Mrs. Winslow's Soothing Syrup

“Are you disturbed at night and broken of your rest by a sick child suffering…. It will relieve the poor sufferer…and is the prescription of one of the oldest and best female physicians and nurses in the United States.” --This is not an ad about our podcast :) This is an add from 1905 for Mrs. Winslow's Soothing Syrup (a morphine based product advertised to help sooth children)

FDA Historian Vanessa Burrows joins Leslie and I, as we dive into a notorious opioid product sold from the 1830's-1930's resulting in countless deaths and misled consumers. This episode underscores the importance of product labeling, advertising, and muckrakers in the history of drug development and regulations.

To learn more about the work of the FDA's History Office, check out their site:
www.fda.gov/history 

Transcript

Aaron Harmon: 0:00

Hi, I'm Aaron Harmon.

Leslie Cooper: 0:01

And I'm Leslie Cooper. Welcome to Inside Out quality.

Aaron Harmon: 0:05

Leslie and I are quality nerds. We like to figure out what can go wrong and how it can be prevented. Cap is our our friend. How can we use quality to build better safer products? Can quality be a tool entrepreneurs use for success? On

Leslie Cooper: 0:19

this podcast we talked to some fascinating guests and listen to their stories about quality events gone both right and wrong. we dissect the stories to teach and learn from the experiences of our guests. So grab your coffee secure the lid, ensure it's not too hot and enjoy our episode.

Aaron Harmon: 0:38

Mrs Winslow's soothing syrup has been used for over 65 years by millions of mothers for their children while teething with perfect success. It soothes the child softens the gums allays all pain dispels when colic is the best remedy for infantile diarrhea sold by druggist in every part of the world. Be sure to ask for Mrs. Winslow's soothing syrup and take no other kind 25 cents a bottle, an old and well tried remedy. This is one ad from an 1813 newspaper. If you were a mom trying to make your child feel better, would you use it? Is it safe? And why wouldn't it be when they actually sell it and advertise it to be perfectly successful? If it wasn't, here's another you disturbed at night and broken up your rest by a sick child suffering, it will relieve the poor suffer and is the prescription of one of the oldest and best female physicians and nurses in the United States. This ran in Lincoln Nebraska newspaper the independent and it's no five. And by the way, it cures diarrhea, regulates the stomach and bowels. Cures when colic softens the gums reduces inflammation and gives tone and energy to the whole system. Other ads read things like operates like magic perfectly safe in cases and buttons to taste. 1000s of ads exist like this. Mrs. Winslow's soothing syrup was an insanely prolific advertiser. mother saw these ads all across the United States and newspapers starting in 1845. Were there a list of side effects? Are there any Mrs Winslow's soothing syrup contains 65 milligrams of morphine and each ounce of alcohol that was suspended in a toddler can be given 260 milligrams a day of morphine by a mom following the instructions on the label. The Mayo Clinic's website post side effects of morphine including a list of 38 which include blurred vision, chills, confusion, cough, decreased urination, fainting, loss of appetite, severe constipation, and this is considering a dose of 10 to 20 milligrams every four hours. In this episode of insightful quality, we will discuss the history of one of the most notorious marketed medicines, Mrs. Winslow's soothing syrup. This product resulted in the death of countless children and cause addiction and their parents. To help us we are joined by Dr. Vanessa barrels. FDA historian extraordinaire, and previous guest on the elixir sulfanilamide episode. Welcome to Inside Out quality, Vanessa.

Vanessa Burrows: 2:49

Thanks. Nice to be here.

Aaron Harmon: 2:51

So right off the bat, what was the drug industry like in the 1840s in the US?

Unknown: 2:56

So this is an important question, because in order to understand, you know, Mrs. Winslow's, and those sorts of products and why they existed in the first place, you kind of have to look at the environment that inspired their development. And it's really different than the medical market, we're used to. The 1840s was actually a really formative period in modern medicine. It came after several decades of concern about the quality of drugs in the marketplace, and the ability of professionals to maintain their legitimacy in the 1810s. And especially in 1820. There was a lot of concern about adulteration of drugs. I bet you didn't think I was going to start with adulteration.

