How Do We Protect Patients From False Promises In Right-To-Try Laws?

My sister Gale had exhausted every option. Metastatic cancer raged through her body, defeating all conventional treatments. She faced a final decision: succumb to the disease, or wage one last battle with an experimental bone marrow transplant known to kill 20 percent of patients. Gale chose to fight, opting to use the unproven therapy at a time when institutional review boards and scientific peer review regulated experimental therapies rather than the Food and Drug Administration (FDA). Now, three decades later, the FDA has an expanded access policy, also known as “compassionate use,” that seeks to ensure the quality of unproven therapies used by dying patients. In Gale’s case, the side effects of the treatment were swift and violent. Within two days, she was dead. Clinical trials have since demonstrated that the therapy had limited efficacy and a greater risk of lethality than reported at the time. Legislation before Congress seeks to grant all terminally ill patients the “Right to Try” experimental therapies once approved alternatives have failed. Although the FDA authorizes 99.5 percent of compassionate use requests, advocates of Right to Try claim the process is too slow. The FDA has streamlined the current process so that requests are reviewed within 24 hours; filling out an application now takes less than an hour. And yet, Right-to-Try laws have been approved by more than 30 statehouses. Unfortunately, the current federal legislation provides almost no protec...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: End of Life & Serious Illness Quality Compassionate Use experimental therapies right to try terminal illness Source Type: blogs