Trust and the Pandemic

One of the necessary requirements of a doctor-patient relationship is the establishment of trust in that relationship. A vulnerable patient presents to a physician who theoretically has the skill and knowledge necessary to help resolve the patient’s problem. Ultimately, the patient has to trust the information and treatment recommendations of his or her physician. Even in situations where the initial diagnosis turns out to be incorrect, it is the trust bond between the patient and physician that allows the two to proceed to other diagnostic and treatment options. If trust is lost, it is less likely the patient will have confidence in the information or treatment suggestions by that physician, often resulting in the patient looking elsewhere for treatment.

On a larger scale, the general population must trust the information and recommendations from their Public Health experts before they will be willing to follow treatment protocols, such as those presently in place for the COVID-19 pandemic. Loss of trust in those public health officials, for any reason, will not only lead the public to look for other sources of information and treatment options, it will also make them less likely to follow guidelines and restrictions currently in place, particularly if those guidelines and restrictions are viewed as inconvenient or harmful.

What does the public do when the usual trusted sources of information on the pandemic are shown to provide false information? Take for instance the recent CBS News story on long lines for testing at Cherry Health in Grand Rapids, MI. It turned out the long car lines awaiting virus testing at this particular testing facility were artificially exaggerated, with both the news network and the health system denying responsibility for the falsehood. Purposefully falsifying the data being shown to the public ostensibly being used to determine healthcare policy related to the pandemic does nothing to foster trust by the general population in either the health system or the news media.

What does the public do when two publicly acknowledged experts on the current pandemic claim the data that the CDC has provided them (and the public) are not only inaccurate but the two experts disagree as to whether the actual data represents an overestimation or underestimation of the problem? This link from the Philadelphia Inquirer quotes Dr Deborah Birx as saying “[t[here is nothing from the CDC that I can trust” in expressing her concern that the number of COVID-19 deaths reported by the CDC are inflated. The same article reports Dr Anthony Fauci expressing concern that the same CDC death toll represents an underestimation. It is no wonder that increasing friction is growing in multiple regions of the US as people struggle with the continued personal safety concerns regarding the virus and the growing economic disruption caused by our personal and public responses to the pandemic. Jerry Risser provided a thoughtful blog entry of the bioethical issues of this public health vs economics struggle (absent this present blog entry’s concern of data reliability)

A recent May 14th podcast from the New England Journal of Medicine (NEJM) provided some optimism in an interesting behind the scenes overview of how a respected medical journal like the NEJM determines how to provide reliable information on the current Pandemic. It is approximately 19 minutes of audio and is well worth review. While the NEJM is not perfect, they transparently discuss how they go about providing reliable, trustworthy medical information to the medical doctors on the front lines treating medical problems in general, and this pandemic in particular. They openly discuss several problems that NEJM has with the sheer magnitude of current data juxtaposed with the goal of getting information out to the public in a timely manner (8:15), the question of actual content selected for publication (complications vs clinical trials – 11:00), issues of best evidence (randomized trials vs how to treat the patient in front of the doctor right now- 12:10) and determining strategies to assist in opening up the economy (14:40). One gets the sense after listening to the podcast that smart people are truly trying to get the best data to the front-line people in public health in order to provide the best care possible and that is reassuring.

I suspect (trust?) that many other medical journals, public health authorities, federal, state and local government officials are working to do the same. One of my patients reminded me that even if that is not the case, Proverbs 3:5-6 is reassuring.

Bioethics and the Study of Health Care Economics

A recent Technology Review article by Peter Dizikes featured a review of the academic work of Dr. Amy Finkelstein, an MIT economics professor who arguably has changed the way we understand the economic impact of health insurance. Though not the primary focus of her work, her results have also led to a better understanding of health care itself. The article may be found HERE. Though a significant part of the article is biographical of Dr. Finkelstein’s academic career and is interesting in its own right, I want to focus on a couple of her findings for this blog entry.

