by Christina Sandefur
October 9, 2018
The Goldwater Institute developed the Right to Try because thousands of Americans every year suffer and die while treatments that could help them are awaiting the outcome of a slow, bureaucratic process—a process that takes, on average, 15 years before potentially lifesaving treatments can receive final government approval for sale. Right to Try is a declaration that in our free country, people should be able to decide for themselves—in consultation with their doctors—whether to try medicines that could save their lives.
On this episode, we talk about why Right to Try was needed. After all, the FDA already has a process—the compassionate use program—whereby patients can ask for an exception to get access to treatment. But that process is highly bureaucratic and woefully inadequate to address terminal patients’ needs. After all, the FDA process only helps about 1,000 individual patients per year. To put that in perspective, over 40,000 women die of breast cancer this year.
I explain that Right to Try is needed because the FDA’s existing system provides little incentive for pharmaceutical companies to help patients outside of a government-approved clinical trial because bad results must be reported to the FDA, even if those results are related to a patient’s other ailments and not the drug itself. These “adverse events” can damage a company’s chances of obtaining final FDA approval and even destroy the company’s financial viability. Yet data showing that the treatment is successful when administered outside of a trial is not counted in favor of the company. Right to Try removes this powerful disincentive against providing treatment and also removes the requirement that dying patients must ask the federal government for permission to try a treatment that is already safely being given to the patients who have made it into clinical trials.
How did we get here? In the podcast, I explain that at their inception, federal drug regulations were geared toward ensuring that products marketed to the public were safe and correctly labeled, so that patients had truthful information. But over time, the FDA’s focus shifted from empowering patients to make their own decisions to replacing the patient as the decision-maker. This reached fruition in 1962, when the law required manufacturers to “provide substantial evidence of effectiveness for the product’s intended use.” Even though the FDA is not authorized to regulate medical practice at all, prohibiting patients from making their own informed decisions imposes de facto regulation on patients—and doctors—nationwide.
But what right have we to control such a fundamental aspect of another person’s being?
On the podcast, we talk about some critics of Right to Try who say that patients don’t have enough information to make their own decisions. But no one—not pharmaceutical companies, nor academics, nor doctors, nor the FDA—knows all the information necessary to make the “right” decision about treatment. That’s all the more reason that the government shouldn’t have a monopoly on medical decision-making. The decision should belong to the patient—after all, it’s her life! That’s what Right to Try is all about—restoring to patients the most fundamental right of all: the right to try to save their own life.
Right to Try has saved lives already, and it will continue to save lives. And despite the enormous power government still wields over our healthcare decisions, I believe there is good reason to be optimistic that this is starting to change. The success of Right to Try shows that our Founders’ promise to our nation, the right of every person to life, liberty, and the pursuit of happiness—the right to hope—has not dimmed. We have it in our power to fix many national problems from the ground up, peel back at the bureaucracy, and empower people to live freer, happier, more hopeful lives.
You can listen to the full podcast here.
Christina Sandefur is the Executive Vice President at the Goldwater Institute.