July 23, 2024 • 16 mins
Cheaper, knockoff versions of Ozempic, Wegovy and Zepbound are flooding the market, often promoted by telehealth companies in online ads and by influencers on TikTok and Instagram. These versions of the drugs are made by so-called compounding pharmacies, an obscure corner of America’s pharmaceutical market which makes drugs that aren’t approved by the Food and Drug Administration.
On today’s Big Take podcast, Bloomberg reporters Ike Swetlitz and Madison Muller tell host Sarah Holder about their investigation into a $1 billion shadow industry that could be putting Americans’ health in danger.
Read more: Unsafe Ozempic Knockoffs Are Flooding the Market
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:02):
Bloomberg Audio Studios, podcasts, radio news. I am a single parent.
I'm a widow.
Speaker 2 (00:11):
My husband was in the military and he died in
the line of duty years.
Speaker 1 (00:16):
Ago, so it's just me.
Speaker 2 (00:19):
So if something happens to me, you know, I think
about my kids.
Speaker 3 (00:25):
Lindsey Posey is a thirty eight year old living in Spartanburg,
South Carolina with her two teenage kids. About a year ago,
after a series of health scares, a doctor told her
she needed to lose weight and offered to write her
a prescription for ozembic or munjaro.
Speaker 2 (00:40):
I told him that I'm like, yeah, I would love to,
but my insurance isn't going to cover it.
Speaker 3 (00:45):
But then she thought about her kids and started looking
into ways to pay for the weight loss drugs, which
can cost hundreds of dollars a month without insurance.
Speaker 2 (00:54):
So I, you know, started going on Reddit, researching different places, googling,
and I came across telehealth companies.
Speaker 3 (01:04):
The telehealth company Lindsay found wrote her a prescription for
a weight loss drug and then hooked her up with
a compounding pharmacy. Compounders make copycats of drugs, often at
cheaper prices, but the compounded versions aren't approved by the FDA.
Lindsay says the first vile she received seemed to work,
lowering her desire for food, but then the second vial
(01:25):
seemed to have no effect.
Speaker 2 (01:27):
So, you know, me, not really knowing what I'm doing,
I thought, Okay, well maybe that means I need to
move up in dose. So I increased my dose and
nothing happened.
Speaker 3 (01:43):
Then Lindsay opened her third fial of medicine.
Speaker 2 (01:46):
And you know, within a week of starting it, my
face just kind of started to break out.
Speaker 1 (01:53):
Within two weeks, it was getting really bad. I think
I did.
Speaker 2 (01:57):
Three weeks of that vial before I had gone through
every avenue and process of elimination.
Speaker 1 (02:04):
Trying to figure out what is causing this.
Speaker 3 (02:07):
Lindsay stopped applying a new moisturizer she'd been using, she
modified her diet.
Speaker 2 (02:12):
You know, I really I couldn't find an answer, so
I thought it has to be this.
Speaker 1 (02:17):
So I ended up throwing the rest of that vial away.
Speaker 3 (02:21):
Lindsay eventually got a replacement vial from the compounding pharmacy.
Speaker 2 (02:25):
I started using that one and it was very strong,
like I had side effects after the first shot, and
I'm like, what in the world is going on? Why
is every vial that I get so inconsistent?
Speaker 3 (02:39):
Lindsay says the experience made her wonder just where these
vials were coming from.
Speaker 1 (02:44):
It's kind of scary. You know.
Speaker 2 (02:46):
They comfort you, They you know, say all of these things. Oh,
you've got nothing to worry about. Everything's you know, tested
and up to standards, and then you start kind of.
Speaker 1 (02:55):
Digging and you're like, okay, well is that the truth?
Speaker 3 (03:00):
Today on the show, how the skyrocketing demand for weight
loss drugs like zetbound, ozempic and wgov is sending Americans
into a one billion dollar shadow industry that could be
putting their health in danger. I'm Sarah Holder, and this
is the big take from Bloomberg News.
Speaker 4 (03:22):
Last year, when you would google ozembic or wagov, most
of the things that would come up online were news
articles or you know so and so celebrities taking ozembic.
Speaker 3 (03:33):
Madison Muller is a health reporter at Bloomberg. She mostly
covers ozempic, wagovi and other weight loss drugs, and she
says over the past year she's noticed different results starting
to show up on Google.
Speaker 4 (03:45):
It's crazy. I mean, if you type ozembic, into Google Search,
like all of the advertisements are for telehealth companies that
are selling compounded drugs.
Speaker 3 (03:55):
You might have seen these results too for telehealth companies
like Hymns and Hers or Row that sometimes advertised cheaper
copycat mets. Madison got to work compiling all of the
results she found for companies that said they sold these
sought after weight loss drugs.
Speaker 4 (04:11):
I mean, I think there were like sixty companies or
something at the time, and I was like, there's something
going on here, and so Ike and I started looking
into this.
Speaker 3 (04:19):
Ike Sweatltz is also a reporter at Bloomberg who focuses
on the business of health and medicine. He was intrigued
by what Madison found out, and he started looking into
these compounding pharmacies that many telehealth companies partner with to
procure weight loss drugs for their patients. To be clear,
compounded drugs aren't just generic versions of brand name products.
(04:40):
There's something else entirely.
Speaker 5 (04:44):
So compounding is how drugs have been made really since
the beginning, you know, prior to modern manufacturing, prior to
the FDA, if you needed a medicine, you went into
the pharmacy and they mixed together some chemicals and you know,
gave it to you and whatever sort of format you
needed it. So that was that was how you got medicines.
Speaker 3 (05:03):
But that changed as drug making became more mechanized and automated. Eventually,
the Food and Drug Administration was established and with it
the regulations that required drug makers to submit medicines for
approval before they could be sold.
Speaker 5 (05:17):
But compounders still had a role making some medicines, mostly
medicines for people who might have might be allergic to
one of the ingredients that's in the FDA approved version,
or patients who like physically could not take the FDA
approved drug.
Speaker 3 (05:34):
Essentially, the FDA left a loophole open for these compounders
to continue making small batches of drugs if a patient
needed a medicine to be slightly tweaked for some reason.
Speaker 5 (05:44):
The FDA you know, sort of knew that, you know, technically,
on paper, this was like a violation of the federal
law because the drugs had not gone through the FDA
approval process. They were just choosing to, you know, exercise
enforcement discretion and not enforce those laws and allow compounding
to continue as long as it was regulated by the states.
Speaker 3 (06:05):
Ike says this worked for a while until twenty twelve,
when dozens of people died from contaminated drugs made at
a compounding center in Massachusetts.
Speaker 6 (06:14):
State officials here in Massachusetts say they found a leaking boiler,
dirty floor mats, even black specs of fungus visible to
the naked eye in sealed vials at the New England
compounding center.
Speaker 3 (06:26):
That led to a national meningitis outbreak, and in twenty
thirteen to the passage of a new law which laid
out more clearly how compounders could operate. But even with
those new rules, there was still a loophole for compounders
who are making drugs that are in short supply, says Madison.
Speaker 4 (06:43):
So compounders got into the weight loss drug industry most
likely around two ish years ago when these drugs were
first falling into shortage, So hozempic would go via manjarros
that bound to have gone in and out of short
supply with the US Food and Drug Administration, and that
sort of loophole allowed them to capitalize on this opportunity
(07:04):
and allowed this market to really proliferate because they were
allowed to do this and they were filling a need
and continue to do so, because these drugs are still
in shortage.
Speaker 3 (07:14):
Even if you've been prescribed ozepic or another some maaglutide drug,
it can often be very difficult to find a pharmacy
with the medicine in stock.
