Loneliness and Health

It's easy to make jokes about the British "Minister of Loneliness," as Steven Colbert did when Theresa May announced creation of the new position this winter. But for several decades we've known that loneliness isn't a joke - it's a significant risk factor for poor health and premature death.

Here's how Vivek Murthy, the former Surgeon General, explains the health impact of loneliness:

...Over thousands of years, the value of social connection has become baked into our nervous system such that the absence of such a protective force creates a stress state in the body. Loneliness causes stress, and long-term or chronic stress leads to more frequent elevations of a key stress hormone, cortisol. It is also linked to higher levels of inflammation in the body. This in turn damages blood vessels and other tissues, increasing the risk of heart disease, diabetes, joint disease, depression, obesity, and premature death.

Understanding the toxicity of loneliness has implications for public policy and health care practice. The UK ministry exemplifies a public policy action. But my interest for this post is health care.

Physicians are overburdened with requirements, but asking about our patients' social connectedness is central to understanding them. Loneliness is often the result of illness. People who are ill may withdraw from the social world, and sometimes others may withdraw from them. And loneliness can cause vulnerability to illness and diminish the resilience we need to recover.

In my psychiatric practice I sometimes took out my prescription pad and wrote instructions like "talk with a friend at least once every day" to dramatize my belief that in many circumstances, persons could be more effective than pills. And I kept a file with resources patients mentioned: AA and NA groups, Alliance for the Mentally Ill support programs, and more. Over time this helped me suggest venues that aligned with my patients' temperaments for those who might benefit from the right kind of peer support.

When I was asked to start an HMO outpatient program for patients with chronic mental illness I surveyed the literature for guidance. While the term "loneliness" wasn't used, the most promising models were group-based programs with an informal, friendly and welcoming atmosphere. For several years I had the privilege of being the psychiatrist who met with the group. Patients could come as often or as rarely as they wished. When a patient had a question about medication of some other aspect of treatment, I could usually direct the question to another patient with first hand experience of the treatment in question. Patients often became friends.

The widening recognition of loneliness as a toxic state and meaningful social connection as a health promoting factor is a positive step for health care. But, unfortunately, valuable insights can be drowned in bureaucratic regulations. Reducing inquiry about loneliness to a required checklist of questions risks coming across to patients as sterile and perfunctory, and to physicians as one more requirement in the ever-lengthening list of externally driven expectations.

But when interest in the social texture of our patients' lives is part of the clinician and patient coming to know each other as human beings and collaborating in service of health, both parties will gain.

Is This Doctor-Patient Marriage Unethical?

I shouldn't have been surprised that the most read posts on this blog have been about doctor-patient sex. When I recently had occasion to review these posts a comment I received on April 23 last year caught my attention:

Let us face it squarely. There are only 4 women that a newly qualified overworked doctor intern is exposed to: a fellow doctor (usually out of reach), a nurse (may lead accusation of sexual harassment) a bar waitress (usually not of the best social character) and the patient. I chose the latter and am happily married to her for 8 years. Did I breach the ethics? Can a distinction be made between sexual attraction and real love?

In my response I made an initial sortie into the connection between professional ethics and the ethics of personal relationships. But in retrospect I wish I'd been clearer:

Congratulations on 8 happy years of marriage. I don't know what area of medicine you're in, and what its code of ethics states. In my own specialty - psychiatry - the code asserts that sex with current or former patients is unethical. So if you're a psychiatrist, the code answers your question - you did breach the ethics of the specialty....

So - you may have violated the ethics of your area of medicine, but I'm guessing that you and your wife distinguished right from the start between "real love" and "sexual attraction." You have 8 years of evidence that you got it right! For you as individuals the professional ethics precept would have been a bad guide. 

Suppose the ethics committee of the former intern's medical specialty were asked to review the ethics of the relationship he formed with his patient 8 years ago. For my specialty (psychiatry), the answer would be unambiguous. Forming a romantic or sexual relationship with a current or former patient is defined as unethical.

Given that he violated the ethics of his specialty, should he be disciplined?

If there had been no problems in his medical practice in the subsequent 8 years I think the right outcome would be (a) to reaffirm the correctness of the ethical standard but (b) to find a way of not disciplining him, while (c) being careful not to set a precedent that undermines the standard.

The rationale for defining romantic/sexual relationships with current and former patients as unethical is twofold: to protect patients from the harms that these relationships can cause, and to prevent the loss of trust in the profession that would accrue if the public concludes that physicians are prepared to exploit patients for personal gain, as by "hitting" on them. The former intern's happy marriage isn't evidence against the standard. The standard doesn't claim that every doctor-patient romantic/sexual relationship will result in harm, just that we know that harm is a significant possibility and is difficult to predict. And the happy marriage says nothing about the overall trustworthiness of the profession.

If this was a current question for a physician with no pattern of exploitation, an ethics committee might require an extended period of supervised practice. Assuming the former intern has practiced in exemplary fashion for 8 years, that would exceed what a probationary period would entail. As a member of the specialty society it's important for him to understand and support the ethical precepts of the society. As a response to the violation that occurred 8 years ago, the ethics committee might ask the former intern to write an essay on how he would respond to a colleague who asked him: "Look how well your doctor-patient relationship worked out - why should I follow the ethical standard on this?"

If the intern's medical specialty and medical society held the same standard as the American Psychiatric Association, the relationship he formed with his patient violated the ethics of the profession. But his report of 8 years of happy marriage suggests that the ethics of his personal relationship is excellent. The professional and personal domains overlap, but not totally. Four years ago I argued that the Karolinska Institute in Stockholm did the right thing in expelling a medical student who had been convicted of murder 8 years earlier, even though he performed competently in his student role.

In the U.K. the medical profession does not have a blanket ethical rule against romantic/sexual relationships with former patients. The General Medical Council (GMC), whose role is to "ensure proper standards in the practice of medicine," has formulated guidance about professional boundaries in terms of personal ethics. Recast to eliminate reference to the doctor-patient relationship, the values in the GMC espouses could form the basis of a high school or college class on relationship ethics:

• You must not pursue a sexual relationship with a former patient, where at the time of the professional relationship the patient was vulnerable, for example, because of mental health problems or because of their lack of maturity.
• Pursuing a sexual relationship with a former patient may be inappropriate, regardless of the length of time elapsed since the therapeutic relationship ended. This is because it may be difficult to be certain that the professional relationship is not being abused.
• If circumstances arise in which social contact with a former patient leads to the possibility of a sexual relationship beginning, you must use your professional judgment and give careful consideration to the nature and circumstances of the relationship, taking account of the following:
     (a) when the professional relationship ended and how long it lasted
     (b) the nature of the previous professional relationship
     (c) whether the patient was particularly vulnerable at the time of the relationship, and whether they are still vulnerable
     (d) whether you will be caring for other members of the patient's family

