AI and the Trolley Car Dilemma

I have always hated the Trolley Car dilemma. The god of that dilemma universe has decreed that either one person or five people will die as a result of an energetic trolley car and a track switch position that only you control. Leave the switch in place and five people are run over by the trolley. Pulling the switch veers the trolley onto an alternate track, successfully saving the original five people but causing the death of a different lone person on the alternate track. Your action or inaction in this horrific Rube Goldberg contraption contributes to the death of either one or five people. Most people I know feel some sort of angst at making their decision. MIT has a website that allows you to pull the switch, so to speak, on several different variations of this dilemma and see how you compare with others who have played this game, if you enjoy that sort of thing.

Kris Hammond, Professor of Computer Science and Journalism at Northwestern, believes a robot would handle the trolley car problem far better than a human since they can just “run the numbers and do the right thing”. Moreover, says Professor Hammond, though we “will need them to be able to explain themselves in all aspects of their reasoning and action…[,his] guess is that they will be able to explain themselves better than we do.” Later in the article he claims that it is the very lack of angst regarding the decision-making process that makes the robot superior, not to mention the fact that the robot, as in the case of self-driving cars, would avoid placing us in the dilemma in the first place by collectively being better drivers.

For the sake of today’s blog, I am willing to grant that second claim to focus on the first: Is there really lack of angst and, if so, does that lack contribute to making the robot’s decision right and therefore superior?

Currently, no robot has sufficient artificial intelligence that might allow for self-awareness sufficient to create angst. Essentially, a robot lacks independent agency and as such cannot be held morally accountable for any actions resulting from its programming. The robot’s programmer certainly does and can. Presumably (hopefully) the programmer would feel some angst, at least eventually, when he or she reviews the results of the robot’s behavior that resulted directly from his or her program. Is the displaced decision-making really advantageous? Is the calculus inherent in the encoded binary utilitarian logic really that simple?

Watson, IBM’s artificial intelligence system, can finally best some human chess grand masters. Chess is a rule-based game with a large but not infinite set of possible moves. Could a robot really be programmed to handle every single variation of the trolley car dilemma? Are the five individuals on the first track or the single individual on the second track pastors, thieves, or some weird combination of both, one of whom recently saved your life? Should any of that matter? Who gets to decide?

Trolley car dilemmas seem to demand utilitarian reasoning. Robots are arguably great at making fast binary decisions so if the utilitarian reasoning can be broken down into binary logic, a robot can make utilitarian decisions faster than humans, and certainly without experiencing human angst. Prof Hammond claims the robots will simply “run the numbers and do the right thing”. But the decisions are only right or superior if we say they are.

Utilitarian decision-making is great if everyone agrees on the utility assigned to every decision.  But this is clearly not the case, as the summary results on the MIT website clearly show.  Further, I think that most normal people have angst over their own decisions in situations like these, even inconsequential decisions offered on MIT’s harmless website.  So in the case of the robot, the angst doesn’t occur when the robot is actualizing its program – it occurred months or years ago when the programmer assigned values to his or her utilitarian decision matrix.

Were those the right values? (hint: there is angst here)
Who gets to decide? (hint: even more angst here)

Secular Bioethical Mumblings of The Supreme Court

In the blog yesterday, Neil Skjoldal reminded us that bioethics will likely again play a role in the upcoming nomination process of Judge Neil Gorsuch to be an Associate Justice on the Supreme Court of the United States (SCOTUS). Why is this the case? To paraphrase Professor H. Tristram Engelhardt, I believe it is due in part to the inability of moral strangers to resolve bioethical and moral controversies. Consider the following:

While it is often said that one cannot legislate morality on an individual level, SCOTUS clearly has the final say on whether a particular law is deemed either constitutional, and therefore permitted to stand, or unconstitutional and therefore struck down. This is important because laws permit or proscribe activity and behaviors that naturally reflect our individual and group morality. Laws pertaining to abortion, assisted suicide and euthanasia are a few bioethical examples. Since we live in a secular, multicultural nation, rulings of constitutionality by SCOTUS are effectively stipulations of or rulings on morality, and so long as “We the People” agree to follow the Constitution, we agree to be bound by the Court’s judgment.

