How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong.
To learn more about the FDA's history check out these sites:
www.fda.gov/history
How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong.
To learn more about the FDA's history check out these sites:
www.fda.gov/history
Hi, I'm Aaron Harmon.
Unknown:And I'm Diane Cox Welcome to Insight out quality.
Aaron Harmon:both Dan and I build and implement quality systems in the biotech and medical device industry. But we often get asked, Is this really necessary? Do we know if we are doing too much too early? Or do we even need a quality system?
Unknown:Our goal is to explore questions like these through real life events and experiences shared by our guests from various regulated industries. We will show you why quality is not just about compliance and how when it's done right, it can help your product and company improve lives and make a difference.
Aaron Harmon:You may not know this, but there was a time in the US when medicines weren't regulated at all. The first law is simply required that the USP be followed. And the USP means United States Pharmacopoeia, which is a set of standardized methods for producing medicines. You can sell a drug in the US without needing any type of approval at that time. In 1938, that all changed. It changed because one drug disaster push lawmakers enough to finally pass laws to prevent it from ever happening again. That drug is elixir sulfanilamide. This is a story every American should know why? Because it tells why we regulate medicine. It tells how a drug meant to heal can kill. It's a story of morality, science and business. I don't feel qualified to tell the story myself. Anyways, the story belongs to the FDA to tell. I contacted the FDA and they connected me with Dr. Vanessa burls, a historian for the FDA, and someone that shares a passion for events. Welcome to the show, Dr. Burrows.
Vanessa Burrows:Thanks for having me, Aaron.
Aaron Harmon:So right away before we kind of dive in to give listeners a little bit of background, like how did you end up working for the FDA? Well,
Vanessa Burrows:I did a PhD in the history of medicine and public health at the City University of New York's Graduate Center. And my coursework, and my dissertation focused on issues that intersected with the regulation of drugs and foods. And I worked a lot with federal archives, Medical History Archives. So I had that background. And then I also worked on documentary film about the precursor to the Department of Health and Human Services was the Department of Health, Education and Welfare. And I worked on a documentary film about he W's role in the desegregation of hospitals. So I also had this sort of HHS history. So I had the documentary experience, and FDA was looking for a historian and I got lucky.
Aaron Harmon:Nice. I can't imagine that being a ton of fun. Any of the previous podcasts we do typically revolve around history and the FDA and stuff. It's, I find it really fascinating.
Vanessa Burrows:And I feel like I have the best job at FDA.
Aaron Harmon:Yeah, I would, I would agree that you do. So, the story of elixir sulfanilamide know, starting off, how did this drug, you know, in the first place, get to patients, what was it used for? Can you give us some of the story around that? Sure.
Unknown:I'd actually take it back just a little bit and talk about the drugs sulfanilamide itself, which had only been discovered and commercially marketed just a couple years before elixir sulfanilamide was developed. Since salvor verson was discovered in 1910. To treat syphilis, there's been this quest to find more broadly therapeutic antibacterial products. And there have been a lot of hopes that were dashed to pieces. And in 1935, German firm named IG Farben Industry came up with this product called pronta cell, which was the first sulfanilamide product, it was proven effective in this sort of proto clinical trial by Lennar colebrooke. That was conducted at Queen Charlotte Hospital in London, amongst women who had just given childbirth and were suffering from peripheral infection. So it was like finally we have this very effective antibacterial product and the way it really became publicly like entered the public consciousness was in the late fall, early winter of 1936, the president's son, who was young and at the time, he was a student at Harvard, Franklin Roosevelt Jr. came down with a really serious, strep infection that spread from his throat and into his sinuses and beyond. And he was hospitalized for several weeks, and he was treated with sulfanilamide and made this miraculous recovery. It was really significant because only a decade earlier another president son, Calvin Coolidge, his son also Jr. came down with a strep infection that actually killed so I mean, if that doesn't illustrate like the dramatic, therapeutic promise of this product, I'm not sure what does but um So sulfanilamide had just come on, become available and it was really perceived as this miracle cure. And it was prescribed largely for streptococcal infections, but also for things like gonorrhea, which of course, people that need treatment for stuff like that seek some privacy and decorum and being able to purchase a product someone anonymously is very helpful for self care in those situations. The downside for picking sulfanilamide was that it was available in a pill form, because it was really difficult to dissolve. So by, you know, within a year, even of it being on the market, there was a notable demand for oral preparation. And this one company in Tennessee, se massengill sort of seized on this opportunity to develop a liquid preparation. And from July of 1937, to early September, their chief chemist came up with a formula dependent on this particular solvent that would let them bring the product to market, it was really just a couple of weeks that they were researching it and were able to bring it to market. And the only testing they did was to make sure that it tasted and smelled good. And they made it this like raspberry flavor. So you know, the the fact that it kind of tastes like candy made it much more palatable to give to kids who of course, are often riddled with strep infections, they were hoping would have a lot of therapeutic potential for pediatric care, as well as more broad use. But they didn't do any safety testing and the solvent they chose. Dye ethylene glycol is toxic, and lethal.
