Something Not Unlike Research

Informed Consent and Standards of Care

post by Paul Kelleher

Austin Frakt has an important post today about the still rocky terrain of informed consent in medicine. You should read the whole (short) post, which revolves around this case:

The date was July 19, 1999, when as a third-year resident I saw a highly educated 53-year-old patient. In June 2002, my residency and I were served with court papers.[...]

On that day in July 1999 I saw the 53-year-old man for a physical examination. I discussed with him, and documented in his chart, the importance of colon cancer screening, seat belts, dental care, exercise, improved diet, and sunscreen use. I also presented the risks and benefits of screening for prostate cancer and documented the discussion. I never saw the patient again, and after I graduated, he went to another office. His new doctor ordered prostate-specific antigen (PSA) testing without discussing the risks and benefits of screening with him. Unfortunately for the patient, his PSA level was very high and he was subsequently diagnosed with incurable advanced prostate cancer. [...]

My residency was found liable for $1 million.

Frakt gives a little more background on the trial that led to this verdict:

[S]everal physicians testified that it was standard to conduct a PSA test without asking the patient. Hence, in the eyes of the law and despite the shared decision making process he employed, Merenstein delivered sub-standard care.

Perhaps the rationale for defining adequate care as that which would be provided by most of one's peers can be ratified by adapting that old Churchillian quip: it's the worst form of government, except for all the rest. After all, do we really want courts to be making decisions about what appropriate medical care consists in, especially when so much of the profession is united on what should be done? On the other hand, it is just as easy--and maybe easier---to raise important worries about determining the standard of care in this "prevailing practice"-based way. Perhaps Frakt's case of the resident and the PSA test is enough to convince you that we need a different standard. If not, consider this case, which comes from Rebecca Skloot's book The Immortal Life of Henrietta Lacks (pp. 129-135): 

Southam injected HeLa and other living cancer cells into more than six hundred people for his research...Patients who'd unknowingly been injected with cancer cells by Southam read the articles and began contacting reporters. New York State Attorney General Louis Lefkowitz learned about Southam's research through media as well, and immediately lauched his own investigation. In a scathing five-page document filled with exclamation points, he accused Southam and Mandel of fraud and unprofessional conduct, and demanded that the Board of Regents of the University of the State of New York revoke their medical licenses. [...]

Many doctors testified before the Board of Regents and in the media on Southam's behalf, saying they'd been conducting similar research for decades. They argued that it was unnecessary to disclose all information to research subjects or get consent in all cases, and that Southam's behavior was considered ethical in the field. Southam's lawyers argued, "If the whole profession is doing it, how can you call it 'unprofessional conduct'?" [...]

The suspensions of Southam's and Mandel's licenses were stayed...[and] soon after the end of his [one year] probationary period, Southam was elected president of the American Association for Cancer Research. 

Our mothers were right: just because everyone else is pushing cancer patients off the Brooklyn bridge doesn't mean it's OK for us to do it. And perhaps, just perhaps, the fact that most other doctors conduct the PSA test without first getting informed consent from the patient does not mean that this is acceptable conduct either. I won't pretend there aren't forcing pulling in different directions. But that is why we need clear examples of when informed consent is required, so we can distill generalized lessons from them.  

Frakt, Aaron, and Alito on Externalities and the Mandate

post by Paul Kelleher

In anticipation of yesterday's Supreme Court oral arguments on the Affordable Care Act's individual mandate, Austin Frakt wrote:

The purpose of the mandate is to address some of the externalities of health insurance coverage decisions made by individuals. (“Externalities” is handy economics jargon for any effects a decision—like buying or not buying health insurance—has on those not directly involved in the decision.) [...]

[W]ithout a mandate (but maintaining the provisions of the law that prohibit insurers from denying coverage or from charging higher premiums because of an individual’s medical history), it’s likelier that relatively sicker individuals will purchase coverage than relatively healthy individuals. [...]

This type of behavior causes premiums to be higher than they otherwise would be, because the pool of people being covered includes more individuals who are sicker and more expensive to cover than would be the case with a mandate. [...]

Frakt reiterated this point yesterday in response to several Justices wanting to know what could be the difference between mandating the purchase of health insurance and mandating the purchase of broccoli:

There is a very clear difference between mandating broccoli purchase and mandating health insurance. I doubt it could be turned into a limiting principle suitable for court, but I’ll offer it anyway. First, if the government mandated purchase of broccoli, average broccoli price would rise. That follows from supply and demand, and I hope it is intuitive.

