Noninvasive prenatal testing and sex-selection abortion

By Steve Phillips

The National Health Service in Great Britain has decided to implement the use of noninvasive prenatal testing (NIPT) and that has raised some concerns. It would seem natural for there to be concern about this test used to detect prenatal genetic conditions such as Down syndrome, which commonly leads to the choice to abort the fetuses with those conditions. However, according to a recent article in The Conversation by Jeremy Williams one of the major concerns is the use of this technique to facilitate sex-selection abortion. Williams states that one of the major political parties has proposed a policy of banning the use of NIPT for sex determination and has described sex-selective abortion as “incredibly unethical”.

Williams concedes that the idea that sex-selection abortion is morally wrong and ought to be prevented is widely held even by those who otherwise have no moral objection to abortion but suggests that taking that position is problematic for those who believe that a woman has a right to choose to have an abortion. Williams lists several reason that people give for why the sex-selection abortion is wrong. These include idea that sex selection abortions are done due to a trivial preference, concern that sex selection abortion constitutes unjust discrimination against female fetuses, concern about women being coerced into this type of abortion, and that it teaches that the lives of girls are not as important as boys. He is concerned that if these reasons are accepted they would apply more broadly than to just this one type of abortion, and he is right. Many abortions are done for reasons that seem trivial compared to the value of the life of the fetus. Any abortion that is done because of the characteristics of the fetus, including having a genetic disorder such as Down syndrome, are both unjust discrimination against those who have such a disorder and express a message that people who have such a disorder do not have the same value as those who do not. Many women are pressured into having abortions, and do not actually freely choose them.

The problem with what Williams has written is that sex-selection abortion is just clearly wrong. It is wrong to kill a fetus because that fetus is female and end the life of the girl and woman who that fetus would have become just because she is female. That is a clear violation of women’s rights. The fact that this helps us see that abortions in other situations are also clear violations of more universal human rights should make people question whether those abortions are also wrong. It does not mean that sex selection abortion is permissible.

Avoiding advanced dementia, part 2

By Steve Phillips

Last week I wrote about one of my moral concerns regarding Norman Cantor’s proposal to avoid advanced dementia, which he views as being intolerably degrading, by using an advance directive stating that when he reached a certain level of dementia he no longer wanted to eat or drink so that his death would result. My concern with this was that the person caring for him would have to concur with him that his life at that time was no longer worth living in order to justify following his directive and cease to feed him and give him fluids to drink. An independent assessment that another person’s life is not worth living is required of any physician or other caregiver who participates in euthanasia or assisted suicide. Such a determination that another person’s life is not worth living is something that we should never do and the need for that determination is a fundamental reason why euthanasia is not permissible.

Dena Davis in her article “Avoiding Dementia, Causing Moral Distress” agrees with Cantor that a person ought to be able to use an advance directive to end his own life to avoid advanced dementia, but sees a flaw in Cantor’s plan. She writes, “As long as the demented person is enjoying her diminished life, it will be psychologically and emotionally difficult, perhaps impossible, for most people to withhold food or even simple medical interventions. Even if they believe they ought to comply with the advance directive, the moral distress is simply too great.” She concludes that since a person cannot rely on others to follow an advance directive like Cantor’s, the only way to avoid advanced dementia is preemptive suicide. The article “A Debate over ‘Rational Suicide’” in the New York Times describes 80-year-old Robert Shoots doing just that.

My second concern is that it is wrong for us to choose to end our own life by rational suicide even if no one else participates in that act. Autonomy and personal liberty are important, but there are some things that can be wrong to do even to ourselves. This is easier to see from a Christian perspective. Christians understand that our lives belong to God and we do not have the authority to end our lives. That authority belongs to God alone. We have been commanded not to kill any innocent human being because we have all been made in the image of God. That includes a command not to end our own lives.