Aaron Harmon:It's just crazy like, conceptually, to think about being able to bring a product to patients on the market within a few with a few weeks of research in such a short amount of time. This is mind blowing, cuz that would never happen today, thankfully, so. Well, that was happening. What was it like at the FDA? Like how much of the FDA even existed at that time point?
Unknown:I think that's a really important question, because, you know, FDA changes so much through time and in response to different forces science, obviously, the law, but also social influences. And, you know, by 1937, we'd had the federal regulation of food and drugs for three decades. The 1906 Peer Food and Drugs Act was the first enacting legislation that enabled the federal government to protect citizens from dangerous products. But it had pretty significant limitations. For one, it's often described as and maybe not entirely accurately, but often described as a truth in labeling law. And the impetus of the law was to give consumers information about a product so that they could make healthy decisions about what they wanted to take. If a product contains alcohol or contain cannabis or morphine 11 Different dangerous habit forming ingredients had to be labeled, but you didn't have to disclose all of the ingredients in a product, a product had to conform with pharmacopeial standard, either the USP or the national formulary. And if it departed from those, then you had to specifically identify it was what was in it, but there was a lot that wasn't actually labeled for in this instance, it was not required for Luxor sulfanilamide, to clearly label all like the flavor, you know, the extent to everything that was in the product. And that was obviously left a lot of room for dangerous products to enter the market. And on the other side of it, the the fact that if you did accurately label a product that was dangerous, for instance, in the 1920s, there was this whole fad for radium infused products, literally hot water with radium in it. Yeah. And it was, as you might imagine, very dangerous and cause uncounted numbers of deaths. And there's nothing that the FDA could do to remove products like that from the market, because if they were accurately labeled, so that was a pretty significant limitation. Back to your original question, what was FDA like? I think it's important to recognize FDA was so much smaller than it is today. This is before we did drug reviews before they entered before you could market a product. Under the Pure Food and Drugs Act. We didn't have any pre market approval authorities or notification. So there was none of that activity and not the workforce to support it, a lot of what the agency was engaged in, under the Pure Food and Drugs Act, authorities was removing violet of products from the market. So it was somewhat reactive to things that had already been made available to consumers. And doing research on adulteration thinks like, it was just a very different culture. I think it's also important to recognize that this is in the midst of one of the greatest crises our country has ever known, the Great Depression, we'd been through eight years of the Depression. And we're on the sort of uptick, like the economy was starting to recover. But the country had been through an awful lot. And alongside that, there'd been, you know, four years of this really intensive reform period under Franklin Roosevelt's presidency, the New Deal. And throughout that time period, there had been this effort to reform Food and Drug Law, that was extremely heated and controversial and brought out a lot of rigorous debate amongst different stakeholders. So like, even in the midst of this New Deal era, where we had record setting levels for passing legislation, we were not able to come up with a compromise to fix some of the problems with the Food and Drugs Act that I already alluded to. And sadly, it took this crisis with Alexa herself LMI to really push legislation,
Aaron Harmon:one thing you had mentioned was getting it on the label so consumers can make a choice. But even their chemist did not understand that this was toxic, I'm assuming. And so to put that expectation on the on the customers that are not as educated, to be able to decipher what is safe and not seems a bit crazy.
