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.

Doctors need to care: It's about the patients, not about you

 

 Recently, a friend of a friend had an accident and fell in her driveway. After two days of pain that did not improve, she went to an urgent care center where an x-ray was taken and the PA told her that there was no rib fracture and her lung had not collapsed, so she went home. The next day the urgent care center called back and said “whoops, there is a rib fracture and you do have a collapsed lung”. They said they’d call her primary care doctor, but didn’t. The patient tried to, but the doctor was on vacation. The covering physician refused to see her. So our mutual friend, who is a physician and surgeon who lives 1000 miles away, called someone who lived in the patient’s town to take her to the emergency room. There, they re-x-rayed her, and admitted her to the hospital, telling her that they would need to insert a small tube to remove the air (called a pneumothorax) from around her lung. The doctors said she refused the procedure, although she says she just asked some questions about it. She was admitted for “observation”, and given oxygen. In the morning, since the x-ray was no better, they said that they would have to keep her in the hospital, but this later was reversed on a visit from the resident on the hospitalist service, who said she could go home.

 Our mutual friend called the resident, asked about it, was told that it was OK to discharge her (quoting the “resident’s best friend”, the medical information website UpToDate®) and would not put the friend in touch with the attending physician. However, the patient was terrified about going home, especially given her accident, that she lived alone, that she had had her bad experience with the urgent care center, and that her physician was out of town. I suggested that our mutual friend might try to contact a hospital administrator to see if the attending physician could be reached. Then I got a message that there was a new hospitalist over the weekend, who happened to be a family physician, and who tried a novel approach: she talked to the patient, examined her, and reviewed the chest x-rays. After this, she decided to call a pulmonary specialist, and it was decided to insert a chest tube. The patient, with the proper treatment, improved and should get better.

 So probably the story will have a happy ending, at least from the point of view of ultimately getting the right treatment. The woman who was the patient may recover physically, but is unlikely to recover a lot of faith in what is amusingly called our health care “system”. The number of things done wrong were many, and most could be blamed on the individuals; the PA in urgent care who mistakenly thought that they could accurately read the chest x-ray, the provider in the emergency department who was apparently in too much of a rush to answer her questions and decided the fact that she had them meant she was refusing the recommended treatment, the hospitalist service who changed their mind about her need for hospitalization without explanation, the resident who would not contact the attending physician, and the attending physician who apparently did not want to be contacted.

 But to blame just the individuals would be incorrect, although we can be very enthusiastic in lauding the weekend hospitalist who decided to actually care for the patient. The system is critical here. I do not know that hospital, but I imagine the doctors in both the emergency department and on the hospital floors are stressed an overworked, and that the way they responded to the patient in question, while unjustifiable, was probably caused in part by that overwork and stress. The resident may have been the “point person” in contact with the patient, but the service attending was ultimately the one making the decision. Poor role modeling by attending physicians and senior residents is common and leads to poor behaviors by residents, who are often more concerned with their own workload or pleasing their bosses than providing proper patient care. In such busy situations, patients are often assessed quickly, and judgements are made not just regarding their medical problem, but their personality. Are they going to be a “good patient” – meaning that they will quickly accede to doing what I am recommending -- or are they going to cause me “trouble” and cost me time? That trouble can be real if the patient is aggressive, intoxicated with alcohol or other substances, or has a serious mental health diagnosis, but it is sadly true that the label “troublesome” patient can even be applied to someone who asks perfectly appropriate and reasonable questions about the treatment being proposed for them.

