Baby, bathwater. I’ve worked on trying (so far unsuccessfully) to push the FDA to approve things, and I can specify in more detail than I’d like about what’s imperfect in that process. However, I’ve also been in the business of coming up with new interventions to things-which-ail-humans for 15 years now, and every project I’m terrified that my embeddedness in the project; my conviction that this was a good path to take (a conviction you really really need to persevere for long enough to get funding and all the rest of it, regardless of source) will turn out to be wrong and real harm will occur. And I rely on the infuriating business of getting IRB (ethics) approval and FDA approval and all the rest of it to help make sure I and my equally driven and obsessed collaborators haven’t missed something. If you have a new take on responsible testing processes that aren’t controlled by the same people who have really strong investments in the testing process continuing, I’d be curious to hear it.
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