Speaker 4 (07:22):
We've seen a lot of issues between the supply shortages, affordability,
insurance companies not covering weight loss drugs. That's made it
really really difficult for patients who need these drugs to
get them. And so what these compounding pharmacies have done is,
I mean their drugs are not in shortage, and so
they've made the drugs a lot more readily available. And
(07:45):
that also helps telehealth companies and other businesses that have
sort of built up a business around prescribing these drugs
to patients.
Speaker 3 (07:54):
Are they using the same active ingredients as ozepic and
we go V and manduro.
Speaker 5 (07:59):
So if if the compounders are doing what they're supposed
to do and following the rules, then yes, they should
be using the same active ingredients.
Speaker 3 (08:07):
But sometimes patients might be confused about exactly what drug
they're getting.
Speaker 4 (08:11):
You know, when you're a patient and you're trying to
sort through all of the medical information online and you're
inundated with a bunch of ads and you just click
on one that's like, oh, this is cheaper, I might
as well. This looks legitimate. It has a nice glossy
website and you know, smiling patients on it and says
that it's selling ozembic, Like, oh, it probably is. So
(08:32):
I think that that's sort of the challenge is in
this you know world of misinformation and online information that
we're like inundated with just so much of it, and
it's hard to sift through it and really determine what
is genuine and what's not.
Speaker 3 (08:48):
Other times, Madison says patients are in fact seeking out
the cheaper, compounded version of the drug.
Speaker 4 (08:54):
And that's one of the things I mean, especially like
the on social media, the compounded drugs have really taken
off off, especially on TikTok.
Speaker 7 (09:02):
Right, So in this bag, I have alcohol slows to
prep your skin. I also have the needles that you
use for injection, and then in this little vial right here, it's.
Speaker 1 (09:13):
Actually the compounded medication.
Speaker 7 (09:15):
You can see it.
Speaker 4 (09:16):
A lot of TikTok influencers and people who have large
followings on Instagram and TikTok are talking about these drugs
and you know, serving as influencers for the telehealth companies
and helping to market these weight loss drugs.
Speaker 2 (09:32):
And with the compounded version, as long as there's a shortage,
I'm going to get my medication.
Speaker 3 (09:36):
Ike says, these compounding pharmacies are growing rapidly, partially to
meet demand and partially because there's a lot of money
to be made.
Speaker 5 (09:45):
One of the bankers who I talked to, you know,
told me that these compounding pharmacy owners are going to
be living like Versace and cruising around and gold plated
bent leaves because of the profits from some of these
compounded medicines.
Speaker 3 (09:58):
Bankers told Ike that annual sales of compounded weight loss
drugs could ultimately be as high as one billion dollars.
So there's demand and there's potentially billions of dollars in revenue,
but there's also one big asterisk. So Madison, now for
the million dollar question, are compounded weight loss drugs safe
(10:18):
to use?
Speaker 6 (10:20):
Yeah?
Speaker 4 (10:20):
I mean that's our million dollar question too, is are
these drugs safe to use? And in the course of
our reporting, that's something that has been very difficult to determine.
Speaker 3 (10:34):
The safety of knockoff of Zepic that's coming up after
the break. Drug safety isn't supposed to be a guessing game.
Regulators have standards that are meant to protect consumers, but
compounded drugs aren't governed by those same rules. Bloomberg Health
(10:57):
reporter Ike Sweatltz told me.
Speaker 5 (10:59):
So, I think that the big difference between the compounded
medicines and FDA approved drugs in terms of regulation is
that FDA approved drugs, both the brands and generics, have
to be approved by the FDA before they can be sold.
So you have to go to the FDA and say,
here's what I'm planning to sell. Here's how I'm going
(11:19):
to make it, here is here is how it is
equivalent to the brand name if it's generic, or you know,
here's how it works if it's a brand name drug.
And the FDA reviews all of that and they say, okay,
we approve your manufacturing process. You know, it looks like
your drug is working or it looks like it's equivalent,
you can sell it. That process does not happen for
the compounders.
Speaker 3 (11:40):
Compounders, I says, are mostly governed by state regulations.
