People, patients, polypills, primary care and POEMs: Making your health better in the real world

A recent article in the New England Journal of Medicine, ”Polypill Strategy in Secondary Cardiovascular Prevention”, also covered by the New York Times, demonstrated that people who had previous cardiovascular events, (ie., myocardial infarction -- MI, heart attack, stroke or urgent need for bypass for impending MI), had fewer recurrent heart attacks, including fatal ones, strokes, and urgent needs for bypass if they were treated with one pill a day (“polypill”) that combined their recommended medications than they did if they took multiple pills multiple times a day. The conclusion (from the Abstract) summarizes it as:

Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care.

This is good news, if not entirely surprising. The effectiveness of medications in preventing recurrent disease is a combination of both how effective the medication is if “taken as directed” and how difficult it is for a person (or, from a doctor-centered perspective, how “compliant” a “patient” is) to take the medication as directed. For an example of what this means, consider birth control, where “theoretical effectiveness” (how effective a method of pregnancy prevention would be if "used as directed" 100% of the time) is contrasted to “use effectiveness” (how likely a person who is ostensibly using a particular method of birth control is to get pregnant). Obviously, what matters to a person who does not want to get pregnant is the latter, and this is greatly impacted by how easy it is to not use it. Condoms and diaphragms have to be used every time and oral contraceptives have to be taken every day, which can contribute to a lower use effectiveness than forms of contraception that do not require this, such as IUDs and implants, known as LARC, long-acting reversible contraception.

So back to prevention of heart attack: Who is surprised that taking one pill a day results in better compliance than taking more pills more often? Hands? No one? Maybe cardiologists, since the alternative was “usual care”, which must have been “multiple pills multiple times a day”. Any sentient person would know, without needing to be a doctor, scientist, statistician, or epidemiologist, that taking one pill a day is not only easier but much more likely to happen than taking multiple pills, and especially taking pills multiple times. Remember, the medication only works if you take it, and the harder you make it to take, the less likely people will and the less likely it is to work. Even drug companies know this; you probably have noticed that when a drug is about to lose its patent one of the first “new drugs” that the company comes out with is a long-acting version of it that you have to take only once a day! I cannot prove that they would have been able to release this in the first place but instead held it in reserve just for this reason, but I would not be surprised. One pill once a day is also likely to be cheaper (except while under patent) and this is a big issue for people who have difficulty affording their medications (ie., most of us, but especially those with lower incomes. In the US, of course).

Though it seems obvious that one pill a day is more likely to be taken, this research study is not without importance. For starters, it showed that it worked to take one pill combining 3 drugs once a day. After all, if it didn’t help prevent disease, it wouldn’t be desirable. That it worked better than “usual care” is almost certainly related to it being one pill once a day, and how difficult it is to remember to take pills more often. [Even those of you who do not have chronic disease: have you ever been given antibiotics to take 4 times a day for 10 days? How often have you actually taken all 40 within the 10 days, even after you’ve started feeling better sooner?] We may presume that taking the multiple pills multiple times a day would have worked as well if people had done it, but because they don’t, it didn’t work as well. The contribution of the study is to show that the one pill once a day works, and because it is one pill once a day, works better.

Another important thing that the study did  is to look at meaningful outcomes: death, repeat heart attack or stroke, need for bypass. This also seems like a “duh”, if you are a regular person, but it has been common in the literature to not measure these but often “intervening variables” such as changes in cholesterol level (or blood sugar, or whatever you are studying) because this is easier to do and requires less follow-up. But having lower cholesterol, for example, only matters to the extent that you are less likely to have a heart attack or stroke!

When this study first came out, I commented on FB and Twitter that

‘Family physicians and other primary care clinicians know this better than subspecialists, since they are focused on "what works best for the disease?" and we on "what is going to work for this person?"!’

