Terminally ill patients in Nevada could take advantage of experimental drugs that haven’t finished a lengthy vetting by the U.S. Food and Drug Administration if a “right to try” bill passes the state Legislature.
The Assembly Health and Human Services Committee held a hearing Friday for AB164, which would allow patients to use drugs that have cleared the first phase of testing by the FDA as long as they’re supervised by a doctor. Similar laws have passed in five states, and are under consideration in more than two dozen others.
“I hope that this passes,” said Assemblyman James Ohrenschall, a Las Vegas Democrat who’s sponsoring the bill. “It will make life a little easier in terms of getting medications that may work.”
Supporters point out that the rigorous FDA approval process can take 10 to 15 years, and many patients will die before new drugs come on the market. Some participate in clinical trials, but only a small percentage of patients are admitted and many may be blocked because they live too far from a research hospital.
Sick patients can use the federal “compassionate use” exemption that allows use of drugs that don’t have final federal approval, but the application process is onerous and only about 1,000 people a year use the exemption out of the estimated 600,000 people diagnosed with terminal cancer each year, according to witnesses from the Arizona-based libertarian think tank The Goldwater Institute.
The bill would only allow drugs that have successfully passed the first stage of FDA approval, which determines whether a treatment is unacceptably toxic. Representatives at The Goldwater Institute testified that about 40 percent of drugs submitted to the vetting process don’t pass the first phase.
“We’ve tried to make sure we’re not opening the door to snake oil salesmen or charlatans that would take advantage of peoples’ desperation,” Ohrenschall said.
Many committee members expressed support for the concept. But they also raised concerns about the broad range of patients who might be eligible under the bill’s current language, which covers patients who have been “diagnosed with a terminal condition.” By other definitions, a person is not terminally ill unless they have less than a year to live or less than six months to live.
Others asked who would decide the cost of the treatments, and whether desperate patients might be gouged in the process.
“When patients have been diagnosed with terminal illness, they’ll do just about anything to save their lives,” said Republican Assemblywoman Robin Titus, who’s a doctor.
The Nevada State Medical Association suggested the bill require a second opinion from another doctor before beginning a course of experimental treatment. The organization also recommended a more robust consent form so patients understood the implications of taking a drug not approved by the FDA.
“Those consequences could include preclusion from future trials, should the patient have otherwise qualified, and potential revocation of eligibility for hospice care,” said association director Stacy Woodbury.
The committee did not take a vote on the bill.
Use the comment form below to begin a discussion about this content.
Sign in to comment