Comment by mlyle
3 years ago
> I'm just taking author's following comment at face value
Plenty of mRNA human trials of cancer treatment are in progress. Indeed, as he stated, he wants into two that are underway, but that he is probably too far along for. He wishes that they had been greenlit even earlier and perhaps made their way to be approved drugs that he could just be given by his local doctor.
> For the situations where there's "no active trial" caused by the FDA not greenlighting the experiments,
There's compassionate use exceptions for circumstances like this.
The big thing is, there's two big bars to cross with getting a trial together:
- You probably want to be doing human research in a way that will produce evidence that will convince the FDA to grant you approval. (Hence, drug companies often are nervous that compassionate use will pollute their data).
- The FDA wants to protect human subjects, and if there's a drug that results in 15% survival for a year, vs. 5% for doing nothing and ???% for your new experimental treatment: they want that drug to be tested as part of a protocol that minimizes potential harms, not to randomly replace the 15% survival treatment. Most experimental treatments end up failing.
> Indeed, as he stated, he wants into two that are underway, but that he is probably too far along for.
The author is incorrect on this, he’s not too far along but he does not meet inclusion criteria for either of the studies he cited as both require systemic therapy.
mRNA is not being pitched or tested as a first-line mono therapy by Moderna. I’m not sure why the author is jumping the gun here and ignoring approved systemic treatment options.
He may not be too far along from the standpoint of inclusion criteria; rather he believes he is likely to die before he is able to join the study.
I’m ignoring that part because it is nearly impossible to prognosticate prior to initiation of systemic therapy, with the exception of some phenotypes but we don’t have the pathology report in this case.
My point is that he doesn’t even meet the inclusion criteria for these studies, regardless of aggressiveness. This has nothing to do with the FDA, he can’t join the studies because Moderna doesn’t want to study him at this point and not because he won’t survive long enough to enroll.
Whether or not his prognosis statement is correct.