Cross examiner podcast tackles rationality versus religion in the case of Internet courtroom

>> Speaker A: For my second season, I was going to start with a joke about homeopathy, but it just didn’t work.

>> Speaker B: Welcome to the Cross examiner podcast, the Internets courtroom in the case of rationality versus religion. Here, our host, huh? Uses his experience as both an attorney and an atheist to put religion on trial. We solemnly swear that it is the most informative, educational, and entertaining jury duty you will ever do. And now it’s time for the cross examiner.

Welcome to the cross examiner podcast. I apologize for the hiatus

>> Speaker A: Welcome, welcome. Welcome to the cross examiner podcast. I am the cross examiner. I am an attorney. I am an atheist, and I am alarmed. I’m most alarmed about the rise of christian nationalism in the United States and around the world, and even more importantly, the mountains of misinformation that are powering that rise. This is the beginning of season two. I’ve taken a hiatus. I’ve got a lot going on in my life. I’ve got a son that’s going into college next year. I’ve got a younger son who’s transitioned into high school as a child on the spectrum. lots of things at work. I still have a full time job. I do this free with no money or financing or anything like that. So, I apologize for the hiatus. I’m eager to get back into things, and today we’re going to be talking about common ground again. My first episode ever, I entitled Common Ground in an attempt to address a subject that I think we can all agree on, regardless of our religious beliefs, our political beliefs, anything like that. And that was the story about the McDonald’s hot coffee case. Well, today I’m going to be covering a subject that’s near and dear to my heart, and that is alternative medicine, specifically homeopathy, but generally alternative medicine. My background in the law is I practiced for many years, FDA regulatory law. It’s kind of dry. It’s administrative law, and it’s all about food safety, drug safety, medical device, cosmetics, all of those sorts of things that FDA regulates, which is much more than most people realize. But in doing so, I learned a lot about alternative medicine and what the practitioners of alternative medicine will do to try to ride the line of the laws to make themselves look as much like legit medicine as possible without crossing a legal line into breaking the law.

