These posts were issued before my FDA employment and do not necessarily represent the views of the FDA or the United States. The account is now inactive.
Here is a running thread of the articles we have published in 2023 with links to tweetorials when possible
But first a summary of the last 2 years, and links to all papers
https://t.co/YxAYKU7cDy
As an alternative to the h-index, I made the Mentorship Index (M-index) to proxy a scientist's contribution to mentoring junior scientists. M10-index = # last-author pubs where the first author had < 10 pubs.
Calculate yours: https://t.co/EJFCq65E4r
🧵👇
PATINA trial: maintenance palbociclib after first line anti-HER2+chemo in HER2/HR+ metastatic BC:
- PFS benefit, no OS (not mature)
- significantly more toxic (including financial)
- significant early censoring imbalance (estimated 6% versus 12% over first 6 months in both arms, see Breaking-ICE App) -> makes PFS results less reliable, particularly in open-label trial
- nonetheless the biological rationale, it is possible that ultimately no OS benefit will be seen
"Adding toxicity without an improvement in clinical endpoints should generally be avoided."
-> read our essay on PFS and other surrogates here : https://t.co/2HxtAMe4bT
@vkprasadlab@VPrasadMDMPH
Twitter thread coming on what @adamcifu@VPrasadMDMPH@AndrewFoy82 and I think is the BEST approach to pt care. This is ...
The Case for Being a Medical Conservative.
https://t.co/nZXrnvMQqP
Thanks to the @amjmed for publishing this.
Dr. Vinay Prasad and @TracyBethHoeg held a panel this morning on Personalized Medicine at #JPMHC26, where they discussed the agency's path toward marketing authorization for ultra-rare disease individualized therapies as well as the success of the Commissioner's National Priority Vouchers pilot program and the extraordinary cross-center collaboration they've developed under the leadership of @DrMakaryFDA.
New post from Alyson Haslam covering their work with @VPrasadMDMPH@vkprasadlab about the "age gap" in oncology.
They found the age gap between registration trials and SEER data has declined over time (7 years during 2002-2012 vs 5 years during 2013-2019 vs 4 years during 2020-2024), but the age gap still persists.
Check out the full post (with link to their work) + subscribe for free content: https://t.co/u77Tthi6pm
Dana-Farber Cancer Institute Agrees to Pay $15 Million to Settle Fraud Allegations Related to Scientific Research Grants. The relator [Sholto David] will receive $2,625,000 under today’s settlement.
https://t.co/8o6zvTAGEU
Vigilant FDA leaders just saw an impressive multiple myeloma trial result published in the ASH program ahead of the conference.
FDA immediately discussed with internal experts and contacted the company THE NEXT DAY to issue them a national priority voucher.
Delivering on our goal to be proactive 💪
#ASH25 and multiple myeloma.
I understand the enthusiam, but my take would be more nuanced. We had great drugs, certainly (we had also terrible ones) but too often we don't how to best sequence them in order to maximizing outcomes, and minimizing toxicity, including financial.
Hard-wired biases in seminal trials (like suboptimal control arms or subsequent therapy) preclude to answer those fundamental questions, and it's problematic.
Time to rewatch one of my favorite video from @VPrasadMDMPH on that topic :
https://t.co/ZIMMckbelA
Most fundamental questions remain, and AQUILA (dara in high-risk Smoldering Myeloma), in my opinion, is also problematic: https://t.co/65fjFud2Js
Also great to see works done in the field trying to answer those key questions @rajshekharucms@ManniMD1 and others.
The approval of this gene therapy is a great example of how we can tailor our regulatory process to the condition being treated.
A win-win for rare disease patients and innovative drug developers!
Do we really know how many patients derive long-term benefits from immunotherapy?
Nice coverage of our new work by @AlysonHaslam, with @VPrasadMDMPH@vkprasadlab
Check it out and subscribe for free at "The Oncology Shot" 👉 https://t.co/4831MR4fn2
Our new article out in JCP, led by @AlysonHaslam@vkprasadlab
We often talk about the tail of the curves and the potential for long term response with immunotherapy.
But how often does this occur ?
This work provide insights on this very question.
https://t.co/YVXfcPbIRi
“Whenever somebody tells you that the incidence of something is going up a lot, ask about the outcome of interest, like mortality, especially as it relates to cancer”
= wise words from @AdeAdamson at the end of Q&A after he presented: "The Rise in Early-Onset Cancer in the US Population—More Apparent Than Real" just out @JAMAInternalMed
here👉https://t.co/BTUEFk3kYx
"Are fears of rising cancer in young adults exaggerated?"
👉Find the answer in this unique video!
So great to have @AdeAdamson for a live talk, followed by a fascinating Q&A with @vkprasadlab core members! Thanks, Ade 🙏
Congrats to @vrpatel97 and Gil Welch who co-authored with Ade the paper we discussed!
Observational studies often make clinical practice recommendations: an empirical evaluation of authors' attitudes
https://t.co/ycIrS08Vxs via @adamcifu et al
In uncontrolled settings, is the observed benefit due to the drug or to indolent tumour biology?
One way to answer this question is the Iceberg Plot, a visual I conceived and we published soon after I joined the @vkprasadlab
Read more about it! https://t.co/F8WgolAOJg