Unknown:Yeah, I mean, I think that's a fair point. Although I am sure that the chemist bully didn't understand the danger of the product. He didn't do a literate, he didn't read the published report. He clearly wasn't aware of FDA guidance, which cautioned against using glycols in food and drugs. And he didn't do his due diligence, but the information was out there. And certainly, consumers could have been protected against this product such as elixer sulfanilamide. But I I also bring up bring this up because he had been in trouble with authorities previously about marketing unsafe products. He, he had been involved in a case where he had his own company, and he marketed a weight loss product that was deemed to be. I think it was misbranded, actually, but I think it just failed to meet the USP standard. But it was also in this culture of really risky weight loss. Guests that culture has shifted over time and not completely gone away. But in the 1920s and 30s. There were some really dangerous products on the market like desiccated thyroid and just other really dangerous products. So there had been some instances where he sort of flouted regulations and safety protocols. But yeah, you're right. I mean, health literacy. Even the most astute consumers shouldn't have been expected to understand how dangerous dye ethylene glycol is.
Aaron Harmon:And to contrast that to our current world of information, if I was to try to find as neither P I have a PhD in microbiology, so it's a bit easier for me. But if I was going to my one of my friends and said, Hey, go figure out if this compound is safe or not. They'll be sitting there with Google hoping to get the accurate information and then trying to make decisions off that just seems a bit wild. Yeah. So the liquid form now gets on the market, and starts being distributed and used. How was it causing death? Like how did it pop up on the radar?
Unknown:I think this is important, because it highlights the extent to which at the time and maybe you know, still to this day, there are lessons to learn from it. The the extent to which the FDA relied on an active professional community, right. So the AMA is notified about these adverse events before the FDA received word and the AMA, in turn, notify the FDA and the AMA did their own analysis and AMA, it's some of their own research to try and determine the root cause of the deaths that were being noted. And particularly, they first started being detected around ALSA. And it was that really get the dedication of the AMA and the fact that they played this sort of role as a fulcrum in our national medical community that helped us have a more expeditious response and have a sort of a nexus for gathering this information. And so basically, the AMA first receives, say it looks for self, no mind goes on the market like the first week of September, and within a month, the AMA starts receiving information about people dying around Tulsa. And at that point that maybe I Tober, 11th, they start receiving these reports, and there's maybe eight or nine deaths at that point. And FDA first, is notified on October 14th. So, you know, not as immediate as we would have today, but still pretty rapid fire, and they immediately dispatched their chief medical officer Theodore calm, and an inspector from the Kansas City district office named William Ford, who is a future commissioner of FDA. And so Ford and Klump go to also to investigate these deaths, and B, and meet with the chief chemists at massengill whose name is Harold. And they meet with the owner of the company down on Africa. And they learn that Nason Gill has already sent out recall notices. They telegram to about 1000 different physicians and pharmacists saying please return the product. A for the but they don't say anything in these telegrams about why you should return the product. It's killing people, we've noted that it's dangerous, they just said to return it. And so they they learn of the contents of the product. They identify ethylene glycol as the likely toxic factor in these deaths. And they require that maths and girls stand out more firmly and clearly worded recall to the dimension like the immediacy and the urgency and actually articulate that it's causing death. And, and that helps recover an awful lot of the product that was distributed. So I guess I should say, the company made about 240 gallons of elixir sulfanilamide. And through the recall and just recovery of pieces that were being distributed, they were able to get almost 230 gallons back and then through a sort of forensic patchwork analysis trying to track down who was prescribed what and where did they move and who, what pharmacies were given or sent shipments and so on and so forth. They recovered another about six gallons of the product, and then the remainder was consumed and, and led to death. In many cases, all in all, it was about 107 people. We estimate that were killed, taking licks yourself and killed in a really tragic and gruesome way. The symptoms of ethylene glycol poisoning were obviously severe abdominal, nausea, vomiting, in some cases, convulsions, stupor, and it was really excruciatingly painful and typically caused death in between seven to 20.
Aaron Harmon:Wow. Just like curiosity did the label have on their diethylene glycol when it went out?
Unknown:I actually I will check for you right now because I have a copy of the label. No, I don't believe it did. The FDA was ordered to create a post action report and submit it to Congress. So it's easy to easy to find this report online. And it contains a printout of the label. And it only indicates that it contains sulfanilamide.
Aaron Harmon:So the consumer really didn't have much chance. Do you have any insight in how the deaths were linked so quickly to the drug?
