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The Unique Harm of Bramhall’s Liver Branding

photograph of surgeon in operating room putting on gloves

In 2013, Simon Bramhall, a surgeon at the U.K.’s Queen Elizabeth Hospital Birmingham, performed a life-saving liver transplant on Patient A. Despite the surgery being a success, a few days later, the liver started failing. So, roughly a week after receiving their first liver, Patient A was back in the operating room for their second transplant, this time under the care of another surgeon. But, when this second surgeon opened up Patient A, they found something remarkable. Burned into the liver’s surface – the one that Simon Bramhall had implanted only a few days before – were two four-centimeter letters: “SB.”

Eventually, after some delay, equivocation, and the sharing of photos, it emerged that, yes, during the first operation, Bramhall had used an argon beam – used for cauterization – to sign the liver after he had transplanted it into Patient A. According to a nurse who had been present at the first surgery, when asked what he was doing, Bramhall said, “I do this.” He has since said he doesn’t recall saying this or that he must have been referencing something else if he did.

Bramhall’s rebuttal, however, is suspect. Not long after news of Bramhall’s actions emerged, a consultant anesthetist came forward and claimed that Bramhall signed his initials on another patient’s liver during a 2013 surgery, known as Patient B. Bramhall claims not to recall doing this.

Despite these revelations, Bramhall didn’t lose his job, at least not immediately. He left Queen Elizabeth Hospital Birmingham of his own accord, feeling that he was no longer welcome there, and continued to practice surgery at another institute until 2020; this is despite his 2017 admission of two counts of assault by beating concerning the liver brandings. Eventually, in 2022, the General Medical Council struck him off the medical register, arguing that his actions had undermined public trust in the medical profession.

Now, this case raises a whole host of questions, from the practical: Why did Bramhall feel the need to do this and has he done this to anyone else? to the ethical and legal: Why didn’t his colleagues immediately raise the alarm and why did it take so long for him to be charged and struck off once they did?

What I want to focus on here is not that he marked the liver unnecessarily but that he did so with a particular vision in mind. He didn’t do a squiggle, a circle, a smiley face, or something meaningless, but he used the argon beam to burn his initials into Patient A’s liver. Does this make a difference? Is it, in some sense, more harmful than if he had done another shape? Or some random letters?

First, it must be noted that the argon beam is commonly used during operation to stop bleeding, so its presence is not unusual. Also, the mark it makes is very shallow, with the beam only penetrating micrometers into the tissue. So, the amount of damage is limited. Finally, tissue can be used as a medium to test the beam’s effectiveness, meaning that the fact that the liver wasn’t pristine when Bramhall closed up Patient A isn’t an intrinsic concern.

This latter point is something which has been raised in Bramhall’s defense with Barbara Moss, a patient of Bramhall and now his co-author (they write thrillers together), arguing that:

He’s got to test the laser on the liver before he can use it – it’s a routine process. If I’m trying out a pen, I might as well just put my initial, because I can do that very quickly. The fact that he did it in a particular shape makes no difference.  

This argument seems slightly odd given that, as another surgeon has noted, such tests normally consist of a couple of dots or a small wiggle, which happens before bleeding occurs, not after as, obviously, you’d test the laser before you have need of it. However, Moss’s argument got me thinking: does the shape matter?

One could make a case for the negative. Whether it’s someone’s initials, a circle, or a couple of dots, the damage done to the liver itself is minimal at most. Any mark is confined to the organ’s surface and doesn’t impact functioning. Indeed, if it hadn’t been for Patient A’s replacement liver failing, the liver may have never been seen again, and they would have never known about the mark’s existence. So, from a rather restrictive point of view, if one is concerned with the potential for physical harm that Bramhall’s actions might have caused, then it seems that it doesn’t matter what shape he etched into the organ as any shape would have the same impact – nothing at all.

However, this would indeed be a very limited conceptualization of harm. It is now common for us to understand harm not only in a purely physical sense (getting hit with a hammer, being run over by a car) but also in a mental and cognitive sense (seeing someone get hit with a hammer, accidentally running someone over with a car). This understanding of harm emerged and became a central factor in Bramhall’s trial as, after seeing images of their branded organ, Patient A began experiencing symptoms of PTSD. This instigating factor led the Criminal Prosecution Service to charge Bramhall in the first place. It was not what he had done to the liver but what his actions had done to Patient A that mattered. So, with a broader understanding of harm, it can become easy to see how Bramhall’s actions might be considered uniquely wrong.

Yet, I am unconvinced that this gets to the nub of the issue. The idea of someone branding their initials into your internal organs is unquestionably horrifying, and I do not doubt that this could lead to PTSD, but I don’t think this fully captures the uniqueness of Bramhall’s offense. The fact that, above all other options, he chose to brand his initials into Patient A means there is something horrifyingly unique, even personable, in his actions.