The War Between QALYs and Death Panels

The current issue of the New England Journal of Medicine has an excellent "Perspective" piece by Peter Neumann and Milton Weinstein - "Legislating Against Use of Cost-Effectiveness Informantion." The authors discuss the fact that the health reform bill calls for a Patient Centered Outcomes Research Institute, but specifically forbids it from considering cost per QALY in its work. Here's the gist of their argument:

The antagonism toward costper-QALY comparisons also suggests a bit of magical thinking — the notion that the country can avoid the difficult trade-offs that cost-utility analysis helps to illuminate. It pretends that we can avert our eyes from such choices, and it kicks the can of cost-consciousness farther down the road. It represents another example of our country’s avoidance of unpleasant truths about our resource constraints. Although opportunities undoubtedly exist to eliminate health care waste, the best way to improve health and save money at the same time is often to redirect patient care resources from interventions with a high cost per QALY to those with a lower cost per QALY. At a time when health care costs loom as the greatest challenge facing our country’s fiscal well-being, legislating against the use of the standard metric in the field of cost-effectiveness analysis is regrettable.

The contrast between the relatively grown up approach to health policy in the U.K. and the immature head-in-the-sand approach in the U.S. couldn't be more stark. The National Institute for Clinical Excellence makes explicit use of QALYs - value for human beings per dollar spent. We forbid it.

Still, creation of the Outcomes Institute is a step forward. The legislation caved in to the death panel crowd, but simply establishing and funding an outcomes process is a positive step. As Churchill said, "You can always count on Americans to do the right thing - after they have tried everything else."

We're not fast learners here in the US!

General Practice Leadership in the NHS

A few days ago I wrote about the split in U.S. health policy between concepts of physician-led reform and market-driven/consumer-led reform.

In England, the new Conservative-Liberal Democrat coalition has opted for a degree of physician-leadership that couldn't be imagined in the U.S. It envisions reorganizing the National Health Service around GP consortia that will "commission" (in U.S. lingo, "purchase") secondary health care services for populations of 100,000 to 750,000. Here's what the new government's White Paper says about GP commissioning:

This change will build on the pivotal and trusted role that primary care professionals already play in coordinating patient care...Primary care professionals coordinate all the services that patients receive, helping them to navigate the system and ensure they get the best care (of course, they do not deliver all the care themselves). For this reason they are best placed to coordinate the commissioning of care for their patients...

In the U.K. approximately 50% of the physician workforce is in primary care, and the numbers are holding steady. In the U.S., we've had a 50% drop in the number of medical students going into primary care in the last ten years. I know from interviewing residency applicants that many would prefer to make a career in primary care, but a combination of the monstrous debts they graduate with, the poor compensation of PCPs relative to specialists, and the increasingly harried worklife of the PCP, drive them away.

We in U.S. talk out of both sides of our mouths with regard to primary care. We construct elegant conceptual models for how primary care would ideally function, but we systematically devalue the field through the way we govern our health system.

Given the declining number of primary care physicians, the concept of consumer/patients who coordinate their own care and shop for a package of services to meet their self-perceived needs, is filling a vacuum. Without consciously intending it, we've been putting patients into the position of "disintermediating" primary care physicians as unnecessary middlemen in the care system. The Conservative-Liberal Democrat White Paper dramatizes just how much we've marginalized general practice here in the U.S.

Not every member of our population wants to have a PCP as care coordinator. Millennials have imbibed the internet along with mother's milk, and many take readily to the consumer model of patient care. But Millenial PCPs, along with Millennially-minded older PCPs, know how to partner with activist patients and thrive in that kind of partnership.

Activist patients partnering with primary care physicians is where our health system needs to go.

(To learn more about GP-led commissioning in the National Health Service see this recent New England Journal article, the full government White Paper, or this analysis from the British Medical Association.)

Bloodgate - a Medical Ethics Violation that Wasn't Sexual

If you don't follow international rugby you probably haven't heard about "Bloodgate."

In April, 2009, Harlequins was trailing Leinster 6-5 in the quarter finals of the Heinecken Cup in Twickenham, England. Harlequins Winger Tom Williams suddenly spouted blood from his mouth, which allowed the team to substitute Nick Evans, a specialist kicker, for him. (It didn't work - Evans's kick missed, and Harlequins lost.) But it wasn't blood coming out of Williams's mouth - it was fake blood, from capsule the trainer had given him.

Leinster and the officials were suspicious. In the locker room Williams panicked. He entreated Dr. Wendy Chapman, an emergency room physician acting as team doctor for Harlequins, to cut his lip to provide an alibi. After some hesitation, Dr. Chapman made a small cut in his mouth. Later, when asked about the incident, she testified that a loose tooth had caused the cut.

But a video of the game showed Williams taking the capsule from his sock, putting it into his mouth before the "blood" appeared, and winking at his teammates as he came off the field. The true story came out. Dean Richards, coach of Harlequins, was barred from coaching in the European league for three years. Steph Brennan, the trainer who gave the fake blood capsule to Williams, was suspended for two years. The team was fined 259,000 pounds. And, in September 2009, the UK General Medical Council suspended Dr. Chapman for a year.

At her recent hearing, Dr. Chapman testified that she was awaiting surgery for breast cancer at the time and was suffering from depression at the time, which impaired her judgment. She was deeply ashamed of what she had done and "horrified" that she had lied about her actions.

The GMC could have made the loss of medical licensure permanent, but elected to let her resume practice. The chair of the GMC panel said "Normally such misconduct could be expected to result in a finding of impaired fitness to practise.. However, the circumstances of this case are wholly exceptional in that the expert medical evidence suggests that in the absence of depression you would have not acted in this way." Apparently her prior performance had been without blemish. The GMC interpreted her actions as an aberrant, one-time matter.

In one of my posts about sex between doctors and patients I explained what makes the relationship unethical as follows:

Developing a sexual relationship with a present or former patient tarnishes the profession itself, whatever its effect on the individual patient. Harm to the patient is a probable outcome of doctor-patient sex. But harm to the profession is an inevitable outcome. Patients, the public, and physicians themselves, will lose trust in and respect for the medical profession.

I think the GMC came to the correct conclusion about Dr. Chapman. Assuming that her ethical lapse in the Williams situation was not part of a pattern of unethical behavior, and that her performance as an emergency physician met clinical and ethical standards, there is no reason to see her as a risky bet for future patients. And the harm to public perception of the integrity of the medical profession is not the same as with a sexual relationship. Dr. Chapman's lapse showed human frailty, but did not represent self-gratification or potential exploitation of a patient. A year of suspension and a full public apology is enough.

(To read more about "Bloodgate" itself, see here, here, and here.)

