October 24, 2022 • 35 mins
“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
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Episode Transcript
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Aaron Harmon (00:00):
Hi, I'm Aaron Harmon.
Leslie Cooper (00:01):
And I'm Leslie Cooper. Welcome to Inside Out
quality.
Aaron Harmon (00:05):
Leslie and I are quality nerds. We like to figure
out what can go wrong and how itcan be prevented. Cap is our our
friend. How can we use qualityto build better safer products?
Can quality be a toolentrepreneurs use for success?
On
Leslie Cooper (00:19):
this podcast we talked to some fascinating
guests and listen to theirstories about quality events
gone both right and wrong. wedissect the stories to teach and
learn from the experiences ofour guests. So grab your coffee
secure the lid, ensure it's nottoo hot and enjoy our episode.
Aaron Harmon (00:38):
Mrs Winslow's soothing syrup has been used for
over 65 years by millions ofmothers for their children while
teething with perfect success.
It soothes the child softens thegums allays all pain dispels
when colic is the best remedyfor infantile diarrhea sold by
druggist in every part of theworld. Be sure to ask for Mrs.
Winslow's soothing syrup andtake no other kind 25 cents a
bottle, an old and well triedremedy. This is one ad from an
(01:01):
1813 newspaper. If you were amom trying to make your child
feel better, would you use it?
Is it safe? And why wouldn't itbe when they actually sell it
and advertise it to be perfectlysuccessful? If it wasn't, here's
another you disturbed at nightand broken up your rest by a
sick child suffering, it willrelieve the poor suffer and is
(01:21):
the prescription of one of theoldest and best female
physicians and nurses in theUnited States. This ran in
Lincoln Nebraska newspaper theindependent and it's no five.
And by the way, it curesdiarrhea, regulates the stomach
and bowels. Cures when colicsoftens the gums reduces
inflammation and gives tone andenergy to the whole system.
Other ads read things likeoperates like magic perfectly
(01:43):
safe in cases and buttons totaste. 1000s of ads exist like
this. Mrs. Winslow's soothingsyrup was an insanely prolific
advertiser. mother saw these adsall across the United States and
newspapers starting in 1845.
Were there a list of sideeffects? Are there any Mrs
Winslow's soothing syrupcontains 65 milligrams of
morphine and each ounce ofalcohol that was suspended in a
(02:04):
toddler can be given 260milligrams a day of morphine by
a mom following the instructionson the label. The Mayo Clinic's
website post side effects ofmorphine including a list of 38
which include blurred vision,chills, confusion, cough,
decreased urination, fainting,loss of appetite, severe
constipation, and this isconsidering a dose of 10 to 20
milligrams every four hours. Inthis episode of insightful
(02:28):
quality, we will discuss thehistory of one of the most
notorious marketed medicines,Mrs. Winslow's soothing syrup.
This product resulted in thedeath of countless children and
cause addiction and theirparents. To help us we are
joined by Dr. Vanessa barrels.
FDA historian extraordinaire,and previous guest on the elixir
sulfanilamide episode. Welcometo Inside Out quality, Vanessa.
Vanessa Burrows (02:49):
Thanks. Nice to be here.
Aaron Harmon (02:51):
So right off the bat, what was the drug industry
like in the 1840s in the US?
Unknown (02:56):
So this is an important question, because in order to
understand, you know, Mrs.
Winslow's, and those sorts ofproducts and why they existed in
the first place, you kind ofhave to look at the environment
that inspired their development.
And it's really different thanthe medical market, we're used
to. The 1840s was actually areally formative period in
(03:19):
modern medicine. It came afterseveral decades of concern about
the quality of drugs in themarketplace, and the ability of
professionals to maintain theirlegitimacy in the 1810s. And
especially in 1820. There was alot of concern about
(03:41):
adulteration of drugs. I bet youdidn't think I was going to
start with adulteration.
Vanessa Burrows (03:47):
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 nothingthat was not illegal at all. You
didn't have to discloseeverything that was in your
drugs. And so there were, therewas just one really influential
(04:08):
work in 1820, by an author namedFrederick Kuhn, who did all of
this analysis and he reported onhis findings about Peruvian
bark, which had been derivedfrom like inferior plants and
was suffering decay and beingsold as if it was a high quality
product, or how essential oilslike the entire industry, he
(04:31):
indicted for being so woefullyadulterated with alcohol or
turpentine, that they're almostunfit for human use a number of
other infractions. So thiscreated a great deal of concern
amongst practicing pharmacistsand led to the creation of a
very important Compendium the USUS Pharmacopoeia. There on there
(04:54):
was a voluntary, professionalbody that created standards of
string purity and identity forMateria Medica. And this starts
to create higher standards ofquality for drugs. You see this
professional movement todistinguish quality medicines
(05:16):
from quack medicines. And it'sparalleled by a movement in
medicine, to distinguishlegitimate medical practitioners
from quacks. And there's alittle bit of social context
that I think is important towrap in here, not just in terms
of these very importantmovements of
professionalization. But 1830sis what in the United States
(05:39):
referred to as JacksonianDemocracy when Andrew Jackson
was president. And there is thisgreat movement for democratizing
society and empowering peoplethat hadn't had power before,
like non land owning white mengetting the right to vote.
There's also a much darker sideof Jacksonian Democracy, like
(06:00):
Indian removal and things likethat. But one of the things that
he was associated with wasexpanding democracy for certain
members of the United Statesthat didn't enjoy rights
previously. So Alongside this,you see people being sort of
skeptical of elites, likemedical practitioners, and
(06:20):
seeking self care, partlyvolitionally, you know, because
they trusted their localpharmacist more than they
trusted medical doctor, maybe,maybe because they had heard so
many stories about crackdoctors, giving people poor care
that they didn't want to risk itfor themselves. But also, very
(06:42):
importantly, because medicalcare costs money. And this is a
period in time when you'restarting to see the growth of
market society, in the sort ofproto industrial economy in the
United States, more people areworking in factories, and there,
they don't have a lot of moneyto spend on medical care. So
going in buying a bottle ofpatent medicine was much more
(07:06):
feasible for a urban factoryworker than taking time off of
work and going to see a doctor.
