13: Warning Letters

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Hosted by
Will Jarvis

Sometimes, pharmaceutical companies mess up. More rarely, the FDA catches them. They write warning letters detailing the problems and post them on the internet for anyone to read. On this episode, we are joined by the author of the new blog, Warning Letters. Warning Letters focuses on quality control in the pharmaceutical industry. We learn how FDA keeps our drugs safe, what the process looks like for supplements, and whether or not it’s worth it to shell out for name brand vs generic drugs.

Check out Warning Letters at warningletters.wordpress.com.


hi i’m will jarvis and i’m will’s dad we both love and are fascinated by stories stories about people stories about places and stories about events our stories give shape and form to life they give texture color and rhythm to the blank canvas that every new day presents to us and they do that by informing us of our past as a directional marker for our future okay will it’s narrative time tell me a story well hey folks today on the podcast we’ve got um the wonderful mr ed what’s that a reference to so if you’ve ever seen the show wonderful mr ed the song goes a horse is a horse of course of course unless it’s the wonderful mr head so that’s awesome so uh and uh it’s a it’s a pseudonym i assume nam day plume i guess that’s super cool and you uh you just started the blog warning letters is that correct yeah so it went live a couple of weeks ago very cool and what is warning letters so a warning letter is something the fda sends out when they find something wrong with the drug manufacturing process so the fda will go and audit manufacturing facilities and then at the conclusion of the audit they’ll write up everything they found that was not right and they’ll send that to the manufacturer and they’ll publish it on the internet so you can read basically anything that’s the fda has ever found for drug manufacturing as long as you can understand it so that’s sort of what i want to do is help interpret what these findings really mean so that consumers can sort of know what’s going on gotcha so fda and have you ever heard that you know insider’s called fda right not the fda not the fda it’s fda it’s like cdc fda you know fda does anyway no definite article before no people responsible for that’s right that’s right um so this so the process goes something like does someone have a um do they do this on a predetermined schedule or does someone like ring an alarm bell and the fda comes so it’s both they have an audit schedule and they’ll come so i do clinical manufacturing so they’ll come every time we start trying to bring a product to market and they’ll also come and edit and audit manufacturing facilities on like a five-year basis and that’s how you get approved to market drugs in the us and then if someone has a problem with a product they’ll tell the fda and the fda will sort of look back and see every product that the consumer has taken to have that problem and they’ll start trying to gather statistics and find out which problem which product they’re having a problem with and then they’ll go back and audit that manufacturer so is it random or is it on a cess like do you know the audits coming or yeah you normally have like three months lead time because you know that five years ago you audited and they’re coming back in five years so they’ll set up a time for them to come okay so they don’t just do it randomly which i think would be actually superior yeah it’s not completely random but it’s it’s somewhat random though it’s somewhat yeah interesting because it seems like optimal would be that um uh you just go in like you roll the dice and then you go check this on this manufacturer sometime within a five-year period and yeah yeah but manufacturers get really upset when you do that i’m sure for obvious reasons and there were a bunch of lawsuits because people were saying oh we’re being discriminated against we came up twice and this company over there never came up so that’s super annoying because all you you could just use a random number generator yeah exactly and actually just pull numbers out of the hat and the reason why i think uh having it be random is important is because you can’t game it at all because if you know they’re coming within the next three months you just beef up you know you quit you know putting sawdust in your vials or whatever that’s what you would expect but the fda will come in there and people will just do the worst [ _ ] in front of them really they’ll just stick their hands and destroy all things and the fda auditor is standing right there and they write that down the warning letters i’m like how does that happen i’ve gone through fda audits and nobody works while the fda auditor is there because you don’t want to be the person they see doing something that costs the company millions of dollars right so it yeah and so people are like performing i assume unless they want to sabotage the company which i don’t think that happened uh and and then that’s the result so it seems like you know you’re you’re selecting these results that are not optimal like so they’re not well they don’t paint a clear picture of what actually is going on in the manufacturing facilities which is horrifying because we’re going to get into some of the things that actually goes on when they’re caught in these audits that uh that uh don’t um yeah don’t turn out so well so so what um so what happens if the fda shows up they knock on the door and say hey we want to check this facility out and you say no so the fda will well that’s fine and they leave and the next that day they come back with the u.s marshals and they open the doors they bring guns and they yeah the next day i had a friend who worked in the supplement industry on sort of the sketchier side he would tell me stories about he would like drive to the plant he worked at and the fda would be there pulling boxes of documents out into the parking lot and he just kept on driving and he just didn’t go back to work because he didn’t want to get caught up in that that’s amazing yeah i know the supplement industry is a bit of uh the wild west so what’s the difference between a supplement and kind of a food or drug product to the fda okay so a supplement is kind of treated like food because for a supplement you don’t have to get approval to market that in the u.s you don’t have to prove that it does anything so it’s called a new drug or supplement so if you have a new supplement you want to bring into the market you have to run like efficiency and safety tests but if you just have something that’s always been marketed like if you have fish oil and you can claim that it’s always been marketed then you don’t have to get it approved by the fda you just have to get you just have to prove that it is what you say it is and that it’s pure so it’s 