Disgraceful Republican Attacks on Don Berwick

The Republican attack machine is at it again. Here's what they're saying about Don Berwick, President Obama's inspired choice to lead Medicare and Medicaid:

Utah Senator Orin Hatch: "Dr. Berwick has a great reputation as a pediatrician, but he's made some of the most outlandish statements I've heard in years."

Wyoming Senator John Barrasso, who is an orthopedic surgeon: "health care rationing czar."

Texas Representative John Carter: "Dr. Berwick is a proponent of the British health care system and believes in rationing your health care and redistributing wealth."

I assume that as with the preposterous "death panel" demagoguery, these intelligent men know better. Unfortunately, the Republican campaign of disinformation is likely to be effective.

Anyone with even a modicum of understanding of health care knows that the U.S. rations by income and access to insurance. Those with a bit more knowledge understand that rationing is an ethical requirement, not a moral abomination, if we're ever going to slow the cancerous growth of health care costs.

Berwick's consistent message is that by steady concentration on quality we will improve health and save money at the same time. And, if it is still necessary to contain costs, which it will be, we should ration in a thoughtful manner, concentrating on high cost/low yield areas, rather than on the purely economic grounds we apply at present.

Claiming that rationing (a) does not happen now and (b) is part of a Democratic plot is (c) in line with the Republican claim that reducing taxes on the wealthy will help to lower the deficit. But telling lies in a tone of certainty, and repeating the lies often enough, has proved, alas, to be a effective partisan tactic.

Attacking Berwick for his recognition of the admirable accomplishments of the National Health Service plays well with American exceptionalism and jingoism. But encouraging the body politic to believe that we have nothing to learn from others is like parents telling children they already know enough so why bother with reading or arithmetic.

Health care ethics requires open mindedness and thoughtful deliberation. The Republican tactics are like shouting "fire" in a theater. Insofar as their campaign of fear and disinformation is listened to it will block meaningful health reform and quality improvement.

I hope the administration can orchestrate bold public statements by all of the hospitals and clinics Berwick and his Institute for Healthcare Improvement have helped. The public trusts doctors and nurses more than politicians. The stories these organizations can tell would show the Republican attacks to be disgracefully ill-informed, disgracefully partisan, or both.

Can we Discuss "How Much is Life Worth" without going ballistic?

I've been invited to speak next week at a conference based on the article by Tito Fojo and Christine Grady ("How Much is Life Worth: Cetuximab, Non-Small Cell Lung Cancer, and the $440 Billion Question") that I wrote a post about three weeks ago. The opportunity has led me to a clearer perspective on the currently undiscussable topic of health care rationing.

Fojo and Grady's central argument - that we in the U.S. should rein in our expenditures on interventions that produce small benefits at enormous cost is so obviously correct that the question to ask is not "are they right?" but rather "what's preventing us from doing what we so obviously need to do?"

I've thought about that question in light of the decision process that NICE (National Institute for Health and Clinical Excellence) uses for the guidance it provides to the National Health Service. NICE has created an elegant approach to setting limits. The logic of NICE's process is simple. (1) The National Health Service has a budget. (2) Every expenditure has an an opportunity cost and should be compared to alternative uses of the funds. (3) For selected new interventions, NICE reviews the evidence about its clinical effectiveness. (4) If the intervention offers clinical benefit NICE asks how much those benefits cost, defined as cost/QALY (Quality Adjusted Life Year). (5) NICE applies a template of social value judgments to the facts that emerge from its analysis. (6) The template includes a threshold range (20-30 thousand pounds/QALY) to guide decisions and a framework for deciding when and how to make exceptions to the threshold. (7) The entire process is conducted in a public manner, with opportunities to see the reasoning behind the conclusions and to raise challenges.

NICE fine tunes its approach over time, but its fundamental logic is sound. The impediment to us in the U.S. doing what Fojo and Grady urge us to do is not the absence of a method for deciding about the worth of marginal benefit. Any country ready to tackle rationing could take NICE's procedures off the shelf, study them, and adapt the process to its own culture and institutions.

The key word here is "ready." And, as Hamlet told us, "readiness is all!"

Experienced psychotherapists teach that the hardest job in treatment is dealing with the resistances to change. Once these impediments have been worked with well enough change almost takes care of itself. That model applies at the level of social process as well.

In my talk I'll take Fojo and Grady's argument as the starting point. They're obviously right. The folks at the conference are predisposed to agree - that's why they invited me. I'm going to suggest that making decisions about marginal benefit is, at heart, not all that difficult. NICE shows us how to do it. The task for all those who agree with Fojo and Grady is not to persuade others to see the same truth, but to chip away at the impediments to seeing the obvious. I'll write more about chipping away impediments in future postings.

(See here for NICE's Social Values Judgments report and here for reports from the Citizens Council.)

Praying with and for patients

I recently attended an inspiring forum sponsored by Andover Bread Loaf, "a private, non-profit organization based at Phillips Academy in Andover that works with U.S. and international public and private school teachers and students to enhance the teaching and learning of writing and to help catalyze educational renewal in classrooms, schools, school systems, and communities."
Teachers from New Orleans described programs they are developing in an effort to rebuild education and community after the Katrina disaster. A young teacher ended her presentation by saying - "if you pray, please pray for my students."

Her request got me thinking about a patient of mine with chronic schizophrenia who I had seen intermittently for several years, a sweet man who - though quite impaired by his ailment - radiated honesty and integrity. He was going through a bad patch in which his baseline anxiety and paranoia were more severe. We reviewed stressors, coping mechanisms and medication. As he left the office he said "please remember me in your prayers." I immediately replied "I will."

I've thought a lot about my response. I don't do petitionary prayer and don't believe in a divine being who might listen and respond. But I felt that I was being truthful with my patient. I interpreted his request to mean something like "I want you to care deeply about my well being," and because I did, my reflexive response was to confirm that I would indeed remember him in my prayers. If he had said "when you go to bed tonight please go onto your knees and ask God to make me better" I would have said something like "doing that isn't my custom, but I hope you know that in my heart I wish for you to be well..."

The U.K is in the midst of a flap about the ethics of prayer in the context of clinical care. Earlier this year a nurse, Caroline Petrie, was temporarily suspended for asking a patient whether she would like to be prayed for. The incident was widely publicized. Comments were highly polarized, some attacking "absurd political correctness" and "discrimination against Christians" while others found "invoking a non-existent deity in the course of medical care is foolish at best and potentially offensive."

This month the following motion will be brought to the British Medical Association:

That this Meeting:

• (i) recognises that the NHS is committed to providing spiritual care for patients;
• (ii) notes the position on inappropriate discussion of faith matters in GMC Guidance on Personal Beliefs and Medical Practice;
• (iii) while welcoming the constructive and necessary advice in the document "Religion or belief", is concerned that some paragraphs suggest that any discussion of spiritual matters with patients or colleagues could lead to disciplinary action;
• (iv) believes that offering to pray for a patient should not be grounds for suspension;
• (v) calls on Health Departments to allow appropriate consensual discussion of spiritual matters within the NHS, when done with respect for the views and sensitivities of individuals.

