Drugs, Tobacco, Doctors and the Health of the Public

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Drugs (the legal prescription type) and drug safety seems to continually return to the news, most recently with reports of serious side effects from a new oral contraceptive pill (OCP), featured on NPR’s "Morning Edition”. With regard to OCPs, it is important to note that virtually all the side effects of oral contraceptives, including the serious ones, are the same as the ones women are at greater risk for from being pregnant. The fact that pregnancy is a “natural” event does not make it risk free; complications such as clots in the veins of the legs (deep venous thrombosis, DVT) do occur, associated with the higher levels of estrogen in pregnancy, and occur more frequently than they do for women taking oral contraceptives. Whatever one’s level of risk for OCPs, a risk that increases with increasing age and dramatically if one smokes, that risk is greater from being pregnant.

However, because the probability of getting pregnant (and thus having serious “side effects” from it) decreases with increasing age while the risk of serious side effects from OCPs goes up, it makes sense for older women who are still fertile to use alternative types of contraception – but, unless they are actively trying to get pregnant, to use contraception. The fact that OCPs can have significant benefits (mainly: preventing unwanted pregnancy) does not make them benign, but neither is pregnancy itself.

The choice to use or not use drugs for any condition (or for prevention of a condition), whether they are prescribed by a health care provider or, in the case of many nonprescription drugs, chosen by the person him/herself, is influenced by number of factors. The best one is that a person has a condition that puts them at risk for bad health outcomes (the “patient important outcomes” of premature death or decreased quality of life; see Calcium, Heart Attack and Osteoporosis, August 2, 2010; Rosiglitazone and the "Holy Grail" July 16, 2010; Statins and scientific integrity, July 6, 2010), and the probability that a drug will decrease that risk is significantly greater than the probability that the drug’s effects will cause a problem. There are sometimes other reasons; a person (patient) will hear from a friend that a drug worked for them, or see on it advertised on television or elsewhere, and decide to try it (if non-prescription) or ask their doctor for it (as so often urged on TV commercials). Depending on a number of factors (whether the drug is in fact useful or potentially useful for something the person has, whether it might create increased risk for the patient, how persistent, or even demanding, the person is) the doctor might in fact prescribe it.

In general, it is fine if you ask your doctor about a medication that you have reason to think might benefit you, but probably not such a good idea to persist/insist if s/he suggests it would not be advisable to take it. A few cautions and things to think about, some of which I have previously discussed (“Conservative” Drug Prescribing March 11 2009):

• Not everything is effectively treatable with a drug. Taking a pill may be easier than changing your diet or exercising or doing other hard or proactive things, but without those other activities it may not work or work as well, and may well be worse;

• Not all drugs are “bad”. Some are really helpful for the right people with the conditions that they are effective in treating, and the potential side effects are far less than the benefits.

• Because some drugs do not require a prescription this does not make them “safe”. They should still only be used when the same criteria are fulfilled: scientific evidence demonstrates that the probability of benefit significantly exceeds the probability of harm. The same applies to any “nutritional supplement”. Because it is not called a “drug” doesn’t make it safe. Everything has potential for harm in the wrong people, the wrong circumstances or the wrong dose (Dietary Supplements can be Dangerous for your Health, October 31,2009)

• If a little is good, more is not necessarily better. Nor is less necessarily better. The right amount is: the right amount!

• Despite our culture’s fascination for the “NEW!!”, new is not necessarily better. Frequently it is worse. Drugs are not cars or cell phones. Newer drugs may have side effects that have not become apparent in the necessarily limited testing that is done before they are marketed, but do manifest when many times more people take them. They sometimes have therapeutic benefit for some people that is greater than old drugs, but often they do not. The only reason to even consider a drug that is new on the market is if your old drug, and the other available old (=”well established”) drugs don’t work adequately or have intolerable side effects, and there is reason (=”evidence”) that the new one will (work better), or won’t (have those side effects).

• Advertising drugs, whether to physicians or to patients, is pretty much a bad thing. As in all advertising, the goal is to sell stuff; it is not (despite pharmaceutical company slogans) improving people’s health. This is highly tied to “NEW!!” because it is the new drugs that are the ones that are advertised. This is because they are the ones that cost the most, that have the highest profit margin, and that the companies need to develop a market for. They also have to amortize their research and development costs, as they will often point out. This would be a less offensive claim if most of the drugs that came out and are heavily marketed were not “me too” drugs – modifications (often quite minor) of existing drugs that are no longer under patent and are being sold generically. Drugs that the doctor may have in his/her “sample closet” will always be these same drugs – the newest, highest cost (and highest profit) options. In health care, if something is being advertised, whether a drug or a procedure available at a local hospital, the meaning is “we would like it if you would buy this because we will make money” and not at all necessarily “this will be good for your health”. By the way, in the case of advertised procedures that you may see on billboards for a hospital or clinic, it means also “if you have insurance”.

The issue of advertising to physicians is addressed in an excellent editorial by Matthew Anderson in the current issue of Social Medicine. It examines the historic and current collaboration by medical organizations with big corporations. In addition to the AAFP/Coca-Cola alliance that I have recently written about, it examines the relationship between the American Academy of Pediatrics (AAP) and infant formula manufacturers and the tight involvement of the AMA with pharmaceutical companies. It is eye opening. In addition, the journal contains a powerful piece by Alan Blum introducing two classic articles about physician activism around tobacco written by the same Dr. Blum when he was, 20 years ago, editor of the New York State Journal of Medicine: “Cigarette smoking and its promotion: Editorials are not enough” and When “More doctors smoked Camels”: Cigarette advertising in the Journal” . The introductory quotation to the first article, from Ira Gershwin of all people, cannot be repeated often enough “One man's death is another man's living”.

And, for those who doubt that, given the current shameful practices, sometimes, given enough time pressure and public awareness, progress is possible, it is worth just looking at the Social Medicine’s cover to see how far we have come, in at least the relationships between doctors and tobacco.
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Advice for building a new primary care based health system for Armenia: How "knowing the future" can inform our actions now

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This is a guest post written by Heidi Chumley, MD. Dr. Chumley is Senior Associate Dean for Medical Education at the University of Kansas School of Medicine.

Recently, my husband and I (both family physicians) and our colleague (a health systems researcher in our family medicine department) visited Armenia as guests of the Kansas National Guard and USAID. Our mission was to learn about the evolving Armenian health care system, develop relationships, and move towards an end goal of providing assistance to Yerevan State Medical University as family medicine continues to develop in Armenia. We knew a little about their health care system before we visited, as our colleagues had made two prior trips.

After the collapse of the Soviet system, the Armenian government endorsed the development of a primary care based health care system and chose family medicine as the discipline to provide that base. We knew they were interested in learning about the family medicine curriculum in medical school, residency, and after residency in the US and specifically at the University of Kansas. So, we prepared our presentations about family medicine training, packed our bags, and worked with the US embassy and YSMU to set up a schedule. We met with officials of YSMU and their department of family medicine, a representative from the ministry of health, and the chair of the department of family medicine at their “NIH”-equivalent. During the course of these meetings, we learned of their two major strategies: 1) retrain "narrow specialists" (their term for physicians who restrict treatment to patients based on age, gender, or organ system) in a one-year program with a national curriculum and 2) begin 2-year family medicine residency programs. Over the past decade, they had retrained 1200 narrow specialists as family physicians. Also, there are 2 government-sponsored family medicine residency programs, training a total of 9 residents per year.

As you might suspect, when there has been no family medicine before in a country seeking to develop family medicine, there are no family physicians to lead the movement. There are narrow specialists who have learned about the value of primary care, endorsed that system, and are working together with other narrow specialists to provide as broad training as possible. This reminded me of what might have happened in the US as family medicine became a specialty. Visiting Armenia was like being granted a rare opportunity: a glimpse into our past, with a known future, poised at an important moment in time. It gave me a chance to reflect on what happened in the US that led us to a specialty-centric health care system and what decisions may affect whether or not Armenia is able to transform to a family medicine based health care system. At our exit meeting with the director of USAID in Armenia, we mentioned that the best way we could help would be to outline pivotal decisions that will either be made or just come to be as if a conscious decision was made. I've scripted those insights into concrete “dos” and “don'ts” based on knowledge of what transpired in the US health care system. Here is my advice, for what it is worth:

· Don't train your primary care doctors in a system where they only rotate with narrow specialists.

· Do train your narrow specialists in primary care settings to help them keep a sense of probabilities.

· Don't make family medicine training shorter or less prestigious.

· Do shorten procedurally based specialty training when possible, creating a system where new narrow specialists continue to develop their procedural skills under a proctoring system funded by private practices seeking new partners instead of the government.

· Do provide a sufficient number of government sponsored family medicine residency positions to produce the physicians needed to provide care for the population.

· Don't provide government sponsored narrow specialty residency positions at a number greater than what is needed for the population.

· Do set goals or metrics for how much a family physician should be able to manage (80% to 90% of what walks in the door).

· Don't enable a system that supports narrow specialist to narrow specialist referral.