However, if the government mandates purchase of health insurance, average price of health insurance falls.

I could be wrong, but Henry Aaron seems much less comfortable with this particular externality-argument. In his recap of yesterday's oral arguments on the mandate, he writes (my emphasis):

Several of the justices, notably Scalia and Alito, responded to the externalities argument by saying that every economic transaction creates similar externalities. "If I don't buy a Volt, I raise the price of Volts," said Scalia. Alito said much the same thing. So did Paul Clement's brief for the plaintiffs.

This response was and is bad economics. It is true that every commodity is produced along what economists call a "cost curve"—raising output may lower average or marginal unit costs by spreading overhead or achieving economies of scale, but it may also raise costs by forcing up the cost of inputs or incurring diseconomies of scale. None of this occasions concerns about fairness or free-loading or, to use the economist's term, "externalities." But the cost shifting that occurs when uninsured patients fail to pay their bills does; it causes one group—the insured—to have to pay part of the cost of services others use. 

Although Aaron almost surely agrees that a mandate will lower average insurance costs, he notes that it may also raise prices elsewhere in the economy. For example, a mandate may increase the wages that non-insurance firms will have to offer to compete with the wages offered by insurance companies. Strictly speaking, this also seems to be a kind of externality. I assume, however, that many economists would argue that every policy "imposes" price-related externalities of some sort or other, and that it is very hard to determine whether one policy's price-related externalities are worse than another's. I suspect this is why Aaron chose to focus exclusively on a specific externality that strikes many as specially unfair. This is what Aaron refers to as "the cost shifting that occurs when uninsured patients fail to pay their bills does; it causes one group—the insured—to have to pay part of the cost of services others use."

A potential problem with this defense of the mandate, however, is that the ACA does not eliminate forces that "cause one group to have to pay part of the cost of services others use." Consider:

Cost of uncompensated hospital care in 2009: $39.1 billion. [1]

Annual ACA revenues from new taxes/fees/penalties on the wealthy, the insured, & industry: $38.4 billion. [2]

Even if we assume that all uncompensated costs are currently shifted to the insured and that the ACA would eliminate this, the ACA appears to create virtually the same degree of cost-shifting by imposing new taxes, fees, and penalties on industry, the wealthy, and the already insured. Just like much of the cost-shifting that currently stems from uncompensated care, the ACA's new revenues are to be used to provide care to those who cannot afford it. At the very least, this suggests that the mandate cannot be defended simply by pointing to the existence of cost-shifting externalities. For the ACA replaces one form of cost-shifting externality with others. What is needed is a rationale for shifting costs to one group rather than another. 

In addition to the new revenues cited above, the ACA clearly hopes that the threat of the mandate's penalty will induce young, relatively healthy individuals into the insurance market, where they will be required to purchase insurance coverage they are unlikely to use, thereby providing premium dollars that can be devoted to the care of others. This is clearly what Justice Alito was getting at in comments that Aaron called "the most glaring instance of the failure to appreciate what an externality really is." Aaron seems to think that Alito was trying to make the point that the uninsured are not in fact shifting costs to the insured:

[Alito] at one point challenged the solicitor general by positing that the cost of all of the care currently used by those who are uninsured is less than would be the cost of the insurance they would be forced to carry. That being the case, Alito asked, how can one say that the uninsured are shifting costs to the insured? This query is painfully detached from an understanding of what an externality really is, how insurance works, or what the impact of insurance would be on service use.

It seems to me, however, that Alito was making a much different point. Here's what Alito said (pp. 33-4, pdf):

If you took the group of people who are subject to the mandate and you calculated the amount of health care services this whole group would consume and figured out the cost of an insurance policy to cover the services  that group would consume, the cost of that policy would be much, much less than the kind of policy that these people are now going to be required to purchase under the Affordable Care Act?  [...]

The point is -- no, you take into account that some people in that group are going to be hit by a bus, some people in that group are going to unexpectedly contract or be diagnosed with a disease that -- that is very expensive to treat. But if you take their costs and you calculate that, that's a lot less than the amount that they are going to be required to pay.  So that you can't just justify this on the basis of their trying to shift their costs off to other people, can you? 

