This post is a part of our Bioethics in the News series
By Marleen Eijkholt, JD, PhD
Imagine your loved one is dying. You have heard about an intervention out there, somewhere, that could help—you think. Not trying this intervention for and on your loved one would seem insane, as who knows, there could be a chance for a cure. Without trying it, your loved one’s death is certain. But by trying it—who knows—this intervention might be the miracle for your beloved. Why not try?
Though death ultimately takes all, most of us resist a final exit for both our loved ones and ourselves. Pursuits to forestall death can take the shape of family’s quests for experimental treatments, like in the Charlie Gard case, or they can come by insisting on a “full code” for a terminally ill loved one who is on their deathbed. This rescue impulse (by unbridled hope) encourages health care professionals as well to marshal all available resources in attempts to circumvent the inevitable.
Where “right to try” creates false hope, I submit, however, that that the health care profession (HCP) has an obligation to avoid collaborating in, participating, propagating or augmenting false hope. By not speaking up against such requests, health care providers precipitate a harm, i.e., the false hope harm (FHH). As such, the HCP should show courage, and show spine to resist more broadly unreasonable “rights” to try.
I call for an active stance from the HCP against populist legislative initiatives, such as the latest U.S. Senate’s “right to try” bill. In the same way, I call for an active stance against unrealistic patient and family requests for rights to try, including resuscitative efforts in terminally ill patients or other demands for non-beneficial treatments. My position thus supports the providers’ prudent approach in the tragic Charlie Gard case, as described at the end of this post. The FHH can best be countered by courageous advocacy from the profession.
Earlier last month, the U.S. Senate passed a “right to try” bill, and if the House approves this legislation, the bill would allow terminally ill individuals to access experimental drugs not yet available on the regular market. Once a drug has passed Phase I drug testing, an individual could petition the pharmaceutical company for access to that experimental drug. This bill also provides protection for pharmaceutical firms. The legislation restricts the FDA from using right-to-try-related adverse outcomes in determining a drug’s safety. Accordingly, the bill limits “penalizing” pharmaceutical companies for their “generosity” in offering access.
A discouraging stance against “right to try” legislation is tricky. It is telling that “right to try” legislation has been dubbed “feel good” legislation, and thirty-nine states already have such legislation, including Michigan. Although there are proponents of these laws, I contend that these laws are “rhetorical pleasers” more harmful than beneficial. Criticism directed at “right to try” legislation focuses on several concerns, including its potential to undermine the clinical trial system and the belief that ultimately such laws only serve the elite. Some critics address false harm arguments, although these concerns are mostly different from mine. Critics argue that the legislation creates false hope, because pharmaceutical companies are less than eager to share their innovative pharmaceuticals, and are afraid of right-to-try-associated risks and harms that might lead to scientific and drug development setbacks. Patients, therefore, most often are unable to obtain access to the medications, so their hope for a “miracle drug” is in fact unfulfilled. Without actionable pathways, patient access cannot be guaranteed. (Indeed, in Michigan, Bridge Magazine suggests that the legislation has failed to change the status quo, and no one has sought access.)
My proposal that the HCP should stand up against unreasonable rights to try comes from my belief that these laws create FHH instead of real benefit. “Right to try” legislation generates false hope as the sought after experimental interventions are unlikely to benefit the patient. Although the legislation requires the drug to have passed Phase I clinical trial safety testing, this measure does not amount to a guarantee that the medication offers benefit. A Phase I clinical trial is safety focused, conducted in a very controlled environment, and in fact many treatments fail to demonstrate benefit outside that controlled environment.
The federal legislation is therefore an even more troublesome example of “feel good” legislation, as it propagates and augments FHH. It endorses the idea that pursing experimental treatment is both feasible and reasonable. Equally, it supports the notion that as long as one has the means, one should have access to try. Most importantly, by limiting FDA oversight, it undermines safeguards and trust in the system, and creates more room for FHH, giving pharmaceutical companies nearly a free reign.
Standing up to false hope is painfully hard, especially in the face of persuasive, emotionally vivid stories. Who would want to deny anyone hope for a miracle? Charlie Gard’s parents wanted to try a new treatment for their son, but their providers refused access. While their son was tragically dying, they were helpless to avert the inevitable. They heard about a treatment in the U.S. and appealed for access. But the UK doctors refused to endorse their appeal and the Court eventually prevented Charlie Gard’s parents from taking their son to the U.S. for treatment. A compassionate intuition could be: provided Charlie did not feel pain, why would there be anything wrong with them pursing this treatment in the U.S.? His parents had sufficient funds to cover related costs, so their pursuit would not further tax the social system. Experts suggested that there was a zero percent chance of health benefits for Charlie, but who can really know zero percent if you haven’t tried? We can never exclude miracles, can we? Even though this drug was not past Phase I, it had shown marginal benefit in other kids with illness that were related to Charlie’s, so safety wasn’t hard to prove.
I propose that if providers would have allowed Charlie to leave for the U.S., their endorsement would have exploited vulnerable individuals; they would have collaborated in FHH. The providers took the right and courageous action. Not speaking out against FHH passively supports initiatives that are more harmful than beneficial, and speaking out requires an active positioning of individual providers—optimally supported by the larger body of HCPs. I submit that this should extend to participating in requests for non-beneficial treatment requests like resuscitative efforts on dying patients. The medical profession rests on elements of trust, guidance, expertise and collaboration. Absent health care providers’ courage to deny treatment, we are doomed to see a further erosion of that profession. Without provider action against “right to try,” under legislation or requests in the clinic, medicine is at risk of further drifting into consumerist medicine, where money, fear, and privilege turn health care (and providers) into hostages of patient demands.
Marleen Eijkholt is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine. Dr. Eijkholt is also a Clinical Ethics Consultant at Spectrum Health System.
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