· Do a national educational campaign on primary care concurrently with the improvement in the training of primary care physicians.

· Don't pay narrow specialists more than primary care physicians.

· Do follow outcomes and reward improved health of a population.

· Don't financially reward overuse of services.

· Do seek to become a nation in the top 10 of all nations on important health care outcomes.

· Don't spend 8 times as much as the other nations and remain below 40 other nations on health care outcomes.

I was also struck with this amazing reality: only a country as economically blessed as the US could even fathom conducting health care as we do. It is irresponsible of us to hold up our version of western medicine as a model. It won't work except in a society where the people have too much.

In fact, it doesn't work in our society for the people who don't have too much. It often doesn't even work that well for those who do.
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Medicine, science, and humanities: what is their role in medical education?

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How much of the practice of medicine is “science”? How much science, as in “how many science courses” should be required of students applying to medical school? How much science must be taught to students once they are in medical school? To what degree does this require the memorization of mountains of facts as opposed to learning to and practicing the scientific approach to thinking and problem solving and analyzing data? What about other material that might help in being an effective physician…the social sciences of psychology, anthropology, sociology, or the broader content of a “liberal” education such as literature, history, philosophy, foreign languages? Is there a place for these in medicine? Is there a need for these in medicine? If there is, what is the best way to ensure that students acquire the knowledge, both temporally (prerequisites or in medical school) and pedagogically?

These questions are important to medical educators, and to students planning to apply to medical school, as well as “pre-med” advisors in colleges. Most medical school faculty are physicians or “basic scientists” (physiologist, biochemists, anatomists, pharmacologists, neuroscientist and those straddling the disciplines or creating new ones). There are usually a few social scientists, especially epidemiologists and psychologists, based in departments of preventive medicine, community medicine, and public health, and psychiatry. There are also likely to be a small number of people with degrees in education (largely in the office of medical education), and in humanities (frequently involved in teaching ethics, the branch of humanities most commonly taught in medical school). In general, the basic science faculty believe that the material they teach is crucial to the creation of competent physicians, while clinicians range from agreement (perhaps less passionate) to a belief that they don’t use or remember much of the biological sciences that they had to learn, and the main thing students need to do is to get through it, pass “Part I” (of the US Medical Licensing Examination, USMLE, which emphasizes basic science and is usually taken after the first two years of medical school), and get on to the “important stuff”, their clinical education and training.

Occasionally, the faculty even engage in in-depth discussion and analysis of how the material is taught; whether intensive study of sciences in the first two years of medical school tested by recall of facts on examinations is the best way to learn – and retain so that it can be used years later in clinical work – the content. Many, if not most, schools, have gone to some form of “integrated” curriculum in the first two years, most often based on organ systems, teaching the aspects of each of the basic sciences relevant to that system, mixed in with clinical perspectives, epidemiology, ethics, and social determinants of health. Most have decreased the number of hours of lecture and increased small-group learning, including Problem-Based Learning (PBL) in which groups of students review a patient case, with a facilitator, with the goal of learning how to approach thinking about a patient and their problems and how to work with not only their disease but with them, in all of complexities of life that they face. Some schools, such as the new Paul L. Foster Texas Tech medical school at El Paso, spent over a year with educators, clinicians, and basic scientists poring over every piece of the curriculum and how it would be delivered and reinforced, before admitting their first class.

I have often written about who does, or should, get into medical school, particularly in the context of predicting specialty choice for primary care (e.g., Medical Student Selection, December 14, 2008; Are we training physicians to be empathic? Apparently not., September 12 2009). A recent article in Academic Medicine, “Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program”[1] by David Muller and Nathan Kase, looked at the performance of students who were taken in a special program that did not have science requirements with that of “traditionally prepared” students. Their conclusion is that “Students without the traditional premedical preparation performed at a level equivalent to their premedical classmates.” Of course, there were some differences; they performed a little worse (statistically significantly, but still well) on the USMLE Part I. They performed better on their psychiatry clinical clerkship, and not significantly better or worse on their other clerkships. The success of the students in this program (“HuMed”) was great enough that more students who were not science (or “pre-med”) majors were accepted by Mt. Sinai outside the program; nationally, 18% of students matriculating in medical school in 2009 were humanities and social science majors while at Mt. Sinai it was 25% without HuMed students and 43% counting them. There are a lot of caveats: the HuMed program offered (voluntary) pre-matriculation introductions to organic and biochemistry, and the HuMed students were all very high performers in their areas of college study. Perhaps it means that if you are a very smart – and skilled, for being a successful student is a skill – student you can make it in medical school even without lots of premedical science, but if you are not, the science helps.

This article does not answer this question, but it did receive significant national coverage. The New York Times article by Anemona Hartocollis on July 29, 2010, “Getting into med school without hard science”, generated many blog comments and letters. One, by a Mills College professor of chemistry and physics, David Keeports, notes that “Many people have great personalities, but medicine is a science. A person who has avoided fundamental scientific and mathematical knowledge and the scientific approach to problem solving isn’t the person I want to see when I have a medical problem.” Well, he is a physical science professor, and maybe not representative of the entire population, most of whom really value the ability of a doctor to successfully communicate with him. More important, however, is his comment, that “I see no place in medical school for anyone who hasn’t demonstrated an ability to easily learn, assimilate and analyze technical information.” I agree with that completely; I have frequently written about the need to understand the scientific approach and thought process. I believe that the most important of these is epidemiology (listed above as a social science). It is critical that physicians are able to understand and interpret the data coming from scientific studies, and be able to explain it effectively to their patients. This is, however, different from being required to memorize huge numbers of facts that you will forget soon after the exam, and not miss later.

Because the amount of scientific information continues to increase, and because much of it renders what we used to “know” incorrect, medical school faculties should be able to identify what pieces of factual information a student really needs to know to become a doctor and to be able to think scientifically, identify how to effectively teach it and measure learning, and tie that to the skills that a practicing physician will need. The concept of “competency based education”, rather than an education devoted to learning and regurgitating content, has been around for a long time. One of the best publications on competency-based medical education was published by the World Health Organization (WHO) in 1978, and examine such education from an international perspective. Competency-Based Curriculum Development in Medical Education. An Introduction. Public Health Papers No. 68., by WC McGaghie, GE Miller, AW Sajid and TV Telder provides guidelines for effective teaching and learning in medicine that are as valuable, and as needed, today as they were more than 30 years ago when it was written. They argue against teaching a course (say, in the first year of medical school) and expecting that the material learned will be remembered and usable in future years. They note that only a small portion of what is learned in a course is remembered only a few years later if it is not used. I would add that the material that is remembered is less likely to be that which the student will need in the future than that which was so counter-intuitive that it took many hours of rote memorization. They argue for a curriculum that teaches relevant material, and effective ways of thinking, in the context in which it will be used, and teaching and measuring competency rather than memory.

Too much of medical education is driven by inertia and vested interest, e.g., these are the kind of students we’ve always taken, this is the material we’ve always taught, this is the way we’ve always taught it, this is the way we’ve always measured it, and (surprise!) the kind of students we’ve always taken are those who do best on the tests that we give which measure retention of what we’ve taught the way we taught it. Rather, we should start from the other end: what kinds of doctors do we want and need, what set of skills and knowledge do we want them to have? Then we need to figure out what characteristics of incoming students (personality, knowledge, and life experience) are most likely to make them become those kind of doctors (input variables), and what content and educational methods will me most effective in helping them to learn the skills they will need (process variables). This makes a lot of sense, but it can challenge existing models of who teaches, how they are reimbursed, and who gets in to school.

Maybe models such as those of Mt. Sinai and Paul L. Foster schools of medicine will help lead the way. But we all need all medical schools to move into the modern era, of identifying societal needs, what their graduates need to look like to meet those needs, and measuring the degree to which these outcomes are achieved.

[1] Muller D, Kase N, “Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program”, Acad Med Aug 2010;85(8):1378-83.
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The AAFP, Coca-Cola, and Ethics: Serving the public interest?

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Last fall, the American Academy of Family Physicians (AAFP) (full disclosure: the organization of family physicians, to which I belong) entered into a partnership agreement with the Coca-Cola Company for support of its patient information website, FamilyDoctor.org. The amount of the funding is uncertain, but it is reputed to be in the “mid-six-figures”. The arrangement came in for a great deal of criticism, both within and outside of the family medicine community, and several members of the organization resigned in protest. I addressed this as a small part of a larger blog, Harvard Medical School limits outside income: a good start, on January 21, 2010.

The debate has not gone away, and has been highlighted by two articles in the recent (July-August 2010) issue of Annals of Family Medicine, the research journal sponsored by all the family medicine organizations in the US and Canada. The first is by Howard Brody, the family physician and medical ethicist from the University of Texas Medical Branch at Galveston, “Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues”, and the second is response by Lori Heim, President of the AAFP, “Identifying and Addressing Potential Conflict of Interest: A Professional Medical Organization’s Code of Ethics.” Brody’s essay is a clearly written review of the ethics of conflict of interest, addressing both whether the relationship between AAFP and Coke is a conflict of interest (COI) and whether it is ethically worrisome, and an analysis of the reasons and defenses put up by AAFP and Coke. In the first, he notes that a conflict of interest can, and often does, exist even when no “bad” outcome can be identified; it is simply a conflict between the primary set of responsibilities (in this case, of physicians and their organizations’ social responsibility for looking out for the best interests of their patients’ health; in other settings it might be awarding of government contracts or foundation grants) and a second, usually financially motivated set of interest.

