FDA is regulating patients to death

The article discusses the challenges faced by terminal patients in accessing potentially life-saving drugs due to stringent FDA regulations and clinical trial eligibility criteria. The author shares the experience of her husband, Jake, who has benefited from clinical trials for recurrent metastatic head and neck cancer. However, the current system favors patients with fewer prior treatments, limiting options for those like Jake who have already undergone multiple therapies. This creates a situation where many patients may die waiting for new drugs to be approved, as the average approval process can take 10 to 14 years. The author argues for a provisional market for terminal patients, allowing them access to promising drugs while still undergoing trials. This approach could provide critical real-world data on drug efficacy and safety, while also addressing the ethical dilemma of withholding treatment from patients who have exhausted standard options. The article emphasizes the need for a balance between ensuring drug safety and providing timely access to potentially life-saving therapies for those with limited time left.

- Terminal patients face significant barriers in accessing new drugs due to FDA regulations and clinical trial restrictions.

- Many promising therapies take years to become available, often out of reach for patients with limited life expectancy.

- The author advocates for a provisional market that allows terminal patients access to drugs still undergoing trials.

- A separate track for terminal patients could generate valuable real-world data on drug effectiveness and safety.

- The current system prioritizes data collection for drug approval over the immediate needs of dying patients.