 Racism provides us with a bit of a metaphor, in the sense that there is both an individual and a structural (or institutional) component. Yes, behavior by individuals can be inappropriate and wrong and blameworthy. But if we leave it at that, if we do not understand the overall structure that encourages or facilitates such individual behavior, we will never solve the problem. We will never decrease or end racist behavior, and we will never ensure that patients get treated with the respect and concern that they should. Racism affects the medical system and medical education as it does the rest of society, but disrespect and self-centeredness can inhibit appropriate medical care even when race is not involved. Indeed, in this case the patient was a 70-ish middle-class white woman. One can imagine with what frequency, and to what degree, people are treated with disrespect – and poor medical care – when they are members of minority groups, poor, homeless, have a psychiatric diagnosis, are not clean and nice-smelling, are not coherent, are under the influence of a substance, etc. Of course, if one is a health care worker, one need not imagine it; one sees it all the time.

 As a family doctor, I would like to take pride in the fact that the “hero” of our story also was one. In fact, I will. I actually believe that the training of family physicians, and the emphasis on caring for the patient rather than a particular problem, makes a difference, and enhances the caring characteristics of the individuals who choose to enter this specialty. That is, I think it is more than a coincidence. However, of course there are wonderful caring physicians, including resident physicians, in every other specialty, as well as family physicians who are jerks. I just think that it is a smaller percent.

 Should there be any jerks in medicine? I have heard it argued that in some specialties, it is not necessary to have good “people skills”. In pathology, or diagnostic radiology, or even anesthesiology, where the doctor spends little or no time with living patients. Or in surgical and other procedural specialties, where technical skill, not “bedside manner”, is what matters. Sometimes I have acknowledged that this made some sense. Until I thought about the colleagues I have had in every specialty. And in every case the good ones cared about the patients they were involved with, whether or not they met them face-to-face.

 The pathologist or radiologist knows it is also their patient, and the use of their skills in the performance of their jobs may make the difference in a person’s life, or death. They care. Caring may not be the same as “people skills”; we recognize that some people have greater difficulty connecting directly with others, and are certainly not trying to create a profession full of hucksters and snake-oil salesman with false charm. But we do want one whose practitioners can convey concern, and caring, and at the minimum not disparage the people who are in their care.

 So, yes, I think that everyone admitted to medical school should care about people. And, yes, I think that we need to ensure that our medical education does not beat or role-model it out of them. Our residents need to have schedules and lives that are reasonable enough that, when they are tired or frustrated, they don’t act out. Our attending physicians need to be available.

 Even when you are tired or overworked, it is not ok to be cruel or insensitive any more than to be racist or sexist. After all, there is a reason that this profession exists, and it is not to provide a good life for the practitioners. It is to try to maximize the health of the people for whom it cares.

Corporate control corrupts medicine and reduces healthcare quality

Medicine and health care is always changing, and the pace of change seems to be accelerating. Some of this change is good for people -- some of the new drugs that come out actually help, either a lot of people, or more commonly a few people. Sometimes new treatments are more effective, less painful, shorter, or less debilitating than older ones. And, sometimes, they are not. One thing we can be sure of, though, when we see a new treatment advertised, whether on TV or in a magazine or on a billboard, is that someone is making a lot of money on it.

There has been a great deal of coverage of two of the most important and egregious industries in which large corporations make lots of money at the expense of our health: pharmaceuticals and insurance. They deserve it, and I have written about them often. But another extremely important area where corporatism and corporate culture has taken hold and is expanding is in the ownership and management of hospitals. The most important thing about this increasing corporatism is that it is about making money (even in “non-profit” hospitals), not primarily about providing the health care that people need; of course, if what you need (or can be persuaded to buy) is profitable for the hospital, they’re all about it. For example, new surgical techniques and imaging, and particularly high-margin, low risk procedures like joint repair and replacement in otherwise relatively young healthy people (let’s go for that high school quarterback or 40-something weekend warrior). Not so much problems that occur in people who have multisystem disease, are old, are high risk, or are poor and uninsured. And some stuff – like psychiatric treatment for the most needy, or trauma care, are big money losers. Hate that if you’re a CEO, although might be good if you are a person who needs it.

