When You Confront a Difficult Dilemma, Give Bioethicists a Pass.
By: Henry Miller, M.S., M.D. and Andrew Fillat
Recently, we co-authored an article about the thorny issues surrounding who would get access to the earliest doses of the COVID-19 vaccine. As we discussed, there are many possible options for setting priorities in terms of who should be vaccinated first. One obvious solution one would be to prioritize the people who are instrumental in mitigating the pandemic, with front-line medical personnel and staff at long-term care facilities going to the head of the line. Another strategy would be to consider “most vulnerable” populations first—those with comorbidities, or over sixty years of age. Or how about those involved in keeping the food supply chain intact, such as farmworkers, truck drivers, and food-store workers? Or how about trying to identify people prone to becoming “super-spreaders” of the virus, an approach to vaccination that has been successful for other pathogens? (For example, it was found that when children were given the pneumococcal vaccine in the early 2000s, rates of bacterial pneumonia in the elderly rapidly dropped because of a “herd effect.”) And how much influence should political considerations have: should Americans automatically receive higher priority, simply because our government subsidized the development of the vaccine?
What we need to avoid, however, is the sort of Social Justice Warrior activism (here in the guise of “bioethics”) applied to the allocation of COVID-19 vaccines that is driving the renaming of schools and toppling statues.
To reconcile this wide range of priorities, as is sometimes done in the medical field when decision-makers are confronted with a complex array of variables, the allocation criteria could theoretically become a complex algorithm—perhaps something analogous to the National Association of EMS physicians SALT Mass Casualty Triage Algorithm. This triage algorithm sorts patients into three categories based on the severity of their condition, and determines the interventions they should get, and in what order. In the case of vaccination, on the basis of the variables mentioned above, individuals could be sorted into the appropriate category, and those within a given category would then receive vaccine in random lottery order. Of course, such an approach would not eliminate value judgments or squelch controversy.
The federal government will receive formal advice on this issue from at least two sources, the National Academies and the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention on vaccine issues. It’s important to note that at least for the National Academies panel, bioethicists will be involved in the deliberations.
The editor of our earlier commentary asked where bioethics, which is “concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments,” would (or should) enter into the calculations that determine who gets access to early vaccine doses. We chose not to open that particular can of worms in that article; let us explain why.
As psychiatrist and American Enterprise Institute scholar Dr. Sally Satel has written, there are, indeed, complex and difficult questions in medical research and practice where the opinion of bioethicists may be useful. These questions include, for instance, whether students should be permitted to use cognition-enhancing drugs; what constitutes informed consent; whether organs for transplant should be sold; who should have access to limited-availability therapies; and so on.
But, she argues (correctly, in our view), their judgment should be sought only to frame issues, not settle them. Moreover, their views should not be given “greater weight than other stakeholders—physicians, scientists, legal scholars—who consider the same issues carefully and come to different conclusions … [because] ideological sway, quirks of intuition, and tolerance of risk play significant roles in what bioethicists, like the rest of us, deem ethical.”
Too often, however, bioethicists’ views are considered dispositive, or at least highly authoritative, and those opinions can do great—even lethal—damage. Bioethicists sometimes allow dogma to preempt real-world choices that are matters of life or death—which is why, as Dr. Satel wrote, we may invite input from bioethicists but cannot let them settle those issues. That should be a basic tenet of the deliberations of the groups entrusted with making recommendations about the allocation of COVID-19 vaccines, and of those who receive those recommendations and make the decisions.
THE LETHAL HISTORY OF BIOETHICS
In September 1999, 18-year-old Jesse Gelsinger, who suffered from a rare metabolic disorder caused by subnormal levels of liver enzyme ornithine transcarbamylase (OTC), and marked by toxic levels of ammonia in the blood, arrived at the Hospital of the University of Pennsylvania to begin an experimental gene therapy regimen. Up until that point, the young man had been quite healthy, having controlled the disease by diet. The new therapy was intended to raise the subnormal enzyme levels in his body.
His condition began to deteriorate within hours of receiving the first treatment, however—an intravenous infusion of a preparation containing the normal gene he lacked, encased in an enfeebled virus called adenovirus. The gene therapy approach used the weakened virus as a kind of shuttle to get the genes to the right tissues in the patient. (Fully competent adenoviruses cause a number of illnesses, including conjunctivitis and colds.) Mr. Gelsinger died, four days later, of multiple-organ failure.
In response, the FDA jumped all over the investigators and the research institution, even shutting down other unrelated gene therapy clinical trials. The nub of the problem, though, was not an issue with the therapy itself, which was being tested in a clinical trial because it was experimental. (Remember, there would be no way of knowing if the treatment was safe and effective without such clinical trials). It was in the choice of patients who were chosen for the first attempts at gene therapy for OTC deficiency—patients like Mr. Gelsinger.
Rather than stable adult patients, it would have been more prudent to treat OTC-deficient babies who were comatose and had a dire prognosis (because of a profound deficiency of the OTC enzyme). That was, in fact, the original intention of the OTC researchers, but they were dissuaded by their bioethicist, Arthur Caplan (now at New York University), who felt that parents of dying infants are “coerced by the disease of their child.” According to Caplan, these parents were incapable of giving informed consent.
