Tuesday, June 28, 2016

Jail Time for Parents for letting Toddler Die from Meningitis

Last week a Canadian court sentenced David Stephan to four months in jail and his wife Collet to three months of house arrest for their role in the death of their 19 month old son Ezekiel in 2012.

When Ezekiel became ill, his parents thought he had some form of "flu," and treated him with herbs and a mixture of apple cider, vinegar, horse radish root, hot peppers, mashed onion, garlic and ginger root. A friend who was a nurse told them he might have meningitis, but they persevered in their efforts to treat him by the "natural" modalities they believed in. A witness testified that when they drove Ezekiel to a naturopathic clinic, he was too stiff to sit in his car seat. As his condition worsened, his parents had to feed him with an eye dropper. They only summoned medical help when Ezekiel stopped breathing. The child suffered severe brain damage from anoxia and died a few days later.

David and Collet are part of a community built around vaccine refusal and faith in "natural" remedies. David's father Anthony founded TrueHope, after his wife, who suffered from bipolar illness, committed suicide. The company markets EMPowerplus, a "natural" product that they claim as a cure for bipolar disorder, depression, and even autism. Ezekiel's father David is Vice-President of the company.

David and Collet were convicted under a Canadian law that requires parents "to provide necessaries of life for a child under the age of sixteen years." The prosecution asked the judge to sentence them to 3.5 - 4 years in prison, close to the maximum the law allows (5 years). The judge called that "too harsh." He required prison for David because David refused to take responsibility for his actions. He asserted that a government conspiracy to squelch vaccine refusal was at work, and blamed Ezekiel's death on faulty ambulance care. In the judge's view, Collet was less responsible for Ezekiel's death. In addition to house arrest, he required her to publish his findings on her website. After their jail and house arrest terms, David and Collet will be on probation for two years, and will be required to obtain regular medical attention for their children.

Adults capable of making decisions are and should be free to choose no treatment or quack interventions. But they should not be free to refuse potentially life saving interventions - like antibiotics for bacterial pneumonia - for their children. Seen through the lens of both law and ethics, the judge ruled correctly. David and Collet loved Ezekiel, but they - especially David - made decisions a "reasonable" parent would know to be wrong. Ezekiel paid for their commitment to their "naturopathic" doctrines with his life.

(For a compendium of articles on the situation, see here.)

Thursday, June 23, 2016

When is Rationing Ethically Accptable?

If I prefer a medicine that produces fewer side effects or marginally better outcomes, how much should you be expected to pay for my preference?

That's a question we in the US run away from. We'd rather say - "rationing is unethical! Period."

In truth, rationing happens all the time. The trend towards requiring us to pay a larger portion of our health care expenses out of pocket aims at making us responsible for our own rationing choices. If my physician recommends a CT scan "so we can be sure..." and I decide it's not worth the cost to me - that's self-imposed rationing. In our personal lives we make rationing decisions based on informal cost-effectiveness decisions every day.

But at the level of policy, acknowledging the need for ethically-grounded rationing is a third rail.

That's why the publication of Cost-Effectiveness of Long-Acting Injectable Paliperidone Palmitate Versus Haloperidol Decanoate in Maintenance Treatment of Schizophrenia is so important. for my field - psychiatry. In addition to providing valuable clinical information, the authors are admirably honest in presenting the rationale for potential rationing decisions.

Here's what the article is about:

Some patients with schizophrenia who benefit from antipsychotic medications follow their regimen reliably. But some don't, and for them a long-acting injectable antipsychotic medication can literally be a life-saver. I remember well a patient of mine who wouldn't take pills and wasn't keen on seeing a "shrink," but who accepted a monthly injection of haldol from his primary care physician. I made a serious joke with my colleague - "I may accomplish some useful things, but you are 'curing' schizophrenia in five minute appointments!" My patient and his family were enormously grateful that he functioned better and was happier than he'd been for a decade.

Paliperidone palmitate is still on patent and theoretically had some advantages over haldol decanoate, a much less costly generic medication. In a well-controlled randomized comparative effectiveness study, the authors compared the two medications, quantifying the differences between them in terms of quality adjusted life years (QALYs). Paliperidone had a slight advantage in terms of side effects, but at a cost of $500,000 per QALY, well-above what virtually every explicit discussion of QALYs has seen as an acceptable cost. Here's part of the author's conclusions:
The results of this study should encourage consideration of older, less expensive drugs, such as HD. Used at moderate dosages in this study, HD’s overall effectiveness and tolerability were only slightly worse...than those of PP, and it had clear advantages in cost-effectiveness...A rational policy for treatment of chronic schizophrenia might limit use of the more expensive [PP] to patients who do not benefit from or cannot tolerate HD. 
My colleague and friend Norman Daniels and I have written extensively about the overall ethics of rationing. I'm proud of the work we've done and believe it's useful. But progress in coming to grips with the need to ration care in a clinically grounded, ethically admirable manner will have to be done specialty by specialty in medicine, in concert with concerned members of the public.

