11–20 of 84 posts
truly amazing. seems seriously unfortunate that it takes the FDA 7 years to approve a device like this. I wonder how much testing they actually spend and how much time is wasted in bureaucratic BS. regardless, the story is amazing and the device seems incredible
But it's not too late to honor her memory. Press on.
This article is inspiring but it fails to mention that no studies have shown that the device actually works. The FDA approval process for medical devices is very different then from pharmaceuticals; to oversimplify, efficacy does not need to be demonstrated, only safety (i.e. the device is not toxic). Thus the fact that the device is FDA approved doesn't really mean much (although it sounds great). As with renewable…
"I found a 1987 Italian funded set of clinical studies that showed successful treatment of tumors by the application of chemotherapy directly into the tumors."
It stands to reason that if it is true that directly treating the tumors themselves is effective, then this device will be effective since all it is is a delivery mechanism for the pre-existing drugs. While I guess it's possible that somehow the design of the device itself is defective, it does seem rather unlikely that they'd have come this far without at least testing the mechanics of the process on a pig or cadaver or something.
Impressive, but also -- in retrospect -- kind of obvious. Why, of course you want to target destructive chemotherapy directly to tumors, via precise physical delivery. I wonder if outdated assumptions about the limits of manufacturing prevented doctors/researchers/incumbent-companies from more actively pursuing this idea. It may take an outsider on a mission to remind a field of what's possible.
Every brilliant idea is obvious in hindsight. That is precisely what makes it brilliant. Nobody saw what was sitting in front of their noses, and then somebody did.
This article is inspiring but it fails to mention that no studies have shown that the device actually works. The FDA approval process for medical devices is very different then from pharmaceuticals; to oversimplify, efficacy does not need to be demonstrated, only safety (i.e. the device is not toxic). Thus the fact that the device is FDA approved doesn't really mean much (although it sounds great). As with renewable…
Assuming it's effective, this guy deserves the Nobel prize.
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Assuming it's effective, this guy deserves the Nobel prize.
This article is inspiring but it fails to mention that no studies have shown that the device actually works. The FDA approval process for medical devices is very different then from pharmaceuticals; to oversimplify, efficacy does not need to be demonstrated, only safety (i.e. the device is not toxic). Thus the fact that the device is FDA approved doesn't really mean much (although it sounds great). As with renewable…
Similarly there is a massive and well funded lobby for power production and very little for power efficiency, which effectively achieves the same result. Instead of spending the money on solar panels in space what about energy efficient fridges? And no, this doesn't shrink the 'economy' it allows us to achieve the same level of wealth with less resource consumption.
Impressive, but also -- in retrospect -- kind of obvious. Why, of course you want to target destructive chemotherapy directly to tumors, via precise physical delivery. I wonder if outdated assumptions about the limits of manufacturing prevented doctors/researchers/incumbent-companies from more actively pursuing this idea. It may take an outsider on a mission to remind a field of what's possible.