Tuesday, March 31, 2009

Walmart, Caterpillar and Medical Ethics

When I think about patient-centered collaboration in medicine I picture teams of physicians, nurses and social workers or primary care physicians working with specialists.

Now I'm thinking about Walmart and Caterpillar.

While Washington girds itself for a mega-debate about health care reform, companies that provide insurance for their employees are trying all sorts of innovations to make health care more affordable. This is what managed care programs did in the 1990s, but providers and patients turned against them for "intruding on the doctor-patient relationship" and challenging "physician autonomy." Insurers backed off. Costs skyrocketed.

An article in the Chicago Tribune describes how Caterpillar got fed up with its ever-rising health care costs. It decided that its pharmacy arrangements were "not adding value, but just higher prices." That led to a contract with Walmart to offer generic drugs to Caterpillar employees for free if obtained at Walmart or Sam's Club!

This is a straightforward business deal. Caterpillar, which is self-insured, lowers its drug costs. Walmart gets additional customers coming into its stores.

From the perspective of health system ethics the important thing here is that Caterpillar employees have an opportunity to understand health care in a more business-like manner. It's a system that can be influenced if we get tough with it. Maybe they will ask - "if my employer can get free generics for us by using its purchasing power why don't we do the same thing with the Medicare drug program, instead of forbidding Medicare from bargaining with drug companies? Look how much I'm saving as an employee? Why not do the same for us as taxpayers?"

We've allowed our health system to fragment the population into so many insurance pools that except in organizations like Kaiser Permanente it's next to impossible to think about the dynamics of cost for a population. Self insured businesses represent "populations" of people with something important in common - they work for the same company. If health care costs get out of hand the company can go down the tubes, as may happen in the auto industry. Thinking about value for money in health care becomes very personal.

In previous posts I've written about cost-containing innovations at Hannaford supermarkets, Foundation Coal and Peabody Energy, and Serigraph/Wellpoint. I hope we're seeing the start of a ground-up movement to treat containing health care costs as a moral and economic imperative.

If the business community gets business-like about the money it lays out for health care, maybe we'll make some progress with this issue nationally!

Monday, March 30, 2009

Research Ethics - Informed Consent for Cluster Randomized Trials

When we make choices in life we compare alternatives with regard to their quality and cost in virtually every area - except for health care! Our systematic failure to consider value in governing our health care system is a central reason that costs have rocketed out of control.

Randomized controlled trials (RCTs) are the gold standard for evidence, but they are very costly and time consuming. And because the populations enrolled in RCTs must be carefully specified and the settings in which the studies are conducted are themselves not typical, it is often difficult to extrapolate results from RCTs to ordinary practice situations.

So what can we do to get more information about the relative quality and cost of different health interventions?

Imagine the following situation. A and B are widely used treatments for a common condition. While clinicians and patients may have preferences for one or the other, by Freedman’s well-known criteria a state of clinical equipoise exists with regard to A and B – i.e.,- “there is no consensus within the expert clinical community about the comparative merits of [A versus B].”

In order to gain information about the relative effectiveness of A and B several health plans agree to participate in a Cluster Randomized Trial. Some health plans will favor A; the others will favor B. “Favor” means that unless clinicians have specific reasons for choosing the non-preferred agent they will use the preferred one. The health plan data bases will be used to follow patterns of side effects, medication changes and clinical outcomes.

This intervention does not require all individuals to receive the treatment to which their group is assigned, only that the fractions treated with A and B in the two groups differ by a substantial amount. Such separation allows estimation of population-level difference in outcomes, which can inform overall treatment strategies (“in general A and B yield similar outcomes,” or “in general people treated with A fare better”).

I recently joined with a group of colleagues to examine the ethics of this kind of drug trial. We (a) interviewed health plan patients, their physicians, and health plan administrators, (b) discussed CRTs with the Harvard Pilgrim Health Care Ethics Advisory Group, and (c) systematically reviewed the relevant ethics literature. We published our conclusions in a Hastings Center Report article - "Comparing Drug Effectiveness at Health Plans: The Ethics of Cluster Randomized Trials." We focused on two large questions - (a) is individual informed consent required for participation in the kind of trial we envisioned and (b) if it is not required, what takes its place?

We concluded that individual informed consent is not required for participation in CRTs of widely used standard treatments that are in a state of equipoise. If a physician believes that the non-preferred agent is indicated she can prescribe it. If a patient wants the non-preferred agent she can receive it. Practicing physicians are familiar with the state of “internal equipoise” in which they would be equally comfortable recommending one agent or another. A CRT of the kind we envisioned simply asks the physician to prescribe the preferred agent unless she has a specific reason for prescribing the alternative. There is nothing in this chain of steps that is inherently different from ordinary practice. With regard to the prescribing of A or B there is no “experiment” being done and nothing requiring informed consent beyond what is ordinarily required in clinical practice.

Not surprisingly, the U.K., which insures the entire population through its National Health Service, and which faces explicit trade-off questions on a daily basis, has paid more attention to the ethics of comparative effectiveness research than we have in the U.S. In 2002 the Medical Research Council published "Cluster Randomized Trials: Methodological and Ethical Considerations. "Here's the essence of what it had to say about informed consent:
An individual body, or mechanism that can represent the interests of the cluster is required – for convenience this will be labeled the “cluster representation mechanism” (CRM). The appropriate nature of the CRM will vary depending on the circumstances – both the nature of the cluster and the nature of the intervention. Thus, agreement to fluoridate the water supply might be obtained by plebiscite, while GPs might agree to the distribution of an information leaflet to people in their waiting rooms...The CRM must produce a formal document for the cluster that certifies and sets out its ability to [consent] (sufficient knowledge of the circumstances, beliefs, and values of members of the cluster, any delegated authority from/for the cluster, lack of conflicts of interest)...The CRM has essentially the same rights as a patient in an individually randomized trial --- including the absolute right to withdraw the cluster, without adverse impact on the cluster, if it decided that the study was not now in the interests of the community.
We agreed with this analysis.