It can be harder for someone who does not understand that his life belongs to God and has value because he has been made in God’s image to see why rational suicide would be wrong. However, all of us are relational beings. We are connected to our families and the rest of humanity. What we do to ourselves impacts others. Those who contemplate rational suicide to avoid things such as advanced dementia forget how their deaths impact others. They have a desire to avoid a part of life they do not want to live and may want to relieve those who love them from the burden of caring for them but caring for those we love when they become dependent is an opportunity for us to be more fully human. Caring for a loved one with dementia is very hard but is one of the ultimate expressions of human love. We should not take that away from those who love us.

Getting the Best Possible Organs for the Rest of Us

By Mark McQuain

A recent September 6th Perspective in the NEJM entitled “Voluntary Euthanasia – Implications for Organ Donation” teases with the following lead-in:“Canada now permits physicians to hasten the death of a patient by means of physician-assisted suicide or voluntary euthanasia. This development creates a new pathway for organ donation – and with it, some challenges.” Kudos to the NEJM marketing department for luring me into finally buying a full subscription. I’ll summarize some key points for those without a subscription.

The article begins by summarizing some differences between the comatose patient receiving end-of-life care in a standard ICU environment and the situation of individual intending voluntary euthanasia in a hospital. Healthcare teams may rely on surrogate decision making in the first instance but require first person consent in the euthanasia instance. Also, use of sedatives and analgesics in traditional end of life care are guided by the doctrine of double effect (intending comfort but not death) whereas physicians are not legally required to titrate those same medications in the instance of voluntary euthanasia (where euthanasia is legal). These issues are effectively the non-controversial portion of the article.

The heart of the article dealt with what one ought to do in the situation of a patient who wants to donate his or her organs “in the best condition possible” while receiving voluntary euthanasia. This would involve “procuring the patient’s organs in the same way that organs are procured from brain-dead patients (with the use of general anesthesia to ensure the patient’s comfort).”

The problem is that these patients aren’t brain dead yet. The authors are frustrated that awaiting brain death, even in voluntary euthanasia, results in sub-optimal quality of the donor organs. Harvesting organs from voluntarily euthanized patients before they are brain-dead “would require an amendment to the Criminal Code of Canada, which defines medical assistance in dying as the administration of a ‘substance’ by a qualified provider. By this definition, organ retrieval is not an accepted cause of death.” (N.B.- Though it most certainly is the cause of death!)

For those unable to retrieve the NEJM article, I offer a similar article by Dominic Wilkinson and Julian Savulescu supporting the same ethical argument (that it is OK to cause the death of an individual by harvesting their organs if they wished voluntary euthanasia). They summarize Dr. Robert Truog’s bioethical position (one of the authors of the present NEJM article) in footnote 66 as follows:

“Truog’s justification for ODE [Organ Donation Euthanasia] is different from that presented here [in our paper]. He argues that current concepts of brain death and the dead-donor rule are incoherent, and he proposes an alternative based upon the principles of autonomy and non-maleficence. We find Truog’s arguments compelling. Our paper can be seen as providing a complementary argument in favour of ODE. Truog favours a narrow definition for the group of patients who may consent to this procedure: only those who will die within minutes of withdrawal of life support, or who are permanently unconscious. Our definition of LSW [Life Support Withdrawal] donors overlaps with Truog’s, but includes the larger group of patients from whom it is permissible to withdraw life support in intensive care, and whose death is highly likely to ensue (though not necessarily instantly).”

To be blunt, what both groups are arguing is that it should be OK to surgically remove organs from an individual who is not brain dead though has already consented to voluntary euthanasia, knowing that the surgical removal of the organs will cause the immediate death of the individual. The priority of marrying euthanasia and organ donation is obtaining the best possible organs for the rest of us.

As a counter argument, I again turn to Wesley Smith for his thoughts in a recent National Review article similarly entitled “Canada Conjoining Euthanasia/Organ Donation”. It is short and to the point.

I must concur with Wesley Smith: The slippery slope of euthanasia is getting more slippery. How long before we grease those skids further by paying for the organs so harvested?