Francis Oldham Kelsey helped create FDA regulation of food in 1935

But today, I wanted to start with a story, and I think it’s a story that people will find interesting, and I’ve not heard the story told very often, and the story starts with a mistake. The year was 1935, and a researcher named EMK Geiling was contacted by a young academic. That academic’s name was Francis Oldham, Kelsey. They reached out to Doctor Geiling and presented their credentials and asked if they needed a research assistant. Their credentials of Francis’s credentials were impressive. They graduated from high school at the age of 15. They attended Victoria College, which is now the University of Victoria, and then enrolled in McGill University, where they received both a bachelor’s of science in 1934 and completed their master’s of science in 1935. So by the age of, let’s see, 35. By the age of 20, they had a master’s in pharmacology. So doctor Geiling received Francis’s communication saying, hey, I’ve got all of these credentials. I’d love to come work with you. And here’s where the mistake comes in. Guiling said, yes. Francis shows up. And due to guiling not understanding the difference between Francis, spelled f r a n c e s versus f r a n c I s, he didn’t realize that Francis was a woman. So he hired a woman that he probably would not have hired back then. 19, 35, 20 year old master’s degree holding woman who was the top of every class she was in. But unfazed, he took her on. The story I’d like to tell is really about Frances Oldham Kelsey. She does a couple of things in her career that you may have never heard of that have saved lives, lots of lives, and saved, many, many people from, suffering birth defects. So to understand her impact, we need to go back and talk about what the state was of United States regulation of drugs in the 1930s. And to understand that, we need to jump further back to understand what it was like in 1906. And I’ll tell you why. 1906 is sort of the beginning of the modern regulatory, scheme that the United States has put in place for medicine, for drugs. Before 1906, there was pretty much no regulation. The only regulation, so to speak, would be what’s called tort, where you sue people, right? You sold me this thing and told me that it would cure my lumbago. and it didn’t. So I’m going to sue you for, false advertising or fraud or whatever there was available. But there was no government agency that was regulating the drugs before it got onto the market or even after it got onto the market. The major milestone here has nothing to do actually with drugs. It has to do with food. And that’s the publication of a book called the Jungle by Upton Sinclair, which described the meatpacking industry at the time. If you haven’t read it, I highly recommend you do. It describes disgusting practices that were going on, completely unsanitary, completely fraudulent fillers that weren’t meat flies in the packing area, disease being spread all over the place, and it shocked the country and the world. In one of the first cases of underground guerrilla journalism, Upton Sinclair spent seven weeks working undercover, incognito, so to speak, in meatpacking plants in Chicago stockyards. The book’s focus was actually on working conditions. It depicted poverty, horrible working conditions, horrible living conditions, no social support for people. This was before Social Security and any sort of safety nets. And it contrasted it with, keep in mind, early 19 hundreds, just before the big depression. So you understand what the wealthiest class, the upper class of America, was doing at the time. In fact, Jack London, who reviewed it, called it the Uncle Tom’s cabin of wage slavery. That was the focus when he described the meat industry. It impacted more in my mind, and from what I can tell, it impacted more the public’s perception over the health violations and sanitation violations than it did about, you know, class inequality. And, that led to many reforms, one of which was the meat inspection act. But the big impact was the passage of the 1906 Pure Food and Drugs act. This was the very first time that the United States did anything on a federal level to regulate food and drugs in a serious way. It was a monumental shift in the use of government powers to protect consumers. It created the first version of the FDA. It required that food and drugs bear truthful labeling statements and meet certain standards of purity and strength. Can’t be adulterated, basically, is the modern terms. So that was the cornerstone. That was the cornerstone that created the. The m. Social awareness, the legal structure, the framework, so to speak, and the scientific thrust to focus on food and drugs. From a scientific standpoint, however, it had a tremendous amount of shortcomings. It limited the agency’s ability to protect consumers because it didn’t offer any way to remove inherently dangerous drugs from the market prior to marketing or even after marketing. So they. They couldn’t do anything prior to marketing pretty much at all. And after marketing, their only cause of action, their only way that they could remove something from the market, is for something called misbranding. This is a labeling issue. You called this aspirin. but it’s not really aspirin. It’s something else. It might still do the job, right? It might be like tylenol, if you call it aspirin. It’s not aspirin. It’s mislabeled. We’re going to pull it off the shelves. But if you label it correctly. Hey, this stuff is a, cough syrup, but it contains the following ingredients, which might kill you. And you have the ingredients on your label. It’s, not misbranded so they, people could sell it. And that was a. Seem to be a real problem, but nothing else significant happened for decades. Keep in mind, as I said, this is the great, depression. And then we have FDR’s, new deal. A new deal plays an inherent part in this, and it really should really speak to why there is a significant impact that government can have on people’s lives. Even if you’re not worried about did Trump swim with a porn star or what we’re doing in Ukraine, or all that sort of stuff. So the new Deal was in the early thirties to mid thirties, 33 to 38. And what it was is a package of work projects, financial acts and regulations and creations. Importantly for this story of federal agencies, there was a massive objection to this, mostly by conservatives. The argument went as follows. You’re here creating all of these agencies, the civilian Conservation Corps, the Works Progress Administration, the Civil Works Administration, the Farm Security Administration, the National Industrial Recovery act. The Social Security Administration comes along right here. These are all administrations. And we know today what administrations do. They create regulations, right? Are regulations, laws? Well, they’re rules. They tell you what you can and can’t do, and they say, hey, if you do this, you’re going to be penalized. If you don’t do this, you’re going to be penalized. Those sound a lot like laws. And the argument the conservatives made were constitutional in nature. They say, hey, Congress has delegated their rulemaking authority to the executive branch. Congress is passing these laws to say, hey, go create this Social Security administration. And it’s going to create a bunch of rules about how people are taxed and how these things get distributed and all of that.

