Here in Minnesota, since 2015, people diagnosed with terminal illnesses have had a legal “right-to-try” medications and treatments not yet federally approved for their conditions. That right does not guarantee access. Manufacturers are not required to provide the treatments and insurers are not required to pay for them. It is simply a small regulatory carve-out for those with nowhere left to turn.
Some three dozen states have passed similar legislation in the last few years. And now, despite ferocious opposition from some of the nation’s leading bioethicists, a federal bill is being advanced to reinforce those rights. It merits strong consideration.
There is a reason state legislatures and governors in both parties have backed right-to-try bills. In Minnesota, a Republican-controlled House passed such a measure unanimously and a Democratic governor signed it promptly. They found common ground in wiping away a barrier to hope for those who had none. Responding to a groundswell of pressure, the U.S. Food and Drug Administration last year dramatically streamlined the process for its “expanded access” program, which permits use of unapproved treatments within certain guidelines. Participation is scant — just 11,000 over 10 years.
Critics argue that right-to-try offers false hope to the desperate, that it does not guarantee equal access to all patients and that it could harm patients without helping them. They fear such laws will weaken the FDA’s control over medical treatment standards and that right-to-try does not contribute to medical science’s overall understanding of drugs because manufacturers are shielded from having to formally report results.
These are not arguments to be dismissed lightly. New drugs and treatments should continue to go through a rigorous process before they are approved for general use. Clinical trials should be stringently conducted and evaluated, to test the outer limits of a treatment’s efficacy and side effects. Manufacturers should be held fully accountable. But those are not safeguards to apply to the dying.
U.S. House file 878 would not impose right-to-try on states that have not already authorized it, but would require the federal government to allow access to experimental treatments for patients whose doctors could certify that all other treatment options had been exhausted. The treatments themselves must have passed initial clinical trials and must be in the process of obtaining FDA approval. Those important restrictions should help allay fears of exploitation by crackpots hawking snake-oil concoctions.
Pennsylvania state Rep. Bob Godshall, a Republican, was told at 72 that he had multiple myeloma, a cancer that attacks bone marrow, and was given less than a year to live. He learned of an experimental treatment that might help, but the age cutoff for the clinical trial was 65. He said no one would have administered unapproved treatments if they bore liability. He signed away those rights and got the procedure. Several years later he was given an experimental drug on the same basis.
Godshall was not cured. But together, those interventions got him 14 good years. His cancer recently re-emerged, but at 84, he continues to work for right-to-try legislation in his state. “I can go home and rot, or I can work on this,” he told an editorial writer. “I chose to work on this. I want people to have the chance I had — to live.”
There are other improvements that can and should be made to improve health outcomes. This nation is in the midst of debating health care legislation that will affect far greater numbers and is of much greater concern to Americans overall. But this modest and humane legislation, which has demonstrated its bipartisan appeal across the country, should be allowed to go forward.