The main study upon which the article focused was the result of an opportunity she identified in 2008 when the State of Oregon increased its enrollment in its Medicaid program by 10,000 people via a random lottery. This allowed her to compare the new enrollees health care access and behavior against a similar control group that had been randomly denied similar access. Some interesting new insights emerged. For instance, it was assumed that since the uninsured people routinely used the ER to access medical care, providing them Medicaid insurance would increase their access to routine care thus decreasing their use of ER care. What Dr. Finkelstein found was that the new Medicaid enrollees increased their visits to the ER and this increase remained elevated for at least 2 years compared with the control group. In fact, the new Medicaid group showed increased doctor visits overall, as well as increased prescription drug use and increased hospitalizations. Their out-of-pocket medical expenses and unpaid medical debt both decreased. And, while their physical health measures did not change appreciably, they reported increased good health and had less incidence of depression.

Additionally, the article summarized seven other interesting findings from Dr. Finkelstein’s body of work thus far. I will leave the reader to explore the whole article for these details. One result of a 2020 study that was particularly interesting to me as a physician was the current practice of so-called “hotspotting”, the practice of providing pro-active care to high-risk populations in an attempt to reduce the patient’s hospital readmissions. Dr. Finkelstein showed that hotspotting appears to have no significant benefit in reducing readmission rates of those patients. It is good to determine whether or not our medical protocols, which sound reasonable on their face and therefore appear justified, are in fact accomplishing their intended results, particularly since these programs require both additional time and financial resources.

The reason to highlight Dr. Finkelstein’s work in a bioethics blog is to reinforce the importance of using good data to make informed decisions in health care. Understanding the true effects of medical policies in health care access, insurance or provision is just as necessary as debating their bioethical challenges, as the former may make the latter debates either more fruitful or completely unnecessary.

Negative QALY Scores and Voluntary Euthanasia

I am all about saving money. I also enjoy reading the bioethical insights of Wesley Smith. His recent commentary in National Review entitled “Bioethicists: Euthanasia Will Save Money and Facilitate Organ Donations” naturally caught my eye. This blog has discussed the ethical problems with euthanasia and organ donation previously (see HERE and HERE). The focus of the remainder of this blog entry is to challenge the use of negative Quality-Adjusted Life Years (QALYs) as a utilitarian determinant of healthcare resource management, particularly with respect to voluntary euthanasia.

The article upon which Smith is commenting appeared in Clinical Ethics on March 10th by David Shaw and Alec Morton and was entitled “Counting the cost of denying assisted suicide” (full article behind firewall – abstract HERE). The authors briefly review the use of QALYs as used within the UK National Health System to determine cost/benefit of allocating medical resources. They explain the concept of negative QALYs, effectively time spent living (and suffering) in a state worse than death. They argue improvement occurs in the overall NHS net QALYs when there is reallocation of actual medical resources consumed “by patients who are denied assisted dying [and therefore experience negative QALYs]…instead be used to provide additional (positive) quality-adjusted life years for patients elsewhere in the healthcare system who wish to continue living and to improve their quality of life.” The argument essentially is that voluntary euthanasia prevents additional negative QALYs in the person requesting euthanasia and increases positive QALYs in one or more individuals in the population at large through the reallocation of the medical resources presently consumed by the person requesting euthanasia. Following the voluntary euthanasia and medical resource re-allocation, the NHS system is subsequently more efficient or economical since there are overall higher system QALYs given the same resources.

For this macabre exercise in utilitarian QALY mathematics to make sense, one has to grant that there is a state in life that is worse than death (by definition death is a QALY = zero). Individuals with terminal diseases and/or chronic pain stipulate their current state is indeed worse than death and therefore they experience a QALY less than zero – a negative QALY. They further believe they have no hope of ever achieving a state of positive QALY so argue their best option is voluntary euthanasia to reach death (so no more negative QALYs). Given all of this subjective stipulation, one might counter that other states of life might also exist that are also worse than death, such as the act of voluntary euthanasia. Perhaps it causes a transitional state of QALY much, much less than zero (something that “regular dying” does not)(since we are all just stipulating here) Any additional stipulations like this potentially further challenge their nice calculus.

