Conflict of interest 2: Clinical practice guidelines and Deans

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My last blog post was about conflict of interest (COI) in medicine; there has been some recent literature on the subject, so I am providing a second posting on the topic.

In “Conflicts of interest in cardiovascular clinical practice guidelines”^[1], in the March 28, 2011 issue of Archives of Internal Medicine, Mendelson and colleagues reviewed the 17 most recent guidelines regarding the diagnosis and management of heart disease promulgated by the American College of Cardiology (ACC) and the American Heart Association (AHA), the most important issuers of such guidelines. These clinical practice guidelines (CPGs) are important, as not only do physicians use them as authoritative sources to inform their patient care, but increasingly payers – and courts -- are looking at whether they were followed to determine payment and bonuses, or culpability in malpractice cases. While thorough review of the published (and unpublished) evidence is required (indeed is a sine qua non) in the issuance of guidelines, these panels of experts are convened to allow their collective experience and knowledge fill the gaps where there is no evidence. The authors point to the 2009 Institute of Medicine (IOM, a group of distinguished physicians and medical scientists convened by the National Academies, which are private citizens gathered with federal support to advise on science and technology) report from its Committee on conflict of interest in medical research, education and practice, which states that there is insufficient study of COIs in guideline reporting, as the fact that both ACC and AHA have “recently placed restrictions on official participation in educational events and guidelines production”.

Using the concept of an “episode” to mean that 1 person participated 1 time in production of 1 guideline, there were a total of 651 episodes by 498 people in the production of the 17 guidelines. Overall, 56% of individuals (277) had some COI, and (coincidentally) a COI was present in 56% (365) of the total episodes, with a range among the 17 guidelines of 13% (2 of 15) to 87% (13 of 15). Interestingly, actual members of the guideline committees, as opposed to those who just reviewed the guidelines (“peer reviewers”) were more likely (63%, a level reaching statistical significance for those who care, p=.006) to have COIs, as were the chairs of the committees (or first authors) compared to committee members, 81% (p=.03). Only 6 of the 17 guideline committees reported whether the COIs were “modest” or “significant”; the authors found that of those 54% were modest and 29% significant. Perhaps more important, according to the authors, was that it was only a few companies, presumably those with the greatest economic stake in the outcomes, who were involved in most of the COIs. They also note that this is “a particular cause for concern given the fact that many of the newest ACC/AHA guideline recommendations are based more on expert opinion than on clinical trial data”.

Dr. Steven Nissen, commenting on the article in the same issue (“Can we trust cardiovascular practice guidelines?”^[2]), calls the “depth and breadth of industry relationships reported in this article…extraordinary,” in that they go beyond scientific collaboration to include significant stock ownership and serving as promotional speakers, and states that “no conceivable logic can defend [this] practice.” He continues “Such relationships are so antithetical to the academic mission that many medical schools have now forbid such relationships for their faculty. To allow such individuals to write CPGs defies logic.” I imagine his use of the word “extraordinary” is in the sense of “amazing”; since this is the first such study, we do not know if such COIs are indeed “extraordinary” in the sense of “well out of the ordinary”, or if they are, indeed, quite typical. Indeed, Mendelson et al cite a 2002 study by Choudry et al[3] in which the found that of the 52% of the authors of 100 CPGs for a variety of adult diseases who responded to their survey, 87% had “some type of relationship with the pharmaceutical industry” (and we would not imagine that the 48% who didn’t respond had fewer!) Dr. Nissen, who is from the Cleveland Clinic, reveals his own potential COIs, including research support from a number of companies and honoraria for speaking which he has turned directly over to charity. As covered in the New York Times (Duff Wilson, “Study finds conflict among panels’ doctors”, March 28, 2011), Dr. Nissen calls for “banning most of these conflicts rather than just disclosing them”.

But sometimes COIs are not even disclosed. The same issues of Archives of Internal Medicine contains a “research letter” titled “Failure by deans of academic medical centers to disclose outside income”^[4]. The authors, Freshwater and Freshwater, looked at holdings of deans of allopathic and osteopathic medical schools on the Morningstar directory of US corporate directors and executives, and EDGAR, the Securities and Exchange Commission database. They found that while there were only a few deans who served as directors of public companies involved in health care (9 of 161, with one serving as a director of 2 companies and one of 4), this information was not always disclosed on the schools’ websites, nor was the compensation received. This compensation for each directorship ranged from $11,250 to $386,439 with a mean of $217,454, with one dean who served on multiple companies receiving $640,038. “One dean’s official Web page disclosed the 2 directorships, but it did not disclose the compensation. Two medical schools’ Web sites disclosed 3 directorships, with one dean holding 1 and the other 2 directorships; however the Web sites underreported the deans’ compensation by 39%, 56%, and 80% compared with the compensation calculated from the companies’ EDGAR forms.” These deans are the same people who are expected to enforce the rules against COIs that Nissen refers to above. In a commentary[5], Lo (who was the chair of the 2009 IOM committee) et al, say that disclosure is not enough, and that “Some relationships need to be managed or even prohibited”. They do not go so far as to suggest that all should be banned, although I would note that 152 of 161 deans seem to do OK without serving as corporate directors.

So should all such conflicts, whether deans serving on boards of directors, guideline authors having financial relationships such as major stock holdings or speakers’ fees, or receiving grants from corporations, be disclosed or prohibited? I think that there is clear consensus that disclosure is the de minimis requirement. As I have noted before, without disclosure there is no way for the consumer of information in a research study to decide if their might be bias; this is at least as important for are those writing CPGs or presiding over our academic medical centers. But, as Nissen states explicitly and Lo hints at, disclosure is not sufficient. To extend the metaphor of the judge referred to by Howard Brody in his article Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues and cited by me in The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010, knowing that a judge in a case you are party to owns large amounts of stock in the company you are suing is not sufficient to make you feel alright about her presiding in the case.

Mendelson et al note that “It has also been argued that relationships with industry may also bring a breadth of perspective and experience, especially if individuals have relationships with multiple different companies. Theoretically, these individuals may be less conflicted than those with fewer industry affiliations…”. Right. Taking graft from many sources makes you less beholden to any one of them. Unfortunately, if you buy this argument, then their study should disappoint you, as only a much smaller percentage of the CPG authors had more than one COI.

Come on. Prominent scholars take money from industry for the same reason that others do. They like the money. Perhaps they are eminent enough that their heads are so swelled that they can believe both that they are being paid solely for their wisdom, and not for any bias they might bring to the deliberations of academic groups like those writing CPGs or in the administration of medical schools, and that, in any case, they are so distinguished that there is no way they would demonstrate such bias. If so, they are deluded. No one else believes it, most especially the companies giving them money. These COIs need to be completely banned if we are to be able to trust their academic integrity and intellectual honesty.

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[1] Mendelson TB, et al, “Conflicts of interest in cardiovascular clinical practice guidelines”, Arch Int Med 28Mar2011;171(6):577-85. (only abstract available on line without subscription).

[2] Nissen SE, “Can we trust cardiovascular practice guidelines?” Arch Int Med 28Mar2011;171(6):584-5.

[3] Choudhry NK et al, “Relationships between authors of clinical practice guidelines and the pharmaceutical industry”, JAMA 2002;287(5):612-17.

[4] Freshwater DM and Freshwater MF, “Failure by deans of academic medical centers to disclose outside income”, Arch Int Med 28Mar2011;1717(6):586-7.

[5] Lo B, Kelch RP, Grady D, “Illuminating physicians’ financial relationship with industry”, Arch Int Med 28Mar2011;1717(6): 587-8.

Conflict of interest reporting

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looks like using Google Chrome instead of IE8 solves the problem. Hmm.

This is the first of a two-part series on conflict of interest, medical ethics, and whether we can trust recommendations.

In several posts last year (Harvard Medical School limits outside income: a good start January 10, 2010, Statins and scientific integrity July 6,2010 and especially The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010), I discussed the question of conflict of interest, citing the work of ethicists such as Howard Brody, along with common sense, to demonstrate that a “conflict of interest” is simply that; a conflict between one set of a person or organization’s interests and another. In the case of the American Academy of Family Physicians (AAFP) and its relationship with the Coca-Cola Company or that between the American Dietetic Association (ADA) and Hershey’s Chocolate, the conflict is between what is in the best interests of the health of the patients that the AAFP’s member physicians or ADA’s member dieticians serve and what is in the best interests of Coke or Hershey (making money). The latter is only important to the professional organization because those companies share some of the money they make with them. In defending themselves against what appears to many people, both within and outside the organizations, to be corruption, the leaders who made these deals (such as then AAFP-President Lori Heim, MD) make the argument that only by looking at whether the information presented on the AAFP’s http://www.familydoctor.org/ website (for which Coke provided support) is biased (presumably toward Coke) can the presence of a conflict be determined.

