Understanding the Complexities of Health Interventions with Dr. Robert Malkin

Q. Could you introduce yourself and what you do as a faculty member at Duke?

A. I am a professor of the practice of Biomedical Engineering and Global Health. I teach classes in both biomedical engineering and global health, and my research is primarily focused medical equipment in resource-poor settings.

Q. In your experience in BME research as well as in the field, are there any unique ethical challenges that a biomedical engineer faces in their line of work?

A. Absolutely. The two that I think are the most prominent are that most medical equipment is attained through donations and the problem of field repairs. But let me talk about donations first. Donations bring up two problems. One is that the majority of donations do not work. This brings up a long list of ethical issues. But primary amongst them is what is your ethical responsibility when you’re donating something. Among the questions would be are you obligated to distribute information. How about manuals, manuals in language they can read and whatnot. How about supplies? There are three major players in all donations: the donor, the middleman, and the recipient hospital. And it is unclear where those responsibilities lie between those three players. And regarding field repairs. It is generally impossible to execute a eld repair of technologies to the same standards as a U.S. repair. Let’s say a piece of technology breaks in Kenya. Even in the capital city of Nairobi, it can be impossible to execute a field repair due to a lot of factors such as a lack of materials or diagnostic tools. This brings up a lot of ethical questions, primarily, is this acceptable? Is it acceptable to have a second standard of repairs in a remote site compared to the United States?

Q. Usually, with many of the innovations in health- care technology, you see that the richer patients are the only ones that can afford them. How can we guarantee that these innovations are accessible to people of all socioeconomic levels?

A. You cannot. That’s absolutely impossible. All medical technology enters the market in narrow slices. You can potentially change the slice that is first served to the neediest, to the poorest, or to the richest. But there is no way for medical innovations to enter the market accessible to all people all at once. There has been no desire to do that. Medical technology is introduced in niches and narrow categories intentionally. It protects the wider public from exposure to technologies that are defective. So that is not going to change. Technology is always going to be introduced into narrow slices and eventually into wider slices.

Q. On a daily basis, how much of a role does medical ethics and patient autonomy play in your line of work?

A. Well every rollout of technology is subject to ethical review. We can’t introduce anything without ethical review. It’s huge. Everybody in a lab, every student, any person that is remotely touching a new piece of equipment has to go through ethical training. Ethics is a major chunk of what biomedical engineers have to address.

Q. So on that note, in the process of product roll- out, what is the typical ethics criteria that an ethics board goes through?

A. The first one that we encounter the most is consent, informed consent. That could be super tricky because you are going across language barriers and cultural barriers. Getting informed consent is the first priority usually. How are we going to inform and how are we going to get consent. After that, there’s the usual criteria such as bene t-risk ratios. But overall, informed consent provides the most challenge.

Q. In terms of medical technology, with the rise of systems such as electronic registration systems, do you see any concerns with the dehumanization of healthcare especially as doctors seem to be seeing their patients less and less?

A. No and yes. First off, most of what I do is in rural parts of the world. For instance, in the U.S. we have a program in West Virginia and also in other parts of the world such as Belize and Guatemala. In the rural parts where we work, most of our patients never see a doctor, so they already have zero contact. So what’s happening is that patient care is being pushed into lower cadres. Nursing assistants, traditional healers, etc. These lower healers, in terms of years of formal training, are what people are actually seeing. It isn’t particularly obvious to me that the number of contact hours for healthcare workers has changed recently. In fact, it may have gone up in some countries. the type of worker that the patient sees has changed, but the amount of time patients are being seen is actually go- ing up. And to address medical registration systems, I cannot see any influence. If anything the time patients are being seen has increased in developing countries as there is less paperwork.

Q. As a conclusion, what is the most important part about your eld of work that you’d like to emphasize.

A. All engineering, including BME, is done to help people. That’s why someone becomes an engineer, they want to make the world a better place. That’s why most of us get into engineering. For biomedical engineering that is done through healthcare equipment. From my perspective, it is the most exciting eld of engineering. I’ve been in engineering for a while, and in my time, BME has constantly been changing. It isa great eld, and I think we have succeeded largely in making the world a better place whether it be in treating polio or eradicating diseases like smallpox. Biomedical engineering has made a significant contribution to society.

Q. In light of all the achievements BME has helped accomplish such as the eradication of smallpox, what is the next step?

A. Well, there’s a couple of things. We’re seeing now a lot of developments in tissue engineering. There is going to be engineering of tissues such as cartilage, and there will even be more complex developments such as retinal replacements. Tissue engineering is going to be huge. Next, there is also engineering at the molecular level. We’re starting to see that in examples like CRISPR. But there is a lot more exciting engineering going on at the molecular level in instances like very targeted cancer treatments. The basis of pharmaceuticals for thousands of years has been finding molecules in the wild and refining them for drugs. But now, specific molecules are being developed artificially.