The conservatives point out, rulemaking is reserved under the Constitution to Congress

The conservatives point out, rulemaking is reserved under the Constitution to Congress. This is what’s known as the non delegation doctrine. It basically says, you can’t, one branch of the government can’t delegate its rule, its role and responsibility to another branch of the government. It can actually be traced back. This doctrine, this non delegation doctrine, can be traced back to John Locke. He wrote about it in 1690, saying, quote, the legislative cannot transfer the power of making laws to any other hands for it being but a delegated power from the people. They who have it cannot pass it over to others. And this thinking, this philosophy, held sway, around the world. This was not just John Locke writing for the United States back in 1690, right? This was philosophy of democracy, sort of 101. We need to clearly define when we, the people, are going to surrender authority to someone or something like Congress and then have very, very clear rules as to what we all agreed to. And the argument is we all agreed that this group that we get to vote for gets to make the rules, and then we will obey them. And if that group says, well, we won’t make the rules, we’ll let the executive do it. All of a sudden, that’s a betrayal of the deal. That’s a betrayal of the deal. But a few things happened between 1690 and 1935 or so, and they are the following. First, we had two industrial revolutions. We had the first industrial revolution in the mid 1840s ish starts, the industrial revolution where, society starts getting more complicated. Pre industrial revolution life is pretty simple. You were a farmer, you were a merchant or you were a, banker or a lawyer or some sort of professional. There was no factory worker. There were no mass produced products. People didn’t live in giant cities the way we do now. Like we had big cities. London, obviously, is a great example. But there was not this skyscraper effect, and there was not mass communication, per se. And, the industrial revolution started to change that. We got more efficient. We could produce more goods more quickly. And then there was a second, what they call the second industrial revolution, which is at the end of the 18 hundreds. And that’s where we start seeing factories mass production, and we start seeing technology increase. And we start giving workers the keys to devices that could cause a lot of damage. Right before industrial revolution, a worker might accidentally release or stampede a, herd of cows or horses. And that could cause a lot of damage. But after the industrial revolution, a single blue collar train engineer could derail a train and spill chemicals and destroy a, small town that was surrounding a particular train track. It was like nothing we’d seen before. So we have that. We have a change in the way that we need to think of the world and to structure how the rules are made. Because pre one, thousand 935, pre administration era, where we are able to delegate authority to agencies, we don’t have as many rules. Congress can’t sit here and make, rules about sunscreen and about sunflower, seeds and about, the cosmetics on your face to try to protect you. They don’t have enough manpower. They don’t have enough time. But we were getting more products. We were getting more people. The products were being mass consumed and mass produced. And we were building trains. We were building skyscrapers. Now, we were creating the ability to do massive amount of damage. So it became more important that we come up with a way that we can create these rules, these regulations, to react to problems that are encountered for the first time. You know the old saying that regulations are written in blood? Well, that’s what happens. We realize that trains can blow up if you don’t maintain the proper boiler pressure, right? so we need to create regulations saying, hey, every train needs to be inspected to make sure its integrity is okay, that the people are licensed to operate, all these sorts of things that we try to do to save lives. So that’s the first piece of the puzzle as to why there was a shift away from this non delegation doctrine. The other big thing that’s happening is the Great Depression. The landmark moment where the Great Depression begins is the 24 October 1929 known as Black Thursday, where the Wall street stock market crashed and the whole world was plunged into financial chaos. Massive unemployment, massive halt to productivity, and it lasted a decade, at least from 1929 to 1939. So here we are with these two forces. The world’s getting more dangerous from, amount of damage that companies can do by, harming people from accidents and producing harmful products. And we have the Great Depression. A couple of major developments that change the way that people look at people in power, and not people elected officials, but people with money and the ability to produce goods and provide financial services, those sorts of things. And it becomes very apparent that the old way of doing things is not going to work anymore. Congress does not have time or the resources to tax and create a bunch of federal agencies and create laws and vote on the laws. Keep in mind that if Congress were to regulate, if Congress ran the FDA, let’s say, for example, every new drug application would have to be reviewed by a committee of Congress, probably their experts, right? The FDA would just sit under Congress, but then any action they wanted to take would have to be brought to the floor of Congress, passed in the House, passed in the Senate, and signed by the president, all of which are subject to a, massive amount of industry capture. M see, for example, the modern NRA, preventing any significant gun legislation for basically my lifetime, right? They capture politicians and prevent actual effective policies from being introduced because the people voting on it are not the experts. It’s also subject to politics in the sense of the, people voting for the politicians are ignorant in a healthy sense. They aren’t the experts on food safety, they aren’t the experts on cosmetic, adulteration. They’re not the experts on medical devices. But any particular industry could create an advertising campaign criticizing a politician for voting for a regulation by providing misinformation to the public. So there’s a lot of problems that we run into if we try to fix all of these issues that come up. The Great Depression really solidifies that, and the supreme court starts shifting their views. Pre 1935. The non delegation held the day after 1935. During the New Deal period, everybody realizes we are way too vulnerable to giving all of the power to these tycoons, the wealthy, who will do whatever it takes to just make profit with no regulation. And it was at that exact moment in history when Francis Oldham Kelsey, the young pharmacology researcher, makes a major impact that inspires, in part, in a large part, the creation of the modern FDA. To demonstrate how she was involved here, I would like to read a story. This is a newspaper story from my home state, Maryland. The paper that published it is the Washington Post, and this is dated October 23, 1937. I will put copies of this story. you only have images. They don’t have it on their website. You have to go to archives to get it. But I will put copies of the story up at my website@thecrossexaminer.net. If you want to see the full story, I’ll read selective, paragraphs. So here we go.