The comparative effectiveness study of paliperidone and haldol illustrates four crucial steps that need to be taken for us as a nation to learn to set limits fairly:
  1. Develop clinically and humanly meaningful evidence about key treatment choices.
  2. Acknowledge the findings in an explicit, east to understand manner.
  3. Do economic analysis to define the costs involved with the choice.
  4. Decide whether the differences between the choices are worth the costs entailed.

The fifth and most difficult step is making use of these findings in the real world. In a health system based on competing health plans, health plan A would be reluctant to apply findings like these in its policies before health plan B does the same. If they did, word on the street would be "health plan A RATIONS CARE! How can we tolerate money grubbers like that in our health system?"

Learning to set limits fairly is more of a challenge to the heart than the head. At an intellectual level it's easy to see that limits are necessary. But thus far in the US, health system leaders, health care organizations, and the public have preferred to act as if rationing is evil and can be avoided.

That may have been true in the Garden of Eden. But, alas, that paradise vanished long ago.

Monday, May 30, 2016

Meditation and Medical Ethics

Medical ethics and mindfulness have a lot in common. I reached that conclusion after a recent conversation with my long-time friend Charlie Halpern about his effort to introduce mindfulness into legal education.

Charlie has been doing this at the UC Berkeley School of Law for the past several years through classes and elective retreats. He's an enthusiast and a believer. He feels, and many legal educators and law schools agree with him, that mindfulness practice increases empathy, compassion, and the ability to really hear what clients and others involved in negotiation and litigation are saying. He described how a professor at Berkely has taken to starting his classes with three minutes of silence. The professor reports that "sacrificing" three minutes of class time leads to a richer, more thoughtful class experience.

I've taught meditation to patients in a medical setting and have recommended meditation to many of my patients over the years. And I've written in this blog about how mindfulness practice can be woven into busy practitioners' lives. (See here and here.) But until the conversation I had with Charlie, I hadn't recognized the obvious connection between mindfulness and the way I've taught medical ethics.

In the semester-long course medical ethics course that I taught at Harvard Medical School, in addition to the topics that formed the intellectual content of the course, I encouraged the students to hone their skill at (a) observing their cognitive and emotional reactions to clinical situations that raise ethical issues, (b) treating these reactions as "data," not "truths," and then (c) reflecting on the "data" presented by their experience as one piece of ethical analysis before (d) reaching a conclusion. Over time, as demonstrated by clinicians who we regard as models of ethical action, this set of actions can become reflexive, done automatically and recurrently.

What I realized is that steps (a) and (b) are close cousins to what meditation teachers encourage their students to do. The setting is different - deliberate quiet and inwardness in meditation versus to what I'm inclined to call "meditation in action" in learning to be an ethically sensitive clinician. But the outcomes the teacher hopes for in the student - empathic connection with others, compassion, and seeing the truths that underlie complexity - are the same.

Recognizing the kinship between mindfulness and medical ethics is a valuable insight for ethics educators. An increasing number of students know something about meditation and respect the practice. Recognizing that skill at meditation can enhance their grasp of medical ethics, and, that skill at medical ethics fosters some of the key skills for meditation, enhances both domains.

Friday, May 27, 2016

An Ethical Perspective on Shared Medical Appointments

Stories about shared medical appointments keep popping up in the news, most recently in this New York Times article. The format involves bringing together a group of patients - as many as 15, but typically 8 - 12 - with a doctor or nurse practitioner, for a 90 minute discussion of shared medical problems, such as diabetes. Although group visits are not for everyone, the response of patients who participate and clinicians who lead the sessions are generally quite positive.

Group visits arose to promote efficiency. Although current discussions describe the format as an innovation developed in response to the parlous state of contemporary medicine, in 1905 Dr. Joseph Hersey Pratt, a Boston physician, began to lead "classes" for patients with tuberculosis. Pratt documented results that were as good as the best sanataria, but his method fell into oblivion.