Of course, this is, probably, not completely true for all family physicians and all subspecialists, but it is certainly true that it is more likely for primary care clinicians to think about and be aware of how a treatment affects the whole person. Subspecialists are usually concerned with treating one condition, “their” disease”, and at how the treatment they prescribe ameliorates that, while primary care clinicians are looking at how it affects the person’s life. One simple example is drug interactions and “side effects” (which are actually just effects, but not the effects we want). Primary care clinicians care for a person with all the conditions that they have and have to not only see how, for example, their heart disease medicine works for the heart disease but if it is bad for another disease they have, or if its side effects (or difficult regimen, multiple pills multiple times a day) means that they don’t take it.

In research, family physicians and other primary care clinicians have looked for Patient-Oriented Evidence (POE) as opposed to Disease-Oriented Evidence (DOE). DOE looks at whether a treatment, usually in an experimental setting (which often has many differences from real life, such as free medicine and people to remind you to take it!) makes a disease better, while POE looks at whether it makes the person’s life, as a whole, better. This is important, especially if you are a person. (Or probably if you are an animal!) Indeed, family physicians have taken this a step farther to Patient-Oriented Evidence that Matters (POEMs), with sections reviewing recent research that does featured in several family medicine journals. POEMs is, in addition to being a cute acronym, has meaning; not all evidence, disease or patient oriented, actually matters. For example, the study cited above: showing that using a polypill decreases your risk of cardiovascular events and improves your life matters, while simply showing a change in a lab value might well not.

It is really good that there are treatments for diseases, whether common (like heart disease) or rare (like, ironically, I just discovered a rare blood condition also called POEMS!) that can make you better. It is also really good that there are subspecialists who know about them and can make recommendations for treatment (especially for the rarer ones) and who keep up on the literature. But it is also important that there is someone keeping an eye on the person, the patient, with all their diseases and medicines and treatment regimens and side effects, and, oh yeah, the stressors of their everyday life with money, and family, and work (or not having work) and how in heck, in this country, they are going to pay for their treatment. These are the real components of real life, sometimes called the “social determinants of health”, that are poorly addressed by US healthcare.

Polypills are good, as are POEMs. And so are primary care clinicians, especially when their employers allow them sufficient time and encouragement to actually provide comprehensive care for their patients.

COVID Vaccine and Privilege: When is it not about you?

Recently, an article from CNN, “A vaccination site meant to serve a hard-hit Latino neighborhood in New York instead serviced more Whites from other areas”, was posted on a medical social justice page of which I am a member. Among a number of others, I expressed my displeasure at this, but I also posted a comment in which I unfortunately said “People are scum”. It did not specifically refer to the white people who had obtained these vaccines, perhaps inappropriately, but certainly could be seen as that. I was called out for that comment, and that was appropriate. People are not scum, for better and worse. Scum is a substance that exists without intentionality. People, however, do have intentionality, and that can make them do things that are very good and very bad and everything in between. Certainly, doing something bad, or wrong, does not make a person bad; many religions have doctrines that are more or less comparable to “hate the sin, love the sinner”.

More to the point is whether the people referred to in the article did anything wrong or objectionable at all. While those quoted in the  article were very critical of this behavior, some of those posting comments on the page felt that these people (presumably people who otherwise met the current criteria in NY for the vaccine, by age or health status) were just trying to do what they could, and not trying to use their privilege to obtain vaccine intended for the minority community. They agreed that the system, and the structure for distributing the vaccine was severely flawed and probably inequitable, but that the individuals pursuing the vaccine should not be condemned. They acknowledged that some people, by virtue of education, wealth, computer-savvy, connections to other family members who may be more computer-savvy, and other characteristics, are more able to avail themselves of benefits. Even when this results in preferentially vaccinating white people rather than the minorities for whom it was intended (by placing vaccination sites in minority communities), it does not mean those individuals (many of whom are sick and elderly) are doing a bad thing, still less are bad people, or certainly scum. Nonetheless, the result is the result; the New York Times on January 31, 2021 reports that “Data showed that while 24% of city residents are Black, only 11% of vaccine recipients were. White New Yorkers received a disproportionate share of the shots.