This trend has been going on for a long time, particularly in large metropolitan areas, where most big hospitals are, and most of them are now part of hospital systems. Of course, big hospitals were always big, but the overemphasis on making decisions based upon money rather than people’s health has been accelerating. And more recently the process has taken over hospitals in smaller communities, including Critical Access Hospitals in rural areas. The Critical Access designation is meant to reflect the geographic isolation of a community, such that travel to the next-closest hospital creates real health risks for the population, and so even if operating it is inefficient, it receives federal support.

This is discussed in an outstanding editorial by Andrea Wendling in the October 2018 issue of Family Medicine, “Times Are Changing”. Dr. Wendling focuses on two major areas, the reinterpretation of the “value” of physicians and the role of family physicians. Family physicians are the most common specialists in rural areas, in part because they can have such a wide scope of practice. They can care for the medical problems of adults and children, deliver babies, provide care for many musculoskeletal problems, mental health, women’s health care, and provide many procedures. At least as important to patients, they can see them in all the venues where they need to be seen – the office, the hospital, the nursing home, and even the patient’s home. Dr. Wendling notes that this is threatened by the corporate perception of physicians’ value, which is their value to the system, measured financially, rather than their value to the health of the community. Yes, you might find it beneficial to have a doctor who knows you, who has cared for you and your family for years, be able to see you in whatever setting you find yourself in, but the system has decided it is more efficient (read “more profitable”) to have your doctor be only an ambulatory care provider, or only a hospitalist.

It is not only family physicians who are affected, although they predominate in rural areas. While some specialists – those that provide care that is not necessarily the most important, but is the most profitable – have always been more highly paid and more sought after by health systems, even they are seeing decreases in their pay and status. It is hard for the family physician to cry for slight cuts in the income and power of doctors (like orthopedists and radiologists) who are making many times what they do, and in fact it is hard for most Americans to cry for the plight of even the lowest-paid doctors. Perhaps it feels like crying for the white men who bemoan their loss of privileges (real and desired) because women and minorities are finally moving the playing field to being, at least a little, more equal. But the corporate influence is far more malignant.

Family doctors believe that their contribution to people’s health is relatively greater than their income. Doctors believe that, whatever their income, they are working to improve people’s health. CEOs and corporations believe that health is a good thing to try to sell, provided we sell the kind that makes money. They do not put the health of the community first; they put the financial well-being of the corporation first. And, not surprisingly, this affects both poor and rural communities the most, because of the limited access to services they had in the first place; an arrogant and self-serving corporation taking over the only hospital in a community does not bode well for the overall health of the people who live there.

And, adding insult to injury, it is not only the dollar-centered approach that is a problem, it is the egos of the local leaders who, emulating their corporate bosses and our political class, think that they as individuals are important and deserve respect and obeisance. I have a friend who led the physician group at a rural hospital when it was taken over by a larger system, and helped negotiate the criteria for bonuses for the medical staff. Soon after, that physician was fired by the local CEO for “embarrassing them”! The doctor got their job back with the help of lawyers, but imagine the gall of that CEO! If what they were doing was right and good, they had no reason to be embarrassed; if they had reason to be embarrassed because what they were doing was corrupt, self-centered, not good for the physicians or for the community’s health, what they were doing was wrong and should have been exposed. I have no doubt that if the people in that town were asked who they valued more, the physician who had cared for them for years or the new CEO put in by a corporation, which one would get more votes. Maybe the CEO would get that of their spouse.

So we have a health care system that is structured to be corrupt, from the insurance companies, to the drug and device makers, to the big health systems, all geared to profit. We have many physicians, in all specialties from the rich and powerful subspecialists to the family physician, who are trying to figure out how to stay on the “good side” of these corporate systems and of the local martinets. We have physician leaders, in hospitals and medical societies and academic departments who often are looking mostly at themselves and how to show that they as individuals are important (like that rural CEO), maybe believing that what is good for them is somehow good for people. Sadly, this is even true in family medicine, no longer the ‘counterculture’[1] its founders, like Gayle Stephens, wrote about, but now often simply other supplicants for corporate largesse.