In 1975 I had the privilege of starting a group visit program for patients with chronic psychiatric ailments at the Harvard Community Health Plan HMO . I conducted the group in collaboration with an excellent psychiatric nurse. I spoke with patients individually and to the group as a whole. If I wanted to recommend a medication to patient A, I often asked patient B, who was taking the medication, to talk with A about it. It was set up as a "drop in" group. Patients could come every week or just intermittently.

Physicians who lead shared medical appointments experience a different relationship with patients than in the 1:1 format. The group is more informal, and the physician often acts as a facilitator of patient-to-patient exchange, rather than as an authority. The framework tends to bring out the humanity of clinicians and patients. It's difficult for the leaders to be cold, detached or pompous.

I don't know how well the aspiration for efficiency holds up, but I do know - from my own experience and from the literature - that group visits encourage a holistic, humane way of relating between doctors and patients. The rationale for the format tends to be presented in an apologetic manner: the health system is in a mess/physicians are too harried to pay enough attention/you'll get to spend more time with your doctor in a group. These statements are true. But apology undersells the value of shared medical appointments. For patients with chronic conditions that must be managed over time, the group format can bring out a patient's own strengths and initiative and allow physicians to tap into their capacity to care in a down-to-earth human manner in new ways.

That's an ethical achievement, not just a matter of efficiency!

[To learn more about shared medical appointments, a Massachusetts General Hospital guide to conducting group visits is here,  a description of the group visit program at the Cleveland Clinic is here, and a VA guide to setting  up a group visit program for patients with diabetes is here. If you would like pdf versions of my articles about Pratt and about the HMO group program, send me your email address via the comment function.]

Wednesday, May 25, 2016

Atheism, Humanism and Secular Ethics at the University of Miami

Between September 10, 2007 and today, I've written 82 posts about religion and spirituality. I've been especially interested in the moral underpinnings of the health professions. I've thought of health care as a calling throughout my career. But where does the call come from?

Historically, the call has been seen as coming from god and god's servants - saints, bodhisattvas and other benevolent beings who urge us to care for others. But what about health care workers who do not derive their calling from a theology?

I hope this question will be high on the list of research topics when the newly endowed chair of "atheism, humanism and secular ethics" at the University of Miami is filled. I learned from the New York Times article about the chair that it was endowed by Louis J. Appignanian 83 year-old retired businessman who supports non-theist causes. The University was uncomfortable defining the chair as one of "atheism" studies, but Mr. Appignani insisted that the "atheism" be part of the title, and accepted the addition of "humanism and secular ethics."

In an increasingly secular population it's crucial to deepen public understanding of morality that is not based on religious theologies. Over the centuries, religious communities have been powerful advocates for good causes (e.g., abolition of slavery) but also for evil causes (e.g., "holy" war). For atheists and secular humanists to make a full contribution to the moral arc of the future, we need a deeper understanding of how the non-theological domain functions. Let's hope that the University of Miami chair contributes to this process.

When the chair is filled, there will be a great deal to learn from studying those who are called to the vocation of health care!

Monday, May 2, 2016

Borderline Personality Disorder and Public Health Ethics

An article in the May issue of the American Journal of Psychiatry - "The Emergence of a Generalist Model to Meet Public Health Needs for Patients with Borderline Personality Disorder" - shows how experts can move from a specialty niche to public health relevance. This isn't just a clinical act. It's also ethics in action!

Borderline Personality Disorder is a relatively common condition, said to affect 1%-2% of the population and to represent 15%-20% of psychiatric hospital admissions and 6% of primary care visits. People with the condition evince symptoms like: vulnerability to feeling abandoned; unstable relationships that oscillate between idealization and disenchantment; destructive impulsiveness; self-harm; difficulties controlling anger; transient psychotic episodes; and more. The condition takes a high toll on individuals, those involved with them, and the health professionals who try to help them.