I find support for this concept in the legal writings of the late Arthur Leff, former professor of law at Yale Law School. He held that normative law or morality cannot exist without a transcendent, unimpeachable source, namely God. Who decides what is right and wrong in His absence? Leff responded as follows in Unspeakable Ethics, Unnatural Law:

As long as the Constitution is accepted, or at least not overthrown, it successfully functions as a God would in a valid ethical system: its restrictions and accommodations govern. They could be other than they are, but they are what they are, and that is that. There will be, as with all divine pronouncements, a continuous controversy over what God says, but whatever the practical importance of the power to determine those questions, they are theoretically unthreatening. It is only when the Constitution ceases to be seen as fulfilling God’s normative role, ceases, that is, to be outside the normative system it normally constitutes, or when, as is impossible with a real God, it is seen to have “gaps,” that a crisis comes to exist. What “wins” when the Constitution will not say, or says two things at the same time? … [Or, put another way], much of the time one can act as if there is, for constitutional determinations, a God, though He may occasionally mumble.

This is crucial because the justices of the Supreme Court are the only ones in privileged positions to interpret those mumblings for the rest of us. What is more troublesome though not surprising is they often understand those mumblings very differently, always settling conflict over their varying interpretations by a simple majority vote. The fact that five individuals can overrule four others and set the legal environment for our nation’s bioethical landscape for their 324 million neighbors is reason enough to desire, if not demand, bioethical acuity in applicants for those positions.

In his book, The Foundations of Bioethics, Engelhardt repeatedly makes the case that moral strangers are not able to resolve moral controversies through “sound rational argument or an appeal to moral authority”¹ , but added later that “…the decisions of limited democracies can create structures of moral authority…[but that authority]…will provide no substantive, nonprocedural moral instruction.”² In the future, SCOTUS may determine a constitutional right to assisted suicide, so long as proper informed consent is obtained. The determination of the rightness or wrongness of the decision will be argued in procedural rather than moral terms. Per Engelhardt, there can be no other secular bioethical determination.

To restate the obvious: it matters who is interpreting our constitutional mumblings as they are grounding our secular bioethics.

 

¹ H. Tristram Engelhardt, Jr., The Foundations of Bioethics 2d ed. (New York: Oxford Uiversity Press, 1996), p. 8.
² Ibid., p. 13.

Ethics of Coordinating Organ Transplantation with Ventilator Cessation in Terminal ALS

The decision not to receive further medical care in the face of a terminal disease is one that is generally honored if made by a fully informed, competent adult in the absence of outside coercion. Decisions to discontinue life-assisting devices already in place with that terminal disease, such as ventilators, feeding tubes and cardiac pacemakers, begin to complicate the decision as the process moves beyond a single autonomous negative decision by the patient to refuse further care to one that often requires other individuals to positively act to accomplish the wishes of the patient in question. In addition, honest disagreements can result in determining whether removing life-assisting devices simply allows death to occur naturally or causes death directly. The timing of the decision to remove a life-assisting device can become more ethically complicated when the individual with the terminal disease wishes to donate his or her organs.

Such was the case with Dave Adox, when at age 42, he was diagnosed with ALS or Lou Gehrig’s disease, a terminal neuromuscular disease that causes progressive muscular weakness resulting in death, usually by respiratory failure, in 2 to 5 years. Within 6 months he was quadriplegic and completely dependent upon his family for all care. He eventually required a ventilator and was able to communicate only by eye movements. By age 44, his eye movements were becoming limited, making it difficult to communicate. He decided that he did not wish to continue to use the ventilator to prolong his life if he could no longer communicate. He had the support of his family and physicians. He had one other goal prior to his death – He wanted to donate his organs.

