Doctor-patient sex and professional self-regulation

The topic that has attracted the largest readership on this blog is doctor-patient sex. In the past 10 years the 30 posts I've written on the topic have received 75,000 hits. An article in today's Boston Globe focuses on an aspect I've discussed only briefly thus far - professional self regulation.

The story concerns a complaint from Ms. Lisa Grover that Dr. Melvin Rabin, the psychologist she sought out when her marriage broke up, drew her into a sexual relationship. Grover's allegations dramatize the way "boundary crossings" like calling the patient at home "just to talk," calling the patient a "special person," and hugging at the end of the appointment, can lead, over time, to "boundary violations" like sex. Apparently Grover brought a malpractice action against Rabin which, the article reports, was "settled for an undisclosed sum."

In February 2016 Grover complained to the Massachusetts Board of Registration of Psychologists, but the case is still "open" and Dr. Rabin's license is still unrestricted.

A core component of the implicit contract between the health professions and society is that in exchange for the autonomy and trust society gives to the professions, the professions will regulate themselves with regard to quality and integrity. Two years is much too long for a professional board to leave a serious complaint like Ms. Grover's unsettled.

In dealing with complaints of the kind Ms. Grover brought, a board must consider three values:

First and foremost, safety for patients. If the board believes Ms. Grover's accusations, it should have suspended Dr. Rabin's license. A therapist who acted as Ms. Grover describes should not have an unrestricted license, which allows unrestricted, unmonitored access to patients. What Ms. Grover describes, if true, is very serious misconduct.

But second, a board must also recognize that complaints are not necessarily true. The board must consider fairness to the accused.

I know this first hand.When I joined the Harvard Community Health Plan practice in 1975, one of my first patients was a sensitive and vulnerable young woman with a mild autism spectrum disorder. The treatment was proceeding well until I cancelled an appointment because I was going away. My patient contacted the psychiatry board to complain that I had molested her. Psychologically my cancellation felt to her like a "molestation." By the time I heard from the board my patient and I had resumed meeting and the treatment was again on track. She explained that she had been upset by the cancellation and apologized for what she said to the board. I didn't appreciate at the time just how serious a threat a false accusation could be.

To the credit of the Boston Globe, the headline to the article refers to an "alleged betrayal." But if the Board does not believe Ms. Grover, it should have closed the case by now. Two years is too long for the case to be in limbo. A false accusation is a serious injury to the clinician.

Finally, a professional board should conduct itself in a way that fosters trust in the profession. The story reported in the Boston Globe does the opposite.

(In addition to the Boston Globe article describing Ms. Grover's allegation, readers may be interested in an interview with Dr. Rabin in which he describes himself and his approach to therapy.)

Who Should be Seen as a "Healthcare Executive" and Why Does it Matter?

The American College of Healthcare Executives (ACHE) has as its vision "To be the premier professional society for healthcare executives dedicated to improving healthcare delivery." ACHE's excellent 2015 statement - Creating an Ethical Culture Within the Healthcare Organization - rests on an assertion I wholeheartedly support: namely, that "all healthcare executives have a professional obligation to create an ethical culture." (I added the emphasis)

If you agree with the ACHE assertion, and I'm prepared to go to the mat for it, the first question is: what counts as a "healthcare executive"? How wide is the scope of the term?

Clearly, executives at hospitals, medical groups, and other organizations that deal directly with patients carry major moral responsibilities. After all, health care is crucial for realizing all three of the "unalienable rights" put forward in the Declaration of Independence: life (sometimes health care saves our lives), liberty (we can't exercise our freedom without health), and pursuit of happiness (we can be happy without health, but it's more difficult, and severe enough pain makes it impossible).

ACHE deliberately leaves the scope of the term vague. It defines itself an an organization for "healthcare executives who lead hospitals, healthcare systems and other healthcare organizations." From my experience as a physician, administrator, and patient, I'd cast a wide net for defining "other healthcare organizations" and setting ethical expectations for them.

In the complex U.S. health system direct care organizations aren't the only important moral agents. Health plans and pharmaceutical companies are perhaps the two most important examples of indirect moral agents.

Over the years I've tried to encourage health plans to create ethics programs the way Harvard Pilgrim Health Care, where I have directed the ethics program for sixteen years, has done. I've had zero success. This doesn't mean that other health plans are unethical, but it does suggest that ethical performance is not seen as something that requires the kind of concerted leadership the ACHE statement on responsibility for creating an ethical culture calls for. (For a previous post about my quixotic efforts, see here.)

Executives in the pharmaceutical industry face especially difficult challenges in relation to the kinds of expectations the ACHE standards articulate. They're clearly crucial participants in  the sacred calling of health care. At the same time, they're embedded in a highly competitive industry with strong profit demands. Pharmaceutical executives work in the jaws of a severe dual agency challenge: sacred calling vs the invisible hand of the market.

More than forty years ago, Arnold Relman warned of the potentially disruptive moral impact of what he called "The New Medical-Industrial Complex." Since his prescient warning there have been efforts to establish a shared moral code for all participants in the world of health care. A distinguished U.S. and U.K. group articulated the "Tavistock Principles," but these, alas, seem to have been dead on arrival, and have not been heard from for fifteen years. And for a number of years the American Medical Association sponsored an "Ethical Force" program that sought to establish measurable ethical standards for the major players in the health sector. I had the privilege of being on the advisory panel on health benefits determination. The project produced some excellent materials and a book, but as with the Tavistock principles, the effort was relatively short-lived.

When I mulled over how to end this post I realized that I don't have a tidy upbeat ending. The image that came to mind was of Sisyphus, eternally pushing a rock up the hill. It seems to me that Arnold Relman's call to action points to an ongoing task captured in this cartoon:

I'll do more rock pushing in future posts!

Mindfulness, Clinical Outcomes, and Patient Safety

Two months ago, when I wrote a post about using the walking we clinicians do in the course of the working day as opportunities for  meditation, I wondered if it was a harebrained idea or a piece of personal eccentricity. But when I came upon "Use Hand Cleaning to Promote Mindfulness in Clinic" published in BMJ earlier this month, I decided there's something to it.

The author is Heather Gilmartin, a nurse fellow in the Colorado VA system. She makes the excellent suggestion that hand washing, a recurrent act of patient care and self care, can be used as a moment of meditation. Here's the practical summary Ms. Gilmartin presents:

A moment of mindfulness

Focus your attention on your thoughts and emotions. Stay present and accept whatever arises, just as it is, without reacting.

Set an intention—be it listening with intent, choosing your words mindfully, or acting with compassion in your next encounter.