98 fish oil and it doesn’t have dog oil in it basically okay so a lot of people will try to game the system by saying it’s a supplement and then they’ll claim that it solves cures health conditions and that’s drug and a drug has to have clinical trials behind it to prove its safety and efficacy so you have to prove that it that it works and it’s also safe exactly so um i i just want to so we’ve got a lot of listeners that are in the fitness community uh so that i think this is important to think about important to understand before you take supplements so they do have so the ingredients have to match the label is that correct yeah it has to be exactly what it says on the label but it doesn’t have to work so it doesn’t have to work okay so i that’s even so that’s better than i than i thought because i thought i didn’t they could just do anything i assumed it was kind of the wild west because i know someone that uh has run a supplement company and i was like man this is like uh pretty worrisome well they don’t get audited that often and you can’t really go to jail very easily for it the fda doesn’t have a lot of resources compared to the size of the supplement industry gotcha so oh so they they don’t get audited like uh drug manufacturers do yeah because there’s not as much risk associated with supplements basically gotcha so it’s illegal but you should because i know um consumer reports did a big study about protein powders and like heavy metal concentrations which i think may actually have to do with like uh you know it’s a whey protein is a byproduct of cheese production um and cal cow’s milk has levels of heavy metals associated with you know they eat grass and soil um and so i think it’s like concentrated you think about think of it kind of like concentrated milk it’s going to have higher heavy metal concentrations yeah but also there could be things people putting in there you know that not super great so the problem with that is you test for protein concentration and you’re going to do that most people do that by high pressure low by chromatography hblc i forget what the acronym stands for so much um it’s hplc it’s high pressure low something chromatography gotcha so basically that test for proteins and sort of a bun it has a detector that detects visible light and proteins absorb visible light at like a280 if you’re a chemistry major what’s a 280 um it’s the absorbance at 280 so proteins absorb light at 280. so if you have a detector it can detect that but metals don’t absorb light in that frequency so if you’re looking exclusively at that frequency you’re not going to catch the heavy metals so you have to do a separate test for heavy heavy metals but you have to do it for each one that you’re looking for so like add lead iron aluminum and that’s really expensive the higher you go yeah so sketchy supplement companies sometimes don’t do that gotcha so there what i’m hearing is there is reason to be skeptical and you need to be careful about supplement intake yeah exactly gotcha that’s super interesting it seems so so supplements are regulated differently than food products as well is that correct um exactly food products i think have higher minimum allowances for bad things that can be in it like the famous cockroach particles minimum that can be in food products you can’t have any cockroaches in supplements interesting so actually a little bit tighter than food yeah exactly oh that’s wild that’s so interesting okay and the cockroach minimum is that that’s that you buy volume you can have a certain percentage of you know cockroach body matter yeah because it gets in there because if you’re harvesting a plant sometimes those bugs on plants you can’t be 100 but with a supplement you can be 100 no cockroaches not allowed not a lot oh yeah and then a quick sidebar in supplements pretty much the only thing that will give you energy is caffeine and creatine which is sort of like caffeine so any supplement that claims to give you energy the main ingredient is probably caffeine so you need to like not stack those because too much caffeine can give you heart attacks you know so uh well although you know i know there’s a couple of pre-workouts that were have been famous and this could be like bodybuilding fitness lore right for having um uh ephedrine or like uh you know amphetamine uh you know yeah that’s just meth so so like yeah exactly so it’s caffeine meth or creatine so stick with the caffeine guys exactly yeah super interesting okay um so that’s supplements getting back to warning letters so the fda goes in um they check out the manufacturing process and what do they tend to find so a big thing is data integrity errors so when you’re testing drugs and you get a failing result then you have to either say why you gotta explain why you got a failing result and it’s not the samples fault or you say the sample is bad and this entire batch which is worth five hundred thousand dollars has to be discarded so a lot of people are trying really hard to get passing results and so a lot of companies will have practices that will sort of put your finger on the scale to make sure it passes so that’s mostly what they find gotcha so like p hacking or whatever they have to do to exactly make it make it clear the bar so throw stuff out interesting um so the fda uh so from your perspective and this may be a bit tangential but you know how effective is the fda at his job um you know i remember in college there was a great talk but i think like jessica flanagan at the university of richmond that i attended and she’s like you know look like the fda like sure there’s uh you know maybe it does some good but there’s all these like costs associated with it so traditionally we think about cost in the fda we think about drug development you know it costs like billions and billions of dollars to get a drug approved because you don’t you have to improve efficacy as well as safety and you have to prove it does better than any other product on the market you can’t just have the same level of efficiency gotcha yeah that seems to be like a big big issue so is that is that a net positive and a negative what do you think about that well the fda um controls drug approvals which is what you’re talking about and it also controls drug manufacturing so i can’t talk so much to the drug approvals because that’s a lot more of a tail-end effects that you have to take into consideration whether or not you should approve drugs more easily or have more information so you can make a better judgment call but with drug manufacturing i can tell you whatever they can catch they absolutely make you fix and it’s very efficient they control really well to make sure that you have the correct permits to be able to market things gotcha so if so even though they can’t audit all the manufacturing plants all the time it’s pretty efficient so they actually do a good job in ensuring