The problem was that Dave Adox would have to be admitted to a hospital to be able to donate his organs immediately after he turned off his ventilator. He received the support of his treating physician, the local hospital’s palliative care team and the local hospital’s ethics committee. He ran into a roadblock with the hospital’s attorneys, who argued that the process was uncomfortably close to assisted suicide. Within weeks, Mr. Adox was able to find another hospital that permitted his admission to their palliative care floor, assisted with the organ donation process, and allowed him to turn off his ventilator.

Ignoring the organ donation issue for the moment, Mr. Adox’s decision to turn off his ventilator in the face of his irreversibly deteriorating neuromuscular condition seems reasonable to me. He was making an informed, uncoerced decision to remove his ventilator as his worsening eye movements threatened his ability to communicate, a situation he considered too burdensome to warrant continued use of the ventilator. The use of a ventilator in the treatment of ALS is never mandatory. Elective use of a ventilator should always include the option to discontinue its use when an individual determines that its further use creates a burden they no longer wish to bear. Continued use of the ventilator in Mr. Adox’s case would not have prevented further deterioration of his ALS. In fact, continued use of the ventilator would likely have allowed him to live long enough to become “locked-in”, a condition where a person is alive, alert and aware, but unable to meaningfully communicate that awareness or one’s future needs to the outside world. With the impending loss of eye movements, Mr. Adox was approaching the “locked-in” state. Discontinuing the ventilator allowed the ALS-induced muscular weakness to cause his natural death via respiratory failure.

I believe the foregoing to be a distinctly different category from assisted suicide where the individual requires the addition of medication to suppress his breathing or terminate his heart rhythm to cause death rather than the death resulting from the disease process directly. That is, the process of the assisted suicide is the proximate cause of death, not the background disease. I appreciate that others may view having ALS at any stage as a burden too much to bear but I am unwilling to act to cause their death prematurely distinct from the disease process itself (See LINK for current study of ALS physicians and their views on assisted suicide – article requires subscription).

If you agree with me that Mr. Adox ought to be able to decide that he had reached a point that he wished to turn off his ventilator, does his decision to donate his organs change this situation to assisted suicide, as was the concern of the local hospital’s legal team? I do not believe it does. He was not turning off his ventilator “just so” he could donate his organs but rather because he had reached a point where continued ventilator use was a burden he no longer wished to bear. The organ donation was not the primary intent of discontinuing the ventilator. I view this in a manner similar to the intention of using pain medication in terminal cancer care: the intention of palliative medication is to provide pain relief during the dying process not cause the dying process, though it can. The intention of discontinuing the ventilator is to allow ALS to cause death naturally not provide organs for transplantation, though it can.

Should it?

CGI Turing Test

[Star Wars fans spoiler alert: The following contains potential story information from “Rogue One: A Star Wars Story”, the Star Wars Episode IV prequel]

I confess that I am a Stars Wars geek in particular and a science fiction movie buff in general. Like many, I am old enough to have seen the first Star Wars movie at its 1977 release, before it was re-indexed as “Episode IV: A New Hope”. The computer generated imagery or CGI special effects in that movie revolutionized the science fiction genre. It is now commonplace to use CGI to accomplish all manner of special effects, transporting moviegoers into all sorts of fantastic virtual worlds and virtual characters that appear, frankly, real. Rogue One has taken CGI up to the next level with one particular character such that I would argue that Rogue One has passed what I am calling the CGI Turing Test.

The original Turing test was described by Alan Turing, a famous British mathematician who designed and built a mechanical computer in the 1940s that successfully decoded the Nazi Enigma machine, a previous unbreakable encoding device that had thwarted Allied efforts to eavesdrop on the Nazi military communications. The Turing test is commonly misconstrued as a test of a computer’s (artificial) intelligence, which it is not. It is actually a test to determine whether a computer can imitate a human well enough to convince an actual human that it (the computer) is human. This test was a variant of a party game known as the “Imitation Game” in which a man (person A) and a woman (person B) would try to convince a third party, called the interrogator (person C) who was in a separate room, that each was the other. The Turing test substitutes a computer for person A.

