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Re:FDA head asks for investigation into Aduhelm drug approval by seriousquestion on Saturday July 10, 2021 @01:48PM (#27795130)
Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared.

"Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization."

https://academic.oup.com/ofid/advance-article/doi/10.1093/of...

"Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low."

https://www.sciencedirect.com/science/article/pii/S187140212...

Re:FDA head asks for investigation into Aduhelm drug approval by WarOnPrivacy on Saturday July 10, 2021 @02:02PM (#27795225)
I see a choice of going down the Invermectin rabbit-hole where the framing and presentation feels a lot like an MLM campaign (except saturated w/ conspiracy) - or walking into a local store and getting sound ~95% efficacy w/ a pair of free Moderna shots.

The latter really seems more compelling to me.

Re:FDA head asks for investigation into Aduhelm drug approval by seriousquestion on Saturday July 10, 2021 @03:29PM (#27795807)
These shots are not FDA approved yet. Usually that's compelling enough to look for and consider alternatives. Especially existing cheap off patent drugs that have been used billions of times over the course of decades and recently won the Nobel Prize. If that plus many doctors and small trials indicate promise with Covid-19, we should take that seriously. That's all.

"The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19."

https://www.fda.gov/media/144638/download

None of this is to say that the vaccines aren't safe or shouldn't be used. They should be, especially for those at risk. The vaccines may well be better than Ivermectin and so far it appears that way. But there is some nuance here and it's valid if people want an alternative until the shots are FDA approved and have long term data. Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma. Which I find bizarre.

Re:FDA head asks for investigation into Aduhelm drug approval by mcguire on Saturday July 10, 2021 @07:38PM (#27797257)
"...recently won the Nobel Prize..."

William C. Campbell and Satoshi Ōmura won the Nobel Prize "for their discoveries concerning a novel therapy against infections caused by roundworm parasites". Not viral respiratory system infections.

Re:FDA head asks for investigation into Aduhelm drug approval by exmadscientist on Saturday July 10, 2021 @05:07PM (#27796480)
> Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma.

I wasn't first in line to get any of these vaccines. Distrust of anything new is pretty rational!

But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?

Especially compared against drugs that have yet to convincingly beat placebos in any large trial?

Personally, I find it bizarre that anyone can weight those two sets of evidence so differently.

Re:FDA head asks for investigation into Aduhelm drug approval by seriousquestion on Saturday July 10, 2021 @06:03PM (#27796787)
Yes, but you also have to weigh the fact that we don't know what the long term effects may be. Some people would rather trust their immune system, with or without drugs that have been in use for decades. That's not my personal calculation, but I can see why others would net out that way. Particularly women who are concerned about the possible effects on fertility.
Re:FDA head asks for investigation into Aduhelm drug approval by forcry on Sunday July 11, 2021 @02:53AM (#27798935)
>But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?

Yes. But there is a problem. This implies an unrestricted flow of information. If there is censorship (self and imposed) going on, then you cannot take this perception for granted.

Is there censorship going on regarding these issue. Absolutely, there is. I think we can all agree on that.

So how much is the ongoing censorship skewing the issue? We have no idea. May be the censorship is done in good faith for noble ends, but may be it is not, again we don't know.

Also as seen in Vioxx issue, even a 100000 additional heart attacks can go un-noticed in a country, even without explicit censorship. We know smoking causes cancer now. But decades ago, people have been smoking for a long time without actually noticing the problem on large enough scale.

This why we do systematic research based on data collected in large scales.

Also one have to wonder why the systems such as VAERS depend on voluntarily reporting, that gives very little credibility to the data collected. Why is not made mandatory to report on adverse events? If you go to the VAERS cdc page, the covid vaccines are not even included in the list of vaccines to include for VAERS reportable events as prescribed by law.

So according to some studies, less than 1% of actual events in reported in VAERS. Even with such a low amount of reporting, we know that reports of blood clots and heart inflammation is concerning. So what is the true picture?

So the point that I am trying to make is that, "We have used these things, or have been using these things for a while without problems", is a poor proof of safety.

Re:FDA head asks for investigation into Aduhelm drug approval by khuey on Saturday July 10, 2021 @04:58PM (#27796428)
When the FDA finally grants full approval to the vaccines the goalposts will just move again to something else.
Re:FDA head asks for investigation into Aduhelm drug approval by WarOnPrivacy on Saturday July 17, 2021 @08:48PM (#27869955)
We recently learn of strong indicators that the Ivermectin studies were entirely fabricated, much of it was content that was plagiarized from other studies.

https://grftr.news/why-was-a-major-study-on-ivermectin-for-c...