Thus, the protocol (the plan for the clinical trial) treated and placed at risk a group that did not need the therapy. Meanwhile, the patients who might have actually benefited from it (and would die without it) supposedly could not have genuine informed consent given on their behalf, and were declared ineligible. FDA officials or the hospital’s Institutional Review Board could, and should, have reversed that decision. The “original sin” was theirs—not the researchers’.
The concept of “coercion” to undergo medical treatment is important, and is one much dwelled upon—and, in our opinion, sometimes distorted—by bioethicists. In 1989, because of what was arguably the unethical advice of bioethicists, the first partial liver transplant from a living donor—from a mother to her 21-month-old daughter—almost didn’t occur. In the end, it was performed by surgeons at the University of Chicago Medical Center, who used the transplant to correct a congenital defect called biliary atresia, which leads to liver failure and, ultimately, death.
At the time, however, Boston University ethicist George J. Annas viewed the mother’s choice of whether to offer part of her liver as inherently coercive: “The parents basically can’t say no,” Annas wrote. In agreement, Arthur Caplan offered this:
“There are several key issues. One is that the procedure really raises some serious questions about the validity of informed consent. I find it very difficult to credit consent when you’re asking the parent to assume a risk to save the life of his or her child. I think most parents would do nearly anything, including killing themselves, to save their child’s life.”
So, given the presence of so-called coercion (this time, owing to a parent’s love of her child), and the supposed absence of informed consent, does a mother not get to choose to save her daughter’s life? We categorically reject that twisted logic. This quote from Teri Smith, the mother who, in that University of Chicago operation, donated a lobe of her liver to her daughter Alyssa and saved the infant’s life, delivers a devastating, yet tender, riposte to Caplan and Annas: “Once you’ve given someone a big piece of your heart, it’s easy to throw in a little bit of liver.” Two decades later, Alyssa, then a self-described “normal teenager,” graduated from college magna cum laude—appropriately, on Mother’s Day—in May 2010. No thanks to the navel-gazing bioethicists.
And yet, they persist.
For instance, Caplan showed his lack of humanity (and logic) yet again, this time on the subject of offering compensation to donors of organs for transplantation: “Paying people to maim themselves for money is a violation of the do no harm ethic of medicine.” In response, the American Enterprise Institute’s Dr. Satel quipped, “Apparently, having them do it for free is not a violation.” These anecdotes show how profoundly out of touch with common sense even the nation’s most prominent bioethicists can be.
BIOETHICS: OUTLANDISH HYPOTHETICALS AND UNANALYZED ‘YUCK’ REACTIONS
A few contemporary critical thinkers have written persuasively about the shortcomings of bioethics, and the damage that can be wrought by the ethics police. In a splendid, must-read article published in 2017, Dr. Satel observed, “Bioethicists’ arguments are often weak, resting on outlandish hypotheticals, unanalyzed ‘yuck’ reactions and thinly disguised religious rationales.” Harvard cognitive psychologist, author and intellectual Steven Pinker aptly expanded on that theme, dismissing the sophistry of slippery-slope arguments and flawed analogies:
“A truly ethical bioethics should not bog down research in red tape, moratoria, or threats of prosecution based on nebulous but sweeping principles such as ‘dignity,’ ‘sacredness,’ or ‘social justice.’ Nor should it thwart research that has likely benefits now or in the near future by sowing panic about speculative harms in the distant future. These include perverse analogies with nuclear weapons and Nazi atrocities, science-fiction dystopias like ‘Brave New World’ and ‘Gattaca,’ and freak-show scenarios like armies of cloned Hitlers, people selling their eyeballs on eBay, or warehouses of zombies to supply people with spare organs.”
Bioethics has become what Professor Pinker has called “a professional guild that all too often impedes sound ethical concerns rather than advancing them.” Professor Pinker continues, elsewhere:
“Take the very foundation of ethics. You’d think it would be an obvious ethical principle that life is better than death, health is better than disease, and vigor is better than disability. But, astonishingly, so-called bioethicists have repeatedly denied these truisms, either explicitly (in the case of the country’s former bioethicist-in-chief, Leon Kass, who argued that the desire to extend life is a sign of shallowness and immaturity), or implicitly, by fetishizing sweeping rubrics such as dignity, equity, social justice, sacredness, privacy, and consent at the expense of the health and lives of actual people.”
How does all this relate to the allocation of early COVID-19 vaccines? Well, for one thing, the National Academies panel referred to above, which just published a discussion draft for public comment, has among its members several bioethicists, whose influence seems to be reflected in the “foundational principles” for an allocation strategy—namely, “maximization of benefits, equal regard, mitigation of health inequities, fairness, evidence-based, and transparency.”
The translation of those somewhat vague concepts and value statements into an actual phased approach was plausible, but only because of the presence of genuine scientists (i.e, non-bioethicists) on the panel. For instance, the highest priority vaccine recipients (Phase 1), would include: “high-risk workers in health care facilities; first responders; people of all ages with comorbid and underlying conditions that put them at significantly higher risk; and older adults living in congregate or overcrowded settings.” And so on, through three additional phases, to eventually arrive at the entire U.S. population.
These are only recommendations in a discussion document draft from a single entity, however. It behooves us all to ensure that the final recommendations, and the ultimate allocation strategy that is put into practice, reflect what is best for society, rather than the airy-fairy inclinations of bioethicists.
Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the Office of Biotechnology at the FDA. Andrew I. Fillat spent his career in technology venture capital and information technology companies. He is also the co-inventor of relational databases. They were undergraduates together at M.I.T.