Smile to acknowledge this act of kindness to yourself and to your patient.

Alcohol based hand rub

Pause, take a breath, and notice the sound and feel of hand rub being delivered to your palm.
Be present in the moment and experience the sensation of rubbing the foam/gel into your wrists, hands, and fingers until the product evaporates and leaves you clean.

Soap and water

Pause, take a breath, notice that you are turning on the faucet, and regard the feeling of water flowing from your wrists to your fingers.
Be present in the moment and experience the sensation of rubbing soap into your wrists, hands, and fingers, and then washing it all down the drain.

The VA system disseminates innovations well. I anticipate the potential for an epidemic of meditative moments arising from Ms. Gilmartin's modest but well articulated proposal!

Via her article I read an empirical study of the simple idea of using recurrent components of our days as opportunities for "mini-meditative-moments." College students were instructed to wash dishes in their usual manner or to do the ordinarily mindless chore in a mindful manner. The group that meditated as they scrubbed showed increased positive emotion and decreased "nervousness." (The article is at:
"Washing Dishes to Wash the Dishes: Brief Instruction in an Informal Mindfulness Practice.")

Reading the two articles emboldens me to out myself for another practice I've built into my day. I'm vigilant about brushing my teeth twice a day. If tooth brushing takes one minute, in a year it adds up to 12 hours. If it takes two minutes, it's a full day. That's a lot of time to devote to an uninspiring chore. I've taken to applying what Ms. Gilmartin recommends for hand washing to those moments of tooth brushing. It's an N of 1 experiment, but I believe it makes a contribution to overall well being.

I believe that most participants in the US health "system" would agree that the "system" is a mess. There's a massive outpouring of proposals for fixing the broken "system." We need to seek mega-solutions. But micro-improvements, such as what Ms. Gilmartin proposes in her BMJ article, are steps all of us in health care can and should take as part of the larger movement of creating an ever-more ethical environment of care.

The Four "As" of Ethics

Here's a mnemonic I've found useful for thinking about the actions health organizations need to take to walk the talk of their values:

1. Analysis ("what is the right thing to do?") This is the activity most familiar to ethics committees and classes in ethics. When is it right to pull the plug? At what age should children make their own health care decisions? When the term "ethicist" is used it's generally associated with the analytic activity.
2. Advocacy ("let's do the right thing!") This is the charismatic leadership function. When  leaders are seen as admirable exemplars of the organization's values, bureaucratic position and natural authority coincide. This is a uniquely powerful configuration. But every group has members who others respect and want to emulate. Wise leaders look to these widely admired member of the group as strong influences on the organization's ethical culture.
3. Administration ("we need to create structures that make it easier to do the right thing.") Ethical behavior is strongly influenced by internal ego ideals, but it's also shaped by external factors like prompts in an electronic record that help us conduct and record advance care planning and nudge us when it hasn't been done.
4. Accountability ("how well are we living our ideals? how can we improve?") Many years ago, a primary care colleague had his assistant ask every patient after their appointment - "did Dr. X do what you needed him to do today?" If the answer was "no," the assistant was trained to intervene, either directly or by calling in to the office. Now we have well developed systems like Press Ganey to assist with accountability at the population level, but the basic function is the one Dr. X implemented on his own.

Ethically admirable health organizations need to cultivate all four of the "As". 

Walking Meditation and Health Care Ethics

Health care can be frantic. Emergency rooms, intensive care units, and surgical suites are obviously high paced, but so is "ordinary" hospital and outpatient care. In my busy days of practice I sometimes had 18 appointments in 10 hours. It's not surprising that clinicians report high levels of tension.

Tension can sharpen our focus, but when it's sustained over time it can lead to irritability and distraction. These create hazards to patient safety and contribute to burnout. That kind of tension is bad.

Insofar as the conditions of practice can be modified to reduce tension, doing what's needed and possible should obviously be done. But clinical practice inevitably brings tension. For our own sake and for the sake of our patients, we need to develop ways to chill out. As the late Ken Schwartz wrote in "A Patient's Story," "...in a high-volume setting, the high-pressure atmosphere tends to stifle a caregiver’s inherent compassion and humanity." To be truly effective caretakers, we need to cherish our capacity for "compassion and humanity"!

For some, meditation is a tremendously valuable tool!

Unfortunately, meditation is often thought of as a touchy-feely matter of sitting in an uncomfortable lotus position and chanting mantras. That view confuses external practice with the internal objective. If meditation is taken to mean sitting in a quiet space for 20 minutes or more to carry out the practice, not many health professionals will make use of it.

That's where walking meditation comes in. In hospitals, doctors and nurses typically walk a few miles - in short bursts - during a shift. In my outpatient practice I often walked from my office to classrooms where I taught and to meetings at the nearby hospitals. I could even take a few paces in the office between appointments. I tried to use these interludes as opportunities for meditation.

There are excellent on line guides to walking meditation. (See here, here and here for examples.) But no approach fits everyone. I found that the excellent descriptions of how to focus on body sensation and the experience of walking didn't work for me. My mind kept wandering to matters I was fretting about. That got me riled up, not settled down.

I recently found a technique that works well for me. I like to look around as I walk. Here's what I learned to do:

1. Breathe in, and, at the same time focus my eyes on some aspect of the external world, as by saying "look at the trees," or "look at the clouds," or "look at the people."
2. As in all forms of meditation, the aim is to experience the trees, clouds, people passing by, or some other focus, not to think about them.
3. I found that for my obsessional nature, it helped to say numbers sequentially as I breathed out - one number for each cycle. That seems to help me stay with the experience rather than drifting off into ruminations. I also like to keep track of how long I can sustain the process before my mind gets filled with trivia.

I present my experience to make the point that it's kosher to develop an approach that works for us. Gurus can be helpful teachers, but the wise ones don't look for slavish followers. If walking meditation clicks for a person it can fit into the interstices of the day. Parents give children a "time out" for the child to regain some composure. Walking meditation has potential for potentially stressed out health professionals to create mini "time outs" for ourselves. When it works it serves us and our patients well! That's good ethics!

Hospital Ethics Committees

Hospital Ethics Committees, the most important organizational structure in health care ethics, are a decidedly mixed bag, as measured by skill, reputation, and utilization of the consultation process. Kevin O’Reilly’s excellent article in the current American Medical Association News provides a very full update.

Almost all hospitals with more than 200 beds offer ethics consultation. But the median use is approximately 3 consults per 100 beds per year. Anyone who has worked in a hospital and seen the conundrums that emerge so regularly knows that 3 per year is very low.

