Coronavirus

[Trell]

Just stop.

Pot meet kettle

If I had meant only the GOP, I would have written that. The House of Representatives signed it and Democrats have the majority, so don't let them off so easily.

Ah yes, "both sides have equal blame"-game that is just false.

The Democrats in the House saw the writing on the wall that to have anything passed in Senate and/or not vetoed by Trump that pork to the very wealthy had to be included.

So, what is the GOP response to states that needs funds to combat the virus and it's effect? As far as I know the states cannot run a deficit, thus increased cost has to be compensated by either increases revenue from taxes (good luck with that), the federal government or cutting the budget.

 

[Swerd]

From what I heard, Johnson&Johnson is investing $1B in that department of theirs to get a vaccine.

Sanofi and GlaxoSmithKline, two of the world’s biggest vaccine players, may be competitors, but the COVID-19 pandemic has now made them partners.

In an unprecedented tie-up unveiled Tuesday, the companies are joining forces to work on a potential COVID-19 vaccine. They aim to start human testing in the second half of this year, and if all goes well, to file for potential approvals by the second half of 2021.

J&J, Sanofi, and GSK aren't the only ones involved. It looks like Merck and AstraZeneca, among others, may also be involved.

The world-wide market for a SARS-CoV-2 vaccine is large enough for several large vaccine makers to partner. At this stage of development, it's important to coordinate the clinical trial efforts so they don't stomp on each other, delaying development. They should not compete over limited numbers of normal volunteers or sick patients willing to participate in the trials. And the trials must ask questions that provide useful answers while minimizing the potential to produce conflicting answers. A chaotic approach would only make development and testing take longer.

The threat from Covid-19 requires that several different methods of making a vaccine be tested at the same time.

From my own experience, the US NIH has experience doing this, as well as the national medical research agencies of the UK and Europe. Canada has often joined forces with the US NIH, and so has Japan. China appears to be eager to join in, but it has little or no experience at such large scale clinical trial testing. The world-wide threat of SARS-CoV-2 requires world-wide cooperation to develop a vaccine.

 

[TLS Guy]

J&J, Sanofi, and GSK aren't the only ones involved. It looks like Merck and AstraZeneca, among others, may also be involved.

The world-wide market for a SARS-CoV-2 vaccine is large enough for several large vaccine makers to partner. At this stage of development, it's important to coordinate the clinical trial efforts so they don't stomp on each other, delaying development. They should not compete over limited numbers of normal volunteers or sick patients willing to participate in the trials. And the trials must ask questions that provide useful answers while minimizing the potential to produce conflicting answers. A chaotic approach would only make development and testing take longer.

The threat from Covid-19 requires that several different methods of making a vaccine be tested at the same time.

From my own experience, the US NIH has experience doing this, as well as the national medical research agencies of the UK and Europe. Canada has often joined forces with the US NIH, and so has Japan. China appears to be eager to join in, but it has little or no experience at such large scale clinical trial testing The world-wide threat of SARS-CoV-2 requires world-wide cooperation to develop a vaccine.

How would you envisage doing an ethical trial of a virus? If it is effective you don't need many people. If you need a bunch of people to get a significant value, then the vaccine is not worth producing. The problem as I see it, some volunteers are going to have to give informed consent to be sprayed with Covid 19 virus if we are going to accomplish this quickly.

 

[TLS Guy]

This is an informative video you should all watch.

 

[Trell]

This is an informative video you should all watch.

Thanks for the link!

Here is the YouTube link to the video as Javascript and Add-blockers interfere if trying to access it from the Telegraph site:

 

[Swerd]

… I'm a Republican but I can't wait to see this idiot gone.

It's time for Republicans opposed to Trump to make certain Trump leaves the White House after one term. Cast a vote for his opponent.

These are the opinions of life-long Republicans, George T. Conway III, Reed Galen, Steve Schmidt, John Weaver & Rick Wilson:
https://www.washingtonpost.com/opinions/2020/04/15/weve-never-backed-democrat-president-trump-must-be-defeated/
"Biden is now the presumptive Democratic nominee and he has our support. Biden has the experience, the attributes and the character to defeat Trump this fall. Unlike Trump, for whom the presidency is just one more opportunity to perfect his narcissism and self-aggrandizement, Biden sees public service as an opportunity to do right by the American people and a privilege to do so."