Death toll from Maryland use of deadly elixir now stands at 29

The title of this story is seizure of deadly elixir saves Marylander as us hastens to check toll already at 29. This is by Gerald G. Gross, GG, in the post. As I said, death in Salisbury, Maryland, from use of the drug elixir of sulfanilamide was narrowly averted yesterday while airplanes and chemists hastily drafted into service failed to save nine lives in other parts of the nation, 29 deaths in the nation were recorded here last night. Although the American Medical association in Chicago reported a total of 30, with seven other mortalities yet to be verified, Doctor Morris Fishbein, editor of the AMA Journal, said there is no known antidote for the poison, and symptomatic treatment is all that can be given. Scores are seriously ill. Seizures of the deadly potion, whose manufacture has been stopped, have been made from San Francisco to New York, from Detroit to San Juan M. After two one pint bottles were confiscated at a Salisbury drug store yesterday, investigators checking prescription lists discovered that a two ounce vial had been sold to a resident there. Rushing to his home, they found it in a medicine cabinet. Fortunately, only half a teaspoon had been consumed. Had the seizure been made a day later, with the patient following the prescribed dosage. In the meantime, another life might have been taken, officials declared. That’s the, first four or five paragraphs. So this is what was called the sulfomilinide disaster. The history here is that sulfamilanide was a drug that was used to treat streptococcal infection, and it had been shown to have dramatic curative effects and had been used safely for quite some time. In 1937, however, a salesman for the Massengill company, this was in Bristol, Tennessee, he came in and reported that there was increased demand in the southern states for the drug to be made available in a liquid form. To date, it had only been used in tablet or powder form. So the company’s chief chemist experimented and found that, sulfanilamide, it’s hard to say, would dissolve in diethylene glycol, a substance that he thought would be great to use, because it dissolved easily and it stayed suspended. Here’s the problem, though. It is the one of the ingredients you may recognize from antifreeze. And if you know anything about antifreeze, it’s a deadly poison. He didn’t know that, though. We didn’t have this testing regime or a knowledge base to understand that this was actually bad for humans. So the company tested it for flavor, appearance, fragrance. All of that was found to be great. They loved it. And this is exactly what the market demanded. So they created immediately. They compounded 633 shipments, worth of this elixir all over the country, and again tested it for everything except toxicity. And at the time, this is, you know, the 1906 Food and Drug act is what’s in effect at the time. Gave nobody any power to require people to test for toxicity. It was bad for business to sell toxic drugs, but it wasn’t illegal, because the non delegation doctrine said you can’t create agencies to make these rules. And Congress doesn’t have rules to make all. It doesn’t have time to make all of these rules about, safety, about every aspect of human life. And so capitalism wins. The market wants something. We’re going to put a product out there and see if people like it. So the AMA, American Medical association, not the FDA at that time. Again, American Medical association, private entity, the Food and Drug Administration existed, but only under the 1906 act and was basically powerless, to do anything. Problem, right? Nothing about marketing, nothing