As such, I do not hold the FDA in a positive light, especially given that during COVID-19, I (like many others) spent hundreds of hours trying to get the agency to allow the limited use of off-patent therapeutics for COVID-19—all of which ultimately went nowhere due to the unjustifiable roadblocks the agency kept putting up.

Note: given my familiarity with the FDA's conduct, I felt the odds were against those endeavors succeeding, but I nonetheless exhausted myself supporting effective alternative therapies because I didn't want to live with the knowledge I could have done something that could have prevented the unfolding tragedy but chose not to.

Over the last year, and especially since Trump won the election, I have received a lot of inquiries as to how the FDA could be reformed over the next four years. Given the importance of presenting the issue correctly, I've spent a lot of time trying to look at both sides of the question.

In medicine, "sensitivity" denotes how likely a test is not to miss something that's there, while "specificity" denotes how likely a test is not to have a false positive. The great challenge with these two concepts is that there's almost always a trade-off. Hence, as you increase one, the other reciprocally declines (e.g., as the PCR cycle threshold was increased on COVID tests, while it was harder to miss an infection, you also became more and more likely to get false positives from the tests—which is frequently what happened). In turn, many issues in medicine result from a poor balance between the two (e.g., Peter C. Gøtzsche made a good case that the sensitivity for routine breast cancer screening is too high, which leads to many women being erroneously diagnosed with dangerous breast cancers and subject to unnecessary treatments).

This same trade-off also exists throughout politics as there are often two conflicting positions (e.g., wanting a robust death penalty to serve as a deterrent against violent crimes but also not wanting to execute innocent individuals), and in many cases the eventual position that's settled on is the result of a prolonged battle that eventually reaches a midpoint between sensitivity and specificity that while not ideal, is begrudgingly acceptable to both sides. In my eyes, the most important thing to understand about this dynamic is that it typically takes an incredible amount of work to reach the functional compromise that's eventually settled upon, so if the existing process is scrapped (e.g. because people who are polarized on the issue can only see it from their side's perspective) what follows (e.g., a complete lack of police enforcement in high crime areas) is often much worse than what preceded it.