This week I was catching up on Kaiser Health News’s What the Health? podcasts, and one of the guests* briefly mentioned that she hoped that the COVID crisis would help advance right-to-try legislation. I wondered what she meant. As someone with mainly non-terminal health issues, I have never been in a position to look for experimental treatments through the right-to-try laws. I knew that there had been a big push a few years ago, and was comforted by the fact that they existed, but didn’t know much else. I didn’t think there was anything else to know.
But of course there was. For those unfamiliar, right to try is the concept that a patient with a terminal diagnosis can approach a drug manufacturer to gain access to an investigational (approved for clinical trials but not FDA-approved for general use) drugs without applying to the FDA for a compassionate use exception, a process that is too cumbersome to be easily attempted for patients with little time left. There are clinical trials, but those take even longer and spots are limited by availability, geographic location, status of the disease, and other factors.
As it happens, right-to-try bills first started passing around 2014, but since then, only about half of the states have adopted them. Not only that, but the bills that had been passed were lacking any actual mechanism to guarantee the right to try. None have mandated that either the drug manufacturers allow access to the experimental treatments or the insurance companies pay for them. Add to that the fact that mailing drugs granted investigational new drug status for use in clinical trials to anywhere but the trial locations is illegal, and it’s no surprise that there are no known cases of a patient taking advantage of right-to-try legislation to gain access to experimental drugs.
So where does that leave us? With legislation that sounds good in a sound bite, but serves no practical purpose. Absolutely, terminal patients should be able to fight for their lives with every tool available, including those that haven’t made it through the ponderous process of FDA approval. I can think of no better exercise of patient self-advocacy than making an informed decision with your clinician to take a risk when the only way open to you is up – either it saves your life or you are in the same position as you were before.
Considering where these laws stand right now, the What the Health? guest was right. COVID could help change the right-to-try process. Both the speed with which the now-several vaccines were developed and approved, and the access to more experimental treatments like the Regeneron cocktail and convalescent plasma for patients that weren’t terminal (yet) may be the precedent we need to push for actually effective right-to-try legislation.
If you would like more information on right to try or you would like to know what you can do to help, check out righttotry.org.
*Apologies to the KHN guest, but going back through the dozen episodes I listened to this week, I couldn’t find the reference again.