The opposition to Federal Right to Try legislation is not as vocal as it should be. After all, who wants to oppose the right to try for those dying from cancer and other ailments? Not Vice President Mike Pence who has been promoting a Federal law for months https://www.bloomberg.com/news/articles/2017-02-08/pence-piles-on-drugmakers-with-push-for-right-to-try-regulation.
But right to try laws offer nothing but false hope. In the more than 30 states that have enacted law including Indiana under then Governor Pence’s signature, no one has gotten access to any drug, oncological or otherwise. Despite a catchy name the right to try turns out to offer nothing but a right to beg those who own experimental drugs to give them away. Nothing in the state or Federal laws mandates that companies give anything to anybody. The laws spend a lot of time fuming about the FDA being in the way while ignoring the fact that the FDA does not control access to experimental drugs—companies do. And Pence and his supporters in Congress do not seem inclined to tell companies that they have to do much of anything these days.
So if right to try is basically a lie then what ought be done to help those dying from cancer to get a last ditch shot at an experimental drug or biologic?
Here are three things that Congress should be doing if they truly cared about helping the terminally ill.
- Budget for and build internet resources to help identify experimental and innovative drugs, vaccines, and devices including improving clinicaltrials.gov to make it consumer friendly which it currently is not. If you just found out you have an incurable cancer, if you or your oncologist can’t find the latest experimental drug on the internet or in databases it is a certainty neither you nor anyone else will get it.
- Create and budget for funds to pay for compassionate use costs including paying small companies for their drugs and helping to cover the costs of patients and families who need to travel to get an experimental drug.
- New drugs and vaccines for cancer are often expensive to make and thus are almost always in short supply. If there is nothing to give no one has anything to get. Once an agent is showing some safety and efficacy then and only then should it be offered. Consider requiring 2% of any new cancer drug be made for compassionate use for the dying and that it be made available after Phase 2 studies.
The dying who want to try untested drugs and treatments do not need catchy phrases or empty rhetoric. They need a chance to find what is out there and the ability to access it. If Congress and the Vice President won’t take these steps then they are not offering much except empty platitudes to the sickest Americans.
Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Bioethics at New York University Langone Medical Center in New York City. He is currently a member of the University of Pennsylvania’s External Advisory Committee for its Orphan Disease Center and a member of the Ethics and Ebola Working Group of the World Health Organization. Dr. Caplan also serves as the Chairperson of the Compassionate Use Advisory Committee (CompAC), an independent group of internationally recognized medical experts, bioethicists and patient representatives which advises Janssen/J&J about requests for compassionate use of some of its investigational medicines.