O’Reilly cites multiple articles and interviews for concluding that (a) consultants are often under prepared for their role, (b) physician attitudes towards the consultation process are often negative, and (c) evidence for the effectiveness of the consultation process is weak. Howard Brody, director of the University of Texas Medical Branch Institute for Medical Humanities, commented that "if ethics committees were a drug, they would not be approved."

For two reasons, however, I expect that in the next 5 – 10 years we will see an upturn for ethics committees and the consultation process.

First, systematic research on the consultation process, combined with quality improvement interventions, will lead to enhanced consultation techniques and outcome monitoring. The Veterans Affairs IntegratedEthics program, initiated in 2007, is an example of the kind of systematic development that is needed.

Second, the change of language in the 2004 Federal Sentencing Guidelines for Organizations from “compliance” to “compliance and ethics” combined with the statement that organizations should “promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law” creates a strong push for strengthening ethics activities.

Hospital ethics committees are at the end of their entrepreneurial phase. They are up and running and widely disseminated. The phase we are entering now is managerial. The primary challenge is getting more mileage from the time, energy, and (limited) dollars that have been invested in launching them.

Medical Ethicists as Secular Priests

In Jonathan Moreno's book "Is There an Ethicist in the House?" I came upon these sentences:

...I have been appointed to ad hoc committees on sensitive administrative problems (such as what to do about a resident who was HIV positive but wanted to stay in the program), even though ethical expertise was not much needed. In such cases I have come to see myself as cast into the role of a “secular priest”: even in a pluralistic and multiethnic society someone must sanctify such delicate proceedings. (pages 14-15)

In psychotherapy the phenomenon Moreno is describing would be seen as "transference" - a perception of the therapist that arises from within the patient, not from a realistic perception of the therapist.

In simplest terms, the therapist has two choices to make with regard to transference - use it to advance the goals of treatment, or interpret it as an opportunity for insight.

The ethics consultant must make a similar choice about the "secular priest" transference. If the group the consultant is meeting with has worked hard and reached a thoughtful, well-reasoned conclusion, but then asks - "what do you think?" - the consultant might accept the "secular priest" role and "bless" the group's work, as by responding - "I'm impressed with the thoughtfulness and depth of the discussion - it looks as if we're all comfortable with where we came out."

One reason for accepting the "secular priest" transference this way would be to encourage the participants to see themselves as competent to grapple with challenging ethical questions. Another reason would be to reinforce their commitment to the method(s) of problem solving they had applied.

But suppose the group has reached an overly certain conclusion about an ambiguous question that isn't susceptible to the kind of closure the group settled on. Here the "priest" might choose to "bless" uncertainty: "We all prefer certainty to uncertainty. That's why Harry Truman only wanted advice from one-armed economists - so that he wouldn't hear "on one hand...on the other hand"! But sometimes certainty is an illusion. I suggest that we go back to the drawing board on this..."

I feel squeamish when I'm introduced as an "ethicist." Since questions about what's the right thing to do come up every day of our lives, we're all "ethicists." Sometimes I make that point. But when I feel the situation requires a "secular priest" I bite my tongue and accept the label.

But there's a serious risk in following that path - we might come to believe the attribution ourself!

A Remarkable Health Initiative at the University of New Hampshire

Watching the federal health reform process has strengthened my conviction that the changes our health system needs will have to come from the bottom up, not the top down, and that employers play a key role.

Here's how I put this idea a month ago in a post about employer incentives:

Federal health reform is the front page news, but states and businesses are the laboratories for change. Next to Governors, who have to deal with hideous budget problems driven by declining revenues and escalating Medicaid costs, employers who offer health insurance to their employees are most directly concerned about health care costs.

Health reform requires three ingredients: (1) facing facts, (2) thinking strategically and (3) embracing individual and population concerns. Given the virulent divisiveness of current U.S. politics, employers who offer health insurance are the most promising venue for applying this triad in a "businesslike" manner!

Employer insurance covers approximately 160 million of the non-elderly U.S. population. Because the business world is way ahead of health care in its zeal for (a) casing the environment for good ideas ("benchmarking") and (b) adopting those that work well elsewhere, (c) promising innovations have the potential for rapid diffusion.

I recently came upon the website for Healthy UNH, a remarkable program launched this fall at the University of New Hampshire. The scope of the program is breathtaking, as evidenced by this statement of vision and goals:

Vision: UNH will be the healthiest campus community in the country by 2020.

Values:

1. Transforming health care delivery
2. Creating value for the money we invest in medical care
3. Ensuring that the care we purchase is the right care at the right time
4. Following medical care practices that are evidence-based
5. Improving the health of our entire community, spanning multiple locations and audiences
6. Sustaining health and health care
7. Collaborating across our community
8. Engaging and educating our community
9. Advancing mental and physical well-being
10. Promoting work/life balance

The website includes action plans for changing the way care is delivered to the UNH community, educating the community about what's driving the cost trend, encouraging the use of evidence-based cost effective care, and increasing wellness-promoting behaviors. It's a comprehensive program about enhancing the bang for the bucks the University invests in health insurance (for approximately 2,800 faculty and staff) and improving the health of the entire community, which includes 15,000 students.

It's too early to know what the Healthy UNH program will accomplish. But the way the program is conceptualized can show other employers how worksites can become a force for health literacy, promotion of wellness, and delivery system change.

Over time, as more employers take a holistic approach to promoting health, reforming health care delivery, and getting a grip on runaway costs, state and federal legislators will get the message. Our leaders will lead us better when the front lines show them what needs to be done and how to do it!

(Additional posts about worksite initiatives are available via the "Employer Insurance Ethics" tab. See also a New England Journal of Medicine article - "The Employer as Health Coach.")

A Practical Approach to Organizational Ethics

I've been meeting with a number of organizations to help them develop new ways to deal with the ethical dimensions of their activities. They've asked for practical pointers on how to get started. I've presented this list of six:

1. Understand two meanings of "should." Even the most collegially managed organizations have an underlying heirarchy. "Higher levels" can tell "subordinates" what they should do. Ethics is about values - what we should do. One reason organization are uneasy about formal ethics activities is fear that ethics folks would feel empowered to tell the organization what it should do in the managerial sense of "should," supplanting the CEO and Board. This isn't a question about the organization's commitment to values, but rather a question of who is in charge. We need to understand the distinction between the "managerial 'should'" and the "ethical 'should'."
   
   


2. Ensure managerial authority. If the CEO isn't "Chief Ethics Officer," organizational ethics activities will be a waste of time. Explicit endorsement and support from senior leadership is a requiremnt. An organizational ethics committee wouldn't have influenced Enron!
   