Rogue One plays a similar game. There is a character in the Star Wars films named Grand Moff Tarkin, a very evil general in the Empire played by British actor Peter Cushing. Cushing debuted his Grand Moff Tarkin character in the original 1977 Star Wars movie. He is again seen reprising this role in the new 2016 Rogue One installment. I thought he was as awesome as ever. Except that he wasn’t. Peter Cushing died 22 years ago in 1994. I promise if you watch Rogue One and put yourself in the role of person C, the interrogator, you will be convinced that the CGI Peter Cushing (person A) is the real Peter Cushing (person B). So, the Academy Award® for Best Actor in a supporting role goes to…a computer at Industrial Light & Magic?

What has this to do with bioethics in general or artificial intelligence in particular? Perhaps not much. The futurist Ray Kurzweil argued in his book “The Singularity is near” that a machine will pass the Turing test in 2029 and perhaps this will come true, though his previous predictions have been called into question. In keeping with this AI/Turing Test theme, I gave the gift of “Google Home” and “Alexa” to different family members this Christmas. I was pleasantly amazed by the speech recognition of both systems and fully expect the technology to rapidly improve. Despite this, the forgoing discussion, and the knowledge that Turing and Kurzweil both disagree with me, I remain convinced that our ability to create a computer to imitate a human, the Imago Hominis, so to speak, will always fall far short of His ability to create a human to reflect Himself, the Imago Dei.

As the interrogator, what do you think?

The 14-day rule: Time to double down?

The “world’s leading scientists” gathered at University College London on 7 December 2016 to explore extending the 14-day limit on embryo experimentation from 14 days to 28 days. Presently the consensus of that meeting is not known. The Guardian has published a nice summary of the background and future implications of the issue (link HERE). Jon Holmlund offered his comments in this blog back in May when researchers artificially grew human embryos to 13 days gestation. Since this issue is back in the news, a few additional thoughts are offered below.

Space does not permit a detailed history of the details of the discussion behind the original 14-day rule endorsed by the Warnock Committee in the UK (see HERE for one such extended summary). The original limit was arbitrary but coincided with the development in the embryo of the primitive streak, a precursor to the nervous system, such that experimentation on an embryo before this stage was believed to eliminate the possibility of that embryo experiencing pain. The implementation of the 14-day rule essentially permitted experimentation to proceed resulting in the successful development of IVF.

Regardless of the ethics, the 14-day rule has been a hard barrier scientifically until just recently. Just because we can breach the 14-day barrier, why go beyond? Allowing experimentation on the embryo out to 28 days would allow scientists to learn about the process of gastrulation, the process that lays down the body plan and where the three tissue layers (ectoderm, mesoderm and endoderm) begin to subspecialize. If we have ethically permitted experimentation on embryos up to 14 days gestation, shouldn’t we just nudge it out a little further?

To quote Jon Holmlund: “In the name of God, forbear!” Interestingly, for different reasons, Mary Warnock agrees with him. Per the Guardian article, she worries:” If we raise the limit, objectors could argue that the 14-day rule has remained intact simply because no researcher had the technique to keep an embryo alive for so long, and that now one has been discovered the rush down the slippery slope will follow. They will say: ‘We always knew that the slippery slope would prove itself.’”

Experimentation on a human embryo at 14 days of gestation is still experimentation on a human being made in the image of God. Perhaps the upcoming debate on extending the 14-day rule will actually result in Warnock’s fear, that we agree that the original 14-day limit was indeed too long to be slipping and sliding?

Pre-Existing Conditions 2.0

Back in 2005, Dr. Ezekiel Emanuel co-wrote an article with Dr. Victor Fuchs entitled “Getting Covered”, where the authors described three factors necessary for major healthcare reform: the problem attracts political attention; major players agree upon a refined and feasible solution; and a transforming political event occurs. Their criteria were met with the election of Barack Obama and a Democrat-controlled Congress in 2008, resulting in Obamacare. Their criteria have been met again with the election of Donald Trump and what will be a Republican-controlled Congress (and perhaps future right-leaning Supreme Court). The result is yet to be determined.