To illustrate this, imagine that, to relieve the stress, two surgeons play a game of noughts and crosses (aka tic-tac-toe) on a patient’s liver, branding the game into the organ with an argon beam much like Bramhall did his initials. It’s not unreasonable to think that, upon finding out that their innards would forever carry the remnants of such a game, they would experience similar distress and symptoms as Patient A (for context, Bramhall says he knows someone who has done this very thing). The game’s presence would represent the reckless attitude such surgeons would have towards their patients and their jobs. Indeed, it would have to be someone holding an awfully cavalier attitude toward their profession to even consider such a thing. Yet, this lacks a certain degree at the core of the Bramhall case: the unabashed egotistical arrogance.

This is not to say that a surgeon who played a child’s game in the tissue of a patient’s organ wouldn’t have this critical flaw – I’m almost certain they would. Nevertheless, the imprinting of the game itself would be separate, to some degree, from the person playing it. It could have been anyone doing that. Bramhall’s initials, however, are an entirely different story. They are tied to him in a very personable way. And, yes, anyone could have put the letters SB into the patient, but someone with those initials did. If the liver hadn’t been rejected, Patient A would have spent the rest of their life walking around with a mark that intimately tied them to Bramhall; not an ambiguous game of noughts and crosses, but one of the very things that Bramhall uses to self-identify.

To emphasize this point further, imagine he branded his entire name into Patient A’s liver. The more personable and unique the mark signifying Bramhall’s actions, the worse it is (at least, that’s how it seems to me).

I suspect we will never really know why Bramhall did what he did (at least twice). He’s claimed that extreme stress led him to make the markings, but I find this doubtful. He has said that he thinks the backlash and subsequent punishment he’s received was over the top and that the GMC sought to make an example out of him. To use him as a way of warning other reckless medical professionals. This might be true. But, given the extreme power doctors hold over us – especially surgeons, who violate our bodies with our permission and are responsible for us when we are at our most vulnerable – might the example be worth making? Is it not better to make an example out of someone who did something terrible, than slap them on the wrists and potentially encourage such behavior in others?

It costs millions of pounds to train a surgeon of Bramhall’s caliber, and if nothing else, he was reportedly a technically sound surgeon. But if the cost of protecting the medical profession is his removal from it, the subsequent loss of his expertise, and all the time spent cultivating his skill, then it strikes me as a price worth paying.

I want to have faith that those who care for me will do just that, and this is fundamentally compromised if I must worry about those professionals using my flesh as an Etch A Sketch when I’m under the knife.

Bedside Conceptual Engineering

What is “obesity”?

The answer you’ll find in medical textbooks is simple. Divide one’s weight in kilograms by the square of their height in meters: if the answer is over 30, then they meet criteria for obesity. But as is always the case, the joints of reality are not cleanly carved by a single equation in a textbook: the reality of obesity, and the depth of the question at hand, is much more complex.

In the clinical setting, obesity is often thought of as a disease. But even if we assume that we have a good grasp on what a disease is, there is significant resistance to thinking of obesity as one: some argue that such a claim ignores personal responsibility and encourages unhealthy behavior, while others argue that thinking of obesity as a disease stigmatizes the people who live with it and further propagates the discrimination which they already face in our society. Others argue that obesity isn’t a disease, but a risk factor: they point out that obesity is associated with conditions classically understood as diseases, such as diabetes or hypertension, but it is not a disease per se. Still others argue that the medicalization of obesity is, in and of itself, a mistake: that akin to a disability, defining obesity as a risk factor or a disease is pathologizing a mere difference in the human experience.

This year, The Lancet, a highly respected medical journal, convened a commission composed of 60 expert clinicians and scientists to tackle these questions. The answers they consider to these questions warrant our attention, whether we are clinicians, philosophers, or laypeople. The Commission on the Definition and Diagnosis of Clinical Obesity takes an approach with a clinical tilt but a deeply philosophical history, and reveal something important about the words we use and the ways in which we use them: preliminary reports are that the commission didn’t just turn to the science to answer these very difficult questions, but sought to change the questions themselves.

*  *  *

The philosopher David Chalmers defines conceptual engineering, as a first pass, as “the process of designing, implementing, and evaluating concepts.

Chalmers uses the example of a bridge – a structure designed to serve a particular purpose. Plans are implemented, the bridge is built, and, over time, the bridge is assessed for any faults which have developed. Conceptual engineering is much of the same, but with words instead of bridges. Take a word which I’ve spent time thinking about: harm. Philosophers write papers designing concepts of harm, often with a particular purpose in mind (whether it be resolving wrongful-life lawsuits or the non-identity problem). Those concepts are then implemented, whether theoretically or in practice, the results are assessed, and improvements are designed and implemented. This is a very common pattern in philosophy, with metaphysics being applied to practical philosophy and ethical practice.

But conceptual engineering is not just something for philosophy journals: in everyday life, concepts radically shape our political and social environments. Take the concept of “citizen”: the question of who is and is not a citizen has fundamentally shaped political life for centuries, and still does. Think of the most saliently divisive political conflicts of the modern day. In most cases, the fundamental disagreement revolves around the definition of basic concepts (life, gender, etc.).