that the supply is safe and people are doing what they say they’re doing exactly and that’s a pretty big issue because drugs can be very dangerous if they’re not manufactured correctly gotcha so um do you want to talk about a case study okay yeah so my favorite case study is this company in india called milan normally in like thailand mylan yeah normally in like data integrity talks they censor the company names because yeah that could be like your next client and you’re talking [ _ ] about them but i’ll just tell you who it is because i’m anonymous on this so mylan um so they were running chromatography on their samples that they were testing so that they could prove that they were what they say they are yeah and so first you have to run a system suitability so that’s a sample that you know what it is so you can test your machine and make sure your machine is working properly so you run a system suitability and then you run your sample and then you test system suitability again and to say that the machine is working properly system suitability has to work both times at the beginning and the end and if it doesn’t work you can’t say anything about the sample because you don’t know what your machine is doing gotcha you got to calibrate the machine essentially yeah exactly so they would run the first set of system suitabilities and then they would run a sample on the 500 000 batch and if the sample failed they would pull the plug on the machine so the second system suitability did not run and they would say oh we just can’t say anything about the sample that we run even though it looks like it’s failing because we don’t have the second suitability so it’s not a calibrated machine essentially oh god right so they would just test into compliance which means you just test and test and test until you get a passing result and that’s the one you take so with statistics i’m sure any statistician is just cringing in their seats right now because that’s really bad so the fda come along and they’re looking through their data they’re like huh you have a lot of these out of spec results that you didn’t investigate and find if they were actually the true result because the system suitability failed why is that and they asked one of the analysts that does the testing and they go like yeah management just tells us to pull the plug on the machine whenever we have failing results i’m sure that guy got fired but good for him you know exactly exactly like just taking out back and shot like a dog exactly you know so you can’t do that but that’s are there any protections for whistleblowers there are yeah but it’s an indium and they’re mostly like legal protections like you can’t get fired in quotes for that but they can like push you out essentially cover their legally and like nothing’s gonna stop somebody who lost their entire livelihood from coming after you really not that you shouldn’t report anything you catch but like it is a little bit dangerous that does sound like a real problem though that you know if people cannot um

what’s the word if people have trouble uh so like if you see something and it’s gonna harm your livelihood for the rest of your life it seems like a real problem that uh yeah there need to be like real protections in place yeah like like you know what do you do like to protect whistleblowers because right because like it can be a black mark on you like for the industry right yeah exactly because i’m pretty sure somewhere it’s redacted like who said that but yeah in the fda records that guy is named right i gotcha yeah exactly so like someone could find out uh it’s it’s also interesting to me that um so you mentioned like running the test over and over until you get the result you want so i had a great professor in undergrad that he was a professor he focused on the european union and one of the big things he talked about was the democratic deficit in the eu and the way that they would get things passed is like well okay you’ve got this you know what a referendum is yeah everyone votes on so like everyone votes on this particular issue so we’re gonna tax um for french squash for x amount and like these bureaucrats like yes this is the best thing it’s going to really improve our lives we’re going to tax french squash uh and so what they would do is you just um the beer cuts have the power to essentially run the referendum as many times as they want so you just keep running and eventually and eventually it will pass because you can’t like vote in abstentia i guess so eventually the people who don’t want it aren’t there so they don’t vote no yeah eventually like you can get things through so it’s like really this interesting problem it just seems like a interesting analog right it’s the p-test in real life exactly it’s speed hacking in real life there we go yeah so i i thought that was interesting okay so um we were talking about my land in india and and running these drugs so that seems like a big problem because that’s just the ones that have been caught correct yeah exactly it also really shows like the culture of your quality control lab has a huge effect on sort of how samples get tested and what gets through to the market so it’s super important to have really good bosses that’ll really stand up and do the right thing because the analyst who’s running the test doesn’t have as much experience like i run tests for release and i have like two years of experience so if i had never started at a good company i would not know all of these requirements for like making good data that has data integrity well and also it seems like again it’s like the uh the political economy of how do you create like in you know this quality control department that’s actually independent enough to you know like whoa whoa whoa we can’t do that i’m saying because which is very it seems very difficult yeah that seems like a very difficult problem so under good manufacturing requirements you actually have to have a different department from your testing department that tests for quality control and they’re like they’re called quality control and the testing lab is called like testing or whatever and they’re an entirely separate department that answers to an entirely separate boss and they look through all of your paperwork before anything gets released and they have to sign off on it so it’s sort of a check that this department is not becoming nepotistic or under the control of someone who’s not doing what they should be doing that’s interesting but it’s still it’s still like internal yeah it’s still within the company yeah which seems to be like an incentive problem right like exactly um and it also seems like you know regulations like these may be good for current like to keep current players in line but they seem to be like great buffers from new entrants yeah that’s a good point it can cost millions and millions of dollars to set up a lab that can