Vanessa Burrows: 3:47

If there were, there were no like laws saying if you're selling, you know, digitalis, you can't extend it with sawdust, there was nothing that was not illegal at all. You didn't have to disclose everything that was in your drugs. And so there were, there was just one really influential work in 1820, by an author named Frederick Kuhn, who did all of this analysis and he reported on his findings about Peruvian bark, which had been derived from like inferior plants and was suffering decay and being sold as if it was a high quality product, or how essential oils like the entire industry, he indicted for being so woefully adulterated with alcohol or turpentine, that they're almost unfit for human use a number of other infractions. So this created a great deal of concern amongst practicing pharmacists and led to the creation of a very important Compendium the US US Pharmacopoeia. There on there was a voluntary, professional body that created standards of string purity and identity for Materia Medica. And this starts to create higher standards of quality for drugs. You see this professional movement to distinguish quality medicines from quack medicines. And it's paralleled by a movement in medicine, to distinguish legitimate medical practitioners from quacks. And there's a little bit of social context that I think is important to wrap in here, not just in terms of these very important movements of professionalization. But 1830s is what in the United States referred to as Jacksonian Democracy when Andrew Jackson was president. And there is this great movement for democratizing society and empowering people that hadn't had power before, like non land owning white men getting the right to vote. There's also a much darker side of Jacksonian Democracy, like Indian removal and things like that. But one of the things that he was associated with was expanding democracy for certain members of the United States that didn't enjoy rights previously. So Alongside this, you see people being sort of skeptical of elites, like medical practitioners, and seeking self care, partly volitionally, you know, because they trusted their local pharmacist more than they trusted medical doctor, maybe, maybe because they had heard so many stories about crack doctors, giving people poor care that they didn't want to risk it for themselves. But also, very importantly, because medical care costs money. And this is a period in time when you're starting to see the growth of market society, in the sort of proto industrial economy in the United States, more people are working in factories, and there, they don't have a lot of money to spend on medical care. So going in buying a bottle of patent medicine was much more feasible for a urban factory worker than taking time off of work and going to see a doctor. So it's important to understand that on one side, you have these professional movements starting to carve out or starting to define what counts as a legitimate medicine and what doesn't. And you also have the social forces that are kind of compelling people to seek medicine in bottles that they can easily procure. Now, alongside that you also have the introduction into the medical armamentarium of this highly addictive substance, morphine, which was an amazing painkiller, but highly addictive. And in the antebellum period, when it was introduced into medicine wasn't very well known how addictive morphine was, that was really more discovered after the Civil War when morphine had been widely used. And after the introduction of hypodermic injection in the 1850s. So you have this nurse, we believe in rural Maine in the 1830s, who apparently developed a tincture that was a blend of alcohol and morphine and other flavorings that was made to calm, fussy, babies, teething babies, babies with colic, babies have so many reasons to be uncomfortable. And so few ways of expressing it that Mrs. Winslow's soothing syrup was meant to be an all purpose soother. And this is a really important thing, sorry to go on and on. And

Unknown: 8:48

this is a very important thing to realize. She didn't have to meet any standards to sell this product. She didn't have to present an NDA to the US Food and Drug Administration. She just created a product that she thought I assume, was very helpful to parents and babies and started selling it. She didn't have to do any safety testing. She didn't have to prove it was effective. And she didn't have to put on the label what it actually was, and keep blaming it on her. But it wasn't actually Mrs. Winslow, who marketed this product. It was her son in law that first put it on the market in partnership with Jeremiah Curtis and Benjamin Perkins first, patenting this medicine. Actually, I'm sorry, I didn't patent it. I maybe should have said this sooner. But patent medicines mostly were a misnomer. They were proprietary because they were made to be sold to make money. But in order to get a patent you would have had to submit to the US Patent Office have listed ingredients and disclose what was in your very profitable special formula. So most patent medicines were actually trademarked, which actually tells us a lot about how they were more Get it, that brand name, that trademark was so important in lieu of a patent, that the name recognition was really important. And the imagery surrounding the name in the marketing was really important as well. So this product was, which is kind of shocking nowadays was very much forged by a number of different social forces and advancements in medicine, but mostly was made possible by a complete lack of regulation in the market at the time,

Aaron Harmon: 10:31

it's hard to imagine being able to just produce anything and market it.

Unknown: 10:37

Agree, except in history.

Aaron Harmon: 10:40

So this was obviously marketed towards women from what I've seen of advertisements. And you mentioned a little bit about people not being able to afford health care. Can you talk about the women's perspective? The mother?

