Hi
@bedger,
you're thinking about Christian Hinrichs MD, who moved to Rutgers after being at the National Cancer Institute (NCI), where on August 13, 2020 he held the position of tenured Senior Investigator and Lasker Clinical Research Scholar. It was due to his representation of the NCI that he was picked by the FDI as an ODAC member.
During the PM session he was merciless in slagging Mesoblast Limited's single-arm Phase III trial at ODAC in August 2020, saying 'principled' things like:
"
Of course, the weakness is that it's a single-arm study that relies on historical data. There's no way to get around that weakness. Single-arm studies that rely on historical data are always inherently weak and they've historically been misleading." (ODAC, PM Session transcript)
and also:
"
The last point is that, especially in a single-arm trial, I would want a very hard objective endpoint. We argue about how objective response rates in tumors may be flawed in that certain endpoints like progression-free survival or disease-free survival are not as hard as overall survival. Here when you're scoring GVHD progression, it may be even softer than those softer endpoints that we don't like. So I just present that for the committee's consideration. "
Then he voted '
NO' when asked to endorse the efficacy of Remestemcel-l in paediatric patients.
He justified his solo decision as follows:
"
Okay. Again, my justification was based on the need for rigorous science and careful clinical trials, especially in the pediatric patient population. I don't think that this single-arm study gives us that kind of rigorous data that we should be using to make these sorts of decisions."
But Dr Hinrichs 'forgot' to mention to the other members of ODAC or to the FDA or to the public present at the hearing that the National Cancer Institute had sought approval of selumetinib for children 2 years of age and older from the FDI & been
granted it in April 2002 i.e. barely 4 months earlier.
The National Cancer Institute's website was still crowing about it. Everyone at NCI would have known about it, right? And what did the FDA base its 'rigorous' approval on? What did the National Cancer Institute that employed Dr Hinrichs take along when it went begging for an FDA approval? It would have been only the most rigorous of data science, eh?
Well, you can read about it
here.
It was a
SINGLE-ARM PHASE II STUDY!!! SPRINT ( link here:
NCT01362803) was an
open-label, single-arm, multicenter, two-part trial of selumetinib in pediatric patients with neurofibromatosis type 1 plexiform neurofibroma. No masking. No blinding. No randomisation. No rigor.
Get this: the study was conducted by the NCI Pediatric Oncology Branch (POB) itself!! - how's that for rigorous independence!! The review on clincicaltrials.gov doesn't disclose even having a Data Montioring Committee.
And the first part - SPRINT phase I - was a mere dose-finding study (N = 24) that only suggested a recommended phase II dose. The great big evidence - SPRINT phase II - came from only N = 50 enrolled patients who formed the primary efficacy population. And that was it.
Since April 2020 selumetinib has been marketed by AstraZeneca as KOSELUGO. Go figure.
Forget about conflicts. National Cancer Institute was Hinrichs own employer. Dr Hinrichs was (& I assume remains) a hypocrite and a deceiver of the highest order.
Scum of the universe. I wouldn't spit on him.
Cheers all
GLTA(LT)H
(20min delay)