The failure of "the world" to deal with the COVID-19 pandemic becomes understandable when it's recalled that (1) "the world" is a geographical expression and (2) "world community" is an oxymoron.
One of science fiction's most annoying themes is the one in which some global catastrophe—an alien invasion, an imminent asteroid strike—induces all nations and all peoples to unite against the threat. But as the current pandemic ought to remind us, it doesn't work that way because people don't think that way.
I am going to have more to say about the podcast tomorrow but it was suggested to me today that the EU Commission made a big mistake in drawing up it's contract with Astra Zeneca under Belgian law instead of Irish Common Law. Of course the capital of the EU is by treaty in Brussels not Dublin and the Belgian govt would not particularly be pleased by this snub on the other hand if the contract was drafted under Irish law and litigated in Dublin the EU and Belgium and Ireland would all have the vaccines by now from Astra-Zeneca it was suggested to me. Anyways this friend of mine mentioned that this issue isn't going away and if the EU is to make large scale purchase agreements more frequently in the future it needs to have a serious discussion as to it's preferred venue for contract performance or bring commercial law in EU member states other than Ireland(in my friend's opinion the best EU member state) up to the performance level of Ireland.
Claire: This is a chance for the Biden Administration to show the world we’re back, not just say so. If we vaccinate the world, we’re back. Failing that, not so much.
Hmmm...Nope. Back? From where? A POTUS not named Joe---a businessman albeit an unpleasant person--- told a bunch of drug companies that the risk/reward ratio dictated it was worth the potential $Trillion bet to go ahead, produce the vaccines (800Million ordered A LONG TIME AGO) and that product liability was not going to be a problem.
(It seems that within days of getting the CV genome the drug companies and advisors convinced Trump A VACCINE WAS AT HAND---soon---NOT 4 - 5 years!)
Gen. Verna of WarpSpeed Fame, many MONTHS ago told the 50 states that when the FDA said "GO" they would be getting vaccines in 2-3 days.
That happened.
The states and their respective bureaucracies blew it when there were 'its' to be blown. Trump had been convinced ---bluster aside---that CV19 had to be beaten and so HE DID act early on. Had that NOT BEEN the case....FILL IN THE BLANK______________.
I submit, as I said before, the Narrative became the News and the Narrative was that whether it be CV19 or energy or the border or voting irregularities (real or imagined) if Trump or anything related to Trump said "A" they would be "NOT A".
Back? From partisanship? OK.
Why does little old me on the Central Coast of CA know doctors across the country who told me the same thing? To wit...Trump made the stupid decision to downplay the seriousness of CV19 for stupid political (ir)rationale (don't sow fear, Fauci TOLD HIM IT WAS NOT SERIOUS, etc...) and AT THE SAME TIME did go full speed ahead, destroying the established FDA bureaucracy...Dr. Collins all but said the same thing. The FDA still operates as if Thalidomide awaits always and everywhere---it's why Aspirin would likely NEVER get approved. Trump--massive bozo that he is---said SCREW IT---GET IT DONE and it's why bigger jerks (Kammy comes to mind) said that if Trump had anything to do with it SHE WOULD not take the vaccine.
Enough--I simply ask "BACK FROM WHAT?"
Hindsight IS IN FACT 20/20 and when it's not the problems will be even worse.
Good show. Entertaining and interesting. Robert Zubrin did make one small mistake. He said that Pfizer licensed vaccine production to Merck. That’s not accurate. Johnson & Johnson licensed some of its vaccine production to Merck. Like Pfizer, J&J has intellectual property that they are loathe to put at risk; there’s a reason they are more inclined than Pfizer to make the arrangement with Merck that they did. Their adenovirus-vector technology is most valuable for vaccines to prevent infectious disease. Pfizer’s (and Moderna’s) ultimate goal is to use its mRNA vaccines to develop vaccines against cancer. The same technology that is used to coax cells to produce spike protein as antigen can be used to coax cells to produce antigens unique to cancer cells. The potential market is absolutely enormous. Pfizer is understandably reluctant to partner with anyone when it comes to sharing their proprietary technology. Cancer is a far larger market than communicable diseases.
While Robert Zubrin is right that some of Moderna’s technology is in the public domain because it was developed by NIAID-NIH (the agency Tony Fauci runs) many of the patents, including for the polymer coating are not in the public domain and are owned lock stock and barrel by Moderna.
What Zubrin gets spectacularly right is his suggestion that FDA approval should have been based exclusively on safety testing and not efficacy testing. To answer a question that Claire asked, when it comes to safety testing for vaccines, there are standard protocols. Most safety data for vaccines are evaluated at several intervals post vaccination, but these intervals almost never extend beyond two years; in most cases, only a year’s worth of safety data is needed for approval. In light of the devastation wrought by Covid, three months of safety data is all that should have been required. That data could have been in hand last summer.