   


3. Ensure moral authority. Managerial authority comes via delegation. Moral authority comes from the respect pertinent others have for those who take the lead in organizational ethics activities. To be effective, organizational ethics activities require both managerial sanction and moral authority.
   
   


4. Ensure appropriate leadership skills. Organizational ethics consultation isn't an academic activity. Analytic and conceptual skills are required, but they have to play out with a wide range of people inside and often outside of the organization. Facilitation, relationship management, and solid understanding of the full range of organizational function are also crucial leadership skills for organizational ethics. To conduct effective organizational ethics activities in hospitals, group practices, and health plans, it's necessary to be comfortable dealing with both clinical and administrative matters and personnel.
   
   


5. Apply stakeholder theory. Here's how the excellent AMA Institute of Ethics publication "Organizational Ethics in Healthcare" defines stakeholder theory:
   
   
   "The core thesis of stakeholder theory is the normative
   claim that the interests of all the parties involved in any
   transaction ought to be considered in determining how
   to act ethically. In order to determine how an organization
   ought to act in a particular situation, it is necessary first to
   identify each of the parties (individual and collective)
   with whom the organization interacts and what each
   party has at stake. Second, one must ask how the
   organization ought to act in relation to each party, and
   then how the organization’s several obligations to these
   parties ought to be ranked, both in general and in the
   situation at hand."
   
   
   
   Faith-based organizations use guidance from their creed in dealing with complex ethical questions, but secular organizations typically find ethical reasoning that draws on the perspectives of its stakeholders more comprehensible and persuasive. Except in the rare situation in which a secular health organization embraces an ethical credo from outside of the organization, the stakeholder approach is most effective.
   
   
   
6. Monitor and adapt as needed. In an ethics class the analytical conclusion is the end point. But organizational ethics consultation isn't a classroom exercise. Well-managed organizations apply a quality improvement approach to all of their activities, including organizational ethics. It's great to make a timely decision, but greater yet if that decision works on the ground. If it doesn't it needs to be tweaked.

I'll probably modify this list of pointers over time, but for the moment these six have been useful in a range of settings.

Patient Access to the Doctor's Notes

With funding from the Robert Wood Johnson Foundation, the Beth Israel Deaconess Hospital in Boston is starting an "open notes" study, in which the patients of 100 physicians will be able to read their doctor's notes on line. I read about the study in an excellent article in today's Boston Globe. Here's the essence of the article:

Researchers hope to learn whether the notes prove more useful than objectionable. They hypothesize that access to doctors’ notes will improve care partly because patients will become more knowledgeable about their treatment and about their doctors’ instructions.

Studies show that “patients remember precious little about what happens in the doctor’s office,’’ said Dr. Tom Delbanco, a Beth Israel Deaconess internist and a co-investigator.

The Robert Wood Johnson Foundation gave Delbanco and his colleagues $1.5 million for the project because doctors have “strong differences of opinion about this. But there is almost a religious character to the debate. It’s uninformed by evidence,’’ said Stephen Downs, an assistant vice president at the foundation. It will be the largest study yet on the issue, he said.

I think it's a great idea!

For the last 10 years of my psychiatric practice at Harvard Vanguard Medical Associates I wrote my own notes directly into an electronic medical record. Although I'd been taught as a resident not to make notes while with the patient, I'd found that waiting until after the appointment or the end of the day resulted in more meager notes. Luckily I'd learned to touch type in middle school, and was able to keep the keyboard on my lap and maintain eye contact while I typed.

But from residency itself I always wrote my notes with the assumption that the patient would read them. The discipline this imposed was useful. As an example, it helped me in relating to people with paranoia. I didn't write "Mr. Jones is paranoid and delusional," but rather "Mr. Jones believes extra-terrestrials have implanted a chip in his brain. He understands that I do not share this view. We discussed why I believe taking anti-psychotic medication would help him in his life..."

I found that people with paranoia appreciated that I recognized the possibility that (in this example) extra-terrestrials might be causing mischief, but that I found this extremely unlikely. We could frame using medication as a hypothesis - "whether or not there is a chip in your brain, I believe that you will sleep better and be less afraid after a few weeks..." rather than as the equivalent of "you're crazy and I'm sane so you should do what I say..."

Writing notes with the patient in the office allowed for discussion of what should be said. With someone I'll call Mr. Jones, it had taken quite a bit of time to elicit a clear picture of how much alcohol he used and how alcohol might be affecting his mood and his physical health. I explained why I thought it was important for his primary care physician to know about his alcohol use. We sat together in front of the terminal to compose my note. Mr. Jones baulked at the word "alcoholism," but accepted "alcohol problem." This wasn't just a piece of collaborative writing and editing - it was an integral part of the treatment process.

Open notes create a different set of problems for primary care physicians than for psychiatrists. PCPs do much more recording of findings and documentation of potential differential diagnoses. PCPs are appropriately concerned with how best to write about the numerous "rule outs" that must be thought about for symptoms that are almost certainly benign. But the challenge of how to write about uncertainties and improbable possibilities may ultimately help the medical profession deal better with uncertainty. In my own care I'd much prefer to read "I believe this headache comes from tension and does not reflect any other underlying cause - I asked him to call me next week if the symptoms persist - we could consider further testing then," rather than "to rule out a brain tumor I have referred him for a CT scan..." In this way open notes might help reduce the defensive medicine and overuse of resources that are so rampant in medical practice today.

This is a research project very worth following. Hats off to the Robert Wood Johnson Foundation for recognizing the potential value in a disciplined study of the domain!

The Upside of Health Care Competition

Last fall I wrote about how the Hannaford supermarket chain was offering incentives to employees to have procedures like hip and knee replacement done in Singapore, where the company believed treatment of comparable quality but significantly lower cost was available. I quoted the director of health benefits:

"Hannaford's new coverage policy was prompted by stinging criticism from its European owners. For them, medical costs and outcomes in the United States just don't add up. [They said] look at what they're spending in the United States. It's two or three times what they're spending in any other industrialized country. But if you look at quality, [the U.S.] is ranked dead last. So the Europeans said, 'why is health care going up at this extraordinary rate in the United States?'"

I speculated that self-insured employers might prod our society to be more thoughtful about value in health care by taking a more businesslike approach to the provision of health benefits.

