Some have argued that these laws have been driven by a dislike of both drug regulation and the FDA. After all, they are designed to achieve the same result as the compassionate use program. The only difference is that they bypass the FDA.
Either way, it’s worth noting just how early-stage these treatments are. A drug that has been through phase I trials might have been tested in just 20 healthy people. Yes, these trials are designed to test the safety of a drug, but they are never conclusive. At that point in a drug’s development, no one can know how a sick person—who is likely to be taking other medicines— will react to it.
Now these Right to Try laws are being expanded even more. The Montana bill, which goes the furthest, will enable people who are not seriously ill to access unproven treatments, and other states have been making moves in the same direction.
Just this week, Georgia’s governor signed into law the Hope for Georgia Patients Act, which allows people with life-threatening illnesses to access personalized treatments, those that are “unique to and produced exclusively for an individual patient based on his or her own genetic profile.” Similar laws, known as “Right to Try 2.0,” have been passed in other states, too, including Arizona, Mississippi, and North Carolina.
And last year, Utah passed a law that allows health care providers (including chiropractors, podiatrists, midwives, and naturopaths) to deliver unapproved placental stem cell therapies. These treatments involve cells collected from placentas, which are thought to hold promise for tissue regeneration. But they haven’t been through human trials. They can cost tens of thousands of dollars, and their effects are unknown. Utah’s law was described as a “pretty blatant broadbrush challenge to the FDA’s authority” by an attorney who specializes in FDA law. And it’s one that could put patients at risk.
Laws like these spark a lot of very sensitive debates. Some argue that it’s a question of medical autonomy, and that people should have the right to choose what they put in their own bodies.
And many argue there’s a cost-benefit calculation to be made. A seriously ill person potentially has more to gain and less to lose from trying an experimental drug, compared to someone who is in good health.
But everyone needs to be protected from ineffective drugs. Most ethicists think it’s unethical to sell a treatment when you have no idea if it will work, and that argument has been supported by numerous US court decisions over the years.
