Wednesday, July 28, 2010

The political campaign and the future of health reform

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

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

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

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

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

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

[1] Health Affairs, July 2010; 29(7):1289-91.
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Thursday, July 22, 2010

Improving quality and access still requires coverage for all

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

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

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

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

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

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

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

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

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

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Friday, July 16, 2010

Rosiglitazone and the "Holy Grail"

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

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

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

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

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

Primary care specialty choice: student characteristics

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

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

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

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

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

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

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

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

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

Whether or not “doing the same thing over and over again and expecting different results is the definition of insanity”, it is sure not going to accomplish any change in the physician workforce.
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Tuesday, July 6, 2010

Statins and scientific integrity

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

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

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

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

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

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

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

I assume that I do not have to review the conflict of interest in the study being funded by the drug company and having the principal investigator a patent holder of a test that is highly used for assessing MI risk. The obvious concern is not that this was a potential conflict in the JUPITER study, but that it in fact led to selective interpretation and presentation of data (and the answers to how they had such a low rate of fatal MIs is still not in). This certainly challenges the claim we sometimes hear that just because there is a potential conflict of interest, it doesn’t mean that there is bad science being done. Of course, intrinsically it doesn’t, but this is one more example – with Vioxx and Neurontin and others – to show that it often does. And it also makes it harder for those who would argue that accepting industry gifts (whether lunch or fancy vacations) is benign. All these issues make a great example for teaching students, about conflict of interest, surrogate measures, scientific integrity, and how, from big issues to small ones, self interest colors our perceptions (see J Dana and G Lowenstein, “A Social Science Perspective on Gifts to Physicians From Industry”, JAMA. 2003;290:252-255).
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Thursday, July 1, 2010

Arrested at the G20: David Wachsmuth

This "Guest Post" is from David Wachsmuth, who was arrested at the G20 event in Toronto. I wanted to share it, and didn't know how else, as it is too long for "Facebook".