The Washington Post Editorial Board:
https://www.washingtonpost.com/opinions/the-anti-trump-coalition-is-forming-the-left-and-right-must-join/2020/04/15/a692d904-7e0b-11ea-8013-1b6da0e4a2b7_story.html
"When Mr. Trump was last on the ballot, many on the right stayed quiet or found ways to justify supporting the GOP nominee, while even some on the left irrationally refused to back Hillary Clinton. The Democrats are on the way to nominating a Trump alternative who would be better on every score that really matters, and who has gone out of his way to avoid demonizing those who disagree with him on less fundamental issues. It is time for unity."

And a well-known conservative, former Republican, Max Boot:

https://www.washingtonpost.com/opinions/2020/04/15/republicans-who-dont-like-trump-have-no-excuses-endorse-biden/

"If Sen. Bernie Sanders (I-Vt.) were the Democratic nominee, the choice would be a difficult one. I would still have voted for Sanders, but a lot of my fellow former Republicans wouldn’t have. Now that Joe Biden is going to be the Democratic nominee, the choice is easy."

"It’s great to see Sanders and former president Barack Obama endorsing Biden. But it is also important for Republican elders to do so, since that will make it clear to middle-of-the-road voters (who will determine the outcome) that it’s safe to vote for a Democrat. We need to hear from the great and the good of what remains of the pre-Trump GOP."

"I have in mind former president George W. Bush and former vice presidents lord helmet Cheney and Dan Quayle; former governors such as Jeb Bush, Mitch Daniels, Mark Sanford and John Kasich; former senators such as Bob Corker, Norm Coleman, Jeff Flake, Mark Kirk and Rick Santorum; former Senate majority leaders Bill Frist and Bob Dole; and former House speakers John Boehner and Paul Ryan. Also former Cabinet members such as secretaries of state James A. Baker III, Condoleezza Rice, Colin Powell, George Shultz and Henry Kissinger; defense secretary Robert Gates; national security adviser Stephen Hadley; treasury secretaries Paul O’Neill and Henry Paulson; homeland security secretaries Michael Chertoff and Tom Ridge; and attorneys general John Ashcroft and Alberto Gonzales.

Many of these Republicans refused to endorse Trump in 2016, but also refused to support Hillary Clinton. (I gladly cast my first-ever ballot for a Democrat by voting for Clinton.) But Biden does not carry Clinton’s baggage. This time around, Republicans who are bothered by Trump’s appalling misconduct have no excuse: They need to actively support the Democratic nominee. Voting for a third-party candidate such as Justin Amash won’t cut it. The election is a binary choice. If you don’t back Biden, you’re backing Trump."

 

[Trell]

This is an informative video you should all watch.

The very unsanitary conditions clearly shows that laissez-faire does not work well, even in a nominal communist state. So something federal, like FDA, is needed. Sorry, I could not help myself

Hopefully, in due time, this additionally would lead to much harsher restrictions on use of antibiotics in animal industry where it is used to promote growth and compensate for poor conditions.

 

[Swerd]

How would you envisage doing an ethical trial of a virus? If it is effective you don't need many people. If you need a bunch of people to get a significant value, then the vaccine is not worth producing. The problem as I see it, some volunteers are going to have to give informed consent to be sprayed with Covid 19 virus if we are going to accomplish this quickly.

From what I understand, it would be absolutely unethical to expose volunteers to a potentially fatal pathogen, even if they signed all the informed consent papers. The lawyers for vaccine manufacturers wouldn't stand for it, regardless of the informed consent language. The NIAID is well aware of this problem, and so is the FDA. Neither of them would back such a proposal.

I'm much better aware of what passes for good clinical trial design in cancer, but not in vaccines for infectious pathogens. There is a different culture (for lack of a better word) for clinical trials in these fields.

