Posted on August 11, 2018 at 5:00 AM
I just published my 8th Law and Ethics in Oncology column in the ASCO Post: “Why Oncologists Should Decline to Participate in the Right to Try Act.”
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.