test to these to the good manufacturing practices and it also costs even more money to set up production lines and sort of making the drugs to these um um good manufacturing practices interesting yeah it’s like the bootleggers and baptist problem like mark zuckerberg and uh it’s like yes you know like it would be great for us to regulate social media uh more because we regulate social media more you know i can comply with everything but the small i can business i can’t lie because i’ve got this flywheel that throws off a hundred billion dollars in cash a year and i could you know i can but you know if i’m the new social media entrant we start the next you know facebook we can’t afford to meet the um requirements that set forth by agency but that’s a different second order effect from these uh uh you know setting up regulations like this yeah but i would say drug manufacturing it’s way more important to get right than like social media that’s true that does seem to have much bigger effect to make sure the drugs are safe very cool um so we talked a little bit about this case study uh what are some things people should look out for in their drugs so basically you’re the last line of quality control before something goes into your body so like just look at your drugs before you take them so if you’re taking advil just look at the drugs and they’re like are they all the same color are they all the same shape do they have giant cracks in your gel capsules and also what’s really important that you can really do really effectively is if you have a vial and it’s a clear liquid just look at it and see if there’s anything floating in it there’s anything else that’s a test i actually run just look at the vial and if there’s something in it you can’t take it okay gotcha yeah just call the manufacturer call whoever just complain and complain and complain if you ever find anything that’s not right with your drugs interesting and never take expired drugs ever we work really hard to find the exact date we can market it to and after that there’s a reason it’s not good anymore oh really so that is like the absolute last yeah there’s a lot of money in this because the longer you can sell it the more you get more you’re sure you can’t get stuck with unsold product right so the stability studies like to the absolute last day you can possibly take it so it’s not yet there’s so there’s not like uh yeah people often think there’s a margin of safety put in by the engineers not really no but it’s not like chinese spoon like oh this looks kind of off but i’ll take eat it anyway like you can’t tell if your advil has gone bad gotcha oh that’s super interesting um very cool are there any anything else about the fda thing it would be good for people to know excuse me fda that you would like um so it’s not really immune to political pressure so you need to make sure when you’re voting like some of the fda positions are elected so if you ever get someone like senators i think appoint the head of the fda so you need to look at your senators and see if they’re gonna promote people to that position who are subject to like market pressures because you really don’t want your fda thinking head of the fda thinking in the back of his mind oh am i going to get fired if i regulate this industry and for instance the supplement industry has pumped billions of dollars lobbying the government to keep supplements from having to meet these qualifications for um safety and efficacy so that’s how sometimes bad things happen with supplements safety seems okay efficacy i’m less yeah i’m excited about um i like i’m a libertarian but the more i read these warning letters i’m more like let the fda regulate fish oil like i don’t even care anymore everybody’s doing clinical trials these yeah everyone has to do it that’s super interesting um yeah we were talking to russ green last week and and russ was the former head of research for crossfit and he did a lot of work um with the primarily cdc nih nsca things like that organizations like that and the big takeaway he had was that you wouldn’t believe how little control congress has over these unelected bureaucracies at this point you know he he would say things like well the bureaucracies and i don’t want to butcher what he said but you know the congress would say you need to go fix this and they just wouldn’t do it because there weren’t any controls to sort of force them to comply there’s no real they’re like you know city they’d be like you have to do this i’m like okay sure whatever they just you know and there’s all different ways you could you could not do something right just slow roll it bureaucratically you can just but long story short they did not just keeping meetings to determine what the problem is exactly exactly and and even even other scary things i’m not sure if this is true for the fda you know cdc has been in the spotlight recently because of the whole bumbling coronavirus response you know the seed centers for disease control only spends about 10 percent of his budget on infectious diseases which is a little odd for the centers of disease control exactly um so you know this cra cdc and nih they have these private foundations which they can just use the money for whatever so you know companies like coca-cola pumping money into like cdc foundation and things like that oh so they’ll say that sugar is actually good for you i feel like they right the cdc writes those recommendations for diets yeah things like that it’s like it’s like oh see the big thing they did one of the big things they did was like well it’s really about energy balance so it’s like calories in and calories out and like sugar doesn’t matter you know forget about insulin response that’s not a thing the crossfit will community will tell you that is not true but what do they know yeah what what are they now they’re just all super fit so these crazy people in these garages doing this stupid stuff yelling while they lift weights it’s terrible exactly they’re that you know they keep saying you know why is the the diabetes rate you know why is there a six-fold increase since 1970 or whatever it’s like we don’t know coca-cola will not let us say so exactly if you want to think about something really scary if you look at coke’s advertising i’m getting on tangent here this is one of my favorite tangents go on if you look at their advertising budget spin so white people essentially have stopped drinking regular coca-cola for a lot of the reasons you know and they haven’t stopped completely but you know they’re buying less so they uh pushed all their marketing towards uh black and brown people in the united states i heard they were also trying to get into the african market and now everybody in africa drinks coca-cola which is full sugar yeah yeah it’s really bad people vulnerable populations are getting kind of attacked and and that’s uh it’s really scary when