Sometimes patients who lack decision-making capacity refuse treatment that would be in their best interests. Imagine, for example, a patient suffering from acute schizophrenia who adamantly and persistently refuses to take antipsychotic medication that would relieve his symptoms. And suppose, further, that this patient poses no danger to himself or others, but that his mental illness prevents him from understanding his diagnosis as well as his likely prognosis with and without the treatment. Should a provider treat such a patient over his objections?
My reflections begin with the observation that in most cases of this kind, physicians tend to respect the patient’s incapacitated refusal, either by honoring it, or, at the very least, by treating it with great seriousness. Why? The simple answer is a legal one: in New York and many other states, it is against the law to treat patients over their objections except in cases in which the treatment will prevent them from endangering themselves or others. My interest here, though, is ethical rather than legal: what ethical justification can we offer for this practice?
Answering this question is challenging in part because honoring incapacitated refusals is not obviously justifiable by appeal to any of Beauchamp and Childress’s famous four principles of biomedical ethics: The decision to honor an incapacitated refusal has nothing to do with the fair distribution of benefits and burdens, and so it is not a matter of justice. Nor can it be justified by appeal to beneficence or non-maleficence, as allowing the patient to forgo treatment would make him worse off. The principle of autonomy does not provide support for honoring the refusal, either, at least on a classical understanding of “autonomy.” This is because autonomy is traditionally understood to involve more than the mere ability to do what one happens to want at a given moment. Rather, autonomy is a matter of rational self-governance: it requires a baseline level of understanding of one’s situation, one’s options, and the possible consequences of selecting one of those options. The right of autonomy is a right to make otherwise permissible decisions without the influence of distorting factors, such as intoxicating drugs, false and misleading information, and coercive threats. Severe mental illness is one of these distorting factors insofar as it prevents a patient from making informed decisions that express his values. In the case I began with, the patient did not understand either his diagnosis or his prognosis, he did not have a good grasp of his options, and he was in no position to weigh different courses of treatment and assess their compatibility with his goals and ideals. Indeed, we may even suppose that treating such a patient over his objections would be the only way to restore his capacity for autonomous self-governance.
To be clear, I am not making the case that we ought to override all incapacitated refusals. I do not believe that we should. My point here is that strict adherence to the four-principle model would make it seem as though we obviously should. After all, beneficence would strongly recommend overriding an incapacitated patient’s wishes, and none of the other principles would recommend honoring them. But this apparent clarity is a mirage: the choice of whether to honor incapacitated refusals is plainly a difficult one, and this difficulty is reflected in the seriousness with which our practice and law approach them. Indeed, in their handbook, Addressing Patient-Centered Issues in Health Care, the American Society for Bioethics and Humanities explains that the strenuous objections of incapacitated patients “should be given ethical weight, and sometimes considerable, or even definitive weight.”
This weightiness is evidence of an unexposed value. Like autonomy, this value seems to demand a kind of interpersonal respect. Unlike autonomy, the capacity we are supposed to value and respect is not a capacity for self-governance in light of a basic understanding of relevant information and one’s goals. Whether one articulates this hidden value as a novel “form” of autonomy that has nothing to do with informed self-governance, or as something altogether new, is not important. No matter what we call it, we must explain exactly what this value is and why we ought to take it seriously. That is the heart of the challenge.
This is a task that I am beginning to undertake as part of my research here at AMBI. By the time I write my next blog post, I hope to be able to share at least some progress toward an answer.
In recent years HIV prevention science has been revolutionized by the realization that some of the drugs originally approved to treat HIV infection are also very effective at preventing HIV infection in people considered at high risk, such as those with HIV-positive partners. Known as “pre-exposure prophylaxis” or “PreP”, the HIV medication Truvada (tenofivir plus an older antiviral called emtricitabine) is now taken on a daily basis by millions of people worldwide in order to prevent HIV infection. While optimists see PreP as an important step on the road to “ending AIDS”, critics note that the drug’s $20,000-a-year price tag impedes adequate access both within the U.S. and globally.