Given the above, and perhaps more concerning, it is unclear (at least to this author) why Shaw and Morton used QALYs to score an act of voluntary euthanasia. It is unlikely that an individual goes through a similar calculus to determine whether his or her life is worth living with respect to the general population. He or she is deciding whether or not they want to continue living. They are not using a QALY score to justify their voluntary euthanasia decision to the population at large. So why the QALY score? Might such a calculus be used by one group to mathematically or scientifically justify imposing euthanasia upon another group, particularly within a system where medical resources are (becoming more) limited? Maybe it is just a way to suggest to those of us who find voluntary euthanasia morally wrong that it can’t be all that bad?

After all, it does save money.

Who gets the Ventilator?

Anyone watching the news coverage of the COVID-19 pandemic here in the US during the past week could not have avoided considering this generic question. Some are living in regions where the question is much more personalized – “If there really are not enough to go around, will I get a ventilator if I need one?” Ethically allocating a scarce resource such as a ventilator during a global pandemic caused by a virus that can strike anyone and potentially cause death by respiratory failure is clearly one of the great bioethical challenges facing us. What follows is a brief, blog length, discussion of some of the pertinent concerns followed by links to more detailed exploration, written by bioethicists who have considered these issues in greater detail.

In the last blog entry, Joy Riley touched on the issue of one individual refusing a ventilator for the expressed benefit of others. While the whole story was more complex, the facts do remind us that treatment (and therefore utilization of scarce resources) should start by determining what the patient actually wants and whether the resource in question can have any meaningful benefit in that patient’s care. Jon Holmund began the discussion of what processes and protocols may ethically change during the pandemic with resource scarcity and what others should remain in force.

My last entry touched on the four Principles of Bioethics (Autonomy, Justice, Beneficence and non-Maleficence) as a simple outline. The Principles are often referenced in guiding the one-to-one ethical relationship between the doctor and patient. Limited resource allocation affecting a population as a whole would seem to demand a different or additional ethical framework. Utilitarianism is often used in this context since it is an ethical system that desires to maximize some good (happiness, pleasure, health), theoretically scalable by maximizing that good for a whole population. Some problems with utilitarianism are determining exactly what that good should be as a population and agreeing on exactly how to measure it.

In the issue of the COVID-19 pandemic, one utility is maximizing access to ventilators or, perhaps more broadly, maximizing the number of lives saved. This sounds promising. But what happens when two people (or more) need, and want, the same ventilator at the same time. How do you determine who gets the ventilator? Utilitarianism does not necessarily answer this question or the many following: Is it “first come-first served”? Do we draw straws (a lottery)? Is it the person who can “pay the highest price”? The person who “needs it immediately”? The person who only needs it for a short time (so that the ventilator can be used again to help someone else)? Does the ventilator go to the person who is responsible for saving other lives (such as a nurse, food supplier, ventilator maker – and if so, how does one prioritize among these)? Assuming these decisions can initially be made, can we change that decision later? For instance, if someone has been using the ventilator for a (long) while, is it ever ethical to remove that person so that someone else “has a chance”? If not, is it ethical to somehow prevent them from being selected for ventilator access in the first place?

None of the preceding questions are easily answered, particularly in the heat of the moment, and are therefore best answered, if they can be, at the outset. Once determined, they should be made public as transparent guidelines. If agreeable to all involved, then applicable equally to all involved, and implemented fairly as specifically outlined. No guidelines will be exhaustively perfect in their ability to stratify and prioritize access to save the lives of all involved – the best that may be accomplished is to save the greatest number of lives until the scarcity of ventilators is resolved or the pandemic has run its course.

Agreeing on an ethically acceptable method to allocate scarce resources in a theoretical pandemic is very difficult, even in the abstract; actually implementing such a plan during the emergency of the real pandemic warrants nothing short of divine guidance.

For those interested in reading further and/or deeper, the Center for Bioethics and Human Dignity has an excellent resource page with multiple links to other references. I found Dr. John Kilner’s “Criteria for the Allocation of Limited Healthcare Resources” very helpful.

