Thailand to import 200,000 courses of Molnupiravir anti-viral drug from USA

[webfact]

 

The Ministry of Public Health is to seek approval from the Thai cabinet for the procurement of 200,000 courses of the Molnupiravir oral anti-viral medicine, using money from the Central Fund, said Deputy Government Spokesperson Rachada Dhnadirek.

 

Jointly developed by Merck and Ridgeback Biotherapeutics of the United States, Molnupiravir has proven to be effective in significantly reducing the risk of hospitalisation or death from COVID-19 infection during Third Phase human trials. The companies are seeking approval from the US Food and Drug Administration for emergency use.

 

Citing information from the Rural Doctor Society, Dr. Rachada said the orally-administered drug was developed from medicine used to treat flu, after studies showed that it is efficacious in inhibiting several types of coronavirus, including COVID-19, adding that the medicine is Third Phase human trials in the United States.

 

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Full story: https://www.thaipbsworld.com/thailand-to-import-200000-courses-of-molnupiravir-anti-viral-drug-from-usa/

 

-- © Copyright Thai PBS 2021-10-06

 

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[cclub75]

Great.

 

Where are the "randomized double blind studies", the so called gold standard of science, about this new molecule ?

 

Meanwhile... molecule decades old, like Ivermectin, that has been used around the planet by millions of people... safe, no IPs super cheap to produce... with many testimonies of doctors using it against Covid... nah.... "too dangerous".

 

It could kill ! We need to make many studies (suddendly, like hydroxychloroquine... invented 70 years ago... and used since then with billions of doses...).

 

It sounds perfectly normal.

[Bkk Brian]

25 minutes ago, webfact said:

The Ministry of Public Health is to seek approval from the Thai cabinet for the procurement of 200,000 courses of the Molnupiravir oral anti-viral medicine, using money from the Central Fund, said Deputy Government Spokesperson Rachada Dhnadirek.

Merck has just announced a signed contract with Singapore for these, hopefully Thailand will drop some of its bureaucracy and get its order in sooner rather than later

[AsiaCheese]

2 hours ago, cclub75 said:

Great.

 

Where are the "randomized double blind studies", the so called gold standard of science, about this new molecule ?

 

Meanwhile... molecule decades old, like Ivermectin, that has been used around the planet by millions of people... safe, no IPs super cheap to produce... with many testimonies of doctors using it against Covid... nah.... "too dangerous".

 

It could kill ! We need to make many studies (suddendly, like hydroxychloroquine... invented 70 years ago... and used since then with billions of doses...).

 

It sounds perfectly normal.

Yes, right, meanwhile... Are you quoting some quacks or home remedies websites (often by quacks), or are you actually a specialist in the matter? If not, please read up on Ivermectin here: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

Treating horses or heart worms, right?

 

[mrfill]

Sounds like snake oil version 2.

 

Is it a copy of ivermectin or something equally useless. Hospitals are busy dealing with overdoses of ivermectin so they should prepare for more patients from this.

[JBChiangRai]

19 minutes ago, mrfill said:

Sounds like snake oil version 2.

 

Is it a copy of ivermectin or something equally useless. Hospitals are busy dealing with overdoses of ivermectin so they should prepare for more patients from this.

According to ViGiBase, Ivermectin is one of the safest drugs on the planet.  There have been less than 6,000 adverse effects reported in 3.7 billion doses given to humans.

 

The worry with Ivermectin is that the anti-vaxxers will promote it as evidence you don’t need to be vaccinated which is of course rubbish.

 

The problem with Ivermectin is it’s out of patent and there’s no money to be made.

 

Really folks, listen to science not politicians.

[JBChiangRai]

1 hour ago, AsiaCheese said:

Yes, right, meanwhile... Are you quoting some quacks or home remedies websites (often by quacks), or are you actually a specialist in the matter? If not, please read up on Ivermectin here: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

Treating horses or heart worms, right?

