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On Medical Freedom

In recent decades, American healthcare has occupied a central place in public discourse. The cornerstone piece of legislation in President Barack Obama’s time in office, the Affordable Care Act, has dominated discussions of access to healthcare and health insurance since its passage into law. President Donald Trump pushed for legislation that repealed portions of the Act but never articulated an alternative vision, infamously noting during a 2024 presidential debate that he had “concepts of a plan” for a replacement. Current Secretary of Health and Human Services, Robert F. Kennedy Jr., launched a failed presidential campaign focusing not on insurance or healthcare access, but instead championing a concept we will call “medical freedom.”

At the heart of medical freedom is the idea that people ought to be allowed to make choices about healthcare free from external interference. This view seems to consist of (at least) two components.

First, the negative component; that people should be free from government mandated treatment. Specifically, proponents of medical freedom argue against preventative treatments such as vaccinations. Although energized by vaccine policy in the wake of COVID-19, this idea has its roots in pushback against smallpox inoculation in the late 18th century and anti-vaccination movements in the 19th and 20th centuries. As with the historical cases, members of the current medical freedom movement view “vaccine mandates” as infringing upon their fundamental liberties, be they religious or personal, and instead seek alternative remedies or treatments for infectious disease.

(It is worth noting, though, that the government cannot mandate vaccines. Competent adults generally have the right to refuse medical treatment. However, access to some goods and organizations may require vaccination; generally students in public school must be vaccinated against common illnesses [although a vast majority of states allow for religious and/or personal exemptions], members of the military must be vaccinated against many infectious diseases, etc. So perhaps we should better understand this component as objecting to the government incentivizing any treatment.)

The idea of alternative remedies links to the positive component; that people ought to have the right to access their preferred treatments without government intervention. This is a relatively new idea, especially compared to the negative component. The federal government only began regulating drugs in the 20th century with the passage of the Pure Food and Drug Act. The law primarily required accurate labeling of products and disclosure of addictive or dangerous ingredients. In 1936, Congress passed the Federal Food, Drug and Cosmetic Act, which granted the Federal Drug Administration greater regulatory authority, including the ability to ban substances and require pre-market testing of drugs.

Both components of this freedom – the positive and the negative – seem to rely on the moral principle of autonomy, the idea that individuals have the right to make informed choices regarding themselves and their body. This right suggests it is wrong to interfere with someone if they make such a choice when sufficiently informed. Others, specifically the government, should seek only to provide information.

But there seems to be an incoherence within the autonomy-grounded medical freedom movement when placed in the context of other policies favored by the movement, at least as enacted by Kennedy thus far as HHS secretary. This incoherence gives rise to a dilemma: Either the freedoms are (nearly) absolute, in which case the movement should focus regulations primarily on providing consumers with information about products, or the freedoms are not (nearly) absolute and incursion upon them may be justified. The trouble for the proponent of medical freedom being that, once we begin condoning incursions, this may justify the very policies members of the movement rail against.

What would regulation look like if we treated these freedoms as unlimited? It seems that regulations would primarily serve to ensure that citizens are fully informed about drugs and other products they are consuming, insofar as they relate to health. Regulation would simply serve to facilitate autonomous decision-making. Give the citizenry as much information about the products on the market as you can, then let them choose for themselves.

However, members of the medical freedom movement often favor policies that work against consumer information. Organizations such as the National Health Federation stress that consumers have the unrestricted right to access dietary supplements. But in the U.S., dietary supplements occupy a different legal category than pharmaceuticals. Makers of dietary supplements must accurately label the contents of their product. However, unlike pharmaceuticals, makers of dietary supplements do not have to provide substantial evidence about purported benefits of their products. Further, manufacturers are not required to provide dosing information. Yet even common nutrients may produce adverse outcomes in high doses. Earlier this year, children in Texas were treated for Vitamin A toxicity when admitted for measles. Kennedy had previously instructed the CDC to change measles guidance to mention vitamin A as a treatment.

Thus, at least in the current legal framework, the medical freedom movement’s emphasis on dietary supplements actually inhibits, rather than supports, autonomous decision-making. Consumers have lesser access to information about these products than about prescription drugs, thus limiting their ability to make fully informed decisions.

Further, other policies favored by members of the medical freedom movement restrict choices that consumers can make. For instance, in April the FDA announced that it is working with industry to phase out synthetic food dyes, including Allura Red AC, more commonly known as Red 40. However, the Environmental Protection Agency lists Red 40 as “verified to be of low concern,” the World Health Organization finds that Red 40 “does not present a health concern,” and the European Food Advisory Committee concludes that there is limited evidence for a link between Red 40 and behavioral issues in children, a claim commonly cited in arguments against the substance.

Still, working to remove products like synthetic dyes seems like good policy. Even if there is little evidence suggesting that synthetic dyes such as Red 40 lead to adverse outcomes, precaution would justify eliminating them; we stand to gain very little by using them, so avoiding the risk, however remote, seems worth it.

The issue, though, is that this policy is in tension with autonomy. By working to remove synthetic dyes, the regulatory system is forcing a precautionary choice onto consumers that may not otherwise choose it. Even if sensible policy, it directly interferes with free consumer choice.

So, the medical freedom movement has an internal tension with the principle of autonomy in two ways. First, by stressing the freedom to access supplements, the movement inhibits the ability for consumers to make informed choices. Second, by adopting precautionary policies, the movement limits consumer choice.

Of course, one might defend the movement by arguing that precautionary policies are advisable. They might simply admit that, although we are not maximizing freedom, the benefits to public health are worth restricting at least some options.

This is an excellent response. Yet it cannot give the advocate of medical freedom everything. It may require abandoning the commitment to supplement access; a precautionary approach would demand greater scrutiny here, rather than encouraging consumers to pursue products with limited knowledge. Although it may successfully defend more restrictive regulation, as in the case of synthetic dyes. However, once we start justifying restrictions of individual freedom on the basis of public health, this may justify some of the very policies that the medical freedom movement criticizes.

Consider the previously alluded to ongoing measles outbreak in Texas. In an op-ed Kennedy emphasized that vaccination against measles is a personal choice, instead choosing to stress nutrition as the best way to combat the disease. But the data suggest encouraging vaccinations is a better policy than letting measles spread among even healthy people. In a longitudinal study of 276,327 doses of the MMR (mumps, measles, rubella) vaccine given to adults and adolescents from January 2010 to December 2018, there were fewer than 6 serious outcomes requiring hospitalization per 100,000 doses during the risk window following vaccination, some of which were attributable to patients’ prior health conditions. For comparison, measles cases in the United States from 1987–2000 led to hospitalizations at a rate of 19,200 per 100,000 cases and 300 deaths per 100,000 cases. If precaution can prevail over freedom, then this seems like as obvious a case as any; the movement ought to emphasize the importance of vaccines rather than individual choice.

But here Kennedy and members of the medical freedom movement opt for choice over public health. So, it is unclear exactly what value motivates them. Thus, members of the medical freedom movement should take a step back and ask themselves: What are we most committed to? If autonomy is their foundational commitment, then they should promote measures that increase choices available to the public while ensuring that they have plentiful access to information about the products that they consume. But if public health is their primary concern, then this would suggest policies that involve limiting individual choice in at least some respects and the policies that most effectively promote public health may be ones that they are likely to reject, such as promotion of mass vaccination.

As an outsider to decision making, it is easy to think you can have it all. But once forced to develop policy, one often finds that all values cannot be maximized simultaneously. In that case, one must choose which value has greater priority. By insisting on the importance of both public health and individual choice, the medical freedom movement fails to achieve either.

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Bloodstained Men and Circumcision Protest

photograph of Bloodstained Men protestor

Images of men dressed in pure white with a vibrant mark of blood around their crotch have littered front pages in past weeks. The Bloodstained Men are protesting the practice of male circumcision – removal of the foreskin from the penis. This surgical practice, although less common in many European countries, is widely accepted and largely performed for social, aesthetic, or religious reasons. The World Health Organization estimated that somewhere between 76-92% of people with penises are circumcised in the United States.

While the practice of circumcision has a long history and has been endorsed by many Western doctors, does this make it ethical?