you think about it a lot of weird incentives like you said you know i’m fairly libertarian in my leanings but then you get into some of these problems you’re like oh man oh you know the fda is responsible for labeling food so that’s why coca-cola has to tell you how many grams of sugar and calories are in your coca-cola can oh yeah yeah very interesting people were very upset about it in the beginning but i think that’s probably the right way to go about it yeah i definitely think so i’m against i’m a libertarian so i’m against fairly i’ll say i’m fairly liberal libertarian maybe not capital l like you know lowercase l libertarian i i tend to think um just enough to ruin thanksgiving exactly just enough to win thanksgiving you know sugar taxes and soda taxes i think are probably the wrong way to like limiting the size of soda cups that you can sell i think is ridiculous yeah i think that’s kind of stupid and like paternalistic and i don’t really like it but i do i’m 100 for labeling exactly i i think uh that that is you know having perfect information is important you know i think they should put a little skull and crossbones and you’re like you know the dive like on the um cigarette packs yeah absolutely i have 100 for that i don’t know it’s interesting okay so let’s see what else we’ve got to cover today

so we talked about quality control so how did you first have the idea for this blog so i i work in the industry i have a lot of meetings and at least half of those meetings are they bring you into an auditorium they sit you down and they’ll read over the warning letters that the fda sent out to other companies so they can learn sort of what’s going on what the fda is really auditing for this year and sort of how not to get caught on it because if you get a warning letter your stock price just nose dives for a little bit until they send another letter saying yeah you’ve mostly fixed it so that was really interesting yeah it was just really interesting what other people were doing i thought you know i bet everyone would be pretty interested in hearing about this that’s yeah it’s super super crazy although again you know it goes back to you know it sounds like people you know they try to match the test right they try to they they just study for the test so you know they see the fda is looking just at cardboard in vials and so they like really may try and make sure they don’t have cardboard and files going forward yeah but that is to a certain extent what happens but sometimes you get side benefits from it like the fda has really been pushing data integrity like we talked about for years so people have started getting like audit trails that will automatically capture what happens and when it happens so people can just delete data for failing results so i think that does significantly impact the actual quality of the products that consumers get that’s that’s very interesting that’s very interesting are there any other case studies you like to talk about so another data integrity issue so up in china they made baby formula and they would run the baby formula samples on the chromatogram and they would try to hit a certain protein percentage because that’s because it’s china and the higher the protein percentage in the baby formula the better it looks so they added a substance that was not baby formula but it increased the specific weight so and then when they ran it over the chromatogram a readout on a chromatogram is sort of a line and then it’s got peaks i’m next to the and if you have a peak that’s something right and you sort of determine where on the peak your result is your sample that you’re testing for is going to come out and you look at it and you say okay that looks like the reference standard which we know has that peak and we know is the substance we’re looking for so they also have this heavy metal peak and what they did is they went back and they whited out the heavy metal god right so it did not look like they had that heavy metal in it and babies developed kidney stones and i think three or four of them just died from that so like four people got executed in china yeah well the fda can’t do that here yeah so the fda not as bad as the chinese fda oh that is like you know that’s kind of the right response though right you gotta do something nobody else puts heavy metals in their baby formula yeah yeah yeah yeah everybody is very concerned yeah it sends the right message i mean you know you start killing kids that’s you gotta do something that’s bad stuff that actually reminds me of the volkswagen do you remember the volkswagen emissions scandal oh yeah they were making it so that they could turn the emissions on or off that’s right so so you know this this is a very similar case it’s based on it’s quality control you know same kind of thing trying to comply with existing regulations yeah more like yeah more trying to comply with existing regulations so they had tdi diesels clean diesels um you may remember them really good you can get like 45 50 miles per gallon on the highway with these things this was back in like the 2000s so that was even better yeah it was even better and this was really big in in europe especially because you know europe gets most of its gasoline from the north sea the norwegians that’s why the norwegians i don’t know if you knew this but um mr ed but norway has the largest like one of the second largest or the largest maybe the largest sau i think it’s the largest sovereign wealth fund oh really so like the saudi arabia of europe yes so it’s like a trillion dollars or something it’s like and it’s a big thing like so they could just do welfare whenever they want because they’re rich so like i and i pretty much so that’s why they have a welfare state exactly they have like a couple hundred thousand dollars for each person and and that’s why also why i tend to think you know when politicians the u.s compare us to these nordic countries well you know there’s like you know we don’t have this massive sovereign wealth fund to pay things out anyway you know when we stop using oil good luck with that exactly um but they’ve actually electrified most of their vehicles now um but they have this massive sovereign wealth fund owns two percent of all publicly traded equities in the world that’s pretty impressive i’m moving to norway going to norway yeah and so it’s hilarious because they just did this index approach and they just bought everything you know um but you know most of the cars are tesla’s over there now for that reason craziness but that’s where they get the oil oil from in the in the in in europe and so oil prices are very high because it’s in the north north sea north sea yeah and it’s like you know very rough to pull out of water it’s not like in venezuela where you can like stick a shovel on the ground and like spurts out yeah um so it’s quite difficult oil prices are high so gas prices