Bioethics and the COVID-19 National Emergency

What a difference a couple of days can make. In the last blog entry, Steve Phillips discussed the problems that fear and panic are causing as we deal the many unknowns of the COVID-19 pandemic. While the current incidence, prevalence, and mortality of COVID-19 lags behind that of seasonal influenza (as well as past influenza pandemics caused by novel influenza strains), the eventual morbidity and mortality remain unknown. This uncertainty has caused public panic, which has lead to significant disruption of life, as we know it. A national emergency was declared in the US last Friday, calming some fears but reinforcing others. Using the four Principles of Bioethics as a simple outline, the following are some of the bioethical implications of the current COVID-19 pandemic I have recently considered – there is certainly space to add others.

Autonomy: The highly infectious nature of the new virus and the risks for the population as a whole place severe restrictions on individual autonomy. An individual is really not free to do whatever he or she wishes to do at this time. Measures to blunt the rate of infection spread have limited travel and will eventually cause some to be quarantined, perhaps against their will. Necessary public health measures will conflict with individual health decisions and desires. Do all individuals have a right to be tested for COVID-19 (particularly now that the test will shortly be free of charge) because they have a right to know or demand to know, or will we defer to protocols of best practice in the face of currently limited test availability, all of which are admittedly our best statistical utilitarian “guesstimates” for the benefit of the population as a whole?

Justice: The details of the pending National Emergency legislation are still not well known as of this writing but will apparently provide financial support to individuals and businesses affected by COVID-19 and this is certainly good, given the considerable disruption already caused by the fear and panic related to the disease, and the projected future impact of the actual illness itself. It is interesting to me that one result of this legislation may be that, with accurate testing, an individual or business will get federal benefits for having COVID-19 related problems but may not for similar influenza related problems. This is despite the fact that from an individual morbidity and mortality standpoint, particularly on a global basis, both COVID-19 and influenza both can end up causing severe health and secondary financial consequences. Asked differently, does justice require federalizing other viruses (or diseases) that, on a case-by-case basis, cause similar individual financial disruption as we will see from COVID-19?

Beneficence: I believe most people want to be helpful to others and do the right thing. Any desire to help others is somewhat counter balanced by lack of knowledge of exactly how infectious is the COVID-19 and therefore what risks do we assume for ourselves and for our immediate family in any benevolent activity in which we engage. Deciding how to help others without harming oneself will become clearer as the public health data grows.

Non-maleficence: Our natural tendency for self-preservation in uncertain times has resulted in a rush to hoard food and supplies, causing a severe strain on supply of these resources. Supply chains in a global “just-in-time” inventory structure are much more fragile as a result of COVID-19 than many had anticipated. Important medications, medical supplies, standard foodstuffs and infant needs are suddenly in short supply and are concerning; recent news videos of fights at your local Cosco over the last role of toilet paper are concerning for other reasons. Calls have gone out asking citizens to “hoard less”; hopefully these pleas will not fall on deaf and selfish ears.

For the Christian, wisely loving our neighbors may be the best ethical guideline and will look different in various regions and will likely change over time as we get a better understanding of COVID-19. I echo the many prayers for the health and safety of all affected by this pandemic and an extra measure of the Lord’s wisdom and strength for those in public health rising to meet and resolve this national (and worldwide) emergency.

The Non-Binary Doctor-Patient Relationship

Today’s blog entry continues another aspect of what Neil Skjoldal began yesterday. Shoshana Rockoff, writing in Yeshiva University’s The Commentator wrote about the changing landscape of physician private practice ownership and how that may be changing the doctor-patient relationship for the worse. She reflects on her grandfather’s private optometry practice when she describes the solid personal relationships that developed with his patients over his some 30 years of private practice. She worries what the future of that doctor-patient relationship will look like as both hospital systems and private equity firms, looking to make a profit, swallow up a growing number of practices. Her editorial is found here.

