‘Right to try’ FDA-OK’d treatments right thing to do

It’s not a question of whether it’s an idea whose time has come, but rather one of why it took so long. The issue is the “Right to Try” legislation signed into law last week by President Donald Trump, which offers new hope to seriously ill patients all across America for whom FDA approved treatments have proven ineffective and who are not eligible to enroll — often because they are too ill — in clinical trials for new drugs still in the investigational stage. Championed by the Arizona-based Goldwater Institute and Sen. Ron Johnson, R-Wisc., the new law will allow those patients who have exhausted all other options to seek treatment with new drugs that have passed FDA Phase One clinical trials — essentially meaning they are safe but still considered experimental. Leading up to the federal law, 41 states passed right-to-try legislation (Alaska’s governor has yet to sign theirs). New Mexico, unfortunately, wasn’t one of them. The state House of Representatives approved a bill unanimously in 2017 but it didn’t get a vote in the Senate. Gov. Susana Martinez had expressed support. It’s a testament to federalism and state support that this law made it on the books (from New Mexico, U.S. Reps. Michelle Lujan Grisham, D-N.M., and Steve Pearce, R-N.M., voted for the bill; Rep. Ben Ray Lujan, D-N.M. voted “no.” It passed the Senate by unanimous consent). Yet hurdles remain. Drug companies are not required to provide the medicines, and opponents of the bill warn that “hucksters” could prey on terminally ill people. But it is important to note that: 1.) It can take up to 15 years to get a drug through the full FDA approval process. 2.) Only those terminally ill patients who have been unable to get into clinical trials and who have exhausted all other treatments are eligible to seek experimental drugs under the new law. 3.) All treatments have passed basic safety testing and remain within the FDA’s approval process. And 4.) The 97 percent of people with terminal illnesses who don’t get into a clinical trial finally get a choice and control — in hand with their physicians — to try investigational treatments. Regulations to implement the legislation are still needed, but the FDA chief says he supports the bill and access by terminally ill patients to “promising investigational medicines.” Going forward it’s essential these outcomes also become part of the FDA record as they speak to everything from efficacy to side effects. As we watch breathtaking advances in “personalized” medicine with immune system therapies, genetic-based treatments and biologics, “right to try” is more than compassionate; it makes sense. N.M. physicians and patients now have another avenue for fighting terminal diseases and expanding knowledge on what will ultimately eradicate them.