Why Oncologists Should Decline to Participate in the Right to Try Act
ASCO Post (August 10, 2018)
10 Pages Posted: 28 Aug 2018
Date Written: August 10, 2018
Abstract
On May 30, 2018, President Donald J. Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. This law creates an additional and alternative pathway for patients with a “life-threatening disease or condition” to access investigational medicines outside the clinical trial system. Since there are more than 1,100 cancer medicines currently under investigation, this law will materially impact oncology patients and clinicians. Specifically, because of the sense of hope and expectation that the new law has created, increasing numbers of patients with cancer will be asking their oncologists questions about the Right to Try Act. Here, we offer guidance on how oncologists should respond to these questions and outline strong concerns regarding the right-to-try program. The U.S. Food and Drug Administration’s (FDA’s) long-standing expanded access program to investigational drugs—also referred to as compassionate use—already provides a way for patients to access unapproved medicines outside a clinical trial, offering all the same benefits as the right-to-try law with fewer risks. Because the extra risks posed by the Right to Try Act are not offset by any countervailing benefit, it would be unethical for oncologists to use it to gain access to an experimental drug for their patients. [NOTE - The ASCO Post, in partnership with the American Society of Clinical Oncology (ASCO), communicates news of evidence-based multidisciplinary cancer care to a broad audience of 30,000 oncology professionals and ASCO members. Professor Pope authors a monthly Law and Ethics in Oncology column that explores the legal and ethical issues oncologists must be aware of in this era of precision medicine and changing health-care policy, both to protect patients’ rights and to safeguard against potential legal jeopardy.]
Note: Reprinted from The ASCO Post, with permission from Harborside. © 2018.
Keywords: Right to Try, FDA, Drugs, Pharmaceutical, Experimental, IRB
JEL Classification: I18, K19, K23
Suggested Citation: Suggested Citation