The Bloodstained Men, and other anti-circumcision activists, would argue that it does not: circumcision is a violation of genital autonomy and is a purely aesthetic surgery that only works to detract sexual pleasure and is performed without the consent of the child. Others, meanwhile, support circumcision, citing its possible medical benefits and ability to increase social, romantic, and sexual acceptance. How can we reconcile these two conflicting views?

Consulting our ethical convictions regarding female genital mutilation (FGM) may bring some clarity on this issue. The practice of altering the female genitalia – either by removing the clitoris, parts of the labia, or closing the vagina – has long been considered a morally impermissible intervention in Western society, and on valid grounds. Still, it must be determined whether our condemnation of FGM should inform a similar objection over male circumcision.

Most significantly, many cite FGM as problematic in its attempt to limit sexual autonomy, maintain ideals of purity, and uphold societal expectations around sex and femininity. The intent behind the procedure, then, may be the key to our acceptance of circumcision. Circumcision has long been a religious custom in the Muslim and Jewish faiths, but gained popularity in the United States for different reasons. Most integral to its growth in practice was a belief that circumcision could cure physical and mental health issues, provide an indication of wealth and social status, and prevent masturbation. Although these reasons may have led to its popularity, they have long been proven incorrect, and now the intent behind circumcision is typically associated with ideas of cleanliness, health, or social acceptance (with a focus on genital uniformity with one’s father or peers).

Are these justifications more morally permissible than those for FGM? Like FGM, there is a historic desire to suppress sexual autonomy paired with a current desire to gain social acceptance, and in both cultures the procedure is viewed as an accepted social custom done to benefit a child in some way. It is possible, then, that an evaluation of impact, rather than intent, will prove more useful for our discussion.

FGM is denounced by its lack of medical benefits, and more broadly by its medical risks, with severe forms causing difficulties birthing, infections, and psychological trauma. Does the moral difference, then, lie in the benefits of circumcision? Possible benefits include a decreased risk for HIV or urinary tract infections, easier hygiene, and social acceptance, with the belief that uncircumcised persons will face social persecution, bullying, or romantic/sexual ostracization. Do these reasons warrant genital surgery?

Research has found that these benefits are much more slight than once believed, especially when making a consideration for policy within the United States where HIV rates are quite low and may be better addressed with proper access to condoms, the drug PREP, or comprehensive sex education. In addition, circumcision, like FGM, reduces sexual pleasure; the foreskin, much like the clitoris, houses a majority of the nerve endings in the penis, so its removal reduces sensation. It is widely known, now, that circumcision is not a medical necessity, yet the practice remains a social custom. Social reasons for circumcision may be convincing, but are also similar to those that inform FGM.

Is social normativity enough to warrant the removal or change to a perfectly healthy organ, especially if it reduces pleasure? Even if there are some medical benefits, is this a decision that should be made for a child?

This discussion really comes down to a conversation about informed consent. For surgeries under the age of 18, parents are given the authority to provide consent for their children; this sacrifice of rights is necessary to serve the medical interests of the child. In the case of circumcision, though, there is absolutely no medical necessity; it is a surgery that involves the removal of a natural part of a healthy organ, an organ that increases pleasure later in life. Should parents be able to consent to surgeries that are not medically necessary?

The value we place on bodily autonomy suggests that this is not a decision that should be made by parents, especially as it is often motivated by a desire to “fit in.” Personal autonomy and the right to control one’s own body, especially such an intimate organ, should supersede social and cultural norms. If we do decide respecting cultural customs and desires for social acceptance are more important than our ethical understanding that people should have the right to control their bodies, why do we denounce FGM?

When evaluating the two procedures, it seems as though circumcision shares many of the qualities that make FGM unethical, so shouldn’t we deem circumcision unethical as well? If we decide to continue the practice of circumcision, where must we fall on the issue of FGM? In order to come to a conclusion about circumcision, we must reckon with our moral attitudes towards FGM and determine whether our values of consent and pleasure are more important than our need to conform to social and cultural customs.

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Whose Rights Matter for Gender-Affirming Care?

photograph of youth holding small Trans Support Flag at rally

Should medical decisions involving children be up to children, parents, physicians, the state, or some combination thereof? This question has been at the core of recent issues including vaccine mandates, but it is also central to a new slate of bills targeting gender-affirming care for trans youth, which are usually supported by appeals to children’s rights.

For example, the Idaho House recently passed a bill that makes it a felony, punishable by life in prison, to provide gender-affirming medical care to trans youth, to provide permission for a minor to receive that care, or to permit a minor to travel out of state to receive care. The bill has since been blocked in the Idaho Senate, due to concerns about parental rights. Similar laws are being proposed in Tennessee, Alabama, and Iowa.

What is interesting about these bills (as well as Florida’s “Parental Rights in Education” bill) is that they are contested on the basis of a conflict between children’s rights and parents’ rights. In the case of gender-affirming medical care, whose rights matter more?

It seems that the proponents of these bills are right to say that it is the children’s rights that are primarily at stake in these decisions — not the parents’. They are wrong, however, to say that children’s rights support this kind of legislation.

Except for therapy, gender-affirming medical care begins around puberty, when children have basic reasoning and decision-making capacities and start to develop as autonomous agents. These capacities may not yet be fully developed (and young adults may not yet be socially and legally independent), but this fledgling autonomy is sufficiently developed to warrant and even require that these children are part of the medical decision-making process. However, before minimal autonomy is reached, parents and physicians should be very careful about making medical interventions to alter a child’s sexed presentation, especially given the long history of medical abuse of intersex people.

Apart from considerations about autonomy and decision-making ability, the other primary consideration is whether these interventions will help or harm the children who undergo them. Both concerns target children’s rights.

The two questions we should ask are thus: Can children who have reached puberty consent to medical intervention? And do these interventions harm or help children? For those proposing these laws, the answers are that the children cannot give informed consent and that these interventions are, on balance, harmful. But are these assertions true?

The answer to the first question is supported by ideas that children cannot yet know their gender identity and how they would like to present, or that they will transition just because it is cool, or that they will choose transition as an easy out from facing misogyny or mental health problems.

If children cannot yet know their gender identity, then it seems that puberty blockers should be recommended for even more children, as it would allow them to delay the changes their bodies undergo so that they can make informed decisions about how they would like their bodies to develop at a later date.

It also seems unlikely that being trans is cool enough to persuade children to transition on that basis alone. In 2019, 2% of high school students identified as transgender. That is hardly as popular as wearing crocs, and it comes with significant social costs.

The last rationale is usually cited in the case of trans men. Misogyny is an issue that many people assigned female at birth have wrestled with and that has informed both cis and trans folks’ gender identities, but transition is not an escape from oppression — it trades one kind of oppression for another. One might also worry that there’s a subtle misogyny in implying that people assigned female at birth are less capable of making competent decisions about their gender identity than those assigned male at birth.

Even if each of these worries were true, they would tell in favor of more care rather than less. Instead of cutting off options to children and leaving them without a good understanding of gender identity or the medical options for transition, we should be providing children with more options and with better counseling to enable effective joint decision-making. This provides children with greater autonomy than if they are left without any choice, and it allows them to explore for themselves where their feelings are coming from and what they indicate.

It is important to note that not all transgender or gender non-conforming children will choose to undergo medical procedures or the same set of medical procedures. There is a critique to be made here that our current system of medical care often prioritizes certain narratives of medical transition over others and tends to overlook the needs of those who don’t fit into these neat categories, especially non-binary people. But again, this tells in favor not of removing medical care but of improving it. We should be striving to provide adequate information to children in the decision-making process and, as the therapy begins, encourage re-evaluation of medical care and adjust that care in response to the child’s wishes.

Turn now to the second question: Even if children can give at least partial consent, is the harm done by gender-affirming care great enough to override what autonomy they have? To determine the answer to this question, we need to separate out different kinds of gender-affirming care. Though gender-affirming care encompasses a wide range of options, let’s simplify those options into the following categories: talk therapy, puberty blockers, hormonal therapy, and surgical intervention.

