Sharing a few threads on whether molnupiravir (new antiviral on the cusp of approval) risks generating new variants because the mutations it induces may, rarely but possibly, not kill the virus but generate viable variants instead. Many on the FDA panel who voted no raised this.https://twitter.com/CT_Bergstrom/status/1467611446053851145 …
-
Show this thread
-
zeynep tufekci Retweeted Michael Lin, MD PhD 🧬
Another thread on the risk of sublethal mutagenesis (on the virus, not the human!) from molnupiravir:https://twitter.com/michaelzlin/status/1464424333246447620 …
zeynep tufekci added,
Michael Lin, MD PhD 🧬 @michaelzlinIn conclusion, it would be highly irresponsible to approve molnupiravir unless the possibility of sublethal accelerated viral mutagenesis is thoroughly addressed and satisfactorily rejected, especially within the target population of patients at risk of hospitalization.Show this thread4 replies 11 retweets 88 likesShow this thread -
zeynep tufekci Retweeted Chase W. Nelson 倪誠志
Another, also with a letter in virological. "Mutagenic antivirals: the evolutionary risk of low doses".https://twitter.com/chasewnelson/status/1465219400064122882 …
zeynep tufekci added,
Chase W. Nelson 倪誠志 @chasewnelsonTODAY at#Virological: throughout the#COVID19 pandemic, there has been a tendency to underestimate the potential of#SARSCoV2 to mutate and adapt. As the@US_FDA meets Tuesday to discuss#molnupiravir,@sarperotto and I fear another oversight.
1/15
https://virological.org/t/mutagenic-antivirals-the-evolutionary-risk-of-low-doses/768 …Show this thread1 reply 5 retweets 72 likesShow this thread -
zeynep tufekci Retweeted James E.K. Hildreth
This is Dr. Hildreth on the FDA advisory phrased it after the vote. (He wasn't the only one on the panel to raise the issue).https://twitter.com/JamesEKHildreth/status/1465806607909064705 …
zeynep tufekci added,
James E.K. Hildreth @JamesEKHildrethFDA AMDAC has voted 13 yes, 10 no for EUA for Merck's molnupiravir COVID-19 drug. I voted no. Inclusive data on mutagenic potential and concerns over generating troublesome SARS-CoV2 variants were not addressed to my satisfaction. Drug has modest 30% reduction in COVID-19 risk.2 replies 6 retweets 68 likesShow this thread -
One question I have is what happen with patience non-compliance? The pill is supposed to be taken over five days, every 12 hours at home (I think 40 pills total). There's going to be a lot of incomplete regimens in this scenario. How does this affect this risk?
2 replies 10 retweets 163 likesShow this thread -
(Also, the trial had two phases and the drug had *zero* efficacy in the second phase which is really weird. It suggests regression to the mean so perhaps there is little to no benefit after all. Seems worth a longer study, but that's a separate question).
3 replies 8 retweets 122 likesShow this thread -
Overall, we have multiple scientists raising the alarm that a new drug may end up generating new variants, many on the FDA panel voting no citing that very concern, and real questions on whether there's any benefit—already on the low side as claimed. Seems worth taking seriously.
6 replies 33 retweets 179 likesShow this thread -
zeynep tufekci Retweeted Sandra
Pfizer antiviral doesn't use the same mechanism, so does not have the same risk. I think antivirals are an excellent addition to our arsenal. That said, so many on the FDA panel raised this issue, and still little news coverage? How do we get more clarity?https://twitter.com/diagionals/status/1467892862092288000 …
zeynep tufekci added,
6 replies 20 retweets 143 likesShow this thread -
Replying to @zeynep
FDA in a tight spot here. There are more effective and less risky options than this Merck drug, but if they fail to approve it, the usual anti-FDA crowd will go berserk that they are murdering people by witholding lifesaving treatment.
2 replies 0 retweets 1 like
It’s always tough. But they should focus on doing the right thing—especially since there are other options with no such risk. A framework for evaluating this seems to be the minimum, no? Their documents don’t have even this atm. Just “uncertain”.
Loading seems to be taking a while.
Twitter may be over capacity or experiencing a momentary hiccup. Try again or visit Twitter Status for more information.