Our interviews with patients, however, showed that some were perplexed by the idea of clinical equipoise. These patients believed that their doctors knew what was best for them. The idea that large swaths of medical practice do not have an evidence base showing that alternative A is better than B was foreign to them.

Conducting comparative effectiveness CRTs of the kind we envision would involve explicit acknowledgement of the degree to which important areas of medical practice are not evidence based. While we did not see individual informed consent as required for conducting this kind of CRT, we recognized that participation in research is not a typical health care activity. Just as teaching hospitals are expected to make clear that they are replete with students and to explain why this is so and what it might mean to patients, we believe that health plans and medical organizations should do the same with regard to participation in research - even research that does not require individual informed consent.

Information about comparative effectiveness is a necessary condition for getting a better grip on our health care system, but it is not sufficient. The more difficult step will be having the guts to use the information we develop.

In addition, those who lead the effort to strengthen comparative effectiveness research will have to educate the public about why the research is so important. The U.S. public has a strong faith in medical science and a rapacious appetite for medical miracles. Transforming our delivery systems into true learning organizations will require open recognition of medical uncertainty in ways that are not often acknowledged by physicians or understood by patients. But using everyday medical practice as a source of systematic learning about treatment effectiveness would be a salutary change in the culture of medical care.

Friday, March 27, 2009

Medicare Open to All

A battle is looming over the question of whether a Medicare-like insurance program should be available to people of all ages.

President Obama appears to favor creating a new public health insurance option: “It gives consumers more choices, and it helps keep the private sector honest, because there’s some competition out there.” Like the President, Senator Max Baucus, chairman of the Finance Committee, favors retaining the current system of competing private insurers but would make Medicare more widely available, especially for those in the 55 - 64 year old category.

A recent New York Times article summarizes the argument for creating a new public program as follows:
The main selling point for a government-run program would be its low cost. It would have a much lower overhead than private plans, with no need to make a profit or spend money on marketing or brokers’ commissions. And, if allowed to flex its muscle, the government would buy medical care at much lower prices.
Insurers criticize the proposal as pseudo-competition, arguing that government programs do not have to bargain with providers in the same way that private insurers do. Here's how Karen Ignani, CEO of America's Health Insurance Plans (AHIP), put it- "There's no way to run a side-by-side competition within the current structure." Senator Grassley said much the same - "There's a lot of us that feel that in the public option the government is an unfair competitor..."

I believe, however, that there are reasons for health insurers to welcome a new public program. There's no way that U.S. health care will become affordable without new forms of managed care. One obvious need is for an entity like NICE (National Institute for Health and Clinical Excellence) that assesses health interventions for both clinical and cost effectiveness for the British National Health Service. And these analyses will have to be used, not simply talked about and then ignored.

Health insurers know how to carry out these management activities, but the public has not sanctioned their taking on the role of (a) allocating resources and (b) setting limits. Insurers did this in the 1990s - sometimes very skillfully and sometimes ineptly. But with the medical profession in the lead there was a massive pushback, and insurance-company led managed care bit the dust.

Karen Ignani may well be right that "side-by-side" a new public program and private insurance will not be competing on even terms. But from another perspective the public program could act like a "downfield blocker" for private insurers. A public program, which is ultimately overseen by the government, has sanction to make tough choices on behalf of the public good. It can't be seen as managing care just to augment the bonus of the CEO or to enhance shareholder equity - critiques that were levelled against private insurers in the 1990s when they tried to manage care.

If the public option is shot down private insurers will face the same dilemma they encountered in the 1990s. To carry out their societal responsibility they will have to make tough choices and foster managed care, but especially after all of the corporate fiascoes we have seen, it isn't likely that the public will allow them to do what needs to be done. Getting a grip on the health care cost trend will require a new form of public leadership.

[To learn more about the public insurance program proposal, I recommend "The Case for Public Plan Choice in National Health Reform" by Jacob Hacker, Professor of Political Science at U.C. Berkeley. For a strong critique I recommend "How a Public Health Plan will Erode Private Care" by Robert Moffitt, Director of the Center for Health Policy Studies at the Heritage Foundation.]

Tuesday, March 24, 2009

Euthanasia, Murder and Medical Ethics

Early this morning I read a student essay on "End-of-Life Care" for this week's medical ethics class at Harvard Medical School. The student made a thoughtful argument that (a) when physicians stop life sustaining treatments like respirators they are "killing" patients, not simply "allowing them to die," and that (b) with proper safeguards it is ethically acceptable for physicians to participate in euthanasia.

I agree with the positions the student took.

Then I turned to the New York Times, and found an article about whether a medical student in Sweden who had served time for murder should be allowed to become a doctor.

In 2000, Karl Svensson was convicted of killing Bjorn Soderberg. Soderberg had complained to his employers about neo-Nazi materials a co-worker had displayed. The co-worker, a friend of Svensson's, was fired. Svensson himself had been under surveillance for his own neo-Nazi activities.