All of this is at worst immaterial and at best subsidiary. The criteria for whether a healthcare system or aspects of it are good is whether it improves the health of people and the community. We have a long way to go in our healthcare system. And it’s long since time to get started.

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[1] Stephens GG. Family Medicine as Counterculture. Fam Med 1989; 21(2):103-9.

Free tuition in medical school is only one step toward producing the doctors America needs

The NYU School of Medicine shook the world of medical education recently by announcing that tuition would be free. The NY Times article about it says that ‘Rising tuition and six-figure loans have been pushing new doctors into higher-paying fields and contributing to a shortage of researchers and primary care physicians.’ Certainly, it is easy to understand that a $55,000 per year tuition bill is going to be way beyond the ability of most medical students and their families to pay, and that a total indebtedness that is often over $250,000 may well affect the specialty choice of medical school graduates. While physicians in any specialty make far more than the average American, compound interest makes the payments a lot more than $25,000 a year for 10 years; often more, indeed, than that average American income (think about the payments on a $250,000 home loan, which usually has a lower interest rate). This may tip the balance between choosing betwee, say, family medicine or anesthesiology, when the latter choice can be expected to result in an additional $7 million in lifetime income.

The other, presumably obvious, impact of free tuition could be the ability of the school’s admissions committee to take more students from lower income families than they currently do. Note “lower income” is not necessarily the same as “low income”, as 80% of medical students now come from the top 20% of income. And, yet, they still have a lot of trouble paying for school, tuition plus the Times’ estimated $29,000 a year in living expenses (in NYC). It is not necessarily true that ability to pay is a significant criterion in the admissions decisions of medical schools, but rather that there are confounders. A big one is that being from a high-income family is associated with having the higher grades and test scores that are so valued by medical school admissions committees (probably especially those, like NYU, that are very interested in producing MD/PhDs and other laboratory researchers). Free tuition, however, might mean that those students from lower-income families who do gain admission will be under less financial pressure to take paying jobs while in school (a really bad idea when trying to succeed in medical school). In addition, those students who have started their own families or whose families of origin have counted on them helping to support them, would have one big less thing to worry about.

We definitely need more family physicians and other primary care doctors than we are producing now (and NYU has produced one of, if not the, lowest number family physicians of all US medical schools). We also need far more students from lower-income and underrepresented minority and rural backgrounds. The reason is not just for ethical or moral, or making up for past practices. It is directly about providing quality healthcare to all the American people, because physicians are most likely to practice in settings like those in which they grew up and feel most comfortable. Thus, students from upper-middle and upper income, primarily white (and Asian) suburbs are most likely to practice in those settings – which are precisely those least in need of more doctors. Students from rural or low-income or minority communities are much more likely to practice in such communities, and these are the places most in need of more doctors. Of course, the correlation is far from 100%, but the trend is overwhelming. Thus, to the extent that free tuition can increase either of these goals, it would be a great thing.

So what is the problem? Well, it is far from certain that free tuition will lead to these desirable outcomes. This point is made by family physician (and NYU medical school graduate) Kenny Lin, MD, in his Common Sense Family Doctor blog. Although Dr. Lin’s 2001 class had only four graduates entering family medicine, it was a larger number than any class since. He points to the fact that NYU has never had a Department of Family Medicine (one of the few such schools, almost all of which are “elite” private and on the East Coast). He also notes that in terms of producing other primary care doctors (general internists and general pediatricians), NYU has also done very poorly.

More important, Dr. Lin cites a study published in the JAMA Network by Grischkan, George, Chaiyachati, et al., that demonstrates that students entering family medicine (one of the lowest paying medical specialties) have a higher average debt load than those entering fields such as radiology, dermatology, and ophthalmology. He writes

These findings suggest, paradoxically, that physicians with the highest debt burden are preferentially choosing a specialty with among the lowest income expectations - why on earth would that be? What it says, actually, is that students from less well-off backgrounds are more likely to be attracted to primary care in the first place.