So it's important to understandthat on one side, you have these
professional movements startingto carve out or starting to
define what counts as alegitimate medicine and what
doesn't. And you also have thesocial forces that are kind of
(07:28):
compelling people to seekmedicine in bottles that they
can easily procure. Now,alongside that you also have the
introduction into the medicalarmamentarium of this highly
addictive substance, morphine,which was an amazing painkiller,
but highly addictive. And in theantebellum period, when it was
(07:54):
introduced into medicine wasn'tvery well known how addictive
morphine was, that was reallymore discovered after the Civil
War when morphine had beenwidely used. And after the
introduction of hypodermicinjection in the 1850s. So you
have this nurse, we believe inrural Maine in the 1830s, who
(08:17):
apparently developed a tincturethat was a blend of alcohol and
morphine and other flavoringsthat was made to calm, fussy,
babies, teething babies, babieswith colic, babies have so many
reasons to be uncomfortable. Andso few ways of expressing it
that Mrs. Winslow's soothingsyrup was meant to be an all
(08:38):
purpose soother. And this is areally important thing, sorry to
go on and on. And
Unknown (08:48):
this is a very important thing to realize. She
didn't have to meet anystandards to sell this product.
She didn't have to present anNDA to the US Food and Drug
Administration. She just createda product that she thought I
assume, was very helpful toparents and babies and started
selling it. She didn't have todo any safety testing. She
(09:10):
didn't have to prove it waseffective. And she didn't have
to put on the label what itactually was, and keep blaming
it on her. But it wasn'tactually Mrs. Winslow, who
marketed this product. It washer son in law that first put it
on the market in partnershipwith Jeremiah Curtis and
Benjamin Perkins first,patenting this medicine.
(09:31):
Actually, I'm sorry, I didn'tpatent it. I maybe should have
said this sooner. But patentmedicines mostly were a
misnomer. They were proprietarybecause they were made to be
sold to make money. But in orderto get a patent you would have
had to submit to the US PatentOffice have listed ingredients
and disclose what was in yourvery profitable special formula.
(09:54):
So most patent medicines wereactually trademarked, which
actually tells us a lot abouthow they were more Get it, that
brand name, that trademark wasso important in lieu of a
patent, that the namerecognition was really
important. And the imagerysurrounding the name in the
marketing was really importantas well. So this product was,
(10:16):
which is kind of shockingnowadays was very much forged by
a number of different socialforces and advancements in
medicine, but mostly was madepossible by a complete lack of
regulation in the market at thetime,
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 ofadvertisements. And you
mentioned a little bit aboutpeople not being able to afford
health care. Can you talk aboutthe 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 usthat women were the agents in
purchasing it. Right. Theimagery for Mrs. Winslow's sorry
that we can't look at a picturetogether but usually depicted a
mother surrounded by children ormaybe even just a child, you
(11:15):
know, rosy cheeks and you know,nice and plump and meant to
imply like health and like aloving home and things like
that. It was very much meant toimpress upon the consumer that
if you buy this, you arefulfilling your maternal role,
you're going to be taking verygood care of your child, why
would you let your child sufferif you're a good mother, and of
(11:36):
course, the consumer has no wayof knowing that what they're
actually purchasing is poisonhas an enough poison easily to
kill an adult person in it.
Nowadays, of course, we take forgranted that any person of any
gender can purchase a medicationbut women, it was marketed to
women to be the purchasers.
Right. And this is at a timewhen you have sort of new
(11:59):
definition of classes inAmerican society, especially
after the Civil War. You havethe emergence of a relatively
wealthy middle class and a muchpoor working class. So on one
hand, you have Mrs. Winslow'smarketed towards working class
mothers who were in fact workingand would lose wages if they had
(12:23):
to take time off of work to takecare of sick children, or had to
send their sick child to someoneto take care of them during the
day. And that person had manychildren to take care of and
needed, you would use Mrs.
Winslow's soothing syrup as anaid for managing the multiple
children in their care. On onehand, you have Mrs. Wentz was
marketed to working class womenwho needed a cheap and effective
(12:47):
treatment for a number ofdifferent ailments for their
kids. And then on the otherhand, you had it marketed
towards these middle class womenwho had status anxiety out there
place in society and did a lotof conspicuous consumption to
justify their higher role fromfrom working class people. So
(13:10):
being able to purchase whatevermedicine they wanted, especially
one that had was depicted ashelping them provide a very
soothing and comfortable homefor their kids. Sort of appeal
to that those sensitivities. Butthis this one thing is really
interesting and little knownabout Mrs. Winslow's Mrs.
(13:32):
Winslow's son in law JeremiahCurtis had a daughter named
Laura Curtis Bellard, she endedup marrying one of the employees
one of Jeremiah Curtis'semployees, the Curtis and
Perkins organization. SoLockhart is Bellard was a
suffragists. And she was anauthor and she was very much
(13:52):
like a women's rights advocate.
And she was one of the foundingofficers of the National Women's
Suffrage Association along withElizabeth Cady Stanton and Susan
B. Anthony. She was, I believeshe was the corresponding
secretary, and they had in anationally circulating journal
called the revolution thatoriginally was managed by
(14:16):
Stanton and Anthony. But after ayear or two, it was really
suffering financially suffering,in part because Susan B. Anthony
and Elizabeth Cady Stantonrefused to allow accept money
from patent medicine companiesto advertise in this journal.
And when it started reallysuffering to the point where
(14:36):
they might have to stopcirculating the journal, Laura
Curtis Bellard purchased it fromthem and started running it. Her
family made millions of dollarsoff of Mrs. Winslow's by the
late 1850s. They were selling1.5 million bottles of this
stuff a year. Wow. I know. It'skind of shocking. Anyway, so She
(15:00):
changed that policy and startedaccepting patent medicine
advertising in the journal andit became much more viable and
had a larger circulation. So,sort of ironically, it
information awareness of Mrs.
Winslow's as a product spreadwith the increased circulation
of suffrage materials. And thenthis national network of
(15:22):
suffragists. And I don't mean tosay at all that suffragists were
pushing Mrs. Winslow's, that isnot my point. It just was a very
sort of ironic tie in, and thekind of women that are reading
the revolution, were middleclass women that were interested
in advancing women's rights. Sothat's definitely an important
(15:43):
angle of the marketing as well.
Aaron Harmon (15:47):
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Unknown (16:30):
So I guess the question is, is when did this product
finally get regulated? Like howdid that come about?
From the post Civil War periodto the early 20th century,
states start to recognize a lotof problems with the patent
medicine industry on their own.
So you have sort of hodgepodgestate reactions, and efforts to
(16:51):
regulate the patent medicineindustry, which of course, was
really infuriating to companiesthat wanted to be able to sell
their product across a likenationally integrated market. If
you have a bunch of differentrules and a bunch of different
states, it makes it so much moredifficult to create one product
that can be sold everywhere. Butit wasn't the hodgepodge state
(17:14):
laws didn't really do much tobait the flow of dangerous
patent medicines. It reallyrequired federal regulation. And
this took a movement. Becausethe problem is these were one of
the reasons these medicinesbecame popular in the first
place, as I was trying toexplain earlier is people had no
(17:35):
idea what was in them if theyknew in the 1830s. If a mother
knew that, if she bought Mrs.