Brody distinguishes between two strategies for addressing COI, a Management Strategy in which COIs are divulged so that others (presumably in this case, patients and the public) can take them into account, and the Divestment Strategy, in which organizations rid themselves of COI relationships. He dispenses with the conflation of COI with intellectual conflicts (that an investigator might want to show that his/her “pet hypothesis” is correct and put it in the best light) because readers will always be aware of the latter, but will not know of commercial relationships unless they are divulged. He notes that the Divestment Strategy is favored in most recent ethical literature (and in increasing numbers of medical schools, as per my January 21 blog), although not by the AAFP.

He then addresses the counterarguments and justifications that the AAFP has put forward in this case. These include:

· “Premature Accusation”, in which the AAFP says “you can’t know that we have a conflict until you see the content. He notes the conflict exists regardless, and offers this “crude” analogy: “imagine that a judge who is sitting on a case involving a contract dispute between two companies is discovered to own $100,000 worth of stock in one of the companies. The judge cannot divert criticism of this conflict of interest by saying, ‘But you haven’t waited until I delivered my verdict—how do you know that I won’t rule against the company in which I own stock?’ In the AAFP case, if the final educational material includes a strong statement against sugary soft drinks, we will never know whether, absent the Coca-Cola funding, the statement would have been even stronger. That such questions will inevitably be raised shows the conflict of interest is both present and serious, quite apart from the eventual contents of the educational materials."

· “Other Party not Evil”, in this case Coca-Cola. The issue, of course, is not whether they are evil, but whether their interests may lie in opposition to the interests of the health of doctors’ patients; “The physician has a duty to prescribe medications or make dietary recommendations based on scientific evidence. The companies have an interest in selling more beverages, or more drugs, regardless of the evidence.”

· “Wrong not to Engage” with organizations such as Coca-Cola. “Schafer[1] noted the propensity for engagement with industry, in such discussions, magically to convert itself into accepting large sums of money from industry.…No one is suggesting that the AAFP not engage Coca-Cola if the engagement avoids conflicts of interest and the result of the engagement would be improved public health.” [my bold]

Brody also addresses the similarities and difference between this and the 1997 relationship in which the American Medical Association (AMA) actually endorsed products made by Sunbeam. He notes that the relationship is called a “Consumer Alliance”, when it is more properly a corporate alliance. (I had missed this Newspeak usage in my January 21 blog, where I mistakenly called it a “corporate partnership”!)

Heim’s response states that Brody misses the point, and goes on to make the same arguments that AAFP has made before, that Brody has addressed and debunked, offering nothing new to the discussion. It refers to the AAFP Code of Ethics, and creates the disturbing sense that “we want the money, we don’t think we are doing anything unethical with the money, and so stop criticizing us.” In other words, it purposely and deliberately misses the point.

Does the AAFP’s relationship with Coke go beyond a conflict of interest (which it clearly is) to actually providing unhealthful material? Some authors believe so; public health attorney Michelle Simon, in her blog Appetite for Profit, addresses the issue on July 22, 2010. She notes that FamilyDoctor.org contains the disclaimer “This content was developed with general underwriting support from The Coca-Cola Company,” and comments “That makes it sound as if the Coca-Cola is just paying someone else to do the writing. But it appears the company is directing the substance of the content as well, since the verbiage is pretty similar to that found on Coca-Cola's own website on these very topics. (See for example, the company's page on sweetener ‘facts and myths’.)”

Simon quotes Dr. Heim’s article, “To gauge an individual or organization’s ethics, one must view its behavior over time, define the goal of that behavior and compare the outcome with the mission and values. Within this context, one can determine whether the assumption or appearance of conflict of interest or ethical lapse was, in fact, correct.” And comments: “What? She lost me somewhere between outcome and values. Taking money from Coca-Cola is not a science experiment that you watch over time, gather data, and then publish the analyzed results. But if one were to approach the issue that way, there's no shortage of evidence of Coca-Cola's 'ethical lapses.' Whether your concern is marketing to children, labor abuses, or contaminating water supplies in developing nations, Coca-Cola would be the one company you'd not choose as a partner. Journalist Michael Blanding has written an entire book called The Coke Machine: The Dirty Truth Behind the World's Favorite Soft Drink, due out in September, which chronicles these misdeeds and more.”

Certainly, the AAFP is not the only organization that has potentially undermined its public trust. For another big one, the American Dietetic Association (ADA) has a partnership (I don’t know if they’ve dared to call it a “consumer alliance”) with – Hershey! (see ADA’s press release at its own website; also see the Fooducate blog).

Maybe the ADA’s partnership is more outrageous, but as a family doctor and educator, I take the AAFP’s relationship with Coke more personally because it undermines me. At the time of this deal, several of the other family medicine organizations, including the Association of Departments of Family Medicine (ADFM, academic department chairs, to which I also belong) expressed serious concerns about this relationship to the AAFP leadership. These concerns related particularly to the fact that, to the public, family medicine is family medicine, and when the largest family medicine organization, AAFP, does something the entire discipline is affected; for example, medical students, or faculty in other departments, who may be distressed by the relationship express that concern to the faculty of family medicine. AAFP, the big dog on the block, listened. It didn’t change its policy, though. Money talks, of course, but if AAFP’s 55,000 active members (not including students, residents, and retirees) each sent in $10, it would be about the same amount as they received from Coke. Are we that cheap? As far as the content on FamilyDoctor.org is concerned, check it out for yourself. You can start by clicking on the benign (but somehow familiar) logo at the top of its web page.

Brody concludes his essay with: “Family physicians are widely trusted by their patients and communities. Merely by having chosen our specialty, family physicians have demonstrated a commendable commitment to putting the health needs of their patients ahead of personal financial gain. They deserve to be represented nationally by an organization that fully reflects those high ethical commitments and standards.” I couldn’t agree more.

[1] Schafer A. Biomedical conflicts of interest: a defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy. J Med Ethics. 2004; 30(1):8–24

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Primary Care, IMGs, and the Health of the People

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For several years now, there has been a great deal of discussion about increasing the number of physicians in the US through increasing the number of students in US medical schools. The Association of American Medical Colleges (AAMC) has called for a very large increase, and it is in fact happening, both through the creation of new medical schools and the expansion of class size in existing schools. AAMC has also called for the expansion of post-graduate specialty training (residency) positions because medical school graduates have to do residencies before they become practicing physicians. What specialties those new positions are will thus determine the makeup of our physician workforce. If we need more primary care physicians we will need both more primary care residency positions and a greater interest on the part of medical students in entering those residencies, which I have discussed previously (Primary care specialty choice: student characteristics , July 12, 2010; Primary Care and Residency Expansion, January 7, 2010).

To recapitulate, increasing the probability that students will choose primary care requires using criteria actually associated with primary care choice, which are both demographic and based on the individual’s previous activities, mainly in volunteer service. The risk of relying on intention as expressed in an essay or interview is made clear in a recent letter to the editor in Family Medicine from the new Commonwealth Medical College in Pennsylvania. An “overwhelming majority” of the students who were accepted to the school had expressed, in their essays and interviews, a very high level of interest in primary care, and had “consistently cited a predilection for small towns,” high priorities for the school. By the time of matriculation, that is when they started school, that only 23% had any interest in any of the primary care specialties, including OB-Gyn!

If US medical schools graduate more students without comparable residency expansion, the probable outcome would be the displacement of graduates of foreign medical schools by graduates of US medical schools. This might, intuitively, sound like a good thing, given the question of whether graduates of foreign medical schools provide care of the same quality that US graduates do. This concern can be more than xenophobia; in the US accrediting bodies, the Liaison Committee for Medical Education (LCME) for allopathic medical schools and the Accreditation Council for Graduate Medical Education (ACGME) for allopathic residencies, along with the American Osteopathic Association (AOA) for osteopathic schools and residencies, provide very rigorous standards enforced by regular re-accreditation. Internationally, the thousands of schools are, in most countries, less standardized; not only may there be dramatic differences in medical education between countries but among medical schools within countries.