Svensson was sentenced to 11 years in prison, but was paroled after 6 1/2 years, as is common in Sweden. While in prison he took many web-based courses and did well enough to meet the Karolinska entry requirements. When Karolinska belatedly discovered Svensson's history it found grounds for expelling him.

Now it emerges that Svensson was subsequently admitted to Uppsala medical school!

When I wrote about Svensson's expulsion from Karolinska a year ago (see here) I concluded:
People convicted of murder can be outstanding physicians. In 2001 a medical specialist to whom I had referred many patients, including a member of my own family, was sent to prison for the 1999 murder of his wife. (He maintains his innocence.) He did more than provide excellent technical care - he gave outstanding human attention as well. I was moved by my patients' description of his skill and compassion and was proud to have him as a colleague.

But the Hippocratic Oath articulates another value - "In purity and holiness I will guard my life and my art."

The classmates who wanted Svensson to stay in Karolinska were half right. People who have done their time should have the opportunity to build a new life. For all we know Svensson may have had wanted to make amends for the crime he had been convicted of. But for me the Hippocratic value is the deciding point here. Medicine has its anthropological roots in religion. Many of the prophets in all religions were healers of the body as well as the soul. The obligations the privilege of being a physician entails go beyond what we do in the office and hospital.

I hope that Svensson is committed to making up in the rest of his life for the murder the court concluded he had done. But Karolinska Institute, which expelled him last week, did the right thing.
If I'm prepared to embrace a physician who has participated in euthanasia as a respected colleague, is it consistent to favor expelling Svensson from medical school?

I believe it is. The compact between clinician and patient is central to ethical assessment of an action. When competent patients (or their surrogates) make a clear request for termination of life support, following their wishes reflects respect for their right to self determination. And although physician assistance in dying (as the process is called in Oregon and Washington, which authorize it) is controversial, with many physicians (though not a majority) opposing it, even opponents recognize that physicians of intelligence and integrity can see assistance in dying - in carefully defined circumstances - as ethically warranted.

Opponents of physician participation in euthanasia can argue that if we allow euthanasia we can't turn around and keep Svensson out of medical school. But I believe this argument is fallacious.

Removing life support, carefully defined voluntary euthanasia and murder all involve actions that bring about the end of life. But just as we can distinguish between a physical exam and sexual assault, we can distinguish between ethically justifiable actions that hasten the end of life and murder.

Friday, March 20, 2009

"Perverse Incentives"

Words matter!

David Kahn, from Columbia University Medical Center, a fellow psychiatrist, has a wise letter in today's New York Times:
Don’t Polarize Health Care

To the Editor:

Re “With Health Care for Nearly All, Massachusetts Now Faces Costs” (front page, March 16):

In the coming debate about universal access to more affordable health care, let’s agree not to use the phrase “perverse incentives,” which you invoke to describe the current fee-for-service system of “paying physicians and hospitals for each patient visit.”

The prospective payment alternatives, such as bundled fees for episodes or capitated fees for populations, each provide incentives to withhold care, no less a dilemma that could also be labeled as perverse. Rationing of expensive procedures under either system, whether fee-for-service or prospective, will no doubt be similarly declaimed.

Calling any of these reimbursement systems “perverse” will only polarize the difficult discussions ahead.

David Kahn
New York, March 16, 2009

The writer, a psychiatrist, is vice chairman for clinical affairs, department of psychiatry, Columbia University Medical Center.
Dr. Kahn is 100% right. All payment systems have risks and benefits. Fee-for-service payment is in no way uniquely "perverse."

For many years I practiced at a not-for-profit HMO, the Harvard Community Health Plan. I viewed the combination of (a) capitation and (b) not-for-profit status as an ideal form of compensation in which a large medical group was committed to taking care of a defined population. Clinicians and patients understood that if we saved money in one area we could use it for the benefit of the insured population in another area. There was an opportunity for collaborative co-management of the practice at the population level as well as in the clinician-patient dyad.

But just as fee-for-service payment can reward overtreatment, capitation payment can reward undertreatment. Opponents of a form of payment call the risks "perverse." Supporters of the payment system, as I was for capitation of not-for-profit HMOs, call the risks "potential concerns to be guarded against."

Dr. Kahn's larger point - that the health care reform process could be scuttled by emotions - is all too real. That's what Harry and Louise did in 1993. It will take skillful and forceful leadership by President Obama and Secretary Sebelius to keep the process from drowning in demagoguery this time around.

I am opposed to building a health care system on fee-for-service reimbursement. But if I ever call the risks fee-for-service creates "perverse incentives," please tell me to wash my mouth out with soap!

Wednesday, March 18, 2009

Containing Health Care Costs in Massachusetts - When the Going Gets Tough the Tough Get Going

Eight months ago I opined - "the wild rumpus of cost control in Massachusetts is just starting. Stay tuned to see how it plays out!"

My timing was off, but I think the cost control rumpus is finally about to start.

For the first three years of the health care reform process, Massachusetts concentrated on access. The state now has 97.4% of its population covered by insurance - the highest rate of insurance in the nation. But the program is costing more than was originally predicted, and, as in other states, revenues are dropping fast.

I'd been told that leaders of the health care reform process deliberately chose not to take on cost containment at the start. The idea was - "let's get the public, providers, employers and health plans to buy in to reform and get the process underway. We know cost will hit the fan before long, but when it does no one will want to give up on what we've accomplished with access, and we'll be able to bite the cost bullet."

