Continuity of care? Hospitalists? Who calls the family?: Corporate control makes health care worse.

I was recently talking with a friend who was still (justifiably, IMO) furious at her local hospital. Last year her husband, 90, was admitted for an attack of diverticulitis. While hospitalized, he suffered a heart attack on a Sunday morning and was transferred to the Intensive Care Unit. The treatment was fine – indeed now, at 91, he is quite improved – but her complaint was that no one called to tell her! She found out when she went to visit him in the hospital that afternoon. I am sure that virtually any adult presented with this scenario would say “of course, as soon as possible, call the family!” Can you imagine that they didn’t?

Sadly, I can. It reflects a lot of issues in the medical care system. One that my friend identified was the hospitalist system, where the doctor who is responsible for the care of a person in the hospital is not their regular physician, but someone employed by the hospital (usually an internist or sometimes a family doctor). In itself this can be an issue, which I will discuss below, but the bigger problem she identified was the frequent change in who this responsible physician was, different on the weekends, and at night, and almost impossible for her to get to know. Indeed, she was not certain if the doctor she talked to later that day, the one who told her, not apologetically, that they were “trying to figure out what to do with him” (as if this was an excuse for not calling the wife of an 90-year-old patient to tell her that he had a heart attack) was the actual hospitalist or a resident working with them. If you don’t know the attending physician du jour, or even know who they are, it is hard to be sure. I might add that my friend is a highly educated and well-insured person. When they suffer such indignities, and they do, it is certainly far worse and more frequent for people who are not.

Why would doctors not want to call the family of a person in the hospital, especially but not only if they are old and frail and suffer a particular acute life-threatening event, as soon as possible? Is it imaginable that they do not? Why would they not want – insist upon – the family knowing who the responsible physician is? Do they just want to be anonymous, not to be bothered?

Maybe, sometimes, but I do not think that this is the primary reason. Think about it. You are the “hospitalist”, a hospital-based physician tasked with responsibility for the care of lots of people (“patients”) who you didn’t know before they were admitted. On top of that, you are not the weekday hospitalist, but the one covering for them on the weekend, a weekendist if you prefer (I sure don’t!). Maybe you are even the nocturnist, the night-time hospitalist. In any case, you have a list of patients to see, and to get to know, and maybe you come into the hospital in the morning to see them all (which, of course, has to be one at a time, someone first, someone last) when all of a sudden you hear from the nurses that one of them has had a heart attack. Maybe someone you have seen already, maybe not, maybe it is the afternoon, and you have already left the hospital. You tell them, the nurses and the residents working with you, to begin their well-practiced routine of treating an acute myocardial infarction (MI, heart attack) and give other instructions, including to call cardiology, and tell them to call you back. Do you specifically instruct them to call the family? Do you think that would be obvious to them? Does it even occur to you? Is it someone else’s job? Whose?

In the “old days”, when someone’s family doctor took care of them even when they entered the hospital, it was almost certain the family would be called. The doctor knew the person, often had been seeing them for years, and knew the family. They knew, of course, that the family would want to know, and felt it to be their responsibility to inform them. This changed with the creation of hospitalists as a separate specialty, and has accelerated with the corporate takeover of medical care and the dramatic increase in physicians as employees of corporations (most often hospitals, sometimes physician-owned groups, sometimes for-profit, often owned by private equity). Different physician roles have been identified, such as caring for people in the office (and very rarely at home), in the hospital, in nursing homes. While these roles had always existed, often the same doctor filled the different roles for their patients; now different doctors would. The delivery system, which had been patient-focused (“I’m your doctor and take care of you wherever you need care”) became provider-focused (“We, as the providers of care, will develop a system that works efficiently for us; unfortunately for you, that means you will not have the same doctor all the time”).

Actually, there were many good reasons for this change. It is not easy, was never easy, to be a “full-spectrum” family doctor, to see people in the office both with appointments and as walk-ins, to do home visits for those who were ill and found it difficult (from age or disease) to get to the office, to see people in nursing homes and in the emergency room, and make “rounds” on and care for your patients in the hospital. And, often, get up in the middle of the night to deliver a baby. It was tough on the doctor, and tough on their families, as many books and films have depicted. In addition, these family doctors had (and have) much lower incomes than most specialists, including those who do shift work where they know exactly which hours they will work. Plus, as more and more things could be cared for in an outpatient setting (we will leave, for now, whether this was always a good idea), the people admitted to the hospital were sicker and often required more specialized knowledge that a physician who focused only on hospital medicine could better stay up on.

