"Abandoning ship": is debunking ineffective screening and therapy removing hope or just removing risk?

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Sometimes I think I sound like a real medical nihilist, since many of my blogs have been about purported treatments that are ineffective, dangerous, done too often, and cost a lot of money (Cardiac stents and profit-driven corruption: do anti-fraud rules address the problem?, December 24, 2010; Greed, corruption and medical procedures: ignoring or suppressing the evidence?, August 12, 2011; Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?, March 15, 2011).  It is a somewhat distressing feeling. I am a doctor; I want to help people, to relieve their suffering, to help facilitate the cure of their diseases. More than that, I am a family doctor, and have a strong preference for prevention, for early detection of disease when it is still treatable rather than waiting for it to be too far gone for treatment to be effective. In addition, I have regularly criticized our health non-system for leaving out too many people, creating financial disincentives for them to seek care early. This leads to their waiting until their diseases become so uncontrolled that they present to the emergency room, then require admission and costly care, making it worse for them (most important) and more expensive for everyone. So I think prevention and early intervention is a really good thing, and it would be great to have tests that could identify disease early in its course so that we can change its trajectory.

But because I want these things to be true doesn’t make them true, as I discuss in the recent post Avastin®, Plan B®, and Magical Thinking, December 31, 2011. Because we can screen you for something doesn’t mean that we should; because a test can be done doesn’t mean that it is a good test. "A good test", in my opinion, is one that has sufficient sensitivity (rate of being positive when a condition is present) or specificity (rate of being negative when a condition is absent) to tell us whether a you have a disease, or if it matters. Because it can be done also doesn’t mean that it is cost-effective. Because a treatment exists doesn’t mean it is a good treatment, a safe treatment, an effective treatment. And, as with most things being sold, the greater the publicity and advertising around it, the more it means someone will be making money on it, which does not exclude its being of benefit, but is certainly not the same thing.

Sometimes, when evidence is discovered that a test or treatment is not of benefit, eventually we stop doing it. "Eventually", however, may be a lot longer than you might think. In a recent “Viewpoint” in JAMA, Prasad, Cifu, and Ionannidis address “Reversals of established medical practice: evidence to abandon ship”[1]. They note that while “Ideally, good medical practices are replaced by better ones, based on robust comparative trials in which new interventions outperform older ones and establish new standards of care. Often, however, established standards must be abandoned not because a better replacement has been identified but simply because what was thought to be beneficial was not.” They go on to discuss a number of treatments that have been “standard of care” but were shown by good, randomized controlled trials, to be ineffective or even dangerous (not to say expensive). These include stenting of coronary arteries for stable coronary artery disease (CAD), postmenopausal hormone therapy to prevent CAD, vertebroplasty for osteoporotic fractures, bevucizamab for breast cancer.

Scarily, but unsurprisingly, “true believers” continued to defend these interventions even after the evidence was clear (their livelihoods depend upon it), and in many cases these treatments continue to be offered and performed. “There are thousands of clinical trials, but most deal with trivialities or efforts to buttress the sales of specific products,” and it is only “Rarely [that]…some investigators find the courage to test established ‘truths’ with large, rigorous randomized trials”. Prasad and colleagues have done many of these latter trials; indeed John Ioannidis is the “guru” of debunking treatments with poor evidence (see David H. Freedman’s article in the November 2011 Atlantic “Lies, damned lies, and medical science.”) The authors have some suggestions, including limiting the role of manufacturers (of drugs, devices, tests) from conducting the trials on them, although they should pay for them: “Large trials of new innovations should be designed and conducted by investigators without conflicts of interest, under the auspices of nonconflicted scientific bodies. Instead of designing, controlling, and conducting the trials, manufacturers may offer the respective budget to a centralized public pool of funding, keeping the trial design and conduct independent.”

