Trell

Trell

Audioholic General
At least here in EU, if you clear your current cookies you can read it and perhaps disabling Javascript as well. Having a trusted Anti-advertisement app might be requires as well, but I always use that as a line of defence against exploit served by advertisement providers.

I almost never quote a full article in order to respect the copyright holders (fair use), but in these times and the seriousness of the subject I'll do so anyway:

Edit; I often link to various news sites, but I then just quote some parts of the article in accordance with fair use. I also try to not distort the intent and meaning of the article with my quotes.

"​
William Haseltine is a former Harvard Medical School professor and founder of the university’s cancer and HIV/AIDS research departments. He serves as chair and president of the think tank ACCESS Health International.
In response to widespread demand for more transparency, pharmaceutical companies Moderna and Pfizer have released clinical study protocols for their covid-19 vaccine trials. The goal is to reassure the public that the trials are being conducted responsibly and that any approved vaccine would be safe for all.​
But the protocols should heighten anxiety rather than alleviate it. A close reading suggests the clinical trials have been designed to ensure the greatest possible success for these candidates — and that could overstate their effectiveness.​
In both the Moderna and Pfizer trials, for example, the primary objective is to prevent any occurrence of covid-19, not necessarily a severe case. Preventing serious illness is a secondary objective. Yet it is the severe cases of covid-19 that have killed nearly 1 million people worldwide and left many millions more with long-term damage. With the current protocols, it is conceivable that a vaccine might be considered effective — and eventually approved — based primarily on its ability to prevent mild cases alone.​
If we were developing a vaccine for a simple cold virus, perhaps this would indeed be enough. But covid-19 is far from a common cold. People are not concerned about the tickle in their throat or a runny nose; they are concerned about being put in the hospital. A covid-19 vaccine should, first and foremost, protect us from severe instances of the disease.​
Equally troubling is the size of the group in which efficacy for each vaccine would be proved. Both Pfizer and Moderna have touted the large number of participants in their trials, at upwards of 30,000 participants slated for each. But while the full trial sizes might be large, the protocols suggest that efficacy can be proved in an initial test group of just 106 for the Moderna vaccine and in a group of 64 for Pfizer. But keep in mind only half of each group receives the vaccine; the other half receives a placebo.​
The protocols suggest that successful initial interim trials for the Moderna and Pfizer vaccines would show efficacy among 74 percent and 76.9 percent of participants, respectively. This means if 39 of those who receive the vaccine do not get sick, Moderna will consider the vaccine a success. For Pfizer, the number is 25.​
At this point, the Food and Drug Administration could grant emergency-use authorization. In other words, the two vaccines could hinge on the combined results of 64 people.​
Granted, proof of efficacy in such a small group doesn’t guarantee that a vaccine candidate will be approved for manufacturing and use worldwide. But the U.S. government has shown that it’s willing to rush new anti-covid-19 drugs to market on promises of even less. Were these two vaccine-makers to come out with early results from an interim analysis of their trials and claim their candidates to be effective, there is little doubt the FDA would grant an emergency-use authorization. The public would likely take such a decision as a sign that the vaccine is completely effective, despite the fact that it would have been proved effective only in a small sampling of individuals and might not be useful at all in preventing severe cases of the disease.​
While both companies say they would continue their trials and continue to explore potential long-term health risks, it might not be possible to do so if participants receiving the placebo demand the real vaccine. As we saw with previous emergency authorizations — namely hydroxychloroquine, convalescent plasma and remdesivir — once they were granted, the trials ended. Are we really willing to conclude a drug is safe based on the health outcomes of so few?​
Recent trials by AstraZeneca were paused after a patient developed symptoms of an inflammatory spinal disease. Rushed Moderna and Pfizer trials could bring about similar short-term health consequences or, potentially far worse, lead to long-term health consequences that we won’t discover until months or years after the vaccine’s approval.​
At a time when an average of 40,000 cases and nearly a thousand deaths are reported every day in the United States — and far more globally — these protocols are outrageous. The fact that one would base the health of billions of humans on the outcomes of a few defies any definition of common sense.​
If — or perhaps when — positive early results from these trials are announced, keep my warnings in mind. These protocols seem designed to get a drug on the market sooner rather than later, on a timeline arguably based more on politics than public health. The lives of millions are at risk; we can and should demand better.​
"​
 
Swerd

Swerd

Audioholic Spartan
Interesting article.
Thanks, that was interesting.

