Non-Maleficence: Long thought to be the primary responsibility of the physician (“do no harm”), non-maleficence addresses the potential negative effects of experimental drug therapy that the patient needs to consider in an informed consent. All of the potential side effects and complications cannot be known, for those drugs and devices that have only passed Phase I trials and may be in Phase II or III have limited discoverable data on adverse effects, including death. Each terminal or near-terminal patient may have unique organ compromise or risks that could enhance the potential for catastrophic side effects. Explaining this inadequate data effect to a patient and their family can be unsettling for them and stressful for the physician. Additionally, electing to petition for a RTT may disqualify the patient from subsequent hospice or palliative care.
Social Justice: Depending on the state, RTT laws may require manufacturers to provide the experimental therapy without cost to the patient (i.e., Texas), but in other states, the patient may be held responsible for the cost of the therapy. Raising funds for treatment takes time, and some patients do not have sufficient time remaining in their lives. Additionally, those patients with lesser resources and inadequate healthcare access may be at a disadvantage with respect to ability to secure physician support to apply to RTT and to pay for the drug if required.
Both proponents and critics of RTT tend to agree that there is a failure of communication between the scientific community and the public with respect to the issues and policies associated with clinical trials, expanded access, and right to treat—this must be improved. There should also be additional clarification of the risks to clinical trials for catastrophic adverse outcomes associated with patients in the RTT access pathway, for drug manufacturers may be reluctant to jeopardize their clinical research by providing experimental drugs to terminal patients. Conversely, there is justifiable concern in public discourse that the federal government has been slow to streamline the processes for expanded access for patients who do not qualify for clinical trials, and the RTT movement has stimulated positive changes in procedures and policies.