Arizona voters on Tuesday became the latest state to approve a law providing terminally ill patients with greater access to unproven medical treatments, following in the footsteps of four states enacting similar measures this year.
Arizona's new law marks the first time a so-called "Right to Try" measure was approved by ballot initiative — and did so convincingly — after Colorado, Louisiana, Missouri and Michigan all passed laws in the past six months. Interestingly, there's a pop culture peg that seems to be providing momentum to this movement. These laws are drawing comparisons to the 2013 movie "Dallas Buyers Club," in which Matthew McConaughey portrays an AIDS patient in the mid-1980s who smuggles in unregulated pharmaceutical drugs from across the border.
These laws are supposed to open up access to drugs that passed through just the first stage of clinical trials and are part of ongoing trials. They've been backed by families of sick patients, who say the current FDA approval process for experimental treatments, despite having a 99 percent approval rate, is just too cumbersome. Here's how the FDA's current system for approving the use of experimental treatments works, according to a USA Today editorial supporting these "Right to Try" laws.
Food and Drug Administration rules require patients to clear a series of hurdles. First, they and their doctors must find a company to provide its drug. Many drug makers — worried that a patient's death will spur a lawsuit or harm their chances for final FDA approval — refuse.
Even then, patients still need a hospital review board to sign off, a contract between the hospital and the drug maker, and FDA approval. The FDA application process, according to its own estimates, can take up to 100 hours.
That's time that dying patients feel they might not have. Under these new state laws, patients would only need approval from the drug company and a doctor's prescription.
Critics of the "Right to Try" laws say these unproven treatments could hurt patients and the drug development process. Further, the drugmakers don't have to provide these treatments, and there are reasons why they might not want to, including liability concerns and a lack of supply early into a drug's development. And insurers don't have to cover the drugs.
New York University bioethicist Arthur Caplan has criticized these laws as a "feel-good" effort that doesn't tackle the main problem — being able to afford these expensive treatments. That goes for the families who want to pay for the drugs, and the small companies funding the lengthy process of getting a drug to market.
The FDA hasn't formerly weighed in on these laws, though agency officials have expressed concern. The Goldwater Institute, a conservative think tank that's been pushing these efforts across the country, says to expect bills in more state legislatures next year.
So the debate on these laws, it seems, is just getting started.