Avoiding advanced dementia

By Stephen Phillips

Norman Cantor has prompted widespread discussion with his recent article “On Avoiding Deep Dementia” in the Hastings Center Report (link is to the abstract only). In his article he states that he finds the possibility of living through progressive cognitive dysfunction and helplessness an intolerably degrading prospect. As a result, he has proposed using an advance directive stating that when he would reach a certain level of cognitive impairment, which would include having lost the capacity to make his own medical decisions, his advance decision to voluntarily stop eating and drinking would be implemented resulting in his death. He argues that it would be morally proper for those caring for him at that point to follow his prior instructions even if he showed no appearance of suffering at that point in his life.

There are many moral concerns related to Cantor’s proposal. I would like to address two concerns. Today I will address a concern that his proposal has in common with any form of euthanasia or assisted suicide that requires the assistance of someone other than the person who is choosing to die. In a later post I will address the issue of true rational suicide in which no assistance from a second party is required.

By proposing a strategy for avoiding advanced dementia that involves waiting until after he is unable to make decisions on his own, Cantor has required that someone other than himself who is providing care for him must implement his instructions. He sees that as respect for his autonomy, but whenever a second person enters into an act of euthanasia that person must make an independent decision that it is reasonable to agree that the life of the person who is to die is not worth living. This is true whether the act that is being requested of them is active euthanasia, assisted suicide, or cessation of eating and drinking. We are not morally obligated to do anything that another person requests of us. One qualification for fulfilling a request from another is that the request be reasonable. If there are any circumstances under which it is morally permissible to participate in ending another person’s life it could only be when that person’s life is no longer worth living. While it might be maintained that a person could make that determination about his or her own life, anyone assisting in that death needs to make an independent decision that the person’s life is not worth living in order to determine that this is a reasonable request which should be granted. However, we should never make a determination that another person’s life is not worth living. Our concepts of human equality, universal human rights, and justice all depend on the idea that every human life has value. All of that is undermined if we can say that there are some human lives that no longer have value.

Cantor’s proposal requires that someone caring for him after he has been become unable to make his own decisions agree with his previous determination that when his dementia reached that point his life would no longer be worth living and should be ended. That is something that we should never do.

Reducing Abortion Regardless of Roe v. Wade

By Mark McQuain

The selection of the next Supreme Court Justice has perhaps naturally unleashed a flurry of op-eds describing the post-apocalyptic world that will result from any partial or complete reversal of Roe v. Wade. In the July 18th, 2018 Perspective in the NEJM, Dr. Julie Ingelfinger offers the tragic case of a foreign nursing student she befriended while both were training in New York in the late 1960s. The student was finishing her final nursing year and was engaged to be married when she became pregnant despite the use of contraceptives. Per Dr. Ingelfinger, neither the student nor fiancé had “the means to provide for a baby, so they reluctantly decided that terminating the pregnancy was the only choice.” The only abortion option available at that time, pre-Roe v. Wade, was a “back-alley abortion.” After the abortion, the student developed sepsis, resulting in a hysterectomy and kidney failure. Dr. Ingelfinger oversaw the dialysis and despite appropriate medical care, the student died suddenly from complications of the dialysis. Dr. Ingelfinger’s reason for sharing this story now is to remind us that back-alley abortions resulted in similar complications in many other young women pre-Roe v. Wade and warn that if Roe v. Wade is overturned in the future, young women seeking abortion will again suffer the same fate as her nursing student friend.

In a similar vein to Dr. Ingelfinger’s editorial, there is a second op-ed on CNN website on May 5, 2018 by Danielle Campoamor entitled “Why Supporting Abortion is a Pro-Life Position”. She fears any future restrictions in Roe v. Wade will result in the suffering or death of young women seeking an abortion and wants everyone to have the “safe, affordable and relatively easy abortion” that she experienced:

“I wasn’t subjected to mandatory waiting periods, forced counseling or an abortion provider required to regurgitate state-mandated, inaccurate information. I didn’t have to travel long distances, worry I was getting there too late in the pregnancy, find money to pay for child care or walk past angry or intrusive protesters. Instead, I went in pregnant and, a few hours later, came out with my future back in my control.”

In both articles, the focus is unilaterally on the health and life of the mother. Ms. Campoamor’s position is easily challenged, if not decimated, by including the health and life of the baby in her calculus. Dr. Ingelfinger’s premise requires more unpacking.

