Dying patients shouldn't have to fight the federal government

Photo by Delcia Lopez

Andrea Sloan was a fixture at the Texas Capitol. When she was diagnosed with breast cancer, she had elected officials in her corner helping make sure every possible treatment avenue was explored.

No system will ensure against all risks. The question, then, is who should ultimately determine what level of risk is acceptable to a patient — federal officials or patients themselves, in consultation with their doctors?

But Andrea and her friends found out the hard way that Americans could be blocked from potentially lifesaving medicines and treatments unless they receive a permission slip from the U.S. Food and Drug Administration. And that permission can take months — time dying patients do not have. Andrea got her permission slip, but it was too late; she died just days after finally getting the green light to try a treatment that was being safely used in clinical trials.

The injustice of stories like Andrea’s, which happen every day, is why in just two years, 31 states — including Texas, with a unanimous vote in the state House and Senate — have passed “right to try” laws to circumvent the bureaucracy and give dying patients a chance at life.

Yet some critics, such as Michelle Rubin and Kirstin R.W. Matthews in a recent TribTalk column, argue these laws, which protect patients’ right to try to save their own lives with investigational medicines that are safely being used in clinical trials, are misguided reforms that are better settled at the federal level.

Decades of attempts to change this system in Washington have met with little success, leaving patients to suffer in limbo with no say in their own destinies. State "right to try" laws are premised on the principle that each of us owns our own lives. They embody the principle of autonomy — which is not just a cornerstone of medical ethics but also one of the basic principles of freedom guaranteed by state and federal constitutions. It is unethical and unconstitutional for government to deny anyone that right — especially patients facing certain death.

The FDA’s system presumes that patients should not have access to medicine until federal officials certify it as both safe and effective. But dying patients face a different risk/benefit calculus. "Right to try" recognizes that if they want to try an investigational treatment that may bring serious risks — but might also save their lives — that choice should be theirs.

"Right to try" is not a guarantee that investigational medications will work, or that patients and doctors will have perfect information to inform their decisions. But the current FDA system is none of these things, either. After all, even fully approved medicines are sometimes withdrawn from the market when undetected risks materialize.

No system will ensure against all risks. The question, then, is who should ultimately determine what level of risk is acceptable to a patient — federal officials or patients themselves, in consultation with their doctors? "Right to try" advocates believe that patients should not be forced to beg for government permission to before trying medicines that might help —medicines that even the FDA itself already considers safe enough to administer in clinical trials.

Rubin and Matthews acknowledge that the FDA’s process for accessing potentially lifesaving medications “has been justifiably critiqued as being arduous and lengthy,” but nevertheless advocate that patients should “work with the FDA” to make its process “more straightforward for patients and physicians” because “the FDA has recently taken steps in the right direction.”

Desperate patients have been seeking FDA reform for decades, and it wasn’t until the state "right to try" movement that the FDA was forced to acknowledge the difficulty that patients face in securing treatments through the Agency’s Expanded Access program.

Even then, two years after Colorado enacted the first state "right to try" law, all the FDA has done is announce its efforts to reduce the paperwork patients and their doctors must fill out and its intention to create a new position to guide patients through the Agency’s labyrinth. Shorter forms and hand-holding bureaucrats do not address the system’s fundamental flaw: The FDA bars access to potentially life-saving medicines without a government permission slip.

"Right to try" isn’t about reforming a broken system — dying patients are beyond that. It’s about protecting and preserving the most fundamental freedom of all. Terminally ill patients have a basic human right to try to save their own lives. Yet our drug approval system routinely denies people like Andrea Sloan that right, often with deadly consequences. Today’s obsolete federal drug regulation process rewards delay and prioritizes bureaucracy over the interests of patients who are now suffering from terminal diseases. That needs to change. People like Andrea deserve better.

Terminal patients have enough on their hands fighting for their lives. They should not have to fight the government, too.

Christina Sandefur

Executive vice president, Goldwater Institute

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