My guess is that one of the paragraphs of concern to those who are bringing the motion to the BMA is the following:

Proselytising

Members of some religions, including Mormons, Jehovah’s Witnesses, evangelical Christians and Muslims, are expected to preach and to try to convert other people. In a workplace environment this can cause many problems, as non-religious people and those from other religions or beliefs could feel harassed and intimidated by this behaviour. This is especially the case when particular views on matters such as sexual orientation, gender and single parents are aired in a workplace environment, potentially causing great offence to other workers or indeed patients or visitors who are within hearing. To avoid misunderstandings and complaints on this issue, it should be made clear to everyone from the first day of training and/or employment, and regularly restated, that such behaviour, notwithstanding religious beliefs, could be construed as harassment under the disciplinary and grievance procedures. Where one or more people from the same religion are working in the same environment, an individual could be pressured to conform to certain religious practices, which is again a form of harassment. There may also be differences of opinion on conformity within groups, for example between orthodox and reformed branches of certain religions, which could cause tensions and make an individual feel under pressure because of his or her religious beliefs.

If Ms. Petrie was trying to convert her patient the suspension would have been warranted. If her patient had asked to be prayed for it would unquestionably have been reasonable to agree to do so.

But what about offering to pray, which is what Ms. Petrie did?

If I were in charge of policy for Ms. Petrie's district or for the NHS I would find it hard to make a rule about offering to pray for a patient. It's clear from multiple research studies that when patients feel that their clinician genuinely cares about them they do better. If Ms. Petrie had a gentle, unintimidating manner, knew that her patient liked to pray and said "I'm a person who likes to pray for those I care about...would you like me to include you in my prayers tonight?" I would find that acceptable. But if she asked in a strong way "would you like me to ask Jesus to touch you with his healing hand?" I would find the episode unacceptable.

It's not a matter of the clinician's freedom of speech or religion. The guiding principle is that we clinicians should shape what we bring into the care relationship based on a reasoned judgment of what's best for the individual patient. (A "reasoned judgment" can come rapidly, as for me with the patient I agreed to remember in my prayers.) It would be wrong to forbid responding to a request to be prayed for. And I would not want to legislate that no clinician should ever offer to pray for a patient, but I would want my colleagues to be capable of distinguishing between their own beliefs about what is best for others (for example, belief in Jesus, Buddha, Allah or in no god) and a thoughtful assessment of what is best for this particular patient.

That's what clinical responsibility entails. But if clinicians at a hospital or in a district were blurring the boundary between preaching and caring, a prohibition would be required.

Drs. Elton and Sanchez Get it Right

I've taken the liberty of copying two letters from today's New York Times. The AMA's ongoing resistance to progressive reforms has given physicians a bad name, so it's a pleasure to see the wisdom of these letters coming from the heartland:

To the Editor:

As a physician, I see every day the type of overuse of medical care described in “Something’s Got to Give in Medicare Spending” (Economic View, June 14).

But the column took too narrow a view in asserting that “the financial incentives for doctors and medical institutions to recommend more procedures” are the chief driving force behind the high cost of care; non financial incentives are at least as strong.

Much has been written about defensive medicine, wherein physicians order additional, and often unnecessary, tests to avoid being sued. Even without the threat of lawsuits, I suspect that this practice would continue. Physicians don’t want to miss things, lawsuits or not. There are also times, perhaps due to the harried nature of medical decision-making, when ordering tests takes the place of careful consideration of a test’s usefulness or the likelihood of an important finding.

Patients are also often insistent on having tests, just as they are insistent on getting prescriptions for the latest, greatest drugs they saw advertised on TV.

Reining in this overuse of care thus goes against the perceived interests of both physicians and patients. Necessary as it may be, changing these attitudes will be difficult.

Eric Elton, M.D.

Evanston, Ill., June 15

To the Editor:

Universal coverage, cost control and quality medical care are essential but insufficient to achieve good health in our nation. As the column stated, factors including where and how we live, as well as social standing, are the significant determinants of health.

Until we begin to seriously address those factors, worsening health status and a growing burden of preventable chronic disease will exceed the health system’s ability to adequately deliver necessary care — health care reform notwithstanding.

Eduardo J. Sanchez, M.D., M.P.H.

Dallas, June 17

The writer is vice president and chief medical officer of Blue Cross and Blue Shield of Texas.

Dr. Elton correctly identifies how poorly we physicians deal with uncertainty as a major driver of runaway costs. And he's right linking our penchant for throwing the kitchen sink at patients to "rule out XYZ" to the "harried nature" of medical practice.

In the 1990s I spent a full day with each of three outstanding GPs in London. Since the average consultation time in the NHS was less than 10 minutes I wondered how they handled their practices. The answer was - they leveraged time and the relationship better than we Yanks do.

With symptoms that could, conceivably, represent what doctors-in-training call a "zebra" (an obscure and frightening but exceedingly rare cause of the symptom), they said - "Here's what I think is going on and here's what I think will happen if we do ABC...Let's try it for two weeks. If things don't work as I expect, please come back to see me..."

Dr. Elton is also right that patients often "insist" on having tests and drugs that aren't necessary. That's where time comes in. A key part of good medical practice is education. Doing a scan or prescribing a branded drug that isn't necessary is harmful, not neutral. Apart from the radiation exposure scans can show "incidentalomas" - findings that look funny but don't mean anything and lead to further unnecessary tests. And unless the patient is paying full freight for the unnecessary branded drug, we're using money that could be put to better use in other ways.

Dr. Sanchez correctly points out that focusing on medical care is a relatively small part of what our nation needs to do to improve health and contain health care costs. Happily, we're beginning to see ideas like keeping high sugar drinks and foods out of school cafeterias and even imposing taxes on foods that are driving the epidemic of obesity and diabetes.

A lot of the success in the effort to improve quality and reduce costs will be driven by what our federal and state governments do. But if we physicians comported ourselves in accord with the common sense wisdom that Drs. Elton and Sanchez propose that would accomplish even more!

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.

NICE is teaching the world about health care limits

Today's New York Times has a fascinating article about the firestorm triggered by NICE's decision not to cover Sutent, an cancer drug that may extend life of kidney cancer patients for 6 months, but at a cost of $54,000.

The article shows that NICE is the world's leading teacher about the ethical imperative for societies to set health care limits. I've quoted some excerpts from the article (in italics) followed by my comments.

"'Everybody should be allowed to have as much life as they can,' Joy Hardy [wife of Michael Hardy, who has kidney cancer] said...'It's hard to know that there is something out there that could help but they're saying you can't have it because of cost...What price is life?'"