Her position appears to be that all future unwanted pregnancies in an overturned-Roe v. Wade world would require a pre-Roe v. Wade “back-alley” surgical abortion. Many Latin American countries have never legalized abortion yet their illegal abortion fatalities have dropped as medical abortifacients (morning after pills) have replaced surgical abortion methods. Interestingly, both the author of the previously linked article on the Latin American experience and Dr. Ingelfinger cited economics (and not legality) as a main reason for choosing abortion. Analysis of the statistics on why women in the US choose to abort challenges this assertion. A clear understanding of these statistics might help identify strategies that lead to a voluntary reduction in the number of abortions, absent changes in the legal status of abortion.

There is a nearly 15-fold increased risk to carry a baby to full-term than it is to have an elective abortion. We have “successfully” divorced sexual activity from the risk and responsibility of bearing and rearing a child, as long as we are willing to use abortion as the definitive stop gap in maintaining our birth control. From my standpoint, this success and this control has come at a terrible price, namely the deaths of over 60 million babies in the US alone. Sadly, I pessimistically do not believe that there will be a meaningful change in the Federal law regarding abortion, regardless of who becomes our next Supreme Court Justice (link requires subscription). There are simply too many women and men who have come to rely upon the type of control of their future activities that abortion provides. Therefore, I ask Dr. Ingelfinger, Ms. Campoamor and all of those on the other side of the abortion divide: must all unwanted pregnancies end in abortion (medical or surgical), regardless of the status of Roe v. Wade?

The Benefits of your local Medical Ethics Committee Consultation

By Mark McQuain

No doctor or hospital system is perfect and, frankly, no one would ever claim to be. Regardless, we hold some medical facilities in very high regard simply because of the consistency of their record of care. One such place is the Mayo Clinic in Rochester, Minnesota. So, it was somewhat of a surprise to see a CNN headline featuring a complicated medical ethics issue gone awry. The story is long and admittedly somewhat one-sided, with more she said than he said. Still, the story as told is instructive by reminding everyone that medical ethics cases are complex, and it is usually best never to “go it alone”.

Briefly, in 2016, a 18-year-old young woman with a brain aneursym was transfered to the Mayo Clinic for urgent surgical treatment. Her surgery went well. The problems did not really begin until she was recovering on the inpatient rehabilitation unit. The patient and family became dissatisfied with her care. The staff believed that the patient was unable to make informed medical decisions due to alleged changes in her cognitive status as a result of treating the brain aneurysm and rather than appoint a family surrogate, began the long complicated process of trying to arrange for third-party guardianship. The mother and stepfather, in advocating for their daughter, came into conflict with the rehabilitation staff, resulting in the mother being banned from the hospital. The staff reached out to the biological father but he declined to become involved. The staff apparently believed the family to be unreliable and began a process to acquire a third party guardian to assist the patient with her medical decisions. The family and patient came to feel the patient was imprisoned against her will. The patient and her family eventually arranged “her escape” after which the rehabilitation staff called the police, claiming the patient was “abducted”. The patient has and is continuing to recover apart from Mayo. The legal issues remain.

Medical ethicists who have reviewed the details of the case agree on at least one detail: Mayo should have utilized their medical ethics committee to assist in determining how best to handle the patient’s possible lack of medical-decision-making ability, and in determining who might best serve as the patient’s surrogate if such was needed. Most medical providers have become involved in contentious medical decision making, where the patient and/or family comes to disagree with a recommended treatment plan by the medical staff. Involving the hospital’s medical ethics committee can be an excellent resource to regain dialog with the patient and family, and hopefully come to a medical decision that best benefits the patient.

Human limitation and ethics

By Steve Phillips

I recently read Cody Chambers’ article “The Concept of Limitation in Emil Brunner’s Ethics” in Ethics in Conversation from the Kirby Laing Institute for Christian Ethics. The article is well done and you need to read it to get the full impact of what he has said. What resonated with me was the idea that being limited is a part of what it means to be human and that our limitations are essential for our relationship with God and each other. It is our limitedness that helps us see that we need both God and other people and that we were made for those relationships. This is central to ethics because it is in our relationships with God and other people that we find our understanding of what ethics is.

