First malaria treatment for babies approved for use

https://www.bbc.com/news/articles/c89e872jdjxo

by toomuchtodo • 1 year ago

137 43 1 year ago

bbc.com

toomuchtodo• 1 year ago

https://www.reuters.com/business/healthcare-pharmaceuticals/... | https://archive.today/Gsw4p

frogarden• 1 year ago

Good news! How do you safely develop medications for babies?

lamuswawir• 1 year ago

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.

zkmon2• 1 year ago

Approved for use means approved for testing on populations.

squigz2• 1 year ago

Isn't that how medicine works?

zkmon2• 1 year ago

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.

1over137• 1 year ago

As opposed to what?

parpfish• 1 year ago

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• 1 year ago

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?

_heimdall9• 1 year ago

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...

_heimdall9• 1 year ago

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?

refulgentis2• 1 year ago

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.

freeone3000• 1 year ago

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• 1 year ago

The famous comparison: you do not need a large N to test the effectiveness of parachutes.

_heimdall9• 1 year ago

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• 1 year ago

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• 1 year ago

a small study.... that then gets approved and released to everyone!

_heimdall9• 1 year ago

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.

dev_l1x_be• 1 year ago

It is pretty common to have a very small (and usually not exactly random) sample size.

_heimdall9• 1 year ago

Whether its common doesn't really matter. Are you arguing that a small, non-random sample size is acceptable in a scientific study?

jschveibinz• 1 year ago

I heard this story on the radio last week, and the Italian physician working in Africa for a very long time said that the treatments have been provided for babies older than 6 months successfully. The new and important step (with Novartis) is to now safely treat babies younger than 6 months with the appropriate dosing. I wish I could find the link to the radio story.

begueradj3• 1 year ago

China had been, until recently, for decades, the most populated country in the world. Still Chinese people don't have a problem called malaria. Why ?

Because they use a plant to prevent and heal it. I can't recall the name of this plant but I remember I saw a documentary stating that China tried multiple times to export that plant to the world but Bill Gates, who is interested in the subject and wanted to develop a vaccine for malaria, for a long time convinced the world health organization to not allow that on the name that the plant has health risks, inefficient and is dangerous to the environment.

hinterlands• 1 year ago

The Chinese medicinal herb you're thinking about is sweet wormwood, from which we isolated artemisinin. Artemisinin isn't a suppressed secret. It's one of the major treatments for malaria and it netted its discoverer a Nobel prize.

The drug the article is talking about contains artemisinin in combination with another substance.

We know how to deal with malaria, so this isn't some story of Big Pharma hiding the truth. The disease used to be endemic in the US and in Europe. Better treatments save lives, but eradication hinges on economic and political factors... which are in turn not helped by malaria.

begueradj3• 1 year ago

"We know how to deal with malaria, so this isn't some story of Big Pharma hiding the truth. The disease used to be endemic in the US and in Europe"

Malaria is still a public health concern in Africa. And that's where Bill Gates does not want to see that plant exported to Africa because, unlike the Big Pharma products, it is a cheap solution.

I do not think we are talking about the same plant because "sweet wormwood" exists in Africa (a variant of it). Unfortunately I can't find the documentary I saw some years ago about this. It was done by few French investigation journalists.

switknee2• 1 year ago

It's a traditional medicine for malaria, and the reason china wasn't exporting it was due to the military importance of anti-malaria medicine. This was a thing before Bill Gates was rich or powerful. Since then, I'm not really aware of any suppression of the drug. The only anti-malaria treatment which has been suppressed by US interests is the vaccine, because they didn't believe it was profitable. Now that it is profitable, they're going forward with it.

Now that the white wormwood based treatment is known worldwide, there are questions about whether it should be kept in reserve like quinine. I'm not sure if things have changed, but I recall an approach is to give Artemisinin alongside another treatment, to prevent malaria from adapting. In africa, people will commonly listen to the doctor's instruction to take the whole course of medicine and will ignore it and just take half. They give the other half to a relative. This causes treatment resistant malaria to develop.

netfortius• 1 year ago

I wonder how RFK Jr will look at this...

First malaria treatment for babies approved for use

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