Mrs. Hardy is profoundly right - deciding not to cover Sutent is a tragic choice. In terms of Albert Schweitzer's concept of reverence for life, the answer to the question "what price is life?" is - "it's priceless." But in economic terms, it's not.

Some years ago, Lester Thurow, then Dean of MIT's Sloan School of Management, suggested that we think about this kind of decision in terms of how much human labor the cost represents. $54,000 is a bit more than the average annual wage in the U.K. Asking "is it right to require John Doe to turn over his entire year's earnings to give Mr. Hardy a chance to live 6 more months?" feels significantly different than asking "should we allow a bureaucrat to sacrifice Mr. Hardy for $54,000?" Money isn't paper - it's ultimately human labor. We should have reverence for John Doe's life as well as Mr. Hardy's.

"Even in the United States, rising costs have led some in Congress to propose an institute that would compare the effectiveness of new medical technologies, although the proposals so far would not allow for price considerations...the idea of using price to determine which drugs or devices Medicare or Medicaid provides has provoked fierce protests."

The idea that we would forbid our government to consider cost - in other words, say that even if 100 or 1,000 John Does had to sacrifice their entire annual income they would have to do so to provide a chance for 6 more months of life - is so preposterous that it calls to mind Schopenhauer's famous comment about a philosophical assertion he found equally preposterous: "As a serious conviction it could be found only in a madhouse; as such it would then need not so much a refutation as a cure."

With regard to our public discourse about health policy, the U.S. is indeed a madhouse!

Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins (director of NICE) and his institute to terrorists..."

This kind of Karl Rove take-no-prisoners rhetoric from a well paid PhRMA shill shows what NICE and its leadership is up against. I hope Michael Rawlins has a thick skin and a good sense of humor.

"Dr. Rawlins said he was frustrated that his institute had been censured instead of the drug company executives who set sky-high prices."

He's right to be frustrated!

Anyone who has brought up children knows how difficult it is to teach about limits and sharing. It takes patience, firmness, love and understanding the cost to the child of not learning. Children don't thank us. Like the hypocritically named "Center for Medicine in the Public Interest" they call us the equivalent of terrorists.

NICE is the kind of teacher the developed world - especially the U.S. - needs. Let's hope Michael Rawlins and his colleagues can keep up the good work!

Catholic & Secular Values in the British National Health Service (2)

In December I wrote about conflict over reproductive ethics at "John and Lizzie's," a well-known Catholic hospital in London.

The Hospital of St. John and St. Elizabeth, founded by the Sisters of Mercy in 1856, is known as a celebrity hospital. Cate Blanchett, Emma Thompson, Kate Moss and Heather Mills-McCartney have all had babies there. The media describes John and Lizzie’s as "the poshest place to push." The hospital is under the governance of the Catholic church, but has been operating as an independent entity, funded by the NHS, self-paying private patients, private health insurance companies, and charitable donations.

In 2007, Cardinal Cormac Murphy O’Connor, head of the Catholic Church in England and Wales, had laid down the law to John and Lizzie’s: “There must be clarity that the hospital, being a Catholic hospital with a distinct vision of what is truly in the interests of human persons, cannot offer its patients, non-Catholic or Catholic, the whole range of services routinely accepted by many in modern secular society as being in a patient's best interest."

In February 2008, Cardinal O'Connor asked for, and received, the resignation of the entire Board. Lord Guthrie of Craigiebank, a former Army Chief of Staff, and Vice President and Knight of the Sovereign Military Order of Malta, an ancient Catholic military order that now focuses on medical charity work around the world, was appointed as the new Board chair.

This week the Board adopted a new code of ethics. In accord with Catholic teaching the code specifies that euthanasia, sex change operations, IVF, pre-natal testing by amniocentesis, sterilizations, fitting of IUDs, and direct provision of abortion are forbidden. It does not mention, however, referrals for abortion, prescriptions for contraceptives or the morning after pill. This means that doctors and nurses at the hospital and in the National Health Service practice based at the hospital could refer patients elsewhere for these services without violating the hospital's ethics code.

Nicholas Bellord, of the Restituta Group (named for St. Restituta, who was martyred in the 4th century, but miraculously saved from fire by the intervention of an angel) which has been lobbying hospital officials to retain its Catholic pro-life policies, complained that "It will be possible for a woman to attend this hospital and be counseled to have an abortion and for her to believe, not unreasonably, that she has the blessing of the Roman Catholic church."

Lord Guthrie spoke about how doctors and nurses would operate under the new code as follows:

"The confidentiality of their consultations with patients must be respected, as must the confidentiality of the advice which they offer to patients in accordance with their professional and legal obligation.

The hospital, however, cannot condone or permit practices in its name which conflict with Catholic teaching on the sanctity of life or respect for the human person."

As I understand his comments, Lord Guthrie is doing an admirable piece of ethical balance. His assertion that the hospital cannot "permit practices in its name..." clearly affirms Catholic teachings. But his comments about the staff's "professional and legal obligation[s]" recognizes pluralism.

In the U.S. fundamentalist terrorists have murdered abortion providers and intimidated those who oppose them. If I understand Lord Guthrie correctly I see him as doing God's work. He has found a path to fidelity to his church's teachings without casting those of good conscience who hold different views as murderers. We in the U.S. need more of Lord Guthrie's combination of fidelity to our beliefs and pragmatitic acceptance of of differing moral perspectives. That's what democratic pluralism requires.

Straight Talk About Rationing in the British National Health Service

We Yanks can only gasp with admiration at the candor of National Health Service leadership and the British media on the resource allocation practice that dare not speak its name in the U.S. - rationing.

Two recent articles in The Independent (here and here) describe at length how UK patient advocacy groups have blasted NICE (National Institute for Health and Clinical Excellence) for refusing to cover certain expensive pharmaceuticals.

"Rationing" is a dirty word in U.S. public discourse. Sadly, almost all U.S. political leaders (with the exception of former Oregon Governor John Kitzhaber) speak of rationing as a moral crime, only contemplated by "uncaring bureaucrats" or "greedy insurance companies." In The Independent, journalist Jeremy Laurance describes rationing more accurately as an ethical imperative:

"NICE is a rationing body, established in 1999 to ensure the cash-limited NHS gets best value for money from the profit-driven pharmaceutical industry. It aims to establish not only whether a drug is effective, but whether it is more effective than existing drugs and, if so, whether it is worth the extra price (£1,000 spent on a cancer drug means £1,000 less for nursing care for cancer patients).

NICE is merely a mechanism for sharing out a limited budget. The real argument should be between the people (who want the drugs), the pharmaceutical companies (who set the prices) and the Government (who fixes the NHS budget)."

