In Oregon, the terminally ill can take advantage of our “right to die” (aka death with dignity) law. Should the terminally ill have access to experimental therapies? A “right to try,” as it were?
The federal government says no, but 22 states have passed laws that say yes. Oregon could be the next to do so this July as the Legislature winds to a close.
Since 2014, laws giving patients expanded access to potentially life-saving but unproven therapies, so called right-to-try legislation, has been proposed in more than half the country, according to the Regulatory Affairs Professionals Society. Many places, including Colorado and Missouri, have passed these bills.
“It has a very compelling story behind it,” says Dennis McNannay, executive director of the Oregon Biosciences Association. “In its most simplistic form why would we not give the terminally ill a drug that might save their life? But there is a tremendous amount of nuance.”
A new drug could prove miraculous, reducing pain or symptoms, sending a disease into remission, maybe even curing the condition, as some are sure to hope. The dark side of an investigational product, given the lack of testing, is that it could go awry and increase patients’ pain, worsen their condition or end their life.
The core legislation that Oregon is considering was developed by the Goldwater Institute in Arizona, a conservative organization that advocates nationally for “constitutionally limited government,” according to its website. Oregon’s law is based on that language with minor adjustments.
That legislation in turn is based on the FDA’s “compassionate use policy.” The FDA has a strict, three-stage process for approving new medicines, but in cases where the patient is terminal, certain treatments can be approved under compassionate use. Oregon’s House Bill 2300-A would allow patients to try therapies that have passed the FDA’s first assessment, but it would not instruct doctors or companies to provide that treatment.
Critics argue the laws sabotage the FDA regulatory process and don’t offer as much hope as people would like to think.
Democratic Sen. Elizabeth Steiner Hayward tells EW, “It’s a very messy problem. These laws haven’t been around long enough for us to know how they will pan out.” She advocates waiting a year or two to see how it goes in the other states.
“People could be stuck with enormous medical bills,” Steiner Hayward says. “That can make it an issue of social justice,” because the rich can access these drugs, but the poor could not.
In the current bill, insurance companies would not have to cover the investigational products.
Speaking June 22, Dr. Samuel Metz, a Portland-based physician, said he was “deeply conflicted” about the right-to-try laws. He said there would be less than one Oregonian per decade who could use the bill. “Medical ethicists are uniformly against right-to-try laws” because of the possibly delays it could cause in approving drugs and the potential for exploitation of families by firms.
McNannay says one of the main reasons against the bill was that patients were more likely to suffer an adverse reaction to experimental treatments.
“There’s a whole lot more to this issue,” he says. “The more you learn about this issue, the more complex it gets.”