Winslow's she was going to begiving her baby alcohol and
morphine, poisonous amounts ofalcohol and morphine. She'd
never would have bought it. Andwe would never even remember
Mrs. Winslow's, right. So it'sthat secrecy or that obfuscation
(17:58):
of the lack of labelingrequirements that made it
possible for these products toproliferate, and be so
profitable. So how do you dealwith that problem, you need to
educate people, you need somemechanism to increase awareness
of what's actually in theseproducts. And this was largely
accomplished in some casesthrough civil society and
(18:20):
through like privateassociations, lectures, things
like that. But mostly it wasaccomplished through journalism.
And through this particulargroup of journalists called
muckrakers, which is not soaffectionate name given to them
by the progressive president,Teddy Roosevelt, who said,
they're always looking at thenegative and society, they're
always like staring down at themuck in the ground and trying to
(18:42):
stir it up. But there was a lotof muck that needed attention
and needed to be cleaned out.
And this certainly was one ofthose things. One really
significant journalist, a mannamed Samuel Hopkins Adams, he
wrote for a number of differentreally well recognized journals
at the time. In fact, he wrotethe story for Cosmopolitan that
(19:02):
ended up being a major Hollywoodmovie called It Happened One
Night with Clark Gable, andClaudette Colbert, which was one
of those few movies to win likeall five major ACC Academy
Awards. Anyway, so he was a hewas a big deal writer. He did
this series in coal yearsmagazine in 1905. In 1906, where
(19:23):
he exposed the contents, he hadscientists analyze some very
popular patent medicines. Heprinted with the analysis
revealed what's actually in themedicines and discuss some of
the ways in which like casestudies ways in which they
impacted people's lives andmarketing practices, why they
(19:45):
are so ubiquitous in society.
This series was called The GreatAmerican fraud. And in the
fourth issue, which was aboutsubtle poisons, it's published
in December. of 1905. He looksat Mrs. Winslow's and other
students syrup's. And he tells astory he referred to as a
(20:07):
housekeeper at a New York lawoffice as a scrub woman who was
excited to go to a ball when youthink, and Adams relates that
the attorney in the office wasasked 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 spoonfulof Mrs. Winslow's, and they lay
(20:28):
like dead until morning, whichkind of eerie kind of language
to use. Yeah. So Adams uses thisto make a point about how Mrs.
Winslow's was marketed to and infact, was actually exploiting
working class mothers. And thiswasn't news, that part wasn't
news, but he's reporting italong with the information about
(20:49):
how it actually contains lethaldoses of morphine. Really, I
think that's what really hithome. And it's tied into this
larger series. That actually,the AMA ended up binding
together and publishing. So thatwas could circulate
independently of the just thereadership for coal years, which
(21:09):
wasn't a small readership inother parts in the great
American fraud. Adams alsoreveals, like how the publishing
industry was just so dependenton patent medicine revenue from
patent medicine advertisements,and his reporting finds that,
like the Chicago Tribunereceived $80,000 in 1905 money
(21:32):
that's like $2.5 million. Today,from Patton, Madison advertisers
in the Hearst Newspapersreceived over 500,000. So that's
like, over $15 million intoday's money. So it's like, so
significant. I mean, I guess, Ican't even imagine how
advertising goes for these days.
But um, in that time period, itwas so significant, it was like,
(21:55):
how could they ever go withoutthe patent medicine advertising.
And alongside Adams research,there was an editor for a
magazine called The Ladies HomeJournal. His name is Edward
Bach, who revealed that a lot ofpatent medicines, companies had
what were called Red clauses intheir advertising contracts,
(22:17):
which basically said that if anystate were the newspaper or
magazine, or whatever wasdistributed if the state passed
an anti patent medicine law,that they didn't owe the
magazine any money. So itbasically encouraged newspapers
and magazines to lobby againstpatent medicine regulation. So
(22:39):
you had this muckraker movementto expose both the dangerous
things that were in patentmedicines, but also the forces
that made them everywhere inAmerican public life. And that
really started to turn publicsupport in favor of federal
regulation of drugs in theUnited States. And of course,
(23:01):
there'd been like legislationintroduced at the federal level
for decades and hadn't goneanywhere. And it often was tied
in with food regulation,proposals. And there was a
collateral movement, the purefood movement to get federal
protections for our food supply.
(23:25):
And we got a huge push from adifferent muckraking journalist
Upton Sinclair also around thetime that the great American
fraud was published, to whichexposed really disgusting things
in the meatpacking industry. Andeverything he reported was true.
And it led to the to huge swellof support for the passage of
(23:47):
what became the 1906 Pure Foodand 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 asmuch 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 youknow what we have now that
really would have been a greathelp to muckrakers in early in
the progressive areas, we haveFreedom of Information Law, so
that they have access toinformation that would have been
(24:22):
much more difficult to get in1906. Just out of curiosity,
you know, you mentioned mothers,if they would have known this
was alcohol and morphine, thatthey wouldn't have given it to
their kids. If they had gone inand asked, did people know this?
Or was it considered proprietaryinformation and nobody who was
(24:42):
selling it pharmacists, doctors,nobody had any idea what was in
it?
That's a really good point. Andlet's keep in mind that we're
talking about, you know, 80years of time. So that the
people's awareness and theirhealth public health concerns
certainly changed. Over time,and we're talking about people
that weren't even born in 1830sthat finally supported the
(25:05):
passage of legislation in 1906.
So, yeah, there wasn't, I don'tknow that if they were wise
enough to say, tell me what's inthis medicine or I don't want
anything that has alcohol in itin the 1840s. I don't know what
the look, it would have beenregulated locally, there would
not have been a federal law. AndMaine was one of those states
that there were a lot of statesbefore the Civil civil war that
(25:28):
passed temperance lawsprohibiting the sale of alcohol,
except often there wereexceptions for medical purposes.
So you would actually and youcould actually find like,
Bourbon for sale and inpharmacies, and actually,
pharmacists were reallyresponsible for doing a lot of
compounding. And sometimes you'dsee like them being given a
(25:48):
prescription that said, use agood bourbon. But, but I
digress. Yeah, I don't know. Ireally, you know, it's very
likely that if someone wasassociated with the temperance
movement, they might say, Idon't want anything that has
alcohol in it. But I don'treally have any I don't have a
(26:09):
good answer for that. And otherthan that, it would have been
very circumscribed by localcontext.
Aaron Harmon (26:16):
If you kind of honed in on Mrs. Winslow's. But
were there other products likethis 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. AndMrs. Winslow's was so widely
recognized and used that it wasa powerful symbol. But there I
mean, there are medicines thatcame and went. And Adams makes
the point that some of the worstoffenders that had the most
(26:46):
dangerous amounts of morphine oralcohol in them, probably didn't
last on the market, becausepeople wouldn't buy them again.