The Independent articles go further. The ostensibly grassroots patient advocacy groups that have blasted NICE receive substantial support from the pharmaceutical industry. For example, the National Kidney Federation, which called NICE's turning down four kidney cancer drugs "barbaric, damaging and unacceptable," receives half of its budget from industry. Here's what Laurance has to say about conflict of interest for the advocacy groups:

"The extent of the drug companies' support for the smaller charities has led to criticisms that supposedly grassroots patient organisations are puppets of the pharmaceutical industry, being used to bludgeon NICE into making the drugs available on the health service. A positive decision by NICE on a drug not only guarantees sales to the NHS but can influence global markets worth billions of pounds.

Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns.

Timothy Statham [chief executive of the National Kidney Federation] said 'We receive sponsorship from as many of the renal industries as we can possibly sign up. We take the view that by having all the pharma and machine-maker companies on board, we cannot be subjected to overbearing influence by any one of them.'

That leaves unanswered the question of whether accepting funding from any company compromises a group's ability to question the behaviour of the industry as a whole. The way in which NICE is pilloried by patient groups, while the drug companies are ignored, suggests a reluctance to bite the hand that feeds them."

The Independentcited an August interview with Sir Michael Rawlins, chairman of NICE. Rawlins and his agency are accustomed to attack. Their government sanctioned role is to make evidence-based tough decisions. Perhaps the Kidney Federation's term "barbaric" got his goat. His response was polite, but clear: "We are told we are being mean all the time, but what nobody mentions is why the drugs are so expensive...We have a finite amount of money for healthcare, and if you spend money one way you can't spend it in another."

Transparency and candor don't make painful decisions any less painful. But the U.S. should take pages from the British book. If we can't talk honestly about resource limits and rationing we will continue our spiral of out of control costs, massive numbers of uninsured citizens, and mediocre health indices.

Let's hope that the recent meltdown of the financial sector will help us in the U.S. move out of La-La Land into the real world in our approach to health and health care.

The Rule of Rescue in the British National Health Service

Today's Daily Telegraph (here and here) bitterly attacks NICE (the National Institute for Health and Clinical Excellence) for not adopting the rule of rescue. Here's the gist of the attack (put together from the two articles):

[NICE] has now rejected the so-called "rule of rescue" which stipulates that people facing death should be treated regardless of the costs. The rule is based on the natural impulse to aid individuals in trouble.

Surely its latest pronouncement to the effect that patients should not expect the NHS to save their lives if the treatment required to do so would be too expensive, must be designed to be so outrageously offensive as to deliberately discredit the whole principle of healthcare funded through taxation.

No? Then what on earth could its members have been thinking when they laid down a ruling that doctors and nurses were to defy the most fundamental moral inclination, not only of the medical professions, but of the human community: to do whatever is necessary to save an individual life in one's care?

The Telegraph's reaction is psychologically understandable, but logically preposterous.

I've been attacked in the same way almost every time I've discussed rationing. Physicians like to say - "with my patients, the only thing for me to consider is providing what my patients need."

My response to this kind of feel-good nonsense is often - "Doctor, that's admirable! I suppose it means that if your patient needs a heart transplant, and you are the only good match, you will donate your heart. Did I understand you right?"

As societies, we must learn how to recognize that life is a blessing, invaluable to each of us, but in economic terms life isn't priceless. In the U.S., our inability (thus far) to achieve this maturity of perspective is the major impediment to controlling our runaway health care costs.

If working people had been able to put into the bank the difference between per capita health care costs in the U.S. compared to the next costliest developed country, many of those losing their homes to foreclosure would be able to pay there mortgages. The smug moralising about NICE that we see in today's Telegraph (which is more characteristic in U.S. than U.K. political discourse) may make the moralist feel virtuous, but the end result is deeply injurious to the population.

In "Setting Limits Fairly: Learning to Share Resources for Health," Norman Daniels and I discuss these issues at much greater length (232 pages). But I think the basic point can be said in eight words: "life is a blessing, but blessings aren't priceless."

I'll discuss "Social Value Judgements: Principles for the development of NICE guidance" (the document the Telegraph is attacking) and the excellent NICE Citizens Council Report "Rule of Rescue" at greater length in the next couple of weeks.

Immigrants, Refugees, and Medical Ethics

After I wrote yesterday's post about refugees and asylum seekers in the British National Health Service, I read a remarkable article in the New York Times about Luis Alberto Jimenez.

Eight years ago, Mr. Jimenez, an illegal immigrant working as a gardener in Florida, was hit by a drunk driver, resulting in severe traumatic brain injury. Martin Memorial Hospital provided care. Given that no insurance coverage was available, Martin was unable to find a rehabilitation placement for Mr. Jimenez. They kept him in the acute hospital, accumulating a bill of $1.5 million. In the midst of litigation about returning him to Guatemala, which his U.S. guardian was resisting, the hospital hired an air ambulance and flew him back.

While accurate figures aren't available, hospital initiated deportations are not uncommon. Advocates for Mr. Jimenez accuse Martin Hospital of "dumping," but it is hard to see how an individual hospital can be expected to provide open-ended financing in circumstances like that of Mr. Jimenez.

An article in this month's Bulletin of the World Health Organization puts Mr. Jimenez's situation into a global context. 200 million or more people are living outside of their country of birth. Access to health care and the question of who will pay is a problem everywhere.

What we're seeing now is the way ethical problems roll downhill when wider societies choose to ignore them. In the U.K., GPs are asked to violate their most fundamental ethical commitments by refusing to treat undocumented immigrants. In Florida, Martin Hospital is asked to finance Mr. Jimenez's care in an open-ended way. Neither request is ethically justifiable.

The U.S., U.K., and every country that receives legal and illegal immigrants need to address the issues openly. International organizations like the WHO are crucial for helping to establish shared expectations and a broad ethical framework. The rehabilitation hospital in Guatemala that Mr. Jimenez was initially transferred to has an annual budget of $400,000, but appeared to provide excellent care. Rather than saddle Martin Hospital with a $1.5 million bill for inappropriate acute care, all parties would have been better served by a U.S.-Guatamala plan for augmenting services in Guatemala.

GP resistance to making them the agents for a National Health Service problem helps to push the complex ethical issues up to where they belong. In the hospital sphere, the American Hospital Association should do the same, so that hospitals like Martin are not forced to choose between financial ruin and spiriting patients out of the country in James Bond fashion.

British GPs Demand Right to Treat Refugees

In January I wrote (here) about GP resistance to a proposed National Health Service directive that they not treat asylum seekers or undocumented migrants. I concluded:

[W]e should cheer for the petition signers. Refusing to care for sick people – whatever their status – violates fundamental medical, and human, values. A policy that orders health professionals to abandon their historical commitment to provide care is not acceptable.

Since then a British physician friend told me that many doctors are simply ignoring the NHS policy.

