Coronavirus

[SithZedi]

The Biden administration recalculation here should be fairly interesting. Too bad this was not done from the beginning.

Biden officials trying to recalculate U.S. Covid-19 hospitalizations

The administration’s goal is to get a more accurate sense of Covid’s impact across the country.

www.politico.com

 

[Swerd]

Finally, after further reading, I get to this paragraph taken from the nih.gov, dated Feb 2021. Does not seem to have been updated since but there is a Clinical Data Tab dated Dec 2021. If there is an update, let me know.

Recommendation:
There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Ivermectin | COVID-19 Treatment Guidelines

Review clinical data on the use of ivermectin for the treatment of COVID-19.

www.covid19treatmentguidelines.nih.gov

Before commenting any further, an honest question: Is this paragraph from a reputable source or is it BS?

You asked if I think the paragraph you quoted is from a reputable source or is it BS? I don't understand why you're asking that. I though it was clear. Please clarify.

That statement is worded in standard, cautious, clinical trial-speak. Translated, it means: Until there is convincing evidence from a clinical trial or trials that are:

• Adequately Powered – Means the trial includes enough patients for statistically significant results. The trial design must pass muster with FDA biostatisticians before approval. The last I looked, there were many ivermectin clinical trials, but they include too few patients to allow statistically significant results. A trial of roughly 100 to 300 patients is too small to allow a valid estimation of patient response rates. It's large enough to answer the question, Yes or No, is there enough evidence of an ivermectin response to justify a much larger trial. These are called Phase 2 trials. Larger Phase 3 trials, with roughly 10× more patients, are expensive and difficult to run.
  
  That TOGETHER trial I discussed in a previous post, had 1,500 patients on the ivermectin arm, 677 of whom received ivermectin, and 678 received a placebo. 86 ivermectin patients and 95 placebo patients required extended ER care or hospitalization. Statistically, 86 out of 677 and 95 out of 678 patients are not different numbers. As far as statistical design, that trial can be thought of as border-line between phase 2 and phase 3. However, the trial results clearly say, no don't bother doing a much larger trial.
• Well Designed – Means the trial is a randomized, double blinded, placebo controlled study. There must be at least two study arms, with identical patient populations, where one arm received standard care for Covid-19 plus ivermectin, and the other arm received standard care plus a placebo. The clinical endpoints and exactly what patient population characteristics are selected, must be carefully considered. They can make or break a trial.
• Well Conducted – Means it must be able to stand up to an FDA clinical trial audit, as well as medical peer review for publication purposes.

The NIH guideline says, so far, there is no clinical evidence that ivermectin has anti-virus activity in Covid-19 patients. That doesn't mean there could never be such evidence in the future. Other trials of ivermectin are still in progress. But, unless there is an unanticipated and major breakthrough, there is no reason to expect that conclusion to change.

Remember, the web page you linked is only a brief digest of the full NIH guidelines for treating Covid-19.
Anti-Viral Drugs – Approved or Under Evaluation for Covid-19

https://files.covid19treatmentguidelines.nih.gov/guidelines/section/section_94.pdf

Full Treatment Guidelines for Covid-19 Treatment

https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf

 

[SithZedi]

You asked if I think the paragraph you quoted is from a reputable source or is it BS? I don't understand why you're asking that. I though it was clear. Please clarify.

That statement is worded in standard, cautious, clinical trial-speak. Translated, it means: Until there is convincing evidence from a clinical trial or trials that are:

• Adequately Powered – Means the trial includes enough patients for statistically significant results. The trial design must pass muster with FDA biostatisticians before approval. The last I looked, there were many ivermectin clinical trials, but they include too few patients to allow statistically significant results. A trial of roughly 100 to 300 patients is too small to allow a valid estimation of patient response rates. It's large enough to answer the question, Yes or No, is there enough evidence of an ivermectin response to justify a much larger trial. These are called Phase 2 trials. Larger Phase 3 trials, with roughly 10× more patients, are expensive and difficult to run.
  
  That TOGETHER trial I discussed in a previous post, had 1,500 patients on the ivermectin arm, 677 of whom received ivermectin, and 678 received a placebo. 86 ivermectin patients and 95 placebo patients required extended ER care or hospitalization. Statistically, 86 out of 677 and 95 out of 678 patients are not different numbers. As far as statistical design, that trial can be thought of as border-line between phase 2 and phase 3. However, the trial results clearly say, no don't bother doing a much larger trial.
  Well Designed – Means the trial is a randomized, double blinded, placebo controlled study. There must be at least two study arms, with identical patient populations, where one arm received standard care for Covid-19 plus ivermectin, and the other arm received standard care plus a placebo. The clinical endpoints and exactly what patient population characteristics are selected, must be carefully considered. They can make or break a trial.
• Well Conducted – Means it must be able to stand up to an FDA clinical trial audit, as well as medical peer review for publication purposes.