Unknown: 10:52

Yeah, this is a, you know, this is I think, really interesting and important, because marketing this product towards women, sort of tells us that women were the agents in purchasing it. Right. The imagery for Mrs. Winslow's sorry that we can't look at a picture together but usually depicted a mother surrounded by children or maybe even just a child, you know, rosy cheeks and you know, nice and plump and meant to imply like health and like a loving home and things like that. It was very much meant to impress upon the consumer that if you buy this, you are fulfilling your maternal role, you're going to be taking very good care of your child, why would you let your child suffer if you're a good mother, and of course, the consumer has no way of knowing that what they're actually purchasing is poison has an enough poison easily to kill an adult person in it. Nowadays, of course, we take for granted that any person of any gender can purchase a medication but women, it was marketed to women to be the purchasers. Right. And this is at a time when you have sort of new definition of classes in American society, especially after the Civil War. You have the emergence of a relatively wealthy middle class and a much poor working class. So on one hand, you have Mrs. Winslow's marketed towards working class mothers who were in fact working and would lose wages if they had to take time off of work to take care of sick children, or had to send their sick child to someone to take care of them during the day. And that person had many children to take care of and needed, you would use Mrs. Winslow's soothing syrup as an aid for managing the multiple children in their care. On one hand, you have Mrs. Wentz was marketed to working class women who needed a cheap and effective treatment for a number of different ailments for their kids. And then on the other hand, you had it marketed towards these middle class women who had status anxiety out there place in society and did a lot of conspicuous consumption to justify their higher role from from working class people. So being able to purchase whatever medicine they wanted, especially one that had was depicted as helping them provide a very soothing and comfortable home for their kids. Sort of appeal to that those sensitivities. But this this one thing is really interesting and little known about Mrs. Winslow's Mrs. Winslow's son in law Jeremiah Curtis had a daughter named Laura Curtis Bellard, she ended up marrying one of the employees one of Jeremiah Curtis's employees, the Curtis and Perkins organization. So Lockhart is Bellard was a suffragists. And she was an author and she was very much like a women's rights advocate. And she was one of the founding officers of the National Women's Suffrage Association along with Elizabeth Cady Stanton and Susan B. Anthony. She was, I believe she was the corresponding secretary, and they had in a nationally circulating journal called the revolution that originally was managed by Stanton and Anthony. But after a year or two, it was really suffering financially suffering, in part because Susan B. Anthony and Elizabeth Cady Stanton refused to allow accept money from patent medicine companies to advertise in this journal. And when it started really suffering to the point where they might have to stop circulating the journal, Laura Curtis Bellard purchased it from them and started running it. Her family made millions of dollars off of Mrs. Winslow's by the late 1850s. They were selling 1.5 million bottles of this stuff a year. Wow. I know. It's kind of shocking. Anyway, so She changed that policy and started accepting patent medicine advertising in the journal and it became much more viable and had a larger circulation. So, sort of ironically, it information awareness of Mrs. Winslow's as a product spread with the increased circulation of suffrage materials. And then this national network of suffragists. And I don't mean to say at all that suffragists were pushing Mrs. Winslow's, that is not my point. It just was a very sort of ironic tie in, and the kind of women that are reading the revolution, were middle class women that were interested in advancing women's rights. So that's definitely an important angle of the marketing as well.

Aaron Harmon: 15:47

Now we'll take a quick break to hear from one of our sponsors.