In yesterday's New York Times a distinguished trio - Arnold Milstein (Medical Director, Pacific Business Group on Health and "National Health Care Thought Leader" at the William M. Mercer consulting company), Mark Smith (CEO, California HealthCare Foundation), and Jerome Kassirer (former editor, New England Journal of Medicine) - discussed the pros and cons of programs like Hannaford's and then asked:

So should offshore surgery be welcomed as a modest way to make American health care more affordable? We can’t know until we can directly compare the outcomes with those of American surgery. To begin, we must adopt a uniform way for American hospitals and surgeons to report on the frequency of short-term surgical complications.

They suggest that U.S. hospitals use the National Surgical Quality Improvement Program tools, available from the American College of Surgeons, and adapt the Swedish system for monitoring hip replacement to assess outcomes.

This is clearly a good idea and should be done. But it was clearly a good idea 5 and 10 years ago and with the exception of programs like Kaiser Permanente we've just sat on our rear ends without doing it.

Overseas hospitals are hungry for U.S. business. If the best ones aren't yet tracking their outcomes the way Milstein, Smith and Kassirer suggest, they'll probably start tomorrow. I'm sure that many will have results to be proud of. They won't be bashful about advertising their favorable balance of quality and cost, and they'll siphon progressively more "business" away from the U.S.

Price competition driven by evidence-based assessment of outcomes is exactly what the invisible hand of the market does best. I hope that leading hospitals in India, Singapore, Thailand and elsewhere put our feet to the fire over delivering better value for our health care dollars! That will be an admirable blending of global capitalism and good ethics!

(For previous posts about medical tourism and health system ethics see here, here, and here.)

MBA Code of Ethics

Before yesterday's graduation, half of the Harvard MBA class signed an oath, promising "to create value responsibly and ethically." I've copied the short version of the pledge the students made. I'm especially interested in the effort to balance Milton Friedman's teaching that the manager's role is to (a) maximize profits while (b) obeying the law with (c) social justice/communitarian values, and I put comments of my own into the oath in bold capitals:

As a manager, my purpose is to serve the greater good by bringing people and resources together to create value that no single individual can build alone. Therefore I will seek a course that enhances the value my enterprise can create for society over the long term. [FRIEDMANITES BELIEVE THAT A SYSTEM OF PROFIT-MAXIMIZING ENTERPRISES WILL PRODUCE MAXIMUM BENEFIT FOR SOCIETY. THE OATH REFLECTS A GROWING LOSS OF FAITH THAT THE INVISIBLE HAND OF THE MARKET CAN BE COUNTED ON TO DO GOD'S WORK!] I recognize my decisions can have far-reaching consequences that affect the well-being of individuals inside and outside my enterprise, today and in the future. As I reconcile the interests of different constituencies, I will face difficult choices.

Therefore, I promise:

• I will act with utmost integrity and pursue my work in an ethical manner. [THIS PROMISE IS CONFUSED. SOCIOPATHS ARE TRULY INDIFFERENT TO MORAL CONSIDERATIONS, BUT IN ALL LIKELIHOOD MANY PROFIT MAXIMIZERS, INCLUDING THOSE WHO BUNDLED SUB-PRIME MORTGAGES INTO ULTIMATELY TOXIC ASSETS, CONDUCTED A REASONING PROCESS ABOUT VALUES. THEY DIDN'T INTEND TO BE UNETHICAL - BUT THEY GAVE THE WRONG VALUES TOO MUCH WEIGHT! ]

• I will safeguard the interests of my shareholders, co-workers, customers, and the society in which we operate. [THIS IS IMPORTANT. THE MBAs ARE PLEDGING TO CONSIDER SOCIAL BENEFIT, NOT SIMPLY TO PURSUE MAXIMUM PROFIT AND SIMPLY ASSUME ON FAITH THAT THE INVISIBLE HAND WILL PERFORM ALCHEMY ON PROFIT MAXIMIZATION AND TURN IT INTO SOCIAL BENEFIT!]

• I will manage my enterprise in good faith, guarding against decisions and behavior that advance my own narrow ambitions but harm the enterprise and the societies it serves.

• I will understand and uphold, both in letter and in spirit, the laws and contracts governing my own conduct and that of my enterprise. [UPHOLDING THE LETTER OF THE LAW IS COMPLIANCE. UPHOLDING ITS SPIRIT AS WELL IS ETHICS. COMPLIANCE WITHOUT ETHICS MEANS WE (a) WON'T GO TO JAIL BUT (b) WON'T GO TO HEAVEN EITHER.]

• I will take responsibility for my actions, and I will represent the performance and risks of my enterprise accurately and honestly.

• I will develop both myself and other managers under my supervision so that the profession continues to grow and contribute to the well-being of society.

• I will strive to create sustainable economic, social, and environmental prosperity worldwide.

• I will be accountable to my peers and they will be accountable to me for living by this oath.

This oath I make freely, and upon my honor.

The Preamble to the AMA Principles of Medical Ethics also grapples with the challenge of helping a profession recognize more than one value. It is clear that a physician's primary commitment is to the patient. But in medicine failure to give adequate weight to population health - as through universal insurance, wide access to primary care, and restraint in overall spending - has led to societal harms in the same way that Friedman's faith in profit maximization has. The Preamble tries to give at least some encouragement to considering a wider range of values:

The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, a physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self.

Cynics have scoffed at the MBA code, but I think they're wrong. Clearly the code has no teeth. Medical societies have ethics committees that can sanction erring physicians, and state medical boards respond to complaints about moral lapses. The management profession has no analogue.

But a movement in which a large number of young entrants into the profession look at their elders and conclude that the emperor has no clothes makes a difference. It's high time that we in the U.S. challenge our faith that the market's invisible hand allows each individual and each enterprise to pursue its own narrow interests without considering other societal values except for the letter of the laws we've passed.

(See today's Economist for an interesting article about the oath.)

Abortion and Conscience

Here's the assignment I developed for today's section of Harvard Medical School's required first year course on "Medical Ethics and Professionalism":

Drawing on the articles by May and Aulisio ["Personal Morality and Professional Obligations] and Curlin ["Religion, Conscience, and Controversial Clinical Practices"], discuss how you would respond to a respected colleague who is strongly against abortion and feels he cannot in good conscience refer a patient to a potential abortion provider and should discuss his moral perspective with his patients.

All 13 students (and I) believed that abortion should be legal, available and safe. My aim for the class was not to have yet another repetitive discussion of abortion ethics, but to engage with the question of whether and how our divided society can reduce the level of rancorous conflict and collaborate despite deep moral differences.

We conducted a segment of the class as a dialogue/role play. One student and I took the role of the anti-abortion physician envisioned in the assignment. The rest of the group was assigned the role of chief of the practice. Here's a summary of the dialogue, written as if it occurred between two people:

Chief: I've been told that you are refusing to refer patients for potential abortion services and are telling them about your personal moral outlook. Is that true?

Physician: It is. I know that abortion is legal and that a majority of the population believes it should be. But it seems so clear to me that abortion is killing a baby-in-the-making that there's no way of not seeing it as a profound wrong. I can't possibly support that - even by referring a patient to someone else.

Chief: Medical ethics is built around patient autonomy - that people have a right to make their own medical choices among legal alternatives. People can refuse life-saving treatment, and two states allow physician assisted suicide!

Physician: I know what the law says. In the country I came from female circumcision was legal and widely practiced, but I refused to do it or refer for it because I saw it as a deep moral wrong. The fact that the law allows abortion or female circumcision doesn't make these practices right or morally acceptable.

Chief: If you can't bring yourself to provide information patients are entitled to maybe you should have gone into a different profession!

Physician: I love medicine, and the feedback we get shows that my patients feel respected and well treated by me. Abortion is the one area where there's a problem for me in the practice.

Chief: It would be better to steer patients who want to consider abortion away from you in the first place.

Physician: That's a good idea.

Chief: Another thing. When you talk with patients about your views, we don't want you using terms like "evil" or "murder." You're entitled to your own views. But people who I regard as just as morally serious as you - including myself - disagree. You can say what you want in a political discussion, but not when you're a doctor dealing with patients.

Physician: I can live with that...

My aim in the class was to challenge us to respect a colleague we deeply disagreed with and not to demonize him because John Salvi and James Kopp felt called upon to murder abortion providers.

As I wrote in a post a few weeks ago, I think the best we can hope for is a gradual reduction of the virulence of the pro and anti abortion debate. (I don't like to use "pro life" and "pro choice" - all decent human beings value both life and choice!) President Obama has made a promising start with the working group he convened and his speech at Notre Dame (see here). And versions of the class experience my students and I had today - if repeated in a few million settings - may make a difference as well.

Good Politics and Good Ethics about Abortion

An article in yesterday's Wall Street Journal described how President Obama has convened a group of abortion rights opponents and supporters to help develop policies both sides can get behind.

This is probably smart politics. It may lead some pro lifers to see the President more favorably. But it's definitely good ethics.

Some years ago, when medical ethics was taught as an elective at Harvard Medical School (it's a required course now), my colleague & friend Lachlan Forrow (president of the Albert Schweitzer Fellowship) and I co-taught the course together. We didn't see how a course on ethics could avoid discussing abortion, but we feared that simply discussing it pro and con would get nowhere, since most people would just be repeating fixed opinions. We decided to approach the issue from the side, through discussing the pros and cons of "selective reduction" in triplet pregnancies, where reducing the pregnancy from three to two increases the likelihood of survival. We also discussed whether an OB/GYN program that included training in abortion should accept or turn down an otherwise well qualified candidate who opposed abortion and refused to participate.

In retrospect I wish we'd asked President Obama's question - how might we create some rapprochement between the pro life and pro choice camps? The issue of whether and how it is possible to promote constructive dialogue in intensely polarized situations should be part of ethics education.

The ideas being discussed in the White House process are constructive but predictable - reducing the frequency of unwanted pregnancies, as by making contraception more available and improving sex education, and making it easier for new mothers to keep their babies and making it easier to adopt.

But the most important outcome could be a greater readiness for the "camps" to appreciate each other's human decency.

Pro choicers should acknowledge that abortion does involve sacrificing a (pre natal) life. That's a deeply serious moral choice and a very sad event. They shouldn't see pro lifers in terms of the lunatic and criminal fringe of the movement. And the pro choice folks shouldn't be demonized as promiscuous baby killers. Comparing abortion to the Nazi gas chambers is preposterous logic and grotesque ethics.

But it's important to have realistic expectations about dialogues of the sort the White House has convened. In 1994, after John Salvi murdered Shannon Lowney, receptionist at Planned Parenthood, and Lee Ann Nichols, receptionist at Preterm (both in Boston), Governor Weld and Cardinal Law promoted talks between six prochoice and prolife leaders. The women, with two facilitators, met for more than 150 hours over the course of five years.

The talks did not lead the leaders to change their basic views, but they did promote a change in tone in the public debate. The "sides" came to see their "opponents" as as people of integrity and decency who held wrong views. But heightened recognition of each others' humanity in Massachusetts did not prevent James Kopp from murdering abortion provider Dr. Barnett Slepian in Buffalo in 1998. And if there is a Salvi/Kopp clone skulking about somewhere, the White House talks will not bring him to sanity.

The fact that even the deepest ethical dialogue has finite impact shouldn't dissuade us from promoting the process. For me one point of the Garden of Eden story is that even an omnipotent creator doesn't have full control over what our species will do!

Here's the final paragraph from a superb Boston Globe article written by the participants in the Massachusetts abortion dialogues:

We hope this account of our experience will encourage people everywhere to consider engaging in dialogues about abortion and other protracted disputes. In this world of polarizing conflicts, we have glimpsed a new possibility: a way in which people can disagree frankly and passionately, become clearer in heart and mind about their activism, and, at the same time, contribute to a more civil and compassionate society.

Ethical Challenges in Veterans Administration Healthcare Facilities

The April issue of the American Journal of Bioethics has a valuable piece of ethics research from the VHA.

To understand the challenges faced by Veterans Administration facilities, the authors conducted focus groups with patients (32) and managers (38), and semi-structured interviews with managers (31), clinicians (55) and ethics committee chairpersons (21). They found that all parties were deeply concerned about the ethics of the enterprise. There was no evidence whatsoever to support the common view held by clinicians that they are concerned with values while bureaucratic "beancounters" are concerned with business and the bottom line.

But the issues that most concerned the groups varied:

• Managers worried about how to distribute resources fairly among the different components of the facility and what kind of process to follow in doing this.



• Clinicians worried about providing high quality care with limited resources and balancing duty to patients with the obligation to be stewards of VA resources.



• Ethics committee chairs were most concerned with improving end-of-life care and ensuring that patient preferences were honored.



• Patients had as their top priorities receiving respectful and caring treatment from all staff and improving service quality.

The good news for those concerned with strengthening the culture of ethics at health care organizations is the fact that everyone saw health care as a value-driven mission. The bad news is the danger that health organizations could become Towers of Babel, with all groups speaking about ethics and values but unable to communicate with each other.

