Tuesday, February 5, 2019

Trump’s ‘Right To Try’ Law Helped at Least One Person So Far. Give Credit Where It's Due.

By Mike Riggs - February 05, 2019 at 10:35PM

President Donald Trump listed his signing of a federal "Right to Try" bill during Tuesday night's State of the Union address. "To give critically ill patients access to life-saving cures, we passed very importantly, right to try," he said.

To Trump's credit, at least one person in the U.S. has been granted access to an experimental therapy under the law he signed in May 2018. Right to Try allows patients diagnosed with a "life-threatening disease" to receive directly from a pharmaceutical company an experimental drug that has begun clinical trials but has not been approved by the Food and Drug Administration.

Bloomberg News reported in January that a California man diagnosed with glioblastoma, a type of brain cancer that is generally fatal within two years of diagnosis, had been granted access in November 2018 to a therapy called Gliovac, made by the Belgian drug company Epitopoietic Research Corporation (ERC).

"The patient's family went to ERC to request the therapy after he didn't qualify for the experimental study of Gliovac or any other trial that was underway," Bloomberg News reported.

One case in just under a year is not quite what Right to Try supporters imagined; in the wake of the bill's signing, some supporters talked of hope for "millions" of patients. But it's also not the bioethical free-for-all critics feared—right to try "opens the gate to a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective," one group said.

Gliovac is in Stage 2 human trials, which means the anonymous California man is one of roughly two dozen or so people currently taking the drug. His therapy is being overseen by Daniela Bota, the co-director of the U.C., Irvine School of Medicine Comprehensive Brain Tumor Program, which means he's likely receiving the best care available for someone with this disease.

ERC's Joe Elliott told Bloomberg that there have been no side effects in the trial thus far. And despite concerns that Right to Try would lead to pharmaceutical companies charging retail prices for unapproved therapies, Elliot says the California man is paying nothing for access to Gliovac, which will conclude trials within the next 18 months. The median survival time for glioblastoma? 15 months.

The law is working for at least one person. Here are some likely reasons why it's not working for more.

from Reason Magazine Articles