Dr. Emanuel has lately been making the rounds on the various networks performing what some might consider the Sisyphean task of defending large portions of Obamacare against the Republican future. In doing so, he points out that several facets of Obamacare are popular with the public and therefore difficult to repeal. The most interesting is the elimination of pre-existing conditions as a pretext for denying insurance coverage, a necessary requirement for universal coverage. Interestingly, Mr. Trump has stated that he wants to keep the Obamacare pre-existing condition reforms.

Pre-existing conditions are the anathema of insurance risk pools. Including individuals with pre-existing conditions in any risk pool necessarily increases the medical costs in that pool. Increasing the size of the pool(s) by encouraging other healthy, low-risk people to join the risk pool relatively reduces the costs by distributing medical costs more broadly. Obamacare included a mandate/tax/fine for those that would not heed the encouragement. Despite this, most people have seen their insurance costs increase significantly. Mr. Trump claims he does not like the mandate and can eliminate it and still reduce costs by making the insurance market more competitive (such as allowing insurers to compete across state borders). Others argue for a consumption tax to increase revenue (see the Emanuel article above). The success of such plans in mitigating costs are yet to be determined.

The other major way to reduce the medical expenditures of a riskier pool is to begin to reduce the services and conditions that will be covered in that pool; that is, to ration care. This is an emotional topic as many of us have already had personal experience with being denied a service we expected to be covered. But it is a necessary topic to examine given finite financial resources, what Dr. Emanuel described in his article as a Rawlsian sense of justice, as “health care is not the only vital service”. A person with a Christian worldview may come to a different conclusion of justice from Professor Rawls. Deciding the appropriate ethical calculus to use to make these decisions is a topic for many other blog entries.

Politically, on both sides of the aisle, we seem resigned to answering the ethical question of whether healthcare should be a right by answering in the affirmative. The hard work is now determining what medical care obligations we are willing to require to actually meet that right. The ethics of those decisions are yet to be determined.

Another Ethical Slippery Slope for A.R.T.?

Medical business opportunities usually seem to make for interesting ethical discussions these days. Forbes recently published an article showcasing Prelude Fertility, an assisted reproduction technology (ART) start-up seeking to combine all the technologies of egg harvesting, cryopreservation and IVF under one umbrella for the purpose of controlling one’s biological clock. Aside from the business issues, the article does a fair job of discussing the medical risks and even some of the ethical concerns. I would like to focus on some of the ethical concerns.

The ethical concerns of standard embryo cryopreservation and IVF fall under two main areas. The first is that IVF often does not use all the embryos created by the process. The frozen embryos not used are human beings not commodities and should not be discarded (i.e. killed) or stored indefinitely (see Steve Phillip’s previous blog entry). The second issue is that although cryopreservation of embryos and IVF have now produced individuals who are beginning their third decade of life, we still do not know for certain what are the long-term health effects of this process (e.g. intelligence, aging, germline, etc.)

Prelude is focusing on an emerging technique of oocyte cryopreservation, which, if successful, will sidestep the first ethical concern – no embryos will be frozen, just the precursor eggs and sperm. Oocytes are very fragile and previous techniques used to cryopreserve them caused their destruction. The newer vitrification process of flash-freezing has significantly improved the preservation success for oocytes. The success rate has sufficiently improved such that the American Society for Reproductive Medicine (ASRM) removed their experimental label from the vitrification procedure. Still ASRM warned: “Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage women to delay childbearing.” They further warn:” There are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging”

This is exactly what Prelude is doing. One of the marketing points is that this process allows women to delay pregnancy to when it is more convenient for their career advancement. The long-term health concerns listed above for embryo cryopreservation are equally valid for oocyte cryopreservation – we simply do not yet know all the long-term human health consequences.

The CEO of Prelude, Martin Varsavsky, is putting his entrepreneurial money where is his mouth is, so to speak. He and his wife are expecting the first Prelude baby this January.

Marketing bravado aside, is career or lifestyle convenience really a good reason to go where ART has not ethically gone before?*

*apologies to Gene Roddenberry

Does Mitochondrial Transfer Really Save Lives?