Right. But yeah, they're I mean,the patent medicine industry,
especially like completelyunregulated, and as we already
discussed, anybody could make aproduct and try to start selling
it. There were a lot of a lot ofcompetitors. And there were, you
(27:10):
know, we're focusing on alcoholand morphine, but there were a
lot of other dangerous things inpatent 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 youif you wanted to sell a drug in
(27:30):
the United States, it had toadhere to the US Pharmacopoeia
or the National formulariesstandards for strength, purity
and identity. And if youdeparted from those at all, it
had to be really clearlyidentified on the label. And in
addition to adhering to thosestandards, you also had to print
(27:51):
on the label if your drugcontained one of any 11
Different habit formingsubstances, which included
alcohol and morphine, but alsocannabis and a number of other
substances. So it's a steptowards trying to educate
consumers about what's in theproduct, also to embarrass
(28:13):
manufacturers to not put thingsin the product that they don't
think that consumers would want.
But I will say unto you thequestion you asked earlier, like
if someone said, Don't give meanything with alcohol in it, I
bet there mean, there, it waswidely known that people did
seek out alcoholic patentmedicines for the purpose of
(28:34):
drinking alcohol, especially instates that had temperance laws,
and especially women, that itwas called tippling. Women that
could drink in the privacy oftheir own home, it wasn't proper
at the time for women to bedrinking in public. Women were
banned from public houses, orbars in New York City until like
(28:54):
1970, there was one famousTavern in New York City that
didn't let. So this wassomething like I'm sure that the
patent medicine industryprofited off of women's private,
some women's private consumptionof alcohol in the home.
Aaron Harmon (29:15):
I've seen a few things in newspapers from the
late 1800s, where there'll be achild that had died from use of
Mrs. Winslow's, and it almostfelt like they were saying the
child died because the parentoverdosed the child and it was
like they were shifting theblame to the parent and not the
manufacturer. Is that just a oneoff? Or was that something that
(29:37):
was common back then?
Unknown (29:39):
So they said like the parent also overdosed or the
parent and did the wrong gavethem 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 dosagedirections on Mrs. Winslow's
didn't say like, don't exceedfour to six doses and In a 24
hour period, you know, like,that definitely was not standard
protocol at the time, eventhough like we knew enough about
the dangers of morphine, thatthey could have included that.
(30:11):
But it's so if a parent thoughttheir kid was still suffering,
they probably give the kid moreright, even though it might be
the product that's making themsuffer. And certainly as kids
were becoming chemicallydependent on Mrs. Winslow's,
that, of course, would createsuffering and needing more of
it. But I, I agree, it's kind ofrevolting that there was no
(30:36):
effort to assign blame to amanufacturer that was creating a
product and not giving parentssufficient information to
protect their kids. But I don'tthink parents are as to blame,
because they didn't, theycouldn't have known how
dangerous the product was. Andit had 65 milligrams of morphine
per ounce. And I think nowadays,we've generally recognized that
(31:01):
200 milligrams of morphine cancause a fatal overdose. So I
mean, it could be very easy. Andthere certainly were documented
cases, by medical authorities ofkids dying from taking Mrs.
Winslow's.
Aaron Harmon (31:20):
I'm guessing it wasn't manufactured by GMP
standards. So their consistencyin 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, Idon'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 therevenue from advertisements,
because they were there's somany ads,
Unknown (31:47):
there's probably I mean, I'm sure there's some
truth to that. I mean, we'd haveto do the sort of the careful
legwork to, to demonstrateconclusively. But Edward box
research was really eye openingin terms of like, how dependent
the publishing industry was onpatent medicine manufacturers.
(32:08):
So it's very, very likely.
I was just kind of thinking to,you know, you mentioned people,
kind of modifying drugs. Do youthink, you know, this obviously
came from the manufacturer, andI don't know how the bottles
came if they were sealed? Or,you know, now you can tell
things have been opened. But youhave to wonder if when the
(32:29):
bottles were arriving at thelocation, they were being sold
for people, modifying them uponarrival, diluting it out with
something and try and make it gofarther.
Interesting. I don't know. Imean, I haven't read anything
about that. But, you know,there's no law against it.
There's certainly economicincentive for doing that.
Yeah, I was just even thinking,you know, the moms that were
(32:51):
lower income, you know, do theyuse part of it, and then maybe
diluted out a little bit withsomething just last week, just
to see if they can make it lasta little longer? Totally. Yeah.
It's just kind of when youbrought up the you could modify
drugs. I was curious, like aftergot 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 overtime. It, of course, changed
most significantly after 1906When they had to print the
ingredients on the label. And asa result, I mean, I said like
one of the main incentives of alaw what were was to embarrass
(33:36):
manufacturers, if they weregoing to continue to put like
morphine in their drugs, thenthey'd either really need to
have a reason for it. And peoplewould want to have a drug that
had morphine in it, or peoplewould be like, Oh, I don't
actually want that. So Mrs.
Winslow's actually moved todramatically reduced the
morphine content in Mrs.
(33:57):
Winslow's and eventuallyultimately, removed it entirely.
But they did print how muchalcohol was on it contained. So
still, I'm sure that deterredsome people alone knowing that
there was alcohol in theirproduct.
Aaron Harmon (34:13):
No, I have to ask since it was alcohol, it should
have been an elixir and not asyrup.
Unknown (34:20):
Yeah, good point. We did have the Bureau of
Chemistry, which was theprecursor to the FDA did take
action against Mrs. Winslow'sfor misbranding. But it wasn't
because they failed to callthemselves an elixir. It's
because of soothing. It wasabout puffed up claims, which
(34:44):
was just epidemic in the patentmedicine industry. And the
Bureau of Chemistry presentedall of these quotes from the
labeling about not just beingsoothing, but all of the
wonderful things that would dofor children and the courts for
On that they had to remove allof 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 timebecause the government was not
paying for it. It was consumers.
Is that correct? I don't know.
Is that most thinking about thismorning over coffee? Well, thank
you, Vanessa. Appreciate youbeing on here.
Unknown (35:26):
My pleasure. Thanks for asking me.
This episode of Inside Outquality was brought to you
thanks to South Dakota biotechAssociation. If you have a story
you'd like us to explore andshare. We'd love to hear from
you. Submit your ideas byvisiting www.sd bio.org
Aaron Harmon (35:44):
You've made it this far in the episode. Thanks
for listening
Hi, I'm Aaron Harmon.
Leslie Cooper (00:01):
And I'm Leslie Cooper. Welcome to Inside Out
quality.