Prevention and screening are also subject to the lure of magical-thinking-compounded-by-the-greed-of-the sellers. Screening for prostate cancer with the use of prostate-specific antigen (PSA) testing is a good recent example about which I have written (while the lack of effectiveness of treatments for prostate cancer is would be included in the group of ineffective therapies that Prasad and colleagues have written about). Pap smears are pretty good screening tests for cervical cancer, but most other cancer screening tests (even mammograms and colon cancer screening, probably the next best) are not nearly as good. Every time there is a recommendation to decrease the frequency of screening (Pap smears, mammography) or not do them at all (PSAs or pelvic exams) there is an outcry from people who think that something has been taken from them. In a scientific sense, what has been taken is unnecessary testing that doesn’t lower their risk of bad outcomes, costs money, and can have significant morbidity when positive screens need additional, more invasive tests, to follow up. But, in a more metaphysical sense, what has been taken is hope, the idea that there is something that they can do that will prevent something bad from happening to them. Something that, while perhaps a little risky (if you understand or believe it), is relatively easy. And also, frankly, something someone else, rather than you, can do. Not like, say, dieting or giving up smoking or exercising. And this false concept is encouraged by half-truths promulgated by passionate advocates of interventions with limited proven benefit, whether traditional allopathic or “alternative”.

Even public health advocates sometimes get so passionate about the health benefits of what they are advocating that they may miss other issues. For example, consider a recent discussion on a progressive public health listserve about “portion control” (limiting the amount eaten at one sitting). This is an important and effective method of addressing obesity, which is in fact a major health problem in this country, but the discussion raised many other issues. These included concerns about “blaming the victim” -- expecting self-control (difficult enough) from people who had historically not had that control in the face of major initiatives by fast-food purveyors to push large portions. Another was the economics involved in asking poor people to pay “more for less” while corporations continue to make huge profits from them. It can, and often is, as difficult for public health advocates to recognize problems arising from their positions and passions as it is for providers or manufacturers to back off from theirs.

The difference, of course, is that the former are really invested in the health of the public, while the latter are invested mostly in, well, their investments.

[1] Prasad V, Cifu A, Ioannidis JPA, Reversals of established medical practices: evidence to abandon ship”, JAMA 4Jan2012;307(1):37-8.

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One thing to NOT worry about: paying for health care -- in France

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I recently saw the film Le Havre, a film set in that French city and made, in French, by Finnish director Aki Kaurismäki. It was a very good film, generally well-reviewed (here is the New York Times review), and part of its appeal for me is its unabashed portrayal of working-class people as the central characters. One of the plots involves the illness of the female lead, Arletty, who suffers severe abdominal pain, is brought to the hospital, and is told that it will be terminal (although, the doctor observes, “miracles do happen”.) I don’t need to share any more of the plot, because what I found striking was really incidental to it.

Kaurismäki goes to some length to depict both the poverty and dignity of his characters. It is an imaginable working class poverty -- this is not the Mumbai of Slumdog Millionaire – but it is certainly poverty. Arletty’s husband is a shoeshine man; they live on an alley off a small street in a house that evokes the apartment of Ralph and Alice Kramden on The Honeymooners. When he sees his wife in such pain, her husband’s main concern is how he will get her to the hospital. He goes to the street to ask a shopkeeper if he can use her phone (they don’t have one), and she offers to drive them.

What is not a concern is whether they can afford her medical care. As I am used to being in the US, to caring for people of limited means, of seeing people in the free clinic who cannot afford to go to the doctor or people admitted to the hospital when they finally show up in the emergency room with disease that is far gone because they haven’t sought care, I found this a bit jarring. I was waiting for Arletty to protest that it was “nothing” (she has been in some denial already), for fear that they couldn’t afford medical care. But she doesn’t, and he says nothing about it, and goes off to find transportation. We could see the same thing in an American movie, and we would expect the same thing in our own lives – when your wife is really sick, you take her to the hospital, you worry about the bills later.

Except that wasn’t why. They weren’t worried about the bills. Because it was France. With a national health insurance system, where everyone, even the wife of a self-employed shoeshine guy living in a tiny house off an alley, has health coverage. In the film, Arletty is in the hospital for several weeks, but of all the issues that occur, how the couple will pay for it never comes up. Not at all. It is not even a thought in their minds. But it is a thought in mine, and I keep having to remind myself that it is not part of the plot because it is not an issue that French people have to concern themselves with. The illness, yes. Whether she will survive, yes. Whether he will earn enough money each day to buy dinner, yes. But not how to pay for several weeks of hospitalization. Amazing.