Zubrin is also entirely right that the failure to permit challenge trials was criminally negligent, and surely resulted in hundreds of thousands of unnecessary deaths. Challenge trials could easily have been executed in a safe and ethical way.
The FDA made other mistakes; it should have mandated that a larger cohort of elderly people were included as trial participants; trials in young children should have been started earlier and bake-off trials, where one vaccine was directly compared to another should have been encouraged.
Claire, you mentioned thalidomide and the horrible congenital malformations that it caused. What you may not know is that in many respects, thalidomide remains a miracle treatment for many maladies even today. It’s a go to treatment for leprosy (still a big problem in poor countries) and other hard to treat skin conditions and it remains a remarkably effective treatment for various blood and bone marrow cancers.
The thalidomide fiasco decades ago was the impetus for ramping up the FDA’s regulatory authority, but that may not have been a good thing. We might be far better off if the FDA was only permitted to test for safety and let assessments for efficacy rest with the physicians and insurance companies. Decisions made by a central agency are inherently fragile; if they get it wrong; they get it wrong for the whole country. Decentralized decision-making is anti-fragile. Some decision-makers will get it wrong and some will get it right. Eventually those who got it wrong will learn from the data produced by those who get it right.
In terms of efficacy decisions, the FDA is fallible and makes bad decisions all the time. Many drugs they approve actually don’t work very well and many drugs they reject almost certainly work in some patient populations. It’s not a knock on the FDA bureaucrats; like all humans they make mistakes. The problem is bureaucracy itself. A better process would limit the FDA’s decision making authority for drugs and devices to safety, while leaving efficacy evaluation to the market.
One last point; the Globalists had a robust discussion during the podcast about the anti technology trends in Western societies, but they missed the key problem; the demise of Christianity in the West. Traditional religious beliefs have been replaced by a new religion; it’s called environmentalism. Anti-nuclear hysteria, panic about genetically modified crops and anti-Inoculation madness has its roots in an unhealthy and uneducated reverence for the “environment.” In the United States, the most famous vaccination opponent is Robert Kennedy, Jr. Sadly, his cause has been taken up by the MAGA crowd even though their hero, Donald Trump, is the most important figure behind Operation Warp Speed.
The West cannot survive the demise of it Judeo-Christian heritage. Substituting the new religion of environmentalism is a recipe for decline followed by disaster.
The failure of "the world" to deal with the COVID-19 pandemic becomes understandable when it's recalled that (1) "the world" is a geographical expression and (2) "world community" is an oxymoron.
One of science fiction's most annoying themes is the one in which some global catastrophe—an alien invasion, an imminent asteroid strike—induces all nations and all peoples to unite against the threat. But as the current pandemic ought to remind us, it doesn't work that way because people don't think that way.
I am going to have more to say about the podcast tomorrow but it was suggested to me today that the EU Commission made a big mistake in drawing up it's contract with Astra Zeneca under Belgian law instead of Irish Common Law. Of course the capital of the EU is by treaty in Brussels not Dublin and the Belgian govt would not particularly be pleased by this snub on the other hand if the contract was drafted under Irish law and litigated in Dublin the EU and Belgium and Ireland would all have the vaccines by now from Astra-Zeneca it was suggested to me. Anyways this friend of mine mentioned that this issue isn't going away and if the EU is to make large scale purchase agreements more frequently in the future it needs to have a serious discussion as to it's preferred venue for contract performance or bring commercial law in EU member states other than Ireland(in my friend's opinion the best EU member state) up to the performance level of Ireland.
Claire: This is a chance for the Biden Administration to show the world we’re back, not just say so. If we vaccinate the world, we’re back. Failing that, not so much.
Hmmm...Nope. Back? From where? A POTUS not named Joe---a businessman albeit an unpleasant person--- told a bunch of drug companies that the risk/reward ratio dictated it was worth the potential $Trillion bet to go ahead, produce the vaccines (800Million ordered A LONG TIME AGO) and that product liability was not going to be a problem.
(It seems that within days of getting the CV genome the drug companies and advisors convinced Trump A VACCINE WAS AT HAND---soon---NOT 4 - 5 years!)
Gen. Verna of WarpSpeed Fame, many MONTHS ago told the 50 states that when the FDA said "GO" they would be getting vaccines in 2-3 days.
That happened.
The states and their respective bureaucracies blew it when there were 'its' to be blown. Trump had been convinced ---bluster aside---that CV19 had to be beaten and so HE DID act early on. Had that NOT BEEN the case....FILL IN THE BLANK______________.
I submit, as I said before, the Narrative became the News and the Narrative was that whether it be CV19 or energy or the border or voting irregularities (real or imagined) if Trump or anything related to Trump said "A" they would be "NOT A".