Unknown:The FDA, again, relying on external experts for this, particularly at Johns Hopkins and at the University of Chicago, and there was one lab pharmacology lab at the University of Chicago headed by Eugene gay Ling think I don't know if that's how you pronounce the name. You ever read it? Gaming was had several as you might imagine grad students in his lab and one of them was his famous at FDA for a completely different reason. Francis, Kelsey, she had just, it was her first year in his lab. I might be wrong about that. And they were in involved in doing the testing to determine the toxicity of Look for sulfanilamide and pretty easily to turn determined that it was the dye ethylene glycol that was causing the causing the death.
Aaron Harmon:So there was the recall stuff happening. But all of that ultimately led to or help lead to the Food, Drug and Cosmetic Dec getting passed in 1938. Did that act only come together because of this drug? Or was this something that had been in the works in the past because I knew the FDA had been doing some consumer awareness trying to prevent these things from happening. Yeah,
Unknown:um, so the food got in cosmetic Dec had been the first draft of it was introduced in 1933. And it was, you know, very shortly after Roosevelt was elected into office in March 1933. Is Undersecretary of agriculture. Because FDA used to be organized under the Department of Agriculture. The man named Rexford Tugwell met with the chief police have to be the chief of the FDA, Walter Campbell, and was on a completely different issue, almost upset about he thought that FDA wasn't being as active and enforcing their authorities as they should be. And Walter Campbell explained to him that we didn't actually have the authority to do what it was regarding pesticides, which regularly, they sat down and talked about the limitations of the Pure Food and Drugs Act and decided that in order to remedy these problems, what they really needed to do was replace the law with a new law. And so the first draft of the bill introduced in the summer of 1933, was very much associated with Tugwell. And he was a little bit of a polarizing character. And there was a lot of opposition to it. And this sponsor that ended up taking it up in the Senate, Senator from your royal Copeland, who wasn't a doctor ended up really becoming the main activist for it. And so we sort of differentiate between the early on Tugwell bill, and then the later on Copeland bill and, and Copeland worked really hard with the different stakeholder groups to try and strike the right compromise. And he did this. He mean, he, he pushed it along for four years. And after the sulfanilamide crisis, the legislation was further amended to include more strict protections regarding new drug safety, particularly regarding premarket review, and the power to remove inherently dangerous drugs from the market. So the bill certainly had been in the works for a while, but it took on a little bit of a different form after the sulfanilamide crisis. And it wasn't passed immediately, it still took another eight months for Congress to find the right.
Aaron Harmon:That was very much a changing moment for the FDA.
Unknown:Yes, it was it was it was revolutionary. It's really the turning point that creates the modern FDA. You know, we could point to a lot of them along the way. But changing from an agency that focused largely on reactive enforcement work to an agency that had the authority to review drugs before they enter the marketplace, was a major transformation. And it transformed the pharmaceutical industry as well with a new focus on investing in clinical studies before a drug could be brought. I guess I should say that the initial legislation under the 38 Act, when a company submitted a new drug application, the FDA had 60 days to review it, again, not have user fees, we did not have overdue for clock, we had 60 days. And if the agency didn't respond within that time, you could just go ahead and market your product.
Aaron Harmon:Now we'll take a quick break to hear from one of our sponsors.