Though perhaps less obvious in everyday discourse, the concept of obesity is no different. Current projections are that 1.4 billion adults will be living with obesity by 2035, with a global economic impact of $4.32 trillion in the same year. 30 years of research has shown that healthcare providers are implicitly biased against people living with obesity. The relationship between stigma, obesity, and poor mental health outcomes has been extensively documented, especially in children. Understanding this concept is not just important for medical practice, but for our society as a whole.

The Lancet’s commission was convened exactly for this reason. Interestingly, their stated approach was to redefine obesity. In an interview with MedScape, Dr. Francesco Rubino, the project lead, said: “renaming ‘obesity’ is very important. The word is so stigmatized, with so much misunderstanding and misperception, some might say the only solution is to change the name.” He notes, further, that the commission focused on the concept of “clinical obesity” rather than obesity more generally, noting how the two may differ in the same way the concepts of “depression” and “clinical depression” might differ. By establishing a definition, then, Rubino and the commission hope to improve access to care and reduce stigma.

As of writing, the commission has not yet released their final report. But the approach that Rubino and the commission intend to take is clear: that of the conceptual engineer. The WHO recognized obesity as a disease 80 years ago, and that concept has been implemented over the intervening time. We see very clearly, though, that there are cracks in the foundation. The concept of obesity has become wrapped up in stigma, doesn’t reliably track a state of disease, and has proven ineffective in guiding research and clinical management. Rubino and his colleagues, just like the engineer who assesses the bridge, have found the foundation lacking, and seek to change the concept of obesity to better serve our purposes.

We shouldn’t lose track, however, of the important insight which can be found here. Concepts are tools which humans use, and often define. In the philosopher’s vocabulary, obesity is not a natural kind: obesity, rather, is a concept designed by humans for human reasons. Charitably, physicians seek to help people live fulfilling lives, and obesity may impede human thriving; more realistically, physicians have pathologized a group of people who already experience discrimination within and beyond healthcare. Seeing this reality, Rubino and his colleagues have hinted at a moral argument for changing the definition of obesity: the concept of obesity propagates harm and is ineffective at producing human good, and, therefore, we should consider changing it.

Many concepts which we encounter in our daily lives can be analyzed in this way: they are human inventions with human intentions and human faults, and we can redraw the lines of these concepts for moral reasons. We decide what our words mean, and, in most cases, the concepts which we rely on can be changed to make the world a better place, whether our concerns be utilitarian or deontological. Our concepts were designed to serve us, and when they fail to fulfill their role, we should ask if they might be changed for the better.

Rural Health Disparities and Telemedicine

photograph of surgery performed with help of teleprescence robot

Rural America has been struggling from a lack of hospitals and physicians at an alarming rate. In the past decade, ER patients in rural communities have increased by 60% and hospitals in those locations have decreased by 15%. A potential solution to the lack of health care providers is to consider telemedicine as an option for these rural locations. Telemedicine is a remote care center which provides hospitals, clinics, or even individuals with direct access to a physician. One such company that provides this service is Avera eCARE. At Avera eCARE, doctors work out of high-tech cubicles, dressed in scrubs to look the part, but never actually physically touching or seeing their patients. Instead, they use a high-resolution camera and microphone to work with their patients and nurses or healthcare professionals at remote locations.

Dr. Brian Skow is an example of a physician who works from one of the Avera eCARE centers that provides remote emergency care for 179 hospitals across the nation. Skow was called in when a comatose, unresponsive patient came into the emergency room in rural Montana with only nurses on staff. Skow remotely instructed the nurse how to incubate the patient – inserting a tube into the patient’s throat in order to get her onto a ventilator. Without his help, this patient would have most likely died from lack of oxygen.

“If anything defines the growing health gap between rural and urban America,” The Washington Post claims, “it’s the rise of emergency telemedicine in the poorest, sickest, and most remote parts of the country, where the choice is increasingly to have a doctor on screen or no doctor at all.” And Dr. Skow’s situation is a perfect example. He watched as 5 people performed the procedure, all with careful instruction and encouragement from his remote location. To compare this to his hospital at Sioux Falls, he has to compete with an emergency physician, trauma surgeon, cardiologist, anesthesiologist, a team of 20 residents, ER nurses, and paramedics to be at the bedside. This has meant that each month telemedicine can help cardiac episodes, traumatic injuries, overdoses, and burns at a rate that is much higher than before.

There are a number of benefits generated by the move to such a system. Telemedicine helps hospitals retain doctors and recruit them because it allows for time off- and on-site support. Many critical-access hospitals are struggling to find even a single doctor or can’t keep physicians long. This technology offers the option for the nurses and physician assistants to call in for immediate health care suggestions. Another benefit is that hospitals are able to treat more patients with more intense conditions than before, as the technology allows hospitals to treat patients without needing to immediately transfer them. These transfers increase the time in which the patient suffers, and for most of these cases, every second counts. Apart from pain and outcome, transferring also greatly increase billing charges for patients. Even hospitals benefit by treating more cases and thus generating more profit.