On October 3, the politics of PreP became even more fraught when the FDA granted approval to a second HIV drug to be used preventatively – but only by men. “Descovy” is made by Gilead Sciences—the same pharmaceutical company that makes Truvada—and in fact differs from Truvada only slightly in its chemical structure. For reasons that Gilead has failed to make clear, the clinical trial of Descovy was conducted almost exclusively in men (transgender women made up about 1% of the 5400 person cohort). For this reason, the FDA refused to approve its use in “those who have receptive vaginal sex.”
The case of Descovy is ripe with some of the same ethical issues that have plagued HIV drug development since the epidemic began.
First, AIDS activists have been fighting pharmaceutical price-gouging since 1987, when members of the newly founded group ACT UP occupied the New York Stock Exchange to protest the high cost of AZT. Since then access to HIV medications has improved both domestically and globally due to generic competition and dedicated funding programs, but Truvada’s $20,000 price tag shows that companies are still willing and able to charge whatever the market will bear. Moreover, by all appearances Descovy’s FDA approval was timed to coincide with the 2020 expiry of the Truvada patent, thus allowing Gilead to charge what they will for a new PrEP formulation just as they lose market exclusivity on the old one. This is despite the fact that Descovy is neither a superior drug nor a new one. (The clinical trial showed that it was simply “non-inferior” to Truvada, and although it was only recently submitted for FDA approval, records show that it was invented no later than 2000.)
Secondly, women have fought for recognition from the AIDS scientific community (and the scientific research community more broadly) since the early days of the epidemic. Until 1993 the CDC’s list of “AIDS-defining illnesses” failed to include the gynecological conditions most often suffered by women with advanced HIV disease. In protest, the activist art collective Gran Fury made a poster quipping “Women Don’t Get AIDS, They Just Die From It” and posted it in bus shelters across New York City. HIV/AIDS is not the only scientific arena that has failed to include women in research. It was only in 2014 that the National Institutes of Health established a policy requiring its scientists to use both female and male animals and cells in their research. Many NIH-funded scientists, it turns out, prefer to use only male animals because they feel that the estrous cycles of females would muddy their results.
The ethical principle at stake here is justice. Both the high price of PrEP and the exclusion of women from PrEP (and other) trials are unjust, though in different ways. The pricing of PrEP represents a breach of social justice in that it contributes to an unequal society in which people’s physical well-being is determined by their ability to pay for life-saving medications. In other words, health is stratified by wealth. Unfortunately, this problem is hardly limited to HIV medications (got insulin? Millions don’t). In addition, the exclusion of women from the Descovy trial is an example of unjust research design, as it effectively prevents women from benefitting equally (or at all) from this research. Worldwide, the majority of adults living with HIV are women, and women also account for 48% of new HIV infections. Yet, a 2016 literature review found that women remain significantly underrepresented in HIV/AIDS trials, making up an average of only 19% of participants in trials of antiretroviral drugs. HIV medications—including tenofivir, the main ingredient in Truvada and Descovy—can metabolize differently in women versus men, and antivirals can also act differently in vaginal versus rectal mucosa, the two major avenues of sexual infection. In other words, there are clear epidemiological and biological reasons why HIV drug trials need to include women as well as men.
In the case of Descovy, it is unclear why a clinical trial of over 5000 people conducted across 93 locations in the U.S., Canada, and Western Europe didn’t face scrutiny earlier for its exclusion of cisgender women. Did Gilead feel that including women would “muddy” their results? Or are women simply a less lucrative drug market, given that most women at high risk for acquiring HIV live in low income countries where antiretroviral drugs are discounted or donated if they are available at all? The Gran Fury artists first made their sardonic protest poster in the early 1990s. Nearly 30 years later, why does Gilead still think “women don’t get AIDS”?
** This article was originally featured on the Genetic Literacy Project on October 1, 2019. This article, along with more information and additional links can be found at: https://geneticliteracyproject.org/2019/10/01/foxs-almost-family-vs-the-handmaidens-tale-sequel-the-testaments-different-takes-on-the-dangers-of-sperm-bank-donations/ . **
I'm dreading the debut of the Fox TV series Almost Family on October 2. In it, Julia Bechley discovers that her dying dad, a famous fertility doctor, had made dozens of personal DNA donations that are now millennials, at least two of whom have unknowingly hooked up.
Many of us in the donor-conceived (DC) community have already seen the series as the Australian show Sisters on Netflix. I hope the new incarnation changes the ending, which was the worst since the supposedly-dead Bobby Ewing appeared in the shower in the 1986 finale of the TV series Dallas and revealed that the entire season, in which he’d died, had been a dream.