Back? From partisanship? OK.
Why does little old me on the Central Coast of CA know doctors across the country who told me the same thing? To wit...Trump made the stupid decision to downplay the seriousness of CV19 for stupid political (ir)rationale (don't sow fear, Fauci TOLD HIM IT WAS NOT SERIOUS, etc...) and AT THE SAME TIME did go full speed ahead, destroying the established FDA bureaucracy...Dr. Collins all but said the same thing. The FDA still operates as if Thalidomide awaits always and everywhere---it's why Aspirin would likely NEVER get approved. Trump--massive bozo that he is---said SCREW IT---GET IT DONE and it's why bigger jerks (Kammy comes to mind) said that if Trump had anything to do with it SHE WOULD not take the vaccine.
Enough--I simply ask "BACK FROM WHAT?"
Hindsight IS IN FACT 20/20 and when it's not the problems will be even worse.
I could be wrong...
Good show. Entertaining and interesting. Robert Zubrin did make one small mistake. He said that Pfizer licensed vaccine production to Merck. That’s not accurate. Johnson & Johnson licensed some of its vaccine production to Merck. Like Pfizer, J&J has intellectual property that they are loathe to put at risk; there’s a reason they are more inclined than Pfizer to make the arrangement with Merck that they did. Their adenovirus-vector technology is most valuable for vaccines to prevent infectious disease. Pfizer’s (and Moderna’s) ultimate goal is to use its mRNA vaccines to develop vaccines against cancer. The same technology that is used to coax cells to produce spike protein as antigen can be used to coax cells to produce antigens unique to cancer cells. The potential market is absolutely enormous. Pfizer is understandably reluctant to partner with anyone when it comes to sharing their proprietary technology. Cancer is a far larger market than communicable diseases.
While Robert Zubrin is right that some of Moderna’s technology is in the public domain because it was developed by NIAID-NIH (the agency Tony Fauci runs) many of the patents, including for the polymer coating are not in the public domain and are owned lock stock and barrel by Moderna.
What Zubrin gets spectacularly right is his suggestion that FDA approval should have been based exclusively on safety testing and not efficacy testing. To answer a question that Claire asked, when it comes to safety testing for vaccines, there are standard protocols. Most safety data for vaccines are evaluated at several intervals post vaccination, but these intervals almost never extend beyond two years; in most cases, only a year’s worth of safety data is needed for approval. In light of the devastation wrought by Covid, three months of safety data is all that should have been required. That data could have been in hand last summer.
Zubrin is also entirely right that the failure to permit challenge trials was criminally negligent, and surely resulted in hundreds of thousands of unnecessary deaths. Challenge trials could easily have been executed in a safe and ethical way.
The FDA made other mistakes; it should have mandated that a larger cohort of elderly people were included as trial participants; trials in young children should have been started earlier and bake-off trials, where one vaccine was directly compared to another should have been encouraged.
Claire, you mentioned thalidomide and the horrible congenital malformations that it caused. What you may not know is that in many respects, thalidomide remains a miracle treatment for many maladies even today. It’s a go to treatment for leprosy (still a big problem in poor countries) and other hard to treat skin conditions and it remains a remarkably effective treatment for various blood and bone marrow cancers.
The thalidomide fiasco decades ago was the impetus for ramping up the FDA’s regulatory authority, but that may not have been a good thing. We might be far better off if the FDA was only permitted to test for safety and let assessments for efficacy rest with the physicians and insurance companies. Decisions made by a central agency are inherently fragile; if they get it wrong; they get it wrong for the whole country. Decentralized decision-making is anti-fragile. Some decision-makers will get it wrong and some will get it right. Eventually those who got it wrong will learn from the data produced by those who get it right.
In terms of efficacy decisions, the FDA is fallible and makes bad decisions all the time. Many drugs they approve actually don’t work very well and many drugs they reject almost certainly work in some patient populations. It’s not a knock on the FDA bureaucrats; like all humans they make mistakes. The problem is bureaucracy itself. A better process would limit the FDA’s decision making authority for drugs and devices to safety, while leaving efficacy evaluation to the market.
One last point; the Globalists had a robust discussion during the podcast about the anti technology trends in Western societies, but they missed the key problem; the demise of Christianity in the West. Traditional religious beliefs have been replaced by a new religion; it’s called environmentalism. Anti-nuclear hysteria, panic about genetically modified crops and anti-Inoculation madness has its roots in an unhealthy and uneducated reverence for the “environment.” In the United States, the most famous vaccination opponent is Robert Kennedy, Jr. Sadly, his cause has been taken up by the MAGA crowd even though their hero, Donald Trump, is the most important figure behind Operation Warp Speed.
The West cannot survive the demise of it Judeo-Christian heritage. Substituting the new religion of environmentalism is a recipe for decline followed by disaster.