The NIH guideline says, so far, there is no clinical evidence that ivermectin has anti-virus activity in Covid-19 patients. That doesn't mean there could never be such evidence in the future. But, unless there is an unanticipated and major breakthrough, there is no reason to expect that conclusion to change.

Thanks for your response and your translation. Couple of comments, and I am speaking about treatment like the NIH is.

The NIH use the word "insufficient" you use the word "No". There is a difference especially when lives are at risk.

Your statement in this post:,
"That doesn't mean there could never be such evidence it the future. "

versus your position in your previous post:

"There is no longer any question about ivermectin – it doesn’t work in people with Covid-19.

Is another difference and is a move from your previous position.

So we agree that the NIH statement is not BS then? Now we'll focus on the latter half of that statement (and you know I like to ask questions).

Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

So in my translation, they are saying that trials "are needed" to gain evidence. They are not saying "no trials" are needed or that it would be a waste of time to do so.

If more well designed / conducted trials are needed because of insufficient evidence then why are we not throwing more money at it? The NIH has the money to fund the killing of monkeys by cocaine injection but not more money to possibly save more human lives.

 

[GO-NAD!]

You asked if I think the paragraph you quoted is from a reputable source or is it BS? I don't understand why you're asking that. I though it was clear. Please clarify.

That statement is worded in standard, cautious, clinical trial-speak. Translated, it means: Until there is convincing evidence from a clinical trial or trials that are:

• Adequately Powered – Means the trial includes enough patients for statistically significant results. The trial design must pass muster with FDA biostatisticians before approval. The last I looked, there were many ivermectin clinical trials, but they include too few patients to allow statistically significant results. A trial of roughly 100 to 300 patients is too small to allow a valid estimation of patient response rates. It's large enough to answer the question, Yes or No, is there enough evidence of an ivermectin response to justify a much larger trial. These are called Phase 2 trials. Larger Phase 3 trials, with roughly 10× more patients, are expensive and difficult to run.
  
  That TOGETHER trial I discussed in a previous post, had 1,500 patients on the ivermectin arm, 677 of whom received ivermectin, and 678 received a placebo. 86 ivermectin patients and 95 placebo patients required extended ER care or hospitalization. Statistically, 86 out of 677 and 95 out of 678 patients are not different numbers. As far as statistical design, that trial can be thought of as border-line between phase 2 and phase 3. However, the trial results clearly say, no don't bother doing a much larger trial.
• Well Designed – Means the trial is a randomized, double blinded, placebo controlled study. There must be at least two study arms, with identical patient populations, where one arm received standard care for Covid-19 plus ivermectin, and the other arm received standard care plus a placebo. The clinical endpoints and exactly what patient population characteristics are selected, must be carefully considered. They can make or break a trial.
• Well Conducted – Means it must be able to stand up to an FDA clinical trial audit, as well as medical peer review for publication purposes.

The NIH guideline says, so far, there is no clinical evidence that ivermectin has anti-virus activity in Covid-19 patients. That doesn't mean there could never be such evidence in the future. Other trials of ivermectin are still in progress. But, unless there is an unanticipated and major breakthrough, there is no reason to expect that conclusion to change.

Remember, the web page you linked is only a brief digest of the full NIH guidelines for treating Covid-19.
Anti-Viral Drugs – Approved or Under Evaluation for Covid-19

https://files.covid19treatmentguidelines.nih.gov/guidelines/section/section_94.pdf

Full Treatment Guidelines for Covid-19 Treatment

https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf

I was wondering how people got the initial idea that ivermectin would be an effective treatment for COVID infections in the first place.
Q&A: What is ivermectin and where did people get the idea it can treat COVID? | The Seattle Times

The idea that ivermectin could be a coronavirus treatment began gaining steam in spring 2020, when Australian researchers observed that the medicine killed the virus in a laboratory setting. The findings had notable caveats, however. For one, the amount of drug required to have an effect on the virus was much higher than the amount approved for use in humans, and could be fatal. And lab-based tests, where the drug and virus interact in a petri dish, also don’t account for the complexities of the human body.