While talk therapy and puberty blockers present some risks, the main worries that proponents of these bills cite primarily target hormonal therapy and surgical intervention. The two major harms presented in support of this legislation are a loss of reproductive ability and the difficulties faced by retransitioners (people who transition back to their gender assigned at birth or who transition to a different gender, e.g., trans man to non-binary person). These are non-negligible considerations. But do they capture everything morally salient for decision-making?

There are other harms we should take into account that would result if these bills were to pass: an inability to medically address gender dysphoria (a psychological incongruity between one’s gender identity and presentation, which can result in psychological distress), the disruption of the patient/doctor relationship, the message that these bills send that trans youth are not seen or appreciated, the tendency of these bills to exaggerate inter-family conflicts when one parent supports a child’s gender transition and the other does not, the tendency of these laws to increase the risk that trans youth commit suicide, and the difficult to alter changes that happen after a child’s body naturally starts producing estrogen and testosterone at puberty, in the absence of puberty-blockers.

The question about access to gender-affirming care isn’t simply one about avoiding these harms — it’s also about promoting positive experiences like gender euphoria (joy felt when one’s gender lines up with one’s presentation and social relations with others). But do the worries about loss of reproductive ability and retransition override these other considerations?

With regard to retransition, several studies have indicated that only around 1% of patients regret their transition. The people who regret their transitions matter, and medical care should be tailored to prevent such regrets and address them when they arise. But the existence of very few who regret medical transition should not be used to deny gender-affirming care to others, especially when that gender-affirming care can be life-saving.

Regarding reproductive worries, many trans folks would like to have children of their own. While we are not yet to the point where trans women can bear children or trans men can produce sperm, trans women and men can rely on technologies that freeze their sperm or eggs and that allow them to produce a biologically related child in the future. Unlike surgery, hormone therapy does not necessarily make the patient infertile, though counseling is recommended to ensure that patients understand the reproductive ramifications of certain medical interventions. And the one surgery that is currently accepted for under 18 individuals is “top surgery” or double mastectomy.

These reproductive ramifications should be fully transparent to teens who are deciding what therapies to access, but these considerations alone do not seem to immediately rule out medical transition, given that they may be outweighed by a number of benefits. In addition, reproductive capacity will mean different things for different trans people, as, for example, some trans men may wish to avoid pregnancy at all for reasons of gender dysphoria.

We also tend to think that adults should have reproductive freedom in choosing whether to have a tubal ligation or vasectomy, and the teens who would have access to hormonal therapy would be much closer to adulthood and full autonomy. Given their greater autonomy, it is less worrisome to allow them to make a joint decision with potentially negative long-term ramifications.

On the whole, gender-affirming care appears to be more helpful than harmful and certainly not harmful enough to warrant overriding the autonomy of older children and young adults. Current practices of gender-affirming care rightly provide less risky treatment to younger children and more risky treatment to older teens, which mirrors the growth of autonomy and decision making through young adulthood.

Bills that would deny gender-affirming care are insidious because they take away the rights of trans youth while claiming to protect those same rights. It turns out that if we want to protect children’s rights, we need to fight legislation that would deny access to gender-affirming care.

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Elective Disability and Body Integrity Dysphoria

image of human x-ray collage

Last month, Queensland police arrested 36-year-old John Yalu under suspicion of murder after he allegedly used a circular saw to cut off the leg of 66-year-old Kalman Tal, who died from his wounds soon after. Passers-by discovered Mr. Tal’s body in his car in a park in Innisfail, Australia, where the incident is believed to have occurred, and alerted the authorities to the situation. Mr. Yalu is currently in custody, and the case has been adjourned until June. Now, it seems that the men knew each other, and while this is not unique in murder cases, it does indicate that the death didn’t result from an indiscriminate, deadly assault. What does make the case distinctive is that, according to news reports, Mr. Tal paid Mr. Yalu $5,000 to use the circular saw to amputate his leg. Mr. Yalu didn’t lunge at Mr. Tal like a slasher-pic serial killer, but instead carried out a service of which Mr. Tal was aware. Indeed, local news reports that Mr. Yalu assisted Mr. Tal back to his car after sawing off his leg below the knee before departing on foot.

At this point, you’re probably wondering what on earth drove Mr. Tal to commission such an act? The simple answer is, currently, we don’t know. However, while police are still unearthing the facts, Mr. Tal’s family have theorized that he suffered from a condition known as Body Integrity Dysphoria (BID), also known as Body Identity Integrity Disorder.

According to the ICD-11, the diagnostic manual published by the World Health Organization and used as the global standard for categorizing health information and causes of death, BID is characterized by:

an intense and persistent desire to become physically disabled in a significant way (e.g., major limb amputee, paraplegic, blind), with onset by early adolescence accompanied by persistent discomfort, or intense feelings of inappropriateness concerning current non-disabled body configuration. The desire to become physically disabled results in harmful consequences, as manifested by either the preoccupation with the desire … significantly interfering with productivity, with leisure activities, or with social functioning … or by attempts to actually become disabled have resulted in the person putting his or her health or life in significant jeopardy.

In short, those with BID suffer due to a discrepancy between their self-perceived identity and their bodily construction (typically a limb); they see themselves as disabled people trapped in the body of non-disabled people. In the case of Mr. Tal then, it seems his family believe that he paid Mr. Yalu to undertake the amputation as a DIY treatment for his undiagnosed BID. The presence of the limb in question caused Mr. Tal suffering to such an extent that he felt he had no other option but to have it removed.

While the ICD-11 recognizes BID, it does not provide any recommended treatment. Indeed, the appropriate treatment option for the condition is disputed as it’s highly resistant to traditional interventions such as psychotherapy and medication management. From the small-scale studies and anecdotal evidence available, it seems that amputation is the only intervention that provides long-lasting and consistent relief from suffering.

However, as I’m sure you can imagine, the prospect of medical professionals deliberately disabling otherwise healthy people to cure them of their mental anguish is one that strikes many as inherently wrong. As the prominent bioethicist Wesley J. Smith writes:

These sufferers deserve our empathy, support, and intensive mental health interventions. But it should go without saying — but no longer can — that doctors should never be allowed to remove healthy limbs or snip spinal cords, which would be, by definition, to cause harm in contravention of the Hippocratic Oath.

Now I don’t begrudge Smith for holding this view (even though he’s criticizing a paper I wrote). The idea that doctors should heal, not hurt their patients is a powerful one, and it is one with which I wholeheartedly agree. Doctors who deliberately harm their patients – such as Simon Bramhall who branded his initials onto two anesthetized patients’ internal organs and Ian Paterson’s numerous bodily mutilations during his time as a public and private surgeon – do act unethically, do breach the Hippocratic Oath, and should face the consequences. I also have some limited sympathy for the idea that one’s intuitions act as a warning against unethical actions, what Leon Kass calls the Wisdom of Repugnance.

However, if the available evidence suggests that interventions that deliberately disable people alleviate the suffering of those with BID, are we not doing more harm by letting our aversion to the prospect guide our judgments? If we’re denying people the chance to access a potentially effective treatment simply because we find the idea of it distasteful, are we not causing them harm? There are multiple accounts of people with BID who, having no access to safe, medical amputations, have taken actions into their own hands. This includes people pouring bleach into their eyes to blind themselves, damaging a limb so severely by freezing it so that a surgeon has to amputate, or seeking out black-market amputations.

Now, this is not to say that amputation is undoubtedly the right treatment option for those with BID. While existing evidence suggests the intervention’s effectiveness, this evidence is limited, and more clinical research needs to be undertaken before any firm conclusions can be made. But, categorically ruling out disabling people for therapeutic purposes simply because the prospect seems harmful does a disservice to everyone involved.

We can’t know for sure that Mr. Tal had BID because, as stated, he was never diagnosed with the condition. Furthermore, even if we did know this, we can’t know if the availability of therapeutic, elective amputation would have prevented him from acquiring Mr. Yalu’s services, thereby potentially preventing his death. What we do know, however, is that people do suffer from BID, and this suffering can exist to a tremendous degree. Therefore, if we are dedicated to the idea of preventing suffering, and if doctors are committed to the idea of doing no harm, then we need to at least consider elective disability as a treatment option based on the merits of the procedure, and not on whether we find the idea repugnant or not.

