 All right, I wanted to talk about the FDA. I've talked a lot about the FDA over COVID, but there was an excellent article. Let me just find it. Where is it? I know I saved it. Here it is. All right, this is excellent article. By somebody I've recommended to you before, Scott Alexander, I highly recommend you subscribe to Substack. Astro Codex 10, Astro Codex 10, or just look up Scott Alexander. He's very insightful. He's a psychiatrist in Silicon Valley, writes about all kinds of topics. Half the time, you'll completely disagree with him and hate him, and half the time, he's brilliant. It's worth it to subscribe for the half time that he's really good. Anyway, he's done an article this last week which I thought was just perfect. It just, I mean, almost perfect. It was like almost there. It, ugh. Unfortunately, on economic issues is kind of a little left of center which doesn't allow him to go all the way with the logic that he was getting to the right point about the FDA. Almost got there and couldn't quite make it. Anyway, give you a little bit of background. The FDA has approved the drug, an Alzheimer's drug. It's called, I can't pronounce it. I do helm, adu helm. It's approved as adu helm drug. Now, the drug assumes that Alzheimer's is caused by something called amyloid plaques that form in the brain as you get older. Now, this theory of amyloid plaques causing Alzheimer's is very controversial and probably untrue. And this drug targets the plaque and supposedly destroys this plaque that's forming in the brain. But the relationship between that and curing or preventing or slowing down Alzheimer is very, very tenuous. Anyway, the FDA approved the drug. I don't see why not. But this has caused a huge backlash against the FDA because it's a very expensive drug and it's a drug that probably doesn't work. So everybody's complaining. It's a $50,000 a year per patient drug. Now, there's the big question of who pays for this. We don't know because all our prices in our drug, in the drug world are hidden from us. We have no idea who pays for it. You know, is it the patients pay for it? Probably not. The insurance company, some, did they pay for it through higher premiums to whom? The taxpayers pay for it, some because it's through Medicare and Medicaid. The hospitals pay for it. The hospitals raise, the hospitals pay for it, but then raise the cost on everybody else. So does everybody else pay for it? Patients who don't have Alzheimer's pay for the Alzheimer's drug because the hospitals charge more for other things because they don't have a competitive market so they can do that. So, you know, we have this crazy healthcare system in the United States that's completely irrational. Completely makes no sense. It's a mixed economy in healthcare and a really terrible mixture. So we have these expensive drugs and nobody knows who pays for them and where they come from and anything like that. Anyway, there's this big backlash against the FDA and against its fast-track program, a fast-track program that if you remember the vaccines were approved under. And of course there's a lot of backlash from the anti-vaxxers. And from even people who have vaccinated against the fast-track with the assumption that it wasn't tested enough, there wasn't enough testing, it wasn't safe enough, this is experimenting on millions of people, all this garbage. Anyway, The Atlantic magazine came out with a paper saying the FDA has eroding standards. They're way too lax. They're way too easy. They're releasing all these drugs that are dangerous. The FDA is too strict according to The Atlantic magazine and many others. They criticize a program that was passed in 1992 that allowed for accelerated approval on the basis of surrogate markers, which are indirect measures of a drug's benefit assessed by laboratory or imaging tests that stand in for more meaningful outcomes such as life expectancy. But the implementation of these accelerated processes was criticized by some scientists and patients even at the time. In 1984, for example, da-da-da-da-da-da-da, right? The New York Times cited skeptics who worried that no one can tell if the drug works. Eight months later, the AIDS Activist Organization act UP San Francisco called Anthony Fauci. Anthony Fauci, a pulp pushing pimp. This is the left, the left called Fauci, a pulp pill pushing pimp for supporting CD4 immune cell counts and viral loads as surrogate markers. They were completely invalid. The activists wrote and nothing more than a marketing exec's wet dream. What's funny about this is that the aid drugs actually worked. Not only did they save the lives of tens of thousands, hundreds of thousands of potential AIDS victims. They worked. They made it possible for people who have AIDS to continue living a normal life. It's, you know, so yes, this thing was criticized, but hey, it worked. An Atlantic magazine admits that it worked. So what are they suggesting? That the FDA should be stricter and not have allowed the drugs that actually saved the lives of tens of thousands, maybe hundreds of thousands of eight patients