But there were also bad reasons, many of them stemming from the movement of physicians from self-employed to employees, increasingly working for hospitals and even for corporations that had no health professionals in charge. This corporate model, based on the industrial concept called “scientific management” or “Taylorism”, focused on increasing efficiency as the most effective way to generate maximum profit. It is more efficient to have some doctors who stay in the hospital all the time and some doctors who care for people in the outpatient setting (“ambulists”, another term that fortunately hasn’t caught on), and others who care for people in nursing home or even in their own homes. This not only reduces travel time, but allows more people to be scheduled (“speed up”) and provides the basis for further increasing the number of patients seen and concomitantly decreasing the time spent with each (see "Direct primary care" not the answer for our health system. Beware "Project 2025"!, July 9, 2024),

The problem is that this is not always the best for the patient. Yes, it is good to have people who are expert and current on the care of people in the hospital (“inpatients”) to take care of you, just as, when you need one, it is good to have experts in an organ (cardiologists, nephrologists, pulmonologists, etc., and various types of surgeons if you need surgery). But it is also good if the person taking care of you knows something about who you are, or at least your medical history. If they have never seen you before you show up in the hospital, they have nothing to compare your current situation with: are you worse? A lot worse? Better? About the same? And, by the way, if someone actually knows you – your family would almost certainly get a call!

Is it possible to have most of the good with little of the bad? The continuity (sometimes called “primary care”) clinician – family doc, internist, pediatrician, family or adult or pediatric NP – can delegate the key medical decisions to hospital experts but stay as the leader of the team. The leader, not the pain-in-the-neck “local doctor”. The professional who can fill their role as the one who cares for the whole person, not as the subspecialist for only one disease or organ. The one who cared for the patient before admission and will continue to do so afterward, not as the hospitalist for whom the patient was essentially born the day of admission and will disappear the day of discharge. Someone who can provide context and understanding and, believe it or not, continuity!

Of course, we’d need more primary care clinicians, not fewer as is the current direction in which we have been and continue to be heading (Incredible (Terrible) Shrinking Physician Supply, Health Justice Monitor, Sept 7, 2024). This would decrease efficiency, perhaps, but increase effectiveness. And while it might cost more money (thus lower profits for the corporations) it might actually save money for the overall system by having historical memory of the person when they go from home to hospital to home, and not change almost daily each time a new doctor is in charge.

Worth thinking about!

Pro tip: If you have to be admitted to the hospital, or have a heart attack, try to do it on Monday, or at least Tuesday. Do not wait for the weekend!

Should hospitals and doctors make value judgements about who deserves treatment?

I heard on NPR’s “Here and Now” (Sept 9, 2021) that Jimmy Kimmel, the late night TV host, had expressed anger and frustration with people continuing to refuse vaccination for COVID-19. He noted that many hospitals no longer have available Intensive Care (ICU) beds available, and were going to have to triage who was admitted to them. According to the host, Robin Young, Kimmel said the decision was easy: you have a heart attack, you’re in; you have COVID and didn’t get vaccinated, you’re out. (His monologue is summarized by The Hill, among other sources.) Kimmel is not the only one to express outrage at the unvaccinated -- “shock jock” Howard Stern has responded to those who would cite their freedom to not be vaccinated with “F—k their freedom; I want my freedom to live!”— and is also not the only one called for such “ICU triage”.

Daniel Wikler, a professor of medical ethics from the Harvard School of Public Health was Ms. Young’s guest, and he said that, while he understood the anger that Kimmel and others were expressing, and empathized with it, he did not believe that it was the business of doctors or hospitals to make such decisions. It was the tradition and history of medicine, he said, to treat the illness of the patient if it was treatable, not to decide that someone had done something to themselves to make them undeserving of treatment. As an example, he noted a skier who might ignore all warnings, ski down the back of the hill, and get injured. There are lots of other potential examples, and they are valid.