My personal practice experience is not too dissimilar. I began in private practice 30 years ago as a rehabilitation physician taking care of mostly inpatients who had recently suffered a stroke, spinal cord or head injury. I saw outpatients in my daily clinic that had the chronic neuromusculoskeletal sequelae of these problems. The chronic nature of their diseases resulted in my getting to know my patients fairly well, an attribute that I very much enjoyed.

What I did not enjoy was negotiating my reimbursement rates with the insurance system, something I was never trained to do in residency. As a solo practitioner, I had no clout with the large insurance carriers and my rates went down every year. Eager to pay back my student loan debt, I had also accepted a stipend to be the rehabilitation hospital’s medical director, which was my first experience with conflict of interest – I was responsible for making sure that only medically appropriate patients were admitted to the hospital while working with the administration of the hospital to maintain its financial viability at a time when insurance companies were beginning to aggressively assert their financial ability to reduce costs. It is rare, if not impossible, to wear two conflicting hats well, particularly at the same time.

I eventually joined a larger, multispecialty (mainly orthopaedic surgery) physician-owned group practice, where I remain today. Being part of a larger group allows us to negotiate more favorable reimbursement rates than my earlier experience but now from the dwindling number of consolidating insurance companies, who, along with the federal government Medicare and Medicaid programs, dictate those rates. My reimbursement rate has still gone down every year, now at a slower rate. A solo practice or small group private practice has no similar negotiating power with the insurance system. This is, if not the main reason, at least a significant reason that many of my colleagues who were in small physician-owned practices have decided to be acquired by large hospital systems or sell a portion of their assets to equity firms, who naturally exert some influence on future medical business decisions.

Economic decisions have not been isolated to the doctor side of the equation. Individual patients and smaller businesses that provide insurance to their employees lack the negotiation power with these same insurance providers and, over time, have had to settle for insurance coverage that contractually pays for fewer benefits at gradually increasing cost to those same patients or small businesses. Only very large companies or unions have any negotiation power to obtain better insurance benefits at less cost. The recipients of government sponsored insurance programs, such as Medicare and Medicaid, have the least direct costs but also the least direct say in their medical benefits, and these programs presently dictate medical reimbursement for well over one-third of the US population.

I think Ms. Rockoff is correct that it is getting harder to maintain the same doctor-patient relationship that her grandfather and his patients enjoyed decades ago. I think the primary reason is that both doctors and patients have allowed third parties into that relationship, largely for economic reasons, a process that began even before her grandfather started his practice.

I am blessed to be part of a physician-run multispecialty group that remains committed to a (Judeo-Christianized) Hippocratic doctor-patient relationship. I know many of my corporate-employed colleagues desire and work to maintain the same relationship with their patients. Many non-medical business people running corporate practices want that type of relationship with their physician.

The real question may be how to have a doctor-patient relationship when the relationship is no longer binary, and likely never will be again.

The Advancing Slippery Slope of Organ Donation and Euthanasia

The timing of organ donation relative to death of the donor is critical to the survivability and future functioning of the donated organs in the transplant recipient. With cardiovascular death, circulation ceases in the donor causing his or her death, making it legally and ethically permissible to retrieve the organs for donation. Unfortunately, cardiovascular death also means that the donated organs have also lost circulation at the moment of death and begin to suffer local tissue destruction, affecting the very health of the donor organs and success of transplantation. If the donor has sustained severe brain damage but without cardiovascular death, he or she may be considered dead secondary to whole brain death criteria. This allows transplant surgeons to begin harvesting the organs from the donor while the organs are still enjoying a normal oxygen supply, maximizing their survivability for the future transplant recipient. These organs are far more viable than those from donors who had cardiovascular death, similar to the situation of a healthy living organ donor voluntarily donating one of her two kidneys. Crudely, the less dead you are when you donate your organs, the better chance of success of the organ transplantation for the recipient. Knowing the exact moment when the donor dies maximizes the timing and therefore the success of the transplant process.

Enter euthanasia, in particular the growing acceptance of medical aid in dying (MAID) or physician assisted suicide (PAS), where a physician is directly controlling the dying process. The union of MAID/PAS and organ donation would seem to be a marriage made in transplant heaven. By controlling the time of death of the donor, the subsequent immediate harvesting of the donated organs would theoretically maximize their viability. What could be better?