If a long life has taught me anything, it's that puzzlingly loud claims of conspiracy are often generated noise to conceal the fact that something simply isn't true.

Re:FDA head asks for investigation into Aduhelm drug approval by swader999 on Saturday July 17, 2021 @11:21PM (#27870558)
One bad study that didn't even get past preprint? Try the ones here from reputable journals. https://covid19criticalcare.com/ivermectin-in-covid-19/
Re:FDA head asks for investigation into Aduhelm drug approval by pjc50 on Saturday July 10, 2021 @05:13PM (#27796518)
The 2015 prize was for its use against worms: https://www.isglobal.org/en/healthisglobal/-/custom-blog-por...

It's not clear how that relates to respiratory medicine.

Re:FDA head asks for investigation into Aduhelm drug approval by Mountain_Skies on Saturday July 10, 2021 @02:01PM (#27795217)
Of course. Veterinary pharmaceuticals have very different manufacturing standards, approvals, and dosages. It's unfortunate that so many have been pushed into this path by authoritarians who have in under a year turned the medical establishment's credibility into a pile of dust.
Re:FDA head asks for investigation into Aduhelm drug approval by raphlinus on Saturday July 10, 2021 @02:31PM (#27795422)
It's not holding up so well in RCT's, like this one[1] that was just discussed on TWiV 778[2].

BTW, I've joined the legions who are addicted to TWiV. It's a time commitment for sure, but it's fascinating how different the perspective is on important topics (like delta variant) than the mainstream press.

[1]: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s128...

[2]: https://www.microbe.tv/twiv/twiv-778/

Re:FDA head asks for investigation into Aduhelm drug approval by mcguire on Saturday July 10, 2021 @07:41PM (#27797279)
[1]: "The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3–6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32–1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes."
Re:FDA head asks for investigation into Aduhelm drug approval by forcry on Sunday July 11, 2021 @11:35AM (#27801630)
Only a very low dose of Ivermectin was used. From the study limitations..

> Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.

I think one would at least use any of the protocols that were being used by the doctors who are seeing an efficacy.

Re:FDA head asks for investigation into Aduhelm drug approval by jollybean on Saturday July 10, 2021 @02:15PM (#27795300)
Folks you need to realize the difference between 'material discussion' within the scientific community etc. and 'drug populism' i.e. people making stuff up on Twitter and that information flowing to millions.

Nobody is 'smearing' the drug or even the people talking abot it.

They're saying 'stop telling the public about it because it's not approved yet and potentially dangerous'.

Whatever Donald Trump says - people believe. And they will go out in droves, self diagnose, self medicate, demand doctors prescribe them the 'cure' (when the doctor knows they shouldn't) etc..

And the amount of stupid conspiratorial memes that come up are pretty shocking. I avoid FB fro this reason and TikTok had a bunch of that for a bit, but I think they've shut down Ivermectin talk.

I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.

If there is some kind of coverup, or there's hard evidence and the FDA is refusing to look at it, or if someone in Big Pharma bribed someone else ... then that's a story, but this is not that.

Oxford has just launched a trial for Ivermectin, and there are others. When the results come in, and if it works and is safe, then CNN et. al. will talk about it and parameterize it appropriately. We'll all hear about it pretty quickly.

The CDC can't stop Joe Rogan from talking about it and the haven't tried, but they can say 'STFU' until we have done the actual science, which is reasonable.

Re:FDA head asks for investigation into Aduhelm drug approval by pumpkinandspice on Saturday July 10, 2021 @03:01PM (#27795634)
> I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.

By this logic, this applies to every single person that aren’t doctors who shouldn’t be talking about the vaccine or the drugs. This includes data scientists and politicians. I’ve watched Dr. Pierre Kory’s full interview with Brett and seems clips of his testimony in front of the senate. He is extremely credible and should have a voice in this as a COVID-19 critical care doctor and who has done meta analysis of the drug (https://covid19criticalcare.com/wp-content/uploads/2020/11/F...). I think people like Joe and Brett help amplify voices of people like Dr. Pierre Kory similar to politicians who amplifies Dr. Fauci

Re:FDA head asks for investigation into Aduhelm drug approval by jollybean on Saturday July 10, 2021 @05:28PM (#27796583)
So I think you might be misunderstanding my point a bit.

Scientists and Doctors should be talking about it in scientific forums and communities. Politicians should be reiterating the 'current consensus'.

People shouldn't be talking about it in public / tabloid forums because the information is vague, misrepresented and will be taken entirely out of context.

I totally support people taking contrarian positions.

I think we should probably assign people towards being 'The Devil's Advocate'.

The issue is not 'freedom of expression and open dialogue' - it's one of 'crude populism and misinformation'.

It's about how information is propagated, and how people react to it.