“You could take many drugs and push them to a high enough concentration that you would see some effect in a laboratory setting against pathogens,” Parikh said. “When we use them in humans, we have to find the sweet spot where the drug has its positive effect, but the risk of any of those side effects is extremely low.”

In other words, we could use almost any old toxic substance to kill the virus. The trick is to not kill the patient, as well. People who claim to have used ivermectin to "cure" themselves of COVID, wouldn't have been able to ingest sufficient quantities to make any practical difference, while not $hitting themselves to death. Simply surviving COVID after ingesting small amounts lead them to confuse correlation with causation.

 

[davidscott]

Got my free government test kits in the mail yesterday. I'll shelve them until I need them. Vaccinated and boosted here and I wonder if I ever had covid. And I will pick up some free masks when they show up at my local pharms or supermarkets.

 

[SithZedi]

I was wondering how people got the initial idea that ivermectin would be an effective treatment for COVID infections in the first place.
Q&A: What is ivermectin and where did people get the idea it can treat COVID? | The Seattle Times

In other words, we could use almost any old toxic substance to kill the virus. The trick is to not kill the patient, as well. People who claim to have used ivermectin to "cure" themselves of COVID, wouldn't have been able to ingest sufficient quantities to make any practical difference, while not $hitting themselves to death. Simply surviving COVID after ingesting small amounts lead them to confuse correlation with causation.

That's a good question. The W.H.O. and health authorities of many countries have crossed wires at times and the result is confusion. WHO issued the below statement at the earliest stage of vaccinations so it raised hopes before the vaccinations took hold. Even if a drug is advised to only be used in a clinical trial, that's enough for some people to clamor for it. Best example of that are cancer patients who don't have treatment options.

WHO advises that ivermectin only be used to treat COVID-19 within clinical trials

www.who.int

The first sentence in the final paragraph from the Seattle Times article captures what many feel.

While worried about the public response, experts say it’s not surprising, given the pandemic. “For those who are frustrated, anxious, scared, it’s understandable to try to find something,

 

[Swerd]

The NIH use the word "insufficient" you use the word "No". There is a difference especially when lives are at risk.

Your statement in this post:,
"That doesn't mean there could never be such evidence it the future. "

versus your position in your previous post:

"There is no longer any question about ivermectin – it doesn’t work in people with Covid-19.

Those who have been around clinical trials of new drugs, or of new uses for old drugs, agree on an unspoken and unwritten observation. If your new drug shows no signs of activity during the early clinical trials, Phase 1 (adverse events and maximum tolerated dose levels in healthy or sick people, regardless of disease) and Phase 2 (small trials in specific diseases), it is not likely to become active only in the much larger Phase 3 trials. In fact, a drug that never shows any activity during Phase 1 or 2 trials, will not make it to the Phase 3 level.

Furthermore, there is no convincing lab evidence, in vitro (cells grown in culture) or in vivo (using animal models of Covid-19) that ivermectin can act as an anti-viral agent.

We've known since the 1990s that ivermectin works for parasitic infections, such as river blindness. We know a safe and effective dose for that, and we already know it's profile of adverse events. The drug is easily made & stored, and has been around long enough for it's patents to have expired. It's available in cheap generic form. So, all the recent trials looked at ivermectin's anti-viral activity in Covid-19 patients. These are the small Phase 2 trials. There have been about 70 or 80 of these trials, with a variety of clinical endpoints and statistical designs. None of them show any signs of anti-viral activity. In baseball terms… No Hits… No Runs… No Errors.

When I say "there is no longer any question that ivermectin works", and the NIH says "insufficient evidence" – there is no difference. I speak from over 20 years of experience in clinical trials of new anti-cancer agents. I worked for the NCI and worked closely with various drug companies and the FDA.

So we agree that the NIH statement is not BS then? Now we'll focus on the latter half of that statement (and you know I like to ask questions).

Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

So in my translation, they are saying that trials "are needed" to gain evidence. They are not saying "no trials" are needed or that it would be a waste of time to do so.

If more well designed / conducted trials are needed because of insufficient evidence then why are we not throwing more money at it? The NIH has the money to fund the killing of monkeys by cocaine injection but not more money to possibly save more human lives.

You are word smithing – jockeying for debate points on the internet. Do you have any experience in this field? Your questions show nothing that would make me believe you do.