If you need a bunch of people to get a significant value, then the vaccine is not worth producing.

The best model may be previous clinical trials of other anti-viral vaccines intended for world-wide use. Such a trial will have at least two cohorts, immunized and not immunized, who must be monitored over time for subsequent illness, and directly compared. For this to be statistically valid, the two cohorts absolutely must be randomly chosen from one large group of volunteers with the same patient demographics. I'm not familiar with the details, but these trials probably have efficacy endpoints already worked out as primary goals using statistically valid methods. They could easily be adapted for SARS-CoV-2 vaccine trials.

The idea that a smaller trial of a few, ~100-300 patients, could provide useful results if they were directly challenged by live virus is wrong both for medical ethics and statistics reasons. Such a small trial cannot provide an accurate or statistically reliable answer to the question of how effective, in terms of % immunized, is the vaccine? This may seem counter-intuitive, but such a small trial is useful only to provide a YES or NO answer to the question of whether it's worthwhile to perform a much larger trial. This is something bio-statisticians who specialize in clinical trial design have long understood.

I wouldn't worry about finding ~10,000 previously uninfected volunteers. Considering the world-wide fear & loathing of Covid-19, it should be easy. I see no other way around the ethics problem created by directly challenging an immunized person with live virus known to be pathogenic to humans.

The vaccine industry, the NIAID, and the FDA are all highly motivated to find what blood tests or other easily tested medlab or clinical markers can indicate which vaccinated volunteers subsequently develop true immunity to Covid-19. I hope these 'surrogate markers' of effective immunization will be investigated as part of the vaccine clinical trials. For example, the various immunogenic protein portions of pathogenic viruses are now easy to produce. These proteins alone are not pathogenic. They could be injected in previously immunized volunteers months after immunization to see what kinds of immune responses occur in response to these recall antigens. If a non-replicating or non-pathogenic variant of SARS-CoV-2 virus can be developed, it might be tested as well. This kind of info, in my opinion, will be more valuable than rapid and possibly chaotic vaccine development would be.

 

[TLS Guy]

From what I understand, it would be absolutely unethical to expose volunteers to a potentially fatal pathogen, even if they signed all the informed consent papers. The lawyers for vaccine manufacturers wouldn't stand for it, regardless of the informed consent language. The NIAID is well aware of this problem, and so is the FDA. Neither of them would back such a proposal.

I'm much better aware of what passes for good clinical trial design in cancer, but not in vaccines for infectious pathogens. There is a different culture (for lack of a better word) for clinical trials in these fields.
The best model may be previous clinical trials of other anti-viral vaccines intended for world-wide use. Such a trial will have at least two cohorts, immunized and not immunized, who must be monitored over time for subsequent illness, and directly compared. For this to be statistically valid, the two cohorts absolutely must be randomly chosen from one large group of volunteers with the same patient demographics. I'm not familiar with the details, but these trials probably have efficacy endpoints already worked out as primary goals using statistically valid methods. They could easily be adapted for SARS-CoV-2 vaccine trials.

The idea that a smaller trial of a few, ~100-300 patients, could provide useful results if they were directly challenged by live virus is wrong both for medical ethics and statistics reasons. Such a small trial cannot provide an accurate or statistically reliable answer to the question of how effective, in terms of % immunized, is the vaccine? This may seem counter-intuitive, but such a small trial is useful only to provide a YES or NO answer to the question of whether it's worthwhile to perform a much larger trial. This is something bio-statisticians who specialize in clinical trial design have long understood.

I wouldn't worry about finding ~10,000 previously uninfected volunteers. Considering the world-wide fear & loathing of Covid-19, it should be easy. I see no other way around the ethics problem created by directly challenging an immunized person with live virus known to be pathogenic to humans.

