Comment by sMarsIntruder
7 hours ago
> In the US, animal-based skin substitutes require levels of scrutiny from the Food and Drug Administration and animal rights groups that can drive up costs, Lee said. Given the substantial supply of donated human skin, tilapia skin is unlikely to arrive at American hospitals anytime soon.
This reminds me of Milton Friedman’s arguments against the FDA.
I wonder what’s the difference between countries that drives that. It’s not like Brazil doesn’t have its own FDA, which is much more strict than the US one, from what I know. Maybe some kind of lobbying? Or are animal rights group that much stronger?
I was having a conversation about this with my father-a retired pharmaceutical industry executive-a few weeks back, about why certain generic prescription medication formulations were unavailable in Australia yet sold in New Zealand. He explained to me that the Australian pharmaceutical regulator (the TGA) and its New Zealand equivalent (Medsafe) had very different regulatory philosophies. Medsafe, if a major international regulator (such as the US FDA or the EU’s EMA) had already approved something, they’ll just approve it too (“if it is good enough for them it is good enough for us”); the TGA’s attitude was very different, just because the FDA or EMA had approved it didn’t mean they automatically would, they wanted to analyse the safety data for themselves and make up their own mind. For blockbuster patented drugs, the extra regulatory cost of Australia was worth it, but for the long tail of miscellaneous generic formulations, the extra cost of dealing with the TGA could make some of them financially nonviable.
Medsafe's strategy only works so long as there is at least one stringent regulator though.
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I imagine it is about this:
> But Brazil lacks the human skin, pig skin, and artificial alternatives that are widely available in the US.
This is not an improvement on existing methods (it may end up being, but that is not the motivation) but rather a case of it being all they have to work with.
Tilapia skin is probably better than no skin at all.
> This is not an improvement on existing methods... a case of it being all they have to work with.
But the article says Tilapia skin is better in multiple aspects:
> "We got a great surprise when we saw that the amount of collagen proteins, types 1 and 3, which are very important for scarring, exist in large quantities in tilapia skin, even more than in human skin and other skins," Maciel said. "Another factor we discovered is that the amount of tension, of resistance in tilapia skin is much greater than in human skin. Also the amount of moisture."
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