This blog has discussed Mitochondrial Transfer, also referred to as Mitochondrial Replacement Techniques (MRTs), several times in the past (HERE and HERE to link a few.). The reason for further comment is that Dr. John Zhang, a New York-based fertility specialist admitted that he assisted in the successful fertilization and healthy delivery of a now 5 month old baby boy using the technique of Mitochondrial Transfer called Spindle Nuclear Transfer. The parents were from Jordan and the procedure was performed in Mexico, “where rules don’t exist [that legally prevent performance of the procedure].” Both Dr. Zhang and Sean Murray, an executive of the Australian Mitochondrial Disease Foundation have ethically justified the decision to perform the procedure in Mexico (to get around bans in other countries such as the US) with the claim that the procedure saves lives (Zhang: “To save lives is the ethical thing to do” and Murray: “This is about saving lives and offering hope to a community.”)

Saving lives is certainly a laudable endeavor. But does the technique really save lives?

The goal of the technique is to remove the diseased maternal mitochondria and replace the mitochondria with healthy donor mitochondria. In this particular case, five donated eggs from an otherwise healthy woman had the cell bodies removed and replaced with the nuclei of eggs from the mother, and these altered eggs were subsequently fertilized by with the father’s sperm. It is unclear whether all of these fertilized eggs were all used in the implantation or if some were destroyed by failure of the technique or purposefully destroyed after genetic testing showed mitochondrial abnormalities. Obviously one egg successfully survived the process to become the (presumably) healthy baby boy. But what about the other four?

More generally, whose life was being saved by the technique? The technique does not cure an individual who already has the disease. It prevents such an individual from being conceived in the first place, creating and selecting another individual conceived in a manner that does not have the diseased mitochondria.

So, it is likely that individuals are destroyed in the process of “creating” the mitochondrial diease-free individual, and, no actual specific individual is being “saved” by this technique.

It is very important to correctly define our terms before we have the ethical discussion to determine the right thing to do.

Late Term Zika Abortions: Thankfully not Euthanasia

If I were the editor of a recent Newsweek article by Cornell Law Professor Sherry F. Colb, the above title would have been my choice for her article. I must encourage you to read the actual article, lest you believe that the summary that follows is somehow taken grossly out of context. Her concern is that a late term abortion to terminate the life of a Zika-infected baby might be morally problematic because it might be misconstrued as euthanasia rather than simply a late term abortion.

She begins factually with her concern for the increasing prevalence of Zika, a virus causing severe microcephaly of babies born to parents with the infection. Further complicating the matter is that the birth defects are not apparent until well into the third trimester. Thus, per Professor Colb, Zika pregnancies require us to answer two moral questions. The first question is whether it is “…right to end a pregnancy because the baby would be severely disabled if brought to term?” The second wonders whether it is “right to take the life of a fetus late in pregnancy, regardless of the reason?” (I was encouraged at this point that she conceded both that the fetus was alive and that a baby was a direct result – my optimism did not last long.)

She was quick to point out that she considers “…the reasons for a woman’s choice to terminate her pregnancy to be irrelevant to the question of whether she should be legally permitted to do so…” as she is “…entitled to be free of the bodily intrusion that is pregnancy, even if her reason for wanting to assert her bodily integrity is an offensive one.” Her reason for even bothering to discuss the moral issues is because she anticipates that large numbers of women may be wanting to terminate their pregnancies so the discussion is worth having, “…even if our answer will not affect the legal conclusion that the woman should be free to terminate.”

In answering her first question in the affirmative, she effectively equates routine abortion to contraception and considers the fetus to be a “potential” life, arguing that even in Down Syndrome, parents choose abortion, and since Zika is a worse condition (her stipulation), “…it may be that an abortion will spare not only the parents but their child a life that is, in some sense, not worth living.” (I have always wondered what it is we are sparing a specific child by not having it live – a non-entity cannot be spared anything – the concept seems incoherent)

The second question is more troubling for her. Her “no-go” line for abortion and moral significance is sentience but she admits that others have different criteria. However she further concedes that the later one goes in the third trimester, “…the more likely that people will have the moral intuition that we are no longer talking about a ‘potential’ child but are instead talking about either an existing child or at least someone worthy of nearly as much moral consideration as a newborn baby.” For her, the moral calculus has changed. Bodily image abortion arguments fail (simply birth the child alive, “…thereby ending the internal occupation…”). Terminating the pregnancy at this point does not need to terminate the life of the fetus or baby, and “…the choice to have an abortion (one that kills the fetus or baby) is really a choice to take the life of the fetus or baby because it is not considered a life worth living.” She is equating late term abortion to euthanasia. (Correctly in my mind, and, since I have different criteria for abortion, specifically, nothing post conception, therefore, all abortion is euthanasia)

She solves her moral dilemma by hiding inside a legal loophole. “If one nonetheless concludes that because of the potentially catastrophic nature of the birth defects, children with Zika are better off not existing than living severely compromised lives that they would otherwise live, the fact that they live inside a pregnant woman may give people a legal –if not a moral—loophole through which they can achieve their desired end, though it is really euthanasia.” The pregnant woman can do all this “…without beginning the slide down the euthanasia slippery slope, because we can fit what she has done under the heading of “abortion” instead of “euthanasia.”

Let that last bit of mental gymnastics sink in.

From what vantage point does one judge the slippery slope of one moral issue whilst sliding down the slope of another?

The $280 Better Mousetrap

The rising cost of the Mylan EpiPen has been in the news. Since 2007, Mylan has raised the cost of their two pack EpiPen from just under $100 to over $600 today. That is a cool $300 per EpiPen, substantially above the ten to twenty dollar retail cost of the raw material epinephrine. Why should I be asked to spend a $280 mark-up? Is this ethical?

Briefly, here is some background. Adrenalin, pharmacologically known as epinephrine, is a substance that your body releases in response to stress. It allows the body to handle emergencies by the so-called “fight or flight response”. Large doses can be lifesaving, as is the case with allergic reactions. Individuals with allergies to peanuts or bee stings can receive epinephrine via an injection under the skin or into a large muscle, which can delay or even eliminate a life-threatening anaphylactic reaction (allergic swelling so widespread that an individual cannot breath or maintain their blood pressure), usually allowing time to travel to the ER for further care.

The EpiPen is one method of administering the epinephrine. An individual simply grabs the device, shaped like a stick, and jabs the end of the stick against his or her thigh muscle. This causes the EpiPen to release a spring-loaded needle, extending the needle into the thigh muscle, delivering a fixed dose of epinephrine into the muscle. The device is very easy to use, so much so that a young child can be taught to use the device safely and reliably.

One does not need to use an EpiPen to self-administer epinephrine. I checked with my local pharmacist and he can set me up with a syringe, needle and vial of epinephrine, and, as long as I can draw up the correct dose, and, as long as I am not squeamish about giving myself an injection in my thigh muscle, I can administer the exact same life-saving dose of epinephrine as the EpiPen. The total cost is around ten to twenty dollars per dose. Many other drugs, most notably insulin, are both self-administered and life saving, so nothing novel is required here. Additionally, according to my pharmacist, the “purse-life” of the generic vial of epinephrine extends several months beyond the one-year limit of the epinephrine in the EpiPen.

In short, Mylan is asking you to pay $280 for the privilege and convenience of using their stick to administer epinephrine rather than doing it yourself. Presently, there are no other options. Mylan’s only other competitor, Sanofi, withdrew in October 2015 their version of the EpiPen, called Auvi-Q, after multiple reports of failing to reliably deliver the correct dose of epinephrine. The present lack of a competitor seems to suggest that Mylan has indeed built a better mousetrap. They seem to be feeling a little guilty about their market dominance, as they have just today promised an identical generic EpiPen at half the cost.

Mylan’s mea culpa aside, is it ethical for them to charge whatever the market will bear, not for the epinephrine, but for the convenience of administering the epinephrine?