This interview was conducted and compiled by Paul Kim of Duke University

Medical Ethics and the Future with Dr. Myaing Nyunt

Q. Could you briefly introduce yourself?

A. I am an associate professor of medicine and global health at Duke. My primary appointment is with infectious diseases in the School of Medicine, but my “academic home” is in global health. I specialize in malaria, anti-malarial drugs, and malaria elimination.

Q. How do you define medical ethics?

A. Medical ethics, I think, is a set of rules, that we as clinicians, or we as researchers follow to make sure that whatever we are doing to our patients or with our patients, is morally, ethically, and legally acceptable, and fair.

Q. What personally drives you to pursue research in, or improvement, in medical ethics?

A. Well, my personal background and personal experiences help me understand and drive me to pay more attention to medical ethics. Specifically, I am from originally from Burma, or Myanmar, in Southeast Asia. I grew up there, and I started medical school there. But in my last year, I got involved in the student movements of 1988. Many students were killed on the streets, and then right after that, the military took over the country in late 1988. So that was where I was first exposed to human rights violations and the experience of having my own human rights violated. That was when I left the country. I took refuge in England, lived there for a couple of years, and eventually emigrated to the US. That was where I basically rebuilt my home. I redid my undergrad, med school, PhD, and my clinical training here. That experience of witnessing the violation of human rights stayed with me all along, and during my last year of med school, I went back to Myanmar, to the border region. That was the time I saw the value of research in building trust, fairness, and transparency. These are the fundamental building blocks of medical ethics. To build respect, you need to build trust.

Q. So in sum, human rights, building trust are intertwined with medical ethics.

A. Absolutely

Q. In your experience working in the health systems of the US and Myanmar, do you find any unique ethical issues?

A. There are huge differences, but there are also similarities. Similarities in that, the nature of humans is similar across the board. We all want to know the truth. We all want to know that we can rely on our doctor/researchers. We all want to be respected. But in health systems, there are differences in stability, consistency. For instance, there is a distinct infrastructure in the U.S., while there is little to none in Myanmar. It doesn’t matter how much money you have, if there is no infrastructure, that doesn’t matter.

Q. How do these distinct differences seem to affect issues of patient autonomy?

A. Well if you have a system with no emphasis on transparency, fairness, and respecting each other, there is no autonomy. Because if you think about it, informed consent’s main principle is autonomy. You have to be able to tell the patient about the potential consequences of your research, and the patient must also have enough power, or be empowered to say, “You know what? No. I’m not participating this.” There has to be an equal distribution of power between patient and the researcher. Even if the patient is illiterate, they must be able to understand the risks they will be involved in. They must be able to understand the system established to protect them. People like to say, “Oh no, these people are so poor and uneducated, so they cannot understand the medical system around them.” That is not true. If you explain things, and take your time, the patient can have autonomy, and they will express their autonomy if they can. As such, patient autonomy cannot be emphasized in a system like that of Myanmar.

Q. In that sense, as a medical student in Myanmar, did you notice any instances in which patient autonomy wasn’t being respected?

A. Oh there were many. There were many times in which the doctor came into the patient’s room with a piece of paper with small print that gave the risks and benefits of the surgery. And they would say, “here is the consent form, sign it” without educating them whatsoever. The doctor didn’t consider how the patient felt. You see this many times in developing countries. Patients suddenly feel smaller, as they are already vulnerable. So when they see a big doctor with a white coat coming in, there is no way they will ask, “what am I signing?” Then they will just sign it. You see this in America as well. Even when I am a patient in America, there will be instances where a nurse simply gives me papers to sign. But the difference here is that I am educated and empowered to ask, “what am I signing?”

Q. In this discussion about the patient- provider dynamic, how important is reconciling that relationship in the advancement of patient autonomy and medical ethics?

A. It is super important. I would say it’s the most important issue. There is significant literature on the power of consent, and the power of the balance between the patient and the doctor. If the patient feels like they have the power to be a part of the treatment plan and can talk shoulder to shoulder with the provider, many believe that there will be, for instance, less medical lawsuits in America. Many times, the patient sues the doctor because they are angry, not because of the bad outcome. The bad outcome alone doesn’t lead to a lawsuit. They feel violated, and they feel like they have been cheated.

Q. On the topic of American healthcare, what do you see as the most pressing issue, in terms of medical ethics and patient autonomy, of American healthcare?

A. It’s education. I truly think that we should have applied teaching of medical ethics. Not just to go through the principles of medical ethics. I really think that, just as anatomy is taught with applications, ethics must be taught in a similar format. The principles of medical ethics and the understanding of medical ethics is not enough. But how to apply medical ethics with your patient daily is crucial. I think that it will even be important to learn these principles and their applications at a high school level. Because building trust and proper communication are very important, but they are not a part of our education system.