There was another aspect of the healthcare portrayed in the film that struck me. The hospital was simple and unostentatious. It looked a little dated, old-fashioned, like the houses and the shops and the working-class lives of the characters, even though the film and its theme are contemporary. Maybe this is also something about France. The hospital is clean, freshly-painted, with clean linen, and private rooms, and IV poles and doctors and nurses. But it is simple. The ceilings are not high, there is not expensive art on the walls, or carpets, or hallways twice as wide as they need to be. It is functional. It is not third-world, but it is basic. It is pretty unlike my hospital, or most of the hospitals that we see in the US (except some of the oldest public institutions). If someone with private health insurance saw this hospital in, say, Kansas City, they would be unimpressed. They might rather, next time, seek one that was “nicer”. Fancier. With really good hotel accommodations. This is what we look for in the US, what we expect. Surely this is what they lose in such national-health-insurance countries as France.

I checked this with a friend, who is from Canada. He said that this is the way hospitals in Canada are; clean, and functional, but not fancy. He told me he was shocked when his wife had a baby in Kansas City and there were hardwood floors. What for, he wondered? Of course, we know what they are for. They are to help to provide a competitive advantage, to make people choose one hospital over another. For the same reason that hospitals buy new MRI scanners when the hospital down the street has one that is underutilized. Why they have fundraisers to be able to support their cancer center, to attract people with cancer (and, of course, insurance!) to them, rather than to the perfectly good cancer center across town. Why, as depicted in a recent New York Times “Opinionator” by Ezekiel Emanuel and Stephen D. Pearson (“It costs more, but is it worth more?”), hospitals such as Mayo Clinic are building their own billion-dollar proton-beam accelerators to treat cancer when there are more than enough in the country to treat the relatively small number of people who require this kind of cancer therapy.

Because, in the US, healthcare provision functions much more as a business than as a social good. The “product” is healthcare for people, but the product is only of value when it can be sold to those who can pay. We have hospitals that compete for some of our people, while there are others who can barely get care. This competition model can work, just as it works for other products – vendors compete for those who can afford it and ignore those who cannot. If we want healthcare to be an industry, a business, rather than health care.

Le Havre is a very good film, and it does not shy away from social issues. In fact, it addresses many of them. But access to health care is not one, it is not Sicko! The themes I discuss here are just in the background of the film,and I imagine they are not even noticed by French audiences. Or Finnish ones. Being able to afford medical care is not an issue in those places.

Which is as it should be.

It’s definitely not about the bike – but is it even about ACOs?

One of the major features of the Affordable Care Act (ACA) is the idea of Accountable Care Organizations (ACOs). The final regulations from Medicare were issued in October, 2011, so the creation of ACOs seems to be moving forward. ACOs will be groups of primary care doctors, specialists, hospitals, and possible other providers who act together to provide comprehensive care, and receive either more money from Medicare (and probably, eventually, other payers) or, at least, smaller reductions in payments. The only thing that is definitely required to form an ACO is a group of primary care doctors, but since groups of primary care doctors rarely have sufficient capital to fund the necessary infrastructure, so it is likely that almost all will include at least one hospital.

The stated purpose behind encouraging ACOs is to increase quality. It is easy enough to see how quality could be improved in our non-system of health. Because the bar is so low, there are tremendous opportunities that come from lack of organization and coordination of care. Hospitals get paid for caring for people who are admitted. Thus, up to a point (the point at which payments do not exceed costs), they want admissions. Patients prefer to stay healthy, or at least healthy enough to not have to be admitted to the hospital, and hopefully their primary care doctors support this goal. Hospitals have already started being financially penalized by not receiving reimbursement from Medicare for readmissions for the same problem they were discharged for, or complications of that problem. Managing this issue will require the ACO to have not only financial relationships with primary care doctors, but often with long-term care facilities as this is where patients are discharged to – and return to the hospital from.