This is patently absurd; the conflict is there, and along with it the suspicion that information may be skewed. This is particularly true when dealing with a site such as http://www.familydoctor.org/, on which the information is intended for the general public, not for professionals. Its value depends entirely upon the trust of the members of the public who use it, and such conflicts of interest undermine that trust. “How can I trust information provided on a medical site with ads from a company that my doctor says makes stuff that is bad for me – heck, that everyone knows is bad for them?” is a reasonable question, a reasonable suspicion, and a legitimate reason for concern by the public. “Hey, take our word for it; taking Coke’s money (or Hershey’s, in the case of the ADA) didn’t influence the content of the information on our website,” is a pretty weak defense, not one that is likely to engender trust of the organization or, of greater concern, of its member professionals.

The issue of conflict of interest has been a significant focus in the medical literature. Most major journals now require the authors of original research studies, particularly those that evaluate the effectiveness of drugs, to indicate if they have conflicts of interest; that is to say, financial connections with the manufacturer of the drug (or any other drug manufacturer or potential conflict of interest). This is in addition to identifying the source of funding for the study – mainly whether it was funded by a drug (or device) manufacturer as opposed to funded by the federal government (through NIH or another agency) or, much less common for such studies, a not-for-profit foundation. Again, the reason is obvious: if the author has a conflict of interest (gets money for speaking for a drug company, say, that manufactures the drug being examined, we all have reason to be more guarded in our interpretation of the results, or at least the confidence that we have that the study was done completely without bias. One problem is that bias can creep in unconsciously, even if there is not intentional fraud. Another problem is selective publication: we may only see the papers that report on studies where the drug had a positive benefit, because negative studies are suppressed; this is further complicated by the general preference of journals for positive results, regardless of who is funding the research. If the authors do not disclose their conflicts of interest, we have no way of knowing about them, and may not be sufficiently skeptical in interpreting the findings.

Am I saying we need to be skeptical? Is it not possible to be paid for speaking by a drug company and still do unbiased scientific research on their drugs? Is it not possible even when the drug company is funding the research? Of course it is possible, but unfortunately the data show that it is less likely. In the Introduction to their recent article in JAMA, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments[1], Michelle Roseman and colleagues note that “Results from positive trials and from favorable analyses are more likely to be published than results unfavorable to sponsors. Compared with nonindustry-funded trials, pharmaceutical industry–funded studies more often yield results or conclusions in support of the sponsor's drug, and authors' relationships with drug manufacturers have been linked to favorable assessments of drug efficacy and safety,” with numerous references for each of these assertions. The actual focus of their study is to look at meta-analyses to see whether they report conflicts of interest (COIs) in the original studies that they are analyzing. Meta-analyses can be the most potent source of information about a question, as they analyze the results of many studies (ideally, all randomized controlled trials) on a particular topic, and if well done can help to resolve the question of conflicting results from different studies. Of course, if the studies that are included are in themselves biased (either intentionally or not) it will of course impact the results of the meta-analysis. Roseman and her colleagues found that, while the authors of the meta-analyses reveal their own conflicts of interest (if any), consistent with the policies of the journals they publish in, they rarely indicate whether the many studies that they are re-analyzing had such conflicts.

This can be important. For example, if the different studies examined by the meta-analysis tend to show differences in the benefit of a drug treatment, it would be good to know if the ones that showed greater benefit were sponsored by a drug company, or if the authors were on that drug company’s speaker’s bureau. It just might make a difference. Wealth makes a difference because it can buy loyalty, buy favors. The old saw “It is as easy to love a rich man as a poor one” can be modified to “it is as easy to use a product made by someone who pays you as by someone who doesn’t”. Or even “it is as easy to believe an idea supported by the rich and the powerful as one supported by only the poor and disenfranchised”. The problem is that the connections are not random – the ideas of the rich and powerful are too frequently self-serving, and “just so happen” to favor them over the poor and disenfranchised. An excellent example, featuring Ayn Rand and her disciple Alan Greenspan, is provided to us by Matt Taibbi in chapter 2 of his book “Griftopia”[2].

Then it isn’t as easy. Then it is corrupt. Then it is immoral. Then it is selling your soul.

[1] Roseman M et al, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments, JAMA. 2011;305(10):1008-1017

[2} Taibbi M. “Griftopia: Bubble machines, vampire squids and the long con that is breaking America“. Speigel and Grau. New York. 2010. Ch. 2, “The biggest asshole in the universe”

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Common Sense Family Doctor: Coronary CT: nonindicated and costly screening test

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Another excellent post by Common Sense Family Doctor Kenny Lin, MD, on the incredible fact that Texas, bankrupt largely due to Medicaid costs and limiting elective Caesarean sections to decrease Neonatal Intensive Care Unit (NICU) costs, will pay for the non-indicated (but very profitable) coronary artery CT screening test. Dr. Lin also calls to task Texas Senator Kay Bailey Hutchinson for her inaccurate article criticizing the US Preventive Services Task Force (USPSTF) for "interfering" with decisions that should be made by a patient and doctor.

Some years ago, after the sudden death of St. Louis Cardinals' pitcher Darryl Kile of a heart attack at age 33, I met someone who asked me if he should get a coronary CT. I said I didn't recommend it, and wondered why he wanted it. He said if it was negative he wouldn't have to worry. I pointed out that he was very overweight and smoked, and that what would help him to live to see his children graduate from High School was not a coronary CT, but eating less and stopping smoking and beginning to exercise.

He was hoping that a negative CT had would mean he wouldn't have to do the hard work of changing his lifestyle.

Sorry, Charlie. It's not a good screening test for coronary artery disease and it is certainly not protective against developing it.
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US Medicine and Medical Education: The Good Part

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I have often, and I think with good justification, been highly critical of the US health (non-) system, particularly in two areas: the fact that we do not have universal financial access to health care (a completely intolerable situation, which cannot be justified or defended morally, although it often is – always by those who have coverage!), and the fact that we have a great deficiency of primary care physicians. I thought it might be time to address two areas in which I think US medical education and practice is superior to that in Europe and much off the rest of the world.

The first is our medical education system. In specific, I am very happy that our medical schools are graduate schools, entered by students after achieving a bachelor’s degree. This is unlike the situation in most countries, such as Britain, where the medical degree is indeed a bachelor’s degree, MBBS, bachelor of medicine/bachelor of surgery. Medicine as a graduate school is the norm only in the US and in Canada; in virtually every other country, students enter medical school out of high school at 18, and graduate 6 years later. While this still can produce excellent physicians, it is in my opinion less desirable. First of all, they do not have the advantage of the broader education that comes with a bachelor’s degree. Secondly, they are very young. In the US, a student entering medical school right from undergraduate studies would usually be 22, but because many take off for a few years (or have another career first) the actual mean entry age in most US medical schools is about 24 (with the median a little lower). This means a more mature student body, with life experiences – at least the experiences of 4 years of college, if not in another profession, in business, in the Peace Corps, etc. This makes a difference. It also means that US medical students are more likely (and, throughout this piece, when I say “more likely”, that is what I mean – greater probability, not 100%) to really want to be doctors, rather than being there because, at 18, their doctor parents told them that they were going to medical school.

I believe that this greater maturity and life experience lead to greater independent community involvement, creation and management of free clinics, etc. As an example, at the University of Kansas Medical School, the Jaydoc student-run Free Clinic is not only completely student-run, it was student developed, maintained and expanded. There are physicians who supervise at each clinic session, but that is their entire role; the students make the schedules, recruit the volunteers, organize the operation, follow up the results, raise the money (including writing grants and doing benefits). When the clinic was created, a call went out from a student, and over 80 students attended the first meeting. They identified what had to be done: find a venue, decide on frequency, raise money, organize scheduling, on and on. Hands went up from volunteers: “I was an accountant!” “I was a community organizer!” “I was a grant writer!” “I was a teacher!” Even those who had not a previous job or career had their college experiences behind them: “I organized the fund raisers for my sorority!” “I volunteered in the free clinic in the community where my college was located!” I don’t think this happens – could happen – in a school whose students all entered at 18.