Arrested at the G20This weekend I was in Toronto demonstrating against the meeting of the G20 that was taking place there. At 2:45 AM on Saturday night I was arrested for a ‘breach of the peace’. The nineteen hours that followed were probably the most infuriating, frustrating, frightening ones of my life. Unfortunately, from what I now know, my experience was very similar to that of many of the over 1000 people who were arrested over the weekend. So what I'm about to describe, despite being intensely personal, probably speaks for many of us, at least in part.In preparation for the huge number of arrests they presumably planned on carrying out, the police had set up an ad hoc detention centre at an old film studio in the east end of Toronto. On Saturday night, I went with one of my best friends—who was a legal observer at the demonstrations—to the detention centre to join a midnight jail solidarity action in support of those who had been picked up earlier in a violent and arbitrary series of beatings and arrests, including of many people not demonstrating at all but simply in the wrong place at the wrong time. After a few hours of peaceful and spirited demonstration (featuring an excellent marching band), the police ordered us to disperse shortly before 2:00 AM. Like everything else this weekend, that was accomplished by surrounding us on all sides in enormous numbers of cops in full riot gear. (I filmed some video of the demonstration and the arrival of the police, which I have uploaded at http://bit.ly/aEiNaV.) The 150 of us were outnumbered at least two to one. There was some discussion of staying despite the order to disperse, but that only lasted a minute or so, and shortly everyone was filing between the ranks of riot police in the direction we had been ordered to go. A few minutes after we started leaving, and with no warning whatsoever, riot cops cut through the column of protesters and sealed off the two dozen of us at the back. We asked to be allowed to leave as they had just told us we were instructed to do, but we were instead told that we had had our chance to leave and had failed to take it (an odd idea, since we were walking away when they sealed us in). We were all arrested.The arrest itself took about 40 minutes and was uneventful. The only notable thing was how uncomfortable and difficult it is to hold your hands on your head for that amount of time. Since I was nearly the last person to get handcuffed, I had a lot of time for this to sink in. It is much more uncomfortable having your hands handcuffed behind your back, which is what happened next, but I expected that. The cop who dealt with me took me to the edge of where all the arrests were being made, asked me various questions, searched me, and so on. After a minute or two, I realized there was quite a lot of light on me, and it turned out that I was being processed right in front of a television camera, with a reporter making a report. So I asked to be moved to somewhere a little less obtrusive, but the reporter apparently got the footage she was looking for, since various people (including my mother) subsequently told me that they saw me on the news. This had at least the positive effect of letting my loved ones know what happened to me, since I was not allowed a phone call in the 19 hours during which I was detained. My arrest papers say I was arrested at 2:49 AM.We were slowly loaded into paddy wagons to be taken to the detention centre. After various delays, we were stuffed into little miniature jails inside the vans (in my van there were four cells, each of which held two of us) and off we went. We spent the next 30 minutes or so sitting in these tiny little van-jails. Sitting, because the drive was only a minute or so to the detention centre (we had been protesting outside of it). The rest of the time we were parked in what sounded (we couldn't see anything out the tiny little grated windows) like a big room with a lot of prisoners in it. The highlight of this time was the spontaneous round of mass meowing that came from the prisoners outside; the cages we were in really did feel like animal pens. The lowlight was my increasingly aching left arm from being held awkwardly behind my back in the handcuffs (the plastic cable-tie kind, incidentally, not the real metal deal).We were unloaded from the paddy wagons into a set of gender-segregated cages. In the end I spent time in three separate ones, although they were all the same. They were twenty feet by ten feet, with a four-by-four-foot washroom inside. The washrooms had no door, and no toilet paper (some previous inhabitant had stashed a little in our first cage, but it was quickly used up). There were generally 25 or 26 people in my cage, which comes out to just over seven square feet of space each. For the entire time we were imprisoned, we had to rotate between standing, sitting and lying down, since there wasn’t nearly enough room for all of us to do either of the latter two at the same time. Lying down wasn’t a means to actually sleep; at least in my case the combination of the cold temperatures and bright lights (plus the steady ruckus) ruled that out.I don’t know how to describe the way we were treated in those cages except as blatant and probably illegal harassment and violation of our basic rights and freedoms. The list is fairly long. None of us was ever given the opportunity to make a phone call or speak with a lawyer, despite having told that we had the right to do so upon being arrested. Some people (not including myself) were never even read their rights in the first place or informed of their charges. We were kept in handcuffs throughout the day. In the entire time I was incarcerated we were given two tiny little ‘sandwiches’—a single slice of soy cheese and a bit of margarine on a dinner roll. I believe we were given four small styrofoam cups of water, although it may have been five. One of us was a minor, who was never allowed to contact his parents. Two people had serious medical problems that received pathetically insufficient attention. It took us something like 40 minutes to get a medic when one of them was bleeding from under his fingernails and on the verge of collapsing. The guards alternatively taunted us, threatened us, lied to us, or ignored us. Once, when we had been calling for food for some time, a guard deliberately sat down in front of our cell and ate his lunch.And it was not as if we were a bunch of hardened criminals. Of course, even if we had been, the guards’ behaviour would have been completely inexcusable, but in fact not a single one of us had been arrested for anything that resembled just cause. A little under half of the people in my cages had been at the same demonstration as me. About the same number had been arrested en masse outside the Novatel hotel; they were surrounded on all sides by police while engaged in a peaceful demonstration, and then beaten and taken into custody. The rest of the people I met were random passersby. The most egregious was a TTC employee in full uniform, who was jumped by riot cops as he was arriving at his shift. I later found out that he spent 36 hours in custody with no phone call, lawyer, or charges, which I understand to be unequivocally illegal (http://bit.ly/aIXnUG). A few people were arrested for the hitherto unknown crime of dressing in black and going to punk rock shows. One of these was in from out of town, and didn’t even know what the G20 was. Two women we talked to cage-to-cage were trampled by cops on horseback (one, who looked like she was in her 60s, got a broken arm), and were being charged with obstruction of police.It would take far too long to describe all the various forms of harassment we were subjected to, but the major theme was fear and uncertainty. The guards took people from one cage and put them in another, keeping them disoriented and preventing them from getting to know their cage-mates, and keeping the rest of us uncertain about whether they had been released or just shuffled. The police told us on a number of occasions that we were about to be released, only to immediately ignore us for hours and hours. We were repeatedly asked to identify ourselves—twice guards took an inventory of everyone’s name and ID number, and tried to do so a third time—but we were also repeatedly asked if so-and-so was in our cage. He almost never was.While I was in the detention centre, I was inclined to chalk these things up to incompetence and confusion on behalf of the police. Almost 900 people were arrested, and the centre was clearly swamped. But after getting out, talking to others who were imprisoned, and thinking more about it, I now find it hard to escape the conclusion that this confusion and uncertainty was deliberate. We were told too many times to count that the guards were working as fast as they could to process us, but that the paperwork was taking a long time. But when they actually released us, the paperwork they had told us we would need to participate in never happened. They just walked us 50 feet to the exit and handed us our possessions. After talking with a number of people who were arrested, it seems clear that many or most people in my situation were held for 18 to 23 hours—just under the legal maximum—and that therefore the endless promises of impending release were deliberate lies.The result of all this was that we were constantly on edge. We were alternately furious, frightened, depressed, manic, and inert. At some points we were all banging on the cage and screaming at the top of our lungs. At other points we brooded silently. One of us went into shock. By the time we were released, the random passersby were sounding just as radical as the protesters. We had been arrested for different reasons, but the appalling treatment we received was the same, and united us in our outrage.Why did this happen? At the largest scale, it seems clear that the police made extended preparations for mass arrests and an intimidation campaign against people exercising their democratic rights to protest. This is a key component of the ‘Miami Model’ of protest disruption and repression that Toronto police followed so strictly (http://bit.ly/al8eaR). Earlier in the day, the police had strategically abandoned the streets to a group of 'black bloc' protesters, and left a few empty police cars in the middle of the road. This point should be emphasized: there were thousands of police on the streets throughout the entire weekend, but, somehow, when a small group of protesters decided to break off from the main rally and ‘go rogue’, the police simply melted away. The Sun has now reported that this was an explicit order from police central command: http://bit.ly/cnAqIv. The resulting hour or two of smashed windows and burned cars happened with more or less no police presence whatsoever, despite the fact that it happened on the busiest streets in the downtown. The cops didn’t lose track of the protesters; police helicopters were filming the black bloc from above (and passing on the footage to the media). It would have been the easiest thing in the world to simply surround the one or two hundred black bloc protesters with five or six hundred cops and arrest them, if that had been what the police had wanted to do. Instead, the cops left them completely undisturbed until they had smashed their way from King and Bay all the way up Yonge St. to College and then back to Queen’s Park (passing by police headquarters, even!), where they changed out of their black clothing.I can’t figure out an explanation for this other than that the police deliberately encouraged property destruction as a pretext for subsequent repression. The black bloc obliged, and after the cruisers were set on fire and a bunch of storefront windows were smashed, the cops announced that their tactics would have to change in response to this property destruction, and began a violent and arbitrary series of beatings and arrests, including of many people not demonstrating at all but simply in the wrong place at the wrong time.This was the context for all the arrests that filled the cages of the detention centre, and the harassment and intimidation that police inflicted inside the cages is an exact counterpart to the violence that they inflicted outside. At a smaller scale, many of the individual guards chose to taunt, harass, and abuse us, when they could have chosen not to. I’m sure many thought that we deserved it, and others who didn’t found it easier to just let it happen. The abuse was worse because it was completely arbitrary. Sometimes if we asked for a medic, guards would show up quickly and our ill cage-mate would be taken to a medic. Sometimes guards would show up quickly but do nothing. Sometimes guards would not show up at all. This is the same arbitrariness that terrorized the peaceful protests at Queens Park and elsewhere, where riot cops made ‘dash and grab’ arrests—rushing quickly at a single protester (or passerby) with no warning, beating her, and taking her into custody. It is one of the most disturbing features of all the police violence that occurred over the weekend, because it defies logic and accountability.I’m acutely aware of how lucky I was relative to so many of the other innocent people who were arrested over the weekend. For one, I wasn’t physically abused prior to being taken into custody. But more than that, I’m an educated, well-off, straight white male. I’m sure it’s not a coincidence that the person in my cage held the longest was an indigenous man. And we now know that queer people were segregated into separate cages; women were threatened with rape and subjected to invasive strip searches (http://bit.ly/9Qlxfb).I’m now back in New York City, where I live, so I haven’t been able to participate directly in the growing collective efforts to seek justice for all the injustice that occurred in Toronto over the weekend. I wish I could. Being on the business end of police brutality hasn’t changed my politics at all; it’s confirmed them, and made me angrier. At the same time, while I am optimistic that forthcoming investigations and inquiries will condemn a certain amount of the police tactics, I don’t think that would be a ‘loss’ for the cops. It’s probably best to see their strategy as one of kicking the ball forward as far as they can in terms of the tactics they can get away with. Public outrage and judicial action may subsequently kick the ball back a certain distance, but as long as it ends up further than it was before last weekend, that is a police victory of sorts. So in general I am pessimistic about how much good can come directly out of all this. Indirectly, though, I think there is reason to hope that this outrage is bringing more people together, and building awareness of the fundamental injustice which underpins our society, which cannot be confronted until it is exposed, and which is now harder to ignore when over 1000 peaceful protesters and bystanders have been arbitrarily beaten, jailed, or both.
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Saturday, June 26, 2010