It is in this context that Norcini et. al. published “Evaluating the quality of care provided by graduates of international medical schools” in Health Affairs, August, 2010 (29[8]:1462-68), to significant national coverage; the article in the New York Times by Denise Grady on August 3, 2010 is called “Foreign born doctors give equal care in the US”, which seems to give us the answer. They do. That is not only reassuring, but could be raise the question “Why, then, increase the number of US medical graduates if the international graduates who come fill unfilled residency spots are just as good?” Well, for one thing there is the very important issue of “brain drain”; physicians from other countries, often underdeveloped countries with great physician shortages of their own, come to train in the US. Ostensibly, for most of them on training visas, the idea is that they will go back to their own countries with the new skills that they have acquired in the US and benefit their own people. In reality, most of them want to, and usually do, find a way to stay in the US. From an individual point of view – the ability of an individual to seek a better life for his/her family, or at least a higher income – it is consistent with the history of the US. From a societal point of view, however, this leaves their home countries with marked shortages of doctors; there are more Ghanaian trained physicians in the US and UK than in Ghana[1]. And, to the extent, which is often the case, that the medical education was paid for by the government and people of the country of origin, not the individual, it can be particularly inappropriate.

Another question is “is it true? That is, do Norcini and colleagues actually demonstrate that “foreign born doctors give equal care in the US”? The population that they studies was doctors in Pennsylvania, a big state with a lot of variety (rural/urban, rich/poor). They looked at physicians who were US-born graduates of US medical schools (USMGs), and compared them to both foreign-born graduates of foreign medical schools (IMGs) and to US-born graduates of foreign medical schools (USIMGs), most from those schools in the Caribbean, which I have previously discussed (Who will care for the underserved? The role of off-shore medical schools, June 2, 2010). They measured the “quality of care” by measuring length of stay and mortality rate of patients hospitalized for acute myocardial infarction (heart attack, MI) and congestive heart failure. They also looked at the outcomes by specialty (cardiologist, general internist, family physician). The results showed that the percentage of in-hospital deaths for these diagnoses were lower for IMGs than for USMGs, and for USMGs lower than USIMGs. These differences were small but statistically significant. For length of stay, USMGs were lower than either, and IMGs were lower than USIMGs. How much to make of these differences since there were other variables: longer time since medical school graduation, being rural vs. urban, and not being a cardiologist resulted in longer stays; interestingly being a cardiologist resulted in higher mortality.

One can think of all kinds of possible explanations, including unmeasured differences in severity of illness, and the authors, in their Discussion, identify several. The most obvious is that they looked at only two parameters (death and length of stay) in two diseases in hospitalized patients. The authors acknowledge this, although they point out that these are very common diagnoses. They virtually ignore that measuring care in the hospital is only one dimension of care, most of which takes place in the outpatient setting, and run the risk (although they do not explicitly say this) of implying that if a doctor can deliver quality care in the hospital, when people are sicker, they obviously can do it in the “simpler” outpatient setting. This is an egregious fallacy, most obviously (see "Uncomplicated" Primary Care?, October 8, 2009) because in the hospital doctors have far more control, while for outpatients they are at best advisors to their patients. The authors did a credible job given the difficulty of measuring what they want to measure – quality of care delivered by physicians – but the validity of the results suffer from another fallacy , that what is measured is what is easy/possible to measure, not necessarily what you are interested in (see Defining "Streetlight" Research, February 26, 2009). Still, it is good work.

The real problem is in identifying the cause(s), speculating on what they might be and then taking this to the next level, raising problems that might exist if the speculations on cause on correct. IMGs might perform well because they are “top performers” in their countries, and have often had prior post-graduate training in their own countries prior to coming to the US and entering residency; much of this is hospital-based. The authors worry about the pool of USIMGs, noting that “Part of this performance difference may be due to variability in the quality of the medical schools that U.S.-citizen international graduates attend, but to some degree, it may also reflect their ability. It will be important to monitor this possibility, since the pool of U.S. applicants to international schools is a potential source of students for U.S. medical schools as they expand.” There is very likely a difference in the training and education of US students at many off-shore medical schools, although, like other foreign schools, they vary a great deal. The danger is in identifying “ability”.

The most important health problem in the US is that some people do not have access, for financial or geographic reasons most commonly. Thus a study like the current one, which looks only at patients who have received hospital care for their diagnoses, are looking at a somewhat skewed sample, and can miss the total impact on population health that comes from including those people not counted because they got no care at all.

Students who get into US allopathic medical schools have higher grades and test scores than the ones who don’t. While many students choose osteopathic schools because of their interest in osteopathy, a large number choose them because they didn’t get into allopathic schools; on average their grades and standardized test scores are lower. Those who do not get into either school may choose offshore schools. Are they less able? Does lower, but still good, performance on standardized tests make a candidate less able? The data that exist show poor correlation between MCAT scores and grades and clinical performance. Moreover, are the students who attend Caribbean medical schools representative of those who do not get into US schools, and might get in if more students are accepted? Not entirely, since on average they come from even higher socioeconomic status than the already high US medical students.

Many outstanding students, measured in many ways, are not accepted in medical schools in the US every year (Medical Student Selection, December 14, 2008). Taking more students (by virtue of larger classes or more schools) may lower the mean MCAT score, but is not, in itself, likely to decrease the clinical performance of graduates. Indeed, if those new students are more likely, because of their backgrounds and/or values, to care for populations that are currently underserved, rural and urban, they will increase the health status of the American people.


[1]Hagopian A, et. al., “The flight of physicians from West Africa: Views of African physicians and implications for policy”, Social Science & Medicine, Volume 61, Issue 8, October 2005, Pages 1750-1760.
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The White Coat Ceremony: New medical students and hope for the future

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I recently attended the “White Coat Ceremony” for entering medical students at the University of Kansas School of Medicine. The entering class, having completed their week of orientation, is welcomed to the school by its dignitaries in front of an audience of their families, friends and loved ones. Then each student walks to the stage while his/her name and hometown are read, and has a white coat placed on them by a member of the faculty. They then take an “Oath of Commitment” (different from the “Oath of Hippocrates” they will take at graduation) and at the end, in a semi-joke, told that “Classes start Monday at 9!”

Hokey? Well, maybe a little when it’s described, but very moving in person. Each one of the 175 people receiving the short white coat (traditional for students) is an individual person who has worked very hard to get there and they are (I assume almost all if not all of them) sincere and committed to helping people and making a difference. If studies have shown a scary drop in empathy in medical students in their 3rd year (Are we training physicians to be empathic? Apparently not., September 12, 2009), that is more than 2 years off. If long hours of classes and studying what will often seem trivia in the biomedical sciences scarcely related to being a doctor will fill most of those 2 years, it is not on the agenda today. Today it is about “keeping their eyes on the prize” but also recognizing it will be hard work. In the Oath of Commitment they pledge to work hard, to know their limitations and seek to learn enough to overcome them, and to be life-long learners. They say:

"I will strive to preserve the dignity, the humanity and the privacy of all my patients, and through my openness and kindness I will seek to earn their trust in turn.
I will treat my patients and my colleagues as my fellow beings and never discriminate against them for their differences; and I will ask that they do the same for me.”

This expostulation of altruism is, obviously, in marked contrast to the mean-spirited negativism that is characterizing the political campaigns of the day in Kansas (and elsewhere) that I recently addressed on this blog (The political campaign and the future of health reform, July 28, 2010), and criticized in the July 30, 2010 editorial in the Kansas City Star, which notes that, while Nancy Pelosi is not running in Kansas, candidates (mostly conservative Republicans) are attacking their primary opponents (mostly conservative Republicans) by calling them supporters of the Speaker, and even (gasp!) the President. In a few cases, such as the Republican primary for Secretary of State, Elizabeth Ensley, the well-qualified, highly-endorsed candidate surprises Star interviewers by "...blurting out 'I’m pro-life.' When asked what that had to do with the record-keeping office for which she was running, she answered, 'Well, nothing, but people always seem to want to know.’ Of course, Ensley could be forgiven for losing focus. Her GOP opponent, Kris Kobach, is trying to define the race as being about illegal immigration. It’s not.”

I really enjoy hearing where the students are from. Some are from surrounding states like Missouri and Colorado and Nebraska, some from farther away like California and New York, and even a few from other countries. But most are from Kansas, and from all over Kansas. Yes, there are higher proportions from the metropolitan areas of Wichita and suburban Kansas City; but also from the “larger” (for Kansas) cities like Lawrence and Topeka and Hutchinson and lots from places like Goodland and Oberlin and Neosho and Medicine Lodge, where maybe, if the people there are lucky, some of them will return to enter practice.

And then the “Doctor’s Notes”, the student a capella singing group, did a beautiful rendition of John Lennon’s "Imagine". It’s a very lovely song, and it expresses sentiments that are very different from those we are hearing on the local and national political scene. Worried about Nancy Pelosi? Barack Obama? They’re nothing but compromising politicians; our students sang Lennon’s lyrics:

“Imagine there's no countries
It isn't hard to do
Nothing to kill or die for
And no religion too,”

Not a position likely to garner a lot of votes in Kansas. I don’t know the politics of the students in the entering class, or their families, are, but having watched the volunteer work of their predecessors, in the student-run free clinic in Kansas City and in work around the world, I wouldn’t be surprised if many of them see some of their beliefs reflected in the verse that says:

“Imagine no possessions
I wonder if you can
No need for greed or hunger
A brotherhood of man
Imagine all the people
Sharing all the world...”