Moreover, US medical schools use a variety of criteria for choosing the students to admit. They look for such volunteer work, demographic diversity, achievements in a variety of arenas. While many students are “pre-med”, majoring in biology and chemistry, as we have seen in Medicine, science, and humanities: what is their role in medical education?, August 26, 2010, many are history, English, or art majors. (“What is the course for pre-med?”, a Brazilian medical student, in his 4th year at 21 and still confused about the 4 years US students do before medical school, asked me.) In most countries a cognitive examination is the sole criterion for entry into medical school, and social values are not even considered. Thus, say, in São Paulo (which I know a little) to say that the top 200 scores go to the most prestigious medical school, 201-400 to #2, 401-600 to #3, etc., would not be far off! I have been critical of US medical admissions because they are so skewed to upper-middle-class suburbanites (80% of our medical students come from the top 20% of income), but this skew is even more pronounced in other countries where the cognitive exam is the only criterion, and the greatest likelihood predictor of doing well on these exams is going to the “best” (and most expensive) private preparatory schools. The top 2 medical schools in São Paulo are both public and free – something the socialist government is proud of – but the catch is that it would be virtually impossible for a public school student to get a high enough score on the exam to get into one of them. To get into the free, public medical school requires attending the most elite private prep schools!

The second area in which I think American medical practice – here I am talking about the practice of family medicine – is better is that, to a large degree, our family doctors take care of their patients in the hospital. In Hospitalists, December 4, 2008, I bemoaned the fact that this was changing and that primary care doctors are more and more often choosing to (or being required by their employers to) delegate the care of their hospitalized patients to others. I will not reprise all the reasons why I think this is largely a negative trend, since they are detailed in that piece; what is relevant here is that in most other countries primary care physicians (who are, in most other countries, all family doctors or general practitioners), never cared for their own hospitalized patients, turning them over to internists or pediatricians. In this sense, the trend in the US to hospitalists is emulating practice in Europe and elsewhere; unfortunately, in my opinion, it is emulating one of the more less-desirable aspects of that practice.

Indeed, the trend over the last several decades to increase the proportion of medical students with a broad liberal education is being challenged by a counter-trend, which sees education not as important in itself, but as “job training”-- whether this is in trade school, technical college, professional school, or university. In Medical Student Selection, December 14, 2008, I present my concerns that we will narrow the cohort of medical students rather than broaden it.

Thus, as I take this opportunity to laud some of the aspects of US medical education and practice, I also caution us to continue the positive aspects of our system and guard against adopting the negative aspects of the health system in other countries, as we continue to stand rigidly against adopting their proven effective strategies of providing access to health care for all.
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Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?

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This blog has previously discussed the use of PSA as a screening tool for prostate cancer (March 21, 2009: PSA Screening: What is the value?, and a guest column by Robert Ferrer, MD MPH in October 27, 2009: PSA Screening: “One of Medicine's Great Success Stories"? ), and indicated that it was not only a poor test, but a dangerous one, leading to unnecessary biopsies, diagnosis of disease that was unlikely to progress and treatment that would probably not change the outcome but would almost certainly lead to significant morbidity.

A new study by Vickers, et al., published in the Journal of the National Cancer Institute (An Empirical Evaluation of Guidelines on Prostate-specific Antigen Velocity in Prostate Cancer Detection, JNCI, doi: 10.1093/jnci/djr028, first published online: February 24, 2011), shows that the use of “PSA velocity” as a screening test for prostate cancer, is flawed and not a valid indicator. PSA velocity refers to the rate of change (presumably, increase) in the level of prostate-specific antigen (PSA) over time; the theory, which this study demonstrates to be invalid, is that the faster the rate of rise (velocity), the more likely someone is to not only have prostate cancer, but to have aggressive cancer needing intervention. In fact, the study shows that “Biopsying men with high PSA velocity but no other indication would lead to a large number of additional biopsies, with close to one in seven men being biopsied….We found no evidence to support the recommendation that men with high PSA velocity should be biopsied in the absence of other indications; this measure should not be included in practice guidelines.” And so another effort to find a way to use PSA to diagnose prostate cancer, like “highly sensitive PSA” before it, bites the dust.

Unfortunately, the issue of PSA screening will probably not die out, despite this study and the recent change in the recommendation of the US Preventive Services Task Force (USPSTF), downgrading PSA testing from an “I” recommendation (evidence is insufficient to recommend for or against testing), to a “D” – not recommended. The political pressure from physicians, hospitals, and others who are at best “true believers” (they know that eventually their faith will be proven correct) to, at worst, motivated by the fear of losing a major source of income, will continue. Indeed, the “PSA velocity” was never even seen as a way of confirming the veracity of a high single PSA value (which, for the true believers, was sufficient) but a way to identify men who had a normal PSA – but maybe slowly rising from one normal value to another – as a market who could be treated.

The USPSTF recommendation was in fact ready several months before it was released, as discussed by Kenny Lin, MD, on February 28, 2011 his blog Common Sense Family Doctor, PSA testing: will science finally trump politics?. Dr. Lin was, at the time, the staff member at the Agency for Health Research and Quality (AHRQ) that put together the evidence review upon which USPSTF based its recommendation, and then quit over political interference from the White House: “The USPSTF scheduled its "re-vote" on prostate cancer screening for its November 2010 meeting. As reported in the Wall Street Journal and on this blog, the Task Force was forced to cancel that meeting due to the unfortunate "scheduling conflict" with the critical midterm Congressional elections.” (Editorial note: postponing the recommendation didn’t help the President’s party in those elections!)

The attraction of PSA screening and prostate cancer goes beyond that single disease; it is the cornerstone of the ostensible discipline of “Men’s Health”. This is a conceit developed by astute marketers to compete, or more correctly, profit from the cachet associated with, the long-established “Women’s Health”. After all, if Women’s Health is a good and established (and profitable) area, why should men – and particularly, those who want to make money caring for men – be left out? Women’s Health (capitalized) has its own specialty, obstetrics and gynecology, but, because this is essentially a surgical discipline, has brought in also providers in family medicine, internal medicine and some of its subspecialties (especially endocrinology, because of the issue of bone loss and osteoporosis), nurse practitioners, and others. There are Women’s Health clinics, journals, and meetings all over the place; surely Men’s Health should be just as important?

The centerpiece from which Women’s Health derived is the classic “Well-Woman Exam”, an annual ritual for most adult women, so deeply enshrined in both the national culture and insurance reimbursement system that it is no danger of being overturned by a USPSTF recommendation, or probably anything else. The essential characteristic of the Well-Woman exam is the provision of preventive services because the woman is, well, Well. This is a critical concept – once someone has symptoms that are addressed by any examination (more history questions, physical exam, laboratory, imaging) or treatment, this is no longer “Well-woman”; these are problems, conceived of, addressed, and even billed separately. “Well-woman” means that the women has no symptoms and involves only screening. This screening has long been centered around the Pap smear for cervical cancer, and the internal examination (medical: bimanual = using two hands) that is so associated with the Pap that popular usage considers them together. In addition, breast health is addressed through some combination of provider exam of the breasts, teaching of self-breast exam, and referral for mammography. All of these have been re-evaluated by evidence-based studies and recommendations have changed, often for fewer tests.

Breast cancer screening has been a subject of intense controversy, with USPSTF recommending that not all women over 40 receive mammography screening, reversing a position that they took 8 years earlier, and which even at that time was not based on evidence (see October 30, 2010: Breast cancer screening: conflicting evidence? what are the important questions for health?). The political response from the “breast cancer” community – and it was a political and emotional, not evidence-based scientific response, was huge, and was likely a major reason for the White House pressure on USPSTF to not release its PSA recommendation. In addition, teaching self-breast exam was no longer recommended (this is not to argue against doing self breast exam, a major way women find lumps, but rather to acknowledge the evidence that routinely teaching it does not add benefit). Pap smears themselves, the single best cancer screening tests among a group that are mostly less effective than we would hope, are no longer recommended in women under 21 by the American College of Obstetricians and Gynecologists (ACOG), and do not need to be done annually if they have been normal. Bimanual exams never had any evidence to support their routine use in asymptomatic women, because they cannot screen for any disease. Osteoporosis treatment with bisphosphonate drugs can sometimes lead to serious fractures; recommendations are now to treat only frank osteoporosis, not the less severe osteopenia, and then only for a limited time. Even calcium supplementation has been found to have risks (August 2, 2010, Calcium, Heart Attack and Osteoporosis).

Does this mean that there is no valid place for Women’s Health as a concept or even a discipline? Not necessarily. Women do have risks for conditions that are different from those of men, including for a number of things that men are deeply involved in – contraception (not a risk if there are not men involved), sexual abuse, domestic violence. Asking about these issues is critical, with counseling about them necessary, even if this is not what “Well-Woman” exams usually pay for. And, to the extent that it increases the likelihood that these issues are addressed, Men’s Health may have a place. But in general, the examples above indicate the slippery slope of creating such a field, because there is a need to justify its existence. This means finding tests that can be done, expanding the use of these tests beyond those in whom they were originally found to be useful, and even implementing treatment for which there is no evidence, and which are often found to create net harm.