Mirror on the Wall: Commonwealth Fund report continues to show US has poor outcomes at high cost

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On December 5, 2008, I commented on the data from the 2008 Commonwealth Fund report comparing health status in a number of countries (Not Getting What We Pay For). The US fared very poorly on that study. The Commonwealth Fund has just released its 2010 study “Mirror, Mirror on the Wall” (Commonwealth Fund executive summary, Commonwealth Fund full report) and the news is no better. In comparing 7 industrialized countries (Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States), the US is #1 in health expenditures per capita at $7,290, 87% higher than second-place Canada, over twice that of the average of the other 6 ($3354) and nearly 2.5 times as much as the UK. [“Expenditures shown in $US PPP (purchasing power parity)”.].

Distressingly, but unsurprisingly to those who pay any attention to the area, including having read this blog or having seen the 2006 or 2008 Commonwealth Fund reports, this expenditure does not lead to good performance on the study’s measures of Quality Care (comprised of Effective Care, Safe Care, Coordinated Care, and Patient-Centered Care), Access (comprised of Cost-related Problems and Timeliness of Care), Efficiency, and Equity, nor on the all-important health outcome “Long, Healthy, Productive Lives”. In fact, the US ranks last -- # 7 – on that outcome indicator. And while there is not one country that leads in all the categories – Australia, for example, ranks #3 overall, but is #1 in “Long, Healthy, Productive Lives”, and is tied with the US for last in “Access”; the UK, while #6 on “Long, Healthy, Productive Lives”, is #2 overall (behind the Netherlands) despite spending the 2nd lowest amount (to New Zealand’s lowest) per capita, and ranks #1 or #2 on 6 of 10 criteria, and #7 on only Patient-centered care.

The US ranks very poorly, as it did in 2008, on Efficiency, which is interesting. We can more easily understand low rankings in Access and Equity, given our completely inequitable system of funding and access, but poor Efficiency scores reflect our poor communication, with tests often being repeated because information is not carried forward, patients being readmitted, and a variety of other characteristics. There are 8 subcategories comprising Efficiency, and the US ranks #6 on 4 and #7 on 4 (and for the whole category).

Of course, this kind of report doesn’t seem to affect policy makers too much. We already knew this, and the health reform process was in part an attempt to address it, but the current bill, PPACA, certainly doesn’t do enough. Some of the additional funding that is targeted to public health will make a difference, but it is clear from the debate in Congress that there are many who simply do not support improving the health of the American people if doing so will require cuts to the profits of the big healthcare industries who contribute large sums to them.

Some critics of the Commonwealth Fund report, such as Dr. Richard Cooper of the University of Pennsylvania, have stated that the problem in the US is not that that we have a health system which is overbuilt on the high-tech, high-cost specialty end rather than on primary care, but rather that we have more poor people; he provides evidence that, on a large regional basis, areas of the country with more poor people (e.g., the Southeast) have worse health status than those with fewer poor people (e.g., the upper Midwest). There can be no doubt that poor health status is tied to low socioeconomic status, and that the large number of poor in the US is in significant part responsible for the poor health system performance identified by the Commonwealth report and others. However, as I and many others have pointed out in the past (Public Health and Changing People's Minds, May 15,2010; Poverty, Primary Care and the Cost of Medical Care, Feb 18, 2010; Health is more than Medical Care, Jan 27, 2010), health is not simply a result of the health care, or medical care, system. The other countries measured in the Commonwealth Fund report do not have a lower percentage of poor people by chance or luck; they are, to greater or lesser extents, social democracies with policies that ensure that their people have housing, food, and education. There are poor people in those countries, but their most basic needs are ensured and this goes a very long way to decreasing their health risk. Public health, medical professionals and others in those countries are well aware – expert in – the social and socioeconomic needs of the poor in their societies, but the situation of those people, is significantly improved, to a much greater degree than in the US by a much more extensive safety net.