OK, maybe not the “no possessions” part, but caring for others part. And, if we are lucky, they will continue to care. They will maintain their empathy through the 3rd year of medical school and beyond. They will be life-long learners who care for people and about people, and live a life not simply of service, but of brotherhood. They will truly be healers, and not destroyers. It’s way too early to know, but we can hope that they will be.

Imagine.
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Calcium, Heart Attack and Osteoporosis

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A recent meta-analysis published in the British Medical Journal by Bolland, et. al., finds that there is a 30% increase in the risk of myocardial infarction (MI) in women taking calcium supplements for osteoporosis (“Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis”, BMJ 2010;341:c3691). If supported by other research, this could be big news, as millions of women are doing just that. A few “bullets”:

· 15 studies were reviewed by the meta-analysis comprising comparisons of 12,000 women either taking or not taking calcium supplementation for osteoporosis. For some of these studies results were available for individual women, and some for just the group as a whole, but the results were similar.

· Women receiving calcium had 30% more MIs than those who were not. Other end points: stroke, death from cardiovascular disease, and death overall, did not show significant differences, although they did show trends toward reduction in the non-calcium groups.

· The studies reviewed in the meta-analysis were all of women taking calcium but not taking vitamin D supplementation with it.

· The studies were not done for the purpose of looking at cardiovascular mortality; the data were re-analyzed and other sources of data were used to look at the outcome events.

The authors recommend that women who are taking calcium without vitamin D for osteoporosis stop doing so unless they are also taking a drug that treats osteoporosis, such as a bisphosphonate (which have their own risks, although in women with osteoporosis these are usually outweighed by the benefits) or selective estrogen receptor modulator (SERM) like raloxifene, usually used for breast cancer treatment (links are to a few different websites, including WebMD, FDA, and BreastCancer.org; they are representative although not definitive, and there are, of course, other sites). They note that their results are similar to other studies of women taking calcium alone, although a Women’s Health Initiative (WHI) study on women taking both calcium and vitamin D did not show any effect on the incidence of coronary artery disease. The authors suggest possible reasons for the difference, including protective effects of vitamin D, the younger age of the WHI participants (mean of 62 vs. 75 for the meta-analysis), and the interesting, but slightly confusing fact, that the WHI study had a much higher percent of women who were taking calcium before the study began (“non-protocol”): 54% vs. 1.2%. If taking calcium is associated with more MIs, why would women who were taking more calcium before the study have lower rates? And yet, the authors note that “Interestingly, the only study in our analysis that reported a relative risk of less than 1.0 for myocardial infarction with calcium also had high non-protocol use of calcium supplements.”

In their accompanying editorial, “Calcium supplements in people with osteoporosis”, BMJ 2010;341:c3856), JGF Cleland, K Witte and S Steel go farther than the authors of the meta-analysis, saying clearly in their sub-head “Should not be given without concomitant treatment for osteoporosis”, even when given with vitamin D. Their justification is the lack of good evidence for improved outcomes, including pathologic fractures, with the use of calcium and vitamin D. “Calcium supplements, given alone, improve bone mineral density, but they are ineffective in reducing the risk of fractures and might even increase risk, they might increase the risk of cardiovascular events and they do not reduce mortality. They seem to be unnecessary in adults with an adequate diet. Given the uncertain benefits of calcium supplements, any level of risk is unwarranted.” With regard to vitamin D, they say “Vitamin D supplements might reduce the risk of falls, might have important clinical effects on cardiovascular function, do not increase mortality, and may mitigate the trend to excess mortality seen with calcium supplements alone. However, no conclusive data are available to show that current doses of vitamin D supplements with or without calcium supplements reduce the rates of fracture, and meta-analyses found evidence of substantial reporting bias.”

The editorialists emphasize that while calcium does increase bone density, this is a surrogate variable while the issues of fractures and mortality are the true outcomes, an issue I have addressed several times recently (Rosiglitazone and the "Holy Grail", July 16, 2010; Statins and scientific integrity, July 6, 2010 ). They say “Surrogate measures may be useful in pilot studies but become problematic when they become the goal of treatment.” They are quite rigorous in looking and risk and benefit, noting even that exercise, while perhaps a good way to increase bone strength, “also carries risk”. They cite Kanis, et. al., from 2002[1], but it should be obvious that exercise can have risk.

The last part of the editorial is, however, more concerning to me. The authors call for greater demonstration that drugs will have positive effects on important outcome variables (a good thing) but they then worry that such requirements will be so burdensome as to stifle research: “Requiring companies to show before licensing that treatments for chronic diseases such as osteoporosis, diabetes, and hypertension reduce long term disability and death could lead to a cessation of research in these areas. The cost and commercial risk would be too high.” They then call for an extension of patents on these drugs to 50 years, similar to the Berne convention for copyrights on a song. The presumption is that this would be long enough for the companies to make back their money. Obviously, however, this also means that consumers would have to pay the higher costs for patent, rather than generic-equivalent drugs, for much longer.

Amazingly these authors, despite citing no conflicts of interests (which might explain such a position if they in fact held patents or were being paid honoraria by pharmaceutical manufacturers) dispense with such concerns in a single sentence “Lower prices for innovative drugs could be negotiated.” By whom? How? What would be the effect on the consumer? All I can imagine is that because they are British, and in Britain there is a National Health Service which charges a fixed fee to patients for all drugs, that they are thinking only of cost to the NHS and have no idea how much the cost of patented drugs is to Americans. Which, as Americans know, can be phenomenally high. (Example: generic alendronate, the oldest bisphosphonate, costs roughly $40 a month for either 35mg [recommended for prevention of osteoporosis] or 70mg [recommended for treatment of osteoporosis] per week doses, while the brand name, Fosamax ® costs about twice that; for those not available generically, risendronate (Actonel ®) costs 3 times as much, and ibandronate (Boniva ®) costs about $350 a month; all prices wholesale from ePocrates and www.drugstore.com.) Taking drugs that you need for a chronic disease is very different from downloading a song!

Of course, this is another strong argument for having a national health insurance plan that covers everyone. In the meantime, while we will wait for the certain flurry of responses and comments, not taking calcium unless one is also taking a bisphosphonate or similar osteoporosis treatment drug, seems prudent; taking vitamin D, without calcium, for its other benefits, is probably still a good idea.

[1] Kanis JA, Brazier JE, Stevenson M, Calvert NW, Lloyd JM. Treatment of established osteoporosis: a systematic review and cost-utility analysis. Health Technol Assess 2002;6:1-146.
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The political campaign and the future of health reform

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The headline story in the June 28, 2010 issue of the Kansas City Star, by Dave Helling and Steve Kraske, is “Mailings turn aggressive”. It is about direct mail campaigns by those seeking elective office, how they have become a major part of the campaigning, and how the content is almost entirely negative – and sometimes hard to believe. For example, a state legislator running for Congress has a mailer attacking his primary opponent as a “Nancy Pelosi Democrat”, although the only obvious similarity this “staunch conservative” former legislator has with Ms. Pelosi is that they are both women.

The more interesting aspect is not the attack aspect of the ads, but that most of the non-attack “positive” campaigning, touting the candidates’ strengths and thus implicitly responding to attacks, is (among Republicans) to emphasize their negativity. Jerry Moran, a Republican congressman from Kansas’ “Big First” district is running against Todd Tiahrt, congressman from the 4th district (Wichita), for the Senate seat of Sam Brownback (who is odds-on favorite to be our next governor). Both have essentially the same, straight-down-the-Republican-line voting record, but Tiahrt has accused Moran of being less conservative. A recent Moran ad indicates that he fights for Kansas and then lists all the things he has opposed – which is essentially everything that the Obama administration has done. Moran is a nice, personable man and presumably has some good positive ideas, but apparently in the campaign it is not cost effective to promote them. (Note that the Tiahrt campaign takes the same tack, except when attacking Moran for not being conservative enough.) In the Republican primary proudly embracing charter membership in the “Party of NO” is apparently the name of the game, It is possible that in some parts of the country, candidates in the general election will feel pressure to say what they are for, but only if absolutely necessary. In Kansas, where the Republican nominee is pretty much guaranteed victory in most venues, it probably won’t.

In a recent article in Health Affairs, “The political challenges that may undermine health reform”[1], Theda Skocpol ties some of these trends to the future implementation of health reform. She accepts that there will be Republican gains, but also discusses the ways in which Democrats will likely respond, hoping to blunt those gains and prevent a complete Republican takeover of Congress. In its absence, she notes it is likely that most of the part’s of PPACA will be implemented, slowly and quietly, although some of the parts most likely to engage support (elimination of discrimination against those with pre-existing conditions on the individual market and allowing children to stay on their parents’ policies until 26) are front-loaded, going into effect this year. Among the most interesting things she says (to me, a non-political scientist), is that “Political scientists have long know that Americans are what is called ‘operational liberals’; they like specific government benefits. Yet these same Americans are also ideologically conservative, when arguments about government versus the free marked are posed in general rhetorical terms.”

