The idea that individuals have a right to access experimental treatments has in fact failed in US courts in the past, says Carl Coleman, a bioethicist and legal scholar at Seton Hall in New Jersey.
He points to a case from 20 years ago: In the early 2000s, Frank Burroughs founded the Abigail Alliance for Better Access to Developmental Drugs. His daughter, Abigail Burroughs, had head and neck cancer, and she had tried and failed to access experimental drugs. In 2003, about two years after Abigail’s death, the group sued the FDA, arguing that people with terminal cancer have a constitutionally protected right to access experimental, unapproved treatments, once those treatments have been through phase I trials. In 2007, however, a court rejected that argument, determining that terminally ill individuals do not have a constitutional right to experimental drugs.
Bateman-House also questions a provision in the Montana bill that claims to make treatments more equitable. It states that “experimental treatment centers” should allocate 2% of their net annual profits “to support access to experimental treatments and healthcare for qualifying Montana residents.” Bateman-House says she’s never seen that kind of language in a bill before. It may sound positive, but it could in practice introduce even more risk to the local community. “On the one hand, I like equity,” she says. “On the other hand, I don’t like equity to snake oil.”
After all, the doctors prescribing these drugs won’t know if they will work. It is never ethical to make somebody pay for a treatment when you don’t have any idea whether it will work, Bateman-House adds. “That’s how the US system has been structured: There’s no profit without evidence of safety and efficacy.”
The clinics are coming
Any clinics that offer experimental treatments in Montana will only be allowed to sell drugs that have been made within the state, says Coleman. “Federal law requires any drug that is going to be distributed in interstate commerce to have FDA approval,” he says.
White isn’t too worried about that. Montana already has manufacturing facilities for biotech and pharmaceutical companies, including Pfizer. “That was one of the specific advantages [of focusing] on Montana, because everything can be done in state,” he says. He also believes that the current administration is “predisposed” to change federal laws around interstate drug manufacturing. (FDA commissioner Marty Makary has been a vocal critic of the agency and the pace at which it approves new drugs.)
At any rate, the clinics are coming to Montana, says Livingston. “We have half a dozen that are interested, and maybe two or three that are definitively going to set up shop out there.” He won’t name names, but he says some of the interested clinicians already have clinics in the US, while others are abroad.
Mac Davis—founder and CEO of Minicircle, the company that developed the controversial “anti-aging” gene therapy—told MIT Technology Review he was “looking into it.”
“I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism,” says Livingston. “There is no other place in the world with this sort of regulatory environment.”