The CNN report was not the only one critical of people “jumping the queue”. In a NY Times Op-Ed on January 28, 2021, Elisabeth Rosenthal MD, editor of Kaiser Health News, writes “Yes, It Matters That People Are Jumping the Vaccine Line”:

For weeks Americans have watched those who are well connected, wealthy or crafty “jump the line” to get a vaccine, while others are stuck, endlessly waiting on hold to get an appointment, watching sign-up websites crash or loitering outside clinics in the often-futile hope of getting a shot.

She adds, agreeing with some of the points made by the commenters on the site, “I don’t blame the lucky recipients; after all, hospitals would just offer the unused vaccine to the next person on the list,” but also notes that “The problem is that often, people are not really being “offered” the vaccine; in some cases, they are grabbing it through position, influence or deceit.” How often? I don’t know, and probably Rosenthal does not either. Or, for that matter, those who posted comments on the page, although they seem to be from NY and likely to know a lot more about the situation there than I do.

Most likely, the predominantly white recipients of the vaccine being offered in minority neighborhood represent a spectrum of people. They would include those who consciously believe that they are special and privileged and deserve to be at the head of the line, those who believe in equity but let that concern be overcome by their self-interest, and those who are appropriately candidates for the vaccine in the current phase but are desperate, confused, and, with no negative or ignoble intent, found their way to that place and time. Defending the latter, however, does not excuse the former, and there are certainly many of them. Freeman’s Law (which I should probably rename “Freeman’s First Law” so as not to confuse it with Freeman’s Second Law, to which I referred in my blog post of January 28, 2021, “Vitamin D, false nostrums, and conspiracy theories: The world has enough real problems,”) states that in any program designed to help a group of people, no matter how narrowly defined, those with the relatively least need are most likely to benefit. Thus in a program designed, say, to help homeless pregnant teenagers with HIV living under bridges, those who have some greater resources (a bit more education, a slightly less traumatic childhood, etc.) will be the ones who are able to access it first. The larger the universe of people who are targeted, the more people who would qualify for services, the greater the disparity is likely to be. This is of course especially true in the case of COVID vaccine, where the target population is, ultimately, everyone.

Another aspect of the comments posted that was interesting to me was that they referred to those seeking to get the vaccine as “patients”. Perhaps this is understandable on a medical site, and it is quite possible that some of those involved were patients of those doctors who made the comments. I have sometimes been critical of the use of the term “patients”, noting that it was the “medical” word for what in English are called “people”, and that it could tend to diminish their humanity. I am quite sure this was not the intent of those using it, but in this context it has quite another flaw. Calling folks “patients”, especially when they are not your patients, carries a connotation of dependency, needing help from their doctor. Calling them “people” implies more that they have agency, the ability to make decisions, prioritize needs and values, and act on them. While it is often true that many people, particularly the sickest and oldest and least educated and least empowered do need help, it is also true that when the affected universe is the entire population, it includes all of us, all people, adults and children, young and old, Black and White, rich and poor, doctors and “patients”. It includes those who are the wealthiest, most educated, most connected, and most empowered, who are often find ways to get to the head of the line. Thus, prioritizing who should get the vaccine first and enforcing that is critical. Social justice is about promoting equity, which means giving more help to those who have the least and need it the most, and reducing the temptation to give in to those whose privilege or loud voice is most demanding.

Rosenthal writes:

The United States has allowed its public health system to become a hollowed-out underfunded mess, and many vaccination clinics are being run and staffed by contracted private companies. And the private sector has so far proved too vulnerable to private favoritism.

Until the supply is sufficient, the government needs to give the shots to the people and places that need it most, and find ways to ensure that the plan is followed; the system could prioritize ZIP codes that have high Covid-19 infection rates or target low-income populations who might otherwise have a difficult time securing an appointment.

