Promising results from an initial clinical trial show that sodium ascorbate – a pH-balanced formulation of vitamin C – is effective in treating sepsis.
I know modern scientific processes require blind studies to prove effectiveness of a new drug but imagine being in a grave spot and you’re given access to a potential life saving treatment, you get some hope back that you might pull through but you end up being one of the placebo recipients. Damn.
I think it’s important to remember that you’re also talking about maybe or maybe not receiving an experimental, unproven treatment that has the potential to make things worse rather than better. If that’s the case, you’d be happy to be the one receiving placebo.
Oh, that in no way means it’s not going to be harmful in the context of life-threatening sepsis. One of the things the study authors checked for is evidence of oxalate crystals forming in the kidneys because high dose vitamin C can cause kidney stones.
In healthy kidneys, that’s a survivable inconvenience. In a severely septic patient? Their kidneys are already not working. That could shut them down completely.
(I’m a critical care nurse. First thing I wondered about was kidney stones.)
You are correct that this is still done in studies where efficacy is very clear.
In fact, this just happened a few days ago in a new trial of semaglutide to treat kidney disease in diabetics. With diabetes being one of the two major causes of the need for dialysis (the other being hypertension), the drug was so successful at improving kidney function that it would have been unethical to withhold it from placebo recipients.
In studies where efficacy is more marginal or harder to demonstrate, then drugs are sometimes given for “compassionate use” to people who are almost guaranteed to die otherwise, so providing an unproven treatment that may work or may harm them is less ethically fraught. That was the basis for a lot of AIDS treatments being distributed back in the day, and in fact AIDS activists were crucial to getting compassionate use rules liberalized.
I know modern scientific processes require blind studies to prove effectiveness of a new drug but imagine being in a grave spot and you’re given access to a potential life saving treatment, you get some hope back that you might pull through but you end up being one of the placebo recipients. Damn.
I think it’s important to remember that you’re also talking about maybe or maybe not receiving an experimental, unproven treatment that has the potential to make things worse rather than better. If that’s the case, you’d be happy to be the one receiving placebo.
It’s just a concentrated high dose of vitamin c, though. It’s already used for other things and deemed safe. You can just buy it off Amazon.
So in the case of most trials, I’d agree. Less so with this trial, though.
Also, the article is pretty vague on the details of how much help it really wound up being.
Oh, that in no way means it’s not going to be harmful in the context of life-threatening sepsis. One of the things the study authors checked for is evidence of oxalate crystals forming in the kidneys because high dose vitamin C can cause kidney stones.
In healthy kidneys, that’s a survivable inconvenience. In a severely septic patient? Their kidneys are already not working. That could shut them down completely.
(I’m a critical care nurse. First thing I wondered about was kidney stones.)
This was actually a big topic during the AIDS epidemic back in the '80s. However, I don’t remember how they resolved that.
I think I’ve heard one semi solution is:
You end the study before people die/get permanent damage. You should have enough data at that point to show efficacy.
Then you offer All placebo people the treatment if they want it (after the study)
You are correct that this is still done in studies where efficacy is very clear.
In fact, this just happened a few days ago in a new trial of semaglutide to treat kidney disease in diabetics. With diabetes being one of the two major causes of the need for dialysis (the other being hypertension), the drug was so successful at improving kidney function that it would have been unethical to withhold it from placebo recipients.
https://www.fiercepharma.com/pharma/novo-nordisks-unstoppable-semaglutide-ends-kidney-disease-trial-early-positive-efficacy
In studies where efficacy is more marginal or harder to demonstrate, then drugs are sometimes given for “compassionate use” to people who are almost guaranteed to die otherwise, so providing an unproven treatment that may work or may harm them is less ethically fraught. That was the basis for a lot of AIDS treatments being distributed back in the day, and in fact AIDS activists were crucial to getting compassionate use rules liberalized.