Poverty is bad for your health, and programs that help ameliorate the impact of poverty improve the health of populations. In addition, the presence of adequate health care services, especially primary care services, further enhances outcomes. It is not an either/or choice. Shi and colleagues demonstrated that the increased infant mortality and low birthweight rates in poor communities are virtually eliminated by a higher primary care presence.[1]

The data provided by the Commonwealth Fund should be embarrassing to every policy maker, every person of influence, and every citizen of the US. It is incontrovertible data that demonstrates yet once again that the issue is not that we aren’t spending enough money, but is the way that the money is spent: We spend it in ways that make our health status poor and our health corporations wealthy. There should be no tension between increasing primary care, increasing public health and prevention, and providing the core needs of people for food, housing, education, and work. They are all components of a society that is not only basically decent, but which is concerned about its future, the health of its people, and its workforce. What we clearly do not need, however, is to continue to spend money in the way that we are on high-tech subspecialty care that benefits few patients and often not for very long. Indeed we need to spend much less, and use the money where it will have a positive impact.

Maybe by 2012 the Commonwealth Fund will show the US making some progress. I hope so, but it is going to take some serious structural changes.

[1] Shi L, Macinko J, Starfield B, Xu J, Regan J, Politzer R and Wulu J, “Primary care, infant mortality, and low birthweight in the states of the USA”,J Epidemiol Community Health 2004;58;374-380.

Sunday, June 20, 2010

A New Way of Ranking Medical Schools: Social Mission

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In the June issue of the Annals of Internal Medicine, Fitzhugh Mullan, Candice Chen, Stephen Petterson, Gretchen Kolsky, and Michael Spagnola, mostly from the Department of Health Policy at the George Washington University (and one from the Robert Graham Center) report on “The social mission of medical education: ranking the schools”. This study, sponsored by the Josiah Macy, Jr. Foundation as part of the Medical Education Futures Study (MEFS) is the first report to look at this area, and should be eye-opening to those who assume that “good” medical schools are “good” at everything. Most ranking systems, most notably those of US News and World Report, are based on NIH research funding, grades and test scores of entering students, “competitiveness” (how low a percent of applicants they accept) and reputation. Obviously, the grades and test scores are related to competitiveness and reputation is a tautology, because it reinforces itself. It should depend upon what you are looking at, of course. I addressed this in “Rankings of Medical Schools: Do they tell us anything?” (September 25, 2009), and observed that what they tell us is who does well in what is measured, and that this should only be important to us if those are the outcomes we value.

Mullan and colleagues evaluate different outcomes, the degree to which medical schools meet their “social mission”, or to put it another way, the degree to which they produce the physicians that will take care of the American people. More to the point, since it can be argued that most medical school graduates take care of some American people, physicians who will take care of those people who need it the most because they don’t already have doctors. This means largely those in poor communities, rural communities, and minority communities (and especially those communities that are two or three of these). They look at 3 characteristics of graduates: 1) what percent of their graduates are practicing primary care, 2) what percent of their graduates are practicing in designated Health Professions Shortage Areas (HPSAs), and 3) what percent of their graduates are members of underrepresented minority groups? This is pretty straightforward, and they take two other steps to try and ensure that this is an accurate reflection.

The first is that they examined students, in the graduating classes of 1999-2001, 8 years after graduation. As I have pointed out several times (Primary Care and Residency Expansion, January 7, 2010; Funding Graduate Medical Education, May 25, 2009), the “credit” medical schools claim for students entering “primary care” residencies includes all those entering internal medicine programs, the vast majority of whom will enter subspecialty training. By looking at students 8 years after graduation, after they have completed residency and subspecialty fellowship training, they are able to get a much more accurate picture of who is actually doing primary care. Similarly, it also means that those who are practicing in HPSAs have been doing it for several years. Overall, public schools did much better than private schools, and Southern, Midwestern, and Western schools better than Northeastern schools.

In terms of underrepresented minority students, the percent of graduates, for public medical schools, is compared to the percent of the underrepresented minority population for the state, while for private schools, which are presumed to draw from a more national base, it is the national percentage (26.5%). Thus, for example, the University of Iowa has a positive ratio with 8.1% minority students in a state that is only 6% minority, while the Universidad de Puerto Rico en Ponce has a negative ratio because, even though their students are 82.5% underrepresented minorities, their “state” is 98.8%. The underrepresented minority scores for the 3 historically black medical schools, Morehouse, Meharry and Howard are so high, compared to the national average (as they are all private) that they are easily the top 3 in the overall social mission score. This tends to wash out the significant differences between them on the other two areas. For example Meharry does well in producing primary care physicians (49.3%, or 2 standard deviations [SD] above the national mean) compared to Howard, which at 36.5% is only 0.19 SD above the mean; Howard, however, does better at placing students in HPSAs (33.7%, +0.78 SD) than Meharry (28.1%, +0.12 SD). Ponce, despite its negative underrepresented minority score and also a negative primary care physician score (-0.31 SD*), ranks #9 nationally in total social mission score. This is based on its high rate of physicians practicing in HPSAs (43.8%, +1.94 SD), because so much of its service area are HPSAs.