over the years and allowed them to go back to normal life. I mean, that's insanity. They save, according to this article actually, AIDS drugs saved tens of thousands of lives annually if you look at the world as a whole. If they had not expedited the drug review for those drugs, people, tens of thousands of people over the world would be dead. I mean, coronavirus vaccines is another example. These were expedited. I think they've saved the lives of thousands, tens of thousands, I don't know. Ultimately on a global scale, probably hundreds of thousands, millions, tens of millions, hard to tell, lot of people. And yet this Atlantic magazine article says, no, no, no, no, we shouldn't have expedited reviews. And you're seeing this on the right as well. People are suspicious. Don't trust the drug companies. Don't trust the FDA. Don't trust anybody. Every study that has looked at FDA approvals over the years, how many lives, you know, and a cost-benefit analysis of you, suggests that the FDA releases too few drugs, that too few drugs are allowed expedited, that the FDA is way too conservative, way too strict. And indeed, as we'll discuss in a bit, it's completely expected. There's no conspiracy here. It's built into the incentive structure that people at the FDA have. The FDA is way, way, way too conservative if you value human life, if that's your standard. It should be approving many, many, many more drugs. And not to mention the drugs that never actually get investigated, never actually go up before the FDA because who wants to spend a billion dollars, a billion dollars per drug to get approval, particularly if it's a drug that's gonna affect only a few people's lives, like rare diseases or small diseases or rare forms of cancer or whatever. Nobody's gonna do that. Yet people complain that the FDA is not conservative enough. So let's look at coronavirus at COVID. Let's look at the FDA's track record with coronavirus. Now I'm gonna read you from the article by Scott Alexander because he says everything that I've been saying for 16, 18 months, it's as if he listened to my show. I don't think he does. But it's just that these facts are just there. Anybody can attain them and rational people are slowly starting to figure this out. And again, I've been saying this basically since April of last year. I'm gonna read from Scott Alexander's piece. The countries that got through COVID the best that is South Korea and Taiwan controlled it through test and trace. This allowed them to scrap by with minimal lockdown and almost no deaths. But it only worked because they started testing and tracing really quickly. Almost the moment they learned that the coronavirus existed. Could the US have done equally well? I think, yes, he says, me too. A bunch of laboratories, universities and healthcare groups came up with COVID tests before the virus was even in the US and were 100% ready to deploy them. But when the US declared that the coronavirus was a quote public health emergency, the FDA announced that the emergency was so grave that they were banning all coronavirus testing so that nobody could take advantage of the emergency to deploy shoddy tests. It was such an emergency, no testing. Perhaps you might feel like this is exactly the opposite of what you should do during an emergency. This is a sure sign that you will never work for the FDA. This is Scott Alexander writing. The FDA supposedly had some plan in place to get non shoddy coronavirus tests. For a while, this plan was to send your samples to the CDC in Atlanta. We'll allow it if and only they do it directly in their headquarters. But the CDC headquarters wasn't set up for large-scale testing and the turnaround time to send samples to Atlanta meant that people had days to go around spreading the virus before results got back. After this proved inadequate, the FDA allowed various other things. They told labs that they would offer emergency approval for their kits, but placed such onerous requirements on getting the approval that almost no lab could achieve it. For example, you needed to prove you tested it against many different coronavirus samples, but it was so early in the pandemic that most people didn't have access to several different versions of the virus. Then they approved a CDC kit which the CDC could send to places other than the headquarters, but this kit contained an effective component and returned positive every time. That effective component was easy to replace, but if you use your own copy like a cowboy, your own copy like a cowboy, you replaced it, right? Then the test wouldn't be FDA approved anymore and you could lose your license for administering it. The FDA did everything in their power to get us not to test. Early February, late January, February, March, I continue. A group called the Association of Public Health Laboratories literally begged the FDA to be allowed to deploy the COVID test they had sitting on the shelves ready to use. The head of the APHL went to the head of the FDA and begged them in what they described as an extraordinary and rare request to be