This understanding that we are in our nature limited beings created by an unlimited God could not be more different from the conception of human beings held by many in the culture around us. They desire to see human beings and particularly themselves as having unlimited potential and freedom with no creator at all. That desire for personal freedom dominates contemporary ethics and shows itself in all areas of bioethics.

Chambers looks at how this impacts thinking about gene editing. Those who advocate doing human germline genetic modification see it as the freedom to create a child who is made to be what the parents creating the child desire the child to be. This is usually expressed in terms of creating a child free from genetic disease, but there are simpler ways to have a child without a disease carried by the parents (including adoption). It is ultimately the desire to be free of natural human reproductive limitations and create a child we have designed and chosen. Being limited helps us to see that we need each other and must respect others, including our children, as they have been made by God. Our natural lack of control over the characteristics of our children leads to an understanding that those children are a gift from God that we should accept unconditionally. Using technology to try to take control of the creation of our children leads to creating children that will fulfill our desires and a loss of the unconditional acceptance that is the foundation of a positive parent-child relationship.

Freedom in the proper context is good. The desire for unlimited freedom leads to putting ourselves above others and ultimately controlling and subjugating others, including our children, to our desires. Proper ethics requires an understanding that our freedom is limited.

The Cost of Getting RNA to Mumble

By Mark McQuain

In my previous blog entry, I crudely summarized the genetic basis for Duchenne Muscular Dystrophy (DMD) and one pharmaceutical company’s (Sarepta) current effort to research, manufacture and finance a genetic treatment that increases the production of a muscle protein missing in patients with DMD called dystrophin. Please see my previous blog entry for that summary or this article for a more detailed thorough overview of the science and investigational process to date. For this blog entry, I want to consider the bioethics of the cost of Sarepta’s treatment eteplirsen (Exondys 51), currently estimated on average to be around $300,000 per year.

DMD is a devastating disease that generally causes the patient’s death by his mid-twenties but it only affects a very small number of boys and young men worldwide, estimated to be around 400-600 newborn males in the US each year. This small number of patients places medications for DMD in a category called Orphan Drugs, those that benefit fewer than 200,00 people per year. Eteplirsen is only beneficial in the 15% of DMD patients that have the specific RNA defect in dystophin protein production that eteplirsen corrects. Back-of-the napkin calculations mean that if 15% of all 600 boys born in the US every year with DMD (90 boys per year) used Sarepta’s $300,000-per-year drug, that is a $27 million increase in revenue (not profit) to Sarepta each year. While that sounds huge, it ignores the massive expensive cost barriers to bringing such a drug to market, including research, investigational studies to gain FDA approval and legal financial risk with future adverse effects yet unknown. Inability to gain FDA approval prohibits access to capital markets necessary to fund such a process. Were it not for grants available for orphan drugs, it is unlikely that eteplirsen would exist. Better for drug makers to target their R&D to a bigger disease market for the chance of a bigger reward (consider Bayer aspirin and their $3.3 BILLION profit in 2011 alone).

There are calls for Sarepta to “give back” some of their potential future income, calls from the very organizations that were their staunchest supporters in their FDA approval process. Strong ethical arguments are made that the company did benefit early on by using federal grants and this alone should require the company to reduce a portion of their future income by lowing the cost to patients. Calls for the FDA to federalize Sarepta’s patents and take government ownership will most certainly go unheeded as that would cause every other orphan drug manufacturer to immediately discontinue any further financial risk for fear of similar confiscation.

There are, however, opportunity costs beyond the financial. Some would say that the FDA approved eteplirsen with extremely flimsy data, as less than 10 boys showed borderline promising results when the drug was approved in November 2016. That FDA approval allowed Sarepta to survive as a company. Per the editorial board at the Wall Street Journal(subscription needed):

“But if FDA had cashiered that therapy, Sarepta would have lacked the resources to continue its research and testing to treat Duchenne and develop what may be an even better drug. If eteplirsen had failed to get approval, dollars and brain power would inevitably have flowed toward treating other diseases with more promise of success. FDA has tremendous influence over private investment.”

