Epistemological Uncertainty & Autonomy

In the September 17, 2014 issue of JAMA Scott Stonington, MD, PhD wrote a remarkable piece entitled “Whose Autonomy?” This short piece should be required reading for everyone in medicine.

Stonington discusses the idea of family roles and puts this in light of his anthropological work in northern Thailand. He uses his fieldwork experience to introduce the idea that, when ill, people may not express their true wishes, but instead play the role that is expected of them by their society. This renders taking a patient at his or her word problematic. One of his examples is of a father dying of cancer who says, “Leave me alone and let me die” but the son says, “No, we are taking you to the hospital and getting you treatment!” Our standard reading of this scenario is: leave the father alone, respect his wishes, and let him die in peace! However, Stonington suggests that in northern Thailand the father does not really want to be left alone to die at home—he says that to fulfill his role of the stoic father. And the son would be remiss if he “took him at his word” because his role is to care for his father despite protests. The point he makes is that this situation is not isolated to northern Thailand, but that elements of family relationships like this exist here in the U.S. as well.

This article is unsettling, because it questions the core of what most physicians these days use as to guide their care of the patient. If we take this story seriously, then we have to dig more deeply and not rely on mere autonomy to sort out the right course of action in a particular situation.

It is my concern that the strong focus on respect for autonomy exacerbates the problem of physicians who think of themselves as “service providers” where the goal is to maximize choices for “healthcare consumers.” This market analogy has been dominant for generations now and is what provides the background for Edmund Pellegrino’s sage writings about the real foundation of the profession of medicine: the fact of illness and the call we feel to respond to those suffering. Once we enter this profession we sign up for an ethics of supererogation—above and beyond what is required of the citizen, or neighbor, or businessman. This article by Stonington reminds us of this by pointing out that “doing the right thing” may be much more complicated than just doing what the patient says.

Limning the Limits

Shortly after I submitted my last post “Limning Autonomy in Surgery” I was contacted by the blog editor letting me know that I had made a typo in my title and that he would go ahead and correct it for me. The problem is that I really do mean to use the word “limn.” When I was at Wheaton College a couple of my professors edited a book entitled Limning the Psyche, so I figured the verb “to limn,” which means to draw, delineate, or describe, was in common parlance. These entries are not an attempt to “limit” autonomy, but rather to draw out what it looks like in the surgical encounter. Indeed, it is as we reach the limits of autonomy in certain situations that we understand its outlines and contours.

The practice of surgery is inherently parentalistic. (Historically paternalistic is the term used, but my wife is also a surgeon. . .  ) For many reasons (which I plan to unpack in subsequent posts) the surgeon’s decision-making takes precedence to the patient’s. I am not arguing that it ought to take precedence; I am merely reporting that it does (c.f. Hume’s fork.) The prime example is the decision that someone is “not a surgical candidate.” This could be due to a tumor being “unresectable” or to the physiologically deconditioned state of the patient, or the narrow margin of improvement a patient could make with an operation. The point is that this is a function of the praxis of the surgeon, which hopefully has been developed in the crucible of residency and through years of experience. Charles Bosk, in his classic text Forgive & Remember: Managing Medical Failure, notes that it is this development of sound surgical judgment that is the most important part of a surgical residency. Surgeons are intimately linked with the outcomes of their patients, and every day is the Catch-22 of cutting someone (for their own good) and the Hippocratic dictum primum non nocere. So we are cautious and, in making a decision who will benefit from an intervention, parentalistic.

But society has rejected paternalism and the abuses that went along with it. Parentalistic actions must be expunged from practice, so all decisions made by the surgeon are open to question. Barron Lerner explored and contrasted the paternalistic / non-paternalistic approach in his recent book The Good Doctor.  One of the results of this is the necessity to define certain interventions as “futile.” Then the hospital can have a futility policy that states that physicians do not have to perform futile procedures. For example, let’s say a family demands that an aortic root replacement be performed on their grandmother who has been deemed “not a surgical candidate” by the cardiac surgeon. The contemporary “way out” of a situation like this is to state the procedure itself is futile, and then invoke the futility policy. The problem that I have with this is that it reifies the idea of a “futile treatment” and pretends to be more objective than it is. There is a tremendous amount of subjectivity involved in decisions like these. The uncertainties surrounding the many variables in play belie precise objective quantification.