It was a risky strategy. But it may prove to have been a smart approach. Massachusetts is being looked to by the federal government and the other 49 states. For Massachusetts to crump now would be humiliating, and a national disappointment to boot!

But I wish I felt more optimistic about what a recent New York Times article expects to come next in Massachusetts:
[Governor] Patrick has shown signs of playing tough with the state’s hospitals and insurers. Responding in January to a series in The Boston Globe that exposed how the state’s most influential hospitals negotiate high reimbursement rates, Mr. Patrick announced that he would explore whether the state could regulate insurance premiums.

“Frankly, it’s very hard for the average consumer, or frankly the average governor, to understand how some of these companies can have the margins they do and the annual increases in premiums that they do,” Mr. Patrick said in an interview. “At some level, you’ve just got to say, ‘Look, that’s just not acceptable, and more to the point, it’s not sustainable.’”
The Governor is right that the cost trend is not sustainable, but in this quote he segues from noticing how high provider prices are in Massachusetts to condemning insurance companies for their margins. It is tempting for the administration to follow the insurance bashing route, but for two big reasons it's a bad idea.

First, the money isn't in the insurance companies. 90% goes to providers. Of course, some of what the providers charge is their own administrative overhead for dealing with insurers. If the administration was pushing for a single payer system, focusing on administrative overhead would make sense, but insiders say that the single payer option is not on the table.

If that is true, insurers will have to drive the cost containment process. On one side insurers will have to influence patient/public expectations about health care. In Massachusetts the public's default position is that more care is better than less, new technologies are better than old ones, and tertiary care is better than primary care. On the other side insurers will have to negotiate about compensation with providers who have the public's trust and what marketers call great "brand equity."

Changing public expectations for care and disappointing provider expectations for compensation would be a tough job for Buddha or Confucius. When insurers tried to manage care in the 1990s they were knocked out of the box by public and provider backlash. If the state government wants insurers to try again it needs to tell the public that it trusts insurers to do the process right and that it's asking them to take on this public responsibility.

Massachusetts has made progress in demonstrating that at least one U.S. state can come close to doing what every other developed economy has been doing for decades - provide health insurance benefits to [almost] all citizens. It has made no progress, however, in showing that it can do this in a financially sustainable manner. Cost containment is the challenge the state has to lock horns with now.

What comes next will determine whether Massachusetts has anything worthwhile to teach or whether its health care reform has been much ado about nothing.

Tuesday, March 17, 2009

Should the NIH Alternative Medicine Center be Defunded?

I only became aware of the controversy about the National Center for Complementary and Alternative Medicine (NCCAM) from an article in this morning's Washington Post - "Critics Object to 'Pseudoscience' Center."

In 1992 Congress allocated $2 million to establish an Office of Alternative Medicine (OAM) at the National Institutes of Health "to investigate and evaluate promising unconventional medical practices." In 1998 NIH Director Dr. Harold Varmus proposed having all alternative medicine research done through the NIH institutes, with the OAM coordinating the process. Senator Tom Harkin (Iowa), who pushed for the founding of the OAM in 1992, now pushed through legislation that elevated its status to that of a Center (NCCAM). Current funding is approximately $120 million.

The current controversy was launched on January 15 by a posting on the website the Obama administration created during the transition to solicit ideas:
Biomedical research funding is falling because of the nation's budget problems, but biomedical research itself has never been more promising, with rapid progress being made on a host of diseases. Here's a way to increase the available funding to NIH without increasing the NIH budget: halt funding to NCCAM, the National Center for Complementary and Alternative Medicine. This Center was created not by scientists, who never thought it was a good idea, but by Congress, and specifically by just two Congressmen in the 1990's who believed in particular "alternative" (but scientifically dubious) treatments. Defunding NCCAM would save at least $225 million, possibly more.

...Any legitimate, promising medical treatment can be funded by one of the existing NIH Institutes. There's no need for a separate center for "alternative" therapies - but what has happened is that NCCAM has become a last refuge for poorly designed, unscientific studies that couldn't get funded through the normal peer-reviewed process.
Senator Harkin's comments, intended to support NCCAM, only make the Center look worse:
"One of the purposes when we drafted that legislation in 1992 . . . was to investigate and validate alternative approaches. Quite frankly, I must say it's fallen short. I think quite frankly that in this center, and previously in the office before it, most of its focus has been on disproving things, rather than seeking out and proving things."
The idea that the Center's role is to validate faith-based health beliefs shows a deep misunderstanding of science. If the Center has a role it is to test hypotheses, not to validate faith.

But the controversy over NCCAM isn't new. In the early 20th century organized medicine was horrified by the growth of Christian Science. Wise physicians recognized that the emergence of Christian Science reflected a sense that something was missing in "conventional" medicine. That hunger is still present. More than 1/3 of U.S. adults use "alternative" medicine techniques.

This enthusiasm proves nothing about effectiveness. But it does point to phenomena that warrant serious scientific study. Otherwise the field will be ceded to quacks and hucksters, in the tradition of Mark Twain's Duke and Dauphin, selling snake oil.

I don't have a sense of how well NCCAM has carried out its mission, but some of its goals seem right on target, as exemplified by:
* Identify the common and specific features of widely used mind-body medicine practices
* Determine the extent to which patient expectations prior to treatment and satisfaction following manipulative and body-based practices are related to objectively measured biological endpoints
* Enhance understanding of the social, cultural, and economic factors relating to the use of CAM.
But there is a worrisome ambiguity in other goals:
* Establish the efficacy of selected biologically based practices to maintain health, prevent disease, and treat conditions of public health importance
* Document the benefits of some CAM whole medical system treatments for selected health conditions
Is the aim here to evaluate whether specific widely used techniques are effective and provide benefit, or to "prove" that public beliefs in these techniques are indeed true?

If it's the latter, NCCAM should be defunded. But insofar as it undertakes serious evaluations of widely used techniques, and studies just what is happening when patients derive significant subjective benefit from techniques that are not validated in controlled trials, NCCAM will be making a worthwhile effort.

In voting with its money and time the public is saying it feels healed by alternative techniques. The mechanisms of healing are worthy of scientific study, just as the mechanisms of disease are.

Monday, March 16, 2009

What Can Medical Ethics Contribute to Health and Health Care in India?

Yesterday I attended a conference at Harvard Business School - "The Indian Growth Story: Sleeping Elephant or Roaring Tiger?" I've been thinking about what medical ethics can contribute to health and health care in India since spending the month of January there, and I thought I might learn some useful things at the conference. (See as well this previous post on ethics teaching in India.)

I wasn't disappointed.

Before the conference started I had coffee with a group of young India men - some still in business school and some in their first jobs. When I told them about my interest in medical ethics, one asked "is it true that before a person (or a country) is established there is no time for ethics; when you are established then you can think about ethics?"

I told them we have to address ethical questions at every phase of personal and societal development, but the questions and expectations are different at each phase. My hunch was that early on the key job is creating an "ethics infrastructure" that will support ethically admirable health system in a later phase.

Several speakers made reference to "jugaad," a Hindi word meaning inventiveness, cleverness and ability to get things done in unorthodox ways. When I looked up the term, here's what I found:
It’s like putting two spoons of turmeric powder into your radiator if you spring a small leak. It works, it will seal the leak. In Punjab, I have seen villagers buying an agricultural water pump at government subsidised rates, cannibalising some other parts from here and there, and turning it into a vehicle. These are jugaads.
The excellent panels and plenary talks described a vibrant economy with lots of opportunity for any of the ambitious and entrepreneurial young people at the gathering who wanted to return to India. Jugaad was a common theme - finding distinctive Indian ways of addressing problems and promoting development.

As I understand it, jugaad is an attitude and set of skills that in themselves are morally neutral. In the U.S. Enron specialized in jugaad - ingenious but virulently unethical and often criminal innovations. But speakers like Dr. Pradip Kumar Sarmah, founder and executive director of the Rickshaw Bank, an enterprise that (a) makes microloans to rickshaw pullers to enable them to own their own rickshaws and (b) has supported design research to develop a new and more efficient rickshaw model showed how jugaad can promote social justice.

In U.S. medical ethics education we tend to focus on ethical nuances and conundrums - like whether a particular patient's refusal of treatment reflects decisional competence and should be respected or doesn't meet the criteria for informed choice. From what my Indian friends tell me I infer that a case like this would be premature - the teaching task would be conveying the concept of informed consent itself and working with the question of whether and why patient preferences should be respected.

My current best guess is that the key pieces of "ethics infrastructure" to focus on are (1) informed consent, (2) research ethics, especially the ethics of clinical trials, which is a booming industry in India, and (3) strengthening the expectation that health professionals must consider population health and the common good as well as their own immediate practices.

The "Beggar's Song" in "Threepenny Opera" told us that some basics must take precedence over ethical niceties - "First feed the face, and then talk right from wrong...for even saintly folk, can act like sinners, unless they've had their customary dinners!" This was behind the question I was asked at the beginning of the day, with the implication that a concern with ethics is an impediment to development.

But I think the ancient rabbis got it right when they taught "Without sustenance there is no Torah (ethics); but without Torah, there is no sustenance." With enough skill at jugaad, ethics and development can go hand in hand!

Saturday, March 14, 2009

What if Madoff Took an Ethics Class?

Here's what Michael Madoff said in court on Thursday:
"I knew what I was doing was wrong, indeed criminal. When I began the Ponzi scheme, I believed it would end shortly and I would be able to extricate myself and my clients. As the years went by I realized this day, and my arrest, would inevitably come. I cannot adequately express how sorry I am for what I have done."
Would it have made a difference if he'd studied ethics in college or business school?

Not a bit!

Ethics courses don't create character. Madoff knew what was right but chose to do wrong. No course would have prevented that. I'm sure he'd heard Deuteronomy 30:19 many times in Sunday School and Synagogue:
I call heaven and earth to witness against you this day: I have put before you life and death, blessing and curse. Choose life - if you and your offspring would live...
But if his family (his brother and two sons were in the business) and employees had studied ethics, that might have made a difference.

Madoff claims that he alone is responsible for the crimes he committed and that no one else was in on it. Even if we accept that implausible claim, it's hard to believe that no one ever felt a quiver of uneasiness over the years. That's where ethics class could have helped.

In medical ethics teaching, most time is spent on teasing out the pros and cons of complex ethical conundrums. But in real life recognizing and acknowledging that there is a conundrum that requires contemplation is as important as the way we reason about it. Concluding that we should question the status quo is the starting point for ethical wisdom. Questioning isn't a wishy-washy academic exercise - recall that the Athenians put Socrates to death for prodding its youth to do just that.

I've been trying to pay more attention to this "pre-analytic" phase of ethical self-management my section of the required first year class on "Medical Ethics and Professionalism" at Harvard Medical School. In the class we try to identify our "gut feelings" about the topics we discuss, not because they are infallible moral intuitions - they're not - but because things we feel, even subliminally, are like divining rods pointing us towards something requiring our attention. We recurrently try to identify the emotions that are stirred by the issues we discuss and then to ask - "what values are behind this reaction?" When we identify the values driving the emotions we can ask - "do we endorse these values or do we want to modify or reject them?"

Even if we take Madoff's implausible claim that he alone "knew" about the Ponzi scheme at face value, there's no way that his family and employees could not have felt glimmerings like "something seems funny here," or, more personally, "Dad seems preoccupied - something's bothering him." It's not unreasonable to hope that a person who did not share Madoff's criminal intent would take feelings like this as a signal to dig deeper, and that digging deeper would have brought the scheme to light earlier.

Our only partly verbalized feelings sometimes mean nothing very special, sometimes give us information about ourselves, but sometimes, as in the history of Madoff's swindle, should have triggered inquiry on the part of an employee or family member. This is what we try to model and practice in the ethics class.

If I were to learn in the future that one of my students had done the equivalent of working for Madoff without getting agitated and active, I'd give myself an F- as a teacher!

Thursday, March 12, 2009

Comparative Effectiveness Research

"Health Care and the American Recovery and Reinvestment Act," an article today's New England Journal of Medicine, should be read by anyone who has not been following the arcane details of the U.S. stimulus program.

The part of the article I want to focus on in this post is funding for comparative effectiveness research (CER). I've put my comments in bold italics:
On the medical research front, comparative effectiveness studies that directly compare the risks and benefits of different treatments for a particular condition are essential for improving practice and slowing cost escalation. Such studies, however, have been controversial; the pharmaceutical and medical device industries may not fund them, and some are concerned that the government or insurers may use the results to mandate specific approaches to treatment or to deny coverage.

I don't believe there is much public concern about CER. In every other aspect of our lives we compare the effectiveness and relative value of the options we must choose among. We also make personal rationing decisions every day when we decide that our resources require us to forgo a benefit - perhaps just a Latte at Starbucks, but possibly attending a lower cost college than our more costly first choice.

We are already seeing, however, a fear-mongering campaign against CER. Harry and Louise haven't come back yet but they will soon be reincarnated as the bogeyman of a "government bureaucrat getting between you and your doctor." More subtly, we will also see efforts to block research on the cost component of CER and to insert regulatory language that forbids Medicare to make use of CER in its coverage decisions!

...With the money allocated in the stimulus bill, the government will be able to fund many more [CER] trials, as well as clinical registries, clinical data networks, and systematic reviews. Indeed, the $1.1 billion in new funding for comparative effectiveness research dwarfs the current $334 million annual budget of the Agency for Healthcare Research and Quality, which will administer $300 million of the funds; the NIH and the DHHS will administer the rest.

We shouldn't expect CER to drive sensible health coverage on its own - that will require active, and often courageous, management and leadership. But as more and more studies are done an embarassment factor may set in for advocates who plead for expenditure of collective funds (public and private insurance) on costlier alternatives.

In addition, the act includes funds for a contract under which the Institute of Medicine will make recommendations (by June 30, 2009) for “national priorities for comparative effectiveness research.” It establishes a Federal Coordinating Council for Comparative Effectiveness Research, which will be composed of up to 15 federal officials (at least half of whom are physicians or others with clinical expertise) and chaired by the secretary of health and human services. The council will be tasked with recommending and coordinating research but will not be able to establish clinical guidelines or to “mandate coverage, reimbursement, or other policies for any public or private payer.

If the Federal Coordinating Council doesn't get hijacked by industry it has the potential of becoming an honest broker and public educator, much as has happened over time with the Federal Reserve. And having three agencies administer CER funding may make it more difficult for commercial foxes to capture the public chicken coop!
Comparative effectiveness research may seem like a wonky topic, but it is central to improving the disgraceful state of our health care "system." The president understands this. I hope that he will bring his superb communication skills to bear on educating us about the common sense validity of using CER to guide health care and the moral and fiscal necessity for doing this.

As a poignant lesson about what is at stake globally for health care, the article I've quoted is immediately followed by "A Lion in Our Village - The Unconscionable Tragedy of Cholera in Africa." A tiny fraction of the funds that produce no benefit at best and harm at worst could save thousands of lives elsewhere in the world!

Wednesday, March 11, 2009

Health Care Robots

The title of this post isn't a metaphor. It's really about robots.

The most recent issue of "Proto," a web-based magazine on innovation published by the Massachusetts General Hospital, describes the development of "socially assistive" robots in fascinating detail. Early trials show that robots can help children with autism. CosmoBot, a 16-inch-tall robot taught Libby, a six year old with severe autism, to imitate movements in a Simple Simon way. Libby hadn't responded to human teaching efforts, but CosmoBot's patient repetition did the job.

In India I've observed remarkable examples of "socially assistive" human care in which poor people carried out repetitive care tasks with the elderly with skill and sensitivity. The U.S. and Europe have fewer people available to do this kind of work and willing to do it. The MGH article quotes Martha Pollack, dean of the University of Michigan School of Information - “The number of younger adults for every older adult is decreasing dramatically, and we’ve never before seen these percentages of people over 85. Robots will never replace human interaction, but they can augment it.”

When I worked at the Massachusetts Mental Health Center during the summer after my first year at medical school I heard about an experiment that would never get by an IRB today. Subjects from a population seeking psychotherapy were given the option of speaking to a tape recorder and were told that a therapist, who they would never meet, would listen to what they said. That was it. No therapist listened to the tapes. No one did. But when the subjects were asked about their "treatment" a remarkable number reported benefit, and felt cared for by their non-existent "therapist."