The vaccine industry, the NIAID, and the FDA are all highly motivated to find what blood tests or other easily tested medlab or clinical markers can indicate which vaccinated volunteers subsequently develop true immunity to Covid-19. I hope these 'surrogate markers' of effective immunization will be investigated as part of the vaccine clinical trials. For example, the various immunogenic protein portions of pathogenic viruses are now easy to produce. These proteins alone are not pathogenic. They could be injected in previously immunized volunteers months after immunization to see what kinds of immune responses occur in response to these recall antigens. If a non-replicating or non-pathogenic variant of SARS-CoV-2 virus can be developed, it might be tested as well. This kind of info, in my opinion, will be more valuable than rapid and possibly chaotic vaccine development would be.

You don't need a large number of people to get a high level of significance if it is highly effective. The original blind trial of penicillin for pneumococcal pneumonia, in WW II I think involved 10 people. It was a big problem in the troops, my father almost died of it. Any how 5 with pneumonia got it and five did not. The five that got it resolved quickly. You are used to cancer trials were we are used to 15 to 20% response rates. If the response rate is close to 100% you only need a small sample size.

The economic mayhem is awful and we are going to have to suspend normal procedures in my view.

If this phase 1 shows an antibody response and they are all fine. Then I think you could actually do a double blind trial in a hot zone. If the vaccine is any good, then it will show significance with few subjects quickly.

Then go ahead and starts releasing in the hot spots, watch for adverse effects, then go quickly to general distribution with a rapid drive to full production.

I think we have to cut at least some red tape in this emergency.

In any case the most likely adverse effects of this new m-rna technology would not show up for years. We can't hang about that long.

I was talking to my brother who still hold a political office and he says the push is really on for fast track vaccines for this and especially future epidemics.

 

[JerryLove]

If I had meant only the GOP, I would have written that. The House of Representatives signed it and Democrats have the majority, so don't let them off so easily.

But the provision in question was, in fact, inserted by senate republicans.

https://www.washingtonpost.com/business/2020/04/14/coronavirus-law-congress-tax-change/

So.. I'm happy to pick on anyone doing ill.. .but despite protests of people who vote for GOP nominees over and over... the doings seem to be heavily done by GOP members.

 

[JerryLove]

You don't need a large number of people to get a high level of significance if it is highly effective. The original blind trial of penicillin for pneumococcal pneumonia, in WW II I think involved 10 people. It was a big problem in the troops, my father almost died of it. Any how 5 with pneumonia got it and five did not. The five that got it resolved quickly. You are used to cancer trials were we are used to 15 to 20% response rates. If the response rate is close to 100% you only need a small sample size.

OTOH: The diagnosed infection rate in the US is, right now, <1% of the population.

And since we are discussing a vaccine rather than a cure, you'll have to have a number where, within the scope of your test, you can make reasonable predictions about the minimum infection rate.

And you need an accurate test for infection.

There are a lot of variables to control for. Honestly: medicine and most everything related to it is rife with questionable conclusions (Remember all those decades when we were told eating foods with fat made us fat rather than it being the number of calories).

But I digress. I guess my point is "does giving this to this person sick with this disease that has basically a zero remission rate cause remission" can be tested with very few people and is different in nature than a vaccine to a disease relatively few have and for which we will not be deliberately exposing. I think the numbers will need to be much higher.

 

[Kvn_Walker]

Remdesivir so far seems to be looking like a promising treatment. Fingers crossed!

 

[Mr._Clark]

All of the reports on plasma transfusion I've seen (which isn't many) seem to suggest it has promise. Of course, I realize these are not double blind clinical studies, but we have to start somewhere.

It will be interesting to see if the immune systems of these patients eventually start producing their own antibodies. One thing I have not seen in the reports so far is if the plasma transfusion patents were tested for antibodies prior to the transfusion.

>>>“The situation is so acute and so serious that we have to try many different things,” Laurence Corash, MD, chief scientific officer and co-founder of Cerus Corp., told Healio. “But, of all the different things that have been tried thus far, convalescent plasma has shown the most consistent and best responses. Based on previous experiences with convalescent plasma in other viral diseases with high death rates, I am optimistic that this will work here.”<<<

Convalescent plasma transfusion shows promise for severely ill patients with COVID-19

Preliminary research has shown the potential of convalescent plasma therapy to improve clinical outcomes of patients with severe disease related to COVID-19.Results of an uncontrolled case series, conducted in China and published in JAMA, showed five patients critically ill with COVID-19 and...

www.healio.com

 

[highfigh]

But the provision in question was, in fact, inserted by senate republicans.

https://www.washingtonpost.com/business/2020/04/14/coronavirus-law-congress-tax-change/

So.. I'm happy to pick on anyone doing ill.. .but despite protests of people who vote for GOP nominees over and over... the doings seem to be heavily done by GOP members.

