No Treatment as the Treatment of Choice

In the October 3 issue of JAMA, Allen Detsky and Amol Verma offered "A New Model for Medical Education: Celebrating Restraint." Restraint in medical practice is decidedly un-American. Not surprisingly, the authors are Canadian!

Detsky and Verma are concerned with both quality and cost. Here's the essence of their argument:

...we suggest complementing health care cost control initiatives by transforming the current approach used in medical education that primarily rewards meticulousness of clinical investigation to one that also celebrates appropriate restraint...Clinical teachers who are role models could embrace a new approach. They could emphasize teaching restraint, both to improve health care quality and to acknowledge the professional duty of resource stewardship.

The worship of obscure diagnoses is a longstanding part of US medical culture. It's exemplified by the "zebra joke," which I first heard as a medical student in the early 1960s:

Two senior physicians are walking alongside a wall. On the other side they hear galloping foot beats. One says to the other - "what's that?" His colleague replies "it must be a zebra."

Sometimes the search for zebras turns up a real striped quadruped. When that happens it makes a heroic story. More typically the search involves "zebra tests" which turn up "incidentalomas," abnormal findings that have no clinical significance, but which elicit further tests. Apart from the wasteful expenditures the search for zebras can produce, the process can create harmful complications - the side effects of unneeded biopsies or even surgeries, excessive radiation exposure, and more.

I'm a skeptic about medical maximalism and the search for zebras. In the early 1970s, supervising psychiatry residents who had been inculcated in concept of the 50 minute hour, I sometimes had dialogues like the following with my supervisees:

Me: What kind of treatment do you want to prescribe for the patient we've been discussing?
Resident: Twice a week intensive psychotherapy.
Me: How long would each session be, and how long would you want the treatment to last?
Resident: This seems kind of silly, but let's say 50 minutes per session for three years.
Me: That would be approximately 270 50 minute sessions. Do you think we could attain the same outcome if each session was 48 minutes and we had 85 sessions per year instead of 90.
Resident: This really does seem silly. But if you insist on the question, I suppose we could attain the same outcome or close to it.
Me: So even before we look at the techniques psychoanalysts like Peter Sifneos have developed for briefer treatment, we've reduced the cost by 10% without meaningful loss of quality. Not bad!

In 1981 I felt I'd encountered kindred spirits, when Allen Frances, who I've posted about before, and John Clarkin wrote "No Treatment as the Prescription of Choice." They weren't nihilists about treatment, but they correctly noted that psychiatric consultants almost always recommended treatment for the folks they evaluated. Frances and Clarkin suggested a typology of patients who would do better without treatment - patients who were not likely to benefit and for whom treatment might inadvertently be harmful.

As a student, some of the old timers I learned from taught me about the curative impact of "tincture of time." Some conditions will get better on their own if the patient is approached in an optimistic spirit and is willing to allow some time to pass. In non-acute situations where it's not clear what is going on, applying "tincture of time" can be a good diagnostic and therapeutic approach.

Sometimes patients push for this kind of low-interventionist approach. Many years ago I saw a young man who had briefly been hospitalized for what looked like an episode of schizophrenia. I suggested that we start an antipsychotic medication. He objected. He was convinced that the episode came from a recreational drug he'd used. We agreed to follow him - initially weekly, but ultimately every month or two. As best we could tell over the course of two years, he was right. We were both happy. With another patient whose history convinced me that she had bipolar illness, she made a similar argument and refused medication. I told her that I wasn't a worrier, but I was worried about her. I hoped I was wrong and she was right. We followed her status and got to know each other. Unfortunately, as I'd feared, she was wrong - a recurrent episode convinced her of that. But it worked better that she was convinced by her own experience, not simply by yielding to medical authority.

Detsky and Verma come across as wise clinicians. I'm on board with their counsel. I hope others join in. The model they propose would promote a salutary change in US medical culture.

More about the Massachusetts "Death with Dignity" Act

Last week I wrote about the Massachusetts "Death with Dignity" ballot initiative. For those who are interested in the initiative and how it is playing out, this morning's Boston Globe has a very informatinve article on the topic.

Is it OK for GP's to have sex with their patients?

For anyone interested in the ethics of doctor-patient sex and the relationship between ethics and law, the recent 5-1 decision of the Supreme Court of Pennsylvania in Thierfelder v Wolfert makes fascinating reading. (If the details interest you, make sure to read Justice Todd's dissent - in my view she got the issue right!)

In 1996 David and Joanne Thierfelder became patients of Dr. Irwin Wolfert, a family physician. He treated them both for conditions that included low libido. In 2002 Ms. Thierfelder told Dr. Wolfert that he had "cured" her problems and was her "hero." They began a sexual relationship that lasted for a year. She became more anxious and depressed and finally ended the relationship in January 2003. She told her husband about the affair two months later, and together they brought malpractice action against Dr. Wolfert.