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Unknown: 16:30

So I guess the question is, is when did this product finally get regulated? Like how did that come about? From the post Civil War period to the early 20th century, states start to recognize a lot of problems with the patent medicine industry on their own. So you have sort of hodgepodge state reactions, and efforts to regulate the patent medicine industry, which of course, was really infuriating to companies that wanted to be able to sell their product across a like nationally integrated market. If you have a bunch of different rules and a bunch of different states, it makes it so much more difficult to create one product that can be sold everywhere. But it wasn't the hodgepodge state laws didn't really do much to bait the flow of dangerous patent medicines. It really required federal regulation. And this took a movement. Because the problem is these were one of the reasons these medicines became popular in the first place, as I was trying to explain earlier is people had no idea what was in them if they knew in the 1830s. If a mother knew that, if she bought Mrs. Winslow's she was going to be giving her baby alcohol and morphine, poisonous amounts of alcohol and morphine. She'd never would have bought it. And we would never even remember Mrs. Winslow's, right. So it's that secrecy or that obfuscation of the lack of labeling requirements that made it possible for these products to proliferate, and be so profitable. So how do you deal with that problem, you need to educate people, you need some mechanism to increase awareness of what's actually in these products. And this was largely accomplished in some cases through civil society and through like private associations, lectures, things like that. But mostly it was accomplished through journalism. And through this particular group of journalists called muckrakers, which is not so affectionate name given to them by the progressive president, Teddy Roosevelt, who said, they're always looking at the negative and society, they're always like staring down at the muck in the ground and trying to stir it up. But there was a lot of muck that needed attention and needed to be cleaned out. And this certainly was one of those things. One really significant journalist, a man named Samuel Hopkins Adams, he wrote for a number of different really well recognized journals at the time. In fact, he wrote the story for Cosmopolitan that ended up being a major Hollywood movie called It Happened One Night with Clark Gable, and Claudette Colbert, which was one of those few movies to win like all five major ACC Academy Awards. Anyway, so he was a he was a big deal writer. He did this series in coal years magazine in 1905. In 1906, where he exposed the contents, he had scientists analyze some very popular patent medicines. He printed with the analysis revealed what's actually in the medicines and discuss some of the ways in which like case studies ways in which they impacted people's lives and marketing practices, why they are so ubiquitous in society. This series was called The Great American fraud. And in the fourth issue, which was about subtle poisons, it's published in December. of 1905. He looks at Mrs. Winslow's and other students syrup's. And he tells a story he referred to as a housekeeper at a New York law office as a scrub woman who was excited to go to a ball when you think, and Adams relates that the attorney in the office was asked her how she was able to do this. And the woman said, Well, it's because of Mrs. Winslow's. I just give my kids a spoonful of Mrs. Winslow's, and they lay like dead until morning, which kind of eerie kind of language to use. Yeah. So Adams uses this to make a point about how Mrs. Winslow's was marketed to and in fact, was actually exploiting working class mothers. And this wasn't news, that part wasn't news, but he's reporting it along with the information about how it actually contains lethal doses of morphine. Really, I think that's what really hit home. And it's tied into this larger series. That actually, the AMA ended up binding together and publishing. So that was could circulate independently of the just the readership for coal years, which wasn't a small readership in other parts in the great American fraud. Adams also reveals, like how the publishing industry was just so dependent on patent medicine revenue from patent medicine advertisements, and his reporting finds that, like the Chicago Tribune received $80,000 in 1905 money that's like $2.5 million. Today, from Patton, Madison advertisers in the Hearst Newspapers received over 500,000. So that's like, over $15 million in today's money. So it's like, so significant. I mean, I guess, I can't even imagine how advertising goes for these days. But um, in that time period, it was so significant, it was like, how could they ever go without the patent medicine advertising. And alongside Adams research, there was an editor for a magazine called The Ladies Home Journal. His name is Edward Bach, who revealed that a lot of patent medicines, companies had what were called Red clauses in their advertising contracts, which basically said that if any state were the newspaper or magazine, or whatever was distributed if the state passed an anti patent medicine law, that they didn't owe the magazine any money. So it basically encouraged newspapers and magazines to lobby against patent medicine regulation. So you had this muckraker movement to expose both the dangerous things that were in patent medicines, but also the forces that made them everywhere in American public life. And that really started to turn public support in favor of federal regulation of drugs in the United States. And of course, there'd been like legislation introduced at the federal level for decades and hadn't gone anywhere. And it often was tied in with food regulation, proposals. And there was a collateral movement, the pure food movement to get federal protections for our food supply. And we got a huge push from a different muckraking journalist Upton Sinclair also around the time that the great American fraud was published, to which exposed really disgusting things in the meatpacking industry. And everything he reported was true. And it led to the to huge swell of support for the passage of what became the 1906 Pure Food and Drugs Act.

Aaron Harmon: 23:50

Do we still have muckrakers today?

Unknown: 23:52

I think we do. I mean,

Aaron Harmon: 23:53

I've seen a few pieces that maybe would fall in that category, but never is as much effort as then from what I've seen.