The corona virus pandemic has been a world-wide disaster. But it has been a boon for epidemiologists. They get to study the emergence of a novel virus and it's rapid spread throughout the world, in real time. Unlike the Spanish Flu pandemic, the coronavirus data isn't 100 years-old. With some time, there should be some major findings that result from this.
 
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TLS Guy

TLS Guy

Audioholic Slumlord
This is interesting:

>>>He has received a single infusion of a promising experimental treatment: an antibody cocktail developed by the biotech company Regeneron, according to a memo from his doctor, Dr. Sean P. Conley. <<<

Yes, this is interesting. I predicted this to my wife earlier today. Apparently the POTUS is quite sick with fever cough and congestion.

He has had a dose of the Regeneron/Roche monoclonal antibody cocktail. Trials are early but promising. In double blind trials of NON hospitalized patients the cocktail rapidly reduced viral load over a weak. This was a small study, I think of 275 people. E.I. Lily also have a cocktail which is further along in study. In a blinded study of non hospitalized patients it reduced hospitalization by 70%. That was in JAMA about a week or so ago.

There is no good data on sicker patients as far as I know.

I suspect this approach may well be an effective treatment, for this disease, and effective enough to may be give us an early get out of jail card.

The problem now is that if the POTUS makes a startling recovery, everyone who has symptoms is going to want the treatment. So I suspect enormous political pressure to make these widely available without much in the way of rigorous testing.

The problem is monoclonal antibodies are used widely to treat auto immune diseases especially, and some cancers. It has had limited use in other infectious diseases and undergoing trials, to combat antibiotic resistance.

There is a huge obstacle though. These monoclonal antibodies are very difficult to reproduce and require regenerative DNA technology. In other words bacteria require genetic alteration to produce them. This is a akin to synthetic human insulin production. The cost of this technology is enormous, with many of these therapies costing thousands upon thousands of dollars per dose. So the real question will become the issue of the scalability and the financial feasibility of this approach. However this pandemic has cost an enormous amount so far in financial losses. So there are vast potential savings if this could truly end this crisis as a bridge to immunization with vaccines.

Some patients do have serious and even fatal complications after being administered monoclonal antibodies. Not common, but I remember a young airman's wide receiving one for Crohn's disease at the Grand Forks Air Force base. She was transferred to our unit in serious condition and we could not save her.

So this is why I'm concerned about clinical use of one of these agents in a high profile case off study. This is going to let a lot of cats out of the bag.
 
TLS Guy

TLS Guy

Audioholic Slumlord
Yes, this is interesting. I predicted this to my wife earlier today. Apparently the POTUS is quite sick with fever cough and congestion.

He has had a dose of the Regeneron/Roche monoclonal antibody cocktail. Trials are early but promising. In double blind trials of NON hospitalized patients the cocktail rapidly reduced viral load over a weak. This was a small study, I think of 275 people. E.I. Lily also have a cocktail which is further along in study. In a blinded study of non hospitalized patients it reduced hospitalization by 70%. That was in JAMA about a week or so ago.

There is no good data on sicker patients as far as I know.

I suspect this approach may well be an effective treatment, for this disease, and effective enough to may be give us an early get out of jail card.

The problem now is that if the POTUS makes a startling recovery, everyone who has symptoms is going to want the treatment. So I suspect enormous political pressure to make these widely available without much in the way of rigorous testing.

The problem is monoclonal antibodies are used widely to treat auto immune diseases especially, and some cancers. It has had limited use in other infectious diseases and undergoing trials, to combat antibiotic resistance.

There is a huge obstacle though. These monoclonal antibodies are very difficult to reproduce and require regenerative DNA technology. In other words bacteria require genetic alteration to produce them. This is a akin to synthetic human insulin production. The cost of this technology is enormous, with many of these therapies costing thousands upon thousands of dollars per dose. So the real question will become the issue of the scalability and the financial feasibility of this approach. However this pandemic has cost an enormous amount so far in financial losses. So there are vast potential savings if this could truly end this crisis as a bridge to immunization with vaccines.

Some patients do have serious and even fatal complications after being administered monoclonal antibodies. Not common, but I remember a young airman's wide receiving one for Crohn's disease at the Grand Forks Air Force base. She was transferred to our unit in serious condition and we could not save her.

