Hi @LearningEachDay, I can't say I see it as ironic. I see it...

Hi @LearningEachDay,

I can't say I see it as ironic. I see it more as actions speaking louder than words.

The publication of this JAMA article is just as important IMO to addressing clinicians and healthcare sponsors current concerns and queries as the NEJM article by the same authors was the other week, viz:




It seems to me that these publications - along with the new Commissioner's quite prolific initiatives like the FDA Direct podcasts or the recent Cell + Gene Roundtable - are perhaps more indicative of freedom of speech in practise (cf. 'cancel' culture by any side of politics).

And that in turn indicates to me the real-world authority that Drs Makary/ Prasad exercise is far, far more potent than mere political rhetoric, even from the Secretary of HHS. Well, that's how it should be from my POV. I'm pretty sure Drs Philip Krause and Marion Gruber would agree.

Of course, that authority should carry a corresponding responsibility. So, I'm also heartened to see e.g. that Dr Nicole Verdun finds reason to continue to be working as part of the same FDA team (including doubling as interim head of Toxicology). I suspect as a practising paediatric haematologist-oncologist she is especially well placed to evaluate the substance of the announced initiatives in pediatric rare disorders that the new Administration appointees like Dr Prasad (also hem-onc) have been discussing so publicly. Otherwise she'd vote with her feet.

I'm happy to accept her judgement.

PS: I'm still waiting for Prasad & Co. to address HCT/Ps directly, rather than the gene-editing bigpharma mob who see cells as dumb vehicles. That will be the acid test, IMO. Take care.

Cheers
GLTALTH