 

[SithZedi]

Those who have been around clinical trials of new drugs, or of new uses for old drugs, agree on an unspoken and unwritten observation. If your new drug shows no signs of activity during the early clinical trials, Phase 1 (adverse events and maximum tolerated dose levels in healthy or sick people, regardless of disease) and Phase 2 (small trials in specific diseases), it is not likely to become active only in the much larger Phase 3 trials. In fact, a drug that never shows any activity during Phase 1 or 2 trials will not make it to the Phase 3 level.

Furthermore, there is no convincing lab evidence, in vitro (cells grown in culture) or in vivo (using animal models of Covid-19) that ivermectin can act as an anti-viral agent.

We've known since the 1990s that ivermectin works for parasitic infections, such as river blindness. We know a safe and effective dose for that, and we already know it's profile of adverse events. The drug is easily made & stored, and has been around long enough for it's patents to have expired. It's available in cheap generic form. So, all the recent trials looked at ivermectin's anti-viral activity in Covid-19 patients. These are the small Phase 2 trials. There have been about 70 or 80 of these trials, with a variety of clinical endpoints and statistical designs. None of them show any signs of anti-viral activity. In baseball terms… No Hits… No Runs… No Errors.

When I say "there is no longer any question that ivermectin works", and the NIH says "insufficient evidence" – there is no difference. I speak from over 20 years of experience in clinical trials of new anti-cancer agents. I worked for the NCI and worked closely with various drug companies and the FDA.
You are word smithing – jockeying for debate points on the internet. Do you have any experience in this field? Your questions show nothing that would make me believe you do.

I respect your perspective and am impressed with your background in industry. God bless.

For my part, I have been working with pharma companies for over 30 years. From the mega billion dollar caps, to the small private about to ipo into public companies. You talk about wordsmithing well yes its important. Billions of dollars of liability costs are at stake if these companies do not get words in their prospectus, press releases, or forward looking comments on their trials correct or in some circumstances, make them as vague as possible. I have worked lab techs, researchers, unit heads, CFOs, members of BoDers to limit the hit on them personally and on their balance sheets from self inflicted errors or spurious litigation. There is an unspoken and unwritten observation in the legal field too. Sometimes, science and ethics go out the window when they've got equity options There is all kinds of happy horse s**t that goes on in drug development. Thankfully this is not the norm at pharmas. I have met some truly brilliant and great people in the business.

So that's the perspective I am coming from. Not that it matters anyway but you're the one who waved their C.V..

I am looking at this as the guy on the street might. When the NIH releases a statement like this:

Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Joe "bag of donuts" on the street might reasonably interpret it as this: "Well conducted trials are needed (have to be done) to get guidance on the role of Ivermectin for possible future use." He will see there is some hope and that the door is not closed on this drug.

The pharma companies better pray to the high heavens that there are no smoking guns, i.r.repression of data & manipulation of results in this matter because there will be hell to pay. They should have learned that lesson during the discovery process of the Opioid Crisis.

On a lighter note, as I was typing, this skit popped into my mind. Maybe it will lighten the mood.

 

[mtrycrafts]

...

For my part, I have been working with pharma companies for over 30 years. ...

In what capacity, exactly? Are you a scientist? What kind?

 

[highfigh]

Got my free government test kits in the mail yesterday. I'll shelve them until I need them. Vaccinated and boosted here and I wonder if I ever had covid. And I will pick up some free masks when they show up at my local pharms or supermarkets.

Make sure they don't have any requirements for storage conditions like temperature.

 

[SithZedi]

In what capacity, exactly? Are you a scientist? What kind?

I'm an Importer/Exporter. Now focusing more on the importing. C. Costanza.

 

[Mr._Clark]

I am looking at this as the guy on the street might. When the NIH releases a statement like this:

Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Joe "bag of donuts" on the street might reasonably interpret it as this: "Well conducted trials are needed (have to be done) to get guidance on the role of Ivermectin for possible future use." He will see there is some hope and that the door is not closed on this drug.

So this is your point? That a hypothetical donut guy might have some hope that ivermectin might work based on the statement at the NIH website?

If so, it hardly seems like its worth arguing about.

 

[SithZedi]

So this is your point? That a hypothetical donut guy might have some hope that ivermectin might work based on the statement at the NIH website?

If so, it hardly seems like its worth arguing about.

Yes its been a long slog. Joey is one of the many points hit on during this back and forth. For the sake of much needed brevity, I pick just two:

The NIH states that Ivermectin needs well conducted trials to provide more specific, evidence-based guidance on the role of Ivermectin in the treatment of COVID-19. They didn't say "No longer any question".