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Aaron Harmon:So, for the company, what happened to the massengill Corporation,
Unknown:um, well, you know the thermal mass and go was sort of notoriously the word and remorseful about the incident. And I don't mean to accuse him of not caring about people dying. But he insisted in the press to the AMA, in throughout the historical record, that he did nothing wrong. He didn't violate a law. He did not feel that there was any responsibility on his part for these deaths. And he didn't violate a law, maybe an ethical law. I'm sorry, I, I should have pointed out earlier on, the only reason the FDA was able to recover, that looks yourself in LMI, from the field that we sent out almost all of our inspectors and chemists that were stationed in the field 239 of them to try and find out who had been prescribed it looks for sulfanilamide and to recover it. And the only reason we were able to do this was because it was misbranded because it was labeled an elixir and under the USP standard, and elixir has alcohol and this product on the diet. So it was that review hole factor? Yeah, that enabled us to prevent further loss of like, tragedy. So he did break that law. But he will he as our saying he he was notoriously on remorseful about this event. He, when he never backed down from that. He actually insisted, for a long time and experimented with mounting a legal defense that it wasn't the Diaclone glycol it was the sulfanilamide that was causing the deaths. He claimed it was you know, it's part of this sort of sulfanilamide craze that I alluded to earlier in our conversation that people were taking too much. And it was and there were some instances where that happened, but his own company marketed a sulfanilamide pill that had not been linked to you. So clearly, it was a specious argument. So he remained remorseful. The chief chemist Watkins initially seemed the FDA inspectors that met with him and the Chief Medical Officer were really a talked about how he seemed so callous and his disregard for life, and that there had been a product he had marketed earlier on in his career that led to death that you didn't seem to be concerned about. And that was their characterization of him. He blamed that when he first started learning about the depths, he took a large dose of elixir sulfanilamide to test it, and that nothing happened to him. So it just, he seemed to be a little defensive in these encounters. But ultimately, he ended up taking his own life as a result of the guilt and the grief. He felt about this tragedy. The company itself was ended up pleading guilty in court, and they were given the largest fine any drug manufacturer had ever been given under the Pure Food and Drugs Act. It was $26,000 $26,100, which is about $500,000. Today, oh, you know it different industry different time different, you know, penalties, but the owner wasn't given any jail time, it wasn't even considered, as far as I am aware. But there were also civil suits. And I don't know very much about the civil suits. There's some accounts, rumored that massengill ended up paying up to half a million dollars in 1938 money in damages, that that's about all I know about that.
Aaron Harmon:I feel like people who maybe this is an overgeneralization, but people getting into the space of drug development medicine, have some kind of altruistic motivations in there to help people and to do something cause harm, and then try to immediately disregarded as and blame others, whatever they're doing, just to me seems like they would be so much better off just accepting what happened and seeking out what the evidence leads to. And if the evidence is there saying, Yeah, that's what it is, and how do we move forward? But to just find it, to me seems a bit crazy.
Unknown:Well, I agree with you in my heart, like if you're in the business of making therapy or doing it out people you should be and certainly, you know, at least you know, arm, but there is also I think, in this case, you see, especially in that sort of like dragnet when the inspectors were going out into the field and just trying their best to like interview whoever they could and get information about where this lethal product was to prevent more people from dying. You see a lot of people they're concerned for? Not quite sure how to put it. I'll give you an example. So, some detail men, for massengill, you know, the salesman would not cooperate, they would not share their sales list, they would not one man that worked out of Texas actually was jailed by authorities for contempt before he would help inspectors find people that might have this product. And some doctors, like outright lied and said, No, that's not my patient, I have no idea who you're talking about. And then inspectors would later actually run into them at a patient. And there's like it, there's accounts of this in the congressional report. It's really troubling and shocking, but you also start to see, well, for some physicians, they were prescribing something that that they had no reason to believe was a lethal preparation. It was I mean, SCMs, and go wasn't a fly by night company. They were they've been around for decades. And they were the biggest pharmaceutical manufacturer in the American style. So that it was a reputable firm. It was a cutting edge therapy, there'd been so much success seen using sulfanilamide. And it was, you know, it was something that they could give to their patients. And I think maybe it was hard for some people to face the guilt of doing that. Or maybe they just worried about the liability involved with it. But it certainly raises a lot of tricky ethical questions. It's not an easy story to grapple with.
Aaron Harmon:Somebody was telling me a story about someone tried to bribe them. And I said the same thing, I guess, is crazy. Why would somebody try to do that? And I said, Well, it's easy to think that way when you're not in that situation. But when you're backed into a corner, and you start realizing the consequences of what went wrong, that it tends to change people's behavior. And I'm sure there was a lot of that going on in this story.
Unknown:Yeah. I mean, I, I think it definitely sort of, it's the must have been the sort of situation where that really tested people's values. There's this really heartbreaking story, that one doctor in South Carolina shared with investigators, I wrote a letter to them talking about how devastated he was knowing that he paused these deaths on patients, one of them was his basketball, and that he just couldn't sleep at night. And, you know, like it's took him he dedicated his life to making people well, and he had been the cause of their deaths. I, I think it Yeah, it certainly was one of those situations that really exposed some of these ethical problems that we have to grapple with those that are difficult to navigate under expand crises.