 

The takeaway from that FDA article is don’t self medicate, don’t use animal drugs, there are risks if you overdose and there are contraindications.

 

WAIT for the studies to conclude, because they will say whether it is effective or not.

 

You might like to read my post a few posts up on a comparison of the pharmacology of Molnupiravir and Ivermectin.  They are both highly active antivirals for SARS-CoV-2.

 

As a postscript, if you’re admitted to a Thai hospital with Covid19 don’t be surprised when they give you 2 of 6mg tablets of Ivermectin amongst everything else.

[partington]

2 hours ago, JBChiangRai said:

 

 

You might like to read my post a few posts up on a comparison of the pharmacology of Molnupiravir and Ivermectin.  They are both highly active antivirals for SARS-CoV-2.

 

 

Ivermectin is not by any means a highly active antiviral - the dose of ivermectin needed to prevent RNA viruses replicating in cells is 60 times that achievable in the blood by the highest doses of ivermectin given to human beings. Antiviral Research June 2020 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172803/

 

This means it is almost impossible to see how any antiviral activity could be attained by the single dose of ivermectin yearly that is given as an anti-parasitic, and upon which a lot of the anecdotal evidence about ivermectin is based, or by repeated doses..

 

The only major double blind studies of ivermectin that have shown significant efficacy against COVID have both been revealed recently as fabricated data and withdrawn.

https://www.theguardian.com/science/2021/jul/16/huge-study-supporting-ivermectin-as-covid-treatment-withdrawn-over-ethical-concerns

 

https://www.buzzfeednews.com/article/stephaniemlee/ivermectin-covid-study-suspect-data

 

https://www.theguardian.com/australia-news/2021/sep/25/fraudulent-ivermectin-studies-open-up-new-battleground-between-science-and-misinformation

 

The binding of ivermectin to the spike 2 protein is a theoretical computer prediction entirely obtained by running software and has not been directly demonstrated in vitro, and therefore neither has its ability to prevent ACE2 mediated entry of SARS CoV-2 ever been shown directly. The same is true of apparent binding to RdRp - this is based on computer modelling without any direct binding studies. https://pubmed.ncbi.nlm.nih.gov/33746908/

 

The inhibition by ivermectin of import proteins that carry viral components into the nucleus has been shown experimentally, but this means it also prevents importation of necessary host proteins into the nucleus, including those which are essential for immune responses. This raises the possibility of toxic interference with normal cell functions if doses are used which prevent viral import. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327999/

 

Again it should be emphasised that the anti-parasitic dose of ivermectin, used world wide, and upon which safety data is based, is ONE dose annually.

[sometimewoodworker]

The point with both Molnupiravir and Ivermectin are that they reduce virus replication, though the costs are rather different at $700 bulk purchases cost for a course of Molnupiravir vs $0.53 for 10 days of Ivermectin

 

Neither is a substitute for vaccination, they will just reduce your chances of death/serious complications once infected until you can be vaccinated 

[CharlieH]

Unattributed cut n paste post removed along with responses to it.

[Toany]

2 hours ago, sometimewoodworker said:

The point with both Molnupiravir and Ivermectin are that they reduce virus replication, though the costs are rather different at $700 bulk purchases cost for a course of Molnupiravir vs $0.53 for 10 days of Ivermectin

 

Neither is a substitute for vaccination, they will just reduce your chances of death/serious complications once infected until you can be vaccinated 

But the course of Ivermectin would cost $59  in Thailand because of the pharmacy mark up

[sometimewoodworker]

5 minutes ago, Toany said:

But the course of Ivermectin would cost $59  in Thailand because of the pharmacy mark up

In a private hospital pharmacy just possibly, in a central dispensing pharmacy absolutely not. The last time I purchased paediatric aspirin it was ฿0.15 per tablet. There is no reason why, from a similar pharmacy, that the cost of a standard 3mg tablet of ivermectin would be higher. The caveat though is that price is for a complete dispensary quantity, the only way they sell, in the case of paediatric aspirin that was for 2,000 tablets. I don’t know the pack size for ivermectin but it’s likely to be a lot.