about testing. The AMA received notifications on October 11 of several deaths caused by the medication in Tulsa, Oklahoma. They notified the Food and Drug Administration, who reached out to Massengill and got the composition of the chemical. They got samples and retained the services of a lab run by doctor Geiling to research. What’s going on here? Doctor Geiling asked our hero, Frances, Frances Oldham, to research this, and she very quickly isolated the toxic ingredient and reported this back to Guiling, who reported it to the FDA. As you heard in the newspaper story, people got onto planes and flew across the country with this new information that she had proven that this was a toxic substance in this drug that was being prescribed in good faith by doctors. This chemical compound had been prescribed for a long time. This was just, a new composition of it in this liquid form. They flew everywhere around the country and probably saved hundreds, if not thousands of lives. 107 people did die, at least that we know of, of, this bad composition. But she, Frances Oldham, saved thousands of lives as a lab researcher under Doctor Geiling, who was contracted by the FDA because they didn’t have all their own labs and all of that sort of stuff. So this made headlines everywhere. You saw them in the Washington Post story. This is in 1937. Yes, yes, 1937. By that time, people had already realized, right, that the old act, the 1906 act, was insufficient and that things had to get going. And they’d already come to an agreement of what the structure would be. Because we’re two years post 1935, coming out of the Great Depression, we’re realizing that the non delegation doctrine is not going to work for a modern technological society. And we have, deals in Congress already to create a new FDA. But it’s stalled. Nobody wants to move it forward. A lot of the details have been ironed out. The courts are ready, as I said. Then this happens. Then Francis proves. Francis Oldham proves that there was nothing the FDA could do. This was a. Ah. Labeled correctly, went out, toxic, would kill people. Doctors prescribed it, caused 107 deaths, and there was nothing the FDA could have done at that point to prevent it. The very, very next year, 1938, the new Food and Drug and Cosmetic act is passed. It’s called the Food, Drug and Cosmetic act of 1938, due in large part to Francis Oldham’s work. And that’s where we get the modern FDA with the power to say, you don’t get to market a thing as a drug unless you submit a new drug application. You submit all of this evidence. We do our own testing if necessary. We have scientists review everything to make sure that it is not only safe. That was the big concern, right? We just killed 107 people because some sales guy said, hey, I want to sell it in a liquid form. A company says, sure, mix it in this thing that dissolves it really easily and sell it, and then we kill 107 people. So not only must it be safe, but importantly, it must also be effective. That’s the language in the FDA. See the federal Food, Drug and Cosmetic act of 1938. A drug must be proven to be safe and effective for the claims made on its label before you’re going to be allowed to market it. And it created a whole agency to enforce this, including law enforcement capabilities. There are agents to this day, gun toting police officers that work for the FDA to enforce this stuff, to go find warehouses where people are storing bad things, drugs that are mislabeled, drugs that are toxic. But it was Frances Oldham who did the legwork to prove what was going on here. And she saved lives and basically gave the final push for the modern FDA to take place.