allowed to test for coronavirus. The FDA head just rolled back saying that, quote, false diagnostic test results can lead to significant adverse public health consequences, unquote, unbelievable. Is any head gonna roll here? Is any investigation gonna be done? Is anybody gonna look into this? I mean, everybody was shouting that Banker's heads needed a roll after the financial crisis. What about CDC, FDA, Department of Health, President maybe, the incompetence of the administration when COVID started, continuing. So everyone sat on the defective of FDA approved coronavirus tests and the excellent high quality non-FDA approved corona tests that were banned from using and didn't test anyone for coronavirus. Meanwhile, American citizens who had recently visited Wuhan and other COVID hotspots started falling sick and asking their doctors or health departments whether they had COVID. Since the FDA had essentially banned testing, those departments told their citizens that they couldn't help and they should just use their best judgment. Most of those people went out and interacted and spread the virus and incidents started growing exponentially. By March one, China was testing millions of people a week. South Korea tested 65,000 a week and the U.S. had done a total, grand total. March one, March one, six, seven weeks after the Trump administration knew the coronavirus was out there and it was out. In March one, the USA had done a grand total of 459 coronavirus tests. Again, South Korea 65,000, China millions. The pandemic in these three countries went pretty much how you would expect based on those numbers. There were so, so many chances to avert this. The New York Times did a great article on Dr. Helen Chu. I talked about Helen Chu on my show. A doctor in Seattle who was running a study on flu prevalence back in February 2020 when nobody thought the coronavirus was in the U.S. She realized that she could test her flu samples for coronavirus. Did it and sure enough discovered that COVID had reached the United States already. The FDA spun into action, awarded her a medal for her initiative and no, no, they shut her down because they hadn't approved her lab for coronavirus testing. She was trying to hand them a test and trace program all ready to go on a silver platter and they shut her down. And we have no idea whether how or where the coronavirus was spreading on the U.S. West Coast for several more weeks. This is nutty, insane, or you could even argue criminal. 600,000 Americans plus or minus have probably died from the coronavirus and it was all preventable. All of it, at least a significant majority of it was preventable. Although the FDA did kill thousands of people by unnecessary delaying COVID tests, at least it also killed thousands of people by necessarily delaying COVID vaccines, which I mean talking about and John Cochran has been talking about for months. I'll let you click on the links for the details. He gives links for all the details of the botched coronavirus vaccine program. Except to remind you that they still have not officially granted full approval to single COVID vaccine. And the only reason we can get these at all is through provisional approvals that they wouldn't have granted without so much political pressure. The one good thing that the Trump administration did was put pressure on the FDA to get provisional approval for the vaccines. Now here's the kicker. I worry that people are going to come away from this with some conclusion, like wow, the FDA seems really unprepared to handle COVID. No, it's not that specific. Every single thing the FDA does is like this. This is Scott Alexander, left of center on economics. This is not some libertarian, some objectivist writing. Every single hour of every single day, the FDA does things exactly this stupid and destructive. And the only reason you never hear about the others is because they're about some disease with a name like Chomo's syndrome and a few hundred cases nationwide instead of something big and media worthy like coronavirus. He says, I am a doctor. And sometimes I have to deal with Chomo's syndrome of the world. And every frigging time, there is some story about FDA doing something exactly this awful and culture productive. And you could go on and on and on. I mean, he has another example of sure. I have to redo this because this is so ridiculous. It's ridiculous. A while back I learned about colostasis in infant short bowel syndrome, a rare condition with only a few hundred cases nationwide. Babies cannot digest food effectively, but you can save their lives by using an IV line to direct nutrients directly into their veins. But you need to use the right nutrient fluid. The FDA approved one version of the nutrient fluid, but it caused some problems, especially liver damage. These are babies. Drawing on European research, some scientists suggested that a version with fish oil would cause less liver damage, but the fish oil version wasn't FDA approved. A bunch of babies kept getting liver damage and everyone knew how to stop it. But if anyone did stop it, the