The data can be analyzed in a number of ways. Osteopathic schools have a much higher rate of producing primary care doctors, but none were in the top 20 because their percent of underrepresented minorities are low. Adding only the two dimensions of primary care and HPSA practice shows only 7 schools with a standardized score above 3, all of them public allopathic schools and 4 of them “community based” medical schools with a specific commitment to primary care (as is Wright State, the #4 ranked school in overall social mission). A few top NIH research schools (4, to be exact) “defied the trend” and were in, at least, the top quartile of social mission scores, again all public schools. Other than the historically black schools, private schools were nowhere to be seen.

The schools that traditionally do well on rankings such as that of US News tended to be at the bottom of this scale. They are overwhelmingly private (14 of the bottom 20) and generally highly NIH-funded. Comments from the leaders of those schools, unsurprisingly, tended to disparage the study and its methods, and to assert, essentially, that “our school does well on all of its missions.” If those missions include the social missions of meeting the health needs of the American people by producing minority and primary care physicians, and those that practice in underserved areas, they clearly do not. And, while some are better than others, no medical schools are doing very well at enrolling underrepresented minorities (except the historically black schools and the Puerto Rican schools) or at producing physicians for rural areas at anything approaching the percent of Americans who live in those areas (Primary Care and Rural Areas, April 28, 2010).

This is not to say that other missions of medical schools, such as biomedical research, cutting-edge medical care, and training of the future generations of academics, including the MD/PhDs who will be laboratory-based researchers, are unimportant. Lawrence G. Smith and Veronica M. Catanese emphasize this point in their accompanying editorial, “The Many Missions of Medical Schools”, as well as noting various possible ways in which the production of physicians who fulfill a social mission might have been underestimated by Mullan, et. al. They also note, as I have above, that different schools do better or worse on the different social mission measures, but also that success in the social mission needs to be pursued, as success in all other missions: “The lack of concordance among the 3 elements of Mullan and colleagues' social mission score suggests that medical schools that accept this mission—as they must—cannot define social mission narrowly. They must have multipronged initiatives and not simply 'wait' for programs aimed at recruiting and retaining underrepresented minority students, or at specifically incentivizing primary care, to bear fruit.”

The key point is that the data produced by Mullan and colleagues that shows that schools which are historically highly ranked do relatively poorly in social mission is not due to a flawed methodology. “The level of NIH support that medical schools received was inversely associated with their output of primary care physicians and physicians practicing in underserved areas.” It is because these schools do not emphasize the characteristics that they are measuring, combined into the concept of social mission, nearly as highly as they do their other missions and do not put as much energy, time, or especially money into them. Mullan et. al. conclude that “Some schools may choose other priorities, but in this time of national reconsideration, it seems appropriate that all schools examine their educational commitment regarding the service needs of their states and the nation. A diverse, equitably distributed physician workforce with a strong primary care base is essential to achieve quality health care that is accessible and affordable, regardless of the nature of any future health care reform.”

The authors note that “Medical schools, however, are the only institutions in our society that can produce physicians”. It is up to the people of the US, particularly the communities in need and the policy makers who represent them, to decide how high a priority producing physicians who will meet our social need by practicing in specialties, in areas, and with populations who do not have doctors, and how to use the public coffers to achieve this. The time is long past, however, for these characteristics not to be measured. We can no longer, in self-indulgence or ignorance, assume that those schools that are the “best” on US News rankings because of NIH research funding, selectivity, and “reputation” are the best in every area. In producing the doctors most needed by this nation’s most needy, they are, with few exceptions, mostly the worst.

*Like the other Puerto Rican Schools, Ponce has a low production of family physicians, ranking 117 out of 128 medical schools for producing FPs in the 10 years from 1999-2008, as reported by the American Academy of Family Physicians (AAFP) annual analysis.
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Monday, June 14, 2010

Oil Slicks and Abortion: Who do we regulate?

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As the nation grapples with the “Deep Horizon” blowout, which will be uncontrovertibly a complete disaster for the Gulf of Mexico and life within it as well as for the people who live along the Gulf Coast and their way of life, a number of things have become apparent. Some of them are detailed in “Don’t Get Mad, Mr. President. Get Even”, the Sunday, June 6, 2010 New York Times column by Frank Rich. Rich, whose primary theme is the response of the President, details the incredible panoply of disasters and near-disasters caused by British Petroleum, and its apparently complete disregard for the few regulations it has been subject to. He is clearly amazed and disappointed that the President continues to place faith in experts, even those at BP, who had an

“…atrocious record prior to this catastrophe. In the last three years, according to the Center for Public Integrity, BP accounted for ‘97 percent of all flagrant violations found in the refining industry by government safety inspectors’ — including 760 citations for ‘egregious, willful’ violations (compared with only eight at the two oil companies that tied for second place). Hayward’s [BP CEO Tony Hayward] predecessor at BP, ousted in a sex-and-blackmail scandal in 2007, had placed cost-cutting (and ever more obscene profits) over safety, culminating in the BP Texas City refinery explosion that killed 15 and injured 170 in 2005. Last October The Times uncovered documents revealing that BP had still failed to address hundreds of safety hazards at that refinery in the four years after the explosion, prompting the largest fine in the history of the Occupational Safety and Health Administration. (The fine, $87 million, was no doubt regarded as petty cash by a company whose profit reached nearly $17 billion last year.)”

Just to restate: BP had 97% of all flagrant violations. Of “egregious, willful” violations – that is, “we ignored the rules on purpose, not by accident” – they had 760, while oil company offender #2 had 8. Clearly then, in an industry known for arrogance, and for preferring to wield political influence (see: George Bush, Dick Cheney) to actually being careful with our world and our environment, BP stands out. It, corporately (and, probably, individually in its leadership ranks) is the true slick scum, from which the oil slick scum washing up on Louisiana owes its paternity.