Actually, this makes it almost sound like Americans are “operationally selfish”. Indeed there are many who are, like the family physician I knew in Texas who would mostly rant against the liberals in Washington and the need to elect more conservative Texans, until, in a cost-saving measure pushed through by those fiscal conservatives, the government delayed sending out Medicare payments to physicians. That was intolerable to him! Dr. Skocpol continues: “That is why we will see Republicans doing all they can to keep the argument at the systemic level through early 2012, when they hope to elect a president who will support repeal or make fundamental changes in the 2010 legislation.” No question that arguing against Big Government is going to win more votes than opposing Medicare, or Social Security. And few of the reliably conservative Republican farmers in Kansas (or elsewhere) are going to be won over by arguments against agricultural subsidies. In Missouri, which has more Democrats than Kansas but has a legislature controlled by Republicans, a statewide referendum is about to take place which would prohibit the federal government from forcing people to purchase health insurance. It is being sold with “freedom” arguments, and might well be unconstitutional, but it will be interesting to see how people vote. When turnout is light, the poor and uninsured are less likely to turn out than those who, like the bill’s legislative sponsors, already have insurance; in particular older voters, already receiving Big Government Socialized Medicine Medicare are likely to vote.

While there is much to criticize in PPACA (done very well by John Geyman, “Hijacked: Stolen health care reform V” in the Huffington Post), there is definitely some good. The insurance companies have backed off their threats to not cover people (or at least children) with pre-existing condition, suggesting that people will begin to see some real benefits. The real issue is seen in Dr. Skocpol’s final sentence, above; the Republicans are running on general conservative principles, but should they gain power they will implement a very anti-regular-people agenda, as was done under the Bush administration. This is not limited to health care; while “everyone” (me, for sure!) hates the bankers who brought on the financial crisis (see Maureen Dowd in the NY Times, July 28, 2010: “Washington gave the Wall Street banks billions, and, in return, they stabbed us in the back, handing out a fortune in bonuses to the grifters who almost wrecked our economy”), the Republican party leadership, far from punishing them or reining them in, has tried to block legislation that would even gently restrict their most outrageous activities.

If we are lucky, maybe voters in Missouri and in other places will show that “operational liberals” who “like specific government benefits” are not all like that Texas doctor, and will also support specific benefits that help others. We have seen many polls showing that a majority of Americans favor universal health care even for all, so the sense of common purpose is not dead. Maybe they won’t, but we can hope.

[1] Health Affairs, July 2010; 29(7):1289-91.
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Improving quality and access still requires coverage for all

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Now that the health reform law, PPACA, has passed into law, and while we wait for the years to pass that will usher in many of the changes, as well as the regulations that will actually guide how those laws will be implemented, policy people and pundits have resumed publishing articles about what other things should be / need to be done. Most of these were suggestions that had been made previously and are either being advanced because PPACA has included funding for them and the authors want to emphasize how beneficial they will be, and others are ideas for health improvement that may not specifically be in the law but that the authors feel are still important and should be advocated for. In addition, of course, there are the “flames” and attacks on “Obamacare” as “socialized medicine” (which it isn’t close to, unfortunately in many people’s opinions, including mine).

In the first group I would include articles that address Community Health Centers (CHCs), or more specifically Federally-Qualified Health Centers (FQHCs), the patient center medical home (PCMH), and increased primary care, for all of which there is enormous funding in the new law. “Health reform and primary care – the growing importance of the community health center” by EY Adashi, HJ Geiger, and MD Fine (NEJM, 3Jun2010;362(22):2047-10) addresses all 3. Dr. Geiger was central to the creation of the first two CHCs, Columbia Point in Boston and Mound Bayou, Mississippi, in 1965. The article talks about how CHCs are built on primary care and on the principles of the patient-centered medical home (before those principles were articulated under that name), and calls for expansion of CHCs as a key vehicle for caring for all Americans, not only the “underserved” and the use of CHCs as venues for demonstration projects for PCMHs. It also includes an excellent map showing the percent of people in each state currently served by CHCs (West Virginia is tops with over 15%), and another with dots showing the location of all of them (very dense over WV).

Other articles on these topics include JF Markuns, B Fraser, and JD Orlander on developing the skills needed for medical directors in CHCs, “The path to physician leadership in community health centers: implications for training”, (Family Medicine Jun2010;42(6):403-7). This is important because a poor relationship between physician and non-physician administrators, often born of unshared assumptions about who is responsible for what, has frequently been a major stressor in many CHCs. Other pieces look at the medical home in particular populations -- “Health care reform and the opportunity to implement a family-centered medical home for children” (D Laraque and CCJ Sia, JAMA 16Jun2010;303(23)2407-8)* and in educational settings – “Medical student exposure to components of the patient-centered medical home during required ambulatory clerkship rotations: implications for education” (JW Saultz, et. al, Acad Med Jun2010;85(6):965-73)*.

The second group of articles address issues that the authors feel remain to be dealt with. A major one is quality of care, obviously of great concern to everyone who receives (and provides) health care. Harold Sox and Sheldon Greenfield, in “Quality of care – how good is good enough?”* (JAMA 16Jun2010;303(2):2403-4) argue that setting threshold values for adherence to practice measures is not a very good way to measure quality as patient characteristics, individually and in populations cared for by different physicians, groups, and hospitals as well as in different regions, differ greatly. They suggest measures of the quality of the decisions made by physicians, and the degree to which they are based on the best evidence in the context of the actual patient. Marco D. Huesch, in “Payment policy based on measurement of health care spending and outcomes” (JAMA 2010 Jun 16;303(23):2405-6)*, further addresses the flaws of many of the assumptions on which “pay for performance” programs pay. In the measurement of quality, we have to be especially careful of the pitfalls of “streetlight research”(see my post of Feb 26, 2009, Defining "Streetlight" Research) and measure what we find easiest to measure, whether or not it is what we really want to know about.

In an area getting, in my opinion, much closer to the edge of a bad idea, Robert Brook, of the RAND Corporation writes in of “Rights and responsibilities in health care: striking a balance” (JAMA 9Jun2010;303(22):2289-90)*. He makes comparisons to car warranties, which are often invalid if the owner has not followed the prescribed maintenance schedule. All of us would agree that it would be better (mainly for their health, I hope, but also for the bottom line) if everyone would adopt only the best health behaviors; indeed, we might argue that individual responsibility is critical. Of course, such arguments are inherently classist (on a group, not individual basis, as in all population issues) and are usually made by those who have the resources (financial, educational, “values”) to be more likely to be able to adopt such behaviors (and we don’t all do it – there are actually white, prosperous people who are overweight, drink, use drugs, smoke, don’t exercise enough, etc.) He calls for “classes” in the workplace using “sophisticated adult learning materials” to educate people. Beyond the fact that this would leave out those who don’t have a workplace, or work in a business too small to afford such class, this construct misses the fact that the reason people do not adopt such behaviors has very little to do with their not knowing that they are good ideas, and very much to do with the other parts of their lives that make adopting such behaviors very difficult. Most important, people are not cars, and refusing to honor a warranty is not the same as refusing to cover health care costs; we are not (and should not) going to allow people to die in the streets because they didn’t behave well and don’t have the money to bail themselves out of these poor decisions by paying for their care out of pocket.

The real problem is that all of these ideas, whether good (CHCs, primary care, the PCMH, emphasis on quality) or not is that under the new PPACA law, as before it, not everyone has adequate access to health care. Our reimbursement systems continue to reward providers (physicians, hospitals, health plans, and the drug and device manufacturers who sell to them) for doing more, using more technology, doing more procedures – for those who (or, mainly, whose insurance) can pay. And many people are still not covered. Medicaid will be expanded (for a while) but not yet, and will only pay (for 2 years) Medicare rates (and even this is rejected by many providers). Undocumented people will not be covered at all, although they will be here and get sick and need care. CHCs are neat, but as I have noted before, they have an incentive to locate where there are lots of Medicare and Medicaid patients, for whom they receive cost-plus reimbursement, not where there are uninsured and undocumented people. We need more primary care providers, we probably would benefit from true medical homes, and for goodness sake we need better quality, but without a health system that is actually universal, covers everyone, and has systematic means of cost-control, they are relatively less important, the cart before the horse, whistling past the graveyard. Even quality.

In 1994, Schiff, Bindman, and Brennan wrote “There is a profound and inseparable relationship between access and quality: universal insurance coverage is a prerequisite for quality care. Because quality must be population based, traditional definitions of quality should be broadened to include the gravest of quality deficits—denial of care. The most important prerequisite for access is health insurance.” (“A Better-Quality Alternative Single-Payer National Health System Reform”, JAMA 14Sep1994;272(10):803-80).

Denial of care and lack of access are still the greatest quality deficit. Discussions of quality that include only those “inside the tent” and ignore all others are specious and offensive; all discussions of quality must start from “everyone needs access”.

*Hyperlinks are not provided to these articles as they are not available free on line.

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Rosiglitazone and the "Holy Grail"

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On Wednesday (July 14, 2010), the FDA advisory council looking at whether to ban rosiglitazone (Avandia ®), a drug for the treatment of diabetes that has been found to significantly increase the rate of heart attacks (MIs) decided to not ban it, but to place significant restrictions on its use. On the NPR story Thursday (July 15, 2010), a panel member who is a consumer said (and I paraphrase, but this is close)
“We were very concerned about it but it is effective for lowering blood sugar, which for we diabetics is the Holy Grail.”

What concerns me is that a very well-informed (at least by virtue of being on this panel) consumer (and, from the comment, presumably a person with diabetes) would refer to lowering blood sugar as “The Holy Grail”. As I have noted in several recent posts (most recently Statins and scientific integrity, July 6, 2010), the only patient-important outcomes are premature death and quality of life (morbidity); the only reason any intermediate, or “surrogate”, variable (e.g., blood sugar or Hemoglobin A1c [HbA1c – a longer-term measure of blood sugar], blood pressure, cholesterol level, etc.) is the degree to which it is linked to one of the two patient-important outcomes (mortality or morbidity); none is in itself a patient important outcome, not to mention a “Holy Grail”. Who cares what one’s blood sugar (or cholesterol or blood pressure) is unless we know that it is likely to lead to a bad outcome? It is the outcome that is important. (again, see GY Gandhi, et. al., “Patient-important outcomes in registered diabetes trials”, JAMA. 2008 Jun 4;299(21):2543-9).

In the case of diabetes and blood sugar, there is good evidence that lower blood sugar significantly reduces the rate of cataracts in the eyes, which is certainly a morbidity. There is some evidence that it may be linked to lower rates of microvascular disease (such as kidney and retinal conditions) which definitely cause morbidity. Much weaker evidence relates it to death. Indeed, in a recent publication from the ACCORD trial[1], “tight” control of diabetes (getting the HbA1c below 6, rather than 7) did not decrease microvascular morbidity and led to increased mortality.

We also know that the major cause of death for people with diabetes is macrovascular disease, primarily heart attack. Thus, a drug which increases the rate of heart attacks (definitely increasing morbidity and probably mortality) even if it decreases blood sugar (a surrogate variable) is of great concern.

The actual decision (if the FDA itself chooses to follow the panel’s recommendation and not ban rosiglitazone) to balance the increased risk of heart attack with the benefit of reduced blood sugar, will rest with the patient and the physician. However, responsible physicians – and certainly the leading diabetes experts who are on this panel – need to move away from emphasizing surrogate variables, like blood sugar and HbA1c, to such a degree that patients lose sight of the real outcomes they want to try to achieve.
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[1] Ismail-Beigi F et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: An analysis of the ACCORD randomised trial. Lancet 2010 Jun 29, 1-12
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Primary care specialty choice: student characteristics

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I have written about both the characteristics of medical schools (recently, in A New Way of Ranking Medical Schools: Social Mission, June 20, 2010; also Rankings of Medical Schools: Do they tell us anything?, September 5, 2009) and of medical students, including the people being accepted into medical school, the specialty choice of those graduating, and what aspects of both schools and students are associated with the kind of doctors students become (Who will care for the underserved? The role of off-shore medical schools, June 2, 2010, Primary Care and Residency Expansion, January 7, 2010, "Uncomplicated" Primary Care?, October 8, 2009, Medical Student Selection, December 4, 2008). A recent study, “Primary care specialty choices of United States medical graduates, 1997-2006” (Academic Medicine June 2010;85(6):947-58) by DB Jeffe, AJ Whelan and DA Andriole from the Washington University School of Medicine in St. Louis provides further information to inform this discussion.

The authors used two surveys administered annually by the Association of American Medical Colleges (AAMC) to medical students: the Matriculating Student Questionnaire (MSQ) given when students begin school and the Graduation Questionnaire (GQ) given at graduation. They were able to match the questionnaires of nearly 2/3 (64.9%) of medical students graduating in the 10 years 1997-2006 to look at the degree to which the answers students gave to questions on the MSQ and GQ would predict their choice of specialty. It takes a while to get through the description of how they grouped questions, and “weighted factors”, but there are a number of important findings. Most of them not surprising, but this study provides additional data support for things we have been seeing.

Fewer graduates are entering primary care. For some reason the AAMC’s GQ counts 6 “primary care” areas, including, in addition to the usual family medicine, general internal medicine, and general pediatrics, also obstetrics/gynecology, internal medicine subspecialities (IMSS), and pediatric subspecialties (PdSS). However, this study separates them out. The percent of students entering the first 4 of these dropped from 1997 to 2006 (GIM from 15.7% to 6.7%, GP from 10.2% to 6.6%, FM from 17.6% to 6.9%, and OBG from 8.2% to 6.1%), while the subsubspecialties increased (IM from 6.8% to 11.4%, Peds from 2.2% to 4.4%). This increase in the last 2, however, did not compensate for the decrease in the first 4 so there was a net decrease from 60.7% to 42.1% for all these “primary care” specialties. The increase was in, then, surgical specialties, and more significantly in specialties such as radiology, anesthesiology, and emergency medicine. And the trend continues – although not part of the study, the article reports that the total % of students entering these 6 specialty areas in 2008 was down to 30.3% from the 42.1% in 2006. Remember, this is not just real primary care – it includes medical and pediatric subspecialties!

The more important part of this article is its correlation of certain demographic and attitudinal characteristics with specialty choice. Being female is important: over the 10 years of the study 45.1% of graduates were women, but they were over-represented in each of the 6 fields except IM subspecialties: 77.3% of OBG, 72.6% of GP, 58.2% of PdSS, 50.8% of FM and 49% of GIM. Indeed, the authors suggest that one of the reasons for the continued downturn in entry of medical students into PC fields is that the % of women in medical school, which was increasing during the study period, tended to compensate somewhat for the decreased interest in PC among men. Now that the % of women in medical school has stabilized, at roughly 50%, while interest in PC continues to go down, this is no longer having the same compensatory effect.

Compared to white students, underrepresented minority (URM) students were somewhat less likely to choose the PC specialties of GIM, GP, and FM, while Asian/Pacific Islander (As/PI) grads were less likely to choose FM, OBG, GP and PdSS, according to the text, but there are subtleties to this. For example, white students were 68% of the total but 75.3% of those entering FM; however, the % of URM students in FM (14%) was also greater than in the overall cohort (12.7%). The difference is that As/PI were much lower in FM, 9.9% compared to 18.2% of the overall cohort. In this report URM students include black, Hispanic, and American Indian/Alaskan natives, while the As/PI group includes some groups that are truly underrepresented in medicine and are usually counted by Federal grantmakers as URM, as well as some groups, e.g., South Asian, Japanese, Chinese, that are in fact over-represented in medicine. Many of these are among the 15.7% of students who had one or more parents who was a physician or the 24.1% more who had a non-physician professional parent. This is important because “…a student’s having a physician parent had a pervasive negative effect on graduates’ choice of any generalist-primary care specialty…” while those with non-physician professionals as parents were more likely to choose GIM, GP, and IMSS.

Though highly-touted as a deterrent to entering PC (and, perhaps, of more significance now than in the early part of this study period) debt had only a “modest” effect; students with higher debt were less likely to choose GP, PdSS, GIM, or IMSS, but more likely to choose OBG, and choice of FM was essentially unaffected. The probability of students from public medical schools entering PC was much greater than from private schools, a consistent finding of all studies, presumably reflecting the curriculum and emphasis of those schools as well as the characteristics of the students they select. The authors linked a number of questions to assess students’ “choice of medicine as a career goal” (including the importance of innovation and research, social responsibility, and prestige), and students’ “perceptions about medicine and medical practice” (including altruistic beliefs and the belief that the demands of medicine interfere with family/other interests). All were high, and few led to big differences in specialty choice. Among the most significant of those that did were “intention to practice in an underserved community” (more PC, especially FM), and “interest in academic faculty positions” (very low FM -- the odds of being interested in academic practice compared to full-time non-university practice was only 12% for someone entering FM, compared to GIM’s 86%, IMSS’ 185% and PdSS’ 316%!).

Among areas that the questionnaires did NOT look at was the probability of entering rural practice; other studies have shown that, except for family medicine, essentially no students are entering practice in rural areas (see Primary Care and Rural Areas, April 28, 2010, Medicare Costs in Rural America: A case of reaping what we haven't sown?, March 26, 2009, Ten Biggest Myths Regarding Primary Care in the Future, January 15, 2009 ). Despite their assertion (probably correct) that “…the predictive validity of planning to practicing in an underserved community at graduation has been established,” intention to practice in an underserved community is not a surrogate for intention to practice in a rural area, because practicing in a rural underserved community means living in a rural community, while one can practice in an urban underserved community and live in a more upscale neighborhood. This is particularly true for pediatrics (see Primary Care, Pediatrics, and Physician Distribution, May 21, 2009).