FDA would take away their licenses and shut them down. Around 2010, Boston Children's Hospital found some loophole and let them add fish oil to their nutrient fluid onsite. And infants with short bowel syndrome at that one hospital stopped getting liver damage and the FDA grudgingly agreed to permit it, but banned them from distributing their formulation or letting it cross state lines. So for a while, if you wanted your baby to get a decent treatment for this condition, you had to have them spend their infancy in one specific hospital in Massachusetts. Around 2015, the FDA said that if your doctor applied for special exemption, they would let you import the fish oil, nutritional fluid from Europe. But you were only able to apply after your baby was getting liver disease, liver damage. And the FDA might just say, no. Finally in 2018, the FDA got around to proving the corrected nutritional fluid and now babies with short bowel syndrome do fine. After 20 years of easily preventable state mandated damage and death. And it's not just this and coronavirus. And this he puts in all bold. I cannot stress enough how typical this is of everything the FDA does all the time. It's unbelievable. If this doesn't make you angry, this is your health. These are your children. This is your old age. This is you getting sick and not having the drugs because these bastards, these bureaucratic bastards won't let you have access to it. These are the drugs that never get developed because of the FDA. Now, Scott goes on to explain why this happens. And I've said this on the show many times. It's cause of the incentive structure. And the strength structure is simple. If the FDA approves a drug, then, and something goes wrong, the FDA gets reamed. They get, oh, this, they might actually lose a job. This huge press, huge involvement. Also, if the FDA approves a drug, insurance companies must fund the drug. Medicare, Medicaid must fund the drug. So even if they approve drugs that are expensive but not very good, like the one in Alzheimer's, suddenly the cost of healthcare goes up because we have a system where once a drug is approved by the FDA, insurance companies have to by regulation and Medicare, Medicaid have to pay for it, which is insanity. So he talks about, let's unbundle this. Unbundle all the things that the FDA is responsible for. So instead of FDA approving a drug and it's legal for doctors to prescribe it and it's mandatory for insurances to cover a drug, what about the FDA just saying it's legal for doctors to prescribe the drug but insurance companies just have to you whether you're gonna use it or not. If something doesn't have FDA approval, then doctors can't prescribe it and insurance companies clearly won't pay for it but if something does have FDA approval, any moron can get it. I'm reading again from this article just because they saw TV ads saying it was a hot new thing and the government insurance, other patients will be forced to cover the entire price. So you just see an advertisement and you go and you say, hey, I demand the drug. The FDA has approved it, it must be good. And you take the doctor's judgment out of it, doctors under pressure by patients and by drug companies to write prescriptions for drugs even when they think it's not appropriate because of the incentive structures. And then the side effects, they don't approve it because of the side effects. So Scott Alexander goes through all of this and he explains it beautifully. I mean, really, I highly recommend you read this. He explains all of this. And then he basically says we need unbundles we have to restructure the FDA and restructure the incentives. And he comes very, very close to saying it should be privatized and there should be competition but he can't go there. He can't quite go there but he comes so close. So let me just say, I encourage you to read it. I encourage you to write to him, encourage him to think about privatization and not wimp out about it. It truly is a great article. It's one of the best on a topic like this and yeah, support this guy. Astro Codex 10, that is Scott Alexander. What we need today, what I call the new intellectual would be any man or woman who is willing to think. Meaning, any man or woman who knows that man's life must be guided by reason, by the intellect not by feelings, wishes, wins or mystic revelations. Any man or woman who values his life and who does not want to give in to today's cult of despair, cynicism and impotence and does not intend to give up the world to the dark ages and to the role of the collectivist, broods. All right, before we go on, reminder, please like the show. We've got 163 live listeners right now, 30 likes. That should be at least 100. I figure at least 100 of you actually like the show. Maybe they're like 60 of the Matthews out there who hate it, but at least the people who are liking it, you know, I wanna see a thumbs up, there you go. Start liking it, I wanna see that go to 100. It all it takes is a click of a thing whether you're looking at this. 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