- BIOETHICS FORUM ESSAY
Ethical Opposition to Right to Try Laws Is Easy to Articulate
Over the last year, nearly half the states in the country have passed “right to try” laws, which give terminally ill patients access to experimental drugs. These laws are controversial: the public favors them, but scientists and health policy experts think they can be harmful, causing false hope and sometimes suffering. But opposition to the laws can be “difficult to articulate,” wrote Rebecca Dresser in the Hastings Center Report, May-June 2015. She argues that state lawmakers and voters should hear stories about “the dashed hopes, misery, and lost opportunities that can follow the resort to unproven measures. These stories are the best way to explain why right to try laws are a misguided effort to help patients.” This post responds to Dresser’s article.
Rebecca Dresser offers a much-needed and timely review of the current right to try movement in “‘Right to Try’ Laws: The Gap between Experts and Advocates” She raises several important points often overlooked in the rush by policy-makers and the public to help terminally ill patients.
First, Dresser highlights the fact that the laws do not actually reduce the Food and Drug Administration’s involvement in the approval process for unapproved therapies. And she writes that, in any case, experts and scientists (and, we would add, ethicists) see little benefit from loosening FDA restrictions. She also notes that pharmaceutical companies’ preapproval access programs are inadequate to meet patient demand. More important is her observation that patients facing death may overestimate how much an unapproved drug might help them while failing to grasp the very real harm it can cause.
But the most important point Dresser raises is that right to try laws do not obligate manufacturers to grant access to the drugs being sought. Not one of the now 24 state laws on the books compels manufacturers to act. Yet article after article—by patients and advocacy groups, by editorial and opinion writers, on social and in mainstream media—hails such laws as last-chance lifelines for very sick people who have exhausted all other treatment options. As Dresser points out, lawmakers can make political hay out of these bills. (After all, there’s nothing to lose and plenty to gain politically from giving the impression of rescuing the desperately ill.) This hollow promise made by the right to try movement—feel-good legislation that terminally ill patients are only too eager to believe—is a chief reason that ethicists oppose the laws.
We do, however, take issue with Dresser in some places. The first is with her contention that commentary on right to try legislation has tended to focus on abstract scientific and policy considerations. In response, we would direct her to the website of the New York University Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access, of which we are both members, and Caplan a founder. There she’ll find dozens of articles, by group members and others, on right to try legislation. Some appeared in peer-reviewed journals, but many others were in mainstream outlets (in national and local newspapers and on network news, patient advocacy, and health care websites). Contrary to what Dresser suggested, we clearly and, we believe, convincingly argue against access to unapproved drugs until ethical safeguards are put in place. The articles are easy to follow; writing them to be so is not that hard to do, because the laws are unethical as written: they can lead to increased suffering in already-suffering patients, and they hold out false hope. Those aren’t complex objections, and they aren’t difficult to articulate plainly. And, of course, many, if not most, of the articles emphasize the “negative impact liberal access [to unapproved therapies] can have on individual patients,” which Dresser felt was lacking in the literature.
Finally, Dresser complains that opponents to right to try legislation haven’t engaged policy-makers “much.” Members of our group have written many opinion pieces on the laws. Recently, we contributed op-eds to the major daily newspapers of Hartford, Connecticut, and Albany, New York. We submitted them there precisely because legislation was under consideration in both of those capitals’ statehouses.
The Hartford article discussed the illusion of hope right to try laws holds out, and the Albany piece focused on the fact that many of the laws and bills stipulate that hospice care may be withdrawn if patients do get access to the drugs sought–again, hardly abstract or policy-oriented concepts.
After those op-eds ran, the working group discussed the ethical concerns they raised with legislators from Connecticut and New York. Both states decided not to pursue the bills further during their current legislative sessions (which have since ended), and the lawmakers indicated that they would be amenable to addressing ethical concerns if the bills are reintroduced in a subsequent session. This may not count as “much” engagement with policy-makers. Yet we consider it to be an encouraging trend that signals that some lawmakers are interested in the smaller, often unethical details of the bills’ texts.
We agree with Dresser that the public and policy-makers need to hear more about how right to try laws dangle the illusion of hope in front of vulnerable patients and about the harm that unapproved drugs can cause. And we agree that this is an area where bioethics has a key role to play.
Lisa Kearns, MS, MA, is a research associate at NYU Langone Medical Center’s Division of Medical Ethics. She is a member of the NYU Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access. Arthur Caplan, PhD, is the founder and director of the NYU Langone Medical Center’s Division of Medical Ethics and a founding member of the NYU Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access.