So what does all this tell us that is new? Not much. There is a dramatic decrease in the number and percent of students entering true primary care specialties, combined with some increase in the number entering obstetrics/gynecology, internal medicine and pediatric subspecialties and a large increase in specialties that are in no way primary care. It tells us that students who are interested in and attracted to, and are wooed by, “high-status” research and specialty care medical schools are less likely to enter primary care; that being the child of a physician or having a high family income makes one less likely to enter primary care; that students interested in caring for the underserved and women are more likely to enter primary care (although not rural practice). So what does this mean “we” should do?

Well, that depends on who “we” are. If “we” are the selective, high-status medical schools who are low on social mission (see A New Way of Ranking Medical Schools: Social Mission, June 20, 2010) and “we” value what “we” do, maybe “we” shouldn’t do anything. The same might be said if “we” are the schools that tend to be high on social mission and production of PC physicians. If, however, “we” are the American people, who need more primary care and rural physicians, or the politicians and policy makers who actually can have some influence, “we” need to make policies that reward schools that select the students whose demographic and attitudinal characteristics make them more likely to enter primary care, underserved, and rural practice. And those schools whose curriculum (formal and informal) and faculty attitudes and relative status-within-the-institution favors those same outcomes. And pay, on the back end, more money to those who do what “we” don’t have enough of (primary care, underserved and rural practice) than those who do what “we” have too much of already.

Whether or not “doing the same thing over and over again and expecting different results is the definition of insanity”, it is sure not going to accomplish any change in the physician workforce.
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Statins and scientific integrity

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“Statins” are a class of drugs that lower lipid levels, especially low-density lipoproteins (LDL, “bad” cholesterol), and raise high-density lipoproteins (HDL, “good” cholesterol). Since we know elevated LDL levels are associated with higher risk for a number of vascular diseases, mainly coronary heart disease but also stroke, it made sense that these drugs would be beneficial for preventing recurrences in people who had prior heart attacks and strokes (“secondary prevention”) as well as preventing a first attack in those who had the risk factor of elevated LDL (“primary prevention”). Indeed, studies have shown the former; that is, that the use of statins reduced the risk of both a second attack and dying. However, most of the studies that have been done, and showed benefit, studied both groups, people who had already had a coronary event and those with elevated LDL who had not, and combined the results. The first big study that presumed to show benefit of these drugs for primary prevention was the JUPITER study (“Justification for the Use of Statins in Primary Prevention” – all these studies have cute, if often tortured, eponyms). It specifically looked at the drug rosuvastatin, marked as Crestor ® by its manufacturer, AstraZeneca, who also happened to fund the JUPITER trial.

Two articles that just appeared in the Archives of Internal Medicine (V 170, #2, June 28, 2010) raise serious questions about the use of statins for primary prevention. But they also raise serious questions about research ethics, particularly when trials are industry funded, and the strategic manipulation (not falsification) of the data that is presented to make drug therapy look better – this can mean billions of dollars in sales for the manufacturer. They also point out the danger of looking at intermediate, or “surrogate”, outcomes (in this case, lowered cholesterol and LDL) rather than the ones of real interest to patients, which are, essentially, death (mortality) and the quality of life (morbidity). I have discussed this previously (“Quality and Chronic Disease Management,” Feb 24, 2009, and “Physician conflict of interest” Dec 8, 2008; see also the article by GY Gandhi, et. al., “Patient-important outcomes in registered diabetes trials”, JAMA. 2008 Jun 4;299(21):2543-9.)

The first article, “Statins and all-cause mortality in high-risk primary prevention”, by KK Ray, et. al. (Arch Int Med, 28 Jun 2010; 170(12):1024-31) is a “meta-analysis”. This is a type of study that looks at a group of previously-done studies to try to determine if there is a consistent conclusion that is stronger because it includes more patients than any one study, or weaker because the various studies contradict each other. The authors’ goal was to tease out the results for primary prevention from studies that had looked at the use of statins for both primary and secondary prevention. There were 11 studies that met their criteria, which had a total of 65,229 (= “a lot”) of participants. Their Conclusion (verbatim from the abstract): “This literature-based meta-analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up.” This is not to say that the statins did not lower LDL; they did, and significantly, but in the population of people that had not yet had a coronary event or stroke, they did not prevent mortality. It is important to note that they did also, to a small degree, decrease the risk of having a heart attack, although not of dying. The reduction in risk was about 1.5%; that is, if 200 people are treated for 5 years, 3 will not have heart attacks (NNT=67 over 5 years). The previous studies, by mixing up those who did have a prior event and did have lower mortality (secondary prevention), with those who had not, showed, on net, a benefit. This study demonstrates that there is no reduction in mortality from using statins as primary prevention; whether the small reduction in MIs and their associated morbidity and cost is worth the administration of statins in high-risk patients is at least questionable, and may be an issue for each patient to decide with their doctor.

What about the JUPITER trial? This is the subject of the second article, “Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy”, by M deLorgeril et.al. (Arch Int Med 28 Jun 2010;170(12):1032-36. In a scathing “critical reappraisal” the authors note a slew of flaws in both the conduct and reporting of the JUPITER study. These include ending the study early, after only 2 years, at a time when it appeared that there was mortality benefit from the patients treated with rosuvastatin but when the curves were beginning to come together (i.e., maybe with more time the apparent benefit to rosuvastatin treatment would have disappeared and there would have turned out to be no difference in mortality rate), publishing reports in which the end of that curve was truncated, to not show the coming together, and publishing “subgroup” analyses that seemed to show benefit (by gender) but not where they didn’t (patients with diabetes). Most surprisingly, JUPITER had what seemed to be an extraordinarily low rate of fatality from myocardial infarction. The authors note that, to be able to get meaningful data to look at, they had to do calculations from the data presented by the JUPITER authors. For example, to know how many people died from heart attacks (myocardial infarction, MI) they had to subtract “nonfatal myocardial infarction” from “any myocardial infarction. This is not falsification, but it is very unusual for authors to present the data in a way that readers are required to make such calculations in order to get very important information. The rate of fatal to non-fatal MI was extremely low compared to studies from the World Health Organization, that show it to be 40-50%; in JUPITER it was 8.8% in the placebo group and 29% in the rosuvastatin group. First of all, it seems, if this data is correct, the fatal to non-fatal MI rate was 3 times as high in the group treated with rosuvastatin as in the group that was not treated (surely not the a point the authors and sponsoring company wanted to emphasize). Moreover, everyone in the study was “…unexpectedly – and inexplicably – highly resistant to acute ischemia and infarction.” The authors of this article suggest that there are many inconsistencies and implausabilities in the JUPITER data.

They then go on to discuss at length the roles of the sponsor (the drug company) and conflict of interest in reporting the data both by the sponsor and the principal investigator, who is co-holder of a patent for a test that is used to show “risk” for coronary artery disease (called “C-reactive protein, or CRP). They refer to other industry-sponsored flawed studies, including those about rofecoxib (Vioxx ®) and gabapentin (Neurontin ®), which I have discussed previously (“The ‘Neurontin Legacy’”, Jan 22, 2009). A superb editorial by Lee Green, “Cholesterol-lowering therapy for primary prevention: still much we don’t know” (Arch Int Med 28 Jun 2010; 170(12):1007-8) summarizes these issues.

Think about this. We have a bunch of studies that seem to show that statins are effective for prevention of cardiovascular events (heart attack and stroke) and prevent death. Turns out that they do this for those who have already had a heart attack, but for those who haven’t, the reduction in heart attack is small and there is no reduction in mortality. The use of statins in the much larger group, people with elevated cholesterol who have not yet had a heart attack, means big money for the drugs’ manufacturers. Studies that mixed the two groups blurred the distinction.

Then we have a big study (JUPITER) that purports to show that statins ARE effective for primary prevention, but that study is funded by the drug company and is seriously flawed. We know elevated cholesterol is associated with heart attack and we presume lowering cholesterol would help prevent those heart attacks, but, amazing and very important, when the study is actually done, the data doesn’t show it. (In studies looking at another such indicator, homocysteine, it was shown that, while elevated homocysteine levels are associated with heart attack, and folate – a cheap drug – lowers homocysteine levels, this did not decrease the rate of MIs. Too bad for the makers of the expensive homocysteine level test.)

I assume that I do not have to review the conflict of interest in the study being funded by the drug company and having the principal investigator a patent holder of a test that is highly used for assessing MI risk. The obvious concern is not that this was a potential conflict in the JUPITER study, but that it in fact led to selective interpretation and presentation of data (and the answers to how they had such a low rate of fatal MIs is still not in). This certainly challenges the claim we sometimes hear that just because there is a potential conflict of interest, it doesn’t mean that there is bad science being done. Of course, intrinsically it doesn’t, but this is one more example – with Vioxx and Neurontin and others – to show that it often does. And it also makes it harder for those who would argue that accepting industry gifts (whether lunch or fancy vacations) is benign. All these issues make a great example for teaching students, about conflict of interest, surrogate measures, scientific integrity, and how, from big issues to small ones, self interest colors our perceptions (see J Dana and G Lowenstein, “A Social Science Perspective on Gifts to Physicians From Industry”, JAMA. 2003;290:252-255).
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