are high if you’ve ever been to europe that’s by the leader and it’s it’s pricey so diesel became commonplace because um it’s a lot cheaper and much more fuel efficient and easier to kind of get around so they started marketing clean diesels but what the what volkswagen dig the volkswagen engineers is they started throwing the emissions test because they couldn’t get them clean enough oh yeah to meet the regulatory standards so yeah i can’t remember exactly what they did but i think they cut horsepower or something in half um to make it and um you know they had a couple engineers on this there’s an executive that made this have like you know we have to get this through because european regulations are quite stringent you know greta turnburg the superintendent climate change um and trying to alleviate that in environmental issues so they did that um and you know there was some engineer that was just working under the direction of higher management to make this happen you know he was just like kind of cog in the machine and this is an important story i think because you know eventually he flew to america and you know they picked him up on the tarmac you know he like got the plane and this guy’s just like a cog in the machine but i think this is an important thing for everyone to think about is like even if you’re directed to do something you know by a higher up you still need to do the right thing because at the end of the day not only is it you know the right thing to do but the authorities will come and get you anyway exactly like working in a giant organization will you work for like one guy so but working in giant bureaucracy you can’t see the big picture you sort of have to do what your boss tells you to do so if your boss says look at these 10 bottles and see if there’s stuff in them i do that but it’s also really valuable to be able to encalculate yourself in the mindset that if i if this doesn’t seem right i need to stop and i need to find someone else yeah exactly even though it’s a very different mindset from just go to work and just do whatever you say and then yeah do whatever yeah exactly well and you got to think about it a lot of a lot of the bad things that have happened in the world are because people are kind of just like wow they just told me to do it you know like whatever yeah you know putting these people on these cattle cars i don’t know where they’re going but it’s not my problem once they get there exactly i’m just locking the doors i don’t push the button exactly so you want to be really you gotta like follow the news a little bit yeah yeah you’ve got to keep your eyes open all the time um so that that’s interesting so we’ve talked about a lot about a lot about quality control i had something else i wanted to cover here

do you know when the fda was created um gosh i think back in like the 1850s it’s actually a really interesting story so it was actually a supplement it was like a supplement they were trying to make for kids so they put in some grape flavor in it and it turns out that the ingredients the grape flavor were very dangerous for kids because they’re smaller they have a lot more body mass so like kids just started dying because they hadn’t done these safety tests on this new formulation for this drug so that’s how the fda sort of got the political impetus to get past and i don’t think we could make something like the fda today because when’s the last time a really efficient government organization had been created like ice was created in like 2010 and it still doesn’t work right right it doesn’t have the government power or the overreach that would really need to really complete its stated goals it’s just sort of a boondoggle right but the fda will come for you and the u.s marshals will put you in jail if you send bad products to people like they will actually it still still kind of works yeah it still works even after all of these years that’s super interesting yeah you know it is it is bizarre this this interplay between executive congressional power and then like these unelected bureaucracies uh because even if you look at the these riots that happened on recently and you know riots protests in portland and things like that and you see these people uh what so you saw these people in fatigues jump out of these rented vans to like snatch people up you know protesters that were like you know trying to destroy a federal courthouse and stuff like that so here comes the federal troops right they don’t play around not like your mayor you elect every year like exactly so so they came but it was what the most interesting thing to me about that was that um you know it’s weird right because these people they’re wearing fatigues unmarked and they’re using like rented eq we’re in advance like what’s going on and the thing i realized is you know there was no one else they could send because you know who those troops were troops police the national guard no no they were not the national guard they weren’t any other and i’m not exactly sure who normally would handle this they were actually the border patrols um so the border patrol has prisons and they have uh i don’t know have you ever toured a jail or anything no okay so i in boy scouts we tore to jail quite impressive uh yeah scared you straight apparently yeah yeah yep scared of that uh so i you know we went to the jail and it was interesting because they talked about well okay like this is how it’s set up and stuff and then they had like all this right gear and things like that and they’re like well this is our right gear if things go south is bad things happen oh so they were using like prison guards because they had riot experience well not quite so we’ll get there um so but they said but there’s a special number we call and these folks based in raleigh come and they are the prison swat team and these are like these are the baddest people and if they come like you have [ __ ] up like this is really not good like you do not want these people to come so that’s what it was is the border patrol’s like swat team and you start thinking about okay like why like why the hell are they using the border patrol swat team in these situations and i think the answer is because the uh this is the only people the executive branch could actually get to do anything oh they’re the only ones that follow their orders from the president not from like congress right one i think even more than that i think uh they’re probably pretty red tried compared to the other law enforcement agencies and so they would actually be willing to go and do it um you know there’s tons of problems with this like you know they’re using like unmarked vans and like really a poor way to do things like unmarked you know fatigues like you shouldn’t be wearing fatigues and then you know they’re just snatching people off the street like very kind of scary you see the videos like oh my god what