Alito is arguing that, in complying with the mandate, many previously uninsured folks will be paying much more than they need to pay to cover the expected costs that would be shifted to the insured in the absence of the ACA. In other words, he's noting that the cost-shifting argument is not sufficient justification for the specific kind of mandate the ACA includes. This strikes me as correct, and it raises additional questions about whether the externality/cost-shift argument can do the work that some of its proponents ask of it.

[1] American Hosptial Association, pdf.

[2] Maggie Mahar. This figure reflects: increased Medicare taxes on the wealthy; new fees on industry; the "Cadillac tax" on expensive insurance policies; reduced tax exemptions for health savings accounts; reducing deductions for itemized medical expenses.

'Health Shock': How childhood chronic illness affects children's schooling and adult employment

Pediatrics is sometimes treated as the least important branch of medicine. This kind of makes sense, because children are mostly healthy. Focusing just on health outcomes, however, is terribly short-sighted. As Jason Fletcher and Michael Richards show, chronic diseases that begin in childhood have powerful effects not only on children's adult health, but also on their non-medical development and achievements. 

Fletcher and Richards looked at the association between the 'health shock' of  getting diabetes in childhood and achievements in schooling and work for more than 15,000 children. They found

effects in several measures of educational attainment, including a high school dropout rate that was six percentage points higher than among young adults without the disease. We also found lower employment and wages: A person with diabetes can conservatively expect to lose more than $160,000 over his or her working life, compared to a peer without the disease. 

This is an observational study, so whether diabetes causes these effects is a matter of inference and interpretation. Fletcher and Richards used a data set that included detailed information on the children's family backgrounds, the health of parents, and other diseases that children had; and their estimates include statistical controls for such factors. We cannot necessarily infer that an intervention that prevented diabetes in a child would increase the years of schooling they would achieve, or how much they would earn as adults. But based on these data, it would be worth a shot.

Thinking, Fast and Slow about Informed Patient Choice

The following is an invited post from Thom Walsh PhD, MSPT, OCS, Diplomat MDT (@thomwalsh on twitter).  Thom very recently completed his doctorate in health policy at The Dartmouth Institute for Health Policy and Clinical Practice.  He is currently on faculty as a curriculum specialist in The Dartmouth Center's Health Care Delivery Science program.

Nobel-Prize winning economist Daniel Kahneman has made it his life’s work to scrutinize the many ways in which human beings fail to behave rationally.  His most recent book, “Thinking, Fast and Slow” summarizes the 40 years of research conducted by him and his colleague Amos Tversky on the topic.

Kahneman categorizes human thinking into two systems: 1) fast and 2) slow.  The fast system (System-1) represents rapid decision making based on assumptions, prior personal experience, and neurologic short cuts that have proven advantageous to survival.  System I “prepares us to perceive the world around us, recognize objects, orient attention, avoid losses, and fear spiders,” using subconscious actions and reactions that are unavoidable.  One cannot unlearn the simple mathematical formula 2+2=4 any more than they can stop themselves from flinching when surprised by the sudden bark from an angry dog.  To work at such instantaneous speed, System-I thinking relies on biases and heuristics.  Kahneman explains the “hindsight bias,” the “optimistic bias,” the “availability heuristic” and the “fast and frugal heuristic,” along with many others.  These multiple biases and heuristics detail the seemingly infinite ways in which humans divert from the utility maximization path laid out by econometrics and utility theory.  See here for a basic overview of decision theory in econometrics

By contrast, the slow system (System-2) is lazy and laborious.  Activating System-2 thinking requires us to pay attention and allows us to follow complex directions, compare choices, reflect on the past and project into the future.  Activities that rely on System-2 thinking require self-control and sustained effort.  In short, engaging System-2 is oftentimes depleting and unpleasant. 

Difficulties arise when we are presented with a situation that intuitively engages System-1 thinking, but actually requires System-2 thinking.  For example, if I told you the price of my son’s new ball and bat was $1.10, and the bat cost $1.00 more than the ball, your brain would likely switch into System-1 thinking by immediately concluding that the ball cost 10¢.  And, you would be wrong.  If the ball were 10¢, the bat would be $1.10 and our total would be $1.20.  By engaging System-2, we find the actual cost of the ball is 5¢.

Kahneman’s brilliant studies also demonstrate that humans are risk-averse when there is hope for a gain, yet risk-seeking when faced with a decision between certain losses.  He goes on to explain that we tend to rely heavily on System-I thinking when faced with uncertainty, trade-offs, or long-term horizons.