The VHA National Center for Ethics in Health Care has developed and is beginning to implement a very promising approach to the Tower of Babel danger - the IntegratedEthics program.

Anyone interested in the ethics of organizations should read the 15 page VHA report. Page 5 of the report has a useful picture of an "ethics iceberg." At the surface are the visible decisions and actions that are carried out every day - respecting/not respecting patient preferences, returning/not returning telephone calls, etc. Immediately under the surface are the organizational systems and processes that shape decisions and actions - such as ethics consultation, staff education and supervisory systems. At the deepest level, least directly observable but most powerful, is the ethical environment and culture of the organization.

What's most distinctive about the VHA approach is the way it links components of the organization that usually live in separate silos. In my teaching about ethics I've used the heuristic device of 3 "As" to describe the components of ethics in organizations. The VHA conception suggests a practical way to make them work together:

• Analysis (What's the right thing to do?) Ethics committees/ethics consultation concentrate on answering these analytical questions.



• Administration (How do we make it easier to do the right thing?) This is the responsibility of the various components of operations management.



• Advocacy (Let's make sure that we all embrace the same values and ideals.) This is the values leadership for which the CEO and her team are crucial.

The IntegratedEthics program envisions these ordinarily disparate functions being brought together in a managerially coordinated way. It's a smart, practical and promising approach to improving the ethics of organizations.

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.

Curing Medical Loneliness

An article in yesterday's Washington Post - "Sharing the Pain: Rare Disease Puts an American University Economist in Touch With Fellow Patients Around the World" - caught my attention.

In 2005 Arturo Porzecanski, an accomplished economist, developed a life threatening and often fatal disease called "systemic capillary leak syndrome." I'd never heard of this rare condition, in which there are sudden episodes of leakage from tiny blood vessels and a precipitous drop in blood pressure. Porzecanski was left with muscle loss after his first episode and was told that the next one might kill him. He "was very depressed and felt increasingly alone" until he found RareShare, a website whose purpose is to foster contact between people who, like Porzecanski, have rare diseases.

In my clinical practice I often referred people with significant psychiatric ailments to organizations like NAMI (National Alliance on Mentally Ill) or the Depression and Bipolar Support Alliance for opportunities to meet and hear from others with similar conditions. For many people organizations like these provided emotional support and sometimes "tips" on coping with symptoms like hearing voices or depressive hopelessness.

But for rare conditions like what Porzecanski has - the Mayo Clinic has seen only 28 cases in 25 years - the isolation can be debilitating. Despite a supportive family he felt very alone. Here's what Porzecanski says about the new website:

"RareShare put me in touch with other patients. It gave me great pleasure to put down everything I knew: all the critical articles, the world's experts, information about custom shoes. For me there was just a lot of support in knowing I was not alone."

I browsed on the website. It's obviously young. Many of the "communities" have just one or two members, and not all have generated real discussions. But some, like the systemic capillary leak syndrome "community" that Porzecanski started, have the beginnings of a rich and meaningful exchange. Some, not surprisingly, have energetic reports of what to me sound like quack ideas. But that's part of human life and not peculiar to the web.

Insofar as the web and portals like RareShare facilitate creation of virtual communities in which people can "meet" others with the same condition to exchange ideas and mutual support it is all to the good. It will be important for doctors and nurses to learn about these new resources and how to counsel patients about using them.

But I fear the risk of corruption of these grassroots enterprises by commercial interests. This has already happened enough to elicit a new term - "astroturf" - for pseudo grassroots organizations driven by corporate support such as pharmaceutical companies that want to market high cost drugs for the condition. (See here for an example of astroturf I wrote about in 2007.) I hope that RareShare's business plan does not involve selling the soul of person-to-person exchange to the highest corporate bidders. If it's able to resist corrupting temptations it could make a meaningful contribution to human well being!

A Mild Wrist Slap for Pharma in India

Last month, before coming to India (where I am now) I wrote about the drug marketing scene. The posting gave a link to an article in the Times of India that suggested to me that the Indian media were on the trail of the Pharma-Medicine story that is currently exploding in the U.S.

In Delhi I met with Rema Nagarajan, the reporter who wrote the Times of India story. Rema is well-informed about developments in the U.S., such as medical schools banning all gifts to medical students, house officers and faculty. Yesterday she had a followup article in the Times of India that suggests that the exposure of excessive pharmaceutical company influence over medical practice is heating up in India. India does not have the same level of consumer advocacy and consumer protection that has been developed in the U.S., but India is on its way in that direction.

Here are excerpts from Rema Nagarajan's article:

If you thought the government would crack the whip on pharmaceutical companies offering freebies to doctors for prescribing their products, think again. The department of pharmaceuticals has indeed taken note of the dubious practices reported by TOI on December 15, but in a surprisingly mild, almost apologetic tone.

Joint secretary Devendra Chaudhury wrote to the various associations of drug manufacturers on December 18 citing the TOI report, but the letter suggests he would be "grateful" if the associations acted on suggestions made by the department.

...The mild tone is despite the fact that the December 18 letter admits: "The allegations cannot be in any way treated as ethical and something that could be endorsed by society in general. This also puts the pharma industry in a bad light since the enhanced promotional expenditure of the pharmaceutical companies result in enhanced market price of the drugs, which has to be borne by the consumer."

Yet, it says the department would be "grateful if you (pharma associations) could kindly take action" on its suggestions and also take steps to "prevent such perception in the mind of the public and other bodies to obviate misuse of promotional expenditure" and to kindly "prevent allegations as well as media reports on this subject as have appeared".

The joint secretary says in the letter that "the matter being extremely sensitive and of great public importance I am constrained to write to you". With such a mild and apologetic tone from the government it is anyone's guess whether the pharma industry would feel the need to take any action.

Both the Organisation of Pharmaceutical Associations of India (OPPI) and the Indian Drug Manufacturers Association (IDMA) had released their own codes of conduct at the beginning of 2007. However, there is no single code applicable to all drug manufacturers, a fact that the letter points out. But again, this is followed up by a gentle nudge: "You may like to consider having such a code for your members"...

Establishing an ethical balance between medicine and commercialism in India will not be easy. Two very strong forces push against efforts to spotlight the problems and suggest solutions. Fist, there is tremendous trust in physicians, beyond what the profession deserves. (Rema quoted a Hindi saying in our discussion - "A doctor is like a God come down to earth.") Second, Pharma is a substantial component of the national thrust for rapid economic development. Successful enterprises aren't totally untouchable, but they are harder to tame than comparable enterprises in the U.S.