A particular surgeon operates on a specific patient on any given day and that event is a performance. We predict outcomes by conglomerating large numbers of these performances and statistically analyzing these data, but I contend that the decision of whether or not a patient “is a surgical candidate” is one that relies on the kind of tacit knowledge that Polanyi described. I am not trying to disparage endeavors to minimize variations in performance nor attempts to capture these statistics in a way to hopefully better understand what exactly our surgical interventions do, I am merely saying that there is much more to it than that.  No matter how well-informed  about an operation a patient is, there is something incommunicable that the surgeon knows that requires him or her to make definitive judgments on behalf of the patient. This is where autonomy hits the wall.

Med Student vs. Dr. Oz

Since my last post was about Dr. Oz I thought I may as well post an update:

Benjamin Mazer, a medical student at the University of Rochester has introduced a policy to the Medical Society of the State of New York in an attempt to regulate the kinds of wild claims that Dr. Oz makes on his show. His proposal is to treat health claims made by “celebrity docs” on TV with the same scrutiny as expert testimony given in court, which has guidelines regarding veracity of statements.

It warms my heart to see a medical student fighting for the integrity of our profession, and going through the proper channels to do it. Fundamentally, a profession is self-regulating and so the state medical society is the perfect place to bring this issue. If New York State actually does something to discipline Dr. Oz, then it would be a demonstration of the process actually working. It is telling that a medical student is leading the charge on something like this–the rest of us are likely too jaded or cynical about the system to believe it can function as it should.

The Oz Effect

My wife remembers when Dr.  Oz was just a handsome and engaging cardiac surgeon at New York Presbyterian Hospital. She graduated from Columbia P&S the same year Mehmet Oz appeared on Oprah and began his journey to being a household name. Dr. Oz has become so popular and pervasive that any “health supplement” he endorses on his show sees a huge boost in sales: the “Oz-effect.” The problem is that there is no evidence to support any of these miraculous claims he makes.  Congress recently gave him a public shaming for these shenanigans.

It is interesting to note how upset much of the press is getting with Dr. Oz. Many other programs on TV make outrageous claims about health, science, and reality. So what’s the big deal?

What Dr. Oz has done with diet supplements is fundamentally unethical because he is exploiting the goodwill extended to him because he is a doctor—a formerly legitimate doctor associated with an Ivy-league medical institution. Currently he is valuing sensationalism, viewership, and ratings over the truth as it relates to health. And while many roll their eyes or guffaw at those of us who continue to promote the Hippocratic ideal in medicine, it is clear that the backlash against Oz is so severe because he has so egregiously violated the principle that the good of the patient should come before anything else.

The internal morality of medicine goes back to Hippocrates the Aesclepiad, which is distinct from the ethics that govern mercantilism and commerce. I love this old engraving (found in Galerie Mythologique: Recueil de Monuments by Aubin Louis Millin, Paris 1811) because it so clearly shows the difference between the practice of medicine and commerce.

It shows Asclepius and his three daughters, Hygeia, Panacea, and Meditrina shunning Mercury, the god of commerce. Many would contend that modern medical practice is often indistinguishable from pure business. Indeed even the symbol of Mercury, the caduceus, is often confused and conflated with the rod of Aesclepius. If it is true that there is no real distinction between the healing profession and mercantilism then why do we hold Dr. Oz to a higher standard than any other person making wild claims on an infomercial?

It is because, just as the engraving shows, there is a deep and abiding distinction between those of us in the healing profession and those selling products claiming miraculous results. Society still expects doctors not to exploit others’ weaknesses—we must always keep their best interests ahead of our own. Dr. Oz has failed to do that. Sadly his reprimand came from Congress and not from our own medical societies.

Killing a Patient to Save Whose Life?

A New York Times article a few weeks ago highlighted a clinical trial that just started in Pittsburgh. The provocative title “Killing a Patient to Save His Life” summarizes the technique that will be used on patients who present in cardiac arrest from a penetrating injury (e.g. gunshot or stab wound.) It involves replacing blood with cold saline to induce hypothermia and decrease the body’s demand for oxygen. Once the patient is in a state of “suspended animation” the surgeons have time to repair whatever organs were shot or stabbed, then they can give the blood back and warm the patient up. It’s called Emergency Preservation & Resuscitation (EPR.)