The 2013 film Delivery Man preceded both versions of Dr. Bechley’s misadventures. In it, Vince Vaughan is the befuddled father of 533 twenty-somethings, thanks to long-ago sperm donations. A lot of them.
The danger of unintentional inbreeding
We hardly need fictional accounts of surprise insta-families. The situation is very real, thanks to a convergence of factors: poor regulation of assisted reproductive technologies over decades, the past prioritization of sperm donor privacy over offsprings’ right-to-know, and the rise of consumer DNA testing that probably no donors, and not even their doctors, ever imagined.
And so the media continues to spit out the stories, still with a tone of awe:
- “A growing family,” from the Associated Press, recently covered 31-year-old Morgan Richardson’s discovery of 15 half-siblings.
- The New York Times Magazine cover from June 30, 2019, displayed all 32 half-siblings of Eli Baden-Lasar, to accompany his photo essay “Brothers, Sisters, Strangers.”
- A class action lawsuit in Indianpolis is targeting a doctor who too widely spread his seed.
Well-meaning friends who know I’ve discovered six half-siblings over the past year send me these articles. I wish they wouldn’t. Not because they upset me anymore, but because the overactive sperm donor stories that make it to the media are a tiny tip of a non-melting, actually explosively growing, iceberg.
Judging from the half dozen private Facebook groups I’m in, and perusing the Donor Sibling Registry, it’s clear that we number in the tens of thousands, and perhaps an order of magnitude more.
The problem isn’t with sperm donation itself, which is after all a way to circumvent infertility, but with using sperm from a single man for too many recipients, because the anonymity introduces the possibility of dating one’s half sibling. And that could spawn inadvertent consanguinity (“shared blood”). Unintentional inbreeding.
When two people share a disease-causing recessive mutation inherited from a shared ancestor, like a great-grandparent, each of their potential kids has a 25% risk of inheriting the associated disease. It’s Mendel’s first law in action.
The anonymity of sperm donations robs the descendants of recipients of the choice not to have children with their blood relatives. A way to methodically avoid consanguinity is described in The Testaments, the sequel to Margaret Atwood’s classic 1998 novel The Handmaid’s Tale.
Gilead’s solution: good record-keeping
Gilead is centered in what was once Boston, with tentacles reaching up and down the east coast. People are assigned to rigidly defined classes by roles and occupations, and a few men rule to a horrific degree. With rampant infertility due to pollution, fertile young women serve as Handmaids to maintain the population.
Handmaids are forced into a red-draped, white-bonneted sameness and assigned to Commanders whose Wives (official castes are capped) haven’t conceived, and then are ritually raped during their fertile periods. The Wives watch and assist the sanctioned serial sexual assaults, then steal, own and raise the resulting children.
Sometimes Handmaids sneak off to become pregnant by someone else, such as a lowly male employee of the household, because if she doesn’t conceive within a year or so, she’s blamed, reassigned, and if that fails too, killed and hung on the Wall like others who disobey the law.
Because in Gilead the mommy isn’t the mommy and the daddy sometimes isn’t the daddy, someone has to track the genetics to avoid consanguinity.
The task of recording and maintaining the true genealogies, inscribed in volumes of the Bloodline Genealogical Archives in a locked room in a heavily guarded mausoleum-like building, falls to the Aunts, a select group of women who are allowed to read and think.
Explains Aunt Lydia:
It’s essential to record who is related to whom, both officially and in fact: due to the Handmaid system, a couple’s child may not be biologically related to the elite mother or even to the official father, for a desperate Handmaid is likely to seek impregnation however she may. It is our business to inform ourselves, since incest must be prevented: there are enough Unbabies already.
Unbabies are the unfortunate consequence of those recessive genes matching up, as well as other birth defects arising from the wrecked environment.
A particular concern is that the Commanders, generally older men, go through many Wives and beget many children. They find crude ways to bring early demise to the Wives, such as poisoning, frequently replacing them with younger models (Atwood claims never to write a scene that doesn’t actually happen).
A fresh, new Wife could, biologically speaking, be a Commander’s daughter. Or even a granddaughter.