Thanks for the link- I fell asleep reading the Bill, looking for the parts about payments to millionaires. Just another example of what I heard from someone on the radio- "I'm getting tired of hearing billionaires telling millionaires what the middle class needs".

Hopefully, they'll get to enjoy the results from what they have done through being voted out of office. I'm not a fan of Sensenbrenner or Ron Johnson (I call him 'Dr No', because he votes against a lot of decent legislation for BS reasons and when asked about it, his explanations are just useless) but I'm just not going to vote for their opponents because I don't agree with much of what they have to say.

Do you not see that people may vote for someone because they dislike the other candidate more?

 

[highfigh]

Pot meet kettle



Ah yes, "both sides have equal blame"-game that is just false.

The Democrats in the House saw the writing on the wall that to have anything passed in Senate and/or not vetoed by Trump that pork to the very wealthy had to be included.

So, what is the GOP response to states that needs funds to combat the virus and it's effect? As far as I know the states cannot run a deficit, thus increased cost has to be compensated by either increases revenue from taxes (good luck with that), the federal government or cutting the budget.

So, it's OK for the House Democrats to just assume the position and take one for the country? BS! The Bill would have passed eventually, but not without a fight.

 

[Mr._Clark]

Remdesivir so far seems to be looking like a promising treatment. Fingers crossed!

I think you may be referring to the recent leaked video from the University of Chicago clinical trial. I am hoping this proves to be effective. We need as many arrows in our quiver as we can get to fight this blasted virus.

>>>A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned. . .

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir. . . .
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital. . . .

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.<<<

Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment

A Chicago hospital treating severe Covid-19 patients with Gilead's remdesivir is seeing rapid recoveries in fever and respiratory symptoms, STAT has learned.

www.statnews.com

 

[JerryLove]

Do you not see that people may vote for someone because they dislike the other candidate more?

That's exactly why you should vote for someone... because you consider them better than the other option.

My bigger issue is the criteria people seem to use to chose "dislike". It seems to never be based on real things (like positions or voting record). This appears more true with conservative voters (such as the Tea Party / Libertarian support of the Pauls despite their huge pork-barrel spending).

 

[JerryLove]

So, it's OK for the House Democrats to just assume the position and take one for the country? BS! The Bill would have passed eventually, but not without a fight.

Which means we'd have a government fighting while its people starve. I think Nero got some flack for something similar.

Of course, Trump demanded his name be on the checks, so that's adding delays.

 

[highfigh]

Which means we'd have a government fighting while its people starve. I think Nero got some flack for something similar.

Of course, Trump demanded his name be on the checks, so that's adding delays.

Exactly. Then, there's the deposits that were made to the wrong accounts, SBA money is already gone and other goodies that should have been defined better.

If Trump plays an instrument, I imagine it sounds like a combination of bagpipes and a chain saw.

EDIT:

Maybe it would have the same effect as Slim Whitman's version of 'Indian Love Call', in the movie 'Mars Attacks'.

 

[highfigh]

That's exactly why you should vote for someone... because you consider them better than the other option.

My bigger issue is the criteria people seem to use to chose "dislike". It seems to never be based on real things (like positions or voting record). This appears more true with conservative voters (such as the Tea Party / Libertarian support of the Pauls despite their huge pork-barrel spending).

Do you vote for people when you disagree with what they say and want to do when/if they're elected just because they're the lesser of two evils? What if everything they accomplish is the opposite of what you believe in and want for the country?

How long do you think Biden's attention span will allow him to remain in office?

Peoples' blind devotion has always been the path to destruction.