A few of the ethical concerns that have been raised are the issue of informed consent, the fact that most patients who will qualify for the study are young black men, and the cognitive function of people who survive ERP is yet unknown.

The informed consent issue seems to be the biggest concern for people who have been commenting and Tweeting on this, but I think that is based on some misconceptions. Most of the interventions that occur in order to save someone’s life in a situation where they have been stabbed or shot is done under the rubric of “implied consent” using a “reasonable person” standard. Intubation, chest tubes, pericardiocentesis, thoracotomy . . . after you’ve been shot and lose your pulses, no one is explaining the risks and benefits and having you sign the bottom of a consent form before they try to save your life. So it is a mistake to think that “informed consent” in the way that most people conceptualize it is happening in these circumstances. But that is totally reasonable and ethical because as a society we accept that we will surrender some autonomy for the sake of saving our life when we are that severely injured.

Also, there is clearly therapeutic equipoise in these cases. In most ERs in the country if you arrive pulseless with a penetrating chest wound they would just pronounce you dead. In large Level 1 trauma centers they will try to save you. There isn’t really a “gold standard” that can reliably save these folks–every case is a hail Mary. I spent 5 years doing trauma surgery in one of the busiest “knife and gun club” inner city hospitals in the country, and unfortunately took care of many patients like this.  Every case you may be trying something new because something else didn’t work last time, and then if it works you use that same technique the next time. If it seems to work most of the time, you review your data and try to write up your “advance.” At least in this study they are being very systematic and prospective about the data collection, which will yield much better data and the ability to extrapolate will be more robust.

So the ethical challenges initially raised about this study do not seem insurmountable. But what people have totally missed about this study is that this does not  really seem to be about bringing people back to life and getting them back to the streets. This is about organ preservation for organ donation. People are dying every day waiting for an organ on the transplant list. Usually a trauma patient who dies from hemorrhagic shock from a penetrating injury goes through a prolonged period of resuscitation and warm ischemia, so they are bad donor candidates (i.e. their heart, liver, lungs, etc are no longer transplantable.) If they are cooled and preserved from the moment they hit the door, and then they never regain consciousness, then they can be declared brain dead (if they meet the criteria) or participate in donation after cardiac death.  It is remarkable that no one has pointed out that the University of Pittsburgh has been a world leader in transplantation almost since the field began.  A fortuitous byproduct of iced-down neurologically devastated people is the potential to salvage their organs and put them in the hands of some of the most skilled transplant surgeons in the country.

I think most of us agree that organ donation is a great lifesaving and life-changing thing and that organ recovery is extremely important to save lives. The question that needs to be answered for me is, “If the actual goal of EPR is to preserve and recover organs in order to save the lives of patients needing a transplant, is it ethically permissible?”

International Research Ethics

More and more research funded by high-income countries (HICs, e.g. the US) is taking place in low- and middle-income countries (LMICs). For example, colleagues at my institution have received grants of over $64 million to do research in Ghana. A search of ClinicalTrials.gov shows that 20 of 29 open studies in Ghana involve women, children, and persons with HIV—all considered vulnerable populations. The obvious concern is how to protect human subjects of research from exploitation. For example, the pregnant woman with HIV who is approached by a US-funded researcher who offers to pay for all her prenatal care if she agrees to be randomized into a trial. How can she best be protected from coercion?

Therefore,  HICs are now taking the responsibility of exporting research ethics to LMICs. The question then comes up: Whose ethics? A cynical view is to look at the effort to teach research ethics in LMICs as a form of missionary work: to proselytize those who haven’t heard the good news of the Georgetown mantra and to help them build research ethics committees that can function like a Western IRB. Certainly many of these countries have been colonized by Western countries and have seen missionary work in their borders. Is this just adding insult to injury as rich countries continue another form of imperialism in South America, Africa, the Middle East and Asian sub-continent? Many authors think so, or at least warn against this approach.