So this is why I'm concerned about clinical use of one of these agents in a high profile case off study. This is going to let a lot of cats out of the bag.
President Trump has been flown by helicopter to Walter Reid Hospital.

The fact that he has got so sick so quickly has to be of great concern to his medical attendants. So this is likely not a minor case.
 
M

Mr._Clark

Full Audioholic
Yes, this is interesting. I predicted this to my wife earlier today. Apparently the POTUS is quite sick with fever cough and congestion.

He has had a dose of the Regeneron/Roche monoclonal antibody cocktail. Trials are early but promising. In double blind trials of NON hospitalized patients the cocktail rapidly reduced viral load over a weak. This was a small study, I think of 275 people. E.I. Lily also have a cocktail which is further along in study. In a blinded study of non hospitalized patients it reduced hospitalization by 70%. That was in JAMA about a week or so ago.

There is no good data on sicker patients as far as I know.

I suspect this approach may well be an effective treatment, for this disease, and effective enough to may be give us an early get out of jail card.

The problem now is that if the POTUS makes a startling recovery, everyone who has symptoms is going to want the treatment. So I suspect enormous political pressure to make these widely available without much in the way of rigorous testing.

The problem is monoclonal antibodies are used widely to treat auto immune diseases especially, and some cancers. It has had limited use in other infectious diseases and undergoing trials, to combat antibiotic resistance.

There is a huge obstacle though. These monoclonal antibodies are very difficult to reproduce and require regenerative DNA technology. In other words bacteria require genetic alteration to produce them. This is a akin to synthetic human insulin production. The cost of this technology is enormous, with many of these therapies costing thousands upon thousands of dollars per dose. So the real question will become the issue of the scalability and the financial feasibility of this approach. However this pandemic has cost an enormous amount so far in financial losses. So there are vast potential savings if this could truly end this crisis as a bridge to immunization with vaccines.

Some patients do have serious and even fatal complications after being administered monoclonal antibodies. Not common, but I remember a young airman's wide receiving one for Crohn's disease at the Grand Forks Air Force base. She was transferred to our unit in serious condition and we could not save her.

So this is why I'm concerned about clinical use of one of these agents in a high profile case off study. This is going to let a lot of cats out of the bag.
Thanks for posting, I appreciate your insights.
 
mtrycrafts

mtrycrafts

Audioholic Slumlord
What happens if he croaks? Pence picks a running mate and loses to Biden in Nov.?
Well, after researching this:
Section 2. Whenever there is a vacancy in the office of the Vice President, the President shall nominate a Vice President who shall take office upon confirmation by a majority vote of both Houses of Congress.
So, there may not be a VP confirmed. ;)
 
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Old Onkyo

Old Onkyo

Senior Audioholic
Trump was a little too smug in his pronouncement that a cure would be here soon. sooner than you think!
Trump goes into “quarantine,“ a week before the election he returns riding on a white horse, “cured,” treatment in hand!
That’s how my mind works...
 
Swerd

Swerd

Audioholic Spartan
I've always liked the Smiling Monkey avatar.
What happens if he croaks?
If he croaks, we will relive a moment from the Wizard of Oz. If you remember, Dorothy tossed a bucket of water on the Scarecrow to put out the fire started by the Wicked Witch of the West. The water splashed on the Witch, causing her to melt. The Witch's Palace Guards first say "You killed her!" and then exclaim "Hail to Dorothy!"

Who will be Dorothy? Hope Hicks?
1601684682628.png
 
Swerd

Swerd

Audioholic Spartan
He has had a dose of the Regeneron/Roche monoclonal antibody cocktail. Trials are early but promising. In double blind trials of NON hospitalized patients the cocktail rapidly reduced viral load over a weak. This was a small study, I think of 275 people. E.I. Lily also have a cocktail which is further along in study. In a blinded study of non hospitalized patients it reduced hospitalization by 70%. That was in JAMA about a week or so ago.

There is no good data on sicker patients as far as I know.
Trump was said to have received an 8 gram dose of Regeneron's experimental monoclonal antibody cocktail. I don't know what volume of saline 8 grams of antibody protein requires, but it won't be small, perhaps as much as a liter. It probably was a slow IV infusion, instead of a faster IV push. Because this is an experimental treatment with limited safety data, I'm not surprised to see Trump hospitalized for that reason alone. Beside that, he's president, he's got Covid-19, he's 74 years old , and he's obese.