Fisher, McClellan, and Safran, in their New England Journal of Medicine article “Building the Path to Accountable Care”  (December 29, 2011; may require subscription)[1], identify five “challenges” to implementing ACOs with suggestions for how to overcome them. The challenges are providing timely and useful data, overcoming transition costs, gaining consumer support, learning what works and using that knowledge to inform policy and practice, and clarifying the path forward. Their suggested approaches to solving them are largely based upon what is being done in existing integrated health systems (such as Kaiser and Geisinger). This makes sense, as these systems were the model for ACOs and are often relatively cost effective, but it will require major restructuring for other such systems to develop in ways that can work as well. The authors do not address a major challenge for ACOs, which is that every patient will be identified with a particular ACO (based on the physician from whom they receive the majority of their primary care) and that ACO will be held financially responsible for that patient’s costs, but that the patient will be free to receive service from outside that ACO. This is a political decision, intended to avoid the criticism that the ACO program is just “managed care” in new clothes by ensuring that the program will not “restrict” people. Of course, it is a huge flaw. If a patient is not happy with the care they receive from members of their “identified” ACO, whether that is for “good” reasons (denying unnecessary, excess, risky procedures, hospitalizations, etc.) or “bad” reasons (less than the best quality), the patient can go elsewhere and receive that service from someone else. And if Medicare deems it unnecessary or excessive, it is the “identified” ACO that will receive the financial penalty, not those providing the service.

The authors’ final challenge, the vaguely worded “clarifying the path forward”, is about future changes, including (from their table) “Create meaningful alternatives to fee for service for all providers.” This is a good idea, and not a new one. It means that rather than have the provider (hospital or doctor) paid for each particular service, the payment is tied to something else. Most simply, it could be a global fee for providing care to a patient, as the capitated payments in traditional HMOs. This allows practices to budget their resources, and also allows patients to get care in the way they need it. If a doctor is being paid a set amount in advance, there is no financial incentive for them to require a person to have to take off from work, travel, park, and wait to be seen when that person has a question that can be answered by phone or email. You would only have to be seen in person if either you or the doctor thought that there was a reason to do so. The disincentive under the current fee-for-service system is that the doctor doesn’t get paid unless you are seen in person. In addition, the ACA law envisions paying more for higher quality (or less for lower quality). So why were these “meaningful alternatives” not included in ACA? Again, political, and the question is “what will change the politics in the future?”

In another NEJM “Perspective”, “Achieving accountable care – “it’s not about the bike” (published online on December 28, 2011), Walker and McKethan argue that it is the skills and competencies of providers, rather than the structure of the systems, that will determine the success of ACOs. Their metaphor is from Lance Armstrong’s memoir, in which Armstrong acknowledges the importance of having a great bike but says that “Although advanced equipment is very important, winning depends more on athletes' riding skills, physical conditioning, and race-day effort.” Cute, but obvious; any athlete with enough money (and all top cyclists have backers with enough money) can buy the best bike, but it is his or her skill and dedication that leads to victory – or not. Is it, however, a good metaphor for medical care? “If an ACO were a bicycle,” Walker and McKethan write, “its wheels, spokes, and gears would be the criteria used by payers such as Medicare to determine providers' eligibility, the methods used to assign patients to a given ACO, and the manner in which financial bonuses are calculated.” They then go on to discuss at some length what ACOs will need to do to “…compel and equip the athletes riding them…” (meaning providers) to do what is necessary, for “…accountable care will depend on a care team's identification of and action on the specific needs and preferences of the individual patient, deploying the most relevant, tailored interventions and supportive services to address patients' specific needs, circumstances, and preferences.”

Sound good? It is an appropriate metaphor in that structure alone will not guarantee success, but it loses strength after that. ACOs are not bicycles, and providers are not athletes. Most important, “success” in the arena of healthcare should not be about “winning”, about “beating” the other “competitors”, but about development structures, methods, practices, and reimbursement procedures in which everyone receives the best, most appropriate care. In which we all win.