Aaron Harmon (00:05):
Leslie and I are quality nerds. We like to figure
out what can go wrong and how itcan be prevented. Cap is our our
friend. How can we use qualityto build better safer products?
Can quality be a toolentrepreneurs use for success?
On
Leslie Cooper (00:19):
this podcast we talked to some fascinating
guests and listen to theirstories about quality events
gone both right and wrong. wedissect the stories to teach and
learn from the experiences ofour guests. So grab your coffee
secure the lid, ensure it's nottoo hot and enjoy our episode.
Aaron Harmon (00:38):
Mrs Winslow's soothing syrup has been used for
over 65 years by millions ofmothers for their children while
teething with perfect success.
It soothes the child softens thegums allays all pain dispels
when colic is the best remedyfor infantile diarrhea sold by
druggist in every part of theworld. Be sure to ask for Mrs.
Winslow's soothing syrup andtake no other kind 25 cents a
bottle, an old and well triedremedy. This is one ad from an
(01:01):
1813 newspaper. If you were amom trying to make your child
feel better, would you use it?
Is it safe? And why wouldn't itbe when they actually sell it
and advertise it to be perfectlysuccessful? If it wasn't, here's
another you disturbed at nightand broken up your rest by a
sick child suffering, it willrelieve the poor suffer and is
(01:21):
the prescription of one of theoldest and best female
physicians and nurses in theUnited States. This ran in
Lincoln Nebraska newspaper theindependent and it's no five.
And by the way, it curesdiarrhea, regulates the stomach
and bowels. Cures when colicsoftens the gums reduces
inflammation and gives tone andenergy to the whole system.
Other ads read things likeoperates like magic perfectly
(01:43):
safe in cases and buttons totaste. 1000s of ads exist like
this. Mrs. Winslow's soothingsyrup was an insanely prolific
advertiser. mother saw these adsall across the United States and
newspapers starting in 1845.
Were there a list of sideeffects? Are there any Mrs
Winslow's soothing syrupcontains 65 milligrams of
morphine and each ounce ofalcohol that was suspended in a
(02:04):
toddler can be given 260milligrams a day of morphine by
a mom following the instructionson the label. The Mayo Clinic's
website post side effects ofmorphine including a list of 38
which include blurred vision,chills, confusion, cough,
decreased urination, fainting,loss of appetite, severe
constipation, and this isconsidering a dose of 10 to 20
milligrams every four hours. Inthis episode of insightful
(02:28):
quality, we will discuss thehistory of one of the most
notorious marketed medicines,Mrs. Winslow's soothing syrup.
This product resulted in thedeath of countless children and
cause addiction and theirparents. To help us we are
joined by Dr. Vanessa barrels.
FDA historian extraordinaire,and previous guest on the elixir
sulfanilamide episode. Welcometo Inside Out quality, Vanessa.
Vanessa Burrows (02:49):
Thanks. Nice to be here.
Aaron Harmon (02:51):
So right off the bat, what was the drug industry
like in the 1840s in the US?
Unknown (02:56):
So this is an important question, because in order to
understand, you know, Mrs.
Winslow's, and those sorts ofproducts and why they existed in
the first place, you kind ofhave to look at the environment
that inspired their development.
And it's really different thanthe medical market, we're used
to. The 1840s was actually areally formative period in
(03:19):
modern medicine. It came afterseveral decades of concern about
the quality of drugs in themarketplace, and the ability of
professionals to maintain theirlegitimacy in the 1810s. And
especially in 1820. There was alot of concern about
(03:41):
adulteration of drugs. I bet youdidn't think I was going to
start with adulteration.
Vanessa Burrows (03:47):
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 nothingthat was not illegal at all. You
didn't have to discloseeverything that was in your
drugs. And so there were, therewas just one really influential
(04:08):
work in 1820, by an author namedFrederick Kuhn, who did all of
this analysis and he reported onhis findings about Peruvian
bark, which had been derivedfrom like inferior plants and
was suffering decay and beingsold as if it was a high quality
product, or how essential oilslike the entire industry, he
(04:31):
indicted for being so woefullyadulterated with alcohol or
turpentine, that they're almostunfit for human use a number of
other infractions. So thiscreated a great deal of concern
amongst practicing pharmacistsand led to the creation of a
very important Compendium the USUS Pharmacopoeia. There on there
(04:54):
was a voluntary, professionalbody that created standards of
string purity and identity forMateria Medica. And this starts
to create higher standards ofquality for drugs. You see this
professional movement todistinguish quality medicines
(05:16):
from quack medicines. And it'sparalleled by a movement in
medicine, to distinguishlegitimate medical practitioners
from quacks. And there's alittle bit of social context
that I think is important towrap in here, not just in terms
of these very importantmovements of
professionalization. But 1830sis what in the United States
(05:39):
referred to as JacksonianDemocracy when Andrew Jackson
was president. And there is thisgreat movement for democratizing
society and empowering peoplethat hadn't had power before,
like non land owning white mengetting the right to vote.
There's also a much darker sideof Jacksonian Democracy, like
(06:00):
Indian removal and things likethat. But one of the things that
he was associated with wasexpanding democracy for certain
members of the United Statesthat didn't enjoy rights
previously. So Alongside this,you see people being sort of
skeptical of elites, likemedical practitioners, and
(06:20):
seeking self care, partlyvolitionally, you know, because
they trusted their localpharmacist more than they
trusted medical doctor, maybe,maybe because they had heard so
many stories about crackdoctors, giving people poor care
that they didn't want to risk itfor themselves. But also, very
(06:42):
importantly, because medicalcare costs money. And this is a
period in time when you'restarting to see the growth of
market society, in the sort ofproto industrial economy in the
United States, more people areworking in factories, and there,
they don't have a lot of moneyto spend on medical care. So
going in buying a bottle ofpatent medicine was much more
(07:06):
feasible for a urban factoryworker than taking time off of
work and going to see a doctor.
So it's important to understandthat on one side, you have these
professional movements startingto carve out or starting to
define what counts as alegitimate medicine and what
doesn't. And you also have thesocial forces that are kind of
(07:28):
compelling people to seekmedicine in bottles that they
can easily procure. Now,alongside that you also have the
introduction into the medicalarmamentarium of this highly
addictive substance, morphine,which was an amazing painkiller,
but highly addictive. And in theantebellum period, when it was
(07:54):
introduced into medicine wasn'tvery well known how addictive
morphine was, that was reallymore discovered after the Civil
War when morphine had beenwidely used. And after the
introduction of hypodermicinjection in the 1850s. So you
have this nurse, we believe inrural Maine in the 1830s, who
(08:17):
apparently developed a tincturethat was a blend of alcohol and
morphine and other flavoringsthat was made to calm, fussy,
babies, teething babies, babieswith colic, babies have so many
reasons to be uncomfortable. Andso few ways of expressing it
that Mrs. Winslow's soothingsyrup was meant to be an all
(08:38):
purpose soother. And this is areally important thing, sorry to
go on and on. And
Unknown (08:48):
this is a very important thing to realize. She
didn't have to meet anystandards to sell this product.
