In the past three years, 33 U.S. states have passed laws aimed at helping dying people get easier access to experimental treatments. Supporters say these patients are just looking for the 鈥渞ight to try鈥 these treatments.
Such laws may sound compassionate, but medical ethicists warn they pose worrisome risks to the health and finances of vulnerable patients.
California鈥檚 right-to-try law was enacted in January. It protects California doctors and hospitals who want to prescribe any medicine that has successfully made it through a Phase 1 drug trial. That鈥檚 the first stage of human testing required by the Food and Drug Administration 鈥 the sort of study that focuses merely on a drug鈥檚 safety, not its effectiveness.
Ian Calderon, a Democrat from Southern California and majority leader in the state鈥檚 Assembly, was one author of the law. He said that if he had just received聽a terrible diagnosis, he would want to try anything possible to live.
鈥淢y thought would be, 鈥榃hat do I have to lose?鈥欌 Calderon said. 鈥淚 have an opportunity to potentially find a cure. Or at least find something that prolongs my life 鈥 find something that could help me.鈥
He said the law seemed to him the logical next step, after California passed a law in 2016 permitting physician-assisted death.
鈥淚t鈥檚 inhumane to have a law on the books that allows you to end your own life, but no law on the books that allows you to fight to extend it,鈥 he argued. 鈥淭hat just seems counterintuitive.鈥
Proponents contend that some doctors have been hesitant to help dying patients, for fear of being penalized for using drugs or devices that don鈥檛 have FDA approval.
California鈥檚 law ensures that doctors can help patients petition to get an investigational medicine from drugmakers without fear of censure from the state鈥檚 medical board. It eliminates regulatory obstacles on the state level and creates processes for patient consent and data collection.
Lina Clark and her husband David Huntley on vacation in Croatia in 2014. Before he died of complications from ALS in 2015, Huntley鈥檚 illness prompted them both to become activists, lobbying for California鈥檚 right-to-try law. (Courtesy of Lina Clark)
, a San Diego State University professor who died from ALS, or Lou Gehrig鈥檚 disease, in 2015, was among the patients who fought for California鈥檚 law. Before he died, Huntley testified in favor of the bill from his wheelchair.
His widow, Lina Clark, founder of the patients鈥 advocacy group , said her husband completely understood what was at stake.
鈥淭he patient community is saying: We are smart, we鈥檙e informed, we feel it is our right to try some of these therapies, because we鈥檙e going to die anyway.鈥
It鈥檚 a compelling argument, but there are serious risks, according to doctors and medical ethicists.
鈥淲e know some people try to take advantage of our desperation when we鈥檙e ill,鈥 said聽, director of the聽聽at University of California, San Francisco. 鈥淚f we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?鈥
Dudley said the FDA and the clinical trial process were put in place for a reason 鈥 not just to shut out would-be snake oil salesmen, but聽to ensure that manufacturers are producing a safe product and not cutting corners.
鈥淚f you say there鈥檚 a path that鈥檚 not through the FDA,鈥 he said, 鈥渢hen there are billions of dollars out there to be made by skipping the important steps that we鈥檝e developed.鈥
The new state laws are called 鈥渞ight to try,鈥 Dudley said, but all that patients can really do is ask for an experimental medicine. Drug companies don鈥檛 have to give them the medicine, and insurance companies don鈥檛 have to pay for it.
David Huntley testified in favor of California鈥檚 right-to-try bill in April 2015 in Sacramento. He died three months later. (Courtesy of Lina Clark)
Dudley said patients could spend huge amounts of money trying a drug that hasn鈥檛 been proven to work. And the patient may also be giving up their hopes for a controlled, peaceful death at home.
鈥淚nstead, you try a drug and you get very severe lung problems,鈥 he said, 鈥渁nd you end up on a breathing machine in a hospital. That could cost hundreds of thousands of dollars.鈥
Although nearly three dozen right-to-try laws are now on the books, researchers at New York University who鈥檝e been looking for evidence of the laws鈥 usefulness haven鈥檛 yet found a single substantiated case of a patient getting a drug using a state law.
That鈥檚 partly, perhaps, because the to help patients and their doctors apply for the use of experimental drugs (and such requests are nearly always approved). Still, Calderon and others point out that the process entailed in these 鈥渃ompassionate use requests鈥 is much too slow and cumbersome for many patients who are dying.
A new federal research law might help change that. The requires drug companies to be more transparent about how they decide who gets experimental access to promising medications, and how long it will take.
This story is part of a partnership that includes , and Kaiser Health News.