And that is going to be one of the big challenges, because neither of these commentaries addresses the fact that not everyone in our country is going to be part of an ACO, and not everyone in our country has health coverage. Those people who do have coverage have found their premiums, co-pays, and deductibles increasing and their benefits diminishing.  ACOs are (at least initially) a program for Medicare recipients, but all we hear from Congress and pundits is that “Medicare costs too much” and that these costs need to be scaled back, so unquestionably the emphasis of programs like ACOs will be on reducing cost.

I have often noted that much of the excess cost in this country is from providing unnecessary, or even harmful, care, and so there is not necessarily a conflict between saving money and increasing quality. But people are different, with different diseases and needs and wants, so there will need to be flexibility. And those who are most disenfranchised will remain outside the pale.

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[1]Fisher ES, McClellan MB, Safran DG, “Building a path to accountable care”, N Engl J Med 29Dec2011;365:2445-2447

Cui bono? Is healthcare financing about funding providers or caring for patients?

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In a recent blog, GME funding must be targeted to Primary Care, December 10, 2011, I wrote about the fact that the financial interests of hospitals lead them to choose to support residency training positions which are not necessarily (or often, or usually) in those specialties that the nation most needs. I urged that funding from the government for graduate medical education (primarily through supplements to Medicare and Medicaid) include mandates as to the proportions of trainees in different specialties, with a strong emphasis on training more primary care physicians. This is only one area, however, in which the financial incentives to hospitals, and indeed all health providers including physicians, do not always jibe with the healthcare needs of our population.

A recent spate of news articles has discussed changes in the organization and financing of healthcare services. The New York Times recently covered the conflict between the governor of the state of New York, Andrew Cuomo, and the mayor of New York City, regarding the potential conversion of Emblem Health to a for-profit company (Bloomberg Predicts Fair Deal if Health Insurer Gets For-Profit Status, by Thomas Kaplan, December 23, 2011). Cuomo wants it because it could bring as much as $1B in tax revenue to state coffers; Bloomberg is concerned because Emblem is the insurer of the majority of municipal employees and he expects such a move will drive premiums up. But, as the title of the article suggests, he thinks they can work it out. Between them. For the benefit of both the city and state governments. Not, however, for the people insured by Emblem. Emblem was created by a merger of Group Health Insurance (GHI) and Health Insurance Plan (HIP) of Greater New York, two early not-for-profit HMOs, or managed care organizations. Except they were created before either term, HMO or managed care, existed. Back in the 1950s, these were consumer cooperatives, where it was recognized that by cutting out the (for-profit) insurance company middleman, people could have more care for the same money, or the same care for less money. No wonder the majority of city employees enrolled.

Over time, rebranded by the Reagan administration with the new name of “HMO” or managed care, became the de facto standard for US health care coverage. Why Republicans could buy into this vaguely populist or socialist concept was that the new HMOs would increasingly be owned by for-profit insurance companies, which they could literally buy into as shareholders. The savings that came from managing care would now accrue to the insurer, not the patient-owner-members. Many of the long-standing HMOs of the early period (e.g., Los Angeles’ Ross-Loos) were purchased by insurance companies, but there were a few holdouts that remained consumer cooperatives (e.g., Group Health of Seattle and the groups that became Emblem). And then, as we remember, came the consumer backlash against HMOs in the late 1990s, with people furious at the restrictions these organizations put on their access to health care. The mistake, however, was thinking that the problem was the organization of care with requirements for only approved therapies, relatively “closed panels” of doctors and hospitals, and capitated payments. The problem was that they were, and are, mostly owned by for-profit corporations, which increase their profits every time care is denied. This is a very different incentive than when the owners are the patients themselves through a cooperative.