Dr. Wolfert argued that as a general practitioner he should not be held to the same standard as psychiatrists, for whom a clear duty not to have sexual involvement with patients had been recognized. The court accepted this view on the basis that psychiatrists are trained to recognize and deal with "transference" (reacting to current relationships, like Ms. Thierfelder's with Dr. Wolfert, in terms of past relationships). GPs, the court concluded, should not be held to the same duty of care, since they are not trained to do treatment based on dealing with transference. If they were held to this standard it would discourage them from providing mental health counseling to their patients, which would be a bad societal outcome.

The majority made clear that the fact that Dr. Wolfert's actions were seen as unethical within the medical profession did not mean that he had violated legally enforceable duty. The Pennsylvania Board of Medicine had in fact sanctioned Dr. Wolfert before the Supreme Court heard the case. (It ordered a three year suspension of his license, but stayed the suspension under terms that included professional development activities, 550 hours of community service, and a fine.)

The majority cited Korper v Weinstein, a case in my home state of Massachusetts. Dr. Weinstein had done a breast biopsy on Ms. Korper at the Harvard University Health Service. (It was benign.) After completing her followup care, the two had lunch together, and a consensual sexual relationship ensued. Dr. Weinstein was not involved in a further treatment relationship. When he ended the relationship two years later she brought action against him. The court opined:

Any trust and confidence she placed in the defendant as a person...even augmented by circumstances that made her emotionally dependent on him, did not create a fiduciary duty in the defendant to prevent the personal relationship that developed consensually between them, especially where he terminated the physician-patient relationship as soon as the personal relationship began.

In her dissent, Dr. Todd concluded that (a) general practitioners frequently provide mental health services and are allowed to do so by their licenses and (b) sexual relations with patients is explicitly prohibited by the medical community, with (c) the result that she had "no hesitation in concluding that general practice physicians who provide mental health disorders to patients have a duty to abstain from sexual relations with their patients...and that these physicians may be potentially liable in professional negligence actions for any harm to their patients - patients they pledged to take no action to harm - as a result of engaging in such conduct" (page 18 in the dissent).

I believe Dr. Todd, though outnumbered 5 to 1, was correct. It's widely known that sexual relationships with patients being treated for mental health conditions have high potential for causing harm. Treating mental health conditions is within the purview of general practitioners. The ethical standards of the profession are well-known to prohibit sexual relationships with current patients. It's hard to see why the allegation of malpractice should not have been judged on the basis of its facts, rather than being prevented from coming to trial. The facts would have shown that Dr. Wolfert breached a duty. But it would have to be further shown that this had directly led to damage to Ms. Thierfelder.

The majority did not argue that it's ethically acceptable for general practitioners to have a sexual relationship with patients they are treating for mental health conditions. But in my view their conclusion that seeing a duty not to do so sets too high a standard is insulting to GPs. Being sued for malpractice is every physician's nightmare, but implying that GPs don't have enough understanding of human psychology and the treatment process to know that sexual relations and mental health treatment don't go together is demeaning to their competence and maturity.

Massachusetts Death with Dignity Ballot Initiative

My home state of Massachusetts has an initiative on the November ballot that would establish a "death with dignity" law closely modeled on the existing laws in Oregon and Washington. Surveys suggest that a majority of the public support the law, but influential groups including the Catholic Church and the Massachusetts Medical Society oppose it.

Today I had the privilege of meeting with a group of elderly men at a community center to tell them about the initiative, summarize the essence of the pro and con positions, and then lead them in discussion. In other words, something like a focus group.

The heart of the discussion was a spirited exchange between two of the participants. One who I'll call "Skeptic," opposed the initiative. Human nature being imperfect, he anticipated that some doctors would "specialize" in certifying that patients met the criteria for receiving a lethal prescription without the kind of careful clinical attention the law encourages. Whether the motivation was financial profit or perverse sadism, Skeptic was certain that this kind of medical misbehavior was inevitable.

The other, who I'll call "Advocate," argued that the right to receive a prescription for ending one's life in the context of a terminal illness is a natural and necessary extension of the right to refuse treatment or to discontinue ongoing treatment. Advocate believed that science has created all manner of life prolonging interventions and that patients need tools to control what they receive or are subjected to.

Skeptic focused on the risks arising from misuse of the proposed law. Advocate focused on the risks arising from lack of autonomy for patients with terminal conditions.

The group agreed that both risks were real. Oversight by the Department of Publich Health, to whom use of the law would have to be reported, and the Board of Medicine, which could sanction outliers of the kind Skeptic envisioned, was trusted by some but not by others.