Speaker 5 (11:44):
The states are checking to see if they're following protocols, right,
you know, if their protocols around cleanliness, protocols, around what
sort of testing they're supposed to be doing, what sort
of records they're supposed to be keeping. But the states
are not going and you know, checking to make sure
that the drugs work.
Speaker 3 (11:59):
Even still, some state investigators have found some pretty worrying things,
like unsterile conditions at a compounder pharmacy in Arizona and
insufficient testing at one in Louisiana. But Bloomberg Health reporter
Madison Muller says that tracing any ill effects back to
compounders can be really difficult.
Speaker 4 (12:17):
Even when a patient says I got so and so reaction,
you know, I had stomach issues or my skin broke
out in hives or whatever from a compounded drug, it's
extremely difficult to actually prove that it was from the
compounded medication and that there was an issue with the
compounded medication versus any other drug. There isn't really the
(12:40):
same level of adverse event tracking that happens with branded medications.
Speaker 3 (12:46):
And Ike says that the worrying thing for doctors wasn't
necessarily wrongdoing at these compounders.
Speaker 5 (12:51):
I spoke with several doctors, and I think they were
in general more concerned with the lack of evidence than
evidence of wrongdoing or widespread bad quality or something like that.
You know, they were talking about the lack of clinical trials.
They were talking about the lack of peer reviewed studies.
There are a lot of questions that they have that
(13:12):
they're looking for answers for about the effectiveness of these
compounded medicines.
Speaker 3 (13:17):
And it's not just doctors who are worried about compounders.
The big pharmaceutical companies behind these drugs are also concerned,
like Novo Nordisk, which makes ozepic and we goo v
and Eli Lilly which makes zep bound.
Speaker 4 (13:30):
Yeah, so Novo Nordisk and Eli Lilly are both very
worried about the compounding that's going on. They say that
it's not necessarily from a competitive perspective. They are making
as much of these drugs as they can, and you know,
as we've seen, they're making a lot of money off
of these drugs as well, So they say that it's
not necessarily a competitive risk, but they are worried about
(13:54):
reputational issues. Both drug makers say that they've tested the
drugs and you know, we haven't seen the results of
those tests, but they say that there are you know,
impurity issues. In some cases, the drugs are no more
than like sugar water basically, and so they're filing a
lot of lawsuits, dozens of lawsuits against some of these
medical spas compounding pharmacies to try to limit and crack
(14:17):
down on some of this.
Speaker 3 (14:19):
But Ike says, many of these pharma company lawsuits aren't
focused on the safety of the compounders, but on the
way they're marketing their products.
Speaker 5 (14:26):
So there's a lot of issues that these companies are
taking with how you know, a website might describe the
drug as as opposed to concerns about whether the drug
is harmful to patients or not.
Speaker 3 (14:40):
Even with the lawsuits and the issues reported by patients
like Lindsay Posey, Ike says, it's important to remember that
compounders can serve an important role in the market, particularly
when there are drug shortages.
Speaker 5 (14:52):
These drugs can be safe and you know, can be
made properly as long as they're made you know, at
high quality pharmacies.
Speaker 3 (15:00):
But the problem is it's very hard for a regular
consumer to know just which pharmacies are high quality and
which ones might have issues, and that's left people like
Lindsay struggling to get answers on just what it is
they're taking and how to stay safe.
Speaker 1 (15:15):
It just kind of seems like.
Speaker 2 (15:19):
No matter which avenue you talk to, it's always someone else.
It could be a bad batch, you know, or it
could be time temperature abused or got overheated and shipping,
you know. It could be a lot of things, and
it's not very comforting.
Speaker 3 (15:38):
Which is why she says that if companies like Novo
Nordisk and Eli Lilly can eventually manufacture enough drugs to
meet the demand, there's still this issue of insurance and cost.
As long as the price of these drugs remain high,
people are going to look for cheaper, potentially less safe options.
Speaker 8 (15:57):
I feel as though, you know, we wouldn't have to
go down this route that you could potentially be unsafe
if these insurance companies started caring it for people like me.