Despite these advantages, there are still many limitations. Telemedicine costs approximately $70,000 monthly and $170,000 to install. Hospitals have to face a difficult decision in choosing between installing this technology or investing money on other life-saving machines like MRI and CAT scans.

Critics also worry that telemedicine takes the humanity out of patient-physician relationship. Instead of physically being with the patient, that crucial interaction is separated by a screen and thousands of miles. This reality can affect treatment in ways that are unexpected. Especially in remote communities, it is very common for the nursing staff to know the patient personally, but for the virtual doctor, the patient can become “less human.” Doctor Kelly Rhone, describes this phenomenon as she watched nurses from North Dakota perform CPR on a patient for over 10 minutes. One of the worst things that the remote doctor can do, Rhone argues, is withdraw care too quickly. Even when a patient has passed, it’s important for the medical staff in the room to acknowledge the situation in their own time. This obligation may even extend to being present with grieving family members.

It is important to consider then, if remote care is an adequate substitute and can offer sufficient support for the human element to medicine. Perception can play a major role in diagnosis, and if doctors aren’t seeing their patients in the same way, they will treat them differently. It may be more likely for doctors to withdraw care or save resources, compared to situations where they are with them in person.

There are also some challenges when it comes to telemedicine being used directly in people’s homes. There are apps which can help patients connect with a doctor via Facetime, text messages, and phone calls. There are some benefits to this option. For busy parents and working folk, this is a quick and easy solution to getting better fast. Some people live an hour or more from the nearest health clinic, and so to be able to describe their symptoms over the phone and get their medicine prescribed within minutes is a great benefit. However, there is also the increased risk of misdiagnosis. It can be easy to miss symptoms of larger health problems – when chest discomfort isn’t just a strained muscle, but an early sign of a heart attack, for example. In this way, reliance on telemedicine can increase risk to patients.

There is a clear injustice in our health care services in the United States for rural areas and urban locations. Telemedicine is one option for those who are suffering from lack of adequate healthcare. It increases virtual staff and gives current staff direct access to help for their situations. With the rising trend toward virtual telemedicine, we must consider what cost to patient health we are willing to accept for increased efficiency.

Walgreens and the Conscience Clause

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

Earlier this month a woman in Arizona, Nicole Arteaga, tried to get a prescription filled at her local Walgreens. The prescription was for misoprostol, a drug that is often used to induce a medical abortion. It was prescribed to Arteaga by her physician for the reason that, after nine weeks of pregnancy, the development of the fetus has ceased. Without intervention Arteaga would have had a miscarriage, and was advised that the best course of action in her circumstances was to terminate the pregnancy early. The pharmacist, however, refused to fill her prescription, on the basis of a moral objection. Arteaga expressed in tweets and interviews afterwards that although she clearly explained to the pharmacist at the time that her situation was urgent, and while the pharmacist recognized that she was in distress, he nevertheless refused to fill her prescription. Continue reading “Walgreens and the Conscience Clause”

Solving Antibiotic Resistance with the Power of Evolution

Photograph of several petrie dishes with growing cultures in them

The problem of antibiotic resistance is real and growing. It is estimated that 700,000 people die from antibiotic resistant infections each year [1]. Further, every year, new multidrug resistant organisms emerge. We might soon face the global crisis of an era in which there is massive spread of bacterial diseases that cannot be treated by any currently available drug. In order to solve this problem, we must recognize that it has both scientific and ethical components: each time a physician prescribes an antibiotic she or he is required to balance individual patient needs with societal risks and benefits [2]. Further, even in the absence of antibiotic use, resistance is, and always has been, an evolutionary problem – natural reservoirs of antibiotic resistance exist even in pristine environments [3]. Added to this is the fact that over the last thirty or so years there has been a decrease in the number of antibiotics that have been developed and approved [4]. These factors make the problem of antibiotic resistance multifaceted and complex, but recent advances in basic scientific research show a promising way forward, even though previously implemented strategies to mitigate the problem have been largely unsuccessful. Continue reading “Solving Antibiotic Resistance with the Power of Evolution”

“Minibrains” and the Future of Drug Testing

Image of a scientist swabbing a petri dish.

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

 NPR recently reported on the efforts of scientists who are growing small and “extremely rudimentary versions of an actual human brain” by transforming human skin cells into neural stem cells and letting them grow into structures like those found in the human brain. These tissues are called cerebral organoids but are more popularly known as “minibrains.” While this may all sound like science fiction, their use has already led to new discoveries in the medical sciences.

The impetus for developing cerebral organoids comes from the difficult situation imposed on research into brain diseases. It is difficult to model complex conditions like autism and schizophrenia using the brains of mice and other animals. Yet, there are also obvious ethical obstacles to experimenting on live human subjects. Cerebral organoids provide a way out of this trap because they present models more akin to the human brain. Already, they have led to notable advances. Cerebral organoids were used in research into how the Zika virus disrupts normal brain development. The potential to use cerebral organoids to test future therapies for such conditions as schizophrenia, autism, and Alzheimer’s Disease seems quite promising.