But even if we all agree that exporting a Western IRB framework is the ideal, implementation still has a long way to go. A recent survey of research ethics committees in LMICs (that will be published next month in the Journal of Medical Ethics) showed that only 40% of these committees had a budget and only 50% included women on the committee—certainly a few stumbling blocks to effective research regulation.

An ideal model would be to facilitate the articulation of ethical guidelines for research in LMICs that are based on local interpretations of the concept of respect for human dignity. What that looks like and how to sustain protections of human subjects of research in LMICs is still a work in progress.

Sperm Donor Problems

The New York Times published an article on Friday entitled “Does Sperm Donor Mean Dad?”  In an interesting turn, they use the sordid story of actor Jason Patric’s fight to be involved in his son’s life as a warning to those who are involved with various assisted reproductive techniques.  Noting that use of these techniques is on the rise and that they are used more and more frequently in situations distinctly different than infertile married couples, the article sends a message that those involved in these arrangements could be making life extremely complicated for themselves.  A quote: “The resonance here is enormous because of the increasing number of families being formed today outside of traditional marriage,” said Naomi R. Cahn, a family law professor at George Washington University and the author of “Test Tube Families.” “Single heterosexual women, lesbian couples, men who donate sperm expecting to be part of a child’s life — they had better be paying attention.”

 

I find this article interesting for two reasons.  The first is that Jason Patric was romantically involved with the mother of his child for several years, so the parallels to other non-anonymous sperm donation (friend of a lesbian couple, for example) are not really a propos–but they are made. The second is that an article in the New York Times would try to give a moral lesson regarding something in reproductive health.  The author of this article went to Marquette for undergrad, so he may be slipping his Catholic values into what on the surface looks like tabloid reporting.  This story “serves as cautionary tale for any man considering donating sperm to a friend and any woman considering accepting it from one, experts say.”  In the public square I suppose arguments that rely on appeals to sanctity or dignity, or other religious notions would be aggressively ridiculed.  So we are left with appeals to our own self-interest.  Fascinating that our unbridled self-interest, what Augustine would say is the root of the problem, is what might prevent us from expanding the commodification of children.

Easter, Fertility, Surrogacy

Most of us who celebrated Easter yesterday likely took part in the tradition of the Easter egg hunt. The egg, an obvious symbol of fertility, is an essential part of our spring celebration. Interestingly, the subject of fertility and “social surrogacy” was the focus of an article in Elle magazine last week. The piece told the story of an aging professional who felt she needed to have a baby, but since actually being pregnant is so inconvenient she hired a surrogate. The interesting part about this article is that it gave voice to the concerns that using a surrogate for non-medical reasons was “wrong” or “selfish.” Of course, none of these concerns were articulated very robustly, but at least they were explored. They actually interviewed Ruth Faden of the Berman Institute of Bioethics at Johns Hopkins and quoted her as saying that the “why” influences the ethical dimension of surrogacy.  It is great that a magazine with such a large readership like Elle would try to tackle a subject like “social surrogacy” as it must feel that this topic is relevant to young women today. What is most striking is how there is clearly an uneasy conscience about this practice, but it cannot be described in a very meaningful way when the reigning paradigm for ethical behavior is utilitarianism and free-market economy. Issues such as the commodification of children are not even discussed.  The narrative that this practice exploits women of lower socioeconomic status is flipped to state that it can actually empower these women.
For those teaching undergrads or even med students, this is an accessible introduction to the issues and can be used to foster discussion. It is really hard to come down against this practice without a content-full account of the meaning of family, motherhood, and the notion that a child is a gift from God.  It is our job to help our students and trainees find that content.

Cyber Life After Death

In The New Yorker this week Laura Parker reports on a new internet start-up that has a technological solution to a vexing old problem: mortality. Eterni.me has the tagline in huge font on its site, “Simply Become Immortal.” The CEO, Marius Ursache, says he is trying to solve the “incredibly challenging problem of humanity.”