An article in today's Guardian reported that the Department of Health has not revealed the extent of advice it has received criticizing the policy. Typically these advisories are made public shortly after submission. The Global Health Advocacy Project obtained a list of those who had submitted comments and obtained most of the materials. (available here) Among these, the submission from Ken Livingstone, the former Mayor of London is especially interesting. Livingstone agrees that well-to-do foreigners who come to the U.K. to seek free NHS treatment can legitimately be charged for care, but argues that asylum seekers and undocumented migrants should be eligible on the basis of medical ethics and public health concerns.

The intersection of globalization and health care will create ever more ethical challenges. Developed countries are siphoning health professionals from poorer locations. In this situation, the rights of individual health professionals to pursue their own interests clash with the health needs of the home countries. Medical tourists from wealthy countries are travelling for care to all sectors of the globe. In that situation, their rights as individuals to seek care where they want it is distorting access to care in the countries they visit.

The British GPs are right in resisting the NHS policy. While it is understandable that local taxpayers, whether in the U.K., U.S., or elsewhere, are reluctant to subsidize care for foreigners, asking nurses, doctors, and others, to act as immigration police, risks undermining the integrity of our own health systems and health care.

Experimental Cancer Treatments in the National Health Service

Today’s Times of London has a poignant article by Andrew Lawson, a 48 year old pain medicine consultant in the British National Health Service and lecturer in medical ethics at Imperial College, about his own quest for cancer treatment. The story he tells raises large questions about health system ethics.

Seventeen months ago Dr. Lawson was diagnosed with mesothelioma, a rare cancer of the lining of the lung, caused by exposure to asbestos. Median survival after diagnosis is 12 months. Currently available treatments don’t work well. Mesothelioma is a bad cancer.

What follows is three excerpts from his article (in italics) followed by my comments:

1. After the diagnosis, Dr. Lawson saw three lung surgeons who gave him three different opinions, all delivered with the same degree of certainty. Here’s Dr. Lawson’s reaction:

“Doctors should discuss what is available and best for the patient, but some are tempted, subconsciously perhaps, to dress up opinion as fact. How many surgeons will tell you if a number of their peers don’t agree with them? That is not to say they don’t have your best interests at heart. It is just that the solution is preordained, the script written…When evidence is poor, what you get depends upon whom you see. So how can you make an informed decision in the absence of information? If your doctors do not know what is best, how can they advise?”

Sadly, this is true on both sides of the Atlantic, and probably throughout the world. It is difficult for physicians to integrate the pervasive uncertainties of medical practice with the intense responsibility we feel for our patients. This leads us to project more certainty than is warranted – sometimes with the rationale that our confidence will increase the likelihood that the treatment will succeed (placebo effect), and sometimes to assuage our own anxieties.

Good ethics require that – with rare exceptions – we should tell it like it is. In my practice I often imagined a panel of ten experts in the situation the patient and I were discussing, and made an educated guess as to the range of opinions they would express. I had at least one experience in which I told the patient my view, and explained that in all likelihood at least nine of the hypothetical experts, perhaps all ten, would disagree, and why.

Here Dr. Lawson is identifying a problem best addressed by professional education and clear ethical guidance from professional societies, combined with an understanding of what the public expects of us.

2.

“There is a lot of talk about ‘choice’ on the NHS, but my experience as a patient has taught me that the choice you get is a choice of what you are offered…if a doctor knows of a better treatment but it is available only in the wicked private sector outside the health service, he or she is not supposed to tell you about it, on pain of disciplinary action.”

I have no independent knowledge as to whether this is a true statement about the NHS. I hope it isn’t. Dr. Lawson’s critique is reminiscent of the infamous “gag rule” that some misguided managed care programs imposed in the 1990s – that physicians should not tell patients about treatments that would not be covered by the insurance! Steffie Woolhandler and David Himmelstein made this practice infamous in their 1995 New England Journal of Medicine article “Extreme Risk – the New Corporate Proposition for Physicians."

I’ve heard non-disclosure defended on the basis of not causing pain for patients with regard to options their insurance will not cover that they could not afford. But obviously individuals should not be denied the opportunity to advocate/appeal and to seek other ways of gaining access to a treatment they believe is right for them. I am a strong supporter of the need for insurance programs – whether the British NHS or a US health insurer – to set limits. But those limits must be explicit, and patients need to be told about the universe of legitimate treatment alternatives.

3.

“Looking at what ‘treatments’ were available, I came across a group led by Dr Dan Sterman at the University of Pennsylvania working on an experimental method of treating mesothelioma. Using genetically modified viruses, they make the body attack the malignant cells. It is unproven and in the early stages of clinical trials, but they have had some success in small numbers. The science behind it is appealing, it does not involve killing healthy cells as with conventional chemotherapy, and it does not involve surgery so radical that the surgical team cannot decide which bit of the patient to send to the recovery ward and which to the pathology lab…Trials of new drugs or therapies might make all the difference to people with a cancer that is difficult to treat. So why shouldn’t patients in the NHS be able to try such innovative trials in the US — or elsewhere — if they wish?”

If I or a family member had mesothelioma I - like Dr. Lawson - would want to explore the Phase I University of Pennsylania trial. I might well want to participate if I was eligible. But should insurance pay for such a trial?

In the US a number of states mandate coverage for Phase I cancer trials. In principle I believe it would be better to have participating in a trial paid for by research funds. The kind of trial Dr. Lawson is participating in is an educated guess. The treatment may be effective, but we don't know. It might even turn out to be harmful. It is difficult enough to try to educate the public about the concept of evidence based medical practice without further confusing the situation by covering treatments that by definition do not have an evidence base.

As medicine becomes more global, more and more patients will want to participate in experimental trials in other countries. Insurers will find it next to impossible to distinguish "reputable" from "sham" trials. As much as I empathize with Dr. Lawson's wish to participate in the Pennsylvania trial and agree that patients "should be able to try such innovative trials," I can't agree that this kind of support for research should be the financial responsibility for a health care system.

Topping-up: Medical Ethics, Equity, and Rationing, in the National Health Service

The British National Health Service is facing an important moment in the global debate about medical ethics, rationing, and equity.

Yesterday’s New York Times described a UK conflict about “topping-up” – buying services above and beyond what the NHS covers. The story is confusing. As I understand it, NHS policy is, at one and the same time, admirably honest and troublingly muddled.

Debbie Hirst has had breast cancer since 1999. It spread. Her doctors advised her to try Avastin, a drug approved by the FDA for advanced colon and lung cancer, but not for breast cancer. The National Health Service does not cover Avastin, and Ms. Hirst has sought to obtain it on a self-pay basis.

(By coincidence, the FDA may decide today about Genentech’s controversial application for breast cancer approval. For an excellent statement opposing approval, see Maggie Mahar’s Health Beat blog.)