“With so many older men marrying such young girls, Gilead could not risk the dangerous and sinful father-daughter inbreeding that might result if no one was keeping track,” Lydia writes in her journal, which forms one of three narrative threads of The Testaments, read from a distant future.
Inspiration from a religious community
Atwood’s Bloodline Genealogical Archives of Gilead may have borrowed from the “confidential premarital testing system” Dor Yeshorim (Hebrew for “upright generation”). The program screens potential partners for mutations in the same recessive genes responsible for diseases that are more prevalent in the Jewish population.
Holocaust survivor and rabbi Josef Ekstein began Dor Yeshorim in Brooklyn in 1983, following the birth of his third child to have inherited the devastating Tay-Sachs disease from the two carrier parents. Today, the organization has an international reach. The process identifies people by numbers, and carriers aren’t told what they carry, just with whom they shouldn’t procreate.
By 2010, more than 300,000 young people worldwide had taken carrier tests for an ever-expanding list of diseases through Dor Yeshorim, and more than 20,000 individuals are screened each year. Similar programs operate throughout the world. Call it eugenics or artificial selection, but Dor Yeshorim has practically vanquished certain devastating diseases.
A brief history of sperm donation
The Handmaids of Gilead knew when sex was being forced upon them. Everyone knew. But in a sickening example of truth being stranger than fiction, women who were artificially inseminated decades ago in the US to help them conceive sometimes didn’t know what was happening to them. Dani Shapiro details the practice in her book Inheritance: A Memoir of Genealogy, Paternity, and Love.
Which one is the dystopia?
In 1909, physician Addison Davis Hard published a letter in The Medical World detailing the insemination of a woman with “carefully selected seed.” He and six other medical students witnessed the event at Sansom Street hospital of Jefferson Medical College in Philadelphia in 1884 and were pledged to keep secret the “artificial impregnation.” The husband made no sperm.
Dr. Hard wrote:
The woman was chloroformed, and with a hard rubber syringe some fresh semen from the best-looking member of the class was deposited in the uterus, and the cervix slightly plugged with gauze. Neither the man nor the woman knew the nature of what had been done at the time, but subsequently the Professor repented of his action, and explained the whole matter to the husband.
The oblivious woman gave birth to a healthy boy, who grew up to become a businessman whom the good Dr. Hard reported having met.
The 1909 paper ends with the peculiar admonition that “the mother is the complete builder of the child,” and lists how her parts are echoed in the child. But this was just nine years after the rediscovery of Mendel’s work, a scientific achievement not nearly as celebrated as that of his contemporary, Charles Darwin. And it’s unlikely that the medical school professor performing the insemination in 1884 had read Mendel’s paper on peas, published in 1865.
I can even understand why physicians in 1953, when I was conceived, might not have considered the fact that each parent contributes half of the genetic material. Watson and Crick’s paper was published in April of that year and I apparently became an “artificially inseminated product” two months before that. I had no idea that I was and don’t even know if my mother knew.
But what was the excuse for ignorance of genetics in 1979?
That year, a seminal article in The New England Journal of Medicine reported a survey of 379 doctors who’d performed artificial insemination by donor in 1977, yielding 3,576 births. Some men indicated that they’d made multiple donations, the winner a man whose sperm impregnated 50 women. And the recipients tended to live in the same communities.
That study inspired the opening of the first sperm bank. Didn’t any medical professional think about what might happen if unknowing half-siblings married? A talk show host did.
I remember an episode of the Phil Donohue show from the 1980s featuring a few couples, from Chicago, who’d somehow found out they were half-siblings, long before spit-in-the-tube consumer DNA testing. They’d all partook of product from the Repository for Germinal Choice, a sperm bank in Escondido, California, that for a time collected, froze, and shipped deposits from Nobel Prizewinners.
Limiting sperm donations today
Although a quick perusal of sperm bank websites reveals that they nowadays try to limit availability of one man’s gametes to 25 to 30 women, the emphasis isn’t enough and the number is still unsettlingly high, because it doesn’t mirror normal human reproduction. Who normally has two dozen half siblings?
At the California Cryobank, the Policy of Offspring Limits states:
The maximum goal is 25-30 family units worldwide per donor. Each donor is limited by the length of time he remains active in the program. CCB also limits the total number of vials distributed and monitors pregnancy and birth reports to help maintain this goal.