Uncertainty, novel situations, trade-offs, hopes, certain and long- term horizons are common features of many health care decisions.

The surprising truth is that medical providers seldom have solid evidence of superior treatment effectiveness.  More frequently, the clinical context is a choice between treatments with outcomes that differ depending on the option chosen without clear evidence to tell the patient or provider which is the superior choice.  Trade-offs exist with probabilities of good and bad outcomes over various time horizons.

For example, a patient suffering from 6 weeks of uncomplicated low back and leg pain from a herniated disc could chose surgical or non-surgical treatment.  Surgical care holds the promise of relieving the leg pain more quickly than non-surgical care but at the added risk of the surgical procedure itself.  Non-surgical care holds the promise of relief over a longer period of time and without the surgical risks.  Existing evidence suggests the long-term outcomes are equivalent.  (See here, here, & here for supporting evidence.) For this reason the patient’s preferences should determine the treatment pathway.  More commonly, however, it is the provider’s opinion that determines the patient’s treatment destiny.

Following this thought process further leads to the uncomfortable realization of a seldom discussed medical error, operating on the wrong patient.  I do not mean operating on patient A instead of patient B.  By “wrong patient,” I mean one who would have, had she been fully informed of the risks and benefits of all treatment options, chosen non-surgical care.  Evidence of the over-use of surgical interventions in this manner is detailed in Dartmouth Professor Jack Wennberg’s latest book, “Tracking Medicine.”

Patient preference-sensitive clinical situations are best addressed by aligning the fully informed patient’s preferences with the care she receives.  Doing so requires System-2 thinking by both the clinician and the patient.  This is not easy and there are legitimate reasons for both the clinician and the patient to be unhappy.

The situation is difficult for clinicians because System-2 thinking is laborious, but not reimbursed.  There are no evaluations or procedures to order.  Further, medical school does not provide the skills required to elicit a patient’s preferences, fears, and risk-tolerance, let alone their numeracy.  This final aspect is especially important because medical decisions frequently involve very small numbers that are difficult to place in context.

Patient preference-sensitive clinical situations are difficult for patients because they may not want to be so involved.  Patients engage the health care system at their most vulnerable times.  They reveal secrets to us their spouses may not know.  They disrobe in front of us and we peer inside of them with our technology or surgical technique.  Despite all this, patients reveal their anxieties and hopes to us, after the briefest of interactions, in the hopes of receiving information, wisdom, and care that can prevent or ease pain and dysfunction.

In return, they should receive our best information and judgment.  Past attempts to involve the patient in sharing the medical decision have, in my opinion, come up short.  They have relied on econometric utility-maximizing theory, weighting each of the probabilities in a decision tree and then mathematically folding branches back to reveal the most rational choices with the highest probability of producing the most utility for the patient.  This process has always struck me as an unusual because, in over 15 years of clinical work, I have never met a truly rational patient.  Nor for that matter, have I encountered a fully rational and unbiased clinician.

The work done by Kahneman and Tversky debunks utility theory and replaces it with “prospect theory.”  Kahneman describe this well in his book.  It is incumbent on us to find ways to design the delivery of care in ways that incorporate the insights gained from prospect theory and employs methods that lead to fully informed patient choice.  I think you’ll agree and look forward to your comments.

 

Before the ACP Ethics Manual, there was the Physician Charter

post by Paul Kelleher

In a nice round-up of reactions to the new American College of Physicians' Ethics Manual (discussed on this blog here, here, and here), bioethicist Daniel Callahan echoes what many others have said:

Just by mentioning the importance of cost-effectiveness, the policy breaks important new ground. The cost problem is getting worse all the time. We’ve got to find a way to break that logjam.

It is, however, worth pointing out that this is actually not new ground for the American College of Physicians. In 2002, the the American College of Physicians–American Society of Internal Medicine (ACP–ASIM), the European Federation of Internal Medicine, and the American Board of Internal Medicine jointly released "A Physician Charter", which was intended a sort of new Hippocratic Oath. According to health economist Victor Fuchs, the Physician Charter "has been adopted by physicians’ organizations that include a majority of U.S. physicians." 