[JBChiangRai]

12 hours ago, partington said:

Ivermectin is not by any means a highly active antiviral - the dose of ivermectin needed to prevent RNA viruses replicating in cells is 60 times that achievable in the blood by the highest doses of ivermectin given to human beings. Antiviral Research June 2020 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172803/

 

This means it is almost impossible to see how any antiviral activity could be attained by the single dose of ivermectin yearly that is given as an anti-parasitic, and upon which a lot of the anecdotal evidence about ivermectin is based, or by repeated doses..

 

The only major double blind studies of ivermectin that have shown significant efficacy against COVID have both been revealed recently as fabricated data and withdrawn.

https://www.theguardian.com/science/2021/jul/16/huge-study-supporting-ivermectin-as-covid-treatment-withdrawn-over-ethical-concerns

 

https://www.buzzfeednews.com/article/stephaniemlee/ivermectin-covid-study-suspect-data

 

https://www.theguardian.com/australia-news/2021/sep/25/fraudulent-ivermectin-studies-open-up-new-battleground-between-science-and-misinformation

 

The binding of ivermectin to the spike 2 protein is a theoretical computer prediction entirely obtained by running software and has not been directly demonstrated in vitro, and therefore neither has its ability to prevent ACE2 mediated entry of SARS CoV-2 ever been shown directly. The same is true of apparent binding to RdRp - this is based on computer modelling without any direct binding studies. https://pubmed.ncbi.nlm.nih.gov/33746908/

 

The inhibition by ivermectin of import proteins that carry viral components into the nucleus has been shown experimentally, but this means it also prevents importation of necessary host proteins into the nucleus, including those which are essential for immune responses. This raises the possibility of toxic interference with normal cell functions if doses are used which prevent viral import. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327999/

 

Again it should be emphasised that the anti-parasitic dose of ivermectin, used world wide, and upon which safety data is based, is ONE dose annually.

 

Firstly, I apologising for not identifying the peer reviewed paper from which I quoted, my post was made from my phone and required repeated going back and forth, copying and pasting to notes before posting here, and it was an oversight, I thought I had done so. The article is here Drugs Shown to Inhibit SARS-CoV-2 in COVID-19 Disease: Comparative Basic and Clinical Pharmacology of Molnupiravir and Ivermectin (austinpublishinggroup.com) and as I said it is peer reviewed.

 

Let me take your last point first, safety data accumulated by ViGiBase is NOT limited to one dose annually.  The most common occurrence was one dose and the second most common occurrence was two doses a week or so apart. No dose limit annually was applied to the collection of adverse effects and the safety of Ivermectin as I previously mentioned is less than 6,000 adverse events in more than 3.7 billion doses given.  It is one of the safest pharmaceuticals on the planet.

 

I'm not going to comment on newspaper articles you quoted (The Guardian) as I don't regard them as science, I rarely believe what I read in the papers, in fact I don't read them anyway.

 

The suspect study you refer to (Elgazzar et al, I assume you mean) has been removed from the meta analyses by Hill, Garratt, Falconer, Ellis, McCann et al, that show 56% mortality reduction.  At no point did I refer to the withdrawn preprint by Elgazzar et al.  Whilst this purported to be largest double blind trial testifying to the efficacy of Ivermectin, it is not the only trial to do so.

 

I have some concerns about the safety of Molnupiravir, as does Zhou, Hill, Sarkar, Tse, Woodburn, Schinazi et al, as the mechanism for viral mutagensis or transition mutations in SARS-CoV-2 is also shown to have the same effect in mammalian cells.  Merck says it is safe however, I would prefer to see more study.

 

Computer modeling is a normal part of drug development, in fact the NIH article you referred to goes on to say "Ivermectin and remdesivir were found to be the most promising drugs."