is going on here well i think it’s very dangerous to try to arrest somebody in a riot about arresting people like that could end up with all the officers dead pretty quickly if there’s 100 of them in 10 of you well well that’s part of it that’s part of my point though is that uh it’s the wrong way to do things because like they’re clearly super under-resourced right because well either you got to go in and you got to do it and you got to arrest everybody and there’s like overwhelming force or you don’t do it i don’t think oh we’re going to sneak in and get somebody it’s the government don’t halfway it yeah the halfway don’t half-ass everything yeah yeah it doesn’t doesn’t really seem to work but point being um i i think people had this idea that you know you go and you elect your congress people and you know they they go and they actually control things and you’re going to like president and he can actually control things i think a lot of these processes are it’s really distributed it’s like kind of it’s super oligarchic so each government agency like the individual bureaucracies have a lot have that’s where most the power resides now um and it’s not in the people we traditionally so we think we think like it it makes sense to us that we go and like we elect these people and then cal cunningham goes and he like he decides what’s gonna happen right to a certain extent uh and i think he may do more especially like the um committees so like in the congressional committees but even then there’s also a great movie um called the report have you seen this oh i have not it’s great it’s on amazon prime it’s got kylo ren is the is the movie star in it what’s his name oh the one with the famine and the ball cans or kylo ren oh yeah um adam driver driver kevin yeah so he’s got adam driver the guy with the weird face exactly oh god that’s the end yeah i’m gonna have to edit that out yeah sorry adam driver if you’re listening to this we love you um you have nice abs so it makes up for it exactly makes up oh god i’m just thinking that hole deeper so

what was i saying so anyway the report so he’s a staffer for dianne feinstein you know dying fighting scientists yeah a senator of some sort yeah super old uh senator from california she’s like you know super old school democrat like gone a long time in the news recently for hugging lindsey graham after the uh barrett hearings probably she has chronic viruses probably neither here so you know he’s the staffer and he gets out of the harvard kennedy school and he i i can’t remember exactly how he started but he catches when that you know uh and she’s on the defense committee or or something like that defense at homeland security can’t quite remember this is in the early 2000s and he starts looking into the black sites so he kind of like broke the black side story and like all this bad stuff happening and he’s like like guantanamo bay yeah like gitmo and like all this stuff they’re doing and and he’s like ends up on this crazy quest to figure out what actually happens it takes like years years and years and years and um you know dianne feinstein you know this very powerful senator is trying to get like and you know she’s like facing political pressure for looking into it um and the cia doesn’t want to turn over these documents and they finally like give adam driver you know this this where i can’t remember the guy’s name for the life of me uh this um we should have him on the podcast oh yeah it’s gonna be uh not i’m driving but actually probably he’s in hiding right now because he’s a whistleblower exactly uh so he gets all these documents he’s going through this like thousands i mean he spends years going through these documents trying to figure things out that’s one way people will sort of mess with regulatory agents they’ll just give them a million documents all sort of pertaining to what they’re doing exactly so the point is like exactly so this is a great point the cia so they’re like okay yeah sure whatever we’ll give you all the documents they’re just giving butt loads and butt clothes and boat loads and gina haspel was actually part of this too the current cia director so and he’s going through the documents it takes years like everyone else is working with him is just like this is just like crazy and he finally like creates this report um but the cia these things are are getting close and weird and they actually send people and they break into the office and like try and find out what is what’s in his report yeah and i mean like literally so this is a secure like this government the senate yeah like they have a secure room with all these lock boxes and things like that only he can access for the defense committee um and they break into it to figure out what’s going on and you’re sitting there and you’re like oh my god i can’t believe the cia did this like because like who’s who’s walking who like you know who’s the [ __ ] because it’s really the dog walking the congress like you don’t know it’s it’s much less clear like who actually has the power here um and just just blows my mind and there’s all kinds of other weird things like uh you know cynic the cia so during these interrogations waterboarding and you know they use like these really like they found these like wacky psychologists um that just came up with these methods for extracting information you know like all these torture methods and like it wasn’t based in science at all and it was really and i think the big big takeaway was like cia wanted to signal that they’re tough on this like you know we’re not going to let this happen again you know what i mean we are we’ll do anything so we’re going to waterboard some waterboards so they couldn’t get physicians to monitor it because you know they’ve got they took this out so you know who they got who uh physicians assistants

i feel like physicians assistants even if they’re not actually doing surgery are still like i’m not going to torture this dude like yeah i’ve met some people who are physicians assistants they don’t seem like the torture and type i know but i gotta say but maybe uh you must have paid them a lot or something i i don’t know and they were paying these contractors probably if you have a person you think would probably torture people for you you could just buy them a physician’s assistance license like it’s like two years of schooling yeah i think probably that’s how that went down i don’t know but long story short like just all this crazy stuff happened and you’re like my point being though is like these these organizations you know they have a lot of power and sometimes things can get like really weird and out of hand yeah i mean if they don’t have any oversight if they don’t have the oversight and i don’t tend to think and even they have oversight you know uh they have a lot of latitude to kind of do what they want mm-hmm because most of it’s secret right i guess most of it’s top secret and the other people that really know about it are like dianne feinstein yeah things like that you know people like that um just super bizarre to me yeah it reminds me of the cuban missile crisis and so these i guess the cubans are in the nuclear missile sub and the broadcast goes out okay so like okay there’s been a nuclear attack we have to launch the nuclear missiles and one commander was able to stop them from launching the nuclear missiles like not like an elective official just like one guy who happened to be there and that’s why we didn’t have nuclear war oh wow yeah that’s crazy that’s crazy you get things get really close um and the world just goes along is what’s really amazing to me like here we still are yeah exactly right cool so is uh anything else that the listener should know about the fda well i’d like to talk about sort of the downsides of my blog maybe i don’t want to scare people off modern medicine