Preaching doesn't create an ethical health system. Public understanding of what constitutes good health system ethics and public demand for accountable performance are required. The media and political leaders are key "educators" for the public. I'll try to glean more about the societal learning process in India while I'm here.

Hatred of Insurance Companies

The Obama transition team is sponsoring 4,200 house party-based grass roots discussions of health care in December. Today's New York Times reported on one of them.

In my work on health system ethics I've often invoked the need for a "societal learning curve" with regard to the health system. The Obama health care house parties will provide HHS Secretary Tom Daschle with a huge opportunity to see where the U.S. public is coming from in its understanding of the health system.

Here are some excerpts from the account of the health care house party, followed by my comments in italics. The report suggests just how much teaching and leadership we need from Secretary Daschle and President Obama:

"When a dozen consumers gathered over the weekend to discuss health care at the behest of President-elect Barack Obama, they quickly agreed on one point: they despise health insurance companies.

They also agreed that health care was a right; that insurance should cover 'everything,' not just some services..."

I run the ethics program at Harvard Pilgrim Health Care. It's a not for profit health insurance company that insures a million people. For the past four years it has been rated #1 in member satisfaction and quality of care by U.S. News and World Report and the National Committee for Quality Assurance. I respect and admire the organization.

That said, health insurance companies are in an unenviable and perhaps impossible position, poised between (a) employers and government agencies frantic to control what they pay for health insurance (b) providers who are largely not held accountable for costs, (c) insurees who want "everything" covered, in a context of (d) severely limited public and political understanding of how health care really works.

"Dr. Lawrence M. Nelson, a scientist at the National Institutes of Health who emphasized that he was speaking as a private citizen, said: 'The incentives in the current health insurance system are upside down. The less care you provide, the bigger your profits.'"

In the 1990s, public policy asked insurers to mediate the gap between what payers wanted to pay, providers wanted to provide and patients wanted to receive by determining which proposed interventions were "medically necessary." That role wouldn't be easy for anyone - even Mother Theresa or Dr. Schweitzer. Insurance companies, especially for profit companies, were ultimately pilloried for setting limits. They've backed off from taking that role. Costs, of course, are skyrocketing again.

But Dr. Nelson's comment suggests just how tough a teaching job Secretary Daschle will face. Less care is often (a) as good as more care or (b) better. That's a counterintuitive lesson for much of the public. Entities that profit from providing less care aren't able to teach it. The Secretary has to find ways to help us learn.

The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a “contribution” — so that everyone could be covered.

Not asking how the health system should be financed strikes me as a major error. There is no way we will come to grips with health care costs until we set a true budget for the health system. The idea that "small contributions" might get us to where we need to go suggests how much we are still living in lala land with regard to health care finances.

If Secretary Daschle uses the health care house parties as an opportunity to refine his agenda for leadership they will provide valuable insight. But if the house parties are used to define the content of proposals we'll just continue down the same path of inexorable cost increases we are on now. Our political leaders - always excepting former Oregon Governor John Kitzhaber - haven't had the guts to help us face the need for limits and to begin to understand health care in a more nuanced way. It remains to be seen whether the new administration is up to the task.

Mayo Clinic Skipped Written Informed Consent - Bravo!

A headline caught my eye this morning - "Mayo Skipped Written Consent."

Before I say more I have to acknowledge a conflict of interest. I admire the Mayo Clinic. I've never been there, but I respect the thoughtfulness of the medical program as reflected in documented outcomes and publications, and the values Mayo has been known for.

Here's the story. George R. Studnicka, a federal prisoner, developed lymphatic cancer. He was referred to the Mayo Clinic for treatment. Mr. Studnicka subsequently claimed that Dr. Daniel Pinheiro operated on him without consent and Dr. Yolanda Garces performed radiation therapy on him, also without consent. (See here for the US District Court Appeal opinion.) Mr. Studnicka's lawyer found no signed informed consent form in the record and complained to the state. An on-site inspection of 12 records showed that none contained signed consent forms.

Mayo wasn't defensive. An administrator told the inspectors "There is no written surgical consent...We don't use them here." The state inspectors reported that Mayo officials told them they "didn't agree with the federal definition of written consent."

Bravo!

The March 2008 issue of the "Proceedings of the Mayo Clinic" had an article on "Medical Informed Consent:General Considerations for Physicians." I don't know whether the timing of the article was coincidental or whether it was meant to present Mayo's philosophy of informed consent. Here's the key summary table from the article:

TABLE 2. Prudent Behaviors of Physicians Engaged in the Process of Medical Informed Consent
* The physician directly involved in the proposed treatment should conduct the informed consent discussion. The discussion should include the treatment, the risks and benefits of treatment, and alternative therapies with associated risks and benefits
* The physician directly involved in the proposed treatment should discuss the most likely outcome with no treatment, on the basis of the best available medical or surgical evidence
* The physician directly involved in the proposed treatment should always discuss the severe risks, such as death, paralysis, loss of cognition, or loss of a limb, even if the probability of occurrences is negligible
* The physician involved in the proposed treatment should always disclose less severe risks that occur frequently. Courts do not place emphasis solely on consequences; they recognize frequency as an important component of risk
* The physician directly involved in the proposed treatment should discuss informed consent in language the patient can understand, and treatment should not proceed until the physician believes the patient understands the risks and benefits and has made a rational decision
* The physician directly involved in the proposed treatment must understand that the medical consent form is not medical consent; it represents evidence that the consent process occurred. The dialogue between the patient and physician is the essence of the consent process (emphasis added)
* The physician directly involved in the proposed treatment should document all patient-imposed restrictions in the medical record and the discussion with the patient about how the restrictions limit the physician’s ability to provide standard medical care...
* When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a partnership, with shared authority, decision making, and responsibility for outcomes The physician directly involved in the proposed treatment can enhance the informed consent process through appropriate use of additional learning materials, such as pamphlets and video, and through involvement of support staff, such as physician assistants, in providing information that can be discussed by the responsible physician

In my view this represents an exemplary approach to informed consent. The recurrent reference to "the physician directly involved..." and the concluding bullet correctly portray informed consent as a crucial clinical process between clinician and patient, not as a bureaucratic event between pen and paper. Sadly, medical students I've taught have described being sent onto the hospital ward to "consent the patient" - i.e., get the patient to sign a document, which demeans informed consent and invites the student to become cynical.

Apparently, and not surprisingly, the level of documentation in Mayo charts was variable. That's not acceptable. And apparently federal regulations require signed forms in certain circumstances. Mayo agreed to implement a written consent form. I hope the Clinic does this in the clinically sensitive spirit embodied in the passage I quoted.