 

It's hard to ignore the anecdotal evidence from India, Africa and some South American countries about the efficacy of Ivermectin, and whist this is not a smoking gun, it warrants further study.

 

My opinion, and this is the first time I have ventured an opinion on Ivermectin, is that it may or may not be much help in treating COVID19 but it appears to act as a prophylactic.  In any event, it is being prescribed in Thai hospitals to COVID19 patients.

[Toany]

18 hours ago, sometimewoodworker said:

In a private hospital pharmacy just possibly, in a central dispensing pharmacy absolutely not. The last time I purchased paediatric aspirin it was ฿0.15 per tablet. There is no reason why, from a similar pharmacy, that the cost of a standard 3mg tablet of ivermectin would be higher. The caveat though is that price is for a complete dispensary quantity, the only way they sell, in the case of paediatric aspirin that was for 2,000 tablets. I don’t know the pack size for ivermectin but it’s likely to be a lot.

Unfortunately you do not know what you are talking about.  You have not bought Ivermectin in Bangkok.

I have at pharmacy that are known to be cheap.  They all charge at a cost of  100 ฿ per 6mg tablet.

It is a fact as I have bought them.

My other medications are cheap as you say.

[partington]

9 hours ago, JBChiangRai said:

 

 

 

Let me take your last point first, safety data accumulated by ViGiBase is NOT limited to one dose annually.  The most common occurrence was one dose and the second most common occurrence was two doses a week or so apart. No dose limit annually was applied to the collection of adverse effects and the safety of Ivermectin as I previously mentioned is less than 6,000 adverse events in more than 3.7 billion doses given.  It is one of the safest pharmaceuticals on the planet.

 

I'm not going to comment on newspaper articles you quoted (The Guardian) as I don't regard them as science, I rarely believe what I read in the papers, in fact I don't read them anyway.

 

 

 

 

 

I did not say a dose limit was applied to the safety data, I said the dosage given to people as anti-parasitics (the major use of ivermectin world wide) is one dose annually: this of necessity means that overwhelming mass of safety data on this drug is derived from patients treated with one dose annually. This is self evident.

 

If you don't read newspapers concerning retractions and problems with randomised double blind studies of ivermectin then probably this article in Nature Medicine 21 Sept 2021 will be more convincing to you. https://www.nature.com/articles/s41591-021-01535-y

 

Extract:

["Research into the use of ivermectin (a drug that has an established safety and efficacy record in many parasitic diseases) for the treatment and/or prophylaxis of COVID-19 has illustrated this problem well. Recently, we described flaws in one randomized control trial of ivermectin¹, 

1. [Elgazzar, A. et al. Preprint at https://www.researchsquare.com/article/rs-100956/v3 (2020).]

the results of which represented more than 10% of the overall effect in at least two major meta-analyses^2,3. We described several irregularities in the data that could not be consistent with them being experimentally derived⁴. That study has now been withdrawn by the preprint server⁵ on which it was hosted. We also raised concerns about unexpected stratification across baseline variables in another randomized controlled trial for ivermectin⁶,

[Shakhsi Niaee, M. et al. Asian Pac. J. Trop. Med. 14, 266–273 (2021).https://www.apjtm.org/article.asp?issn=1995-7645;year=2021;volume=14;issue=6;spage=266;epage=273;aulast=Shakhsi]

 

which were highly suggestive of randomization failure. We have requested data from the authors but, as of 6 September 2021, have not yet received a response. This second ivermectin study has now been published⁶, and there is still no response from the authors in a request for data.

 

The authors of one recently published meta-analysis of ivermectin for COVID-19³ 

1. [Hill, A. et al. Open Forum Infectious Diseases https://doi.org/10.1093/ofid/ofab358 (2021).]

have publicly stated that they will now reanalyze and republish their now-retracted meta-analysis and will no longer include either of the two papers just mentioned. As these two papers^1,6were the only studies included in that meta-analysis to demonstrate an independently significant reduction in mortality, the revision will probably show no mortality benefit for ivermectin.