In the past 25-30 years, three evidence-based forms of treatment have emerged:

  • Dialectical behavior therapy. DBT involves a combination of weekly individual and group therapy that emphasizes understanding one's vulnerabilities and reaction patterns, combined with learning new self-management skills. 
  • Mentalization-based treatment. This treatment is a variant of psychodynamic psychotherapy that focuses on better understanding of mental states in oneself and others, based on the hypothesis that patients with borderline personality disorder interpret and react to others in terms of their own fantasies, and that more realistic understanding will decrease their desperate emotional over-reactivity. Like DBT, mentalization-based therapy typically involves weekly individual and group sessions.
  • Transference-focused psychotherapy. For this approach, twice weekly individual sessions are recommended. The treatment makes maximum use of the patient's reactions to the therapist as an avenue into modifying the internal structures that lead to the chaotic life pattern.
All three approaches can legitimately claim to have been validated. But all three require training and skill beyond the level of most mental health clinicians. Nine years ago Glen Gabbard, perhaps the leading educator in psychiatry, asked "Do all roads lead to Rome?" and suggested that the three techniques may reflect different ways of delivering common healing processes. In the just-published article that I cited above, John Gunderson, a leading researcher on BPD, builds on Gabbard's suggestion and offers a common-sense generalist model that emphasizes educating the patient about the condition, focusing on life outside of the office more than on the interaction between patient and therapist, integrating medication management, and selectively involving family and significant others.

I'm writing about this clinical issue in a venue devoted to health system ethics because the move from a specialist orientation to generalism embodies admirable public health ethics. Our U.S. health system tilts towards a specialist for every organ and condition. At its best, this approach cultivates deep clinical skills. But it also disarticulates the care of individuals into unrelated segments and mirrors the inequity of our wider society by providing a lot for the few and much less for the many.

When I did my residency in the 1960s, psychoanalytic training was regarded as the pinnacle of professional development. I valued the deep intellectual rigor of psychoanalysis, but couldn't see limiting my practice to a relatively small number of patients who would be seen 3-5 times per week, and who, by practical necessity, would have to be relatively affluent. 

Gunderson's article points in the direction I'd mapped out for myself at the start of my career. U.S. health care needs to strengthen its generalist orientation at the level of primary care and within specialties. Moving towards health insurance for all is the first step in correcting the moral failings of our health system. But the ultimate challenge is improving our commitment and capacity to provide excellent cost-effective care for the entire population. Gunderson's work illustrates what every segment of medicine needs to do.

Thursday, April 28, 2016

Robber Baron Capitalism victimizes Mother Theresa

Yesterday the Senate Special Committee on Aging held a feel-good hearing at which the Senators excoriated Michael Pearson, the soon-to-be ex-CEO of Valeant Pharmaceuticals, for rapacious drug pricing, and hedge fund manager William Ackman for making Valeant a darling of the Wall Street world.

It's a valuable truth about organizational life that every system is perfectly designed to achieve the results it actually produces. The two articles cited in the previous paragraph and a third about "The Complex Math Behind Spiraling Prescription Drug Prices" provide insight about how the current U.S. system inevitably produces stratospheric drug prices. Here's how it works:

  1. The first step involves rewarding CEOs lavishly for short-term profits. It's important not to look too deeply into how the profits are made, as long as the method is - or appears to be - legal. My my previous post  about Michael Pearson's compensation shows how this first step towards moral corruption can best be carried out.
  2. One variant of step two involves identifying a valuable old drug that is priced affordably. Make sure it has no competitors. Then, buy it and jack up the price by hundreds of percents. That's the route Michael Pearson at Valeant and Martin Shkreli at Turing Pharmaceuticals took.
  3. As an alternative, identify a serious medical condition for which there is no effective treatment. Develop a new, better approach. This is the path of discovery and developing genuine new value. Up to the the point of setting a price, this step is morally admirable.
  4. Recognizing that (a) we control a vital component for human health, and (b) health organizations are committed to human health, (c) set a stratospheric price, since (d) we have the health system over a barrel. 
  5. If whoever is purchasing our stratospherically-priced drug protests, accuse them of (a) rationing care, (b) stifling innovation, or best (c) both.
This is how the fine-tuned medical-industrial complex facilitates runaway drug costs. Historically, providers have been governed by Mother Theresa's ethics - do what is needed for human health no matter what it costs. The Michael Pearsons and Martin Shkrelis may be acting within the law, but they're not acting within the ethics of care. Unlike Pearson and Shkreli, who simply recycle established products at new prices, pharmaceutical companies that develop treatments that create new possibilities for human healing are participating in the health care calling. But when they charge astronomical prices, they're joining with the Pearsons and Shkrelis in robber baron conduct.

Hard bargaining helps, but it isn't likely to be enough to lead to fair pricing. My guess is that some form of regulation or other change in law is likely to be required. How to do it is beyond my pay grade. But happily, we in Massachusetts elected Elizabeth Warren as Senator, and consumer protection is her specialty. I'm going to send this post to her office with a simple message: PLEASE HELP!