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Informed Consent and the Joe Rogan Experience

photograph of microphone and headphones n recording studio

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.

The Joe Rogan Experience (JRE) podcast was again the subject of controversy when a recent episode was criticized by scientific experts for spreading misinformation about COVID-19 vaccinations. It was not the first time this has happened: Rogan has frequently been on the hot seat for espousing views on COVID-19 that contradict the advice of scientific experts, and for entertaining guests who provided similar views. The most recent incident involved Dr. Robert Malone, who relied on his medical credentials to make views that have been widely rejected seem more reliable. Malone has himself recently been at the center of a few controversies: he was recently kicked off of YouTube and Twitter for violating their respective policies regarding the spread of misinformation, and his appearance on the JRE podcast has prompted some to call for Spotify (where the podcast is hosted) to employ a more rigorous misinformation policy.

While Malone made many dubious claims during his talk with Rogan – including that the public has been “hypnotized,” and that policies that have been enforced by governments are comparable to policies enforced during the Holocaust – there was a specific, ethical argument that perhaps passed under the radar. Malone made the case that it was, in fact, the moral duty of himself (and presumably other doctors and healthcare workers) to tell those considering the COVID-19 vaccine about a wide range of potential detrimental effects. For instance, in the podcast he stated:

So, you know my position all the way through this comes off of the platform of bioethics and the importance of informed consent, so my position is that people should have the freedom of choice particularly for their children… so I’ve tried really hard to make sure that people have access to the information about those risks and potential benefits, the true unfiltered academic papers and raw data, etc., … People like me that do clinical research for a living, we get drummed into our head bioethics on a regular basis, it’s obligatory training, and we have to be retrained all the time… because there’s a long history of physicians doing bad stuff.

Here, then, is an argument that someone like Malone may be making, and that you’ve potentially heard at some point over the past two years: Doctors and healthcare workers have a moral obligation to provide patients who are receiving any kind of health care with adequate information in order for them to make an informed decision. Failing to provide the full extent of information about possible side-effects of the COVID-19 vaccine represents a failure to provide the full extent of information needed for patients to make informed decisions. It is therefore morally impermissible to refrain from informing patients about the full extent of possible consequences of receiving the COVID-19 vaccine.

Is this a good argument? Let’s think about how it might work.

The first thing to consider is the notion of informed consent. The general idea is that providing patients with adequate information is required for them to have agency in their decisions: patients should understand the nature of a procedure and its potential risks so that the decision they make really is their decision. Withholding relevant information would thus constitute a failure to respect the agency of the patient.

The extent and nature of information that patients need to be informed of, however, is open for debate. Of course, there’s no obligation for doctors and healthcare workers to provide false or misleading information to patients: being adequately informed means receiving the best possible information at the doctor’s disposal. Many of the worries surrounding the advice given by Malone, and others like him, pertain to just this worry: the concerns that they have are overblown, or have been debunked, or are generally not accepted by the scientific community, and thus there is no obligation to provide information that falls under those categories to patients.

Regardless, one might still think that in order to have fully informed consent, one should be presented with the widest range of possible information, after which the patient can make up their own mind. Of course, Malone’s thinking is much closer to the realm of the conspiratorial – for example, he stated during his interview with Rogan that scientists manipulate data in order to appease drug companies, as well as his aforementioned claims to mass hypnosis. Even so, if these views are genuinely held by a healthcare practitioner, should they present them to their patients?

While informed consent is important, there is also debate about how fully informed, exactly, one ought to be, or can be. For instance, while an ideal situation would be one in which patients had a complete, comprehensive understanding of the nature of a relevant procedure, treatment, etc., there is reason to think that many patients fail to achieve that degree of understanding even after being informed. This isn’t really surprising: most patients aren’t doctors, and so will be at a disadvantage when it comes to having a complete medical understanding, especially if the issue is complex. A consequence, then, may be that patients who are not experts could end up in a worse position when it comes to understanding the nature of a medical procedure when presented with too much information, or else information that could lead them astray.

Malone’s charge that doctors are failing to adhere to their moral duties by not fully informing patients of a full range of all possible consequences of the COVID-19 vaccination therefore seems misplaced. While people may disagree about what constitutes relevant information, a failure to disclose all possible information is not a violation of a patient’s right to be informed.

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Medical Challenge Trials: Time to Embrace the Challenge?

photograph of military personnel receiving shot

The development of the COVID-19 vaccines is worthy of celebration. Never has a vaccine for a  novel virus been so quickly developed, tested, and rolled out. Despite this success, we could have done much better. In particular, a recent study estimates that by allowing “challenge trials” in the early months of the pandemic, we would have completed the vaccine licensing process between one and eight months faster than we did using streamlined conventional trials. The study also provides a conservative estimate of the years of life that an earlier vaccine rollout would have saved: between 720,000 and 5,760,000. However, whether we should have used challenge trials depends on a number of ethical considerations.

Here is an extraordinary fact: we first genetically sequenced the virus in January 2020. Moderna then developed their RNA vaccine in just two days. But the F.D.A. could only grant the vaccine emergency authorization in late December — almost a year later. Over this period the virus killed approximately 320,000 U.S. citizens. The vast majority of the delay between development and approval was due to the time needed to run the necessary medical trials. Enough data needed to be collected to show the vaccines were effective and, even more importantly, safe.

Here’s how those trials worked. Volunteers from a large pool (for example, 30,420 volunteers in Moderna’s phase three trial) were randomly provided either a vaccine or a placebo. They then went about their lives. Some caught the virus, others didn’t. Researchers, meanwhile, were forced to wait until enough volunteers caught the illness for the results to be statistically valid. The fact that the virus spread so quickly was a blessing in this one respect; it sped up their research considerably.

So-called “challenge trials” are an alternative way to run medical trials. The difference is that in a  challenge trial healthy (and informed) volunteers are intentionally infected with the pathogen responsible for the illness researchers want to study. The advantages are that statistically significant results can be found with far fewer volunteers far more quickly. If we vaccinate volunteers and then expose them to the virus, we’ll have a good idea of the vaccine’s effectiveness within days. This means faster licensing, faster deployment of the vaccine, and, therefore, thousands of saved lives.

Challenge trials are generally blocked from proceeding on ethical grounds. Infecting healthy people with a patho­gen they might nev­er oth­er­wise be ex­posed to — a patho­gen which might cause them ser­i­ous or per­man­ent harm or even death — might seem dif­fi­cult to jus­ti­fy. Some med­ic­al prac­ti­tion­ers con­sider it a vi­ol­a­tion of the Hip­po­crat­ic oath they have sworn to up­hold — “First, do no harm.” Ad­voc­ates of chal­lenge tri­als point out that slow, tra­di­tion­al med­ic­al tri­als can cause even great­er harm. Hun­dreds of thou­sands of lives could likely have been saved had COV­ID-19 chal­lenge tri­als been per­mit­ted and the various vac­cines’ emer­gency approv­al occurred months earli­er.

Ad­mit­tedly, chal­lenge tri­als ef­fect­ively shift some risk of harm from the pub­lic at large to a small group of med­ic­al vo­lun­teers. Can we really accept greater risk of harm and death in a small group in order to protect society as a whole? Or are there moral limits to what we can do for the ‘greater good’? Per­haps it is this unequal distribution of burdens and benefits that critics object to as un­eth­ic­al or un­just.

Ad­vocates of chal­lenge tri­als point out that vo­lun­teers con­sent to these risks. Hence, per­mit­ting chal­lenge tri­als is, fun­da­ment­ally, simply per­mitting fully con­sent­ing adults to put them­selves at risk to save oth­ers. We don’t ban healthy adults from run­ning into dan­ger­ous wa­ter to save drowning swim­mers (even though these adults would be risk­ing harm or death). So, the reas­on­ing goes, nor should we ban healthy adults from vo­lun­teer­ing in med­ic­al tri­als to save oth­ers’ lives.

