President Trump again touted “right-to-try” legislation during the State of the Union. Many of its provisions would harm patients rather than help them.
While President Trump’s State of the Union address last night was light on health topics, he again called on Congress to pass a federal “right-to-try” law. Such a measure would allow terminally ill patients access to experimental drugs from drug companies.
At face value, the law sounds like a no-brainer. After all, if a seriously ill patient has run out of options to treat a condition, why not allow them to try an experimental treatment as a last resort?
There are plenty of reasons why the law is a bad deal for patients.
First, a pharmaceutical company can give a drug to a patient with little information on whether the drug is effective, and what the side effects are. Second, there are no legal safeguards for the patient in case they are harmed by the experimental treatment. In fact, a company is freed of any liability should something go wrong. Third, any results from a drug given under “right-to-try” are not considered by the FDA when later evaluating the drug for approval.
The good news is that there is already an existing program that allows terminally ill patients access to experimental treatments but without the risks of “right-to-try.” It’s called Expanded Access. Under the program, the FDA receives a request from a doctor on behalf of a patient to try a non-approved drug. The FDA reviews it within 4 days (on average) and within 1 day in emergencies. It is rare for the FDA to not to approve a request.
Because the drug is in clinical trials, the FDA has researchers working with the drug companies on the trial. Patients can get an unbiased medical opinion from FDA scientists about the chances for success and the risks of adverse events and debilitating side effects.
Right-to-try laws provide “a way for drug companies to test experimental treatments without having any responsibility if something bad happens to a patient while taking it.”
If there’s an existing framework for patients to gain access to experimental drugs, why the push for “right-to-try.” Simple. It provides a way to undermine the FDA’s regulatory authority. Worse, it provides a way for drug companies to test experimental treatments without having any responsibility if something bad happens to a patient while taking it.
Right-to-try laws are currently on the books in 38 states. But as David Gorski, MD, an oncologist who runs the insightful Respectful Insolence blog, writes, state right-to-try laws have a more nefarious objective. “The purpose of state-level right-to-try laws was never really to help terminally ill patients. It was to put pressure on lawmakers to pass a federal right-to-try law as a first big step towards weakening the FDA.”
Don’t be fooled by proponents of “right-to-try” laws. While it appears to be noble, there is nothing noble about subjecting desperate patients to experimental treatments without proper safeguards and attempting to undermine the FDA’s authority in protecting patients.