She didn't have to present anNDA to the US Food and Drug
Administration. She just createda product that she thought I
assume, was very helpful toparents and babies and started
selling it. She didn't have todo any safety testing. She
(09:10):
didn't have to prove it waseffective. And she didn't have
to put on the label what itactually was, and keep blaming
it on her. But it wasn'tactually Mrs. Winslow, who
marketed this product. It washer son in law that first put it
on the market in partnershipwith Jeremiah Curtis and
Benjamin Perkins first,patenting this medicine.
(09:31):
Actually, I'm sorry, I didn'tpatent it. I maybe should have
said this sooner. But patentmedicines mostly were a
misnomer. They were proprietarybecause they were made to be
sold to make money. But in orderto get a patent you would have
had to submit to the US PatentOffice have listed ingredients
and disclose what was in yourvery profitable special formula.
(09:54):
So most patent medicines wereactually trademarked, which
actually tells us a lot abouthow they were more Get it, that
brand name, that trademark wasso important in lieu of a
patent, that the namerecognition was really
important. And the imagerysurrounding the name in the
marketing was really importantas well. So this product was,
(10:16):
which is kind of shockingnowadays was very much forged by
a number of different socialforces and advancements in
medicine, but mostly was madepossible by a complete lack of
regulation in the market at thetime,
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 ofadvertisements. And you
mentioned a little bit aboutpeople not being able to afford
health care. Can you talk aboutthe 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 usthat women were the agents in
purchasing it. Right. Theimagery for Mrs. Winslow's sorry
that we can't look at a picturetogether but usually depicted a
mother surrounded by children ormaybe even just a child, you
(11:15):
know, rosy cheeks and you know,nice and plump and meant to
imply like health and like aloving home and things like
that. It was very much meant toimpress upon the consumer that
if you buy this, you arefulfilling your maternal role,
you're going to be taking verygood care of your child, why
would you let your child sufferif you're a good mother, and of
(11:36):
course, the consumer has no wayof knowing that what they're
actually purchasing is poisonhas an enough poison easily to
kill an adult person in it.
Nowadays, of course, we take forgranted that any person of any
gender can purchase a medicationbut women, it was marketed to
women to be the purchasers.
Right. And this is at a timewhen you have sort of new
(11:59):
definition of classes inAmerican society, especially
after the Civil War. You havethe emergence of a relatively
wealthy middle class and a muchpoor working class. So on one
hand, you have Mrs. Winslow'smarketed towards working class
mothers who were in fact workingand would lose wages if they had
(12:23):
to take time off of work to takecare of sick children, or had to
send their sick child to someoneto take care of them during the
day. And that person had manychildren to take care of and
needed, you would use Mrs.
Winslow's soothing syrup as anaid for managing the multiple
children in their care. On onehand, you have Mrs. Wentz was
marketed to working class womenwho needed a cheap and effective
(12:47):
treatment for a number ofdifferent ailments for their
kids. And then on the otherhand, you had it marketed
towards these middle class womenwho had status anxiety out there
place in society and did a lotof conspicuous consumption to
justify their higher role fromfrom working class people. So
(13:10):
being able to purchase whatevermedicine they wanted, especially
one that had was depicted ashelping them provide a very
soothing and comfortable homefor their kids. Sort of appeal
to that those sensitivities. Butthis this one thing is really
interesting and little knownabout Mrs. Winslow's Mrs.
(13:32):
Winslow's son in law JeremiahCurtis had a daughter named
Laura Curtis Bellard, she endedup marrying one of the employees
one of Jeremiah Curtis'semployees, the Curtis and
Perkins organization. SoLockhart is Bellard was a
suffragists. And she was anauthor and she was very much
(13:52):
like a women's rights advocate.
And she was one of the foundingofficers of the National Women's
Suffrage Association along withElizabeth Cady Stanton and Susan
B. Anthony. She was, I believeshe was the corresponding
secretary, and they had in anationally circulating journal
called the revolution thatoriginally was managed by
(14:16):
Stanton and Anthony. But after ayear or two, it was really
suffering financially suffering,in part because Susan B. Anthony
and Elizabeth Cady Stantonrefused to allow accept money
from patent medicine companiesto advertise in this journal.
And when it started reallysuffering to the point where
(14:36):
they might have to stopcirculating the journal, Laura
Curtis Bellard purchased it fromthem and started running it. Her
family made millions of dollarsoff of Mrs. Winslow's by the
late 1850s. They were selling1.5 million bottles of this
stuff a year. Wow. I know. It'skind of shocking. Anyway, so She
(15:00):
changed that policy and startedaccepting patent medicine
advertising in the journal andit became much more viable and
had a larger circulation. So,sort of ironically, it
information awareness of Mrs.
Winslow's as a product spreadwith the increased circulation
of suffrage materials. And thenthis national network of
(15:22):
suffragists. And I don't mean tosay at all that suffragists were
pushing Mrs. Winslow's, that isnot my point. It just was a very
sort of ironic tie in, and thekind of women that are reading
the revolution, were middleclass women that were interested
in advancing women's rights. Sothat's definitely an important
(15:43):
angle of the marketing as well.
Aaron Harmon (15:47):
Now we'll take a quick break to hear from one of
our sponsors.
Joni Ekstrum (15:50):
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(16:10):
world. So it's good a biotech ishere to inform, to connect, and
to advocate for our criticalindustry. Whether you're
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learn more about it, we want tohear from you find us at www
that SD bio.org. Now back to theshow.
Unknown (16:30):
So I guess the question is, is when did this product
finally get regulated? Like howdid that come about?
From the post Civil War periodto the early 20th century,
states start to recognize a lotof problems with the patent
medicine industry on their own.
So you have sort of hodgepodgestate reactions, and efforts to
(16:51):
regulate the patent medicineindustry, which of course, was
really infuriating to companiesthat wanted to be able to sell
their product across a likenationally integrated market. If
you have a bunch of differentrules and a bunch of different
states, it makes it so much moredifficult to create one product
that can be sold everywhere. Butit wasn't the hodgepodge state
(17:14):
laws didn't really do much tobait the flow of dangerous
patent medicines. It reallyrequired federal regulation. And
this took a movement. Becausethe problem is these were one of
the reasons these medicinesbecame popular in the first
place, as I was trying toexplain earlier is people had no
(17:35):
idea what was in them if theyknew in the 1830s. If a mother
knew that, if she bought Mrs.
