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Holly Fernandez Lynch Profile picture
Holly Fernandez Lynch
@HollyLynchez
Bioethics+law faculty @PennMEHP/@PennCarey_Law studying IRB quality (https://t.co/IknSpy21wk), preapproval access to investigational drugs, FDA pharma policy, + psychedelics
Oct 6, 2023 • 12 tweets • 2 min read
Excited to hear from @jeeeberts and Carolina Reid about their experiences participating in human infection challenge studies. Why did they enroll? $, curiosity, desire to contribute to important science. Image Important point from @jeeeberts: helpful and appropriate for ads and consent materials to emphasize the purpose and social value of the research. Material to decision making but not covered in enough detail.
Jun 16, 2022 • 15 tweets • 5 min read
Expanded Access has traditionally had treatment goals rooted in clinical care, not research. @sandymorris333 @JinsyMd & I have a paper out in @lancetneurology discussing a new law (ACT for ALS) that takes a different approach: grant funding for a hybrid model of EA research. 1/ First, here’s the paper. Message me or any of the coauthors if you need access. Academic publishing has its challenges! (We also had a 2x longer version that we had to cut down to meet word limits, making some necessary compromises for brevity.) 2/ thelancet.com/journals/laneu…
Oct 6, 2021 • 4 tweets • 3 min read
In a new Pediatrics "Ethics Rounds," @GovindPersad @pzettler and I discuss a case involving a request to vaccinate a high-risk 11-year old against COVID-19. pediatrics.aappublications.org/content/early/… We argue that off-label administration of the approved Pfizer vaccine should be treated with care - but allowed at clinician discretion, just like other off-label uses. This is contrary to @AmerAcadPeds, @US_FDA, and @CDCgov, but we think ethically appropriate...
Jul 1, 2020 • 17 tweets • 4 min read
Finally had a chance to review FDA's COVID vaccine development guidance: fda.gov/media/139638/d…. Hard to improve on @AlecGaffney's excellent thread, but here are a few more thoughts. First, @AlecGaffney covered this, but I was relieved after reading full guidance that FDA's going to demand protection from infection/disease and not just immune response. (Maybe immune response later, when it's better understood whether/what response could predict protection.)
Jun 11, 2020 • 27 tweets • 12 min read
Bioethics Tweeps: As we do the long-overdue work of diversifying our syllabi, speaker invitation lists, scholarly networks + field more broadly, here are some #BlackBioethics scholars to follow/read/cite/invite/amplify/know. If you’ve already started this work, please add to this list! I’m especially interested to learn more about rising #BlackBioethics stars who deserve more attention.
Mar 30, 2020 • 18 tweets • 4 min read
FDA has issued first #EmergencyUseAuthorization for therapeutics to treat COVID-19 (rest have all been for in-vitro diagnostics, PPE, and other med devices). EUA issued to BARDA for hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile. IMPT: Although some versions of chloroquine phosphate are approved by FDA for other indications, the CP covered by this EUA has NOT been approved at all. For hydroxychloroquine sulfate, the EUA appears to apply to approved versions (although of course not for COVID-19).
Mar 25, 2020 • 9 tweets • 2 min read
This is indeed a thoughtful take on #challengetrials for coronavirus vaccine development. I have a few thoughts too. First, appreciate that Nir and @mlipsitch posted this ASAP for the world to see as a preprint. Marc, is it under review?