The Physician Charter includes three Fundamental Principles and 10 Commitments. The three principles are: a Principle of Primacy of Patient Welfare, a Principle of Patient Autonomy, and a Principle of Social Justice. Among the commitments (and presumably justified by the Principle of Social Justice) is this one:

Commitment to a just distribution of finite resources. While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician's professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures. The provision of unnecessary services not only exposes one's patients to avoidable harm and expense but also diminishes the resources available for others.

A couple comments. First, notice that physicians are called upon to work with other stakeholders on the development of "guidelines for cost-effective care." My experience in talking with physicians (and physicians in training) is that they would rather be constrained by thoughtful, collaboratively developed treatment and diagnostic protocols than to be expected to "practice cost-effective medicine" in a discretionary manner at the bedside. Physicians would then not feel like they were "playing God," and would view themselves instead as providing "appropriate medical care" when they refuse to treat/screen/refer someone who does not fit a cost-effective protocol's indications.

Second, notice that what the charter does expect physicians themselves to do is to avoid the "provision of unnecessary services" through "scrupulous avoidance of superfluous tests and procedures." I have already suggested that this exhausts what the ACP meant when they encouraged physicians to practice "parsimonious care" in the Ethics Manual. (On "parsimonious," see Dr. Don Goldmann's comments in the round-up.) Again, the reflective view of physicians seems to be that while the doctor's job is to avoid providing harmful or unnecessary care, an understanding of what amounts to justified cost-effective care is more difficult to grasp, and should await a collaboration between different stakeholders with the power to shape cost-effective policy in a politically legitimate way.

A final theme in the round-up on ACP's Ethics Manual is that the Manual does not explain what it means to practice cost-effective medicine or how physicians are supposed to learn how to do it (this problem arises for the Physician Charter as well). Dr. Goldmann articulates what would surely be the first step envisioned by the Manual:

The true cost and effectiveness of a given treatment should be made available and utilized by clinicians as part of their decision making process. What I would love to see is increased pressure on the health care industry to be transparent about the true cost of what they’re making available to their providers and not make it so obscure that you can’t figure it out.

 But history suggests that simply knowing the costs will not be enough. Here is Steven Schroeder:

During the administration of President Jimmy Carter, hospital cost containment became a prominent health policy initiative. In response, the hospital industry argued that it could achieve those goals on its own, without government interference. This “voluntary effort” featured physician education as a strategy to produce more rational spending patterns and thereby lower costs. We tested this hypothesis at UCSF, evaluating 3 different educational strategies on the medical and surgical services over a 2-year period. The educational efforts, which included teaching about costs and benefits of various services as well as a detailed cost audit of services ordered by individual residents, were well received. But there was no significant decline in hospital charges compared with control groups. We concluded that—absent major involvement by hospital authority figures or changes in incentives— voluntary cost containment would fail. Eisenberg and Williams, who conducted similar studies at the University of Pennsylvania, likened voluntary medical cost containment to the fox guarding the chicken coop. Predictably, after Carter lost his reelection to Ronald Reagan in 1980, the voluntary effort vanished.

All this suggests that there is great virtue in having cost-effectiveness be a property of policies and protocols, not discretionary physician behavior. 

May Employers Ethically Refuse to Hire Smokers?

post by Paul Kelleher

From USA Today:

More job-seekers are facing an added requirement: no smoking — at work or anytime.

As bans on smoking sweep the USA, an increasing number of employers — primarily hospitals — are also imposing bans on smokers. They won't hire applicants whose urine tests positive for nicotine use, whether cigarettes, smokeless tobacco or even patches.

Such tobacco-free hiring policies, designed to promote health and reduce insurance premiums, took effect this month at the Baylor Health Care System in Texas and will apply at the Hollywood Casino in Toledo, Ohio, when it opens this year.

"We have to walk the walk if we talk the talk," says Dave Fotsch of Idaho's Central District Health Department, which voted last month to stop hiring smokers.

When I read a story like this, I always think first of the following passage from Michael Marmot's The Status Syndrome (pp. 68-9):

Here is a more contemporary picture of poverty. In an American city a young woman, let's call her Patty, sits and contemplates her life. She recalls that a researcher, doing a health survey, came to the local grocery store, where Patty works as a cashier, and asked her how much exercise she did. She laughed. Most of the day is spent sitting or standing behind the till. What about exercise at home? She lives in a crowded inner-city tenement building. She won't let the children play on the strip of asphalt nearby. Apart from broken glass, she is worried about the violence in this part of town.