The experimental use of cerebral organoids is still quite new; the first ones were successfully developed in 2013. As such, it is the right time to begin serious reflection on the potential ethical hurdles for research conducted on cerebral organoids. To that end, a group of ethicists, law professors, biologists, and neuroscientists recently published a commentary in Nature on the ethics of minibrains.

The commentary raises many interesting issues. Let us consider just three:

The prospect of conscious cerebral organoids

Thus far, the cerebral organoids experimented upon have been roughly the size of peas. According to the Nature commentary, they lack certain cell types, receive sensory input only in primitive form, and have limited connection between brain regions. Yet, there do not appear to be insurmountable hurdles to advances that will allow us to scale these organoids up into larger and more complex neural structures. As the brain is the seat of consciousness, scaled-up organoids may rise to the level of such sensitivity to external stimuli that it may be proper to ascribe consciousness to them. Conscious organisms sensitive to external stimuli can likely experience negative and positive sensations. Such beings have welfare interests. Whether we had ethical obligations to these organoids prior to the onset of feelings, it would be difficult to deny such obligations to them once they achieve this state. Bioethicists and medical researchers ought to develop principles to govern these obligations. They may be able to model them after our current approaches to research obligations regarding animal test subjects. However, it is likely the biological affinity between cerebral organoids and human beings will require significant departure from the animal test subject model.

Additionally, research into consciousness has not nailed down the neural correlates of consciousness. As such, we may not necessarily know if a particularly advanced cerebral organoid is likely to be conscious. Either we ought to purposefully slow the progress into developing complex cerebral organoids until we understand consciousness better, or we pre-emptively treat organoids as beings deserving moral consideration so that we don’t accidentally mistreat an organoid we incorrectly identify as non-conscious.

Human-animal blurring

Cerebral organoids have also been developed in the brains of other animals. This gives the brain cells a more “physiologically natural” environment. According to the Nature commentary, cerebral organoids have been transplanted into mice and have become vascularized in the process. Such vascularization is an important step in the further development in size and complexity of cerebral organoids.

There appears to be a general aversion to the prospect of transplanting human minibrains into mice. Many perceive the creation of such human-animal hybrids (chimeras) as crossing the inviolable boundary between species.  The transplantation of any cells of one animal, especially those of a human (and even more especially those of the brain cells of a human) may violate this sacred boundary.

An earlier entry on The Prindle Post approached the vexing issues of the creation of human-animal chimeras. It appeared that much of the opposition to chimeras was based in part on an objection to “playing God.” Though some have ridiculed the “playing God” argument as based on “a meaningless, dangerous cliché,” people’s strong intuitions against the blurring of species boundaries ought to influence policies put in place to govern such research. If anything, this will help tamp down a strong public backlash.

Changing definitions of death

Cerebral organoids may also threaten the scientific and legal consensus around defining death as the permanent cessation of organismic functioning and understanding the criterion in humans for this as the cessation of functioning in the whole brain. This consensus itself developed in response to emerging technologies in the 1950’s and 1960’s enabling doctors to maintain the functioning of a person’s cardio-pulmonary system after their brain had ceased functioning. Because of this technological change, the criterion of death could no longer be the stopping of the heart. What if research into cerebral organoids and stem cell biology enables us to restore some functions of the brain to a person already declared brain dead? This undercuts the notion that brain death is permanent and may force us to revisit the consensus on death once again.

Minibrains raise many other ethical issues not considered in this brief post. How should medical researchers obtain consent from the human beings who donate cells that are eventually turned into cerebral organoids? Will cerebral organoids who develop feelings need to be appointed legally empowered guardians to look after their interests? Who is the rightful owner of these minibrains? Let us get in front of these ethical questions before science sets its own path.

The Ethics of Short-Term Medical Missions

Photo of a doctor giving an eye exam to a child.

According to NPR, doctors and medical students in the United States are increasingly seeking out programs that enable them to spend a limited amount of time (from weeks to months) in developing countries providing free medical care. This sounds like an unmitigated good thing, given the amount of need for medical resources in many parts of the world and the opportunity to save and improve lives that this represents. However, as has been a common refrain in discussions concerning foreign aid generally, helping residents of poorer countries can have numerous unintended consequences, and short-term medical missions are not exempt from this insight. The NPR article provides several examples of these unintended negative consequences:

Continue reading “The Ethics of Short-Term Medical Missions”

Questions on the Ethics of Triage, Posed by a Sub-Saharan Ant

an image of an anthill

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

In a new study published in Proceedings of the Royal Society B, behavioral ecologist Erik Frank at the University of Lausanne in Switzerland and his colleagues discuss their findings that a species of sub-Saharan ants bring their wounded hive-mates back to the colony after a termite hunt. This practice of not leaving wounded ants behind is noteworthy on its own, but Frank and fellow behavioral ecologists note that the Matabele ants (Megaponera analis) engage in triage judgments to determine which injured ants are worth or possible to save–not all living wounded are brought back to the nest for treatment.