Speaker 3 (16:14):
That's it for this episode of The Big Take from
Bloomberg News. I'm Sarah Holder. This episode was produced by
Adrianna Tapia and Jessica Beck. It was edited by Aaron
Edwards and Cynthia Koons. It was fact checked by Thomas
lu It was mixed by Robert Williams. Our senior producers
are Naomi Shaven and Kim Gettelson. Our senior editor is
(16:35):
Elizabeth Ponso. Nicole beamsterbor is our executive producer. Say Bowman
is Bloomberg's head of podcasts. If you liked this episode,
make sure to subscribe and review The Big Take wherever
you listen to podcasts. It helps people find the show.
Thank you so much for listening. We'll be back tomorrow
Bloomberg Audio Studios, podcasts, radio news. I am a single parent.
I'm a widow.
Speaker 2 (00:11):
My husband was in the military and he died in
the line of duty years.
Speaker 1 (00:16):
Ago, so it's just me.
Speaker 2 (00:19):
So if something happens to me, you know, I think
about my kids.
Speaker 3 (00:25):
Lindsey Posey is a thirty eight year old living in Spartanburg,
South Carolina with her two teenage kids. About a year ago,
after a series of health scares, a doctor told her
she needed to lose weight and offered to write her
a prescription for ozembic or munjaro.
Speaker 2 (00:40):
I told him that I'm like, yeah, I would love to,
but my insurance isn't going to cover it.
Speaker 3 (00:45):
But then she thought about her kids and started looking
into ways to pay for the weight loss drugs, which
can cost hundreds of dollars a month without insurance.
Speaker 2 (00:54):
So I, you know, started going on Reddit, researching different places, googling,
and I came across telehealth companies.
Speaker 3 (01:04):
The telehealth company Lindsay found wrote her a prescription for
a weight loss drug and then hooked her up with
a compounding pharmacy. Compounders make copycats of drugs, often at
cheaper prices, but the compounded versions aren't approved by the FDA.
Lindsay says the first vile she received seemed to work,
lowering her desire for food, but then the second vial
(01:25):
seemed to have no effect.
Speaker 2 (01:27):
So, you know, me, not really knowing what I'm doing,
I thought, Okay, well maybe that means I need to
move up in dose. So I increased my dose and
nothing happened.
Speaker 3 (01:43):
Then Lindsay opened her third fial of medicine.
Speaker 2 (01:46):
And you know, within a week of starting it, my
face just kind of started to break out.
Speaker 1 (01:53):
Within two weeks, it was getting really bad. I think
I did.
Speaker 2 (01:57):
Three weeks of that vial before I had gone through
every avenue and process of elimination.
Speaker 1 (02:04):
Trying to figure out what is causing this.
Speaker 3 (02:07):
Lindsay stopped applying a new moisturizer she'd been using, she
modified her diet.
Speaker 2 (02:12):
You know, I really I couldn't find an answer, so
I thought it has to be this.
Speaker 1 (02:17):
So I ended up throwing the rest of that vial away.
Speaker 3 (02:21):
Lindsay eventually got a replacement vial from the compounding pharmacy.
Speaker 2 (02:25):
I started using that one and it was very strong,
like I had side effects after the first shot, and
I'm like, what in the world is going on? Why
is every vial that I get so inconsistent?
Speaker 3 (02:39):
Lindsay says the experience made her wonder just where these
vials were coming from.
Speaker 1 (02:44):
It's kind of scary. You know.
Speaker 2 (02:46):
They comfort you, They you know, say all of these things. Oh,
you've got nothing to worry about. Everything's you know, tested
and up to standards, and then you start kind of.
Speaker 1 (02:55):
Digging and you're like, okay, well is that the truth?
Speaker 3 (03:00):
Today on the show, how the skyrocketing demand for weight
loss drugs like zetbound, ozempic and wgov is sending Americans
into a one billion dollar shadow industry that could be
putting their health in danger. I'm Sarah Holder, and this
is the big take from Bloomberg News.