Patty's reverie continues. The children come home from school and ask if they can go swimming. It would certainly relieve the long oppressive hours from Friday night to Monday morning that is the lot of a Single mother with two children. But joining a fitness club had been out of the question. They might as easily have a vacation on the moon. There is the Y. But it is an hour on the bus. With the bus, entry, snacks, and sodas for the kids, the trip would cost $30. A king's ransom, but it would fill a couple of hours at least. Then what? She and the children sit cooped up in their two bedroom apartment going quietly stir-crazy. Not so quietly. The children yell at each other and start to fight again. Patty lights another cigarette.

As she contemplates the week ahead, she thinks that the boy needs new sneakers. Why they have to be the ones with special laces, when he never does them up, is beyond her. Something about all the other kids having them. The girl has been to three different friends for dinner and a sleepover in the last month. She wants friends home to her place. Four children, pizzas all round ... Where is that money going to come from? Patty lights another cigarette. She remembers when she splurged and bought herself a pair of designer jeans. It was Mother's Day before last. Gallows humor of the Single mother to buy herself clothes that she could not afford on Mother's Day.

As she thinks about it, she realizes that the only money she spends on herself is the cigarettes. When she took the children to the clinic the other day, the nurse told her, for the umpteenth time, that she shouldn't be smoking: bad for her health and a bad example for the children. The hell with that, thought Patty, take the cigarettes away and what am I left with? That clinic nurse should try leading my life, and see if she's still worried about lung cancer in thirty years' time. I have enough trouble getting through next week.

Lots of "lifestyle choices" have effects on health care costs. A provocative example I cite in the classroom is a employee's choice to have a child. I don't know how the added costs of this choice stack up to the added costs of smoking; I need to look into that further. But putting the examples side by side makes for a useful thought experiment: do we have the same intuitions in each case about whether it's OK to refuse to hire the potentially health-costly applicant? If not, why not? If it is because having children is a "respectable" choice while smoking is not, then I would urge that we spend more time thinking about passages like Marmot's, as well as all the information we have about how people become smokers and what makes it so hard for them to stop.

I don't insist that these Marmot-inspired thoughts are dispositive. There's of course a lot more to say on this issue. As always, I'd welcome your thoughts and a continued discussion in the comments section.

So you want to think more about rationing...

post by Paul Kelleher

In light of the conversation we've been having about the American College of Physicians' Ethics Manual's statements on resource allocation, I thought I'd point to some short, web-accessible sources that can help advance our thinking about these issues. It should go without saying that this is a non-exhaustive list, and that I intend for these to provide useful food for thought, not knockdown arguments or silver bullets.

1. Peter Ubel's contribution here (begins on page 11).

2. Peter Singer's NYT Magazine article, "Why We Must Ration Health Care," here. 

3. Frances Kamm's Letter in response to Singer's article, here.

(if you hit NYT's paywall when trying to access Singer and Kamm, let me know in the comments and I can help you out)

4. Norman Daniels's contribution here, especially from page 50 onward.

5. Marthe Gold's podcast here (the first is longer [14min] and worth your time). It is based on this 2005 paper in Health Affairs.

6. Jonathan Wolff's remarks here, especially from about 16:45 onward.

These last two focus on the ways in which the UK's National Institute for Health and Clinical Excellence (NICE) sets health care limits and priorities. 

Rationing and the American College of Physicians Ethics Manual

post by Paul Kelleher

Aaron Carroll writes about the ethics guidelines (pdf) recently released by the American College of Physicans:

But the part that raised my eyebrows the most, and where I’m not sure I am in total agreement has to do with a physician’s responsibility to society:

Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available.

I’m sure many of you are shocked by my concern with this statement. Let me explain.

I talk a lot about the fact that we, as a society, need to think about cost-effectiveness if we are going to get a handle on the cost of health care. This means saying no to some treatments and tests, because we have to use health care resources responsibly. When I say such things, inevitably someone counters me by questioning whether I would feel the same way if my child’s life was on the line.

The answer is, of course not. If my child’s life were at stake, I would fight tooth and nail to get anything – and I mean anything – to save him or her. I’d do it even it it cost a fortune and might not work. That’s why I don’t think you should leave these kind of decisions up to the individual. [...]

Similarly, I don’t think that it’s necessarily fair to make it a physician’s responsibility. I also want my child’s doctor to fight tooth and nail to get anything that might save my child...Asking them to divorce themselves from the very human feelings that compel them to do anything that might help their patients is not something that I think will necessarily improve the practice of medicine. They also should be human.