This is a very important point. Dr. Lin, focused on the critical issue of producing more family physicians and primary care doctors, believes that eliminating tuition and thus taking students from more diverse backgrounds “will likely have a small, but measurable, positive effect on primary care.” He urges that NYU and other schools increase their “pipeline” programs to help students from less advantaged background gain the skills that they need to be both admitted to and successful in medical school. I agree, but I would go beyond that.

Medical schools should train the doctors America needs. This means fewer subspecialists, and more primary care doctors. This means a smaller percentage of doctors practicing in the suburbs of big cities, and a larger percentage practicing in rural areas and underserved inner-city communities. This is not going to happen if we keep taking the same students we currently do, no matter how nice they are, no matter how high their grades are, and no matter how much they are like (or often are) the children of the faculty of the medical school. If you don’t think this is important, a recent paper from the National Bureau of Economic Research by Alsan, Garrick, and Graziani titled “Does Diversity Matter for Health? Experimental Evidence from Oakland” (reported in the Times article “The Secret to Keeping Black Men Healthy? Maybe Black Doctors”) demonstrates that it does: a significantly higher percentage of black men received important tests, took medicines, and made lifestyle changes when advised to by a black doctor rather than a white or Asian one. Importantly, this comes from more than a knee-jerk reaction to the race of the physician; it has a lot to do with how they were treated. While the ‘white and Asian doctors often wrote comments like “weight loss,” “tb test” and “anxiety” — cryptic notations that referred to medical recommendations…black doctors often left more personal notes, like “needs food, shelter, clothing, job’. This goes beyond race, and suggests that both our overall medical curriculum focuses too much on the disease and not the person, and further that minority physicians may be more likely to realize that it is a person who needs to be treated, and identify the social determinants of health.

Indeed, Elisabeth Rosenthal, the editor of Kaiser Health News, argues in an Op-Ed in the Times that medical school should be free only for those who make a firm commitment to entering specialties and practicing in areas that have real need:

…if a student chooses to become an ear, nose and throat surgeon in suburban New York or a private cardiologist in Miami, fine. He or she can pay back what has been borrowed. But if that doctor chooses to deliver babies in rural Oklahoma or practice pediatrics on the South Side of Chicago, then he or she should get to keep every penny of salary.

I agree, and believe that to make this likely, medical schools, both private “elite” schools like NYU, and certainly state-supported schools, need to take a much higher percentage of students from the lower half of the family income scale, from rural areas and from groups that have been historically underrepresented in medicine. And not just a few more, not just a pilot program with 2% or 5% or 10% of the class. These programs must be far more extensive. The entire class should be composed either these groups of students or of students who, while perhaps from wealthier, whiter, more suburban backgrounds, have demonstrated an extended commitment to service to others. Extended, like the Peace Corps, or Teach for America, or VISTA, or working abroad for years in service programs, not a car wash fundraiser one Saturday.

Some, and sadly this may include many in the administration of medical schools, particularly “elite” ones, will say this can result in the exclusion of the “best” applicants. It may, in fact, lead to the exclusion of some of those with the highest grades, and may even require additional work on the part of the faculty to help students with less rigorous academic preparation. Or, perhaps, elimination of much of the nonsense memorize-detail coursework of the pre-clinical curriculum. But while “best” can mean many things, if the definition is not “most likely to make a positive difference in the health of all the American people” it needs to change, and soon.

Free tuition, at NYU, or other private schools, or state-sponsored schools, may be a terrific idea, and one that should be widely imitated. But it is only one part of an overall strategy, including changes in the selection of applicants, the curriculum of the schools, and the reimbursement of primary care, to significantly change the kinds of doctors that are produced so that they meet our nation’s needs.