When all other treatment options have been exhausted, physicians sometimes apply for “expanded access” or “compassionate use” to treat their patients with non-FDA approved pharmaceuticals. The agency recently released a new form for the application, and it’s much shorter and easier to understand than its predecessor. Physicians still need to obtain permission from the drug manufacturer first, but shortening the overall process is the goal. Patients have been eager to speed things up, as evidenced by the 20 states with“right to try” laws, which allow patients to seek post-Phase I experimental therapies without FDA involvement. Who can blame them—red tape has, after all, been linked to adverse health outcomes. Headaches brought on by hours at the DMV count as real-world evidence, right?
You probably know cardiovascular disease and cancer are the leading causes of death, but a risk you may not be familiar with is going to the hospital. A new study from Johns Hopkins University School of Medicine reviewed Medicare data and statistics from 13 hospitals to gain insight into the frequency at which medical errors contribute to death. In the study, the authors focused on preventable lethal events and their findings may give you a heart attack—medical error is the 3rd most common cause of death in the United States. The goals of the study are to increase funding for research into patient safety and to draw attention to the need for system improvements, not to scare the living daylights out of you. Too late.