Aaron Harmon:One of the former CEOs of Novartis said that, that as their company, if they make the best, or the best medicines for patients, then there'll be value in that, and the shareholders will see the value. And essentially, the patients win and the business side wins. But he said, If we pursue doing what's best for the shareholders, we won't always do what's best for the patients. And that's where we might lose, I hung on to that quote, because I think it's the best way to view these things. And if we seek out to do the best for the patients, for those that we're trying to heal and help, then everything else in the business side will work out. But as soon as we get so focused on profitability as a company, then these things can go awry. And we have these issues.
Unknown:And you just have to have the strength of your convictions and a strong culture to support them. Right.
Aaron Harmon:And then regulations that now prevent a lot of that stuff from happening. Is that, yeah, it's unfortunate that we had to get to a space regulations. But just in what you described, I was thinking of, nope, over the counter that got changed by by regulations and law, the need for clinical trials to show safety that was changed by regulations in law, pre clinical trials to make sure that the products going into human patients before this safety trials that was put into law, like so many things along the way have been put in, and almost all of them recording. Yep, has another one. Yeah. But all of that was because there was something that had to go wrong first to drive that, which I feel is unfortunate that we could have prevented so much tragedy and so much regulation requirements just by doing things right the first time.
Unknown:Yeah. In in our correspondence before we got to talk you mentioned like that you sort of put this in the context of like GM PS and now this is often embedded in courses about factory practices. And you know what, when I talk about the Luxor sulfanilamide crisis as an FDA historian, for me, the story is really about the it's an enforcement story about obstacles to enforcement, and the need for powerful enforcement. And it's also a story about regulatory authorities and the limitations and, and powers that they offer. And I think that it is really sad, when you look back through FDA history that so often it takes a crisis, and a crisis that often involves the loss of human life in order to get protections for other people. And I wish that there was a way to depart from that, a way to see that safety and innovation are not in contradiction. There may be a dynamic tension there, but that there they are mutually supportive, like you mentioned, the CEO of Novartis. But I do think that that takes that will take a culture shift to get there.
Aaron Harmon:Yeah, it will. And that's one of the hopes of this podcast is that listeners will hear the stories here, how we got to where we are now, and how no simplistic quality system can help prevent these things from happening. And hopefully get to a point of embracing them and saying, Hey, if we implement continuous improvement, if we implement a good quality system, we're going through all these preclinical trials or whatever, because we don't want to have these things go wrong, and we want the smoothest path to market without, you know, something, throwing it all out, because of the tragedy we could have avoided. Yeah. So when I go to a physician now and get prescribed a drug, I get provided with a lot of information, I get information from the pharmacist that coaches me through, you know, have you used this before, here's things you need to know about this. And I have a high level of anticipation that's going to work and be efficacious. And it's been very well for me. And I feel like I owe that to the FDA. Because anything that's gone through that approval process. I know his pass through these, these gates to make sure that by time it gets to me, as the as the consumer as the patient, that it's been checked for safety. It's been checked for efficacy that I know I'm getting the right dose, all those things are in place to make sure that I'm safe and protected.
Unknown:Yeah, I mean, that's the whole point of federal regulation. Right. It's to keep people safe and to and to make sure that they can have faith in the market. Right. It's who would turn to products stepped out of desperation that they didn't have faith in. So yeah, I mean, I feel the same way. I, I am, you know, probably you and I are both a little bit more aware of the role that the FDA plays in doing that. But yeah, I don't take my my confidence in the medical product market for granted.
Aaron Harmon:So a long time ago, I was in, do my undergrad. And I had the side project of looking into old newspapers to look at something for an ecology study I was helping with. And it seemed like every page of newspapers from the early 1900s, we had somewhere on there, someone's concoction, to treat you for whatever. And they had the wildest claims, they could just advertise whatever they want. I guarantee there's no efficacy data, find anything that was out there. But it's the whole snake oil concept. And now that's pretty much unheard of, unless you're out on the web, you might find a few things here and there if you're looking around, but we've come a long ways.
Unknown:We sure have come a long way. I I pretty sure we still have some crazy products out there. And I bet you know the people in the field that investigate fraud. I have to contend with your your statement that there isn't that much out there. But we do have people that are vigilant, keeping an eye on on what's being sold to try and do consumers. We do have protections and consumers have recourse and they have someone they can bring an agency that they can raise concerns to about products, they don't think really pass muster. We of course have like different, more complex regulatory environment now than we did in the 1930s especially with the globalized market. And that, you know, I think we should anticipate that that's going to perpetually change and we're gonna have to perpetually adapt.
