[HN Gopher] First malaria treatment for babies approved for use
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First malaria treatment for babies approved for use
Author : toomuchtodo
Score : 113 points
Date : 2025-07-08 15:16 UTC (4 days ago)
(HTM) web link (www.bbc.com)
(TXT) w3m dump (www.bbc.com)
| toomuchtodo wrote:
| https://www.reuters.com/business/healthcare-pharmaceuticals/... |
| https://archive.today/Gsw4p
| frogarden wrote:
| Good news! How do you safely develop medications for babies?
| lamuswawir wrote:
| This particular one is mostly about dosing, the available
| medicines were weight based, with lowest dosages in the 5-15kg
| range. This brings dosages lower allowing more precise dosing
| for the lighter babies.
|
| Edit: it's a very welcome addition. Limits side effects.
| zkmon wrote:
| Approved for use means approved for testing on populations.
| squigz wrote:
| Isn't that how medicine works?
| zkmon wrote:
| Only for lab mice. Humans require making it clear that they
| are not being used as lab mice. But often, you see report
| saying that "After seeing the results for x years of use by
| populations, we found that it has y side effect which was not
| known earlier". A doctor literally said this to me last week.
| Calavar wrote:
| What alternative process do you propose that will discover
| all side effects, including those with well under 1%
| occurence, without human use?
| squigz wrote:
| > "After seeing the results for x years of use by
| populations, we found that it has y side effect which was
| not known earlier"
|
| I would think that any reasonably intelligent adult could
| think about things for a few moments and come to the
| realization that... yeah, that's how things work. This is
| how we progress and learn. We develop, test, use, and learn
| about things - and if we learn that hey, turns out, this is
| bad over a long period of time... we change things.
|
| And this of course doesn't apply to just medicine - it's
| just technological progress.
| wizzwizz4 wrote:
| What's the alternative? "Oh, sorry, we would _like_ to
| treat your baby 's malaria, but that would disregard the
| baby's inherent dignity: we don't yet know the full side-
| effect profile up to 3 sigmas."
|
| Most indignities are lesser than dying of malaria.
| 1over137 wrote:
| As opposed to what?
| parpfish wrote:
| Probably as opposed to "approved for general use in the
| population because we've passed all of our tests", which is
| what I'd assume "approved for use" means
| rsynnott wrote:
| Are you taking the stance that no drug should ever be released
| on the basis that it is impossible for trials to cover
| literally the entire population? Like, what are you looking for
| here?
| _heimdall wrote:
| Unless I'm reading the original study [1] wrong, I'm surprised
| the study only used a population size of 28.
|
| They did do a 12 month check-in which is good, but why such a
| small group of study participants, especially when malaria is so
| widespread?
|
| [1]
| https://clinicaltrials.gov/study/NCT04300309?term=CALINA&ran...
| _heimdall wrote:
| Also they apparently didn't use a control group, the study was
| terminated early, and after the 43 day test window 9 of the 28
| participants are listed as having the adverse event of malaria.
|
| I'm particularly confused by that last one. How is malaria
| considered an adverse event when testing an anti-malaria
| treatment? Other data in the study shows that 1 participant had
| malaria again with matching DNA, meaning the original infection
| likely came back. 6 others were reported as getting malaria
| again but with different DNA. So what does it mean to have 9
| with the adverse event of malaria?
| refulgentis wrote:
| Think you're over-parsing a bit: adverse events ~= something
| we should mention, not Bad Things The Treatment Did. "What
| does it mean?" is a qualitative question, not a quantitative
| one. Taking that question more colloquially, in this case,
| I'd say it means "the vaccine did not prevent infections in 9
| of 28 cases and / or they had an infection before the vaccine
| was taken"
|
| I'm sure you mean well -- since your post, the thread got
| cluttered up with outright know-nothing-type comments. I am
| being very literal in order to help teach people in despair
| what we expect when we read these.
| _heimdall wrote:
| I did mean well, thanks for assuming good intent here. I
| still don't understand how 9 of 28 could have the adverse
| event of malaria, though, given that other data in the
| results show that 1 participant had what seemed to be a
| reinfection with a genetic match and 6 others were infected
| again with a parasite that didn't match their original
| infection's genetic makeup. That is 7 individuals, where do
| the other 2 come from?
|
| My uncertainty is that I may be misunderstanding the
| meaning of malaria as an adverse event entirely here - I
| don't get how reinfection would be an adverse event rather
| than a potential failure of treatment.
| freeone3000 wrote:
| Statistical power. Malaria doesn't go away on its own. They
| know the treatment should be overwhelmingly effective if dosed
| correctly, it's merely a measure of determining dosage vs
| negative effects.
| 3eb7988a1663 wrote:
| The famous comparison: you do not need a large N to test the
| effectiveness of parachutes.
| _heimdall wrote:
| Right, in this case my concern really wouldn't be with
| efficacy as much as safety. When the test group is only 28
| participants how can we assume that we would have found most
| of the safety concerns? Is the assumption being made that the
| only concerning factor is age and that there are no other
| contribution factors that could lead to negative outcomes?
| BugsJustFindMe wrote:
| Ethics dictate always using the smallest viable cohort to show
| that giving the treatment regimen (in this case dosage for a
| drug known to be effective) isn't obviously worse than the
| thing it's supposed to treat, even if we're already pretty
| sure. This also keeps the costs of running the studies down so
| we can effectively conduct more studies for more treatments.
|
| We also already have data about its use in babies over 11 lbs,
| and this is just going even smaller to 4.4 lbs, so a strong
| baseline has already been demonstrated.
| verisimi wrote:
| a small study.... that then gets approved and released to
| everyone!
| refulgentis wrote:
| A little dull assertion can't hurt you, individually, and I
| bet it feels fun.
|
| I assume you're well-aware the process for something like
| this doesn't fit in a sentence.
|
| Additionally, there's context in the comment you're
| replying to, this isn't the only study.
| _heimdall wrote:
| What do you mean "ethics dictates?" We define ethics and they
| generally reflect the current culture, ethics aren't
| universal and can't dictate anything.
|
| The scientific method, though, would dictate that a cohort
| size should be large enough to show a high probability of
| safety and efficacy, assuming that is what is being tested.
| It would also dictate that a control group would be needed to
| compare against the test group.
|
| I totally understand the ethical concerns of potentially
| allowing children to be harmed while part of a control group,
| but when the test is being done specifically because there is
| currently no treatment the only change is that they would
| pick a group of untreated children that are a valid control
| group for the study. Either way those children wouldn't be
| treated and there really isn't an ethical issue to deal with.
| roywiggins wrote:
| There is a treatment, but it's done ad-hoc:
|
| > Until now there have been no approved malaria drugs
| specifically for babies.
|
| > Instead they have been treated with versions formulated
| for older children which presents a risk of overdose.
| _heimdall wrote:
| The claim still holds then that there are no approved
| treatments for malaria in this age range. If we were
| already treating patients off book, and that were the
| reason we couldn't have a control group, then there is no
| real reason to do the study at all.
| dev_l1x_be wrote:
| It is pretty common to have a very small (and usually not
| exactly random) sample size.
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