Of course, if a volunteer is lied to or otherwise misinformed about the risks of a medical trial, their consent to the trial does not make participation ethically permissible. For consent to be ethically meaningful, it must be informed. Volunteers must understand the risks they face and judge them to be acceptable. But making sure that volunteers fully understand the risks involved (including the ‘unknown’ risks) can be difficult. For example, a well-replicated finding from psychology is that people are not very good at understanding the likelihood of very low- (or high-) probability events occurring. We tend to “round down” low probability events to “won’t happen” and “round up” high probability events to “will happen”. A 0.2% probability of death doesn’t seem very different from a 0.1% probability to most of us, even though it’s double the risk.

Informed consent also cannot be obtained from children or those who are mentally incapable of providing it, perhaps due to extreme old age, disability, or illness. So members of these groups cannot participate in challenge trials. This limitation, combined with the fact that younger, healthier people may be more likely to volunteer for challenge trials than their more vulnerable elders, means that the insights we gain from the trial data may not translate well to the broader population. This could weaken the cost-benefit ratio of conducting challenge trials, at least in certain cases.

A fur­ther eth­ic­al worry about chal­lenge tri­als is that the poor and the dis­ad­vant­aged, those with no oth­er op­tions, might be indirectly coerced to take part. If in­dividu­als are des­per­ate enough to ac­cess fin­an­cial resources, for ex­ample for food or shel­ter they require, they might take on in­cred­ible per­son­al risk to do so. This dy­nam­ic is called “des­per­ate ex­change,” and it must be avoided if chal­lenge tri­als are to be eth­ically per­miss­ible.

One way to pre­vent des­per­ate ex­changes is to place lim­its on the fin­an­cial com­pens­a­tion provided to vo­lun­teers, for ex­ample merely cov­er­ing travel and in­con­veni­ence costs. But this solu­tion might be thought to threaten to un­der­mine the pos­sib­il­ity of run­ning chal­lenge tri­als at all. Who is go­ing to volun­teer to put his life at risk for noth­ing?

There’s some evid­ence that people would be will­ing to vo­lun­teer even without ser­i­ous fisc­al com­pens­ation. In the case of blood dona­tion, un­paid vol­untary sys­tems see high dona­tion rates and high­er donor qual­ity than mar­ket-based, paid-dona­tion sys­tems such as the U.S.’s. As I write this 38,659 vo­lun­teers from 166 coun­tries have already signed up to be Chal­lenge Tri­al volun­teers with “1 Day Soon­er,” a pro-Chal­lenge Tri­al or­gan­iz­a­tion fo­cus­ing on COV­ID-19 tri­als. These vo­lun­teers ex­pect no mon­et­ary com­pens­a­tion, and are primar­ily mo­tiv­ated by eth­ic­al con­sid­er­a­tions.

The ad­voc­ates of chal­lenge tri­als sys­tem­at­ic­ally failed to win the ar­gu­ment as COV­ID-19 spread across the globe in 2020. Med­ic­al reg­u­lat­ors deemed the eth­ic­al con­cerns too great. But the tide may now be chan­ging. This Feb­ru­ary, Brit­ish reg­ulat­ors ap­proved a COV­ID-19 chal­lenge tri­al. When time-in-tri­al equates with lives lost, the prom­ise of chal­lenge tri­als may prove too strong to ig­nore.

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Autonomy, Euthanasia, and Non-Terminal Patients

photograph of hospital room with empty beds

In March of this year, changes to the law regarding assisted suicide and euthanasia in Canada loosened some of the restrictions about who is eligible to apply. Assisted suicide and voluntary active euthanasia has been legal in Canada since 2016, however, the law governing such procedures was recently challenged for being too restrictive and not in keeping with the original ruling of the Supreme Court. Initially, to be eligible for assisted suicide or euthanasia the patient’s terminal condition must have been considered “reasonably foreseeable,” but now that criterion has been dropped so that even people suffering from grievous and irremediable mental illnesses will be eligible. But this new-found freedom only raises more questions about the concept of consent, especially in those cases where patients with impaired mental faculties express a desire to end their life.

There are relatively few nations in the world which permit either physician-assisted suicide or physician-assisted euthanasia, and even fewer that permit them for people who are not terminally ill. For example, in the United States passive euthanasia is legal, and in a few states voluntary active euthanasia is permitted but only in situations where there is a terminal illness. On the other hand, Canada will now join nations like Belgium and the Netherlands in permitting voluntary active euthanasia and assisted suicide to patients who are not terminally ill. In Belgium, patients with psychiatric conditions, even children, can request euthanasia. But in non-terminal situations where a patient may request that their life end because of a psychiatric condition like depression or dementia, the issue is complicated. In all of the above nations, the notion of informed consent is paramount, but it isn’t always easy to determine if a patient is competent enough to provide consent.

As Scott Kim, a psychiatrist and philosopher, notes,

“It is not easy to distinguish between a patient who is suicidal and a patient who qualifies for psychiatric euthanasia, because they share many key traits…one does not need to be a psychiatrist to appreciate how psychiatric disorders, especially when severe enough to lead to euthanasia requires, could interfere with a patient’s ability to make ‘voluntary and well considered’ decisions.”

Unlike in the case of terminal illness which may be determined by a chemical or imaging test, it can be difficult to say for sure whether a patient with a psychiatric illness has “unbearable suffering without the prospect of improvement.” For example, a Dutch woman elected to be euthanized 12 months after her husband’s death for “prolonged grief disorder,” despite being otherwise physically healthy. To make this determination even more complicated, just last year, the Dutch Supreme Court expanded the law to extend this choice to those suffering from dementia as well.

Those who defend the idea of psychiatric-assisted dying in non-terminal patients argue that the suffering caused by mental illness justifies physician-assisted dying, but only if the patient is able to request such a procedure autonomously and rationally. However, some philosophers and ethicists take issue with this criterion. In a paper on the subject, Jukka Varelius points out that, “Given that the distress of a psychiatric patient undergoes can be very severe and that there may not always be adequate means of alleviating it (short of ending the patient’s life), the idea that psychiatric-assisted dying could sometimes be morally acceptable does merit attention.” Indeed, many argue that excluding the mentally ill from enjoying this freedom on the basis of disability is objectionably discriminatory.

For a patient to make an autonomous decision, it is commonly thought that it must be voluntary, intentional, and based on sufficient understanding of the nature and consequences of the decision. But certain mental illnesses undermine a patient’s ability to understand the world. A similar problem occurs in cases of dementia. As noted in a paper on the subject from the Journal of Neurology, “those suffering from dementia suffer from a disease that itself infiltrates the very center of autonomy and voluntariness.” But Varelius makes the case that even if their conception of reality is distorted, non-autonomous psychiatric patients can also suffer unbearably if they are unable to express a reasoned decision to end their life. It is already common practice, for example, to engage in non-voluntary euthanasia by withdrawing life support from non-autonomous patients if it is deemed to be in the patient’s best interests, such as those who are in an irreversible comatose state or those with severe brain damage. It is, however, difficult to argue that we have any certainty regarding the patient’s personal preferences. Because of this, our standards involving autonomous choice may be less important than we often make them, and it would be cruel to claim that the suffering we force people to endure due to our skepticism of their “true” interests is not morally significant.

On the other hand, many may argue that there is a significant difference between active and passive euthanasia, or even that passive euthanasia should be endorsed at all. Also, when it comes to issues like dementia and mental illness, it won’t always be clear if suffering can be abated. Longitudinal studies show that patients with chronic psychiatric disorders sometimes get better or worse for reasons beyond the control of healthcare providers. So, it might not ever be clear whether there are other reasonable alternatives to euthanasia. And, without the ability to predict the future or have a meaningful conversation with a patient, there is no more reason to think that a person would want to be euthanized than to think that they wouldn’t.

There is also strong rejection of euthanasia from psychiatrists stemming from the nature of the profession. A fundamental core of psychiatry, to many, is to prevent suicide and to address hopeless, helplessness, the desire to die, and the inability to see the future. The shift in policy towards psychiatric euthanasia is considered a fundamental change to the practice of psychiatry. Many worry about slippery slope precedents of the ever-expanding criteria for euthanasia which are beginning to include reasons those who feel “like they have a completed life” and are tired of living. And some studies of the system in Holland reveal that the no-reasonable-alternative criterion is not always met.