 

 

Several other studies that claim a clinical benefit for ivermectin are similarly fraught, and contain impossible numbers in their results, unexplainable mismatches between trial registry updates and published patient demographics, purported timelines that are not consistent with the veracity of the data collection, and substantial methodological weaknesses. We expect further studies supporting ivermectin to be withdrawn over the coming months.

 

Since the above primary studies were published, many hundreds of thousands of patients have been dosed with ivermectin, relying on an evidence base that has substantially evaporated under close scrutiny."]

Edited October 7, 2021 by partington

[LetsGoBrandon]

The initial test results were so encouraging that they reportedly discontinued the trials 

to bring this to save people ASAP. So says a man who calls himself "Dr" Eric Feigl-Ding

 

Others say that the way this med works is by causing mutations in the virus cells so they can't replicate.

 

Of course, we do not know whether it causes other cells in the human body to mutate as well. 

Edited October 7, 2021 by LetsGoBrandon

[sometimewoodworker]

2 hours ago, Toany said:

Unfortunately you do not know what you are talking about.  You have not bought Ivermectin in Bangkok.

I have at pharmacy that are known to be cheap.  They all charge at a cost of  100 ฿ per 6mg tablet.

It is a fact as I have bought them.

My other medications are cheap as you say.

Please reread what I wrote before jumping to conclusions and putting words in my mouth.

 

What was the minimum number of tablets you could buy that were at that price. The cost in any pharmacy that will dispense small quantities is dramatically higher (for good reasons) than in a central dispensing pharmacy where they will not break down packages. 
 

I don’t claim to know the current cost that has likely risen due to demand, however even assuming your figure is correct for bulk purchase and that a course of ivermectin is 12mg each 3 days (the bloodstream data is 84 hours so that’s being conservative)

Quote

The plasma half life were 7 hours for M and 81-91 hours for IV.

and that you treat for 10 days (double the course time for Molnupiravir which is 5 days) you still only get to 600 Baht or $18 still far away from your $57 isn’t it?

Edited October 7, 2021 by sometimewoodworker

[Toany]

1 hour ago, sometimewoodworker said:

Please reread what I wrote before jumping to conclusions and putting words in my mouth.

 

What was the minimum number of tablets you could buy that were at that price. The cost in any pharmacy that will dispense small quantities is dramatically higher (for good reasons) than in a central dispensing pharmacy where they will not break down packages. 
 

I don’t claim to know the current cost that has likely risen due to demand, however even assuming your figure is correct for bulk purchase and that a course of ivermectin is 12mg each 3 days (the bloodstream data is 84 hours so that’s being conservative)

and that you treat for 10 days (double the course time for Molnupiravir which is 5 days) you still only get to 600 Baht or $18 still far away from your $57 isn’t it?

1 hour ago, sometimewoodworker said:

100฿ per 6 Mg Tablet. Normal dose is 0.4 mg per KG over 5 days.  0.4 x 60 = 24 mg = 4 tablets.  x 5days - 2,000฿  The will not sell bulk Ivermectin

 

[JBChiangRai]

On 10/7/2021 at 5:52 PM, partington said:

I did not say a dose limit was applied to the safety data, I said the dosage given to people as anti-parasitics (the major use of ivermectin world wide) is one dose annually: this of necessity means that overwhelming mass of safety data on this drug is derived from patients treated with one dose annually. This is self evident.