Prevention is a good thing, but if a test or intervention has not been shown to actually prevent something, doing it is useless and costly at best, and maybe dangerous at worst. Women and men should get the screening tests that are indicated, but not those that aren’t. These include Pap smears and mammography (in the appropriate women), colon cancer screening, blood pressure screening and treatment, counseling about tobacco and alcohol, contraception and investigation of risks of violence and abuse. There are others, particularly in certain sub-populations. But we need to be cautious about the creation of new disciplines and the motivation for their creation – is it increasing health or increasing revenue? Providers, doctors and hospitals, like to do things that make money and promote the fact that they do them; cancer prevention and care is particularly emphasized (January 16, 2010: Cancer Care and Hospital Advertising).

We have “Hallmark holidays” (and as a resident of Kansas City, home of Hallmark, I have to be cautious here), like Mother’s Day and Father’s Day, created and promoted to sell things, that have become very beloved by a large number of people. We don’t need “Hallmark medical care”, designed by marketers to fill a niche as an opportunity to make profit.
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The Education of Health Professionals and Prospects for Transformation

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This is a guest blog post by Seiji Yamada, MD, University of Hawaii.

The Commission on the Education of Health Professionals for the 21st Century, chaired by Julio Frenk (Dean of the Harvard School of Public Health) and Lincoln Chen (President of the China Medical Board), published its report in the December 4, 2010 issue of the Lancet. Titled “Health professionals for a new century: transforming education to strengthen health systems in an interdependent world,” the report was released in the centennial year of the Flexner Report of 1910. In contrast to the Flexner Report, however, the current report broadens its focus from medicine alone to include nursing and public health education. In addition, instead of focusing on the U.S., the report takes global health to be within its purview.

As noted by Richard Horton, the editor of the Lancet, "A strong case is made that the present content, organisation, and delivery of health professionals' education have failed to serve the needs and interests of patients and populations."

The commission reviews a century of reforms in health professional education, identifying the Flexner Report as a key document of the first generation. The Flexner report is widely credited with placing American medical education on a scientific basis and leading to the closure of institutions that did not meet its standards. (A critical view of the Flexner Report, that it was a means for allopathic medicine to enhance its dominance over competing philosophies of health and healing might be gleaned from Paul Starr’s The Social Transformation of American Medicine.)

The Commission associates the second generation of reforms with the “instructional breakthroughs” of problem-based learning (PBL) and disciplinarily integrated curricula. Identifying McMaster University as its pioneer, the key aspects of PBL are identified as its learner-centered philosophy and small groups. Newcastle and Case Western are identified as the pioneers of disciplinarily integrated curricula. Other second generation instructional innovations include the use of standardized patients, a focus on the patient-doctor relationship, earlier introduction to patients, and expanding clinical sites to include community settings. (p. 1932)

My own medical school experience (University of Illinois at Chicago, 1983-1987) was singularly uninspired and had none of these elements. I’m assuming (hoping) that UIC is doing better now. It was not until residency (family practice at Cook County Hospital, where Josh Freeman was one of my teachers) that I was introduced to training in the community setting (the South Lawndale Health Center). But it does make me wonder to what extent these “second generation” reforms have been instituted in U.S. medical schools.

I was introduced to PBL (as well as disciplinary integration, discussions about the patient-doctor relationship in the family medicine clerkship, clinical experiences for MS1s, and student rotations in community health centers) when I joined the faculty of the University of Hawaii John A. Burns School of Medicine (UH JABSOM). Initially skeptical, I have become a proselytizer for PBL in a way that only a former unbeliever can be. (My friend Mark Durand prefers to say that he once was a sinner, now he’s a preacher.)

I do know that PBL has become the organizing principle of medical education in only ten or so U.S. medical schools. The institutional barriers to changing over an entire curriculum to PBL are significant. Basic science departments generally have to give up ownership of courses, as disciplinary integration is inherent to PBL. In addition, the faculty resources for conducting small group tutorials are significant. PBL fails without faculty enthusiastic about serving as tutors.

The Commission calls for a third generation of educational reforms. They call for health professional education that is patient-centered and population-centered. By “population” is meant the global population. The goal is that all people around the world have access to health care. “The ultimate purpose is to assure universal coverage of the high-quality comprehensive services that are essential to advance opportunity for health equity within and between countries.” (p. 1924)

This point is what makes this report of interest for the readers of Medicine and Social Justice. Our educational system is charged with creating the next generation of workers who will transform the health care system into one that will serve all of humanity. This cannot be achieved without inculcating an ethic of social justice.

The Commission calls for two educational outcomes in this third generation of reforms: transformative learning and interdependence in education. “Transformative learning is the proposed outcome of instructional reforms; interdependence in education should result from institutional reforms.” (p. 1924) Generally, we tend to view our role as educators as informative and formative: we transmit knowledge to our learners (inform) and place them in settings to develop professional attitudes (form), so that they become competent and eligible for licensure. However, if we expect the next generation to lead the reform of the health system so that it delivers health for all, then we must train them to become agents of change, that is, we must inculcate transformative learning.

The second outcome called for by the Commission, interdependence in education, reflects the need for teamwork in the delivery of all health services. Disciplinary boundaries among the health professions can be overcome by interprofessional and transprofessional educational models. [The Commission defines interprofessional as teamwork with other health professional students and transprofessional as teamwork with "basic and ancillary health workers, administrators and managers, policy makers, and leaders of the local community" (pp. 1943-1944).] This will require integration of institutions as well as disciplines. Curricula will need to take more advantage of global flows of information and educational resources.

The University of Hawaii made a foray into community-based interprofessional education in the early 1990s, when the schools of social work, nursing, public health, and medicine collaborated education at community health centers. Initially funded by the Kellogg Foundation, then by the Area Health Education Center (AHEC), this effort petered out after about ten years. With external funding running dry, the various schools involved failed to commit resources to the effort.

With regards to the transprofessional educational model - in a separate piece, Marshall MacLachlan of Trinity College, calls for integrative expertise in research and research training for global health. Noting that global health is a composite field, MacLachlan proposes “integrating research about ‘what’ (content), with research about ‘where’ (context) and ‘how’ (process).” (p.2) As an example, he offers “Paul Farmer’s work on HIV/AIDS (Content), his socio-political analysis of power relations (Context), and his service delivery role in Partners in Health (Process).” (p.3) Of course, Farmer is a neo-polymath (to use MacLachlan’s term), but MacLachlan’s point is that “these people tend to emerge individually, we don’t have an explicit way of producing or encouraging such skills, or encouraging a more integrative orientation in general; and we don’t have a structure for teaching it.” (p.3)

But the fact of the matter is that our learners are demanding such teaching. As Skip Burkle points out (personal communication), young people and second career adults are demanding educational programs in humanitarian assistance. He notes that the majority of people responding to the Haiti earthquake were under thirty years old, and for many, it was their first experience in disaster assistance. Young people recognize that their working years will be spent in a globalized world, and that much of the world is characterized by poor governance and poor social and physical protections. Burkle, Clarke, and VanRooyen point out that humanitarian community inadequately translates humanitarian action into public policy. Young people recognize that they will also need to lead at the policy level.

At UH JABSOM, students formed their own organizations, the Global Health Interest Group (GHIG) and the Partnership for Social Justice (PSJ). Students in the PSJ are organizing their own leadership workshop to learn about how to improve the health system. They are motivated by a moral belief in health as a human right and the need for more social justice in health and medicine. The tasks in store for us as teachers are self-evident. Our students are demonstrating their commitment to globalism, to social justice, and to a conception of health that transcends narrow disciplines. We need to make sure that we can help prepare them to achieve these goals.
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Fighting for freedom abroad -- and at home

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In two side-by-side Op-Ed pieces in the NY Times on Sunday, February 27, 2011, Nicholas Kristof and Frank Rich discuss apparently very different topics. Rich’s piece, “Why wouldn’t the Tea Party shut it down?”, can be described as “depressing-with-a-glimmer-of-hope.” It compares the current situation in Congress, with a new, empowered, Republican majority with 83 freshman and firm ideology, to that of 1995, when a similar class of mid-term-elected Republicans took control under Newt Gingrich with their “Contract for America”. The similarities are obvious, but he points to the differences as well. Structurally, these include the advent of FoxNews trumpeting the GOP line that this is all about cutting spending and reducing the deficit, and pressures such as Gingrich himself urging current Speaker of the House John Boehner to push ahead with this agenda. Importantly, it highlights the role of massive funding of this agenda by the secretive-but-being-dragged-into-the-open billionaire Koch brothers, whose financial self-interest is being massively served by the Republican policies of tax cuts for the wealthy, and even more by gutting of all regulation of the oil industry (EPA) and financial industry (SEC, IRS and others). As the House moves toward actually shutting down funding for the government, it hopes (believes?) that it can convince the public to blame the President.