Winslow's she was going to begiving her baby alcohol and
morphine, poisonous amounts ofalcohol and morphine. She'd
never would have bought it. Andwe would never even remember
Mrs. Winslow's, right. So it'sthat secrecy or that obfuscation
(17:58):
of the lack of labelingrequirements that made it
possible for these products toproliferate, and be so
profitable. So how do you dealwith that problem, you need to
educate people, you need somemechanism to increase awareness
of what's actually in theseproducts. And this was largely
accomplished in some casesthrough civil society and
(18:20):
through like privateassociations, lectures, things
like that. But mostly it wasaccomplished through journalism.
And through this particulargroup of journalists called
muckrakers, which is not soaffectionate name given to them
by the progressive president,Teddy Roosevelt, who said,
they're always looking at thenegative and society, they're
always like staring down at themuck in the ground and trying to
(18:42):
stir it up. But there was a lotof muck that needed attention
and needed to be cleaned out.
And this certainly was one ofthose things. One really
significant journalist, a mannamed Samuel Hopkins Adams, he
wrote for a number of differentreally well recognized journals
at the time. In fact, he wrotethe story for Cosmopolitan that
(19:02):
ended up being a major Hollywoodmovie called It Happened One
Night with Clark Gable, andClaudette Colbert, which was one
of those few movies to win likeall five major ACC Academy
Awards. Anyway, so he was a hewas a big deal writer. He did
this series in coal yearsmagazine in 1905. In 1906, where
(19:23):
he exposed the contents, he hadscientists analyze some very
popular patent medicines. Heprinted with the analysis
revealed what's actually in themedicines and discuss some of
the ways in which like casestudies ways in which they
impacted people's lives andmarketing practices, why they
(19:45):
are so ubiquitous in society.
This series was called The GreatAmerican fraud. And in the
fourth issue, which was aboutsubtle poisons, it's published
in December. of 1905. He looksat Mrs. Winslow's and other
students syrup's. And he tells astory he referred to as a
(20:07):
housekeeper at a New York lawoffice as a scrub woman who was
excited to go to a ball when youthink, and Adams relates that
the attorney in the office wasasked 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 spoonfulof Mrs. Winslow's, and they lay
(20:28):
like dead until morning, whichkind of eerie kind of language
to use. Yeah. So Adams uses thisto make a point about how Mrs.
Winslow's was marketed to and infact, was actually exploiting
working class mothers. And thiswasn't news, that part wasn't
news, but he's reporting italong with the information about
(20:49):
how it actually contains lethaldoses of morphine. Really, I
think that's what really hithome. And it's tied into this
larger series. That actually,the AMA ended up binding
together and publishing. So thatwas could circulate
independently of the just thereadership for coal years, which
(21:09):
wasn't a small readership inother parts in the great
American fraud. Adams alsoreveals, like how the publishing
industry was just so dependenton patent medicine revenue from
patent medicine advertisements,and his reporting finds that,
like the Chicago Tribunereceived $80,000 in 1905 money
(21:32):
that's like $2.5 million. Today,from Patton, Madison advertisers
in the Hearst Newspapersreceived over 500,000. So that's
like, over $15 million intoday's money. So it's like, so
significant. I mean, I guess, Ican't even imagine how
advertising goes for these days.
But um, in that time period, itwas so significant, it was like,
(21:55):
how could they ever go withoutthe patent medicine advertising.
And alongside Adams research,there was an editor for a
magazine called The Ladies HomeJournal. His name is Edward
Bach, who revealed that a lot ofpatent medicines, companies had
what were called Red clauses intheir advertising contracts,
(22:17):
which basically said that if anystate were the newspaper or
magazine, or whatever wasdistributed if the state passed
an anti patent medicine law,that they didn't owe the
magazine any money. So itbasically encouraged newspapers
and magazines to lobby againstpatent medicine regulation. So
(22:39):
you had this muckraker movementto expose both the dangerous
things that were in patentmedicines, but also the forces
that made them everywhere inAmerican public life. And that
really started to turn publicsupport in favor of federal
regulation of drugs in theUnited States. And of course,
(23:01):
there'd been like legislationintroduced at the federal level
for decades and hadn't goneanywhere. And it often was tied
in with food regulation,proposals. And there was a
collateral movement, the purefood movement to get federal
protections for our food supply.
(23:25):
And we got a huge push from adifferent muckraking journalist
Upton Sinclair also around thetime that the great American
fraud was published, to whichexposed really disgusting things
in the meatpacking industry. Andeverything he reported was true.
And it led to the to huge swellof support for the passage of
(23:47):
what became the 1906 Pure Foodand 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 asmuch 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 youknow what we have now that
really would have been a greathelp to muckrakers in early in
the progressive areas, we haveFreedom of Information Law, so
that they have access toinformation that would have been
(24:22):
much more difficult to get in1906. Just out of curiosity,
you know, you mentioned mothers,if they would have known this
was alcohol and morphine, thatthey wouldn't have given it to
their kids. If they had gone inand asked, did people know this?
Or was it considered proprietaryinformation and nobody who was
(24:42):
selling it pharmacists, doctors,nobody had any idea what was in
it?
That's a really good point. Andlet's keep in mind that we're
talking about, you know, 80years of time. So that the
people's awareness and theirhealth public health concerns
certainly changed. Over time,and we're talking about people
that weren't even born in 1830sthat finally supported the
(25:05):
passage of legislation in 1906.
So, yeah, there wasn't, I don'tknow that if they were wise
enough to say, tell me what's inthis medicine or I don't want
anything that has alcohol in itin the 1840s. I don't know what
the look, it would have beenregulated locally, there would
not have been a federal law. AndMaine was one of those states
that there were a lot of statesbefore the Civil civil war that
(25:28):
passed temperance lawsprohibiting the sale of alcohol,
except often there wereexceptions for medical purposes.
So you would actually and youcould actually find like,
Bourbon for sale and inpharmacies, and actually,
pharmacists were reallyresponsible for doing a lot of
compounding. And sometimes you'dsee like them being given a
(25:48):
prescription that said, use agood bourbon. But, but I
digress. Yeah, I don't know. Ireally, you know, it's very
likely that if someone wasassociated with the temperance
movement, they might say, Idon't want anything that has
alcohol in it. But I don'treally have any I don't have a
(26:09):
good answer for that. And otherthan that, it would have been
very circumscribed by localcontext.