For these reasons, it is difficult to assess whether a decision is autonomous or how important that determination is in many of these cases. We need to explore the various frameworks in place to determine appropriate eligibility criteria and approval processes. Finding the right balance (if there even is such a thing) may be something that can only be learned the hard way.

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Consent, Commodification, and Anderson Cooper’s Surrogacy Case 

Anderson Cooper standing at a podium with a woman sitting in a chair behind him

Recently, CNN anchor Anderson Cooper announced the birth of his son through surrogacy. On June 10th, Cooper and his son made an appearance on People magazine where Cooper talked about the experience of surrogacy and raising his 6 week old son. However, his decision to have a baby through surrogacy has been met with significant controversy: where some congratulated Anderson Cooper, others questioned the ethics of surrogacy. Surprisingly, surrogacy isn’t a partisan issue where even in left leaning circles, many disagree about surrogacy’s place as a way for gay or lesbian couples to have a chance to raise a child while others argue it is a commodification of women’s bodies. Anderson Cooper’s surrogacy case is now starting larger discussions about the ethics of surrogacy. 

The first question that arises is if surrogates can give informed consent. The definition of informed consent is stated as permission granted in the knowledge of the possible consequences with full knowledge of the possible risks and benefits. When a surrogate signs a contract to give all legal rights away to the connection of the child, many times, surrogates do not know the feeling of the emotional bond of mother to baby nor the experience of carrying a child. So how could a surrogate, especially a first-time mother, know the experience of having a strong emotional bond to the baby? They don’t, so to have potential surrogates sign contracts, while not knowing the experience of being mothers, means that surrogates cannot give informed consent because they cannot possibly know what it is like to give up their baby. 

However, even if a surrogate is not a first-time mother and can give full consent, one needs to consider whose choice is forgotten in this case? The baby’s choice. If you put yourself in the baby’s position, would you want to stay with your mother or a foreign family you are being sold to? Not only can some surrogate mothers not give full informed consent, but the baby’s preferred choice has not been taken into account. Many think only two parties are involved in surrogacy: the surrogate and the adopters, but the baby is the third party that has to be considered.  

Secondly, surrogates cannot provide informed consent because surrogacy disproportionally attracts women of lower income. This explains why surrogacy is especially prevalent in developing countries such as Ukraine, Russia, and India where laws are lax and many people are of lower income. Whether or not surrogates are from the US or other countries, women who are struggling through financially hard times are more vulnerable to coercion due to the mindset of scarcity when struggling through poverty. Women are often coerced into risking their health or even their lives when signing the unbreakable contract to giving away the child. Furthermore, when in circumstances of financial scarcity, potential surrogates are more likely to sign exploitative contracts where pregnancy-related medical issues during or after pregnancy are not covered or where the surrogate is not sufficiently paid. 

Another key part of surrogacy is if it pays for the baby, the service, or both. The answer yields two very different moral viewpoints; if surrogacy pays for a baby, this means a baby is being bought and sold, putting a price tag on human life. This carries enormous consequences to individual rights of the modern world because it would mean human life and value can be measured instead of being infinitely valuable. But if surrogacy only pays for the service of carrying the baby, some would say there isn’t much of a difference between a surrogate and a 24/7, nine-month-long babysitter. The debate around if surrogacy is a payment for the service or the baby depends on the situation. If the surrogate mother is artificially inseminated, some argue surrogacy pays for the baby because it uses the oocyte of the surrogate to produce the baby. If the surrogate were to carry an embryo of the biological parents, then it would be considered a service, because the surrogate is only raising the baby in the womb, not providing reproductive material. However, this reasoning leads to the assumption that new life (reproduction) starts at conception. If one believes that life starts at birth, then surrogacy implies paying for the baby because the pregnancy is part of the process of making new life. Surrogacy would only seem ethically permissible if the surrogate is carrying the “living” embryo of the two biological parents, because the embryo has already been created and now carrying it is a service. Even then, a biological reproductive service seems quite different in moral worth from an economic service like babysitting. 

However, advocates of surrogacy would argue that disallowing women to sell their reproductive services would be unequal, because men are able to sell their reproductive services. So why would we allow sperm donation but not allow surrogacy? There are two significant differences between sperm donors and surrogate mothers. Sperm donors can give implied consent because they have full knowledge of how their sperm will be used, whereas surrogates might experience unexpected effects like an emotional bond to the baby. Secondly, surrogacy requires nine months of pregnancy and the delivery of a baby, while sperm donors have no interaction with the baby; therefore, these differences cannot be held at an equal standard. Rather, egg donors seem to be the equal standard to sperm donors since both meet the same standards of consent and disconnect from offspring. In surrogacy, the moral worth of mother and baby and the ability to develop new life is inexplicably precious, but putting a monetary value on pregnancy might degrade the intrinsic value of carrying and delivering a baby. Society would no longer view pregnancy as an unbreakable bond with a baby but view it as something able to be bought and sold. 

To exemplify this concept of how money changes societal morals, consider the case of an Israeli child care center. The childcare center wanted to decrease the number of parents late to pick up their children, so it implemented a small fine for parents who arrived late for pickup. The result had the opposite effect than many predicted: more parents picked up their children late; the societal moral standard to not give the childcare workers a burden was gone. By implementing a monetary value on being late, it degraded the moral standard of being late. The childcare center reversed the decision after experiencing higher rates of late pickups, but even afterward, the childcare center continued to experience the high rates of late pickups. Once a monetary number is assigned to something, it can degrade the moral value of it. The same might happen to pregnancy if surrogacy was widespread: the intrinsic value of the bond between mother and baby would simply be defined by financial cost. The mother to child bond is something inexplicably precious. We see it when adopted children go looking for their biological mothers or mothers spend years looking for their lost child. This emotional bond is sacred; it’s something no one would put a moral utility measurement on. However, surrogacy risks breaking the mother to baby bond because something infinitely and intrinsically valued has changed to a monetary value.   

In the end, although Anderson Cooper’s case has been one of few high profile cases of celebrities taking the path of surrogacy, the surrogacy process is often used by many people who want biologically related children. On the surface, surrogacy may seem like a 9 month biological babysitter, but surrogacy brings along serious moral questions that need to be addressed. From (un)informed consent, exploitative contracts, the transaction of human beings, and the degradation of mother-baby bonds, surrogacy could have dangerous moral implications to human wellbeing and the core question of human value.

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McKamey Manor: The House of No Consent

black-and-white photograph of silhouetted figure behind glass

Since 2005 Russ McKamey has been running McKamey Manor, an extreme horror attraction. When patrons sign-up for the tour they are signing-up for being physically and psychologically mistreated. Before participating, patrons must go through extensive interviews, a medical examination, and sign a long legal waiver. However some participants complain that the experience is too extreme and that the legal waiver does not excuse their behavior. The nature of the attraction brings up a host of issues concerning the nature and extent of consent.

A waiver is a voluntary surrender of a right or opportunity to enforce a right. Many horror attractions require patrons to sign a waiver before entering, in which the participants acknowledge that they are knowingly taking on the risk of various losses and relinquish the right to seek damages they may suffer while attending the attraction. For example, if a person who attended a horror attraction suffered from a heart condition and experienced a heart attack during their participation, they would not be able to sue that attraction for any medical expenses incurred as a result of that heart attack. In the case of McKamey Manor the waiver is reportedly about 40-pages long. In addition to the waiver, potential patrons are required to watch videos of other people’s experiences at McKamey Manor. The participants in these videos all ask to have their experience ended prematurely, and advise the potential participants that they “don’t want to do this.”

But does it follow that potential participants, duly informed of what may happen to them, truly consent to be buried alive, forced to ingest their own vomit, held under water, cut, struck, and verbally abused? Not necessarily. Not even a signed legal form, or other explicit signal of consent automatically creates genuine consent. There are several conditions which render void apparent consent such as when no genuine choice is available to participants or when the participant is offered something that undermines their ability to make rational decisions. McKamey Manor offers participants $20,000 if they can survive the entire experience (which is of variable length, ranging from 4 – 10 hours). Even in the longest scenario a successful participant would stand to make $2,000 per hour of their time — an inducement that undermines a person’s ability to think clearly.