As time went on, even the non-profit HMOs and other non-profit groups like the Blue Cross / Blue Shields that are not part of the for-profit Anthem/Wellpoint, have had to act like for-profits to compete. The advantages have all been for the insurers, which remain very profitable, not for the patients, who find both many of the same restrictions they bridled at in the past, and, in addition, increasing premiums, co-payments, and deductibles. If Emblem becomes for-profit, Michael Bloomberg may be able to work a deal where the city government is spared a major premium increase, but the city workers who are insured by Emblem will not be so lucky. In a typically excellent “Quote of the Day”, Don McCanne, MD, discusses the fact that the National Business Group for Health (NBGH) is predicting major increases in deductibles for all employees. As reported in an article in the Nashville Tennesseean, “High deductible plans on the rise”, by Tom Wilemon, December 27, 2011, “Helen Darling, its [NBGH] president, predicts that by 2016 the majority of all health plans will have high deductibles.” McCanne notes correctly that the members of NBGH are the nation’s largest corporations, mostly Fortune 500 companies, which have historically had the best health insurance coverage for their employees. If these deductibles – the amount a family has to pay out-of-pocket before any insurance coverage kicks in – rise to $1500 a year, it will be much worse for those working for smaller, less prosperous companies.

McCanne also comments on reports from the AMA that Highmark, the large Western Pennsylvania Blue Cross / Blue Shield affiliate, will be purchasing its own health system, where it will be able to profit on both ends, or, at least not pay as much for care. He observes that this will enhance its financial status, but not benefit patients, who will be preferentially locked into care at West Penn. The greatest complaints are from the competing University of Pittsburgh Health System, which believes it will Iose patient revenue from such an arrangement. So the conflict here is between the benefit for one health system versus another. It is not benefit for state versus city government as in the Emblem case, but it is still not about the health of the people. It continues to be about how the money from healthcare is distributed among the various players, including as insurance companies, hospitals and doctors.

My hospital, the University of Kansas Hospital (UKH), has done very well financially. In the most recent “Book of Lists” sent to subscribers to the Kansas City Business Journal (not on line; a copy will cost you $65, or $169.95 for immediate download!), it had the greatest revenue in the Kansas City area, at over $2.5B, more than $1B ahead of #2. The physicians who staff the hospital, faculty of the University of Kansas Medical Center, are seeking a restructuring of the current affiliation agreement to share more of that revenue with the doctors. As one of them, I do not disagree with the concept that the physicians, whose work generates much of the revenue, should share more equally, but, as with West Penn and University of Pittsburgh, this is about who gets what, not about how to provide better healthcare for less money to more people.

Health industry consulting groups, such as the Advisory Board, warn hospitals that there will be major cuts to their income resulting from federal budget cuts and programs such as pay-for-performance (P4P) and “value based purchasing” (this is “value” in the economic sense, that is cheaper, rather than having anything to do with “values”, such as caring for the sick!) Hospitals like UKH worry about whether their up-to-this-point successful strategy of investing in the highest-profit “product lines” such as heart disease and cancer will continue to work in the changing reimbursement system. They sense a pressure, as do physicians, to enter into “health systems”, collaborations, to maximize efficiency and profit (or at least not make much less than they are). There is a certain irony in pressures to re-create the managed care era.

But, because that “re-creation” is still about how hospitals, doctors, and insurers can make money, not about how we can provide the best health care for the most people, it is re-arranging deck chairs on the Titanic. If, when, we hit that proverbial iceberg and the ship goes down, many people will be hurt. Sure, just as on the Titanic, it will be the poor people on the lowest decks who get hit the worst. Then, the middle class. And even some of the rich, and some of the officers will go down. But, if you are a betting person, you bet on the most privileged being the most likely to survive; you would have been right in on the 1912 sinking of the boat, and you’d be right 100 years later in health care.

One day maybe we will develop a health policy that engenders behaviors that are about providing the best health to all of our people.
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"How Doctors Die"; post on Zocalo Public Square by Ken Murray

I would like to call your attention to a superb post on "Zocalo Public Square" by Dr. Ken Murray, "How Doctors Die." It addresses what doctors want for themselves when they are dying, which is generally much LESS intervention.

I would suggest that if patients knew that doctors felt this way, rather than that we were trying to "deny" something to them or their relatives, it might be much more effective.