Speaker 4 (03:22):
Last year, when you would google ozembic or wagov, most
of the things that would come up online were news
articles or you know so and so celebrities taking ozembic.
Speaker 3 (03:33):
Madison Muller is a health reporter at Bloomberg. She mostly
covers ozempic, wagovi and other weight loss drugs, and she
says over the past year she's noticed different results starting
to show up on Google.
Speaker 4 (03:45):
It's crazy. I mean, if you type ozembic, into Google Search,
like all of the advertisements are for telehealth companies that
are selling compounded drugs.
Speaker 3 (03:55):
You might have seen these results too for telehealth companies
like Hymns and Hers or Row that sometimes advertised cheaper
copycat mets. Madison got to work compiling all of the
results she found for companies that said they sold these
sought after weight loss drugs.
Speaker 4 (04:11):
I mean, I think there were like sixty companies or
something at the time, and I was like, there's something
going on here, and so Ike and I started looking
into this.
Speaker 3 (04:19):
Ike Sweatltz is also a reporter at Bloomberg who focuses
on the business of health and medicine. He was intrigued
by what Madison found out, and he started looking into
these compounding pharmacies that many telehealth companies partner with to
procure weight loss drugs for their patients. To be clear,
compounded drugs aren't just generic versions of brand name products.
(04:40):
There's something else entirely.
Speaker 5 (04:44):
So compounding is how drugs have been made really since
the beginning, you know, prior to modern manufacturing, prior to
the FDA, if you needed a medicine, you went into
the pharmacy and they mixed together some chemicals and you know,
gave it to you and whatever sort of format you
needed it. So that was that was how you got medicines.
Speaker 3 (05:03):
But that changed as drug making became more mechanized and automated. Eventually,
the Food and Drug Administration was established and with it
the regulations that required drug makers to submit medicines for
approval before they could be sold.
Speaker 5 (05:17):
But compounders still had a role making some medicines, mostly
medicines for people who might have might be allergic to
one of the ingredients that's in the FDA approved version,
or patients who like physically could not take the FDA
approved drug.
Speaker 3 (05:34):
Essentially, the FDA left a loophole open for these compounders
to continue making small batches of drugs if a patient
needed a medicine to be slightly tweaked for some reason.
Speaker 5 (05:44):
The FDA you know, sort of knew that, you know, technically,
on paper, this was like a violation of the federal
law because the drugs had not gone through the FDA
approval process. They were just choosing to, you know, exercise
enforcement discretion and not enforce those laws and allow compounding
to continue as long as it was regulated by the states.
Speaker 3 (06:05):
Ike says this worked for a while until twenty twelve,
when dozens of people died from contaminated drugs made at
a compounding center in Massachusetts.
Speaker 6 (06:14):
State officials here in Massachusetts say they found a leaking boiler,
dirty floor mats, even black specs of fungus visible to
the naked eye in sealed vials at the New England
compounding center.
Speaker 3 (06:26):
That led to a national meningitis outbreak, and in twenty
thirteen to the passage of a new law which laid
out more clearly how compounders could operate. But even with
those new rules, there was still a loophole for compounders
who are making drugs that are in short supply, says Madison.
Speaker 4 (06:43):
So compounders got into the weight loss drug industry most
likely around two ish years ago when these drugs were
first falling into shortage, So hozempic would go via manjarros
that bound to have gone in and out of short
supply with the US Food and Drug Administration, and that
sort of loophole allowed them to capitalize on this opportunity
(07:04):
and allowed this market to really proliferate because they were
allowed to do this and they were filling a need
and continue to do so, because these drugs are still
in shortage.
Speaker 3 (07:14):
Even if you've been prescribed ozepic or another some maaglutide drug,
it can often be very difficult to find a pharmacy
with the medicine in stock.