Indeed Sarepta has new genetic treatments in the pipeline which reportedly do provide increased levels of dystrophin, even for RNA patterns beyond what eteplirsen can presently correct. Have the ends justified the means? Presently, for DMD patients, despite the $300K yearly price tag for eteplirsen, that answer may be – yes. Sadly, there are no other currently functional treatment options for DMD – yet.

From a public health standpoint (and a public funding standpoint), orphan drugs for treatment of small population diseases like DMD are non-starters. Is the only answer to provide the opportunity for great financial reward to encourage individuals to assume all of the private risk?

Every Day is a Gift

By Neil Skjoldal

Into the genre of news reports about physician assisted suicide comes a powerful piece from The Washington Post.   It is the story of J. J. Hanson who was diagnosed with a glioblastoma multiforme.  It traces his difficult journey as it relates to PAS.  Because of the poor prognosis, treatments at times seemed too difficult.  His wife Kristen reported that “he told her that if he had had the lethal dose of medication on his bedside during his darkest of days, he might have used it and then missed out on three more years with his family.”  Her hopes now, since her husband’s death last year, are that lawmakers will “work to improve hospice and palliative care for patients” and “to encourage terminally ill patients to have hope and families to enjoy every moment they have together.”

I am aware that a story such as the Hanson’s will not convince those who are strongly committed to PAS. The argument would be something like, “That’s ok for him.  He died his way, just give me the freedom to die in my way.”  But, at the very least, this story provides a counter-narrative to some PAS advocates, who almost by default go to “I know a person who died very poorly and I want to stop that by helping them end their suffering.”

My observation in talking to people about this subject is that their greatest fear is dying with horrible suffering. Almost everyone can re-tell the story of a friend or loved one that died in this way.  For those of us who think that PAS creates many more ethical problems than it solves, our focus needs to be, as Kristen Hanson suggests, to continue to improve hospice and palliative care.  I am grateful for her courage in telling her story and am reminded that every moment of life should be precious to us.

Public input into gene-editing decisions

Lyme disease is caused by a type of bacteria that lives in mice, which are considered a “reservoir” for the disease-causing agent.  Ticks bite the mice, pick up the bacteria, and then infect people when they bite them.  (Ticks are called the “vector” for the disease.)

If mice were immune to the bacteria, their immune systems would destroy them, and there’s be no reservoir, and no Lyme disease.  If scientists genetically engineered mice to make them immune—for example, by editing their genes—they could make progress toward that goal.  But to work, the mouse population would have to be predominantly made of bacteria-immune mice.  That could be accomplished by using “gene drive,” an approach that would make the altered gene spread preferentially and rapidly in the population.  However, doing that could alter the environment in unpredictable ways.

Because of the risks, scientists on the “Mice Against Ticks” project are determined that even if they succeed in genetically altering mice as suggested, they will not release those mice into the wild without full public awareness and approval.  They are holding public meetings—specifically, in Martha’s Vineyard and Nantucket—well in advance of the project coming to full fruition.  And they are trying to figure out, with the public, what level of communication and acceptance constitutes public approval.

Similarly, scientists in New Zealand would like to use a form of gene drive to greatly reduce the population of rats, possums, and other destructive predators that are decimating the environment.  And their public deliberations include seeking advice and, before taking action, buy-in from a network of Maori leaders.  Those conversations are so sensitive that the Maori objected when the scientists published a “what-if” type of article discussing the issues raised by the technology.  Among the concerns: some readers got the impression that gene editing of the animals was imminent, not hypothetical, as it still is.  Some of the news coverage of the Nuffield Council’s recent deliberations about the potential acceptability of heritable human gene editing seemed, likewise, to create the impression that the birth of the first gene-edited human is upon us—which it is not, not quite yet.

The public discussions above are two commendable moves toward true public involvement in decision-making about gene editing.  They were described in a recent Wall Street Journal article.  If you have subscription access, by all means read it.