i went off modern medicine because of the things i talk about like modern medicine isn’t great but it’s the best we have and it’s way better than any like homeopathy even if sometimes you end up with cockroaches next to your sterile eye injections and then people go blind you know oh god does that really happen that really happened it was not a great time for the compounding industry or the fda wait what how did how did that happen how do people end up going blind so basically if you’re a compounding pharmacy you take like a bulk drug substance that’s just the active ingredient and you mix it with other things those are called the excipients and they’re like everything else in a drug that holds it together and it makes it easier to mix so if you have like a gel capsule the gel capsule is an excipient and inside it is advil the active ingredient which is acetaminophen in like a solution so if you can’t if for instance you’re lactose intolerant they can recom they can compound a drug for you that doesn’t have lactose in it or gelatin if you’re like gelatin intolerant okay yeah so they have a lot looser regulations because they don’t have to abide by good manufacturing processes so because they’re only making it for one person and it’s super expensive to do good manufacturing so they have a lot so they don’t get audited to the same standards by the fda so people started going blind from these eye injections and the fda comes along and they find that all of these injections are coming from this pharmacy called frank’s pharmacy and they go and they audit the pharmacy and in the light bulb above the sterile area they find dead cockroaches and i’m like that’s not a good time for anyone right exactly right like so so it wasn’t directly related to the cockroaches they were just doing something wrong yeah it was just the cockroaches were bringing in this bacteria and then the bacteria was getting into the sterile drugs right they were able to match to the species the bacteria in the drugs to the bacteria in the patient’s eye which is like the most specific you can get by genetic typing for bacteria and it’s pretty much a smoking gun for any lawsuit those patients want to go through with that’s super amazing right it’s crazy oh my god that’s nuts so so in other words like you know your blog which is super awesome and we’ll put the link up here it’s really cool um super informative and very witty and and fun and you know me mondays every monday exactly if you’re kind of like what does tyler count saying if for infowar like us you’ll really enjoy reading about it it’s just like super cool um this whole world you’ve never heard about yeah i think it’s a good point so i i think the takeaway i think you’re trying to get across is that yes like uh you know there’s all these crazy things that happen but you know it somehow it ends up pretty well like i still would take a flu shot or a sterile injection even knowing what i know right because one i think the big point is like we catch them here yeah like we actually you know it would be more scary if the cockroaches were there forever and nobody ever mentions exactly that’s very interesting very interesting so quality control in the fda i think we’ve learned quite a bit is there anything else that the layperson i think would not understand that you do that is important so i don’t think generics like nobody in my lab takes generics my boss won’t take generics i will take name brand medications and i don’t want to say that to people because they’re so much cheaper and name brand medications that have copyrights on them are sort of a reason for the rising cost of health care but i won’t take them like i don’t know who generic um company number four is i don’t know their quality control practices but i do know that the company i work for whatever company name has really great com quality control practices and a really strong culture of quality which prevents sort of a lot of what we’re talking about so i’m going to take that i’m going to pay the money and i’m not going to take the generics no way so interesting so um so name brand drugs by the big pharmaceutical companies are actually you think it’s actually worth showing up shelling out for them i can’t claim that even though i’m anonymous but i do because generic companies they spent one year perfecting their manufacturing processes maybe these name brands that have developed it and then spent years and years and years perfecting their manufacturing processes and seeing where the problems happen and then fixing them that’s a lot more reassuring to me than the generic company who kicked up six months ago because the copyright ran out is now making this that is super interesting right it’s not the safety it’s not the effect efficacy of the drug which has been proved through clinical trials it’s how they’re manufacturing it that they can be a different thing yeah wow that’s super amazing well well that i think that’s that’s wow something to consider yeah yeah and so well and that that is a sign if everyone in your lab does not take generic drugs yeah well again we get paid real well so that’s probably also a fact exactly like if it’s generic insulin or no insulin just take the insulin yeah absolutely but yeah gotcha but if you if you do have that extra something to think about yeah awesome well like a tail risk for sure terrorist but still it scares me in the face every day yeah exactly it does i’m sure it dominates lots of you yeah very cool well thank you mr ed for coming on and thanks for having me we’ll have put the blog up and go check it out it’s what’s the url again it’s warninglighters.wordpress.com man we got to get you we’ll get rid of you gotta give me a org yeah don’t worry we’ll redirect it’ll be great okay awesome thanks thanks

well that’s our show for today i’m will jarvis and i’m will’s dad join us next week for more narratives foreign you

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