While recent McKamey attractions allow participants to create safe words to automatically end their horror experience, this was not always this case. And McKamey patron Amy Milligan claims that even when she begged the actors to stop, they continued to torment her. If a person cannot end the experience at will — if they are at the mercy of the actors creating the experience — then that person has been robbed of their autonomy, even if only for a limited time. This creates another type of situation in which the explicit consent signal, in the form of the waiver, is a legal fiction. It is not possible for a person to fully waive their autonomy, as doing so would be to essentially sign themselves into slavery.

The idea that such “voluntary slavery” could exist is discounted as a possibility by philosophers with views and methodologies as different as Jean-Jacques Rousseau and John Stuart Mill. Rousseau argued that once a person becomes a slave by losing all autonomy, they cease to be a moral agent at all. As such to consent to being a slave would be to consent to no longer being a moral or legal person. Mill argued that voluntary slavery was an exception to his harm-to-others principle, which stated that any person could do as they pleased so long as they did not harm someone else. He claimed that although a person attempting to sell themselves into slavery may not be causing harm to anyone but themselves, it nonetheless stood in contradiction with the whole point of the harm-to-others principle — to maintain maximum individual liberty.

Though McKamey Manor residents do not sign themselves away into permanent slavery, they do “waive” their autonomy for a limited amount of time. Importantly, the effective duration of this “waiver” is determined not by the participants, but rather by the actors. Moreover some of the experiences patrons are subjected to are essentially torture. Here again the substantiveness, or, at least, relevance, of patrons’ consent is dubious. Consider waterboarding, a form of simulated drowning. (McKamey contends that no participants are waterboarded, but admits that they will be made to feel like they are drowning — a spurious distinction.) The problem with military detainees being waterboarded is not that they weren’t asked for their permission first. Indeed lack of permission is not the sole moral shortcoming of any form of torture. The problem is instead the nature of the activity and the relationship it creates between people: a relationship in which one person is inflicting suffering an another for enjoyment or profit.

McKamey and his defenders claim that the screening and waiver process creates a situation in which McKamey Mansion patrons consent to a prolonged period of physical and emotional abuse. However there are some things that no waiver, no matter how length and legalistic can create consent for. A person’s autonomy is inalienable. This doesn’t just mean that it cannot be taken away, but also that it can’t be given away.

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When Your Will Is Not Enough: Ethical Restrictions on Entering into Agreements

CRISPR image

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 43-year-old with a deadly skin cancer is asking doctors to use the recent developments in CRISPR to experiment with treatments that may help him as well as advance medical understanding. Malakkar Vohryzek is offering to be a test subject, contacting a number of researchers and doctors asking if they would be interested in modifying his genetic code. Such treatment falls well outside approved parameters for human exposure to risk with the gene-editing technology, but the potential patient seems to be providing straightforward consent. In medicine and law, however, consent is often not enough. Currently the international scientific community remains critical of researchers in China that edited the genes of twin children last year, saying that such interference was premature and that the understanding of CRISPR and the impact on human subjects was not advanced enough for such research (for discussion see A.G. Holdier’s “Lulu and Nana: The Surprise of Genetically-Modified Humans”). Vohrysek’s case is interesting, though, because with a terminal illness and clearly expressed desire, why stick to standards that aim to promote and protect a subject’s welfare? If Vohrysek is willing to risk his health (what is left of it given his illness), why should doctors and researchers hesitate to proceed?

The ethics surrounding agreements or contracts incorporate a number of dimensions of our agency and the way we relate to one another. These standards attempt to take seriously the import of being able to direct one’s own life and the significance of the harm of manipulating the lives of others.

Paternalism is the term used to describe efforts to promote others’ best interests when those actions run counter to their expressed wishes. In such cases, someone believes that if a person’s will were effective, it wouldn’t promote what is in their best interests, and therefore interference is justified. The standard case of paternalism is that of a parent who overrules the will of a child. Say, for example, a 5-year-old wants ice cream for dinner but a parent disregards this preference and instead makes the child eat a nutritious meal believing that this will be better for the child. Typically, we think parents are morally justified in disregarding the child’s expressed preferences in circumstances like these. But when, and under what circumstances, paternalism can be justified outside of these clear-cut parent-child cases is much less clear. In Vorysek’s case, there is something paternalistic about not prioritizing the autonomous choice he is communicating. In general, regulatory standards are meant to promote subjects’ welfare and interests, but Vorysek isn’t a child, so what countervailing reasons apply here?

One class of cases where paternalistic interference is typically considered justified is where there isn’t a clear of expression of an agent’s will to interfere with in the first place. We may interpret the parent-child case in this way: a child hasn’t developed their full autonomous capabilities, therefore superseding their expressions of will when it runs counter to their best interests doesn’t seem as problematic as thwarting the will of a fully autonomous, mature adult. Vorysek, and other patients facing terminal prognoses who knowingly choose to expose themselves to risk, seem to be in a different class than those whose illness or condition of life diminishes their autonomy.

One barrier to truly just agreements is an unethical power dynamic founded on asymmetric information. For instance, if one party uses legal understanding and jargon to obscure the stakes and conditions of an agreement so that the other party can’t fully weigh the possible outcomes that they are agreeing to, this is intuitively not a fair case of agreement. These concerns are relevant in many legal contracts, for instance in end-user license agreements that consumers accept in order to use apps and software.

Another arena where there is often an asymmetry of technical understanding is in physician-patient exchanges (for discussion see Tucker Sechrest’s “The Inherent Conflict in Informed Consent”). In order to get informed consent from patients, physicians must communicate effectively about diagnoses, potential treatment options, as well as their outcomes and likely effects to patients who frequently do not have the breadth of understanding that the physician possesses. If a doctor does not ensure that the patient comprehends the stakes of the treatment choices, the patient may enter into agreements that do not reflect their priorities, preferences, and values. This asymmetric understanding is also the ethically problematic dimension of predatory lending, “the practice of a lender deceptively convincing borrowers to agree to unfair and abusive loan terms, or systematically violating those terms in ways that make it difficult for the borrower to defend against.”

But there remain further ethical considerations even when mutual understanding can be assured. It’s true that only when both parties to an agreement have a full grasp of the stakes and possible outcomes of the agreement is there the potential for each to weigh this information against their preferences, priorities, and values in order to determine whether the agreement is right for them. However, this doesn’t exhaust all ethical dimensions of making agreements. We could imagine that the 43-year-old patient seeking un-approved CRISPR treatments to be in such a position — he might understand the risks and not be mistaken about how the facts of the matter relate to his particular values, preferences, and priorities. What ethical reservations are left?

Exploitation refers to a type of advantage-taking that is ethically problematic. Consider a case where an individual with little money is offered $500 in exchange for taking part in medical research. It could be the case that this is the “right” choice for them — the $500 is sorely needed, say to maintain access to shelter and food, and the risk involved in the medical research is processed and understood clearly and the person determines that shelter and food outweigh the risk. In such cases, the ethical issue isn’t that a person may be entering agreements without understanding or against their best interests. Indeed, this individual is making the best choice in their circumstances. However, the structure of the choice itself may be problematic. The financial incentive for taking on unknown risk of bodily harm is a thorny ethical question in bioethics because of the potential exploitative relationship it sets up. When financial incentives are in place, the disadvantaged portion of a population will bear the brunt of the risk of medical research.

In order to avoid exploitation, there are regulatory standards for the kinds of exchanges that are permissible for exposing one’s body to risk of unknown harm, as in medical research. There are high standards for such research in terms of likelihood of scientific validity – the hypothesized outcome can’t just be an informed “guess,” for instance. Vorysek likely won’t find a researcher to agree to run experiments on him for fear that terminal patients, in general, will become vulnerable to experimentation. As a practice, this may be ethically problematic because patients are a vulnerable population and this vulnerability may be exploited — the ethical constraint on agreements can be a concern even when making the agreement may be both in the individual’s best interest and satisfying their will.