So let’s talk about Louisiana. It has a long, well-deserved, reputation as one of our more politically corrupt states. It is the home, most famously until this blowout, of the city of New Orleans that, you may remember, was the victim of Hurricane Katrina in 2005, a disaster that the city has nowhere near recovered from despite its absence from the front pages. The incompetence involved in not maintaining the levees that protected the city, especially its poorest parts, and not planning for what was obviously an event that was going to happen, was only eclipsed by the incompetence of the governmental response. The federal government’s terrible response (see: George Bush, Dick Cheney, FEMA director Michael “Brownie” Brown) has gotten most of the criticism, deservedly so, but the response of the state of Louisiana, under Governor Kathleen Blanco, was at least as incompetent – and it was their home state. Of course, in many ways, government in Louisiana has had some of the characteristics of that in nearby places such as Haiti – close collaboration with the wealthy minority that exploit its resources for their personal gain, and, of course, that of the politicians that they pay. It has frequently led to enough anger that populist, if scarcely reformist, politicians have been elected by regular people angry at this exploitation. They too, we well know, have been bought (see: Long, any first name).

The lack of regulation by the state government, in fact its coziness with, the oil industry has been a characteristic of Louisiana. The benefits are jobs for its citizens who work in the oil and gas industry that is so important to the state’s economy (and of course to the politicians who receive “contributions” if not outright graft). The risks are to those same workers, who, like their brethren in the coal industry, are periodically subjected to accidents leading to maiming and death, or, if they are lucky enough not to be sudden death victims, to long term health consequences from their occupational exposures. These industries need to be tightly regulated and controlled, and they can be. As in the case of Haiti (in the 19th century), and much of Africa, and other places rich in natural resources, the large corporations need them. The natural resources – oil and gas, or coal, or diamonds and goal, or tungsten and bauxite and copper – exist where they exist and the corporations need them, and despite their bluster will make the investment in safety, for the people and the environment, if they are absolutely forced to, not just by law but by enforcement.

And then there are oil rig blowouts polluting the waters of the Gulf and the marshes, as the strip mining in Appalachia scars the land there. And then there is Deepwater Horizon, an ecological disaster that may – likely will -- exceed the Exxon Valdez spill in Alaska, a result of the greed of a few and the lack of regulation by the state and federal government. Or, at least, enforcement of regulations.

Make no mistake, Louisiana is capable of passing laws with strict regulations and enforcing them. Take, for example, abortion. Striving to compete with the many other states that have wanted to take the lead in controlling women’s reproduction (see In Ultrasound, Abortion Fight Has New Front by Kevin Sack, NY Times May 27, 2010), Louisiana has passed some of the most restrictive abortion laws in the country. Many of these laws are clearly directed at harassing abortion providers so that they go out of business, and mainly have the effect of harassing the women who are seeking abortions. Recent laws include the requirement that a woman who wants an abortion see an ultrasound of the fetus within 2 hours of the procedure, having the images on the screen described to her, and be given a copy of the ultrasound in an envelope with sonogram results written on the front. There is no exception for fetal demise, rape, incest or anything.

Louisiana’s governor (Bobby Jindahl) and its anti-choice legislature may take pleasure in their “F” rating by the National Abortion Rights Action League (NARAL); the negative impact is suffered by the actual women who are already struggling with having decided that an abortion is the right thing for them, in their lives, at that time, and don’t need this additional harassment from their government. It would be wonderful if the Louisiana governor and legislator could take the same pride in the rigorous regulation of the oil industry in their state, protecting their people and their livelihoods and the environment from destruction with anything approaching the same vigor.

But they can’t take such pride. Because they don’t do it. If they did, we’d be living in a much better world.
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Tuesday, June 8, 2010

Reinventing Primary Care: Themes and Challenges

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My May 27 entry, Universal Coverage and Primary Care: The US needs both, focused on one article from the May 2010 issue of the journal Health Affairs. That article, by Barbara Starfield, (“Reinventing Primary Care: Lessons from Canada for the United States”) was just one of 65 articles in this issue that addressed the topic of “reinventing primary care”. The articles cover the gamut of the history of primary care, the problem of undersupply of primary care providers, proposals for increasing the number of primary care providers, analyses (such as Dr. Starfield’s) of the health systems of other nations’ that are based on primary care, proposals for how the organization and structure of primary care practices need to be changed, and case studies of models of practices and demonstration projects that have implicated innovative approaches to primary care delivery. Many of these practice changes are contained under the rubric of the Primary Care Medical Home (PCMH), which is also the abbreviation for the related Patient Centered Medical Home. Indeed, the Patient Centered Primary Care Collaborative (PCPCC), a coalition of major employers, insurers, providers, pharmaceutical and device makers, and consumers, uses both “PC”s in its name (one hesitates to say that it is thus very PC!)

One of the articles is in fact “The multistakeholder movement for primary care renewal and reform”, by Paul Grundy, et. al., specifically addresses and discusses this collaborative, as well as its proposals for change in the entire structure of the primary care delivery system. Grundy, who is vice-president for global health reform of IBM, is president of the collaborative. It has brought together these various stakeholders in recognition not only of the overwhelming data that shows systems that are built upon primary care are more efficient, more cost-effective, and lead to better health outcomes, but on the actual experience of IBM and other multinational companies. These companies find that their health costs, and the health (and thus lack of time off for illness) of their workers is dramatically lower in countries in which the health system is built upon a primary care base. It is actively involved in educating, advocating, and demonstrating the importance of developing such a base in the US.

