memfree

We already had the Expanded Access Program (thank you ACT UP) and we don’t want a repeat of thalidomide babies like we had before there were strong protections on how drugs get tested.

So now we have Expanded Access (EAP) with FDA oversite and Right to Try (RTT) without that oversight. Having both is confusing for everyone and most people don’t know which covers what. From Journal of Law and the Biosciences (they only sampled 17 neuro-oncologists from 15 different academic medical centers):

Many physicians described having difficulty in distinguishing between RTT and EAP or demonstrated misconceptions in their responses. A physician with knowledge of both pathways spoke about his colleagues generally: ‘I don’t think a lot of people understand the difference between expanded access and Right-To-Try’ [Participant 1]. The confusion resulted in conflation with the different features between EAP and RTT including structure, intent, and processes of these pathways. In response to our question ‘Have you provided a drug through Right-to-Try?’ one clinician erroneously replied, ‘I think most compassionate use is under that category’ [Participant 2]. Another drew a rough equivalence between the two despite the absence of FDA oversight for RTT: ‘I guess the way I try to think about Right-to-Try is like compassionate use.

The latest pluralistic article starts with a long rant about “rent” and what’s wrong with it (then explains how Intellectual Property rights are basically the same thing and talks about software). Anyway, you might like the rent part: https://pluralistic.net/2024/07/29/faithful-user-agents/

You don’t see them. You are on the ice and so are they. They hunker down and purposefully cover their nose with their paw when you look in their direction. When you look away, they creep closer until your head starts to turn again. They don’t want you don’t see the little black spot getting closer and closer. If you are lucky and looking around while you are out on the ice, you will see a little black spot disappear. If you do. GET OUT NOW. If the spot was big enough to notice, the bear is probably close enough to charge. I hope your snow machines are close and ready to go.