Euthanasia via organ donation, of course.

The NEJM offered a recent Perspective entitled “Altruism in Extremis – The Evolving Ethics of Organ Donation” by Dr. Lisa Rosenbaum. The article is behind a subscription firewall that does offer limited free access with registration. In short, Dr. Rosenbaum explores many of these ethical issues in organ transplantation as she describes the case of a man who was dying of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease) and wanted to donate his organs in the process of his MAID/PAS (hence her title “Altruism in Extremis“). In his case, the plan was to donate one kidney, then be taken back to the intensive care unit and extubated, technically allowing the ALS respiratory muscle weakness to cause his death, and the remainder of his organs harvested immediately thereafter. The hospital ethics committee approved the plan but the hospital attorneys warned the doctors they might be “charged with murder or acceleration of the patient’s death” (facts not apparently obvious to the doctors). In the end, the patient died in hospice care, unable to donate his organs.

An interesting sidebar discussion of a similar case involving “live donation prior to planned withdrawal” (LD-PPW – that is, removing the organs before withdrawal of life support – what I have labelled Euthanasia via Organ Donation) was considered ethically permissible but politically problematic, the concern being LD-PPW might reduce the number of willing donors who saw the “surgeons as ‘vultures’ stealing organs from those not quite dead”.

What struck me was the obvious slippery slope on which we find ourselves. The question as to whether the patient in Dr. Rosenbaum’s article should proceed with MAID/PAS given his terminal ALS was NOT the ethical debate but rather how to ethically marry MAID/PAS (perhaps ideally with LD-PPW) with his desire for organ transplantation. Labeling this type of organ donation as obviously altruistic will undoubtedly place further pressure on some presently terminally-ill patients to get on with their deaths to make their organs available for the rest of us who apparently have an unspecified ethically superior claim to their use. Organ donation from a living donor is itself a supererogatory act – additionally encouraging the donor’s suicide (and labelling it altruistic) just to improve the success of the transplant is calling evil good. Why is one more minute of life-giving use of my heart or liver by me necessarily less ethical than 1 year of life-giving use of those organs in another?

P.S. Frankly, I thought the vulture metaphor failed as even vultures normally wait for their prey to be dead before enjoying their harvest.

Twenty-first Century Divorce: Who Gets Custody of the Embryos?

A recent CBS news story provides yet another example of the technology and legal cart pulling the ethical horse.

In short, in 2014, an Arizona couple used in vitro fertilization (IVF) to preserve her eggs after she learned she had breast cancer and would require chemotherapy. The woman’s then boyfriend originally declined to be the sperm donor but later agreed when the woman, perhaps desperate to preserve her eggs, considered using a former boyfriend as the donor (fertilized eggs survive cryogenic preservation far better than unfertilized eggs). The couple executed a contractual agreement, provided by the clinic, as to the disposition of the frozen embryos (“their joint property”) should their relationship divorce or dissolve prior to implantation. They married several days later, underwent IVF yielding 7 embryos, which were cryogenically preserved and the woman underwent successful chemotherapy.

Unfortunately, after 2 years of marriage but prior to implantation, the husband filed for divorce. The pre-IVF contract stipulated that both husband and wife had to mutually agree on the disposition of the embryos – if not, they agreed a court could decide the embryos’ fate. Recently, the Arizona Supreme Court determined that the embryos should be put up for adoption, siding in one sense with the ex-husband to prevent the ex-wife from “using” the embryos. The decision upset many in Arizona to the point where the Arizona Legislature enacted a law to award the frozen embryos, in the future cases of divorce, to the spouse who “intends to use them to have a baby.” The new law will not benefit the ex-wife so, at the time of this blog entry, she was considering whether or not to appeal her case to the US Supreme Court.