Our human nature prepares us to be helped by inanimate objects or non-existent therapists.

Experimenting with robot caretakers could seem like an ultimate form of dehumanization. In my view, the robots themselves are ethically admirable. The ethical uncertainty is how we humans use the robots. Ventilators are a kind of primitive robot carrying out a single repetitive function. When we use them well we help sick people recover and save lives. When we use them mindlessly (robotically) we flog patients and prolong the dying process.

Here's what Carole Samango-Sprouse, director of the Neurodevelopmental Diagnostic Center for Young Children at George Washington University said about Libby, the six year old with autism: “Her mother and the professionals who saw [Libby's new learning] were in tears. It was incredibly encouraging that the robot, through repetition and predictable behavior, was successful in getting her to perform the motions she had seen adults doing for years.”

As Albert Einstein said about atomic energy - "The release of atom power has changed everything except our way of thinking...the solution to this problem lies in the heart of mankind."

Monday, March 9, 2009

Up with Zagat! Down with Patient Waivers!

I recently discussed the collaboration between Wellpoint and Zagat for rating physicians and concluded that the benefits of web-based rating systems outweigh the risks. Since writing that post I have come upon (a) a very informative report about physician-rating websites by Ruth Given and (b) a seven year old physician protection enterprise called "Medical Justice."

Ruth Given's survey of 40 physician-rating sites indicates that they are not ready for prime time in statistical validity. Medical Justice raises the spectre of malicious anonymous comments from disgruntled patients, competitors, ex-spouses and former employees ruining a physician's practice. It offers (for a not insignificant fee) a "mutual privacy contract" under which patients agree not to use the Internet sites and "are granted additional privacy protections by the doctor above and beyond those mandated by law."

I empathize with physicians' concern about being slandered. Several decades ago a patient of mine who suffered from a serious psychiatric ailment went to a series of emergency rooms all around Boston complaining about me. I received some polite and some not-so-polite inquiries about what I was up to and why I was treating my patient so badly. When that phase of the ailment lifted the ER visits stopped and the treatment continued successfully. Anonymous Internet slander would be much worse - at least I had the opportunity to continue working with my patient.

But the idea of asking new patients to sign a contract eschewing physician-rating sites and sweetening the deal with "additional privacy protections" is unseemly. Meaningful privacy protections are fundamental moral obligations - they're not chits to use as enticements for patients to sign a contract. If a physician greeted me by asking me to sign such a contract I'd be out of the office in an instant and badmouthing the physician shortly thereafter.

Still, the potential harm from anonymous slander is real. Medical Justice warns its potential customers about Section 230 of the "Communications Decency Act," which gives strong endorsement to free speech on the web:
The Congress finds the following:

(1) The rapidly developing array of Internet and other interactive computer services available to individual Americans represent an extraordinary advance in the availability of educational and informational resources to our citizens.
(2) These services offer users a great degree of control over the information that they receive, as well as the potential for even greater control in the future as technology develops.
(3) The Internet and other interactive computer services offer a forum for a true diversity of political discourse, unique opportunities for cultural development, and myriad avenues for intellectual activity.
(4) The Internet and other interactive computer services have flourished, to the benefit of all Americans, with a minimum of government regulation.
(5) Increasingly Americans are relying on interactive media for a variety of political, educational, cultural, and entertainment services.

It is the policy of the United States—

(1) to promote the continued development of the Internet and other interactive computer services and other interactive media;
(2) to preserve the vibrant and competitive free market that presently exists for the Internet and other interactive computer services, unfettered by Federal or State regulation...


No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider...
If we wait until statistically reliable well validated rating systems are developed before going ahead we'll still be waiting long after the cows have come home. There is definitely a danger to physicians from maliciously intended anonymous postings. But that danger is outweighed by the potential for the web to provide patients with a better level of guidance about the humanistic dimensions of how we physicians comport ourselves than is currently available. And asking patients to forswear the web will sully the medical profession without deterring maliciously intended behavior.

Sunday, March 8, 2009

Ethics in Time of Financial Crisis

Nancy Walton, lead author for the Research Ethics Blog had an excellent post yesterday about "Ethics on the chopping block." She reports on proposals to end ethics program at the University of Memphis in Tennessee and in New Zealand, and argues - correctly I believe - that ethics programs are more important during a financial crisis, not less.

Here's her key conclusion:
Ethics review boards, in either academic or medical settings, should be doing more than reviewing protocols, providing approvals and monitoring ongoing research in a silo somewhere, unconcerned that these kinds of cuts, as they don't name "research ethics" explicitly, have nothing to do with them. While reviewing research takes up a tremendous amount of time and energy, as I well know chairing an ethics review board myself, there is a certain amount of advocacy, outreach and education that an ethics review board must be committed to doing, on an ongoing and iterative basis.
This is right on. When my own organization experienced a major financial crisis in late 1999 many painful cuts were made, and I expected that our ethics program might be among them. Instead the COO gave our Ethics Advisory Group a special assignment - recommend a framework of values for dealing with the crisis. He said - wisely - "it's fine to say we endorse five values, but when we have to make tough choices we have to set priorities among them..."

Ethics programs can't solve financial problems by printing money, but they can contribute guidance about how to deal with the crisis in ways most consistent with mission and core values.