Many of the other articles in the journal address changes that need to happen to allow the small (and, as I have pointed out, likely to stay too small even if there is a significant increase in production from our current paltry 16%) number of primary care providers to care for larger panels of patients, while maintaining or increasing quality of care, patient satisfaction, and efficiency. Two of these are co-written by Thomas Bodenheimer, MD, ‘Primary Care: Current Problems And Proposed Solutions”, by Bodenheimer and H.H. Pham, and “Transforming Primary Care: From Past Practice To The Practice Of The Future”, by D. Margolius and Bodenheimer. Another perspective, more from that of the individual physician than the overall health system, is Lawrence P. Casalino’s contribution, “A Martian’s Prescription For Primary Care: Overhaul The Physician’s Workday”

What is striking about these articles in the similarity of their recommendations. The recurrent themes include the need for multi-disciplinary teams of health professionals who all play roles in caring for patients, and panels of patients. This goes beyond the simple “nurses doing callbacks” to patients before, or instead of, the physician. It means that nurses provide the care that they can, that pharmacists and psychologists and social workers all are part of the team, communicating with each other but often operating independently. Group visits are another theme; often people with the same (or, in fact, different) conditions can benefit from being seen in a group. This can be for a more formal didactic session of patient education about their condition by a nurse, or pharmacist, or health educator, or physical therapist, or physician, or medications, or other treatments, often combined with a great deal of person-to-person interaction. There is more to this than efficiency; people actually benefit from the fact of being in a group, of sharing experiences, and ideas, and successes and failures.

Another important and recurrent theme is that of physician-patient interactions that do not involve face-to-face contact, but rather phone calls or emails. Again, this is not just a matter of efficiency for the physician; patients often have concerns that can be successfully addressed by one of these other methods that do not involve them having to take off work, drive a long distance, look for parking, and wait in the waiting room. A physician can be far more effective, and interact with a much larger number of people, if an afternoon consists of seeing a few in person, a much larger number by telephone, and an even larger number by email; a number of products exist that provide not only secure email communication, but provide a structure for the patient to supply information that will help the doctor (or NP, or nurse, or whoever on the team is most appropriate) provide the greatest help.

In his article, Casalino lists five reasons why a physician should see someone in person:
“(1) for a first visit; (2) when it may be necessary to engage in some physical maneuver for diagnostic purposes—such as palpating the abdomen, listening to the heart, or performing a skin biopsy; (3) for specific therapeutic purposes, such as injecting a joint; (4) when the patient has problems for which lengthy discussion would be helpful; (5) when for psychological or emotional reasons it seems better to see the patient face-to-face; and (6) when face-to-face visits are necessary to build trust.”
These are very good, but I would simplify it even more: the physician should see the patient face-to-face when either the patient or the physician think it is important.

The effectiveness and satisfaction from increased phone calls substituting for visits was clear in the late 1990s when capitation, rather than fee-for-service, was a dominant mode of payment (of course, at that time the internet was not yet developed enough for most people to be using email). To reprise, and to improve upon that process will, obviously, require a reimbursement system that does not pay only for face-to-face physician visits. This is another common theme to many of the articles in this issue. It is also not happening in most places. It is, however, a sine qua non for such practice reorganization. And increasing the primary care supply.

Which of these themes is the most important: increasing the supply of primary care physicians, reorganizing practices to become true Patient Centered Medical homes, utilizing all of the strategies above and more, or restructuring the way health care is paid for? They are all important, all related, and all dependent upon each other for success. What is not addressed in most of the articles in this issue of Health Affairs, however, is arguably the most important: ensuring health coverage for everyone. The work of the Patient Centered Primary Care Collaborative may go a long way to having a more rational delivery system for those with access, but as long as the same old hands, in particular the insurance companies but also the drug and device makers, are part of the decision-making process, they are unlikely to come up with a plan that truly covers everyone, single-payer, “Medicare for All”, or any other rational system. And without that, all the primary care reform is not going to really work. It is not only a moral issue (although that should be enough!); it is that the cost, in terms of work hours lost, unnecessary suffering, direct dollars spent on diseases that have advanced too far because people have delayed care, and ultimately worse outcomes, is unsupportable and unsustainable.

We’ve passed PPACA. Now it’s time for real health reform.
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Wednesday, June 2, 2010

Who will care for the underserved? The role of off-shore medical schools

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I have written in several previous posts (most recently Universal Coverage and Primary Care: The US needs both, May 27, 2010) about the challenges facing American medicine, particularly regarding specialty choice (=not primary care, not rural, not underserved) of US allopathic graduates, and the problems this has already created in providing health care to the American people, which is only likely to worsen as this trend continues. I have noted that, in the production of physicians as in any other process, the outcome results from variables in inputs (who is admitted in this case), the process itself (in education, the curriculum, both formal and informal), and output variables (in the case of physicians, what the practice environment is: reimbursement, work load, quality of life, respect and regard within the profession and community). I have argued that, while output variables may be the most important in terms of specialty choice and practice location, it is the one over which medical educators have the least control. While the curriculum, the process through which we educate medical students, is critical (see Are we training physicians to be empathic? Apparently not., Sept 12, 2009), it is likely that the characteristics of the students selected is most important in determining practice location, particularly for rural areas, but also for urban underserved settings (Medical Student Selection, Dec 14, 2008). Selecting students who grew up in the suburbs of major cities (what Robert Bowman, MD, who has done much research in this area, calls “major medical centers”) in homes with high socioeconomic status and excellent high school and college educations (which is what is mainly done) will result in students with excellent test performance and is likely to produce skilled physicians, but not ones likely to practice in rural or underserved areas.