What is the “glimmer”? First of all, this strategy did not work in 1995, when the Republicans, not Bill Clinton were blamed for the government shutdown. Second, in 1995 the economy was in very good shape, while now it is still a disaster. While the unemployed and fearing-unemployment portion of the public, may not want to pay taxes, they are their slightly-better-off countrymen both need and want the services provided by the government in that small sliver of discretionary spending (not counting Medicare, Medicaid, and the military) that is on the table. People want their Medicare and Social Security and Veteran’s benefits and are not going to be happy if the checks don’t come because the Republicans shut down government. Moreover, Rich notes that “…the latest Pew survey found that Americans want to increase, not decrease most areas of federal spending – and by large margins in the cases of health care and education.”

Republicans think that they can continue screaming “deficit” and Americans will ignore the fact that the cuts that they propose, targeting social programs they are ideologically opposed to (Head Start, Planned Parenthood, etc.), will not make any significant difference in the deficit, while the cuts they oppose, such as repealing the tax-cuts for the wealthiest individuals and corporations, would. Maybe people will. Hopefully, especially if the President can make these points clearly, they won’t.

Kristof, on the other hand, provides a tale of inspiration and hope-with-a-serious-measure-of-caution. In “Unfit for Democracy?” he challenges the “crude stereotype” that the peoples of the Middle East (along with those of Africa, China, and other parts of the non-western-European world) are “too politically immature for democracy.” He acknowledges the state failures of Yugoslavia after Tito and the Congo; he is aware of the fears that regime change led to civil war in Iraq, chaos in Somalia[1], repressive theocracy in Iran. I have had friends tell me that the uprisings in the Middle East are about economic opportunity, not freedom. I’m sure economics, in these very poor countries, are part of it, but people are bravely dying for freedom, and they are at home, and not in the military.

Kristof tells us of unspeakable tortures endured in Bahrain, of the bravery of the double amputee he met in Cairo who wheeled his chair to the front lines as Mubarak’s thugs attacked with “rocks, clubs, and Molotov cocktails, of people marching unarmed in Bahrain toward security forces who had opened fire on them the day before.” That while there have been bad, even horrible, outcomes when people have overthrown repressive governments, “countries usually pull through”. That the solution cannot be the continuance in power by the current corrupt and brutal dictators. This is a myth perpetrated by the very dictators themselves to justify their continuance in power, to justify both pocketing most of the money and oppressing their own people.

What is the relationship between these two stories? Tyrants in power share with elites in power the professed (and often believed) myth that those who they oppress are lesser peoples, inferior races, too “childlike” to manage themselves not to mention be “trusted” with managing their country. Bigotry and exploitation exist in a homeostatic relationship, one used to “justify” the other, in a history of atrocities, from the colonialist “White Man’s Burden” to Hitler’s attempt to exterminate all Jews in the Holocaust. This position characterized attitudes toward American Indians, black people, immigrants in the late 19th and early 20th century, workers and the labor movement, and women. It justified – in our country, built on the idea of freedom and democracy – not only discrimination, degradation, and intimidation, but violent repressive attacks on: American Indians (genocide), black people (slavery and Jim Crow), immigrants, workers, and even women.

Well, these days are not over. American Indians and Black Americans, as well as other minorities continue to be on the bottom rungs of our economic and social order. Attacking immigrants is the new paradigm, with Arizona and its continued escalation of ignoble and often unconstitutional laws being hand-in-glove with the iron fists of those such as the Sheriff of Maricopa County (a worthy successor to the evil Sheriff of Nottingham, Robin Hood’s nemesis on the old television program). Wisconsin moves to the front lines in attacks on workers, with its governor seeking to eliminate collective bargaining under the myth that it is about money, despite the complete accession of the public sector unions to the financial cuts (and despite the fact that it is their own money they are giving back).[2] An astute observer notes: “You look at what is happening in the Middle East where people long kept "under the thumb" are expressing their yearnings for freedom and then contrast that with the fomenting battles over pensions and collective bargaining here in the US. It doesn't take long to start asking "What is wrong with this picture?![3]" What indeed?

“In Egypt and Bahrain in recent weeks,” Kristof writes, “I’ve been humbled by the lion-hearted men and women I’ve seen defying tear gas and bullets for freedom we take for granted. How can we say that these people are unready for a democracy that they are prepared to die for?”

Most of us in the US, those who are not the mostly young and mostly poor and working class people deployed in the at-best-futile wars in Afghanistan and Iraq, are not in danger of dying from government-directed violence. But we are certainly in danger of losing the freedom as our rights are all sold off to the highest bidder, and we must stand against it.

[1] See also the article on the Somali pirates and what the response might be,
[2] See Rick Ungars piece on Forbes.com, “The Wisconsin Lie Exposed – Taxpayers Actually Contribute Nothing To Public Employee Pensions”.
[3] R. Aistrope, personal communication.
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Common Sense Family Doctor blog: Maybe PSA's time has finally come -- to an end!

I highly recommend reviewing Dr. Kenny Lin's blog post on "Common Sense Family Doctor" regarding PSA testing, http://commonsensemd.blogspot.com/2011/02/psa-testing-will-science-finally-trump.html
It reviews not only Dr. Lin's experience in helping write the guidelines but the political pressure to "trump" science.
Hopefully, now, the evidence on the non-utility of PSA testing is clear -- but read his piece for the details.

We are moving in the wrong direction: the health care crisis and American hubris

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The passion for democracy and liberation from tyranny continues to spread across the Middle East, with major actions (and reactions from dictators) taking place in Bahrain, Yemen, Libya and even Iran. While decades of US foreign policy has focused on supporting these dictators while talking democracy, the people in these countries are looking at the US as a model, not of foreign policy, but of democracy. They may have economic interests, but -- in Libya, for sure, they are willing to die for freedom. Finally, our President, from whom we (and they) had expected great things, is speaking on behalf of freedom.

However, as I wrote last week, things are moving in the wrong direction in the US itself, where right-wing zealots funded by billionaires have taken over not just Congress but the legislatures of many states. Wisconsin is the prime example of an attempt, which may yet be successful, to strip the basic rights of labor unions to organize and fight for their members, a class war thinly veiled by statements of fiscal responsibility negated by the fact that the unions have already agreed to the financial cuts. On NPR’s Morning Edition on Feb 21, 2011 Steve Inskeep,the host interviewing Senate President Scott Fitzgerald, who is carrying the water for Gov. Scott Walker’s bill, could barely contain his irritation as Sen. Fitzgerald kept dodging the questions, reiterating boilerplate talking points rather than answering.

And we are not doing so well. In Empire at the End of Decadence (NY Times, Feb 18, 2011), Charles Blow provides a stunning graphic chart comparing the United States to other countries in the developed world across a variety of areas on which we do, or should, pride ourselves. We don’t come out very well. Among the International Monetary Fund’s (IMF) 33 advanced countries, we are not in the best in any of the 9 areas. We are dead last in prison population per 100,000 (745, more than twice 2nd place Israel’s 325), and tied for worst, with Korea, with 16% of people indicating that they had not enough money for food in the last year. In the only direct health measure, life expectancy at birth, we are, at 78.24 years, ahead of only 5 of the other 32 countries; Slovakia at 75.62, is the lowest, and Taiwan is jus t behind us at 78.15 (the other 3 are Slovenia, Cyprus, and the Czech Republic).

While Republicans rant about individual mandates and repealing “Obamacare”, the health insurance crisis is not over. In the New York Times, Feb 20, 2011, Donna Dubinsky wrote “Money won’t buy you health insurance”. This “co-founder of Palm Computer and Handspring, is the chief executive of a computer software company” describes the difficulty that she had in obtaining insurance on the private market despite being quite well-to-do when neither she nor her husband worked for a large company any more. After being denied coverage at all because of “pre-existing conditions” (“For me, it was a corn on my toe for which my podiatrist had recommended an in-office procedure. My daughter was denied because she takes regular medication for a common teenage issue. My husband was denied because his ophthalmologist had identified a slow-growing cataract,” she finally found a company that would insure them at a high rate with a high deductible, and the rates have continued to rise although they pay (because of the deductible) most of the bills themselves.

The point is not that she is in tough straits. I am sure Ms. Dubinsky would agree that there are a lot of people who we should have a lot more sympathy for than her; people who are homeless and jobless and hungry, and millions more who are on the verge of becoming so. And yet there are many who continue to see the uninsured as “other”, the “them”, rather than the “me and my neighbors”, despite the fact that many of their neighbors, and relative, and friends, must be in this boat. Ms. Dubinsky’s article points out, if there were any more evidence needed, that insurance companies are greedy and absolutely not to be trusted with the health care of the American people. The Affordable Care Act, (ACA) mandates individuals to purchase health insurance, ostensibly the objection of the Republican right (who are presumably either well insured or healthy and optimists), which was the only way the insurance companies would buy in: they basically said “We can only allow no underwriting (denying insurance to people they assess as too high a risk) this if you make everyone buy insurance.”

