September 17, 2019 | The Los Angeles Times
The Koch-Backed Right-to-Try Law Has Been a Bust — But Still Threatens Our Health
The greater threat of right-to-try is to the broad American public. As Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warned last year in the New England Journal of Medicine, granting patients with life-threatening illnesses a “right to try” experimental drugs without FDA oversight is a slippery slope. “This logic could ultimately extend to patients with serious chronic illnesses and … to all patients who find their approved treatment options unsatisfactory.”
The consequences could reach all patients who depend on the FDA to determine the safety and efficacy of drugs. “Are we prepared to abandon the FDA’s gatekeeping role in favor of unfettered patient autonomy and market forces,” Fernandez Lynch and Joffe asked, “risking precisely the problems that prompted Congress to grant the FDA its present authority?”
As it has turned out, most responsible drug companies don’t relish the latitude granted them by the right-to-try law. They prefer the oversight afforded by the FDA process, which requires a physician to be closely involved in the application for access and keeps the FDA in the loop. Only companies hoping to profiteer from the desperation of terminal patients and their families tend to show interest in right-to-try — them, and right-wing ideologues who believe that a government regulator’s efforts to protect consumers from useless or dangerous drugs is an unacceptable infringement on individual liberty.
On the plus side, most drug companies seem still to desire to play it straight. On the negative side, right-to-try was the first step in eroding the authority of one of the nation’s most important agencies safeguarding public health. Members of the public — those who suffer from terminal diseases and those who just want safe and effective drugs for any condition — are the losers.