Students from rural areas, from underserved communities, from low socioeconomic status backgrounds, and from underrepresented minority groups are much more likely to serve these populations, as are students who are older at the time of matriculation. But their lower grades and MCATs, may make them less likely to be accepted, and to have difficulty with the pre-clinical medical curriculum. Students, even from privileged backgrounds, whose prior life history includes significant service are also more likely to work in urban underserved settings; less so (although more than their colleagues without these characteristics) in rural areas. But what about schools of other types or medical schools not in the US?

In a conversation with US Senator Sam Brownback on a visit to his office last year, members of the Kansas Academy of Family Physicians (KAFP) noted the challenges in getting KUMC graduates to work in rural areas. In an off-the-cuff response (I don’t mean to suggest that this was thought-out or his real position; I use the statement as a basis for comment) he suggested that we then just start a medical school at Kansas State University that would train rural primary care doctors. This type of response to a system that is not having the impact that policy makers wish for is common – create a new school, or focus on another different type of school (e.g., osteopathic), or another profession (nurse practitioners, physician’s assistants). But, of course, if they take the same sorts of students and offer them the same range of career opportunities, why would one expect different outcomes? Osteopathic graduates, while still entering family medicine and primary care at higher rates than allopathic, are increasingly becoming specialists. NPs, and especially PAs, are increasingly joining specialty physician practices and remaining in urban areas with high income potential rather than high need. Why would they not? Would you, or your children?

Because there are far more residency training positions than there are US graduates, many of these positions are filled with international medical graduates. A special group of these are “US IMGs”, Americans who, unable to be admitted to US medical schools, attend those outside the country. In the Caribbean, there are many schools, for-profit, set up for precisely this purpose. I recently had the opportunity to give the “White Coat Ceremony” talk to the class entering the largest of these: Ross University School of Medicine (http://www.rossu.edu) on the island of Dominica. Ross, in existence for over 30 years and now owned by DeVry, the largest for-profit educational company in the US, has a “business model” that enrolls 3 classes per year paying tuition much the same as a private US private school or an out-of-state student at a US public medical school. After the first two years, students do clinical clerkships in 70 hospitals in the US that are affiliated with the school – and paid by them. The student body is ethnically very diverse, with over half the members of the class I spoke to born outside the US (although 95% are US citizens or permanent residents; the rest mostly Canadian), but not including a large percentage of students from traditional underrepresented minority groups, and certainly not many from poor families. Ross graduate disproportionately enter primary care specialties, but this is almost certainly because primary care is less competitive than many subspecialties, and the fact that they didn’t train at US schools puts them at a competitive disadvantage in the selection process. Nonetheless, there are several positive things to be said about the Ross experience. First, Ross has a single mission – medical education. The considerable funds it generates are not required to support a large research or clinical enterprise, but can be directed to that mission. Second, it takes students who, because of their grades, wouldn’t – didn’t – get into US medical schools, and gives them a chance to succeed. If there is a high failure rate as a result, there are also unquestionably outstanding doctors produced who would not have otherwise existed. They are able, because of their business model, to take a “chance” on these students – and if they work hard, they can be successful.

While there a very many Caribbean medical schools, of different ages, quality, and size, operated more-or-less on the Ross model, a quite different model exists on another island – Cuba. Whatever its failures, one of the great successes in Cuba since the revolution of 1959 has been the expansion of medical care to the entire citizenry of the nation, and exportation of trained physicians, both Cuban nationals (they are even on Ross’ home island of Dominica) and those from other countries educated in Cuba. The Latin American Medical School (Escuela Latino-Americana de Medicina – ELAM), which educates students from other Latin American countries, began to take students from the US a number of years ago. Unlike those attending Ross and other costly schools, US students at ELAM are virtually all from low socioeconomic backgrounds and mainly from underrepresented minority groups. Tuition is free and living expenses are paid, but there are prices for the students to pay. Admission requires a bachelor’s degree, but students are still required to spend the entire 6 years of medical school that is the usual for countries outside the US and Canada, or 7 if they need to learn Spanish first. They live in minimal dormitories, have very limited access to the internet (1-2 hours per week), and work very hard. They receive a medical education that particularly emphasizes public health, community medicine, and prevention. They promise to complete their training and enter practice in service to the communities from which they come, but it is a promise – obviously the Cubans have no way to enforce this. They receive no training in the US prior to graduation unless they are able to arrange summer observerships on their own, and are not particularly prepared for the “National Board” exams, the USMLE, that are required for US licensure and admission to US residencies. MEDICC (Medical Education in Cooperation with Cuba) , a US group that exists to support US students at ELAM and its graduates, tries to find them mentors who will help orient them to the health system in their own country, the US, teach them about applying to US residencies, and offer guidance in the study for USMLE. The first US graduates of ELAM have entered a few US residencies this year; I have met one, who is phenomenal. Other US medical educators are working with ELAM graduates and offering both advice and opportunities for volunteer training.

The US students at ELAM are the “right students”. They come from underserved backgrounds, are committed to their communities, and are willing to work very hard (perhaps ten years between bachelor’s degree and entering a residency). The question, of course, is not “how can they go to that Communist country?” but rather why are we allowing Cuba to pick up the role that our own medical education system fails to fulfill. Indeed, it would be particularly for those who oppose Cuba and socialism to develop such programs in our own country.

Senator Brownback, if we are going to start a new school in Kansas, let’s model much of it on ELAM. Let’s make it free, and recruit students from underserved communities and underrepresented minority groups, and low socioeconomic backgrounds, and teach them public health and prevention and primary care, and send them out to serve their communities of origin. In the meantime, let us at least have a “sliding scale” loan repayment program where the percent of your loan your repay is tied to your post-residency income, as well as your practice location and specialty choice.
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