Should you even think for a moment that for-profit insurance companies are anything but self-serving, it is worth looking at Jacob S. Hacker and Carl DeTorres’ scorecard, The Health of Reform (NY Times, Feb 17.2011). They grade the ACA in Rollout, Reaction, and Results and give the overall program so far a “B”. The reaction of the insurance companies gets a “C”: “Eager to have millions of new private customers, the big private plans and their lobby are against repeal. Still, they spent tens of millions of dollars supporting the anti-reform candidates in the elections and are fighting key consumer protections and cost controls”.

Paul Krugman is generally a supporter of the ACA health plan, believing that it actually will be a major step to addressing our fiscal problems. “What would a serious approach to our fiscal problems involve? I can summarize it in seven words: health care, health care, health care, revenue. “He continues (Willie Sutton Wept, NY Times, Feb 18, 2011),
“What would a serious approach to our fiscal problems involve? I can summarize it in seven words: health care, health care, health care, revenue….What would real action on health look like? Well, it might include things like giving an independent commission the power to ensure that Medicare only pays for procedures with real medical value; rewarding health care providers for delivering quality care rather than simply paying a fixed sum for every procedure; limiting the tax deductibility of private insurance plans; and so on. And what do these things have in common? They’re all in last year’s health reform bill. That’s why I say that Mr. Obama gets too little credit. He has done more to rein in long-run deficits than any previous president. And if his opponents were serious about those deficits, they’d be backing his actions and calling for more; instead, they’ve been screaming about death panels.”
So, while the President’s plan might be criticized for being a giveaway to insurance companies, the right is attacking it for all the things it actually does well!

Dubinsky ends her article “If members of Congress feel so strongly about undoing this important legislation, perhaps we should stop providing them with health insurance. Let’s credit their pay for the amount that has been paid by the taxpayers, and let them try to buy health insurance in the individual market. My bet is that they all would be denied. Health insurance reform might suddenly not seem to them like such a bad idea.”

Maybe, but some folks have no shame. It is not a bad idea, it is, as Krugman demonstrates, a pretty good idea from an economic as well as health standpoint. And Blow may be right when he says that, rather than confront the realities of developing a population with the health and education to compete in a global economy, too many people “…would prefer to continue to bathe in platitudes about America’s greatness, to view our eroding empire through the gauzy vapors of past grandeur.”

That is not a conceit that we can afford.

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The challenge of expanded Medicaid and the dearth of primary care physicians

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The shortage – current and future – of primary care physicians in the US has been a recurrent theme on both this blog and many other venues in journals and the blogosphere. In addition, several posts relating to the Affordable Care Act (ACA) have noted the difficulty Massachusetts has had since it implemented an individual mandate, with many more people covered and not enough primary care doctors to see them (Solving Medicare costs and the budget deficit: primary care, cost-effectiveness, and universal health coverage, Jan 5, 2011; PPACA, The New Health Reform Law: How will it affect the public's health and primary care?, Apr 12, 2010). Apparently, there are a lot of states that will be in worse shape than Massachusetts, according to a study by Leighton Ku and colleagues in the New England Journal of Medicine.

In The States' Next Challenge — Securing Primary Care for Expanded Medicaid Populations (NEJM 10Feb2011;364(6):493-5) the authors look at the expansion of Medicaid mandated in ACA, to 133% of poverty for nonelderly adults by 2014, and note that this expansion will be far greater for states that currently have the most restrictive eligibility for Medicaid than those that have the most generous (e.g., Massachusetts). They note that this will require far more primary care doctors, and observe that many of these same states have the greatest deficit in primary care capacity. Using a creative approach, they create a “Medicaid expansion index” to identify how much a state’s Medicaid population will grow as well as a “primary care capacity index”. They standardized them so 100 was the average, and combined them to get a relative assessment of each state’s “challenge”; over 100 is worse than average, under is better. The scores ranged from 212.6 (Oklahoma) to 15.2 (Massachusetts, in fact!). Unsurprisingly, the states that face the greatest challenges are mostly in the South and Midwest, like Oklahoma, while the other states with low scores tend to be in the Northeast. Some of this is, as Ku notes, a primary care physician deficit in those states with high scores, while and much of it is a result of the fact that these high-score states have such limited current eligibility for their current Medicaid programs that they will have the largest number of newly-insured people.

The authors acknowledge that the “Access to care is determined in local service areas, not at the state level. Access problems could be more severe in rural or inner-city areas than in suburban communities, for example.” No doubt they will be; as many posts on this blog (e.g., Primary Care and Rural Areas, Apr 28, 2010) have noted, distribution of providers (not only physicians but nurse practitioners and other “midlevels”) is not even close to adequate, both for primary and subspecialty care. There are too few providers in the inner-city, but in rural areas the situation is worse -- 20% of Americans live in these areas, but well under 10% of doctors practice there. Only family physicians distribute in proportion to the population, but 20% of family physicians is not anywhere near 20% of doctors. Other primary care specialties, such as pediatrics, are very concentrated in urban areas (Primary Care, Pediatrics, and Physician Distribution, May 21, 2009).

Ku, et.al., express some guarded optimism, suggesting that expanded insurance coverage will support more primary care doctors – but note that the expansion also doesn’t begin until 2014. Given the long time frame to create physicians in any specialty, this will at best leave us with several years of shortages. And, at the current rate, “at best” is unlikely. The authors emphasize the need for training more primary care doctors, especially in the most “challenged” states, but really make no suggestions that are likely to have a significant impact, citing such things as expanded scope for “midlevels” (does not address distribution) and expectation that increased funding for Federally-Qualified Health Centers (FQHCs).

In the very next article in the same issue of the NEJM, Stephen R. Smith does make some suggestions for change that would likely produce more primary care doctors. In A Recipe for Medical Schools to Produce Primary Care Physicians[1], he starts with the admissions process, suggesting that admissions be MCAT (Medical College Admissions Test) “blind”, meaning that above a pre-defined minimum score, MCAT scores will not be considered (so that a student with a very high score is considered “more desirable” than one with just a high score). He emphasizes the need to select students “…who express a desire to serve underserved populations, who demonstrate altruism, and who are committed to social responsibility” because “they are more likely to go into primary care”. (However,expressing interest is not the same as actually having interest. See the experience of Pennsylvania’s Commonwealth Medical College. [2]) He suggests that the curriculum be based on a “patient-centered learning approach” with continuity follow-up of actual patients and teaching of “basic science” in the context of these actual patients. He urges that the entire curriculum be built around the competencies needed for a primary care physician, that students be taught in inter-professional teams, and that community-based settings be used for training.

These are all good ideas. They are consonant with recommendations I have made (of course, this makes them good :)!). While they do not look at “output variables” (mainly income/reimbursement), they do address the two areas over which medical schools have the greatest control – the students they admit (“input variables”) and the curriculum (the “process”). The suggestions that Smith makes have all been tried, and they all work to a significant degree to increase the number and percent of primary care doctors. At the University of Kansas, for example, we do have essentially “MCAT-blind” admissions, and look for the characteristics he suggests, among others, believing that such personal characteristics as caring, altruism, and communication skills are not only important for primary care, but for all physicians. The problem is absolutely not that we don’t know what works; we do. The problem is that we have, nationally, lacked the commitment to implement these strategies on a large enough scale to have a sufficient impact on the supply of physicians.

There are two big issues, though. Obviously, the first is that “output variables” – mainly the enormous differential in expected physician income – are not addressed. This is critical. As long as reimbursement policies by Medicare (see “Outing the RUC: Medicare reimbursement and Primary Care”, Feb 2, 2011) and other insurers dramatically favor subspecialists and especially proceduralists, there will not be enough primary care doctors. Indeed, the other “problem” medical students often identify with primary care – less than appealing “lifestyle” (read: “too much work”) is related to this; if you make a lot more per hour, you have to work fewer hours.

The other big issue is that Smith addresses his suggestions to the many new allopathic (“MD”) medical schools being currently created. He notes that these are (mostly, although not all) designed to increase production of primary care physicians (although, as noted in the footnote about the Commonwealth Medical College, even those may have trouble getting students who are actually interested in primary care), and he is correct that adopting his suggestions, among others, is more likely to keep them on that path. However, this is too simple; it forgives existing medical schools from fulfilling this responsibility, and they absolutely should not be so forgiven. This is particularly true for the most “elite” schools, many of them private and in the Northeast and very “selective” (indeed “selectivity” – the percent of applicants that you turn down – is a criterion for high rank by US News and World Report). Such schools are also the ones with the highest amounts of National Institutes of Health (NIH) research support, and pride themselves on producing researchers. Different schools, the refrain goes, have different mission; we produce “physician scientists”, somebody else should produce the primary care doctors (hey, like those “new schools!”).