She is absolutely correct, but clearly targeting certain ZIP codes is not sufficient, as the Times describes on February 2, 2021 in ‘Even in Poorer Neighborhoods, the Wealthy Are Lining Up for Vaccines’ (Feb 3 print title: ‘Where poor suffer most, wealthy find vaccines’). And a 52-year old celebrity on-line fitness trainer got the vaccine as an ‘educator’.  Meanwhile the COVID surge most hurts those in the poorest neighborhoods, as in LA. And people behaving as though the doors were opening at a department store the day after Thanksgiving is not just a NY problem. a friend in another city, on seeing the pushing and shoving, both literal and figurative, that went on when they went to get their vaccine, said “I wouldn’t want to be in a concentration camp with those people.”

The problem, if you think it is a problem, of empowered people going to poor neighborhood to get their vaccines is real and ongoing. I think that folks who do so are doing a selfish thing, a bad thing. This in itself does not make them bad people, or certainly scum. However, for the record, I personally believe that there are indeed bad people, and that doing enough bad things often enough, predictably enough, and bad enough does make someone a bad person (see, e.g.,”Nazis”).

We should have compassion for those with need, and the most compassion for the greatest need. And recognize that “me” is not the hallmark of social justice.

Scamming Medicare: It's the providers and insurers, not the patients!

I have often written about universal health care and favored a single-payer system, or, in its current incarnation, Medicare for All. I still do and will have some more to say about it in a bit, but wanted to begin by providing some recent examples of the outrageous abuses of our non-system of health care. More important, abuses of the people who are supposed to be receiving health care. Actually, it is not so much that these are examples of new practices, but rather that there have been important recent articles exposing them.

In “Where the frauds are all legal” on December 7, 2019 in the NY Times, Elisabeth Rosenthal, an opinion writer, physician, and editor of Kaiser Health News, describes exactly that. Dr. Rosenthal has often written on the same theme, notably in a wonderful book that I have recommended before, “An American sickness: how healthcare became big business and how you can take it back”, but this recent article was precipitated by the experience of her husband following a serious bicycle accident. Dr. Rosenthal describes a number of scams (and they are scams, even if they are legal) perpetrated by the hospital, and gives them cute and memorable names; it is good enough to summarize here.

1.      Medical Swag, such as charging $319 for a plastic brace that was in place for an hour (and you may or may not get to keep it!) and other such goodies, “…like the sling you can buy at Walgreens for $15 but for which you or your insurer get a bill for $120 after it is given to you at urgent care.”

2.      The Cover Charge. This was the $7143.99 “trauma activation fee” charged by the hospital. This was in addition to whatever else was charged by physicians, for x-rays, labs and medical equipment. ‘Trauma activation fees have been allowed since 2002, after 9/11, when the Trauma Center Association of America, an industry group, convinced regulators that they needed to be compensated for maintaining a state of “readiness.”’ But, she asks, ‘Wait. Isn’t the purpose of an E.R. to be “ready”? Isn’t that why the doctors’ services and scans are billed at higher rates when they are performed in an emergency department?’ Note: Dr. Rosenthal in an emergency physician.

3.      Imposter billing. This is when the physician bills for a service that s/he didn’t provide directly, such as when it was done by a resident or PA or NP. Sometimes the physician is on site, sometimes not. But they are billed at the full physician rates. Cool beans. This is what allows some doctors to see a panel of patients in clinic while they are in the operating room at the same time!

4.      The Drive-By. Charging for full examinations (which are documented as full examinations after just a few questions – or even a phone call). Sometimes only a few questions are all that is appropriate, but you can’t – or shouldn’t – be able to bill for a physical examination!

5.      The Enforced Upgrade. Meeting someone in the ER, even for a minor problem, because the office is closed (in the specific case, the clinic the doctors used was open only 2 hours 45 minutes two days a week), causes much, much higher charges.