There is a lot here to consider. I want to focus on just a few issues. First, I left scare quotes around several of the terms used in this case. The frozen embryos are indeed legally “joint property”, much like children in other cases of divorce. The couple could have just as easily checked the box on the contract to select “Destroy the Embryos” in case of their divorce. This same choice is one that many married (and unmarried) couples make regularly in IVF absent divorce when deciding the fate of unwanted or unused embryos following successful pregnancy and birth from prior IVF cycles. So asking a court to decide the fate of the frozen embryos is similar to children of divorced couples (though their “destruction” is not currently an option.)

“Using the embryos” is terminology that further emphasizes the commodification of frozen embryos as we consider them as a convenience for, or, for the sole benefit of, the parent(s). While I can empathize with the ex-wife’s desire to preserve her ability to have future children in the face of cancer treatment, her choice of an ambivalent (then) boyfriend over an ex-boyfriend as the father of her future children has proven disappointing, if not disastrous, for her in the present. It is harder for me to grasp the rationale of the ex-husband, who, though previously agreeing to father his ex-wife’s children, now (vindictively?) refuses to allow her to mother them, particularly since (continuing with my horse analogy) that fatherhood horse left the barn years ago.

As we allegedly advance our technical and scientific skills by increasing the various situations in which women can become pregnant, we are demanding more legal decisions when these new situations cause conflict rather than discussing and agreeing beforehand whether or not to permit these situations from occurring in the first place.

Autonomy of Access vs. Autonomy of Decision Making in Opioid Addiction

A recent Perspective in The NEJM by Dr. Amy Caruso Brown discussed the ethics consultation involved in treating addiction as a terminal disease. Since the article is behind a subscription firewall, I will briefly summarize the case and some of the ethical problems outlined by Dr. Brown. The focus of this blog is to ask the limited question as to whether or not there is sufficient patient autonomy to make decisions in an addiction situation described as terminal if, as Dr. Brown claims, society has failed to provide sufficient access to and services for patients with chronic addiction and/or mental health problems associated with similar levels of addiction.

Dr. Brown’s patient, Ms. A, was an unemployed, homeless woman who had a history of chronic opioid use/abuse and had failed multiple impatient rehabilitation, methadone maintenance and buprenorphine treatment programs. She was hospitalized for septic shock secondary to endocarditis, which had damaged two heart valves to such a degree that she was not considered healthy enough to survive surgery to correct the problem. Her only relative, a brother, who had recently finally cut ties with his sister to protect exposing his children to her illness and habits, agreed to a do-not-resuscitate order. To the surprise of her treating staff, her condition stabilized to the point where the cardiothoracic surgeon agreed to operate. She declined, wanting to be discharged so she could seek morphine to self-treat the intractable chest pain. She fired her attending physician as he made the ethics consultation referral questioning her decision-making capacity.

Dr. Brown nicely outlines the particular issues of legal capacity requirements required in New York and the limited capacity that surrogates have if they we not previously designated as such. Dr. Brown also discussed whether or not Ms. A met the criteria for terminal illness, specifically whether or not ongoing chronic opioid addiction, in the face of now severe cardiac compromise, would be expected to cause death within 6 months. Dr. Brown maintained that Ms. A was lucid and capable to make informed decisions, which were that she “simply wanted to go home, or to a hospice facility, and die peacefully.” Dr. Brown did not find her depressed or emotionally compromised, though quoted her as saying “I’m done. I’m ready to be done. I’ve fought long enough” and described her as “exhausted and grieving”. Dr. Brown believed Ms. A’s “decisional capacity was clear.”

Finally, Dr. Brown argued that society had failed Ms. A by not facilitating access to a treatment program that “included medication for opioid use disorder (OUD) – preferably initiated in an inpatient setting and coupled with ongoing trauma-informed mental health care and various social supports – [in the absence of which Ms. A] would almost certainly have a relapse”, further making it likely she would die within 6 months. Though the article noted Ms. A had previously failed inpatient rehabilitation, methadone maintenance and buprenorphine, it was not stated how coordinated or integrated the previous programs were. Was the proposed program new or simply a second (or third) chance through a similar program? Thankfully, Ms. A decided to accept palliative terminal care, which resolved her homeless situation, as it would be provided at an inpatient facility.