Unknown: 24:01

Yeah, I mean, we certainly there's plenty of issues to touch on. But and you know what we have now that really would have been a great help to muckrakers in early in the progressive areas, we have Freedom of Information Law, so that they have access to information that would have been much more difficult to get in 1906. Just out of curiosity, you know, you mentioned mothers, if they would have known this was alcohol and morphine, that they wouldn't have given it to their kids. If they had gone in and asked, did people know this? Or was it considered proprietary information and nobody who was selling it pharmacists, doctors, nobody had any idea what was in it? That's a really good point. And let's keep in mind that we're talking about, you know, 80 years of time. So that the people's awareness and their health public health concerns certainly changed. Over time, and we're talking about people that weren't even born in 1830s that finally supported the passage of legislation in 1906. So, yeah, there wasn't, I don't know that if they were wise enough to say, tell me what's in this medicine or I don't want anything that has alcohol in it in the 1840s. I don't know what the look, it would have been regulated locally, there would not have been a federal law. And Maine was one of those states that there were a lot of states before the Civil civil war that passed temperance laws prohibiting the sale of alcohol, except often there were exceptions for medical purposes. So you would actually and you could actually find like, Bourbon for sale and in pharmacies, and actually, pharmacists were really responsible for doing a lot of compounding. And sometimes you'd see like them being given a prescription that said, use a good bourbon. But, but I digress. Yeah, I don't know. I really, you know, it's very likely that if someone was associated with the temperance movement, they might say, I don't want anything that has alcohol in it. But I don't really have any I don't have a good answer for that. And other than that, it would have been very circumscribed by local context.

Aaron Harmon: 26:16

If you kind of honed in on Mrs. Winslow's. But were there other products like this at that time that were doing the same thing? Morphine, alcohol? Oh, yeah,

Unknown: 26:24

I think the muckrakers had to kind of end lawmakers had to focus on like examples. And Mrs. Winslow's was so widely recognized and used that it was a powerful symbol. But there I mean, there are medicines that came and went. And Adams makes the point that some of the worst offenders that had the most dangerous amounts of morphine or alcohol in them, probably didn't last on the market, because people wouldn't buy them again. Right. But yeah, they're I mean, the patent medicine industry, especially like completely unregulated, and as we already discussed, anybody could make a product and try to start selling it. There were a lot of a lot of competitors. And there were, you know, we're focusing on alcohol and morphine, but there were a lot of other dangerous things in patent medicines as well. And when the 1906 law was passed, banning adulteration and misbranding, and food and drugs, it also included additional protections with drugs that you if you wanted to sell a drug in the United States, it had to adhere to the US Pharmacopoeia or the National formularies standards for strength, purity and identity. And if you departed from those at all, it had to be really clearly identified on the label. And in addition to adhering to those standards, you also had to print on the label if your drug contained one of any 11 Different habit forming substances, which included alcohol and morphine, but also cannabis and a number of other substances. So it's a step towards trying to educate consumers about what's in the product, also to embarrass manufacturers to not put things in the product that they don't think that consumers would want. But I will say unto you the question you asked earlier, like if someone said, Don't give me anything with alcohol in it, I bet there mean, there, it was widely known that people did seek out alcoholic patent medicines for the purpose of drinking alcohol, especially in states that had temperance laws, and especially women, that it was called tippling. Women that could drink in the privacy of their own home, it wasn't proper at the time for women to be drinking in public. Women were banned from public houses, or bars in New York City until like 1970, there was one famous Tavern in New York City that didn't let. So this was something like I'm sure that the patent medicine industry profited off of women's private, some women's private consumption of alcohol in the home.

Aaron Harmon: 29:15

I've seen a few things in newspapers from the late 1800s, where there'll be a child that had died from use of Mrs. Winslow's, and it almost felt like they were saying the child died because the parent overdosed the child and it was like they were shifting the blame to the parent and not the manufacturer. Is that just a one off? Or was that something that was common back then?