So whose job is it? Well, mine for instance. That’s what I do as a health services researcher. That’s what policy makers should also do. That’s what we, as society should do. There are people who should have the responsibility of debating and deciding what is and is not cost-effective. They should have to make decisions that may be unpopular, and they should have to face the wrath of those whom the decisions impact.

On my reading of the ethics guidelines, the American College of Physicans is largely in agreement with Carroll. Consider again the passage he quotes:

Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available.

The College defines parsimonious care not as care that "maximizes QALYs per dollar spent" or care that "maximizes net monetized benefits", but as "care that utilizes the most efficient means to effectively diagnose a condition and treat a patient." Here the stipulated goal is effective diagnosis and treatment, and physicians are instructed to use the most efficient means available to achieve it. Dr. Virginia Hood, the president of the College, elaborates:

"Parsimonious is a good word in the sense that it means that you use only what's necessary," she said.

So I don't see the College recommending that physicians should withhold effective therapies from their patients based on cost. But then there is also this in the College's guidelines:

In making recommendations to patients, designing practice guidelines and formularies, and making decisions on medical benefits review boards, physicians’ considered judgments should reflect the best available evidence in the biomedical literature, including data on the cost-effectiveness of different clinical approaches.

Unfortunately, the College does not make it clear exactly how cost-effectiveness data is to be used by physicians. Later in a section entitled "The Physician and Society," and in a sub-section entitled "Resource Allocation," the College writes that "decisions about resource allocations challenge the physician’s primary role as patient advocate." Still, the document is quite clear where the physician's loyalties should be. Indeed, the document echoes Carroll's remarks about his preferred division of labor:

1. As a physician performs his or her primary role as a patient’s trusted advocate, he or she has a responsibility to use all health-related resources in a technically appropriate and efficient manner. He or she should plan work-ups carefully and avoid unnecessary testing, medications, surgery, and consultations.

2. Resource allocation decisions are most appropriately made at the policy level rather than entirely in the context of an individual patient–physician encounter. Ethical allocation policy is best achieved when all affected parties discuss what resources exist, to what extent they are limited, what costs attach to various benefits, and how to equitably balance all these factors. Physicians, patient advocates, insurers, and payers should participate together in decisions at the policy level; should emphasize the value of health to society; should promote justice in the health care system; and should base allocations on medical need, efficacy, cost-effectiveness, and proper distribution of benefits and burdens in society.

I tend to agree with Carroll's take on whether doctors should ration at the bedside. And I think the American College of Physicians does too.

Gender equity in the US and Canada

post by Bill Gardner

Aaron Carroll recounts an amazing incident (reported here by Carey Goldberg):

In 2007, Sophie Currier of Brookline, holder of M.D. and PhD degrees from Harvard, asked for extra time to take an all-day medical board exam. Her daughter was four months old at the time and exclusively breast-fed, and she needed more than the standard 45 minutes of total break time to pump her breast milk. The test’s overseers, the National Board of Medical Examiners, said no.

There are many things wrong with Canadian healthcare, but I would be deeply shocked if this happened here. The laws vary slightly across province, but mothers get a year's paid leave. Perhaps for this reason, there seem to many more female hospital CEOs and chiefs of medical departments here, compared to the US.

The point is that the problem may be bigger than just the need of physicians to haze their apprentices. The US should support parents with maternity and paternity leave rights comparable to those in Canada and Europe.

When the high price of health care is a good thing

post by Paul Kelleher

If an [Implantable Cardiac Defibrillator] were a buck and a quarter, would we have gone through this entire process of reviewing the evidence at all? Maybe not. But because it's a bit more than a buck and a quarter we wanted to make sure the evidence was clear and that it was a benefit. We don't use cost to decide the evidence issue, but we do use cost to decide if this is important enough to address.

That is Dr Steve Phurrough, then-acting director of the Centers for Medicare and Medicaid Services Coverage and Analysis Group, speaking in 2003. I find this quotation shocking, and I wonder if others do as well.

I have no idea if things at CMS have changed since 2003, but this strikes me as illustrating one reason why it can be good for health care to be pricey. I do not claim that this reason makes it true, all things considered, that health care is so expensive. But its just not clear that we would be better off if health care grew on trees.