The Cryos International Sperm & Egg Bank also limits distribution to 25, but will deliver sperm to a customer’s home! To share, all one needs is a turkey baste
A Catholic physician who invokes conscientious objection to refuse offering a legal service in a secular institution is legally protected from retaliation by their employer. However, a secular physician who attempts to invoke conscience legislation to provide a legal service in a Catholic institution is not legally protected. In the bioethics literature on conscientious objection, this is sometimes referred to as the asymmetry problem.
This is precisely the situation that has played out recently in Colorado where a veteran physician, Dr. Barbara Morris, was fired after suing her employer for the right to assist her patient, Cornelius Mahoney, in ending his life. The employer is Centura Health, a system jointly run by Catholic and Seventh-Day Adventist churches that believes physician aid in dying to be an intrinsically evil act even though it is now legal in Colorado. Dr. Morris sued the hospital on the grounds that its faith-based policy violates the law that now permits physicians to provide physician aid in dying.
Positive claims of conscience involve an insistence on performing some act, whereas negative claims of conscience involve a refusal to perform an act. Bioethicist Mark Wicclair has pointed out that, in health care, positive claims of conscience often align with liberal values (e.g., providing abortion, emergency contraception, physician aid in dying), whereas negative claims of conscience often align with conservative values (e.g., refusals to perform abortions, provide emergency contraception, or physician aid in dying). Given that positive claims of conscience tend to be asserted by those with liberal values, and negative claims asserted by those with conservative values, does the asymmetry problem represent a legal bias towards conservative over liberal values?
At first pass, this may seem like a straightforward case of unjustified bias, but there are important reasons to consider positive claims of conscience different from negative claims. The first reason involves the value integrity of the institution employing the physician. Secular hospitals committed to providing ethically controversial yet legal services to patients (e.g., abortion) are often able to accommodate conscientious refusals while upholding their commitment to providing a service. With good communication and some advanced planning, it is generally possible to locate another willing provider to step in and provide the service. However, it is not as easy for an institution to maintain value integrity if physicians are able to provide services the hospital conscientiously objects to. For a hospital that objects to physician aid in dying, if only one physician asserts a positive conscience claim to provide that service then the hospital is no longer able to uphold their values. A second reason to think positive claims of conscience are different from negative claims is that the hospital is forced to provide the resources by which the physician enacts physician aid in dying. Nothing stops a physician who believes in providing physician aid in dying from organizing with other like-minded individuals and opening a clinic that provides this service, but situations similar to what unfolded in Colorado ask institutions to provide physicians with the resources needed to perform an act with which the institution morally objects. Not only would the Catholic hospital be unable to uphold their value, it must pay for the service it objects to. These concerns show the asymmetry problem in conscientious objection may not be a case of simple bias but may be driven by substantive reasons why conscientious refusals are different from conscientious provisions.
However, there may be other reasons to consider constraining conscientious refusals, such as instances where refusal creates a significant barrier of access for the patient. In the Colorado case, the patient did not want to be referred to another institution because of the additional diagnostics, travel, and costs that would be encountered in the face of debilitating symptoms. Should burdens of access to legal medical services be considered when deciding how to respond to conscientious refusals, and, if so, how great of a burden is needed to justify what sort of limitations can be placed on a conscientious refusal?
Beyond these considerations, there is a range of additional issues looming over how to handle conscientious refusals in health care. Are those exercising a conscientious refusal obligated to inform or even refer patients for medical procedures they do not agree with? Should conscientious refusals be permitted in emergencies? Although conscientious refusals often focus on abortion or physician assisted suicide, what about other procedures, such as the provision of IVF or organ procurement? Should conscientious refusals only be permitted for procedures, or can a physician conscientiously refuse to treat a type of patient? For example, there have been cases of Muslim medical students refusing to see patients of the opposite sex, a physician who refused to treat democrats, and a group of physicians who objected to treating sexual dysfunction in convicted sex offenders. Should conscientious refusals need to satisfy a standard of reasonability, such as consistency with empirical facts or the goals of medicine? These questions show that these cases of conscientious objection are rarely straightforward, making the topic a place for lively discussion in bioethics now and likely for some time in the future.