Continue reading “Questions on the Ethics of Triage, Posed by a Sub-Saharan Ant”

For Humanitarian Organizations in War Zones, the Ethical Challenge of Neutrality

An image of a cemetery near Mosul, Iraq

When institutions fail to fulfill their long-established responsibilities, other groups must fill the void and meet the needs that are going unmet. When this happens, the new responsibilities assumed can conflict with these groups’ prior expectations and prior responsibilities. In states of war and civil unrest, such problems are compounded a thousand-fold.

Continue reading “For Humanitarian Organizations in War Zones, the Ethical Challenge of Neutrality”

Do Terminally Ill Patients Have a “Right to Try” Experimental Drugs?

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

In his recent State of the Union speech, President Trump urged Congress to pass legislation to give Americans a “right to try” potentially life-saving experimental drugs. He said, “People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home.  It is time for the Congress to give these wonderful Americans the ‘right to try.’” Though only a brief line in a long speech, the ethical implications of the push to expand access to experimental drugs are worth much more attention.

First, let us be clear on what federal “right to try” legislation would entail. Generally, a new drug must go through several phases of clinical research trials before a pharmaceutical company can successfully apply for approval from the Food and Drug Administration to market the drug for use. Advocates of “right to try” legislation want some terminally ill patients to have access to drugs before they go through this rigorous and often protracted process. Recent legislation in California, for example, protects doctors and hospitals from legal action if they prescribe medicine that has passed phase I of clinical trials, but not yet phase II and phase III. Phase I trials test a drug for its safety on human subjects. Phase II tests drugs for effectiveness. Phase III tests drugs to see if they are better than any available alternative treatments.

Thus, “right to try” is a misnomer. First, these experimental drugs are still expected to meet some safety standards before patients can access them. Second, such legislation would not likely mandate that a pharmaceutical company provides access to their experimental drugs. The company can always deny the patient’s request. Third, these laws do not address cost issues. Insurance plans are unlikely to cover any portion of the costs, and pharmaceutical companies are likely to expect the patient to foot the entire bill.

Ethical debate over “right to try” legislation recapitulates a conflict that regularly occurs in American political debate: to what extent does government intervention to protect public welfare by ensuring that drugs are both safe and effective impede the rightful exercise of a patient’s autonomy to choose for herself what risks she is willing to take? Advocates of expanded “right to try” laws view regulatory obstacles set up by the FDA as patronizing hindrances. Lina Clark, the founder of the patient advocacy group HopeNowforALS, put it this way: “The patient community is saying: ‘We are smart, we’re informed, we feel it is our right to try some of these therapies, because we’re going to die anyway.’” While safety and efficacy regulations for new pharmaceuticals generally protect the public from an industry in which some bad actors may be otherwise motivated to push out untested and unsafe drugs on an uninformed populace, the regulations can also prevent some well-informed patients from taking reasonable risks to save their lives by preventing them from getting access to drugs that may be helpful. Therefore, it is reasonable to carve out certain exceptions from these regulations for terminally ill patients.

On the other hand, medical ethicists worry that terminally ill patients are uniquely vulnerable to the allure of “miracle cures.” Dr. R. Adams Dudley, director of UCSF’s Center for Healthcare Value, argues that “we know some people try to take advantage of our desperation when we’re ill.” Terminally ill patients may be vulnerable to exploitation of their desire to find hope in any possible avenue. Their intense desire to find a miracle cure may prevent them from rationally weighing the costs and benefits of trying an unproven drug. A terminal patient may place too much emphasis on the small possibility that an experimental drug will extend his or her life while ignoring greater possibilities that side effects from these drugs will worsen the quality of the life he or she has left. Unscrupulous pharmaceutical companies who see a market in providing terminally ill patients “miracle cures” may exploit this desire to circumvent the regular FDA process.

The Food and Drug Administration already has “compassionate use” regulations that allow patients with no other treatment options to gain access to experimental drugs that have not yet been approved. The pharmaceutical company still must agree to supply the experimental drug, and the FDA still must approve the patient’s application. According to a recent opinion piece in the San Francisco Chronicle, nearly 99 percent of these requests are granted already. “Right to try” legislation at the federal level would not likely mandate that pharmaceutical companies provide the treatment. Such legislation would likely only remove the FDA review step from the process described above.

Proponents of the current system at the FDA view it as a reasonable compromise between respect for patient autonomy and protections for the public welfare. Terminally ill patients have an avenue to apply for and obtain potentially life-saving drugs, but the FDA review process helps safeguard patients from being exploited due to their vulnerable status. The FDA serves as an outside party that can more dispassionately weigh the costs and benefits of pursuing an experimental treatment, thus providing that important step in the rational decision-making process that might otherwise be unduly influenced by the patient’s hope for a miracle cure.

Should Conscientious Objections Apply to Healthcare?

An image of a surgeon operating on a patient.