The problem is twofold. First, these schools produce a lot of physicians, and they need to produce the kind of physicians that the community needs. Second, these schools set the standard for what most other schools want to be like – to be highly ranked by US News and get lots of NIH money. The last big expansion of medical schools, in the early 1970s, was also supposed to produce primary care doctors, but many or most of them immediately abandoned that mission and began trying to be like Harvard or Johns Hopkins. What needs to happen is that Harvard and Johns Hopkins need to look more like the University of Kansas, and produce a much higher percent of community-serving primary care doctors. In fact, so does the Warren Alpert School of Medicine at Brown University, where Dr. Smith works.

So, in case I haven’t been clear, two things need to happen:
1. Current physician reimbursement formulas need to be abandoned, and Medicare needs to adopt a reimbursement scheme that will result in primary care physicians having at least 70% of the income of subspecialists. Where Medicare leads, private insurers will follow.
2. All medical schools must adopt admissions policies that de-emphasize high exam scores and emphasize desirable personal characteristics, and lead to much greater diversity of students by socioeconomic status, geographic origins, and race/ethnicity. They need a curriculum that reinforces these skills, problem solving, independent learning, and communication. The elite private schools should take the lead; where they lead others will follow.

When? What should be the timeline? Immediately. Right now. No delays. Both should have been done yesterday.

[1] Smith SR, “A Recipe for Medical Schools to Produce Primary Care Physicians”, NEJM 10Feb2011;364(6):496-7 (online available only to subscribers)
[2] The Commonwealth Medical College in Scranton, Pennsylvania selected its students based on an expressed interest in primary care, but found that in their first class, on a pre-matriculation survey (before they even started school!) only 23% still said they wanted to be primary care doctors! (Tracy & Smego, “Discordance of Self-reported Career Goals of First-year Medical Students During Admission Interviews and Prematriculation Orientation”, Family Medicine, Jul-Aug 2010.
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Freedom abroad, health at home: experiments in preventive health care

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First, we must celebrate the victory of the people of Egypt in ousting the 30-year dictator Hosni Mubarak, and we revel in the democratic character of both this peaceful revolution and that in Tunisia last month. We hope that all of the dreams and aspirations of the masses of people involved are realized – freedom of speech, freedom for women and minorities, freedom from hunger. Thinking and reading about it brings tears of joy and admiration for these brave people. It is truly inspiring and encouraging to see this part of the world moving in the right direction. I feel that it may be wrong to have a post that dilutes this excitement with discussion of other topics, but take comfort in the fact that the papers, magazines, and blogosphere are talking about little else.
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Unfortunately, at the same time it is sobering to think about how much, in the US, we are moving in the wrong direction (see Bob Herbert, “When democracy weakens”, NY Times, Feb 12, 2011). Politicians elected, with money coming from the wealthiest corporations and individuals, on the platform of promising to create jobs, do nothing of the kind (see Robert Reich, “The recession isn’t over until the jobs come back”, Kansas City Star, Feb 12, 2011. At the federal level, to the extent Congress is doing anything, it is giving money away to the richest and taking away from poor and working people. State legislatures are also focused on eliminating support for poor people, as well as oppressing immigrants and banning gay marriage – or any rights for gay people (see Charles Blow, “Repeal, restrict, and repress”, NY Times, Feb 12, 2011). And, of course, on further restricting abortion rights. Indeed, there are those in Congress who wish to eliminate Title X funding for contraception. Given that contraception is the most effective way to decrease the abortion rate, this seems bizarre, but only if you are into “reality-based” policy making.

Where is the good news in our country? We all know that there are lots of good people out there, doing lots of good things. In health care, much of the positive news is people pitching in, volunteering to try to fill the holes left by a health care system that does not, despite the Affordable Care Act (ACA), provide care for much of our population. One example is the JayDoc Clinic, an operation entirely run by students from the University of Kansas School of Medicine, featured in the Feb 12 Kansas City Star (“Student run JayDoc clinic serves the uninsured”). Great work, and a great article, but one result is going to be more people who are in need hearing about it, and further overwhelming the clinic. The JayDoc, like so many “safety net” clinics, is a “finger in the dike”, struggling to survive in providing basic care while billions are spent on what Don Berwick, currently head of the Center for Medicare and Medicaid Services (CMS) and his colleague Brent James at the Institute for Healthcare Improvement (IHI) call “rescue care”.

Meeting the basic health care needs of the really-needy is not only right and compassionate, but is likely to cost less (in dollars and pain) if it prevents serious illness later. Since this does not seem to be a focus of government, which is busy cutting taxes on billionaires like David and Charles Koch and cutting access to contraception, some progressive and thoughtful parts of the private sector have been creating models across the country. Many of these are detailed by surgeon and writer Atul Gawande in his article “The hot spotters: can we lower medical costs by giving the neediest patients better care?” (New Yorker, Jan 24, 2011).

Gawande examines several cities where efforts have been made to identify the sickest, neediest, and highest-cost-users of health care, and intervene to try to reverse or ameliorate the causes. Some of them, like the lead story of the program in Camden, NJ, are the result of hard and extended volunteer work, by Dr. Jeffrey Brenner and friends. Others, such as in Atlantic City, result from partnerships between existing institutions (in this case, a hospital and a union). None are the result of wise governmental leadership investing in these programs to reap a benefit of greater health and lower cost. In Red, Blue, and Purple: The Math of Health Care Spending, Oct 20, 2009, I discussed the implications of the fact that most people use little health care, and a small percent use most of it. Managed care in the late 1990s failed in part because it put major hurdles in the way of receiving health care for the large proportion of the population whose health care use accounted for a small percent of health care spending in any case.

The programs described by Gawande do the opposite; they identify the actual people who account for most of the health costs in these communities and provide services and support to help those people. In Camden, for example, 1% of the population – 1000 people – accounted for 30% of its costs. 900 people in two buildings (a nursing home and a low-income housing project) accounted for more than 4000 hospital visits and $200,000,000 in health care bills over a 6 ½ year period. And, as Gawande points out, Camden is not unique. There is no money for this from the public sector or insurance industry because it is being spent (in addition to insurance company profit and administrative waste) on “rescue care” for people with conditions that advanced so far because they never received sufficient preventive and primary care.

Public funds are also not being spent (indeed, as noted above, they are being cut) to support the myriad other “determinants of health”, social, economic, cultural and linguistic that are necessary for them to take advantage of preventive and primary care, to have the capability (Capability: understanding why people may not adopt healthful behaviors, Sep 24, 2010) of improving their health. Planning to achieve reductions in health care costs by “solutions” such as increasing copayments and deductibles so that people have “more skin in the game” are based on belief but not on facts. Gawande cites the experiences of benefit manager Verisk Health, which showed that such obstacles caused people to use less of all kinds of care – including primary and preventive care – until they finally got so acutely ill that needed to come to an emergency room, get admitted, go into an intensive care unit, so that costs in fact went up. One man “…had badly worsening heart disease and diabetes, and medical bills over 2 years in excess of $80,000. The man, dealing with higher co-payments on a fixed income, had cut back to filling only half his medication prescriptions for his high cholesterol and diabetes. He made few doctor visits. He avoided the ER – until a heart attack necessitated emergency surgery and left him disabled with chronic heart failure. The higher co-payments had backfired…” This outcome has been known for a long time; the RAND health insurance experiment in the 1970s and published in the New England Journal of Medicine in 1983[1] (see also: Joseph P. Newhouse, "Free for all?: lessons from the RAND Health Insurance Experiment", RAND 1993) showed that the opposite strategy – elimination of co-payments and deductibles -- resulted in higher utilization of health care; of both that which might be seen as “unnecessary” (colds) and that which was clearly necessary. And it saved money.

The interventions that have had success in Camden and other places were not “one size fits all”. Different people had different issues that required different interventions. Some were about poverty, some were about substance abuse or mental illness, some were about cultural misunderstandings or about language, and on and on. Interventions required more from nurse case managers for some people, social workers for others, physicians and nurse practitioners for others, and “health coaches” or promotoras for others. A lot of the latter; people who were familiar with the needs of the high-utilizer patients, who spoke their language, lived in their communities, and were often willing to “talk like [my] mother” to them.

