Experimental Treatments, Innovations, and Giving Patients a Fighting Chance

At age 15 and out of hope, Nick Zerwas’s life was saved by a last-ditch experimental heart surgery. As CEO of a cutting-edge medical device company, Howard Root improved the lives of thousands of patients suffering from vascular disease. Yet incredibly, the federal government stands in the way of the kinds of treatments that saved Nick’s life and the cutting-edge products that Howard brought to market. This week, I joined the Minnesota Lawyers Chapter of the Federalist Society to talk with both of them about how government red tape stifles healthcare innovation and what we can do to unleash the future of medicine so that more patients can get the treatments they need.

The Food and Drug Administration (FDA) is perhaps the federal agency most plagued by bureaucratic inertia. Medical innovation has long outpaced FDA regulation, at the expense of patients in need. While the FDA did fast-track the study of COVID-19 vaccines, that’s the rare exception to its exceedingly sluggish drug approval process, which can take decades to approve treatments.

Although the FDA is not authorized to regulate the practice of medicine, the Agency routinely intrudes on the doctor-patient relationship. Created over a century ago to empower patients to make medical choices, the FDA now blocks patients from making these choices and even takes away the tools they need to make informed decisions.

Former Minnesota state representative Nick Zerwas knows all too well how red tape can keep cutting-edge treatments away from patients – and how giving patients a chance can save their lives. Born with a three-chambered heart, at age 15, doctors told Nick he was dying. Then his doctor learned of a long-shot experimental surgery that involved removing part of his heart and replacing it with a cow’s. Luckily for Nick, the doctor had the resources and wherewithal to secure government permission for him to get the treatment. And it saved his life.

Howard Root had firsthand experience with the FDA’s overreach. For decades, he served as the head of a medical device company whose treatments improved the lives of many patients suffering from vascular disease. But thanks to overzealous FDA regulators, he suddenly found himself facing criminal charges and prison, simply because someone at his company had shared honest information with a doctor about a lawful treatment.

In reaction to the FDA’s intransigence, my colleagues and I at the Goldwater Institute worked with patients, doctors, advocates, and policymakers across the country to pass the Right to Try, a law which allows terminally ill patients to try safe, investigational medicines that aren’t fully FDA approved. Nick was one of those policymakers. Decades after his own lifesaving treatment, he worked to pass Right to Try as a legislator in Minnesota so that others could have that same chance he did. After 41 states passed Right to Try with overwhelming bipartisan support, it became law in 2018. Right to Try is saving and improving lives across the country. We developed the Right to Try because the right to make one’s own medical choices, especially when faced with a terminal illness, is fundamental. It’s both unethical and unconstitutional to deny a dying person that choice.

There’s more work to do, though, to expand access to care, including ensuring that doctors have the most up-to-date information about treatments. As Howard Root learned, federal law and FDA practices often keep doctors and patients in the dark. This is especially true of “off-label” treatments, which is the legal prescription of drugs for purposes, patients, or dosages different from what the FDA approved. Although off-label treatments are perfectly legal and extremely common, federal law often prohibits manufacturers from sharing truthful scientific information about their treatments with doctors. This FDA gag rule ultimately harms patients, whose doctors and insurance companies are often unaware of the best standards of care. Although courts have said that stifling off-label speech violates the First Amendment, the FDA has repeatedly ignored these rulings and continues to harass medical innovators, even charging them with crimes for doing nothing more than sharing important information that could help patients. So the Goldwater Institute is working on a new reform measure to protect Truth in Medicine. It’s already law in Arizona and Tennessee and is under consideration in a number of other states.

For more about these incredible personal stories and a deeper discussion about how the FDA gets in the way of rapid, responsive, cutting-edge healthcare, check out the video of the event here.