What is sometimes more amazing to me is that the insurer paid for all these things. Part of the reason is that they have no way of knowing if these upcharges were medically necessary. Sometimes (as pointed out in Rosenthal’s book) it is because they just pass the charges on by raising their premium rates. Of course, insurers don’t pay the full charges – they pay a significant discount. Only uninsured people are expected to pay the full charge!

So these are pretty outrageous, but mostly (as the title points out) legal, if outrageous. Not, however, necessarily legal would be the overcharges and payments from Medicare to certain insurers documented in a report from the DHHS Office of the Inspector General, and covered by the Times in “Federal Watchdog Questions Billions of Dollars Paid to Private Medicare Plans” by Reed Abelson, December 12, 2019. This is a different sort of scam, perpetrated by Medicare Advantage plans. To start with, Medicare Advantage plans are something of a scam to begin with. Why? Well, on the surface, “all” they do is to essentially provide Medicare patients with the benefits of an managed care plan – indeed, often you may an additional premium on top of Medicare to the insurer and you have wrap-around HMO-type coverage. This can be really good for you as a consumer; you can get covered for vision, hearing, prescription drugs (without the need for an additional Part D plan), and copays. What makes it at its essence a scam is that the Medicare Advantage plans get higher payments for a variety of reasons than does traditional Medicare.

One reason is that they tend to enroll lower-risk patients, who cost less to care for. To some degree this is because they have the disadvantages of HMOs as well as the advantages; limited physician and hospital networks and limited portability if you are out of the geographical service area. But most of it is from the way that they are marketed. It is to these insurers’ financial advantage if as many of the high-utilizing, high-cost, older, and sicker Medicare patients are in traditional Medicare, and the ones who are younger, less-sick, and lower-utilizers – thus lower cost – are in their plans. They work hard to make this happen, When the Trump administration pushes Medicare Advantage, as when Center for Medicare and Medicaid Services (CMS) administrator Seema Verma says “What works in the Medicare program is Medicare Advantage — because plans are competing on the basis of cost and quality, driving toward value and increasing choice to beneficiaries,” it is true – but, as with any other for-profit product, it markets its advantages to those most likely to make it money.

Then there are the probably-illegal actions found in this report. Primarily, these result from “up-coding”, having administrative personnel comb the entire medical records to find things that they claim allow them to bill for higher-complexity in patients who have more diagnoses, even when the person providing the care did not address those issues. Hospitals use reviewers to upcode all the time, and sometimes it may be legitimate, in cases in which the care was provided but not completely documented. This “data-mining” approach to upcoding, however, is not. And this is not all. The Times article also notes  that ‘An earlier report from the inspector general’s office also raised concerns about Medicare Advantage, concluding last year that plans were inappropriately denying medical claims as a way to increase profits.’ The amount involved is not chump change; an additional $6.7 Billion in payments in 2017.

So no good either way, “legal” scams by providers (read mainly “hospitals”) or probably illegal scams by insurers. Both illegitimately take our money (whether paid as taxes, premiums, co-pays, etc.) and funnel it toward profit. Would a single payer, Medicare-for-All program prevent this? Yes, although it would have to be the “Improved and Expanded” Medicare called for by the current bills in the House (HR 1384) and Senate (S1129). From the patient point of view everything is covered. From the provider point of view, they would not be able to game the system by upcoding and other techniques. From the insurer point of view, they would not make so much profit.

For too long, healthcare in the US has been a struggle between insurers (who think they pay the providers too much) and providers (who think that they don’t pay enough). The interests of the actual people, patients, taxpayers, rate-payers, are lost in this struggle, crushed by the tectonic plates of those big industries. Many politicians and pundits say we can’t go against them. I say we have to. As Jim Hightower says “Who’s afraid of Medicare for All: Not ordinary Democrats or independents — just insurance companies, lobbyists, and old-line politicians”.

Time to make them put our interests first!