Thursday, March 5, 2009

President Obama's Health Care Summit

President Obama delivered the key message at today's health care summit - controlling costs is a moral responsibility as well as an economic necessity. He described our out-of-control health care costs as "one of the greatest threats not just to the well-being of our families and the prosperity of our businesses but to the very foundation of our economy."

By stating that health care costs lead to a bankruptcy every 30 seconds (!) and could make another 1.5 million families lose their homes by the end of the year he made clear the human toll out-of-control costs are taking.

Because he's speaking in the context of daily economic news that keeps getting worse I think the public is prepared to see health care costs as a societal cancer. This has to be the starting point of any serious engagement with health care reform.

House Republican leader John Boehner has indicated what the two prongs of pushback will be.

First, Boehner makes this ostensibly reasonable statement - "We believe families and their physicians should make decisions about what treatments are 'appropriate,' not government bureaucrats."

This may be a good sound bite, but it's dead wrong. There is no way to control costs without some form of management of the ways in which we use medical care. If we leave care decisions to each physician and each family we'll just continue on the same bankruptcy-every-30-seconds spiral. President Obama will soon have to start educating us about the anarchy of misuse, overuse and underuse created by leaving decisions to each physician and family.

The second sound bite missile Boehner will invoke is the spectre of rationing. President Obama will need all of his rhetorical skill to respond, because mere invocation of the word "rationing," like "Nazi," is intended to be a trump card conversation stopper.

I'm no politician, but my leaning would be to say something like this: "The only place where there are no limits is paradise. The opposite of 'rationing' is 'irrationality,' not 'unlimited access.' Those who try to sandbag health care reform by shouting 'rationing' prefer to set limits by shutting almost one in six Americans out of health insurance and bankrupting a family every 30 seconds."
What's being launched today is a struggle about values, not an intellectual exercise. We've been miseducated about health care for so long that the President will have to be a patient teacher, repeating the key lessons in slightly different form day after day.

Monday, March 2, 2009

Three Key Health Care Messages for President Obama to Deliver

On Thursday President Obama will convene a health care summit in Washington. Here's my view of the key steps he must take in public leadership for us to take control of runaway health care costs.

1. The first key first step is to reinforce our understanding that as important as health care is, it is one of many important social goods. Medicare and Medicaid are crippling federal and state capacity to address other priorities and pushing us into a deeper economic decline. Employer insurance is crippling businesses and constraining wages. It is fiscally and morally irresponsible not to hold health care to a budget, rather than passively letting the sector determine its own level of expenditure.

The President is already saying this, most recently today: “If we are going to help families, save businesses and improve the long-term economic health of our nation, we must realize that fixing what’s wrong with our health care system is no longer just a moral imperative, but a fiscal imperative. Health care reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve — it’s a necessity we have to achieve.”

2. Having raised a sense of urgency, the second step is for the President to provide hope that we can actually get a grip on cost. Here he can draw on "Slowing the Growth of Health Care Costs — Lessons from Regional Variation" from last week's New England Journal of Medicine. The article reports that in 1992 Boston, San Francisco and Eastern Long Island all had nearly identical per capita spending. But expenditures in the three regions grew at markedly different annual rates: 2.4% in San Francisco, 3.0% in Boston, and 4.0% in East Long Island. By 2006, per capita spending in East Long Island was $2,500 more than in San Francisco — which translates into about $1 billion in additional annual Medicare spending from this region alone. And by every indication patients are doing at least as well in San Francisco as in the pricier areas.

The President could take this piece of his script from the New England Journal article - "Using data from the 2008 Medicare trustees' report on projected revenues and total Part A and B spending, we estimate that Medicare will be $660 billion in the hole by 2023. But if we reduce annual growth in per capita spending from 3.5% (the national average) to 2.4% (the rate in San Francisco) Medicare would end up with $758 billion in the black. By practicing medicine the way we've learned to do it in San Francisco we can save $1.42 trillion in the next 14 years."

3. Point # 1 raises our anxiety - health care is creating a fiscal crisis. Point # 2 gives us hope - we have areas in the country that have learned to practice medicine in an economically viable manner. But how do we get from here to there?

This is the toughest point for the President to make. We can't make the needed changes without active management. Current policy discussions pose two main alternatives:

A. The Federal Government could take the lead, through Medicare or through a singe payer system. But Rush Limbaugh and the Republican troops are lined up to attack "big government" and the spectre of "government sponsored rationing." Sadly, we now have an almost 30 year history of reinforcement of Reagan view that "government is not the solution to our problem - it is the problem." As appealing as the single payer concept is to many, the reflexive scorn for government that our political process has cultivated since 1980 would make selling the public on an expanded government role a significant challenge even for President Obama's communication skills.

B. Or, we could look to the array of public and private insurers to take the lead. In the 1990s insurers showed that they could move the health system onto a more cost constrained trajectory. But physicians and the public revolted against the demon of "managed care." Insurers could take on this job again. Vast improvements in information technology would strengthen their ability to provide management. And physicians may be readier to move in the direction of collaborative management as pioneered by Kaiser Permanente than they were 20 years ago. But the legacy of public distrust of insurance companies is very strong, and corporate scandals in other sectors only reinforce distrust of insurer-directed managed care.

I think we will probably see a spell of wishful thinking about the potential for electronic medical records, comparative effectiveness research, medical homes, and other innovations, to bend the cost trend on their own, without impinging on "patient choice" and "physician autonomy." It won't happen. We'll need active management of the health care system to get there. Whether we'll have to slide further into health care driven economic decline before we learn that lesson will depend in great measure on President Obama's courage and leadership skills.