What if Ms. A had declined inpatient palliative care? Dr. Brown made a strong case that Ms. A’s social situation (poor, homelessness, mental health history of abuse and chronic opioid dependence/abuse) limited access to an appropriate treatment program for her problems, likely the only one with any expectation of success, however limited. Even if we grant that Ms. A was indeed terminal and had clear decision-making ability not compromised by depression, ongoing opioid dependence and other mental health factors, did her social situation really allow her to be autonomous in decision making? Said differently, how can we consider her autonomous for decision-making when she apparently lacks autonomy for access to her treatment? Further, how much support can an individual demand or expect from society and still be considered autonomous? I have touched on a similar issue in this blog previously with regard to serial pregnancy in opioid addicted women, asking when should the risks to the children (and social and financial burden to society) supersede the mother’s autonomy for having more children?

We need to improve access to treatment and support for mental health in general and opioid treatment in particular. This will likely include further discussion regarding the level of autonomy of those needing that treatment and support.

Scientific Validity vs. Bioethical Violation?

In a previous blog entry, Dr. Riley covered the 30 December 2019 conviction of He Jiankui, the Chinese scientist who allegedly created the first genetically altered human babies born in November 2018, to three years in prison for “illegal medical practices”. His criminal conviction is somewhat surprising to me because I believe Dr. He must have received at least initial support from the Chinese government for his human genetic experimentation, particularly since he was allowed to travel to Hong Kong in late 2018 and make public a portion of his research. My surprise is that the almost universal uproar about the bioethical violations in this case can (at least presently) make even the Chinese government admit that a line has been crossed that warrants public condemnation and punishment of those involved. Though the crime cited was crossing a thinner bioethical line (lying on the informed consent about the risks of genetic engineering to the babies) rather than the fuller bioethical line (the actual risks of genetic engineering to the babies and humanity in general), a bioethical crime was committed.

There are other aspects of this story that need our bioethical consideration. Antonio Regalado in a recent Technology Review, describes the still circuitous path Dr. He’s research has taken en route to ANY publication. In fact, it appears that Technology Review is the first publication to make any portion of the original manuscript public (there is a link within the link provided above of excerpts of Dr. He’s manuscript). I cannot do justice to Mr Regalado’s sleuthful efforts at piecing together this story (it defies a simple summary) and encourage those interested to read his account in the link above.

Regalado reports that Dr. Howard Bauchner, editor-in-chief at JAMA, was given access to the original manuscript just days after the 2018 Hong Kong conference. Regalado found Dr. Bauchner to be generally supportive of genetic editing of embryos:

“I think it’s inevitable that it will move ahead, and I think it should move ahead… Oftentimes early scientific breakthroughs [such as organ transplantation and IVF] are seen as unethical, and then over time that changes, [as the technologies prove successful].”

In fact, a main dilemma for Bauchner remains the following: “If someone thinks it’s scientifically valid but not ethical, does that mean the study will stay in the shadows?…It’s such an interesting question.”

An interesting question indeed. One online repository of pre-published scientific papers called bioRxiv rejected the manuscript, likening the manuscript to a paper it might have received from Dr. Josef Mengele, the infamous Nazi death camp doctor. One might therefore wonder why Technology Review has published any portion of the manuscript. They are not a scientific journal per se, with strict peer review to validate the scientific method and results. They are a publisher of scientific news, and Dr. He’s experiment, regardless of it’s many bioethical failures, is certainly scientific news. Technology Review offers a more in-depth opinion as to why they believe it is appropriate to make the manuscript public.

Back to Dr. Bauchner’s interesting question. Does he mean by scientific validity that Dr. He’s experiment (may have) accurately edited the section of human genome that Dr. He claimed and therefore the scientific community should be able to learn from that? Even so, it still seems to me that that Dr. Bauchner is putting the scientific cart before the bioethical horse. Shouldn’t we decide whether it is right to edit the human genome in the first place before worrying about the validity of the technique to edit that genome?