While executive orders and high-profile legislation garner the most media coverage, much of the change that comes with a new presidential administration happens in the individual departments staffed by new political appointees. The current administration has pushed far-reaching changes regarding the place of religious belief in the healthcare system through actions at the Health and Human Services Department. I’ve previously covered the administration’s decision in October 2017 to widen the scope of exemptions to the contraception mandate. More recently, NPR reported that the Department of Health and Human Services is opening a new Division of Conscience and Religious Freedom to defend health care workers who object to participating in medical care for patients because of their sincerely held religious beliefs. Notably, the establishment of the division also reverses an Obama-era rule barring “health care workers from refusing to treat transgender individuals or people who have had or are seeking abortions.”

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CRISPR, Moral Obligations and Editing the Human Genome

A close-up image of a scientist examining DNA test results

As our understanding of the human genome improves, pathways leading in the direction of new and powerful technologies are cleared.  In recent years, scientists have developed a new technique called CRISPR, which allows them to edit the genome—adding, subtracting, or deleting pieces of genetic code.  This process has the potential to bring about significant changes in human health.  CRISPR could prevent children from being born with a wide range of painful or life-threatening conditions.  So far, scientists have used this process in attempts to prevent blood disorders, allergies, heart disease, and to mutate the genome in such a way that the resulting person is less likely to get HIV.   Continue reading “CRISPR, Moral Obligations and Editing the Human Genome”

Rules Versus Results in Vaccine Research

A photo of a person withdrawing medicine from a vial with a syringe

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

A group called Rational Vaccines, which conducted a clinical trial of a herpes vaccine, has brought legal and ethical standards for medical research into the news recently. The trial, conducted from April to August of 2016, used human subjects and was conducted in the Caribbean in order to avoid being overseen by the FDA or cleared by the institutional review board, or IRB, which is required of trials in the US.

Peter Thiel, co-founder of PayPal, has invested $4 million in Rational Vaccines this month. Thiel is an outspoken critic of the safety regulations the FDA and considers the oversight of the organization to needlessly delay scientific advancement. In an interview, he claimed that our current system of checks would prevent the polio vaccine from being developed today. However, his contribution to the group was contingent on their future compliance with FDA regulations in order for the findings of their research to be able to help more people.

The group has faced a great deal of controversy over the herpes vaccine study, not only for blatantly avoiding the jurisdiction of the US, but also for failing to meet standards of scientific rigor. However, the Chief of Rational Vaccines, Augustin Fernandez, stands by the results and is concerned that the import of the study is being lost in the uproar over the conditions of the trial.

Medical research has the aim of advancing our understanding of treatment and developing new ways of preventing ailments and healing the sick. However, this aim is in conflict with a competing value: that of imposing risk to the subjects. Clinical trials in medicine are experiments that explore what happens when humans engage in some treatment, and thus expose humans to risk of harm. Medical research thus has its own burden of justification that other scientific research (for instance, in physics or chemistry) doesn’t necessarily need to meet.

A basic ethical burden for medical research is that of scientific merit: a study must meet the standards of scientific method that peers dictate. Because studies are taking place in a scientific context, ideally this includes some possibility of replication of the results, suitable sample size and distribution, and objectivity of data collection. Including a control group and controlling variables is similarly important. Because clinical trials are exposing humans to harm, the study needs to be of scientific merit. Unfortunately, the herpes vaccine trial is not clearly meeting these standards because it included only 20 subjects without a clearly established control group, and the results involved the subjects who received the vaccine self-reporting their impression of whether there was an improvement of their condition. These aspects have undermined the scientific merit of the study, making it unlikely to be published in the US.

Also, because the research is experimental in nature, meaning it is not the standard of care, it is thus risky, and there are ethical demands on how this risk must be managed. Because humans are involved and potentially harmed by the trial, when medical research is conducted on humans, the subjects must give informed consent to adopting the risk of the study.

Other ways of managing the risk of the study go beyond the consent of the participants. The possible benefit must be proportional to the risk assumed by the subjects. Further, the benefit must not be directed towards a different group than those assuming the risk. This concern ties into selecting the subjects. If the treatment or drug that results from the trial will be prohibitively expensive, for instance, then it is ethically fraught to test the drug on subjects from economically disadvantaged groups. It may save a significant amount of money to conduct research on new treatments in less developed areas or nations, but to do so often means centering the risk of the trials on groups that will not be able to benefit from the results.  

This ethical constraint on medical trials is especially pertinent to studies being conducted transnationally. In Rational Vaccine’s trial for this herpes vaccine, subjects from the US and UK were flown to the Caribbean to take part in the study so this concern doesn’t overtly arise. However, transferring their patients outside the country highlights their attempts to avoid government regulations.

The criticisms that Thiel and other libertarians lob against the FDA claim that the regulations prevent medical progress. That’s true. Regulations are meant to promote the aims discussed above in order to prevent harm and exploitation of human subjects. In conducting research, the tension between developing a life-saving treatment and conducting your trial in a respectful and ethical manner can be fraught.