This is the admirably honest part of the story. The NHS has made an explicit rationing decision, something we in the US, always excepting the original Oregon Health Plan, haven’t had the guts to do openly. We prefer to leave 47 million uninsured and to claim sanctimoniously that while the UK rations, we don’t. The NHS has concluded that on the basis of what we currently know about Avastin for breast cancer, there are better uses of NHS funds and it should not be covered.

I am not an expert on Avastin, and have not reviewed the primary source data. But I do know about fair process for setting limits. The NHS is a model. The key components of fair process are honesty, openness, and humility. Honesty requires that the rationale for policy must be clearly stated. Openness requires that the rationale be readily available to the public. Humility requires opportunity for critique, appeal, and new learning. It is more ethical by far to set an evidence-based limit on what is cost-worthy for collective funds as the NHS does than to pretend that rationing is an evil and to ignore 47 million uninsured as we do.

Unfortunately, at least to my reading, the NHS is muddled about the ethics of topping up. Debbie Hirst and her doctors were told that if she bought uncovered services outside of the NHS she could not use the NHS for what it does cover. The health secretary is quoted as saying:

"Patients cannot, in one episode of treatment, be treated on the NHS. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs...That way lies the end of the founding principles of the NHS."

This seems wrong. We may believe that wealth is distributed unjustly, but that is not the fault of the NHS. Collective funding should be governed by considerations of cost-worthiness. Making that determination is technically and ethically challenging. But it is what every 21st century society will ultimately have to do. Individuals should then be free to use their own funds, as for Avastin.

Setting limits on what collective funds will pay for is not intended to preclude the use of private funds. That doesn't make conceptual sense, and will certainly not be acceptable politically. This piece of muddled limit-setting process is sure to be seized upon by those who want to claim that health care rationing is a moral abomination, not, as is really the case, an ethical necessity.

(Readers who want to delve into the details of topping-up should read "Free at the point of delivery - reality or political mirage?" by members of the UK group Doctors for Reform.)

Civil Disobedience in the British National Health Service

This week the UK government considered ruling that GPs in the National Health Service will no longer be allowed to provide treatment to asylum seekers or undocumented migrants.

During the same week, in a highly publicized case, the UK deported 39 year old Ama Sumani to Ghana. Ms. Sumani had come to the UK on a student visa, but had overstayed and was working when, in 2006, she developed multiple myeloma. She developed kidney failure and was on dialysis in Wales when she was deported. Immigration officers escorted her back to Ghana, but the supposed plan for continued dialysis collapsed when Ms. Sumani was not able to make the required $5,000 deposit. The payment was made by a concerned individual in the UK, so three months of dialysis is now assured.

A Lancet editorial described the deportation as “an atrocious barbarism,” and chided medical leaders for not coming forward against it. In response, a petition signed by 276 GPs declared:

“This would impose serious health risks on [undocumented migrants] and on the general public. It would also interfere with our ability to carry out our duties as doctors. It is not in keeping with the ethics of our profession to refuse to see any person who may be ill, particularly pregnant women with complications, sick children or men crippled by torture. No one would want such a doctor for their GP.

We call on the government to retreat from this foolish proposal, which would prevent doctors from investigating, prescribing for, or referring such patients on the NHS.

We pledge that, in the event this regulation comes into effect, we will: (a) continue to see and examine asylum seekers and to advise them about their health needs, whatever their immigration status; (b) document their diagnoses and required clinical care; (c) with suitable anonymisation and consent, copy this documentation to the responsible ministers, [members of parliament] and the press; (d) inform the public of the human costs, to harness popular disgust at what is being ordered by the government in their name; (e) campaign to speedily reverse these ill-advised policies.”

The European Union is facing a real problem. Citizens of poorer countries, not surprisingly, are coming to EU countries in hope of receiving needed treatment that is not available at home. Others, like Ama Sumani, become ill after their [illegal] migration. As we are seeing in the U.S., there is a public backlash against undocumented migrants.

But we should cheer for the petition signers. Refusing to care for sick people – whatever their status – violates fundamental medical, and human, values. A policy that orders health professionals to abandon their historical commitment to provide care is not acceptable.

Catholic & Secular Values in the British National Health Service

Four days ago I discussed the conflict over reproductive health care at Lutheran Health Center in Wheat Ridge, Colorado. This posting is about a similar conflict currently unfolding at “John and Lizzie’s” in north London.

The Hospital of St. John and St. Elizabeth, founded by the Sisters of Mercy in 1856, is known as a celebrity hospital. Cate Blanchett, Emma Thompson, Kate Moss and Heather Mills-McCartney have all had babies there. The media describes John and Lizzie’s as "the poshest place to push." The hospital is under the governance of the Catholic church, but has been operating as an independent entity, funded by the NHS, self-paying private patients, private health insurance companies, and charitable donations.

Debate about abortion has been much less virulent in the U.K. than the U.S. Last year a British journalist wrote, with some satisfaction, “Over here [in comparison to the U.S.], abortion can be a medical issue and a psychological issue; it can be an issue of social ethics.”

For reasons unclear to me on this side of the Atlantic, the tone of British debate is heating up. Cardinal Cormac Murphy O’Connor, head of the Catholic Church in England and Wales, laid down the law to John and Lizzie’s: “There must be clarity that the hospital, being a Catholic hospital with a distinct vision of what is truly in the interests of human persons, cannot offer its patients, non-Catholic or Catholic, the whole range of services routinely accepted by many in modern secular society as being in a patient's best interest."

In response, Dr Martin Scurr, founder of the Portobello Clinic in Notting Hill, and a director at the hospital, shot back a strong response: “I am convinced that the Cardinal has been badly advised, as so often has happened with the Catholic Church. Expert advisers have been chosen who give the hierarchy of the church the answers they wish to hear ... in the matter of modern medical care the cardinal has chosen to listen to individuals who have no specific expertise in that arena…we are now in an era where the Catholic Church must withdraw from involvement in frontline healthcare here in the UK, as it appears to be unable to reach the degree of tolerance that has been reached elsewhere in the world." When the hospital adopted the code of ethics demanded by the Cardinal, Scurr and another director resigned. The board chair is expected to join them next week.

Notice two things about the British debate. First, the Cardinal acknowledges that the reproductive services current church teachings preclude are “routinely accepted by many…as being in a patient’s best interest.” He acknowledges that his opponents are seeking to serve the patient’s interests, not to commit murder. And, Scurr insulates the Cardinal, by construing him as having “been badly advised.” Their positions keep the debate at the level of social ethics and leave room for further discussion.

I think the Brits, with their tradition of sharp-edged but civil debate, are likelier to advance the Catholic/Secular standoff than we Yanks are. We oscillate between politically correct vapidity and hate-laden rhetoric that encourages terrorists like James Kopp to commit murder on behalf of “right to life.” An ethically governed health system requires societal ability to debate contentious, value-laden issues, without loss of social cohesion. I hope to come back to the conflicts at Lutheran Health Center and John and Lizzie's in a future posting.