Market pressure forces companies to take huge risks, just like in this case

So I’m looking at the clock. I’m a half an hour through my episode. I haven’t even gotten to homeopathy. But I do want to celebrate Frances Oldham in one other way and tell one other story. And this is probably going to turn into a two parter. I’m guessing the next major thing that she did is a whole other story. I’ll try to make it a lot shorter, but I really want to celebrate her because it demonstrates what the point of this episode is. And that is there is market pressure in a capitalist society, in a democratic society, where the rules are made, a lot of times by popular vote, there is a pressure to take huge risks, just like we saw in this case, right? We took a big risk of mixing this thing in an a substance we weren’t really that familiar with. Its only property we cared about it is that it dissolves this chemical really easily. And then, we killed a bunch of people. That pressure exists throughout history where there is money to be made, where there’s power to be had. There’s a pressure to sweep that risk under the rug, right? There’s this motivation to sweep it under the rug, I should say. And it takes massive oversight to save lives. And one could argue, like the conservatives still do to this day, that, oh, you know, the market will take care of it. That if you become known as a reckless marketer of toxic drugs, you’re going to go out of business and you will be subject to lawsuit. Individual victims can sue you. Hundred and seven people that died, their families could sue the drug manufacturer. But you know what happens, right? The drug manufacturer has been granted this protection by the state called incorporation. That’s their protection. So when I sue them, I sue the company, but I don’t sue the individuals that were doing it because they were working for the company. Now, you can sue the individuals. You could sue that chemist who did the mixture and say you were unreasonably lackadaisical in your testing. You should have tested for toxicity, so you were negligent. You could sue that individual, but most likely the company will have indemnified them, and you’re going to have a lot of defenses to that. And the money? The money is with the company, then the money’s not with the chemist. He’s making good money, I’m sure. But 107 people, states, are not going to be made whole by suing an individual chemist. But when you sue the company, you don’t get to any of the assets of the underlying employees. You just get the assets of the company. And what does a company like that do? They shift their assets around. They may declare bankruptcy. Right? They won’t pay off everybody. And then those people will go off and go work for other companies or start up a new organization somewhere else. They’re never held personally responsible. And we like that as a society to some degree, because it. By giving people protection to say, hey, if you guys mess up while you’re running your company, you’re not going to lose your house, you’re not going to, you know, your kids aren’t going to starve because you can’t be sued personally, we’re just going to sue the company that encourages, innovation, that encourages people to go out and create companies small and big. Like, I have an LLC for this podcast, and if I ever get sued for something on this, the podcast has, a shell around it that I’m hope, hopefully personally, will not get sued. And it encourages that, and we like that. But there’s a dark side to it, which is it also absolves, to some degree, people of the consequences of taking unacceptable risk. So if we can’t get it on the back end, if we can’t control companies behaviors by punishing them on the back end, we as a society have to create regulations up front to try to stem the tide of bad motivations. And that’s the culture coming out of the Great Depression. Again, what was that? A bunch of people in corporations isolating themselves personally from liability and causing a massive amount of loss of income to, the whole country. Right? So we now have said as a society, we are going to put all these rules into place, and we are going to inspect, it’s kind of a trust but verify type of system. We’re not going to inspect every single pill that goes onto the market. You’re going to report to us what you’re doing under some penalties of perjury, under a lot of different things, and then when you mess up, we’re going to get you and we will do random inspections and those sorts of things up front. So that’s all tied up in one big ball. Great Depression, industrial revolution, sulfonilamide, all of it. And that brings about the FDA. But she wasn’t done, as I said. So she went on to get her PhD and then joined University of Chicago faculty. And in 1942, she learned she was looking for a synthetic cure for malaria. Malaria kills. To this day, mosquitoes are the deadliest animals on the planet to humans. They kill more humans by orders of magnitude than any other animal on the planet. And she was looking for a synthetic cure to malaria, like many people were at the time. But as a result of those studies, she learned something. She learned that drugs, some drugs are able to pass through the placental barrier. When a mother’s, pregnant, she’s, got a place placental barrier between her and the baby. She learned that drugs can leak through. She went on to get her md, she got married. She ended up being an, associate editor for the AMA journal for a couple of years. And then in 1960, she was hired by the FDA in Washington, DC. At that time, she was one of only seven full time physicians reviewing drugs for the FDA. This is 1960, right? This is 23 years after the new FDA was created, 22 years after the new FDA is created. And they have only seven full time physicians and a few part time physicians reviewing drugs. One of her first assignments was to review a new drug application. This is under the new FDA regime for a drug called Kevadon. It’s a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Now, Kavadon had already been approved by Canada and more than 20 european and african countries. And so it was viewed as, oh, this thing is just going to sail on through. Let’s, let’s give it to this new doctor that’s reviewing for us. But she withheld approval. She requested further studies. She had read studies, at least one study in the british medical journal that showed possible neurological symptoms associated with the use of Kevadon. She also requested data showing that the drug was not harmful to fetuses because she, she had that past experience. There was tremendous pressure from the drugs manufacturer, with the german company, I believe, to get approval. But she stuck to her guns. This young, relatively young, this young doctor new to her position said, nope, there’s enough evidence here of a problem that I want your data and I want you to fully test this for safety and fetuses. I want you to test this for other issues. Now, you may not know the end result that the drug named Kevadon, was not allowed to be marketed in the United States, but you may recognize it by its more technical name, and that is thalidomide. Thalidomide was shown to cause birth defects in babies. If you took this drug while you were pregnant, and she was vindicated with her skepticism, she was vindicated for her research. She saved countless people from being born with birth defects. Typically, you don’t have any arms. You may just have a hand on your shoulder or a small limb sticking out. Thousands of children were born this way in Europe, and it took a long time for them to figure out what was going on. The headline in the Washington Post when this came out, this was in July 15, of 1962.