Q. Our world is becoming and already has become increasingly interconnected. As multiple cultures become interconnected, do you see this intersection creating any unique issues for patient autonomy and medical ethics for professionals?

A. I would think that, yes, there are more challenges, but there are also more opportunities. Because we are so interconnected, it becomes more complex to respect medical ethics. There is no one-size-fits-all approach. SO that means that you need more and more tools and methods and approaches to make sure everyone is being respected.

Q. That’s where the opportunities you mentioned come in?

A. Yes of course. As you know, there is the common discussion about why the people in the poorest countries can still be happy while we have unhappy people in the richest parts of the world. So we can always learn from each other. This intersection, I believe, will help many of the issues we face in medical care.

Q. The common conflict that we see in the patient-provider dynamic is striking a balance between the autonomy of the patient while also respecting the expertise of the professional. What do you see as the most effective means of respecting both sides of the argument?

A. I would say that it is important for the doctor to come down to the level at which a patient can understand everything. My mentor would teach me, “You should always talk at the level of a sixth or seventh grader when talking to a patient.” Even though the patient may have a PhD, the level of vulnerability that comes with being a patient makes people less receptive to what you’re trying to explain. It’s a matter of taking time, being patient, and basically being empathetic. Think about how YOU would want to be treated.

Q. With each patient, the effects of healthcare on a patient can be heavily influenced by their. socioeconomic class. So that obviously leads to people of lower socioeconomic class finding it harder to navigate the healthcare system. How can we guarantee that people of all classes will be able to express their autonomy as a patient?

A. I think that this solution comes at an institutional level. Specifically, I think we need a more diverse medical system of professionals. This would mean that the professionals in the system will be able to better understand the vulnerabilities of more populations of people, and they will be able to recognize the special treatment and tools that people need. There are things you cannot learn from books, we need a more diverse population of professionals making the decisions for patients who can understand the perspectives of a wider variety of people.

Q. So in your perspective and experience, what is your opinion on the status of medical ethics and patient autonomy? Has it improved?

A. I want to say that it’s getting better compared to what we were doing to our patients 50 years ago. Today, patients are being protected not only by ethical principles, but also the legal system. Risk management systems in our hospitals teach medical residents and doctors how to practice ethics. In the past, we didn’t have this, the doctors were considered the cream of society, and they were allowed to do anything. So, to answer your question, things have gotten better.

Q. Thank you so much for your time, so, to cap this interview off, if the person reading this interview is to get one thing from it, what is the most important aspect about patient autonomy and medical ethics that you would like to emphasize?

A.We need to do more. We need to do more to underline the importance of ethical practice, and that of course is linked to building trust and effective communication between the patient and doctor.

This interview was conducted and compiled by Paul Kim of Duke University

I Didn't Sleep Last Night: Physician Disclosure

In 2010, a group of sleep specialists published a paper in the New England Journal of Medicine, proposing a thought experiment in which a surgeon stays awake for an entire night after receiving a call for surgery at 11:00 p.m. and not being able to sleep before having to perform an elective surgery at 9:00 a.m. (Nurok et al, 2010). After presenting arguments about the effects of sleep deprivation, the authors argue that the physician must disclose their sleep deprivation as a potential risk to surgery to the patient, and a new informed consent must be acquired.

Two years later, Dr. Charles Czeisler, an author from the original paper, wrote a second paper published in the Annals of Thoracic Surgery, debating the pros and cons of obtaining a new informed consent (Czeisler et al, 2013). Whereas Czeisler wrote in affirmation, Dr. Carlos Pelligrini negated the idea that a new informed consent was needed. Pelligrini aired on the side of caution, pointing out that the lack of consistent research showcasing that sleep deprivation in surgeons affects surgery outcome, requesting a new informed consent before a surgery, in which the patient is most vulnerable, is inhumane, and the issue of the sleep deprived surgeon could be avoided through institutional intervention. Pelligrini argued that disclosure is important, but questions how far this disclosure should go. He posited that if physicians had to disclose whether or not they slept due to being on call, should they also be compelled to disclose whether or not they were able to sleep well? Taking it one step farther, what about other personal information such as financial or marital problems that might also affect their concentration? Although Pelligrini’s hypotheticals are made in jest, his questions touch upon a key issue: how far should physician disclosure go?

