In this podcast episode, the host discusses the controversy around individuals being allowed to take risks with drugs and participate in thoughtful trials backed by scientific research, despite not being qualified to understand the risk.
The discussion centers around the morality and ethics of challenge trials, particularly when developing cancer drugs that require multi-phase trials. While it's possible to take a specific pathway with the FDA when developing a drug for rare diseases, challenge trials carry a significant amount of risk and require careful consideration.
The tension between individual responsibility and government regulation exists mainly in fields where people take extreme risks like space exploration or mountain climbing. While the government tries to protect individuals from harm, some people argue that individuals should have the freedom to take risks and responsibility for their own actions.
People often engage in potentially harmful behaviors like gambling even though they do not have the capacity, generally speaking, to recognize the negative expected value they have. However, just because behavior is potentially harmful does not mean that people should not be allowed to do it.
The regulatory capture in the pharmaceutical industry has created an industry that is a retardant of R&D velocity and has driven the structure around risk-taking in drug trials particularly in the US.