Unknown: 29:39

So they said like the parent also overdosed or the parent and did the wrong gave them the wrong dosage? It

Aaron Harmon: 29:45

was the parent gave the wrong dose. Well, that's,

Unknown: 29:48

I mean, kind of crazy. I mean, the dosing the dosage directions on Mrs. Winslow's didn't say like, don't exceed four to six doses and In a 24 hour period, you know, like, that definitely was not standard protocol at the time, even though like we knew enough about the dangers of morphine, that they could have included that. But it's so if a parent thought their kid was still suffering, they probably give the kid more right, even though it might be the product that's making them suffer. And certainly as kids were becoming chemically dependent on Mrs. Winslow's, that, of course, would create suffering and needing more of it. But I, I agree, it's kind of revolting that there was no effort to assign blame to a manufacturer that was creating a product and not giving parents sufficient information to protect their kids. But I don't think parents are as to blame, because they didn't, they couldn't have known how dangerous the product was. And it had 65 milligrams of morphine per ounce. And I think nowadays, we've generally recognized that 200 milligrams of morphine can cause a fatal overdose. So I mean, it could be very easy. And there certainly were documented cases, by medical authorities of kids dying from taking Mrs. Winslow's.

Aaron Harmon: 31:20

I'm guessing it wasn't manufactured by GMP standards. So their consistency in bottle the bottle might not be there either.

Unknown: 31:27

Well, I that that's a whole other can of worms would not be any records. You know, I don't know how we could even look into that.

Aaron Harmon: 31:38

Yeah. But I do wonder if the newspapers also tried to protect Mrs. Winslow's? If they're relying on the revenue from advertisements, because they were there's so many ads,

Unknown: 31:47

there's probably I mean, I'm sure there's some truth to that. I mean, we'd have to do the sort of the careful legwork to, to demonstrate conclusively. But Edward box research was really eye opening in terms of like, how dependent the publishing industry was on patent medicine manufacturers. So it's very, very likely. I was just kind of thinking to, you know, you mentioned people, kind of modifying drugs. Do you think, you know, this obviously came from the manufacturer, and I don't know how the bottles came if they were sealed? Or, you know, now you can tell things have been opened. But you have to wonder if when the bottles were arriving at the location, they were being sold for people, modifying them upon arrival, diluting it out with something and try and make it go farther. Interesting. I don't know. I mean, I haven't read anything about that. But, you know, there's no law against it. There's certainly economic incentive for doing that. Yeah, I was just even thinking, you know, the moms that were lower income, you know, do they use part of it, and then maybe diluted out a little bit with something just last week, just to see if they can make it last a little longer? Totally. Yeah. It's just kind of when you brought up the you could modify drugs. I was curious, like after got from the manufacturer, people would do that.

Aaron Harmon: 33:09

Do you happen to have the label with the directions on it? Well,

Unknown: 33:13

I don't have it with me, we do have copies of the labels. But it did change over time. It, of course, changed most significantly after 1906 When they had to print the ingredients on the label. And as a result, I mean, I said like one of the main incentives of a law what were was to embarrass manufacturers, if they were going to continue to put like morphine in their drugs, then they'd either really need to have a reason for it. And people would want to have a drug that had morphine in it, or people would be like, Oh, I don't actually want that. So Mrs. Winslow's actually moved to dramatically reduced the morphine content in Mrs. Winslow's and eventually ultimately, removed it entirely. But they did print how much alcohol was on it contained. So still, I'm sure that deterred some people alone knowing that there was alcohol in their product.

Aaron Harmon: 34:13

No, I have to ask since it was alcohol, it should have been an elixir and not a syrup.

Unknown: 34:20

Yeah, good point. We did have the Bureau of Chemistry, which was the precursor to the FDA did take action against Mrs. Winslow's for misbranding. But it wasn't because they failed to call themselves an elixir. It's because of soothing. It was about puffed up claims, which was just epidemic in the patent medicine industry. And the Bureau of Chemistry presented all of these quotes from the labeling about not just being soothing, but all of the wonderful things that would do for children and the courts for On that they had to remove all of those statements. That could not be conclusively demonstrated

Aaron Harmon: 35:06

no false claims act would not have applied if I understand it right at that time because the government was not paying for it. It was consumers. Is that correct? I don't know. Is that most thinking about this morning over coffee? Well, thank you, Vanessa. Appreciate you being on here.

Unknown: 35:26

My pleasure. Thanks for asking me. This episode of Inside Out quality was brought to you thanks to South Dakota biotech Association. If you have a story you'd like us to explore and share. We'd love to hear from you. Submit your ideas by visiting www.sd bio.org

Aaron Harmon: 35:44

You've made it this far in the episode. Thanks for listening