The Keyless Car Dilemma of In Vitro Gametogenesis: What good is a car without keys?

The first time I witnessed someone using a “keyless” car, I was astonished. They could simply walk up to their car, open the door, press a button, and the car would start. When I tried to recreate this magic for myself, I quickly realized that I couldn’t even get into the car, let alone take it for a joyride. I was so amazed by this new technology that I didn’t stop to realize that it only worked for the person who had the key, even if said key was nowhere in sight.

When it comes to medical innovations, the confusion that I experienced around the keyless car is a sentiment commonly felt by much of the technology’s target population. So much effort is put into the research and design process that by the time we get to the implementation phase the idea has been stripped and rebuilt so many times that we forget to ensure that it can be used by the very people we claimed to be designing it for.

While this is common in almost every arena, my current focus is on the newly developed technique of in vitro gametogenesis (IVG). The basic idea of IVG is to recreate the process of gametogenesis outside of the human body. Normally the body creates either specialized egg or sperm cells, and during reproduction, the sperm fertilizes the egg that will eventually become the embryo. This technology is still in the research and design phase, but that is precisely why it’s so important to have this conversation now. IVG is currently being discussed as a revolutionary possibility for cisgender same-sex couples[1], but I worry that in reality, it may never serve this target audience in the way that it is currently projected to.

Navigating fertility as a queer person often involves a series of hoops to jump through, and unfortunately, this issue can be exacerbated by the very innovations that we thought would help. Imagine that someone buys you a new car (IVG technology), but they never give you the key (a straightforward path to said technology that doesn’t involve peeling back layers upon layers of bureaucratic red tape). There is no point in having a car without the key, so you call the dealership (insurance company) and explain your situation. They tell you that you are in luck because they help people with key replacements all the time. The only caveat is that they require you to confirm loss of the key (infertility) by searching for it (trying to conceive naturally) for a period of time before they will be able to help you. You explain that you never had the key in the first place (could not physiologically conceive a child naturally), but they insist that this is simply their policy for new vehicles (innovative technologies).

From an ethical standpoint, is it enough to develop the new technology and stop there? Is it enough to innovate with hopes of helping specific communities if we never make sure that said innovations get to them? My stance is simple: No. Innovation is an important step, but it isn’t the final one. Just because we build it does not mean that the people who need it most will be able to use it. It is our moral responsibility to do everything in our power to alleviate the barriers to our technology, not to stack them higher. I’m hopeful that IVG will be what breaks the current pattern and that it will one day deliver on its promises to the queer community.

In short, if you give someone a car, make sure you give them the key too.

[1] Spar, D. L. (2020, August 12). The Poly-Parent Households Are Coming. Retrieved September 12, 2020, from https://www.nytimes.com/2020/08/12/opinion/ivg-reproductive-technology.html

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