Aaron Harmon:Yeah, just going all the way back to the beginning of this episode. I've had strep throat my kids have all had strep throat. My wife's had strep throat. And I've never at any point thought this could kill us. And I know nobody personally has ever died from stress. throat. I feel like that is all owed to modern medicine and where we've gotten to today.
Unknown:And there's that balance too, right? You know from Calvin Coolidge Jr, dying of strep throat to FDR, Jr, surviving strep throat to, you know, there's this one really devastating letter that a mother of a sulfanilamide victim sent to Franklin Roosevelt, a year after his son had survived through her six year old daughter, the first time she ever had to call the doctor was prescribed to Luxor sulfanilamide and died within nine days. And she calls upon Roosevelt get an act stronger drug reformed. And it's that that delicate balance between we have this extremely promising new product, we we have to make sure that it's safe.
Aaron Harmon:I'll curiosity. This is kind of a side question. There's an FTA Museum, correct? I understand this, right?
Unknown:Well, it's not a museum, we have a large museum collection, which is, we have a lot of artifacts, and we do have an elixir. So we have two different selling products.
Aaron Harmon:Okay, that's what I was gonna ask. Because the next time around that area, I want to go and visit this.
Unknown:Well, I sure hope you will come visit, we have one on display in white oak, the main building, building one. And we also have a picture of it on the agency's Flickr album. It's called Flickr feed. And I can send you the link I feel like that. Yeah. And we, you know, the one we have on display as a sample, the we also have an empty bottle of, you know, the one that would have been supplied to pharmacies, the Gallon Bottle.
Aaron Harmon:Oh, this is crazy. And is if people want to learn more about FDA history, where would you direct them to,
Unknown:I would strongly encourage them to visit www.fda.gov forward slash history. We have a lot of narrative materials about the agency's past, as well as just in general about the regulation of the products we regulate. We have a fantastic oral history collection that has really rich stories. So we have our oral history with Francis LC talking about her research on ethylene glycol and many and her time at the University of South Dakota.
Aaron Harmon:And I have to look this up. So I've read some of your stuff. But if you've got any other things, I'd love to dive into it. Alright, I'll send you that to
Unknown:great historical images, fantastic. The some of the crazy products you were talking about, but also other images, inspection, images, things like that. And we've got some video blogs about some of the interesting items in our artifact collection. Oh, and we also have research guides. If you want to do more like deep dive into FDA history. There's also the National Library of Medicine has a great collection of all of the notices of judgment that the FDA issued under the pure food, not just the fear of doing drugs back from 1906 to 1966. Oh, that's a great collection. And if there's any other like specific queries that aren't covered in the materials that are available, you can always email FDA history. office@fda.hhs.gov.
Aaron Harmon:Great. I hope we certainly diving into some of these things. And I want to do a future episode on Mrs. Winslow's soothing syrup. That one's ah, on on the dagger.
Unknown:We also have that I'm sure you do. That's a pretty easy to come by.
Aaron Harmon:Well, thanks for being on the show.
Unknown:Thank you.
Aaron Harmon:This is great. I'm sure the listeners will enjoy it.
Unknown:Well, I'm glad you're covering this these topics. There's so much to learn from them. And I'm glad to be a part of it.
Aaron Harmon:This is exactly why we have historians, because there's so much we can learn and hopefully do better as we push forward in the future. Amen. Hi, thank you. And thank you for listening to this episode of Inside Out quality.
Unknown:We hope you enjoyed this episode. This was brought to you thanks to South Dakota biotech Association. If you have a story you'd like us to explore and share, let us know by visiting www.sd bio.org.
Aaron Harmon:Other resources for quality include the University of South Dakota's biomedical engineering department where you can find courses on quality systems, regulatory affairs, and medical product development. Also, if you live in the Sioux Falls area, check out QUIBIT a local Quality Assurance Professionals Network. You can find out more about pivot by clicking on the link on our website to the end and I would like to thank several people that a few hosts And out per Nate peple for his support with audio mixing Barbara Durrell Christian or support with graphics design and web and lastly the support from South Dakota bio