Transhumanists like Ray Kurzweil have been arguing for a while now that it is our unique arrangement of information that makes us human—not anything to do with flesh, or emotions, or spirit, per se. Therefore if you capture those data sets and upload them, then “you” could “live” forever. The Transhumanists are more hopeful that artificial intelligence would allow the sine qua non of sentience to emerge from the machines into which our data becomes hard-wired. This Eterni.me website really only strives to maintain your “digital footprints” and through a scanned 3D avatar present a facsimile of you to those whom you choose. For example, Facebook posts, timelines, Twitter feeds , Instagram posts, and emails are all collated, and then they are “taught” to interact with your loved ones after you pass on. Not quite as nefarious a project as the Transhumanists have in mind. Think of the hologram of Princess Leia popping out of R2D2 in Star Wars, “Help us Obi-Wan Kenobi, you are our only hope.” An image with historical content meant to remind those you left behind of your absence.

This is clearly the next logical step as more and more of our relationships are limited to a virtual realm, and authentic face-to-face encounters are becoming almost quaint. Theologically, this is just a further expression of St. Augustine’s homo incurvatus in se, or humankind’s turning in toward itself rather than looking to God for salvation. It’s a classic expression for our times: a technological solution trading on our narcissistic concern that we all die and will be forgotten, utilizing our curated and projected “self-image” as portrayed online, and sent to haunt those whom we choose. While it is a little bit creepy, it is more of a barometer for the state of human affairs as we continue the secular search for meaning beyond death.

Consent, Human Subjects, & Equipoise

The Editorial Board of the New York Times recently condemned as unethical a study that randomized premature infants to higher levels of oxygen or slightly lower levels of oxygen. The study found that the group that received the lower levels of oxygen were at greater risk of dying than the group that received higher levels of oxygen.  The ethical breech, as cited initially by the federal Office of Human Research Protections (OHRP) was “violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death.”  Specifically, the consent forms used in this huge (>1300 patients enrolled) multi-institutional trial did not specifically state as a risk a higher incidence of death.  The editorial calls the study “deplorable” and states “if the institutions do not offer strong reforms, the agency [Department of Health and Human Services] can suspend their ability to conduct federally financed research on human subjects.”

The story of the emergence of Bioethics as a field is shaped significantly by responses to violations of respect for human dignity in the course of conducting clinical trials.  Informed consent became paramount in light of the atrocities performed by Nazi doctors, in the studies highlighted by Henry K. Beecher’s article in the New England Journal of Medicine, and in the Tuskegee study.  However, when I read this editorial the venom and vitriol of the authors did not resonate with me.  I think that it is probably because of the concept of clinical equipoise, and a mistaken concept that the status quo of medical practice is actually backed by statistically significant evidence.

The SUPPORT group (Surfactant, Positive Pressure, Oxygenation, Randomized Trial) was trying to answer a very important question: what level of oxygenation is ideal to avoid the Scylla and Charybdis of retinopathy of prematurity and brain damage (too much oxygen can cause blindness, too little can damage the brain).  When the trial was started it was an unsettled matter as to what the best level of oxygen was.  There were divided opinions and conflicting data.  In fact, Institutional Review Boards take this sort of thing into consideration all the time when they are approving studies.  And in the SUPPORT group the IRBs of each institution deemed it ethically permissible to randomize patients to each arm of the study–because the data to support either treatment was equivocal.  Also, since the evidence for one treatment versus the other was not clear, the idea that the “standard of care” was superior to being enrolled into the trial is fallacious.

It is worth reading noted ethicist and pediatrician John Lantos response to the strong allegations that this study was unethical.  He articulates this far better and at greater length than I can.  He reiterates that the study was designed appropriately, that the consent forms used were appropriate, and he cites data that show that patients who were enrolled in the trial had higher survival rates than premature babies who were not enrolled in the trial.  So, all the rancor about improper consent is somewhat diffused when you realize that patients not enrolled in the trial who received the “standard of care” actually were at the highest risk of death.  Parents did not sign a consent form to not enroll them in the trial.

Why is this important?  A misunderstanding of the actual conditions surrounding the study and a highly visible condemnation makes it even tougher for clinician-researchers to reach significant conclusions–and that is the more regrettable situation. While it is absolutely essential that human subjects are only enrolled in trials following all the ethical safeguards that were developed in the latter half of the 20th century, it looks like in this case the New York Times is fighting a straw man.