Opinion: “Right to Try” Legislation and the Responsibility of Physicians

Last Updated on June 24, 2022 by Laura Turner

The “right to try movement” is often presented as an altruistic effort to provide patients with terminal illness increased access to potentially lifesaving experimental medication. This rosy rhetoric stands in stark contrast with reality, however. Far more often than it provides a service to desperate patients, “right to try” legislation facilitates the propagation of false hope, undermines the fiduciary duty of physicians at the cost of patients, and embodies a slippery slope to the worst consequences of radical patient autonomy.

Given the recency with which they have emerged to the fore, many readers may be unfamiliar with what “right to try” legislation is and the general arguments surrounding it. “Right to try” laws emerge largely from libertarian philosophy and are promoted by their supporters as a mechanism to help terminally ill patients access investigational medical products. Such access, known as “expanded access” or “compassionate use,” allows physicians to request access on behalf of a patient to an investigational agent from the organization or entity developing the product. Supporters of “right to try” legislation express the belief that they are simply seeking to empower individuals with the power to save their own lives. Even with the limited knowledge I possess at this early stage in my career, I am extremely skeptical of whether these are their primary motives. The reasons behind my cynicism will be the focus of the remainder of this article.

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One of the most insidious aspects of “right to try” legislation is the propagation of false hope to some of the most vulnerable members of society. Despite their soaring rhetoric, the laws can do “nothing to compel cooperation from drug makers, who often are reluctant to hand out unapproved drugs, for reasons including high costs, lack of adequate supply and worries over liability.” Even without a specific reason, manufacturers may decline requests or charge the patient hefty sums for the investigational treatment, as best suits the company’s goals and priorities. Compounding this latter point is the fact that many “right to try” laws allow insurance providers to stop covering a patient once the use of the experimental drug begins. A further concern is that patients in the last months of their lives could reject palliative care and a meaningful opportunity to spend time with loved ones in favor of an experimental drug with terrible side effects. It could also lead them to chase the false hope of an investigational drug and disqualify themselves from a later clinical trial offering a more scientifically rigorous hope of improvement. As is rapidly becoming apparent, contrary to the hype surrounding them, so-called “right to try” laws do not create any additional rights for patients.

Also worth considering is the potential impact the radical patient autonomy reflected by “right to try legislation” can have for clinicians. One major concern stems from an unspoken reliance on physicians being intelligent, virtuous, and devoted to their patients’ well-being to the extent they eschew personal interests if “right to try” is to be implemented ethically and safely. Most “right to try” laws do not set qualifications for either the healthcare provider making the attestation of terminal illness or the physician recommending experimental treatments. As a consequence, patients are not assured of an optimal or even adequate assessment of their condition, prognosis, or chance of benefit from an experimental treatment. In addition, it is all too easy for the unscrupulous or inept to prey on desperately ill patients and their families since no rules are in place to stop the creation of “research ‘mills’ in which interventions with no scientific evidence are promoted as possible cures”. In fact, far from empowering patients as they so boldly claim, the laws absolve companies and physicians from legal liability should the experimental product cause harm. While this is a vital safeguard for a well-meaning company truly acting compassionately, without other regulations it also opens the floodgate for the far less well intentioned.

Given the legislation’s utter failure to empower patients, it is my belief that the true objective of “right to try” is to innervate not bolster. To my eyes, the foremost objective of “right to try” legislation is to nullify the FDA’s power. This attempt to undermine a vital federal agency naturally brings with it serious consequences. The first of these is to engender yet more false hope. Despite assertion by supporters of the laws, there are no reports of patients gaining increased access to experimental medication through “right to try” legislation’s attempt to circumvent the supposed barriers constructed by federal authorities. In fact, rather than expanding access for terminally ill patients, “right to try” laws in fact potentially limit it by allowing those skeptical of the federal government to present the FDA as the sinister enemy blinding those in need to already well-established protocols for obtaining experimental therapies. The FDA’s mechanism of “compassionate use” already allows for “access to investigational drugs outside of a clinical trial for patients who have serious or life-threatening illnesses and have no comparable alternatives.” The agency approves more than 99% of the compassionate use requests received. Additionally, far from constructing barriers, the FDA vigorously supports patients in obtaining the novel therapeutics they desire. In direct response to arguments from “right to try” advocates that FDA approval was too slow to be useful, in February 2015, the agency revised its paperwork and announced that the new form could be completed in 45 minutes rather than the 100 hours the Goldwater Institute and other critics contend. The organization even aids patients in filling out the paperwork.

Central to the arguments of “right to try” advocates is the seemingly unobjectionable right to have the freedom as rational and free people to make our own decision and live with the consequences. What is overlooked when advocates of such policies make this argument is that none of us exist in a bubble. When we gamble with experimental drugs we hurt not only gravely ill people desperately grasping for hope, but also their families—both financially and emotionally, the medical profession by leaving it vulnerable to internal corruption, and perhaps most ironically, future terminally ill patients, as the research apparatus is undermined and potential innovations are scrapped due to the disruption, deregulation, and resource redistribution engendered in the name of the “right to try”.

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The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of Student Doctor Network

“Right to Try” Legislation and the Responsibility of Physicians was published on Student Doctor Network.


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