Ethical Challenges of ‘Right to Try’ Laws for Clinicians

Clinical Scenario

© Maxx-Studio / shutterstock.com

Your first patient of the day is a 59-year-old man with advanced stage IV head and neck cancer, who will be meeting with you and his medical oncologist in a discussion regarding future management of his recurrent and metastatic cancer. In spite of chemo-radiation therapy, surgical excision, and adjuvant immunotherapy, the patient’s cancer has continued to spread, and there appears to be no other approved treatment available to him. The discussion today with the patient and his wife will be to examine what options might be available to the patient at this late stage of his disease, and determine how the patient would prefer to handle what is now an end-of-life decision process.

During your last appointment with the patient, you indicated that the patient should consider palliative care and hospice with a physician in that specialty. In a separate discussion with his medical oncologist, both of you were unable to identify a current clinical trial which addressed his specific cancer state and for which he would qualify, given his near-terminal condition.

At the onset of your discussion, the patient indicates that he and his wife have learned about a new federal law that provides an accelerated pathway for patients to work directly with a drug manufacturer to utilize a drug under investigation without involving the FDA—the so-called “right to try” (RTT) law. They are hopeful that there might be an investigational drug that could be appropriate for his cancer, and want to discuss how to proceed with this process.

How should you and the medical oncologist provide a balanced analysis of the risks, benefits, and alternative choices for the patient and his wife on this critical and current topic in bioethics and clinical medicine?

Discussion

Since 2014, an increasing number of states have passed RTT laws based on the premise that some patients with terminal medical diseases are unable to access traditional Federal Drug Administration clinical trials owing to their advanced disease or exclusionary patient selection criteria. RTT laws offer the opportunity for such patients to directly petition, in conjunction with their physicians, drug manufacturers for the opportunity to be treated with a drug (or device) that has passed Phase I clinical trial testing, and is in Phase II or III testing. The drug in question will not yet have been approved by the FDA, but the clinical trial is addressing the specific disease pertinent to a specific patient. In May 2018, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017” was signed into law by President Trump.