I agree with Dr. Wikler on both points. First, I understand and empathize with Mr. Kimmel and others who are furious that those who have refused vaccination not only threaten the health of the rest of us but also end up utilizing a huge amount of health resources and services that not only can limit access to these services for others in need, and in any case cost huge amounts in time and effort by health professionals as well as in money. But I also agree that doctors and hospitals have no business refusing to care for these people, and that a core ethical value in medical care has been to provide care, if you are able, to help the illness of the patient, not to judge whether they are worthy of care because of their previous actions. One of the most dramatic and important examples are medical facilities in war zones, which are obligated by the Geneva Convention to treat all injured on the basis of need, not which side they fought on. To treat one’s own soldiers and not injured enemy soldiers who are prisoners is a war crime.

Many of those people who have the heart attacks that Mr. Kimmel thinks should get them into the ICU smoked cigarettes, or ate a very poor diet, or did not exercise, or all of these. While I’m sure that there are some people who are judgmental and smug enough to believe that they should suffer the results of their own life decisions and not receive care, this is not the approach that doctors and hospitals take.

There are certainly many people whose illnesses are at least partly a result of other poor decisions, including use of alcohol – both heavy lifetime use and even one episode which led to the car accident that has them in the emergency room – or other drugs. In addition, while less common than from alcohol, illness and death related to illegal drugs such as opiates and opioids and stimulants is still very common; we have all heard of the “opioid epidemic”. And there are infinite possibilities for blame when you go beyond “sins of commission” – things you did that were bad for you – and enter the realm of “sins of omission” – thing that you didn’t do that are, at least in the view of the one making the judgement, would have been good for you (e.g., diet and exercise).

Back to domestic hospital use, I would like to discuss two examples from my own experience. Suicide attempts are definitely self-inflicted, but the motivation to act is often transient, and many people who attempt suicide and survive do not attempt it again. Guns are very lethal, however, with well over 90% of suicide attempts by gun being “successful”; drugs are less so. My son killed himself with a gun, but if his attempt had been with a less lethal method, I  certainly would have wanted him treated.

On our inpatient services, residents and I have cared for many people who are repeatedly admitted with the effects of their use of alcohol or other drugs. One person I remember well. Regularly admitted for the toxic effects of alcohol overdose, on treatment and release he always pledged to get treatment for his disease, most strongly motivated by caring for his daughter, but never followed through. After many admissions, some residents thought it wasteful to continue to treat him and argued against it. My position was not only was recovery a difficult process, often with many failed attempts, but that our role was to treat his medical condition and refer him for treatment for his alcoholism. We could make the judgement that he was at fault, and each of us might have our own opinion about whether he “deserved” treatment, but that was irrelevant to our obligation to take care of it. It would be a slippery slope indeed. And I would be remiss to not point out the most common reason people are “triaged” to not receive care, at least in the US, is financial: they do not have money or good insurance. That is totally immoral and unacceptable.

There are some differences with those who refused to be vaccinated against COVID or wear masks or distance, but these are variations on a theme. Yes, they put others as well as themselves and their families at risk, but so do those who drink and drive or use other drugs, or who do many other things. It is our job to take care of them to the best of our ability. To do otherwise is to risk great hypocrisy, thinking that those who do the dangerous things we ourselves do are less culpable than those who do dangerous things we do not do and decry. I call it the “Jesse Helms fallacy” after the former powerful North Carolina senator who both opposed treatment for people with HIV/AIDS, who he said were suffering God’s punishment for their homosexuality, and also smoked like a chimney and fought for the tobacco industry. When he had developed heart disease, he sought and received treatment, despite being largely personally responsible for it.

That so many are refusing vaccination and care that there are no beds in ICUs in many states (as a person from Alabama did from heart disease after being unable to get a bed in 43 hospitals in 3 states, and as is occurring across the poorly-vaccinated South) is shameful, discouraging, and incredibly dangerous. These people are misguided, stupid, and many are even evil. But we also hear of those who (because they are dying, to be sure) regret their decisions. We can feel some sense of self-righteousness when we hear about anti-vax personalities who have died. If we are in institutions where there are not enough beds and patients have to be triaged, that triage must be on the basis of their condition and our ability to help them. The social/political fight cannot be waged at the bedside of an individual patient.

As much as we might be tempted to do so.

Calcium, Heart Attack and Osteoporosis

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

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

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

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

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

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

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

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

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

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

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

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