Is it possible that bioethics, which is "concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments" is sometimes more obstructionist than ethical?
As psychiatrist and American Enterprise Institute scholar, Dr. Sally Satel has written that there are, indeed, complex and difficult questions in medical research and practice on which bioethicists' opinions may be useful. These questions include: 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, 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.
Consider the case of 18-year-old Jesse Gelsinger, who suffered from a rare metabolic disorder marked by toxic levels of ammonia in the blood and caused by subnormal levels of liver enzyme ornithine transcarbamylase, or OTC.
With his disease controlled by diet, Mr. Gelsinger was quite healthy when, in September 1999, he arrived at the Hospital of the University of Pennsylvania to begin an experimental gene therapy regimen intended to enhance activity of the enzyme in his body. But his condition began to deteriorate within hours of receiving the first treatment, an intravenous infusion of a preparation containing the normal gene he lacked, which was 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.
The FDA jumped all over the investigators and the research institution and even shut down other unrelated gene therapy clinical trials, but if there was an identifiable mistake, it was in the choice of patients for the first attempts at gene therapy for OTC deficiency.
Rather than stable adult patients, it would have been more prudent to treat OTC-deficient babies who were comatose and had a dire prognosis. 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" and are, therefore, incapable of giving informed consent.
Thus, the protocol treated and placed at risk a group that did not need the therapy, because the patients who might have benefited from it (and would die without it) could not have genuine informed consent given on their behalf and were declared ineligible. FDA officials of the hospital's Institutional Review Board could have and should have reversed that decision.
The concept of "coercion" to undergo medical treatment is important, and is one much dwelled upon — and, in my opinion, distorted — by bioethicists.
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 in November 1989 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." And 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 supposed presence of coercion and the supposed absence of informed consent, a mother doesn't get to choose to save her daughter's life?
I reject that twisted logic.
I think 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 riposte to Caplan: "Once you've given someone a big piece of your heart, it's easy to throw in a little bit of liver." 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.
Caplan shows his lack of humanity (and logic) again 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, AEI's Dr. Satel quipped, "Apparently, having them do it for free is not a violation."
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, Dr. Satel observed, "Bioethicists' arguments are often weak, resting on outlandish hypotheticals, unanalyzed 'yuck' reactions and thinly disguised religious rationales"; and 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."
In separate op-eds, he and I have argued that bioethicists have a moral obligation to "get out of the way" of groundbreaking research to treat horrific genetic diseases even if the treatments involve alterations in the "germline" of patients that could result in the inheritance of the genetic corrections in future generations. Of course, the navel-gazers disagree.
Professor Pinker gets the last word:
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.
Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA.