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The Ivermectin discussion

wadacrack

This appears to have gone under the radar but Ivermectin treatment was associated with lower mortality during treatment of COVID-19 in studies. Very promising.

Video by John Campbell

https://www.youtube.com/watch?v=BLWQtT7dHGE

Ivermectin treatment was associated with lower mortality during treatment of COVID-19

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Piollaire

is_that_so wrote: »

So just a lil' conspiracy!

Ha! It's just business nothing personal.

Piollaire

DaSilva wrote: »

I am still confused though, do Merck own all the IP to this drug? If so couldn't they make a fortune from it if they actually do hold the cure for covid? And if they don't then isn't some other company able to make it and run the trials if they have the cure for covid?

No company is going to spend the money to get it approved when other companies can then freely undercut them as it off patent.

Johnboy1951

DaSilva wrote: »

I am still confused though, do Merck own all the IP to this drug? If so couldn't they make a fortune from it if they actually do hold the cure for covid? And if they don't then isn't some other company able to make it and run the trials if they have the cure for covid?

It is not a 'cure'. It is a treatment ...... or could be if even a fraction of what is being reported can be proven.

There is little money to be made form this as it is 'off patent' and anyone can manufacture it for just the manufacturing costs.

So no commercial entity is going to fund a costly trial to prove or disprove its efficacy.
That is what happens when almost all such trials are not government funded and instead funded by commercial agencies.

banie01

Piollaire wrote: »

No company is going to spend the money to get it approved when other companies can then freely undercut them as it off patent.

Bollox.

Dexamethasone is off patent, no company stands to gain the lottery win that comes with proving it was effective as a treatment.

And yet the NHS recovery trial initiated a review into its efficacy aswell as a whole host of other proposed treatments.
https://www.recoverytrial.net/
There are multiple ongoing efforts to review existing drugs for their efficacy in treating Covid.
https://www.sciencedirect.com/science/article/pii/S0014299921000431?dgcid=rss_sd_all
This particular review pulls data on multiple other studies and meta reviews.
It includes Ivermectin, and has some potentially promising results albeit in small studies and in comparison with Hydroxychloroquine and AZ.
Which is already fairly discredited as a treatment.

Alluding to some big pharma conspiracy to not forward Ivermectin for review as it's not profitable enough?
Well it's frankly ludicrous in light of the recovery trial and ongoing efforts to repurpose existing drugs.

Any hospital or health system can propose Ivermectin for trial.
It will be reviewed by both an ethics and a science committee before trial is undertaken.
That Ivermectin hasn't being picked up for wider trials or championed as a treatment?
Says far more about it's efficacy vis a vis current treatment options, than it does about any overlooking it in the interest of profits.

See19

Just seen this Irish article, maybe it will be available to everyone in Ireland sooner than later, hopefully. Except the published evidience so far is recommending Ivermectin is more effective as a treatment pre & early stage Covid and not in ICU.

Irish Independent - February 28 2021 02:30 AM
Irish Covid patients being treated in intensive care (ICU) are to start receiving the drug ivermectin as part of an international clinical trial.
Ivermectin is an anti-parasitic drug that has been controversially promoted by some as a cure for the disease.
In 2015, Donegal scientist Professor William Campbell shared the Nobel Prize in Physiology or Medicine for his role in the discovery of ivermectin.

Piollaire

banie01 wrote: »

Bollox.

Dexamethasone is off patent, no company stands to gain the lottery win that comes with proving it was effective as a treatment.

And yet the NHS recovery trial initiated a review into its efficacy aswell as a whole host of other proposed treatments.
https://www.recoverytrial.net/
There are multiple ongoing efforts to review existing drugs for their efficacy in treating Covid.
https://www.sciencedirect.com/science/article/pii/S0014299921000431?dgcid=rss_sd_all
This particular review pulls data on multiple other studies and meta reviews.
It includes Ivermectin, and has some potentially promising results albeit in small studies and in comparison with Hydroxychloroquine and AZ.
Which is already fairly discredited as a treatment.

Alluding to some big pharma conspiracy to not forward Ivermectin for review as it's not profitable enough?
Well it's frankly ludicrous in light of the recovery trial and ongoing efforts to repurpose existing drugs.

Any hospital or health system can propose Ivermectin for trial.
It will be reviewed by both an ethics and a science committee before trial is undertaken.
That Ivermectin hasn't being picked up for wider trials or championed as a treatment?
Says far more about it's efficacy vis a vis current treatment options, than it does about any overlooking it in the inte

I don't see anything in your post showing that manufacturers of generics are funding trials.

Ivermectin's absence from the government funded Recovery trial is a huge blunder.

Johnboy1951

See19 wrote: »

Just seen this Irish article, maybe it will be available to everyone in Ireland sooner than later, hopefully. Except the published evidience so far is recommending Ivermectin is more effective as a treatment pre & early stage Covid and not in ICU.

Irish Independent - February 28 2021 02:30 AM
Irish Covid patients being treated in intensive care (ICU) are to start receiving the drug ivermectin as part of an international clinical trial.
Ivermectin is an anti-parasitic drug that has been controversially promoted by some as a cure for the disease.
In 2015, Donegal scientist Professor William Campbell shared the Nobel Prize in Physiology or Medicine for his role in the discovery of ivermectin.

https://www.boards.ie/vbulletin/showpost.php?p=116430898&postcount=78

banie01

Piollaire wrote: »

I don't see anything in your post showing that manufacturers of generics are funding trials.

Ivermectin's absence from the government funded Recovery trial is a huge blunder.

Because at no point in my post did I say that generic manufacturers are funding trials.

Here's a list of the 6 Ivermectin trials underway in the EU.
https://www.clinicaltrialsregister.eu/ctr-search/search?query=ivermectin+AND+covid-19

And here's the 61 trials currently underway in the US.
https://clinicaltrials.gov/ct2/results?term=ivermectin&recrs=abcdefghl&cond=covid19

See19

My understanding from some doctors treating Covid is they are following three phases: Anyone think this makes sense? So why are the Irish Ivermectin trials used in ICU were it is least effective?

1. Home: Ivermectin used in the pre /early stage of the disease works wonders. (Home treatment)
2. Hospital: hydroxychloroquine (or similar) - Respiratory symptoms the hydroxychloroquine inhibits the over immune response to the virus.
3. ICU: Anticoagulants with antibiotics and cortisone reduces the severity if the last phase of the disease.

Piollaire

banie01 wrote: »

Because at no point in my post did I say that generic manufacturers are funding trials.

Here's a list of the 6 Ivermectin trials underway in the EU.
https://www.clinicaltrialsregister.eu/ctr-search/search?query=ivermectin+AND+covid-19

And here's the 61 trials currently underway in the US.
https://clinicaltrials.gov/ct2/results?term=ivermectin&recrs=abcdefghl&cond=covid19

Thanks for the links - the second one is international rather than US only.

Are any of these trials of sufficient size and design to give results that would satisfy health authorities?

At this stage I think Ivermectin would have to bring people back from the dead for it to be given appopriate consideration.

[Deleted User]

Dubious about evidence base for Ivermectin as don't understand proposed mechanism of action.

Think it's probably going to be a similar dud to hydroxychloroquine

banie01

Piollaire wrote: »

Thanks for the links - the second one is international rather than US only.

Are any of these trials of sufficient size and design to give results that would satisfy health authorities?

At this stage I think Ivermectin would have to bring people back from the dead for it to be given appopriate consideration.

The US linked ones are carried out internationally but with US oversight rather than local.
Schedule of practice as per FDA standards.

I'm at a loss as to how someone can be shown 67 active trials of a drug, and think it's not being considered?

Consideration as a treatment is, in general, wholly predicated upon high quality data.
These trials will provide that.

If it provides a good therapy, the data will bear that out and then it becomes a treatment.

Piollaire

See19 wrote: »

My understanding from some doctors treating Covid is they are following three phases: Anyone think this makes sense? So why are the Irish Ivermectin trials used in ICU were it is least effective?

1. Home: Ivermectin used in the pre /early stage of the disease works wonders. (Home treatment)
2. Hospital: hydroxychloroquine (or similar) - Respiratory symptoms the hydroxychloroquine inhibits the over immune response to the virus.
3. ICU: Anticoagulants with antibiotics and cortisone reduces the severity if the last phase of the disease.

I believe Ivermectin also has anti-inflammatory properties which could help at the ICU stage.

Piollaire

banie01 wrote: »

The US linked ones are carried out internationally but with US oversight rather than local.
Schedule of practice as per FDA standards.

I'm at a loss as to how someone can be shown 67 active trials of a drug, and think it's not being considered?

Consideration as a treatment is, in general, wholly predicated upon high quality data.
These trials will provide that.

If it provides a good therapy, the data will bear that out and then it becomes a treatment.

Thanks for the clarification.

There has been 45 trials of various sizes and designs so far. None of them have passed muster so far, either individually or in compilation, to prompt health authorities to act. What's in the next 65 that will be different?

banie01

Piollaire wrote: »

Thanks for the clarification.

There has been 45 trials of various sizes and designs so far. None of them have passed muster so far, either individually or in compilation, to prompt health authorities to act. What's in the next 65 that will be different?

Without reviewing them individually I wouldn't know.
However, if 45 trials to date have failed to generate statistical data to support its adoption over current treatments?
That would imply that current treatments are better.

The remaining trials may present evidence that changes that stance.
It's not a definitive Ivermectin "bad" position, rather that it's yet to be proven any better.

As an aside though, 45 completed trials and 67 active trials are hardly indicative of a move by Merck or big pharma to suppress use of the drug in favour of "new" therapeutics.
It really refutes the notion that Big Pharma is ignoring or stifling efforts to use it.

is_that_so

Here's a trial with mild COVID from Colombia, not a very positive outcome.

Early administration of the antiparasitic drug ivermectin didn't significantly shorten time to clinical improvement in 400 adults mildly ill with COVID-19, a clinical trial today in JAMA finds.

https://www.cidrap.umn.edu/news-perspective/2021/03/ivermectin-doesnt-speed-recovery-mild-covid-19-study-shows

Piollaire

is_that_so wrote: »

Here's a trial with mild COVID from Colombia, not a very positive outcome.

https://www.cidrap.umn.edu/news-perspective/2021/03/ivermectin-doesnt-speed-recovery-mild-covid-19-study-shows

Mix ups between the groups does not instil confidence in the results of this study

Piollaire

banie01 wrote: »

Without reviewing them individually I wouldn't know.
However, if 45 trials to date have failed to generate statistical data to support its adoption over current treatments?
That would imply that current treatments are better.

FLCCC, Dr. Tess Lawrie, Dr. Andrew Hill are impressed with the statistical data generated so far. Irish/EU health authorities aren't looking at the studies. The FDA and NIH are rife with paid lobbyists on their advisory committees.

As an aside though, 45 completed trials and 67 active trials are hardly indicative of a move by Merck or big pharma to suppress use of the drug in favour of "new" therapeutics.
It really refutes the notion that Big Pharma is ignoring or stifling efforts to use it.

Merck released a statement last month calling into question the validity of all these studies. Merck did not find a single redeeming feature in any of them:

https://www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19-pandemic/

banie01

Piollaire wrote: »

FLCCC, Dr. Tess Lawrie, Dr. Andrew Hill are impressed with the statistical data generated so far. Irish/EU health authorities aren't looking at the studies. The FDA and NIH are rife with paid lobbyists on their advisory committees.

Merck released a statement last month calling into question the validity of all these studies. Merck did not find a single redeeming feature in any of them:

https://www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19-pandemic/

What's your opinion on this?

Why do you think no treatment protocol has been proposed from studies to date?

Why does Merck's opinion regarding an out of patent drug matter if a successful protocol for it exists?

If quality data can be found, approval is really a non-issue as emergency use authority would be granted.

That doesn't square with your earlier post that

Piollaire wrote: »

No company is going to spend the money to get it approved when other companies can then freely undercut them as it off patent.

No company needs to, multiple studies funded by multiple sources are underway into the efficacy of Ivermectin.
Yet, you seem to keep bringing it back to Merck and not paying for approval.

Could you just lay out what you think is happening with the studies and what their aim is then?
I just want to be sure I am not picking you up wrong?
As it's coming across very much as "big pharma" bad?
Despite the 100+ studies (total ongoing and complete) for an off patent drug?
Studies in the main undertaken by hospitals, universities and health systems desperate to save money, but have yet to present any data to support its replacing any other treatment option?

Piollaire

Deleted User wrote: »

Dubious about evidence base for Ivermectin as don't understand proposed mechanism of action.

Think it's probably going to be a similar dud to hydroxychloroquine

Dr. Mobeen Syed gives proposed mechanisms of actions for Ivermectin:

https://www.youtube.com/watch?v=GZoBAuR4ajs&t=287s

is_that_so

Piollaire wrote: »

Mix ups between the groups does not instil confidence in the results of this study

Sorry I really don't do YouTube videos. YouTube is only evidence of someone's ability to make a video. I've shared a few links to what's going on with it and it's clear it's not there yet as a treatment.

Piollaire

banie01 wrote: »

What's your opinion on this?

Why do you think no treatment protocol has been proposed from studies to date?

Why does Merck's opinion regarding an out of patent drug matter if a successful protocol for it exists?

If quality data can be found, approval is really a non-issue as emergency use authority would be granted.

That doesn't square with your earlier post that

No company needs to, multiple studies funded by multiple sources are underway into the efficacy of Ivermectin.
Yet, you seem to keep bringing it back to Merck and not paying for approval.

Could you just lay out what you think is happening with the studies and what their aim is then?
I just want to be sure I am not picking you up wrong?
As it's coming across very much as "big pharma" bad?
Despite the 100+ studies (total ongoing and complete) for an off patent drug?
Studies in the main undertaken by hospitals, universities and health systems desperate to save money, but have yet to present any data to support its replacing any other treatment option?

I'll try to boil it down. There is a complete structural failure here. In order for an emergency authorisation to be issued by our HPRA or the EMA then a request must come from a pharmaceutical company. Yet there is no financial incentive for a pharmaceutical company to do that when the drug is off patent. It's a perfect catch 22. Merck could take the hit and go through the process in the interests of public health but it is obvious that Merck is not going to do so. It doesn't matter how many studies are done. The solution is to empower the HPRA and EMA to issue emergency authorisations on their own initiative.

banie01

Piollaire wrote: »

I'll try to boil it down. There is a complete structural failure here. In order for an emergency authorisation to be issued by our HPRA or the EMA then a request must come from a pharmaceutical company. Yet there is no financial incentive for a pharmaceutical company to do that when the drug is off patent. It's a perfect catch 22. Merck could take the hit and go through the process in the interests of public health but it is obvious that Merck is not going to do so. It doesn't matter how many studies are done. The solution is to empower the HPRA and EMA to issue emergency authorisations on their own initiative.

Then why was there an incentive for TAW pharma to apply for an EUA for Dexamethasone in the EU?

Why is EUA or alternative licensing applied for by any generic manufacturers?
Surely it's not a cost effective measure, even if they offload all research costs on top of zero clinical study costs.

Why after multiple inconclusive studies has no generic manufacturer done this for Ivermectin.

Do you think if quality data for Ivermectin existed that health systems would not pursue of label prescription and seek EUA?
That a generic manufacturer would not take forward an EUA application on the basis of a trio of definite sales, minimal costs and state supported orders?

Are we now in the realm of Big Pharma and National Health Systems and the EMA being in collusion to spend ever greater sums of public money and precipitate a higher death rate?
Rather than embrace the cheap and cheerful?

Can you point me to any double blinded study supporting Ivermectin as better than any alternatives?
Can you tell me if you believe the EMA and HPRA should issue EUA's without such data?

Piollaire

banie01 wrote: »

Then why was there an incentive for TAW pharma to apply for an EUA for Dexamethasone in the EU?

Why is EUA or alternative licensing applied for by any generic manufacturers?
Surely it's not a cost effective measure, even if they offload all research costs on top of zero clinical study costs.

Why after multiple inconclusive studies has no generic manufacturer done this for Ivermectin.

Do you think if quality data for Ivermectin existed that health systems would not pursue of label prescription and seek EUA?
That a generic manufacturer would not take forward an EUA application on the basis of a trio of definite sales, minimal costs and state supported orders?

Are we now in the realm of Big Pharma and National Health Systems and the EMA being in collusion to spend ever greater sums of public money and precipitate a higher death rate?
Rather than embrace the cheap and cheerful?

Can you point me to any double blinded study supporting Ivermectin as better than any alternatives?
Can you tell me if you believe the EMA and HPRA should issue EUA's without such data?

TAW got authorisation off the back of the Recovery Trial. The costs of getting an EUA are in producing the safety and efficacy data rather than submitting the paperwork.

The HPRA and EMA cannot issue an EUA without an application from a pharmaceutical company no matter how good the data is.

It's not collusion - just a wonky system.

We're back to the blunder of excluding Ivermectin from the Recovery Trial in the UK. We don't have an equivalent of the Recovery Trial in the EU as far as I'm aware. If Ivermectin was proved efficacious by a major government sponsored study then a manufacturer would come forward.

Thanks for the discussion Banie01.

banie01

Piollaire wrote: »

TAW got authorisation off the back of the Recovery Trial. The costs of getting an EUA are in producing the safety and efficacy data rather than submitting the paperwork.

The HPRA and EMA cannot issue an EUA without an application from a pharmaceutical company no matter how good the data is.

It's not collusion - just a wonky system.

We're back to the blunder of excluding Ivermectin from the Recovery Trial in the UK. We don't have an equivalent of the Recovery Trial in the EU as far as I'm aware. If Ivermectin was proved efficacious by a major government sponsored study then a manufacturer would come forward.