This, of course, leads to tensions and controversy. Should Vorysek and others in similar positions be able to use their tenuous prognosis for scientific gain? “If I die of melanoma, it won’t help anyone,” he said. “If I die because of an experimental treatment, it will at least help science.”

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Corporate Responsibility and Human Rights: DNA Data Collection in Xinjiang

photograph of Uighur gathering

Since 2006 China has engaged in a large-scale campaign of collecting DNA samples, iris images, and blood types in the province of Xinjiang. In 2016, a program under the name “Physicals for All” was used to take samples of everyone between ages of 12 to 65 in a region home to 11 million Uighurs. Since the beginning of the program, it has been unclear whether the patients were at any point “informed of the authorities’ intention to collect, store, or use sensitive DNA data,” raising serious questions about the consent and privacy of the patients. The authorities largely characterized the program as providing benefits for the relatively economically poor region, with a stated goal: “to improve the service delivery of health authorities, to screen and detect for major diseases, and to establish digital health records for all residents.” Often accompanying program coverage were testimonies describing life-saving diagnostics due to this program. Despite being officially voluntary, some program participants described feeling pressured to undergo the medical checks. The Guardian reported numerous stories in local newspapers that encouraged officials to convince people to participate. 

Once a person decided to participate and medical information had been taken from them, the information was stored and linked to the individual’s national identification number. Certainly, questions concerning the coercive and secretive nature of the campaign arise as the government is collecting a whole population’s biodata, including DNA, under the auspices of a free healthcare program. In addition, this is a gross violation of human rights, which requires the free and informed consent of patients prior to medical interventions. The case is especially troublesome as it pertains to Uighurs, a Muslim minority that has been facing pressures from China since the early 20th century, when they briefly declared independence. China is holding around million Uighurs in “massive internment camps,” which China refers to as “re-education camps” (see Meredith McFadden’s “Uighur Re-education and Freedom of Conscience” for discussion). According to The New York Times, several human rights groups and Uighurs pointed to the fact that Chinese DNA collection may be used “to chase down any Uighurs who resist conforming to the campaign.” 

To be able to ensure the success of this campaign police in Xinjiang bought DNA sequencers from the US company Thermo Fisher Scientific. When asked to respond to the apparent misuse of their DNA sequencers, the company said that they are not responsible for the ways the technology they are producing is being used, and that they expect all their customers to act in accordance with appropriate regulation. Human Rights Watch has been vocal in demanding responsibility from Thermo Fisher Scientific, claiming that the company has a responsibility to avoid facilitating human rights violations, and that the company has an obligation to investigate misuse of their products and potentially suspend future sales.

Should transnational actors, especially those providing technology such as Thermo Fisher Scientific, have a moral responsibility to cease sale of their product if it is being used for “immoral” purposes? One could claim that a company that operates in a democratic country, and is therefore required to follow certain certain ethical guidelines, should act to enforce those same guidelines among their clientele. Otherwise they are not actually abiding by our agreed-upon rules. Other positions may demand the company’s moral responsibility on the basis of obligations that companies have to society. These principles are often outlined in company’s handbooks, and used to keep them accountable. These often stem from convictions about intrinsic moral worth or the duty to do no harm.

On the other hand, others may claim that a company is not responsible for the use to which others put their goods. These companies’ primary duty is to their shareholders; they are profit-driven actors which have an obligation to pursue that which is most useful to itself, and not the broader community. They operate in a free-market economy that ought not be constrained simply as a matter of feasibility. As Thermo Fisher Scientific notes, “given the global nature of [their] operations, it is not possible for [them] to monitor the use or application of all products [they’ve] manufactured.” It may be that a company should only be expected to abide by the rules of the country it operates in, with the expectation that all customers “act in accordance with appropriate regulations and industry-standard best practices.”

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The Inherent Conflict in Informed Consent

photograph of doctor's shingle with caduceus image

A recent study has drawn attention to the relatively poor medical reasoning capabilities of terminally-ill patients. These groups continue to show a marked lack of understanding of their condition and their future care. More concerning, perhaps, is the study’s finding that medical staff consistently failed to recognize these deficiencies in competence. Ultimately, the study supports mounting evidence that the bright line we draw to separate individual autonomy from institutional paternalism is too simplistic. Patient competence is overestimated and physicians’ impact is underappreciated. And this has important implications for how we see informed consent.

Informed consent is a process, made up of the many communications between a doctor and a patient (or clinical investigator and research participant). Details regarding the purpose, benefits, and risks of, as well as alternatives to, a given treatment are relayed so as to enable potential clients to deliberate and decide whether the medical intervention offered aligns with their interests. As a patient has all the freedom to decide what should or should not happen to her body prior to undergoing a clinical trial or medical procedure, the decision is to be made free from coercion; the doctor acts so as to facilitate patient decision-making. Achieving this requires adequate, accurate information be provided in terms the patient can easily understand.

Legally, informed consent represents a basic threshold of competency that a patient must be assisted in meeting in order to legally acquiesce to a medical procedure. It exists to safeguard bodily integrity — the right of self-determination over our bodies. It grants legal permission and protects healthcare providers from liability.

Morally, informed consent is a compromise between epistemic merits and welfare interests. Informed consent balances doctors’ medical expertise against patients’ unique knowledge of their preferences. While physicians might know best how to treat injury and combat afflictions, they are less equipped to make determinations about the kind of risks a patient is willing to take or the value she might place on different health outcomes. As patients must live with the consequences of whatever decision is made, we tend to privilege patient autonomy. Once properly informed, we believe that the patient is best-positioned to determine the most suitable course of treatment.

The trouble, as studies like this show, is that patients are not the autonomous healthcare consumers we assume them to be. They are often dependent on the doctor’s expertise and medical advice as many suffer from some combination of informational overload and emotional overwhelm. Patients’ weak grasp of their medical prognosis is offset only by the trust they have in their physician and a general deference to authority.

This means that informed consent is, in many cases, simply not possible. Patients who are very young, very ill, mentally impaired, or even merely confused are not capable of demonstrating sufficient competence or granting meaningful permission. Unfortunately, patient literacy is overestimated, communication barriers go undetected, and patient misunderstanding and noncompliance continues. Findings suggest that thorough assessment of patient competence is rare, and patients’ comprehension is questioned only when their choice deviates from the physician’s recommendations.

An increased focus on patient education may not be enough to combat these problems. Efforts to present information in a more accessible manner may bring some improvement, but there are many medical situations where the sheer complexity or volume of the information involved outstrips the decision-making capacity of everyday patients. Some types of medical information, like risk assessments, use probability estimates that would require formal training to fully appreciate and thus overburden patients’ capacity to adequately comprehend and reasonably deliberate. In such cases, no amount of dialogue would allow a patient to attain the understanding necessary for informed decision-making.

In the end, the possibility of an equitable doctor/patient consultation is rarely a reality. As Oonagh Corrigan explains,

There needs to be a realisation that the type of illness a patient is suffering from, her anxiety about the likely trajectory of her illness, her expectations about treatment and, in general, her implicit trust in the doctor and medical science mean that ‘informed choices’ based on an adequate understanding of the information and on careful consideration of the potential benefits and risks, are difficult to achieve in practice.

We cannot maintain our idealistic divide between autonomous decision‐making on the one hand, and autocratic paternalism on the other. From framing effects to geographic bias, a physician is bound to have a greater hand in decision-making than our common conception of the dynamic allows.

Some may say that the trouble is sufficiently curtailed by the Hippocratic Oath. A doctor’s duty to the health of a patient is thought to limit the possibility of abuse. But the physician’s obligation to do no harm offers little guidance on the ground. The duties of nonmaleficence and beneficence share no necessary tie to the particular social and cultural values of patients. They would, for example, recommend the administering of blood transfusions to patients whose deeply-held religious beliefs disallow it.

Finding a suitable middle ground between individual autonomy and institutional paternalism is particularly tricky. The territory of informed consent is already a political battleground. One need look no further than the dispute concerning mandatory pre-abortion counseling or talk therapy for transgender patients. While we may wish physicians to take a larger role in the care of those who genuinely lack capacity, this would inevitably lead to the silencing of legitimate interests. Any acceptable resolution of this tension is bound to be hard-won.