Establishing a precedent of mandating physicians disclose health-related variables has the potential to implicate how a physician is treated, especially in the context of physicians who experience illness and disability. Disclosing such information reinforces the stereotype of the “super able” doctor and disproportionately affects disabled doctors. Initially, requiring physicians to disclose health in the informed consent process bolsters a culture in medicine of the “super able” doctor. Doctors are often held to a higher standard of physical and mental health despite operating in environments that often fail to facilitate either. Viewing doctors as the cornerstone of health puts them at risk when they fail to live up to these expectations. Moreover, accessing a physician’s proficiency on the appearance of physical and health metrics alone has proven to be inexact. For example, patients often base expected physician success and skill on length of experience and reputation instead of a more accurate metric, which is a physician’s engagement in “deliberate practice” (Ericsson, 2008). Adding in a metric such as “sleep hours” has similarly been shown to be a weak way to determine physician ability (Banfi et al, 2019). Allowing patients to decide their doctors based on perceived ability and stereotypes without compelling evidence of the implication on outcome, effectively punishes doctors for not being able to meet unrealistic standards on how to apportion their time to practicing.

A much stronger approach to mitigating possible damage from lack of sleep health is by focusing on improving the work environment for surgeons and physicians overall by implementing rules and changes at the administrative level. Instead of relying on the physician or surgeon to make an ethical decision on how to balance practice and sleep while also adhering to rigorous expectations, creating administrative stops and policies that prevent surgeons from engaging in rigorous on call hours and immediately performing elective surgeries the next morning help reduce unproductive competition and peer measuring within surgical units and hospitals (Czeisler et al, 2013).

Additionally it must be recognized that decisions based on the design of operating theaters and protocol can greatly affect the performance of surgeons, which can mitigate specific symptoms of exhaustion that are of concern for patients. For example, surgical checklists and the integration of multiple layers of accountability can greatly assist with human error (McCarroll et al 2014). Requiring information related to physician health be utilized within the informed consent process without clear evidence of impact on outcome does little to solve a greater problem. Instead of expecting the patient to assess the ability of the physician in a moment of vulnerability, better effort could be allocated to placing responsibility on hospital administration as well as careful attention to the design and engineering of the surgical environment to reduce any negative outcomes tied to lack of adequate sleep or other factors that undermine the well-being of physicians.

The disclosure of health related physician variables could also disproportionately affect doctors with disability and chronic illness. Despite the strides that have taken place to diversify medicine in the last few decades, disabled individuals in biomedical fields continues to be underrepresented. It has been argued that the presence of disabled doctors could improve the quality of care provided for disabled patients, and disabled academics and doctors have called for institutions to go beyond mission statements and follow a multifaceted approach in insuring access (Iezzoni, 2016; Bonnielin and Meeks, 2019). Mandating that informed consent should now include the health and disability of the physician could effectively undermine the agency of disabled doctors. Patients would have the decision making power to turn away a physician based once again on the perception of ability. Harmful stereotypes, stigma, and widespread ableism skew awareness of what people with disabilities or chronic illness can accomplish. Ultimately, a patient has the power to reduce a physician to their medical status even if said physician is healthy, well-adjusted, and capable. This reduction reflects the antiquated notion that a disability will always compromise the physician’s efficacy, even if the condition has no impact on the physicians work.

Failure of a physician to disclose their medical condition in informed consent has already been challenged in courts before. In the 2001 case of May v. Cusick, a surgeon was accused of not disclosing his medical history of strokes despite having two in the past and making a full recovery. Later that year in the case of Halkyard v. Mathew, a surgeon performed a hysterectomy which later resulted in complications that led to the patient’s death. It was argued in court that if the doctor had disclosed his history of epilepsy, the patient, a nurse at the time, would have chosen a different physician. In both instances, the courts ruled that because the medical condition did not influence the procedure or the outcome, then it wasn’t necessary for the physician to disclose (Bal and Choma, 2012). Some legal scholars have disagreed. In the case of Halkyard v Mathew, the courts have been criticized for linking the lack of disclosure to health risk and injury in order to appeal to liability in negligence. Instead, the true injury sustained by the patient is they were denied full information and thus the right to decide if they want a different doctor (Ginsberg 2010, 45). However, this still operates under the impetus that one’s disability will affect outcome. If the argument stands that it isn’t related to disability but the patient’s right to decide, then why should disability be a decisive factor in disclosure? Without a clear association between disability and outcome, the disclosure of one’s health status as a doctor walks a fine line between obtaining true informed consent and facilitating discrimination.

One of the driving reasons behind informed consent is providing relevant information to patients that they may construct sound decisions about their health care choices and options. It is imperative then to only include information within the process of informed consent that is based on proven standards. Without clear evidence of patient outcome, mandating the disclosure of any physician variables related to health has serious implications beyond elective surgery. Securing proper informed consent is vital to maintaining trust in the medical profession, but asking doctors to disclose unnecessary medical information is a short term solution to a widespread problem. Institutions should prioritize the health of their physicians as much as physicians prioritize the health of their patients. Mandating this type of disclosure could set back progress made by disabled doctors in the medical field and could further facilitate a culture where doctor’s body is meant to be an able one.

This article was written by Jordan Taylor of the University of Alabama and Jake Howard of the University of Central Florida. References and acknowledgements can be found in our journal under "Current Issue."