Pharma

Goldwater Institute EVP and attorney/bioethicist to debate Right to Try – and we’ll live stream it

The Right to Try debate involving patients’ right to experimental drugs is a thorny topic that will be debated by experts holding opposing viewpoints. The discussion, part of MedCity CONVERGE in Philadelphia, will be live streamed via Facebook Live on Aug. 1.

There’s nothing like a verbal tug of war over a hot-button topic in healthcare and making that available to numerous people through the magic of live streaming.

And that’s what MedCity intends to do with one of the most emotionally charged issues in healthcare: the Right to Try (RTT) legislation, which makes it easier for critically ill patients to access experimental drugs that have completed Phase 1 FDA testing and thereby are unapproved.

Supporters of RTT at the state and national level argue that it gives patients access to potentially life-saving treatment. But the legislation varies among the 37 states that have passed it. Those opposing it observe that the feel-good legislation leaves too many unanswered questions about patient safety and note that the FDA’s expanded access program (also referred to as compassionate use) lets doctors petition the regulator for access to experimental treatments on behalf of patients.

This issue will be the focus of a lively debate at the MedCity CONVERGE conference, which is focusing on innovation in cancer in Philadelphia, July 31 to August 1. The RTT session, which will begin at 3:45 PM ET will be live streamed on MedCity’s Facebook page via Facebook Live.

Representing the pro Right to Try position will be Christina Sandefur, executive vice president of the Goldwater Institute, which has been on the forefront of moving the legislation forward. Her sparring partner will be Beth Roxland, Associate of the Division of Medical Ethics at NYU, and a Senior Legal and Policy Consultant. The panel will be moderated by Peter Loftus, a reporter with The Wall Street Journal.

There’s no shortage of debate over which approved drugs insurance companies should cover. Payers aren’t about to cover the expense of experimental treatments, so who pays for these investigational drugs outside the confines of a clinical trial? Who pays when patients suffer from the unknown side effects of these treatments?  Could unexpected reactions to an experimental drug prolong the already costly drug development process?

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The ethical issues at the center of the case of British infant Charlie Gard illustrate how the emotionally fraught debate over experimental treatment is spilling over into mainstream news. The infant was born with a rare genetic condition causing progressive muscle weakness and brain damage. His parents tried to arrange for him to receive experimental treatment — nucleoside therapy at Columbia University Medical Center in the U.S. The effort was backed by U.S. President Donald Trump and Pope Francis. The parents fought Britain’s courts, which refused permission, claiming it would prolong the infant’s suffering, a Reuters report noted. Ultimately, doctors convinced the parents the disease was too far advanced for the treatment to help the child.

Which side did you find yourself rooting for? What ethical questions does RTT raise for you? Submit some that you’d like our CONVERGE debate moderator to ask Sandfeur and Roxland by clicking on the link below and become part of what is undoubtedly going to be a fascinating discussion.


Submit Your 'Right To Try' Questions Here

Photo: Ieremy, Getty Images