Aaron Harmon (26:16):
If you kind of honed in on Mrs. Winslow's. But
were there other products likethis 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. AndMrs. Winslow's was so widely
recognized and used that it wasa powerful symbol. But there I
mean, there are medicines thatcame and went. And Adams makes
the point that some of the worstoffenders that had the most
(26:46):
dangerous amounts of morphine oralcohol in them, probably didn't
last on the market, becausepeople wouldn't buy them again.
Right. But yeah, they're I mean,the patent medicine industry,
especially like completelyunregulated, and as we already
discussed, anybody could make aproduct and try to start selling
it. There were a lot of a lot ofcompetitors. And there were, you
(27:10):
know, we're focusing on alcoholand morphine, but there were a
lot of other dangerous things inpatent 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 youif you wanted to sell a drug in
(27:30):
the United States, it had toadhere to the US Pharmacopoeia
or the National formulariesstandards for strength, purity
and identity. And if youdeparted from those at all, it
had to be really clearlyidentified on the label. And in
addition to adhering to thosestandards, you also had to print
(27:51):
on the label if your drugcontained one of any 11
Different habit formingsubstances, which included
alcohol and morphine, but alsocannabis and a number of other
substances. So it's a steptowards trying to educate
consumers about what's in theproduct, also to embarrass
(28:13):
manufacturers to not put thingsin the product that they don't
think that consumers would want.
But I will say unto you thequestion you asked earlier, like
if someone said, Don't give meanything with alcohol in it, I
bet there mean, there, it waswidely known that people did
seek out alcoholic patentmedicines for the purpose of
(28:34):
drinking alcohol, especially instates that had temperance laws,
and especially women, that itwas called tippling. Women that
could drink in the privacy oftheir own home, it wasn't proper
at the time for women to bedrinking in public. Women were
banned from public houses, orbars in New York City until like
(28:54):
1970, there was one famousTavern in New York City that
didn't let. So this wassomething like I'm sure that the
patent medicine industryprofited off of women's private,
some women's private consumptionof alcohol in the home.
Aaron Harmon (29:15):
I've seen a few things in newspapers from the
late 1800s, where there'll be achild that had died from use of
Mrs. Winslow's, and it almostfelt like they were saying the
child died because the parentoverdosed the child and it was
like they were shifting theblame to the parent and not the
manufacturer. Is that just a oneoff? Or was that something that
(29:37):
was common back then?
Unknown (29:39):
So they said like the parent also overdosed or the
parent and did the wrong gavethem 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 dosagedirections on Mrs. Winslow's
didn't say like, don't exceedfour to six doses and In a 24
hour period, you know, like,that definitely was not standard
protocol at the time, eventhough like we knew enough about
the dangers of morphine, thatthey could have included that.
(30:11):
But it's so if a parent thoughttheir kid was still suffering,
they probably give the kid moreright, even though it might be
the product that's making themsuffer. And certainly as kids
were becoming chemicallydependent on Mrs. Winslow's,
that, of course, would createsuffering and needing more of
it. But I, I agree, it's kind ofrevolting that there was no
(30:36):
effort to assign blame to amanufacturer that was creating a
product and not giving parentssufficient information to
protect their kids. But I don'tthink parents are as to blame,
because they didn't, theycouldn't have known how
dangerous the product was. Andit had 65 milligrams of morphine
per ounce. And I think nowadays,we've generally recognized that
(31:01):
200 milligrams of morphine cancause a fatal overdose. So I
mean, it could be very easy. Andthere certainly were documented
cases, by medical authorities ofkids dying from taking Mrs.
Winslow's.
Aaron Harmon (31:20):
I'm guessing it wasn't manufactured by GMP
standards. So their consistencyin 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, Idon'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 therevenue from advertisements,
because they were there's somany ads,
Unknown (31:47):
there's probably I mean, I'm sure there's some
truth to that. I mean, we'd haveto do the sort of the careful
legwork to, to demonstrateconclusively. But Edward box
research was really eye openingin terms of like, how dependent
the publishing industry was onpatent medicine manufacturers.
(32:08):
So it's very, very likely.
I was just kind of thinking to,you know, you mentioned people,
kind of modifying drugs. Do youthink, you know, this obviously
came from the manufacturer, andI don't know how the bottles
came if they were sealed? Or,you know, now you can tell
things have been opened. But youhave to wonder if when the
(32:29):
bottles were arriving at thelocation, they were being sold
for people, modifying them uponarrival, diluting it out with
something and try and make it gofarther.
Interesting. I don't know. Imean, I haven't read anything
about that. But, you know,there's no law against it.
There's certainly economicincentive for doing that.
Yeah, I was just even thinking,you know, the moms that were
(32:51):
lower income, you know, do theyuse part of it, and then maybe
diluted out a little bit withsomething just last week, just
to see if they can make it lasta little longer? Totally. Yeah.
It's just kind of when youbrought up the you could modify
drugs. I was curious, like aftergot 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 overtime. It, of course, changed
most significantly after 1906When they had to print the
ingredients on the label. And asa result, I mean, I said like
one of the main incentives of alaw what were was to embarrass
(33:36):
manufacturers, if they weregoing to continue to put like
morphine in their drugs, thenthey'd either really need to
have a reason for it. And peoplewould want to have a drug that
had morphine in it, or peoplewould be like, Oh, I don't
actually want that. So Mrs.
Winslow's actually moved todramatically reduced the
morphine content in Mrs.
(33:57):
Winslow's and eventuallyultimately, removed it entirely.
But they did print how muchalcohol was on it contained. So
still, I'm sure that deterredsome people alone knowing that
there was alcohol in theirproduct.
Aaron Harmon (34:13):
No, I have to ask since it was alcohol, it should
have been an elixir and not asyrup.
Unknown (34:20):
Yeah, good point. We did have the Bureau of
Chemistry, which was theprecursor to the FDA did take
action against Mrs. Winslow'sfor misbranding. But it wasn't
because they failed to callthemselves an elixir. It's
because of soothing. It wasabout puffed up claims, which
(34:44):
was just epidemic in the patentmedicine industry. And the
Bureau of Chemistry presentedall of these quotes from the
labeling about not just beingsoothing, but all of the
wonderful things that would dofor children and the courts for
On that they had to remove allof 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 timebecause the government was not
paying for it. It was consumers.
Is that correct? I don't know.
Is that most thinking about thismorning over coffee? Well, thank
you, Vanessa. Appreciate youbeing on here.
Unknown (35:26):
My pleasure. Thanks for asking me.
This episode of Inside Outquality was brought to you
thanks to South Dakota biotechAssociation. If you have a story
you'd like us to explore andshare. We'd love to hear from
you. Submit your ideas byvisiting www.sd bio.org
Aaron Harmon (35:44):
You've made it this far in the episode. Thanks
for listening
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