Francis Kelsey helped create the modern FDA drug regulatory system

By the time they realized what was going on, two years or more, I mean, two years after they applied, for approval in the United States, long after they had been selling this drug in other parts of the world, the headline in the United States on the front page was, heroin of FDA keeps bad drug off of market. Celebrated. She averted a tragedy. The author said, quote, she prevented the births of hundreds or indeed thousands of armless and legless children. She was very humble. She insisted that her assistants as well as her FDA superiors, who backed her stance, deserved credit as well. And yet again, she caused change because the public had a huge outcry after that story came out. There was something called the Harris Amendment, I think it was called, was passed unanimously by Congress in 1962. As a reaction to her work to strengthen drug regulation, companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical trials, none of which were in the original or, the 1938 act. So now companies had to demonstrate efficacy. They didn’t just have to be reviewed for efficacy, they were. The burden was now on the companies to do the tests ahead of time. The adverse reactions segment of that is still a major way that we save lives today, that you can’t sweep adverse reactions under the table. There are people who are identified as people who need to report adverse reactions, doctors and nurses and all of that sort of stuff. But the companies as well, everything has to have a serial number on it so we can trace and say, this person took this drug, this serial number from this batch, and had some sort of adverse reaction. I need to report that to a central database so that if we start to see a pattern, we can start pulling things from the shelves, just like we did back in 1937 with the. The antifreeze. Right? So yet again, here she is, making change for the better in the United States. This one woman sticking to her guns. As a result of her blocking the approval, she was awarded the President’s award for distinguished federal civilian service by John F. Kennedy in August of 1962. She was the second woman ever honored that way. After receiving her award, she continued to work at the FDA. She played a, key role in shaping and enforcing the 1962 amendments that I just talked about. And she became responsible for directing all the surveillance of drug testing at the FDA. And she retired in 2005 at the age of 90 years old, after serving with the FDA for 46 years. In 2010, the FDA named the Kelsey Award. That was her married name, Kelsey Award, for her to be awarded annually to an FDA employee for, quote, excellence and courage in protecting public health. And that is her legacy. Frances Oldham Kelsey, nobody you’ve ever heard about, most likely in your life, basically responsible for the modern FDA drug regulatory scheme. Now, why is this important? Why have I spent 40 minutes or so talking about her? not only is she a personal hero of mine, but this story demonstrates one little piece of the big puzzle that we call the scientific method. One little piece of what we call fact based regulation. Science based regulation. One little piece of the puzzle as to why things like homeopathy and acupuncture and crystals should be criticized, should be attacked, should be viewed with. With skepticism. Because when lives matter, we trust the FDA. We trust experts like Francis Kelsey. We trust these people with our lives because they’ve spent their entire lives researching a, topic, pharmacology, specifically pharmacology, with respect to infants, with respect to safety, things like that. They spend their entire lives doing this. They save lives again and again and again. And in our modern world, with the misinformation that goes around the Internet, they’re attacked. They spend 40 years doing something like this. And if she were around today and posting on the Internet, hey, I did this and that, another thing, she died, by the way, in 2015. She was 101. but if she were around today posting on the Internet, hey, this is how this drug works. Or this is why homeopathy doesn’t work. You’d have, ah, 100 people telling her she’s an idiot that doesn’t know what she’s talking about. That’s where crystals and homeopathy and acupuncture, all of that come from, and if it were just a waste of time, a laugh, that, oh, it’s homeopathy. That’s idiotic. It’s just water. What do we care? I wouldn’t be doing these episodes, right. I wouldn’t be talking about this. But I think we can all agree, and this is where I want to find the common ground here. I think we can all agree that we have