This is not a scientific statment: "There is no longer any question about "fill in the blank". Science is never settled.

 

[Dude#1279435]

There might also be the issue of time and to facilitate, pick one and just go with it. Depends when ivermectin was discovered for the use of covid etc. Why ivermectin and not one of the other drugs further up on the list of effectiveness Mr. Clark pointed out. (Sorry, thought it was you anyway.) Ivermectin may have been the cheapest, but are we not basically getting the shots for free? I'm playing devil's advocate but thought there are other questions to be asked. Did Pfizer bury their data for the next 75 years due to corruption, or might some of it have had to do with blowback from the non-scientists in news media? Things like that.

 

[GO-NAD!]

I am looking at this as the guy on the street might. When the NIH releases a statement like this:

Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Joe "bag of donuts" on the street might reasonably interpret it as this: "Well conducted trials are needed (have to be done) to get guidance on the role of Ivermectin for possible future use." He will see there is some hope and that the door is not closed on this drug.

It would be far more advisable for Joe to just get the full course of jabs with the vaccines that have been approved around the world and are probably the most scrutinized in the history of modern medicine, than to rest his hopes on the miniscule possibility that Ivermectin would be an effective treatment. I would suggest that the Venn diagram of people who insist Ivermectin is an effective COVID anti-viral and those who refuse to get vaccinated is darned close to a single circle.

In the meantime, all this conjecture about the possible use of Ivermectin to treat COVID is as constructive as discussing self-spelunking with an ultraviolet light or shooting up with bleach.

Ivermectin during the COVID-19 pandemic - Wikipedia

The pharma companies better pray to the high heavens that there are no smoking guns, i.r.repression of data & manipulation of results in this matter because there will be hell to pay. They should have learned that lesson during the discovery process of the Opioid Crisis.

Why would they need to pray about it? If there are any smoking guns, they would know it and praying wouldn't make them go away. Besides, any possible benefit they might derive from "repression of data & manipulation of results" wouldn't justify the enormous risk they would be taking.

 

[Alex2507]

What kind?

Earthling. You?

 

[SithZedi]

Earthling. You?

Yes born here but sometimes feel like an alien. We are an interesting species, no?

 

[SithZedi]

I
Why would they need to pray about it? If there are any smoking guns, they would know it and praying wouldn't make them go away. Besides, any possible benefit they might derive from "repression of data & manipulation of results" wouldn't justify the enormous risk they would be taking.

Faith can be important if your sitting in court.

Data fraud in clinical trials - PMC

Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data ...

www.ncbi.nlm.nih.gov

 

[SithZedi]

There might also be the issue of time and to facilitate, pick one and just go with it. Depends when ivermectin was discovered for the use of covid etc. Why ivermectin and not one of the other drugs further up on the list of effectiveness Mr. Clark pointed out. (Sorry, thought it was you anyway.) Ivermectin may have been the cheapest, but are we not basically getting the shots for free? I'm playing devil's advocate but thought there are other questions to be asked. Did Pfizer bury their data for the next 75 years due to corruption, or might some of it have had to do with blowback from the non-scientists in news media? Things like that.

Dude, don't know why Pfizer filed to bury there data for 75 years, but its quite unusual. Non scientists in the media are the least of their worries. They should be worried about the plainiff bar lawyers who will be representing shareholders if they are sued. Not to mention other class action lawyers.

The below are some interesting comments made by Rubicon Capital's Kelly Brown (not the Scottish Rugby player). What ever his motivation (he could be looking to short) he's looking at 3Q to 4Q releases.
If Pfizer's stock is in your portfolio, I'd think twice about holding long term.
As always, read and make up your own mind.

https://twitter.com/i/web/status/1491132509593436160

 

[Dude#1279435]

Dude, don't know why Pfizer filed to bury there data for 75 years, but its quite unusual. Non scientists in the media are the least of their worries. They should be worried about the plainiff bar lawyers who will be representing shareholders if they are sued. Not to mention other class action lawyers.

The below are some interesting comments made by Rubicon Capital's Kelly Brown (not the Scottish Rugby player). What ever his motivation (he could be looking to short) he's looking at 3Q to 4Q releases.
If Pfizer's stock is in your portfolio, I'd think twice about holding long term.
As always, read and make up your own mind.

https://twitter.com/i/web/status/1491132509593436160

That doesn't look too good.