 

If you don't read newspapers concerning retractions and problems with randomised double blind studies of ivermectin then probably this article in Nature Medicine 21 Sept 2021 will be more convincing to you. https://www.nature.com/articles/s41591-021-01535-y

 

Extract:

["Research into the use of ivermectin (a drug that has an established safety and efficacy record in many parasitic diseases) for the treatment and/or prophylaxis of COVID-19 has illustrated this problem well. Recently, we described flaws in one randomized control trial of ivermectin¹, 

1. [Elgazzar, A. et al. Preprint at https://www.researchsquare.com/article/rs-100956/v3 (2020).]

the results of which represented more than 10% of the overall effect in at least two major meta-analyses^2,3. We described several irregularities in the data that could not be consistent with them being experimentally derived⁴. That study has now been withdrawn by the preprint server⁵ on which it was hosted. We also raised concerns about unexpected stratification across baseline variables in another randomized controlled trial for ivermectin⁶,

[Shakhsi Niaee, M. et al. Asian Pac. J. Trop. Med. 14, 266–273 (2021).https://www.apjtm.org/article.asp?issn=1995-7645;year=2021;volume=14;issue=6;spage=266;epage=273;aulast=Shakhsi]

 

which were highly suggestive of randomization failure. We have requested data from the authors but, as of 6 September 2021, have not yet received a response. This second ivermectin study has now been published⁶, and there is still no response from the authors in a request for data.

 

The authors of one recently published meta-analysis of ivermectin for COVID-19³ 

1. [Hill, A. et al. Open Forum Infectious Diseases https://doi.org/10.1093/ofid/ofab358 (2021).]

have publicly stated that they will now reanalyze and republish their now-retracted meta-analysis and will no longer include either of the two papers just mentioned. As these two papers^1,6were the only studies included in that meta-analysis to demonstrate an independently significant reduction in mortality, the revision will probably show no mortality benefit for ivermectin.

 

 

Several other studies that claim a clinical benefit for ivermectin are similarly fraught, and contain impossible numbers in their results, unexplainable mismatches between trial registry updates and published patient demographics, purported timelines that are not consistent with the veracity of the data collection, and substantial methodological weaknesses. We expect further studies supporting ivermectin to be withdrawn over the coming months.

 

Since the above primary studies were published, many hundreds of thousands of patients have been dosed with ivermectin, relying on an evidence base that has substantially evaporated under close scrutiny."]

You might like to read Ivermectin for COVID-19: real-time meta analysis of 64 studies (ivmmeta.com) the meta analyis is updated in real time with suspicious or withdrawn studies removed in real time.

 

Meta analysis using the most serious outcome reported shows 66% [52‑76%] and 86% [75‑92%] improvement for early treatment and prophylaxis, with similar results after exclusion based sensitivity analysis and restriction to peer-reviewed studies or Randomized Controlled Trials

 

We talked about newspapers etc, even the BBC gets it wrong, they published a fluffy opinion piece last week based on an article by a student and his 5 twitter friends.

 

In case you're not aware, even one of the 2015 Nobel Prize winners for Ivermectin, asked Merck to conduct clinical trials as he believes in its efficacy, Merck declined, could it be because Ivermectin is out of patent and they have a competing new product?

[vinny]

There are concerns about Molnupiravir.

 

https://www.forbes.com/sites/williamhaseltine/2021/10/08/anti-covid-drugs-are-coming-but-at-what-cost/

[vinny]

On 10/6/2021 at 4:33 PM, AsiaCheese said:

Yes, right, meanwhile... Are you quoting some quacks or home remedies websites (often by quacks), or are you actually a specialist in the matter? If not, please read up on Ivermectin here: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

Treating horses or heart worms, right?

 

See also https://rescue.substack.com/p/horse-bleep-how-4-calls-on-animal

[vinny]

https://ago.nebraska.gov/opinions/prescription-ivermectin-or-hydroxychloroquine-label-medicines-prevention-or-treatment-covid

[Karma80]

I mean you could just spend the boat load of cash on feeding the starving population or more vaccines. But nah, let's get some more experimental stuff and then recommend only take half the course followed by a half dose of cough medicine which boosts efficiency according to Dr Nobody and his study of his 3 cats.