a real juggling act for the government, although for a different reason from the one the families above are doing. It is balance between wanting to spend less money and continuing to support the profits of health care corporations such as insurance companies, hospital systems, and drug makers. The rational solution to this problem is to decide that it is not the government’s business to guarantee the often obscene profits of such private corporations, but rather to spend the money on whatever maximally increases the level of health of the American people.

This should include at least two major changes: first, a national health insurance plan (such as “Medicare for All”, recently reintroduced with major improvements by Reps. Pramila Jayapal and Debbie DIngell) that ensures that everyone is covered – everyone, all in one plan, no exceptions by age, disease, etc.), and second, a massive and continuing re-investment in public health, the need for which should have been made clear by the COVID pandemic. Historically in the US, in Democratic and Republican administrations, funding for public health is about 1% of the health budget, with the rest going to individual medical care. When we have a crisis, we bemoan the lack of public health infrastructure for a while, but then it recedes. Yet this is the most important component of keeping us healthy. Fighting an active enemy (like COVID) can garner support, while maintaining programs of prevention absent an obvious crisis gets less. How often do we wake up and say “I’m glad I don’t have cholera today because we have clean water and sewage”? And, yet, recently folks in Mississippi and Texas can count themselves lucky that their lack of water did not come with cholera or another infectious disease.

Instead of such wholesale reimagining we have had programs like “value-based care” for Medicare, adopted with the ACA (“Obamacare) in 2010. When this was first rolled out, I was enthusiastic because I misunderstood it – I thought it was about providing care based upon values, presumably decent human values. Sadly, I was wrong. It was about spending less money. Did it work? To do what? If the goal was spend less, yes, to some degree (see Austin Frakt in the NY Times Upshot Oct 9, 2019, “more singles than home runs”). One of the big goals was to substitute “value” for “volume”. Paying for volume, the number of patients seen, was the accepted way to pay doctors. But what does paying for value mean? This whole issue is reviewed by Dr. Don McCanne in his “Quote of the Day” for March 17, 2021 “Policy community hung up on ‘volume to value’”. Dr. McCanne reviews the recent article “The Future of Value-Based Payment: A Roadmap to 2030” from the University of Pennsylvania on the topic, but in his comments he notes that

“All health care has “volume” – time, effort and resources devoted to health care. Volume varies tremendously depending on the clinical situation. Think of management of a common cold as opposed to management of severe multiple injuries in an accident. Can payment schemes ignore volume? Of course not. Volume is built into the problem.”

Here is a volume/value solution that I have discussed before but will now say clearly: Revise the way that physicians (and other providers) are paid so that family physicians and other primary care doctors make at least as much as those providing subspecialty care. This is the third step to add to universal health coverage and investment in public health. When I go to a shoulder orthopedist for the pain in my shoulder, that is the ONLY PROBLEM they deal with. Not BP, not abdominal pain, not my cold -- not even the arthritis in my knees.  My PCP would deal with every problem on my – and all their patients’ -- problem list (to greater or less extent, depending upon severity and acuity), and thus rarely has enough time for any on person. If you go to the cardiologist, and mention that you have knee pain, they say "I don't do knees; here is a referral to the orthopedist". And you go to the orthopedist, they make a recommendation, you come back to the cardiologist who says "I don't do knees; whatever they said". So, for the subspecialist, referral is a time saver.

But if you come to a PC doc and say your knee hurts, they make some diagnostic and treatment suggestions. After examining your knee, maybe ordering imaging and lab, and thinking about it, if they think it might need surgery, they might refer you to the orthopedist. Then you go and the ortho says "maybe surgery", so you come back and ask your PC doc’s opinion, so they read the whole consult and review the films and think about it and discuss it with you. Result: referral for a PC doc makes MORE work.

And they get paid less.

PC docs need more time with everyone, and thus fewer patients each day/week/year. How much money should they make? I don't care, pick a number, but it should be able to be earned by seeing no more than half the number of visits that they currently do. People's complaint is ALWAYS about not having enough time with the doctor.  

So, increase funding for public health, develop a universal single-payer health insurance system, and pay PC docs at least as much per hour or patient as the highest-paid subspecialist in the outpatient setting. 

Now we begin to have “value”!