demonstrated through her story that when you have unregulated manufacturing practices, when you have unregulated marketing, when you have non experts being responsible for the composition of substances that you are marketing for people to put in their bodies, when you have ignorance on the side of the consumers, and when you have sort of this woo element added into this mix, this faithful, mystical, religious element, as you will see when we talk about, homeopathy and other things, it’s a recipe for disaster. To summarize, the FDA’s mission with respect to drugs, it is to make sure that they are safe and effective. And both of those matter. We’ve talked about stories about safety, right? The sulfonylamide, the thalidomide, those things. That’s. The drug isn’t safe. But what about the other end? Why does FDA say it must be safe and effective? Well, that’s where we, we come into the other areas where we can run into disasters. And I think we can all agree, no matter what, if we’re, if we’re conservative, liberal, male, female, old, young, whatever we may be, that in today’s world, where any fool can put together a website that says that they’re a company that has insurance and looks respectable and has stock photos of doctors in white coats that are just actors on their front page and is selling a product to help cure your foot pain, that they run the risk of killing a lot of people and may never get caught, may never be punished, may never be held liable, may never make the families or estates of those dead people whole, that we want to regulate that behavior in a reasonable way so that the good stuff can get to market, but the bad stuff, as much as possible, is kept off the market. I think we can all agree on that. I think this plus many other stories demonstrates that money corrupts. And when there’s a buck to be made, there will be snake oil salesmen at every corner. So I’m going to end this episode here. We’ll dive in next episode with the actual, you know, background history of homeopathy and what the FDA is doing about it right now. Hint, not very much. but I hope you’ve enjoyed this story. I really enjoyed making it. I went through, as you heard, maybe on my trailers for this season, I’ve recorded an episode of this. I have gotten a new computer, and I was. I somehow corrupted the recording, and I was able to use it. So I decided to come back and I added a little bit. It was originally just about homeopathy, but I decided I really like human stories. I think they tell something. So I did a little more research on Frances Kelsey because I had known generally what she had done. But the more I read about what she had done and what her life was like, the more I realized I need to tell her story as the introduction. So consider this your introduction to why we need drug regulation and food and cosmetics and other things as well, but generally, why regulation is good and can save lives. Because under any other system where we let the market handle it, thousands if not tens of thousands or hundreds of thousands of kids, borns without arms and legs, thousands of people dead every year to contaminated and corrupted products because the market solution is too slow and the people running the companies are too unlikely to be personally punished for any of those problems. So this is a great solution. So, as I said, I had to re record this. I did it without a script, pausing now and then to look up, things I forgot. So I apologize for any sort of stuttering or ums or AHs there, but I really wanted to get back into the saddle. I’m excited for this season.

Next episode will focus on creationism in schools and legal issues

I’m going to be. I’m going to be talking about homeopathy as sort of the common ground episode for the first few episodes, and then I’m going to be moving into, creationism in schools. We’re going to be reviewing the, Dover versus Kitzmiller case in depth to understand the lengths to which evangelical Christians in the United States will lie to not only you, not only to school systems, but try to lie to courts to sneak their religion into schools. So next episode, we’ll follow up on more of the homeopathy, and then after that, we’ll get into more of the legal issues. Oh, and I forgot to mention, in my next episode, please tune in to watch me ingest 480 pain relief pills in one sitting, and we’re going to see what happens. Until then, please stay safe. I look forward to talking to you again.

>> Speaker B: This has been the cross examiner podcast, the Internet’s courtroom in the case of rationality versus religion. If you enjoyed this podcast, please consider subscribing.

>> Speaker A: See you soon.