Unfortunately, the history of clinical trials is riddled with cases that highlight how important it is to attend to the ethical implications of medical research. It is very possible to conduct research in countries with fewer regulations and underprivileged citizens that are willing to adopt high risk in exchange for not receiving any benefit. From 1946-1948, US scientists infected patients in Guatemala with STDS. Within the US, patients’ rights have been disrespected and exploited, for instance in the well-known and egregious case of the Tuskegee experiments, where a group of African American patients were denied treatment for their syphilis in order to see how the disease progressed over their lives.

There is, of course, value in pursuing scientific advancement through clinical trials. The results of such trials could help a number of people, increasing the quality of life for many. This benefit must be weighed against the possible exploitation of research subjects and accepting the risk that the experiment will result in harm to the subjects.

Who Should Decide Charlie Gard’s Fate?

This article has a set of discussion questions tailored for classroom use. Click here to download them. To see a full list of articles with discussion questions and other resources, visit our “Educational Resources” page.

Charlie Gard is an 11-month-old boy suffering from an inherited and terminal mitochondrial disease. He cannot move his arms and legs or breathe unaided. At the time of writing, Charlie was still in intensive care at a UK hospital. Charlie’s parents decided that Charlie should be brought to the United States to receive an experimental treatment that may help alleviate his condition. However, the doctors at the UK hospital decided that the experimental treatment would not likely improve Charlie’s quality of life. Since the parents and the doctors disagreed on what would be in Charlie’s best interests, the courts got involved.  The UK legal system has so far ruled that receiving the experimental treatment would not be in Charlie’s best interest, and Charlie should be removed from life-sustaining treatment to receive palliative care; the legal process is still in process concerning Charlie’s ultimate fate.

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Ryke Geerd Hamer and the Dangers of Positive Thinking

Dr. Ryke Geerd Hamer died on July 2. It was hardly noticed in English language media. This is not surprising as, indeed, he was an obscure person. But, unfortunately, his legacy lives on, and the harm he has caused far outweighs the media attention that he has been given (Spanish and German newspapers have dedicated more attention to his death). Continue reading “Ryke Geerd Hamer and the Dangers of Positive Thinking”

Drug Addiction: Criminal Behavior or Public Health Crisis?

It is painfully obvious that the United States is in the midst of an epidemic of opioid abuse. According to the US Department of Health and Human Services (DHHS), more people died from drug overdoses in 2014 than any other recorded year, and the majority of those overdose deaths involved opioids. DHHS and the Centers for Disease Control (CDC) claim that an increase in the prescription of pain medication is a primary driver of the opioid epidemic. According to the CDC, the amount of prescription opioids sold in the US has nearly quadrupled since 1999. However, Americans do not report higher levels of pain than they did in 1999.

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Respecting the Dead: The Case of Charles Byrne, the Irish Giant

Charles Byrne died quite young, at the age of 22, and quite tall, at approximately seven feet, eight inches. This is still tall for today, but must have been more impressive during Mr. Byrne’s short life in the late 18th century. According to an Ohio State University researcher, the average height for men in Northern Europe in the 17th and 18th centuries was only about five feet, five inches. Today, the average height for men in Northern Ireland has been calculated to be about five feet, 10 inches.

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On Labeling Over-the-Counter Homeopathy

Homeopathy, the medical philosophy that “like cures like,” is big business. According to the latest estimates from the Centers for Disease Control, $2.9 billion were spent in out-of-pocket costs by adults in the United States for homeopathic medicine in 2007. The medical philosophy of homeopathy, developed in Germany over 200 years ago, posits that any substance that produces certain symptoms in a healthy person can also be used to cure those symptoms in a sick person. Homeopathic cures introduce one of these substances to cure a person of their symptoms.

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Life, Death, and Cryonics

Cryogenics, also known as cryonics, is a form of preservation involving the storing and preservation of a body at very low temperatures in hopes of one day reviving and repairing the body. Although to date no humans have been revived after freezing, some scientists think they are coming closer to making revivement though cryogenics a real possibility. Recent reports of a terminally ill British teen being frozen upon her death have brought cryogenics and the ethical debates surrounding the topic back into the news.

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Pricing the EpiPen

American drug prices have long been the object of controversy, from the price hiking on AIDS treatments conducted by the now-infamous Martin Shkreli or the $1,000 per pill Hepatitis C treatment that prompted Senate investigation. The average American spent $695 a year on drugs ten years ago, and now spends $935. Recently, the pharmaceutical Mylan received extensive backlash for the increase in the price of EpiPens, which are used in emergency situations to save someone from a life-threatening allergic reaction. EpiPens now cost $600, a 450% increase from their price in 2004. Analysts have determined that the cost of the drug within each Epipen is about one dollar.

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Consent to Dying: The Case of Julianne Snow

Recently, a 5-year-old child named Julianne Snow passed away from from a neurological disease known as Charcot-Marie-Tooth, causing nerves in the brain to degenerate and loss in the muscles related to chewing, swallowing, and eventually breathing. Although Charcot-Marie-Tooth disease is one of the world’s most commonly inherited neurological disorders, this story made national headlines due to Julianne’s independent decision to refuse treatment.

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