Thanks for the discussion Banie01.

TAW presented high quality research that merited the issuance.
The source is irrelevant, it's the quality of the data that matters.

If similar quality of research exists for Ivermectin, it's open to any manufacturer of Ivermectin to submit it in support of an EUA.
Does any such Data exist?

Excluding Ivermectin from the recovery trial is an issue for you.
Most trials to date indicate it to be as effective as Hydroxychloroquine, as in not very at all.
So what rationale would support its inclusion in the recovery trial?

What about, the by your count 45 completed trials to date?
Even in aggregation they present no evidence that Ivermectin is a better treatment than those already in use.
There are 67 further trials in progress, if they all return the same verdict?

If no qualitative evidence that Ivermectin is a better treatment?
Why would any company seek to apply for an EUA in such a circumstance?

So can I assume that since you haven't referenced any double blinded or quality assured trial that illustrates Ivermectin as more effective than current alternatives?
That there isn't one.

Now let's place that lack of evidence in the context of an EUA application?
Even in a utopian context where the EMA can grant a license despite no-one actually wanting one.
Should the EMA grant an EUA in the absence of any quality supporting trial data?

The hypothesis presented by those pushing Ivermectin is compelling, but what's more compelling at present is despite that hypothesis, there is a dearth of actual evidence despite multiple studies.

As I said in an earlier post, the position may well change on publication of quality research but in the absence of that?
The number of studies returning evidence of near zero benefit versus the current proven treatments has to hold sway.

If the remaining studies outstanding return some high quality evidence of a benefit?
One of the generic manufacturers will undoubtedly use it in support of an EUA application.

Johnboy1951

Anyone seen this?
https://twitter.com/fatemperor/status/1368304768775557123

FFS they have a PATENTED Ivermectin now - get ready to see it suddenly become a wonder drug

https://assets-global.website-files.com/60085ac8fa8263a049a4d1b4/603f24dbfc810677b7597008_PR%202021-03-03%20-%20MVMD%20Commencing%20FDA%20505(b)(2)%20Pathway%20for%20Ivectosol.pdf

I have yet to read it through ...

Piollaire

Johnboy1951 wrote: »

Anyone seen this?
https://twitter.com/fatemperor/status/1368304768775557123

https://assets-global.website-
files.com/60085ac8fa8263a049a4d1b4/603f24dbfc810677b7597008_PR%202021-03-03%20-%20MVMD%20Commencing%20FDA%20505(b)(2)%20Pathway%20for%20Ivectosol.pdf

I have yet to read it through ...

Will be very interesting to see how they get on. If they can get this patented solublized version of Ivermectin approved for the treatment of Covid then this will open the way for the generic tablet form too.

Previous press releases are available on their homepage
https://www.mountainvalleymd.com

Probes

Johnboy1951 wrote: »

Anyone seen this?
https://twitter.com/fatemperor/status/1368304768775557123

https://assets-global.website-files.com/60085ac8fa8263a049a4d1b4/603f24dbfc810677b7597008_PR%202021-03-03%20-%20MVMD%20Commencing%20FDA%20505(b)(2)%20Pathway%20for%20Ivectosol.pdf

I have yet to read it through ...

How are they going to patent Ivermectin? It’s been in the public domain for quarter of a century. It looks like they are trying to patent a particular formulation to ingest it, but ivermectin will remain public domain.

Obligatory: Ivor Cummins has zero credibility and is as thick as two short planks.

Kiith

Probes wrote: »

How are they going to patent Ivermectin? It’s been in the public domain for quarter of a century. It looks like they are trying to patent a particular formulation to ingest it, but ivermectin will remain public domain

Patent laws in the US are absolutely bonkers. Logic often doesn't come into it.

banie01

Probes wrote: »

How are they going to patent Ivermectin? It’s been in the public domain for quarter of a century. It looks like they are trying to patent a particular formulation to ingest it, but ivermectin will remain public domain.

Obligatory: Ivor Cummins has zero credibility and is as thick as two short planks.

They aren't patenting Ivermectin though.
They are patenting a soluble variation of it for use as a delivery method.

If, and given the current state of the evidence it is a very conditional if.
Ivermectin is shown to be a more efficacious treatment than those currently used, it may be that this company will gain sales based upon the novelty of the "newly patented" formulation.

But I'm at a loss to see as to why a company would patent a new delivery vector, with those associated costs?
But not progress with an EUA application based on the trials to date?

It's almost as if, there's no quality data supporting a stance that the EUA is appropriate but that taking advantage of off label prescribing may present a sales opportunity.