And it is not always successful. But it is successful enough, far more successful than just pouring dollars into rescue care, that it needs to move beyond the limits that volunteers and a few forward-thinking institutions are constrained by. It needs to recognize the critical nature of teams, of integrating preventive and primary health care with basic social (and sometimes legal) services, with meeting core needs for food, housing and transportation that are all too often not even considered by policy makers. Funding is key; depending on volunteers in such efforts as these, or the JayDoc student–run free clinic will never come close to being a solution.

About Dr. Brenner’s program in Camden, Dr. Gawande writes “It remains unclear how the program will make ends meet”. In fact, these sorts of programs need to become the mainstream of health care and service delivery, and need to become the priority of federal, state, and local government.

[1] Brook RH, et. Al., “Does Free Care Improve Adults' Health? — Results from a Randomized Controlled Trial”,N Engl J Med 1983; 309:1426-1434.
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Education in Medicine: The characteristics of future physicians

Education in Medicine: The characteristics of future physicians: "In my blog from 2/4/11 'Why do we put so much import on the MCAT?', I discussed some of the negative characteristics that can be associated ..."

Non-preventive Health Screenings: Common Sense Family Doctor

A good review of the (non-) value of many highly marketed screening tests (these are "sold" at health fairs) by Dr. Kenny Lin, the Common Sense Family Doctor.
http://commonsensemd.blogspot.com/2011/02/preventive-health-screenings-that-are.html#comment-form

AMA response to "Outing the RUC"

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In general, I do not post comments regarding "Comments" posted to my blog. I appreciate them, would encourage you to post them and will reply personally if asked and given an email address, but the nature of a blog does not really encourage dialogue among readers. This is because once you have read a post, you are unlikely to come back and check to see if there are any "comments" posted that you might wish to comment further on.

I am making an exception in this case to call attention to the comment from the American Medical Association.
They indicate that "The entire premise of this column is false." They note that "The RUC often recommends increases for primary care services; RUC recommendations have resulted in $4 billion in annual increased payments for office and hospital visits – the most common services performed by a primary care physician." I note that this is not entirely responsive; while the "office and hospital visits" are the most common services provided by primary care physicians, they are also provided by many subspecialists, and we don't know what % has gone to PCPs vs. subspecialists, nor do they indicate what % of Medicare physician payments $4billion is. The sources of my information are cited; also the data in the graphic showing that the ratio of subspecialists to PCPs is INCREASING, not DECREASING, is the important point. Indeed, the graphic here, from the recently-released 20th report of the Council on Graduate Medical Education (COGME) shows that this definitely affects entry into primary care.

Please add your comments if you wish.

Outing the RUC: Medicare reimbursement and Primary Care

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Along with many others, I have written extensively about the need for more primary care physicians in the US. I have also addressed the various disincentives that exist for medical students to enter primary care specialties, such as family medicine, rather than narrower subspecialties or procedural specialties. One of these is the lower income earned by doctors in primary care; this is felt by many to be one of the major issues in specialty selection, and is increasing in importance as students graduate from medical school with larger and larger debt burdens, often exceeding $200,000. A study by the Robert Graham Center of the American Academy of Family Physicians (AAFP), “Income disparities shape medical student choice”, finds that the difference in income between primary care on subspecialists has been increasing since 1981, and that by now there is a difference of $3.5 million in the lifetime income of the average subspecialist (not even the most highly paid) and the average primary care physician.


So why is there such great variation in the reimbursement of different specialists? It is not on hours worked; many studies have taken this into account and found that on an hourly basis there is a great variation. The Wall St. Journal’s Anna Wilde Matthews and Tom McGinty, in “Physician panel prescribes the fees paid by Medicare”, describe a study done for the Medicare Payment Advisory Commission, MedPAC, that found a wide-range in per-hour reimbursement, from $101 for primary care physicians to $161 for surgeons to $193 for radiologists and $214 for dermatologists. It is not on the basis of length of training; all physicians go to medical school and the training, for example, for surgeons is considerably longer than that for dermatologists. Is it how hard the work is? After all, not everything is brain surgery. Well, to an extent, but there is considerable latitude in how “hard” is valued. What about “necessary to the health of a person” or “necessary to the health of the population”? Hardly. Let’s discuss this some more.


First, it is important to understand that the reimbursement paid to physicians by Medicare is essentially the basis for payment from all payers; contracts and reimbursements are almost always based upon multiples of what Medicare pays. Depending upon the size of the physician group negotiating with an insurance company, the particular multiplier may be greater or smaller, but Medicare reimbursement is the yardstick. Medicare payment itself is based on a formula that is primarily based upon the work that a certain activity involves, with several smaller modifications (regional variation, malpractice cost, etc.). This formula is described by health economist Uwe Reinhardt in his December 10, 2010 Economix blog for the NY Times, “The little-known decision makers for Medicare physicians fees”. Based on complex (or not) scenarios constructed for this purpose, the amount of “work” involved in over 7,000 “procedures” (for this purpose, “procedure” includes things like office visits of varying length and complexity) are assigned relative value; indeed they are assigned “relative value units” (RVUs).


But over time things change. A surgical procedure that might have taken a long time and required a hospital stay may now be done quickly in an outpatient setting. Counseling and managing several complex diseases in a primary care setting may take a lot more work and time. So the relative values may change, and reimbursement could go up or down for any of these “procedures”.


Except that, in order to keep Medicare spending from spiraling even more out of control than it has, the total number of RVUs has to stay constant. So when the number of RVUs (specifically, work-RVUs, or wRVUs) for one procedure goes up, those for others have to go down. Enter the RUC.


Several recent articles, included the Matthews and McGinty and the Reinhardt pieces cited above, have addressed the role played American Medical Association’s (AMA) Relative Value Scale Update Committee, or RUC, an organization most physicians, not to mention most other Americans, have never heard of. This group of appointed doctors makes recommendations to the Center for Medicare and Medicaid Services (CMS) about the relative amount that Medicare should pay for different physician activities. While not required to do so, CMS takes the recommendations of the RUC more than 95% of the time. While about half the services provided by physicians are in primary care, primary care doctors, according to an article in the New England Journal of Medicine by Washington state Congressman and physician Jim McDermott, “Harnessing our opportunity to make primary care sustainable”, only 6% to 13% of the 29 physicians on the RUC are in primary care. While they are supposed to be unbiased toward their own specialties, this does not seem to be what happens. Psychologically, even when they are trying to be fair, they know more about what they do and how “hard” it is than they do about what others do. Concretely, it may be easier to measure the work involved in “1 colonoscopy” or “1 gall bladder surgery” or “reading one chest x-ray” than the complex variation in primary care visits. In any case, the record demonstrates that RVU assignment, and thus reimbursement, has continued to go up for specialist procedures and thus down for primary care.


So we have a bunch of physicians, appointed essentially by their specialty societies, making recommendations on how much physicians should get paid, and a bunch of specialists deciding how to value what they do compared to what others do (certainly a conflict of interest, as defined by Howard Brody and discussed by me in The AAFP, Coca-Cola, and Ethics: Serving the public interest?, August 20, 2010), and a tremendous dominance of non-primary care over primary care physicians among this group. Why should we be surprised that we get the results that we get?


More important, for the health of the American people, the decisions made about reimbursement drive what procedures are done and what activities physicians pursue. Since reimbursement is based on “work”, not “benefit” – to the individual or certainly to the population – we get the bizarre mix of health care services that we have. Writing in Kaiser Health News, Brian Klepper and David C. Kibbe, in an article titled “Quit the RUC”, note this:


“But there is a more insidious and destructive issue at hand. The perverse incentives that are embedded in fee-for-service physician payments influence care decisions and are a principal driver of the health system's immense excesses. Encouraged by the RUC, sometimes unnecessary specialty procedures may appear more valuable and appropriate than primary care services. The system pays more for invasive approaches, so conservative treatment choices that are lower cost and lower risk to the patient may be passed over, especially near the end of life. The resulting waste, half or more of all health care dollars, has fueled a cost explosion that has led the industry and the larger economy to the brink of instability.”



Different solutions have been proposed. Klepper and Kibbe suggest that the primary care professional groups drop out of participation in the RUC altogether (“Quit the RUC”). Reinhardt feels that there is value in getting advice from this independent group, but that CMS should be much more cautious about taking its recommendations. McDermott agrees, or suggests that at least the number of RUC members be adjusted or increased to include a much larger percentage of primary care physicians.

One or more of these solutions needs to occur. Most importantly, the solution needs to look at overall benefit when assigning reimbursement value. I considered titling this piece “Wreck the RUC” (alliterative and less offensive than the other obvious, rhyming, option). If we are interested in improving the health of the American people, we need more primary care doctors, and we need to address all the open and hidden factors that are in place to work against such change. The RUC is a good place to start.
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