CHEYENNE, Wyo. — A proposed bill that would allow terminally ill patients to seek experimental drugs as a last-ditch effort to improve their condition drew conflicting testimony during a hearing before a Senate committee.
Senate File 3, also known as the “right to try” bill, would allow such patients to pursue any experimental drug, biological product or device that has passed the first phase of U.S. Food and Drug Administration clinical trials but has not yet been approved by the FDA for general use.
The use of any such drug or device would require the patient to already have a terminal prognosis, as well as a recommendation from their doctor for such treatment.
The patient also would have to provide written informed consent for the use of any such treatment, and it would be up to the drug’s manufacturer whether to actually provide the drug.
Further, the patient’s insurer would be able to choose whether to cover the expense of the experimental treatment, and the physician recommending the treatment would be exempt from any punitive action for doing so, provided their recommendations are “consistent with medical standards of care.”
Sen. Bruce Burns, R-Sheridan, the bill’s key sponsor, said five other states have implemented such a policy.
Burns argued that the patients who would be impacted by the bill were a small niche and that such patients, especially in rural areas, currently have trouble being accepted into clinical trials, given their condition.
The Senate Labor, Health and Social Services Committee on Friday took testimony on the bill from both supporters and opponents.
Cheyenne physician Dr. Rob Monger argued that the bill was unnecessary, as the FDA already has a program that allows patients to access unapproved drugs on an expedited basis. He added that it’s also not uncommon for doctors to prescribe FDA-approved drugs for off-label uses in an attempt to help a terminal patient.
“So part of the issue we have is that the bill doesn’t really change things in the real world,” Monger said, adding that the only thing the bill seems to do in his eyes is “remove the ability for the Board of Medicine to revoke licenses and discipline physicians. We think that’s a problem; the main thing the Board of Medicine does is protect the public, and in this case, you’re talking about vulnerable people, desperate people.”
But Craig Handzlik, with the Arizona-based Goldwater Institute, argued in favor of the bill, countering some of Monger’s assertions. For one, he said it can still take a while for terminal patients to access untested drugs through the FDA’s expanded access program.
Handzlik described two such patients who tried to access the program, one of whom only received the medication after months of lobbying, at which point her cancer was so far advanced that any potential benefit the medication could have provided wouldn’t have helped her.
The family of the second patient, a young boy diagnosed with bone cancer in one of his legs, found a possible treatment that had been approved for use in the United Kingdom but could not get approval to use it in the United States.
Handzlik said the boy’s family ultimately decided to move from Phoenix to the UK just to access the drug, which ended up saving the boy’s life.
The bill was held back by the committee until Monday, at which point it will be taken up again.