As you correctly pointed out, even if this monoclonal cocktail is safe & effective, there will not be enough to treat everyone who might need such a treatment. There is simply not enough production capacity in the industry in the USA or elsewhere. Producing monoclonal antibodies is slow, costly work. Most antibodies I know about are produced not by fast growing bacteria, but by much slower growing mamalian cells, Chinese Hamster Ovary (CHO) cells grown in large scale liquid culture.

As an example of cost, I now take Humira, a monoclonal antibody to treat an autoimmune condition. I inject 40 mg (0.040 gram) every two weeks. It costs me $1,437 for two doses, said to be 25% of the street price, where insurance pays the other 75%. That total comes to $5,749 every 4 weeks, or $74,732 per year. If these anti-SARS-CoV-2 cocktails are approved and sold, I don't know what their street price will be, but they will not be cheap. Compared to the monoclonals, vaccines are a bargain.
 
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Swerd

Swerd

Audioholic Spartan
The election is delayed, and there has to ne another convention and nomination.
I believe that there has never been a delayed election in US history. Not even during the Civil War.

I also believe, but am not 100% sure, that the US Constitution requires an election for president every 4 years, and by US Code these elections take place on the 1st Tuesday after November 1st. These elections cannot be delayed.
 
Irvrobinson

Irvrobinson

Audioholic Spartan
I believe that there has never been a delayed election in US history. Not even during the Civil War.

I also believe, but am not 100% sure, that the US Constitution requires an election for president every 4 years, and by US Code these elections take place on the 1st Tuesday after November 1st. These elections cannot be delayed.
You are basically correct. The details from the Washington Post:

 
Swerd

Swerd

Audioholic Spartan
Walter Reed National Military Medical Center was created in 2005, dedicated in 2011, combining the older Walter Reed Army Hospital with Bethesda Naval Hospital opened in 1940. The location is on the site of the original Bethesda Naval Hospital. When I worked in the National Cancer Institute, I was across the road on the NIH campus.

This where many of those badly injured Army, Navy, and Marine GIs are treated for serious battle wounds and illnesses. Trump, who now is in Walter Reed's Presidential Suite, called them 'suckers and losers'. I hope he sleeps well at Walter Reed.
1601688818770.png
 
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mtrycrafts

mtrycrafts

Audioholic Slumlord
Trump was a little too smug in his pronouncement that a cure would be here soon. sooner than you think!
Trump goes into “quarantine,“ a week before the election he returns riding on a white horse, “cured,” treatment in hand!
That’s how my mind works...
I would not put it past him. But, you'd have to have a number of conspirators with him, all those who tested positive in his circle from Saturday's Barrett announcement
 
D

domicd

Audiophyte
I hope president Trump gets better soon. I may not agree with everything he says or believes but I still like him. (I realiy enjoyed his first debate with Biden, it was funny!!!!). Although when the coronavirus first started, he should of closed the US borders 1 month or at least 2 weeks sooner, that would of prevented alot of people around the world including China from entering into USA. Had he closed the borders sooner, the total deaths in US may have been lower or much lower. No one really knows for a fact.

The thing is, there have been many pandemics in the past and eventually everyone becomes immune to it or it dies out. Lets hope theres a vaccine soon. The problem is the whole world cannot shut down or else there will be a shortened food supply. People cannot live off the government forever, they need to go back to work.
 
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TLS Guy

TLS Guy

Audioholic Slumlord
I believe that there has never been a delayed election in US history. Not even during the Civil War.

I also believe, but am not 100% sure, that the US Constitution requires an election for president every 4 years, and by US Code these elections take place on the 1st Tuesday after November 1st. These elections cannot be delayed.
On the way back form Mayo today, we had MPR on the radio. A constitutional expert said that if Trump dies then Pence does not become the candidate.
In my congressional district one candidate for congress died about a week ago. So another candidate can not just be appointed. My vote for the congressional candidate would have been null and void apparently, even though the candidate that died, was for "The Marihuana Party!" So we have to have another election for congress in February. Until then the current incumbent can not be reseated. I guess the constitution is not entirely clear about the procedure after the death of a candidate, and so that issue here is now before the courts.

But as I understood the issue today, if Trump dies the election can not take place on November 3 this year. I and my wife voted last weekend. The advice was NOT to vote for any of the congressional candidates. Hopefully people who have already voted have cast a valid vote. However that apparently is not even certain and open to be contested. However I'm pretty certain their votes for other candidates standing for election are valid.
 

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