In my summary of the pros and cons I cited religious beliefs about the wrongness of hastening one's own death and told the group about the Roman Catholic Archdiocese website "Suicide is Always a Tragedy." No one in the group, however, brought in theological reasoning. I don't know if this was because theology was not a driving force for them or if they regarded religious belief as private.

Where we ended was with a sense that the exchange between Skeptic and Advocate was best understood as a "good versus good" conflict. Skeptic took a consequentialist view - the law would allow unethical physicians to consign people to death without application of the safeguards the law sought to put into place. Advocate took a rights-based view - patients need and deserve more tools to allow them to advance their own autonomous choices.

I wasn't trying to persuade the group to any position on the law. My aim was to (a) inform them and then (b) get a sense of how a population for whom the law, if passed, could become relevant, thought about the law. We concluded that intelligent, thoughtful, well-motivated persons of good will could, would, and did disagree.

I'll write more about the topic after November 6!

Death by bedsores

The September 15 issue of The Lancet has a fascinating article by Arthur Caplan, who is now at the Division of Medical Ethics at New York University Medical Center.

Caplan tells the story of "Harold Brennan" (a pseudonym), an 88 year old man who had lived an independent life until a series of ministrokes left him helpless and bedridden. He was in a community hospital where, despite apparently good care, he developed bedsores. He experienced great pain whenever he was moved and decided he no longer wanted to be turned. When told that this would lead to worsening infections and death his resolve was all the stronger. A psychiatric consultant assessed him as angry but not depressed and competent to make decisions.

The nurses were horrified. How could they stand by and not provide the most basic form of nursing care? The hospital tried to get Mr. Brennan's daughter to come to a conference, but she couldn't bear to see him deteriorating and did not attend.

Mr. Brennan was not turned. As the infections worsened, his roommate was moved to another room. The nurses had to wear masks when they entered the room because of the smell that came from his decaying body. He died after 5 weeks.

Here's Caplan's conclusion:

Must do not turn requests by competent patients be honoured? Patient autonomy is a strong value in the ethical values that guide health care. It is not, however, the only value. It should not be honoured when such requests pose unacceptable risks and dangers to other patients or the ability of staff to function. Where and how these values are to be balanced against patient autonomy is not clear. That they ought to be balanced is. The “simple” case of a request not to turn reveals a key moral truth—that autonomy has its limits.

I discussed the case with a colleague I respect, who felt that Caplan violated the principle of autonomy "egregiously." I would guess that this would currently be the majority view among US physicians.

Caplan makes two basic arguments - one with reference to other patients and one to "the ability of staff to function." The first point is clear. As John Stuart Mill argued so forcefully in On Liberty, If Mr. Brennan's request endangers other patients - even relatively slightly - via the potential for transmitted infection or some other mechanism, his request should be overruled. His liberty does not give allow him to choose a course of action that threatens the well being of other patients.

But what about the nurses? Caplan's reference to "ability of the staff to function" is too vague. If Mr. Brennan's request prevented them from caring for other patients, the harm to others factor would apply. But if his decision causes moral distress ("how can we let him die that way - it's too terrible?") or disgust ("the smell makes me vomit"), we're on shakier grounds. Moral distress and disgust are subjective reactions. If your decision to refuse dialysis or chemotherapy causes moral distress or disgust for me that's my problem, not yours.

Voluntary refusal of food and liquid is a "cleaner" way to end one's life than allowing rampant skin ulcers to fester untreated. But if we are prepared to allow competent persons to refuse intake, which I believe we should, we should be prepared to allow refusal of turning, unless the refusal endangers others.

Malignant: Medical Ethicists Confront Cancer

I've just read Malignant: Medical Ethicists Confront Cancer, edited by Rebecca Dresser. Seven ethicists who have either had cancer themselves (5) or cared for a spouse with cancer (2), or both (1), write about their experience and discuss what that experience might mean for ethics and clinical care. It's a very approachable book. I think most readers of this blog would find it powerful.

Here are some of the main lessons I gleaned from the book:

1. Not surprisingly, direct experience deepens our understanding of the issues we teach about in the classroom and write about on blogs and in print. The deepening isn't conceptual knowledge. It's more that the experience acts as a filter, indicating what's truly important in what we've thought and where we've been naive or callous. In my ethics seminar section at Harvard Medical School we regularly work with cases. I've taken to "becoming" the patient in the case, and interacting with the class in that role. I've found that taking on the persona of the patient - even when that persona is very different, as when I play a teen age female - the role comes alive for me in feelings and perceptions. I become a better teacher for it. If the students learn half as much as I do from those exchanges, the class is a success.
2. Norman Fost describes a remarkable experience. Being worked up for what seemed clearly to be a recurrent kidney stone the resident evaluating him ordered a CT scan. Fost explained to the resident why he thought the scan was (a) medically not called for and therefore (b) an wasteful expenditure. But he didn't refuse it. The scan confirmed what he knew - he had yet another kidney stone. But it also showed a mass, which on further exploration turned out to be an early, and apparently curable, kidney cancer. Kidney cancers are often found too late for cure. Fost believes the CT scan may have saved his life. But he holds to the view that it was wrong to order it and that it reflects an overly interventionist, inadequately cost attentive, US medical culture.
3. Rebecca Dresser and Dan Brock write about decisions they made that in retrospect (a) went against their values and (b) about which they wish their physicians had discussed/argued with them. Dresser's example is especially telling. She refused a feeding tube and was close to death when a nurse talked her into changing her mind. Dresser and Brock speculate that physicians may have learned the lesson of respecting patients' decisions too well! Rather than challenging bad decisions - decisions that go against the patient's values, they too readily acquiesced. In terms of "Four Models of the Physician-Patient Relationship," a valuable paper  by Linda and Zeke Emanuel from twenty years ago, their physicians applied the "informative" model - provided information and then, in effect, followed the patient's "orders," when the reflective give-and-take of the "deliberative" model would have been more useful.
4. Arthur Frank sees cancer support groups as potentially hugely valuable for patients, but he warns that these groups and what he calls the "survivorship industry" can thrust identities that don't fit onto patients. His comments helped me understand something I observed several times in my clinical practice. Patients who had experienced a loss, and who by all appearances were going through painful, but "healthy" grief, were frightened by the fact that they weren't crying more. They had imbibed the view that "proper" grief involved lots of tears and feared that they were full of unshed tears that would act like a poison. Explaining that there wasn't a single "correct" way to experience grief reassured them.
5. Finally, and with most personal impact for me, John Robertson and Leon Kass write in painfully raw terms about accompanying their wives on their journeys with ovarian cancer. Robertson's wife Carlota Smith died. Kass's wife has experienced recurrences, but is still in treatment. I hope that if my wife encounters a similar experience I will respond with the commitment, care, and courage that Robertson and Kass displayed.

There's lots more than I've written about to glean from this moving book!

Allowing import of needed drugs from Canada

Last year I wrote about a well-intended FDA policy about colchicine, a drug used since ancient times for gout, and now for other serious conditions, such as Familial Mediterranean Fever. As an ancient treatment widely used prior to formation of the FDA, colchicine did not require FDA approval as a new drug. Then in 2009, the FDA granted approval to URL Pharma for Colcrys, its version of colchicine, based on randomized controlled trials the company conducted. Because colchicine had never been subjected to the FDA approval process, Colcrys was, in a technical sense, a "new" drug approved for a "new" indication - treatment of gout and FMF - despite the centuries of prior use, and by regulation was entitled to market exclusivity. In 2010 the FDA ordered all other manufacturers to cease production and marketing of their versions of colchicine.

Unfortunately, Colcrys is not effective for some patients with Familial Mediterranean Fever. To maintain their health these patients need the generic form, which must be imported from abroad. A friend recently told me about the new roadblock a family member is encountering. Here's the letter that went to the patient's senators:

I am writing with regards to the recently passed Food and Drug Administration Safety and Innovation Act (S. 3187). The bill includes a provision (Section 708) that may prevent me from being able to import my prescription from Canada, which I depend on for my health and quality of life.

This legislation authorizes the seizure and destruction of safe prescription drug imports valued under $2500. I have a prescription for generic colchicine for a rare genetic disease which I have, Familial Mediterranean Fever. When I tried the US brand of colchicine, Colcrys, I experienced extreme side effects and a relapse of symptoms, resulting in a month of illness, including an overnight stay in the hospital with high fevers and dehydration. Through this experience, my doctor and I discovered that it is essential that I be able to access an alternative brand of colchicine. Due to an FDA ruling, all brands of colchicine except Colcrys were taken off the US market several years ago. I now depend on my prescription from Canada for my health and well being.

When I am able to take colchicine imported from Canada, I have no symptoms and live a normal, healthy life. Without access to this medication, I will experience fever episodes lasting from several days to a month, pain, and inability to eat. It will compromise my ability to finish graduate school, where I am currently working on a challenging program. It will put me at risk of future complications from my genetic disorder.

I am extremely concerned that when Section 708 of Act 3187 is implemented, I will lose access to my direly needed medication. Please let me know what you plan to do to change Act 3187 to allow me to continue my life. Thank you for your time and consideration.

I don't fault the FDA's intentions. But in a country of 300 million people, it will be the rare policy that applies to all in a fair manner. Justice requires a robust exception process in situations like the dilemma of FMF patients who require the generic drug.

The patient did her part in putting the issue onto the public table. Now it's up to the FDA to respond.