.
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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Thursday, August 26, 2010
Friday, August 20, 2010
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
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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Saturday, August 14, 2010
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.
.
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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Sunday, August 8, 2010
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.
.
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.
.
Monday, August 2, 2010
Calcium, Heart Attack and Osteoporosis
.
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.
.
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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