Speaker 4 (07:22):
We've seen a lot of issues between the supply shortages, affordability,
insurance companies not covering weight loss drugs. That's made it
really really difficult for patients who need these drugs to
get them. And so what these compounding pharmacies have done is,
I mean their drugs are not in shortage, and so
they've made the drugs a lot more readily available. And
(07:45):
that also helps telehealth companies and other businesses that have
sort of built up a business around prescribing these drugs
to patients.
Speaker 3 (07:54):
Are they using the same active ingredients as ozepic and
we go V and manduro.
Speaker 5 (07:59):
So if if the compounders are doing what they're supposed
to do and following the rules, then yes, they should
be using the same active ingredients.
Speaker 3 (08:07):
But sometimes patients might be confused about exactly what drug
they're getting.
Speaker 4 (08:11):
You know, when you're a patient and you're trying to
sort through all of the medical information online and you're
inundated with a bunch of ads and you just click
on one that's like, oh, this is cheaper, I might
as well. This looks legitimate. It has a nice glossy
website and you know, smiling patients on it and says
that it's selling ozembic, Like, oh, it probably is. So
(08:32):
I think that that's sort of the challenge is in
this you know world of misinformation and online information that
we're like inundated with just so much of it, and
it's hard to sift through it and really determine what
is genuine and what's not.
Speaker 3 (08:48):
Other times, Madison says patients are in fact seeking out
the cheaper, compounded version of the drug.
Speaker 4 (08:54):
And that's one of the things I mean, especially like
the on social media, the compounded drugs have really taken
off off, especially on TikTok.
Speaker 7 (09:02):
Right, So in this bag, I have alcohol slows to
prep your skin. I also have the needles that you
use for injection, and then in this little vial right here, it's.
Speaker 1 (09:13):
Actually the compounded medication.
Speaker 7 (09:15):
You can see it.
Speaker 4 (09:16):
A lot of TikTok influencers and people who have large
followings on Instagram and TikTok are talking about these drugs
and you know, serving as influencers for the telehealth companies
and helping to market these weight loss drugs.
Speaker 2 (09:32):
And with the compounded version, as long as there's a shortage,
I'm going to get my medication.
Speaker 3 (09:36):
Ike says, these compounding pharmacies are growing rapidly, partially to
meet demand and partially because there's a lot of money
to be made.
Speaker 5 (09:45):
One of the bankers who I talked to, you know,
told me that these compounding pharmacy owners are going to
be living like Versace and cruising around and gold plated
bent leaves because of the profits from some of these
compounded medicines.
Speaker 3 (09:58):
Bankers told Ike that annual sales of compounded weight loss
drugs could ultimately be as high as one billion dollars.
So there's demand and there's potentially billions of dollars in revenue,
but there's also one big asterisk. So Madison, now for
the million dollar question, are compounded weight loss drugs safe
(10:18):
to use?
Speaker 6 (10:20):
Yeah?
Speaker 4 (10:20):
I mean that's our million dollar question too, is are
these drugs safe to use? And in the course of
our reporting, that's something that has been very difficult to determine.
Speaker 3 (10:34):
The safety of knockoff of Zepic that's coming up after
the break. Drug safety isn't supposed to be a guessing game.
Regulators have standards that are meant to protect consumers, but
compounded drugs aren't governed by those same rules. Bloomberg Health
(10:57):
reporter Ike Sweatltz told me.
Speaker 5 (10:59):
So, I think that the big difference between the compounded
medicines and FDA approved drugs in terms of regulation is
that FDA approved drugs, both the brands and generics, have
to be approved by the FDA before they can be sold.
So you have to go to the FDA and say,
here's what I'm planning to sell. Here's how I'm going
(11:19):
to make it, here is here is how it is
equivalent to the brand name if it's generic, or you know,
here's how it works if it's a brand name drug.
And the FDA reviews all of that and they say, okay,
we approve your manufacturing process. You know, it looks like
your drug is working or it looks like it's equivalent,
you can sell it. That process does not happen for
the compounders.
Speaker 3 (11:40):
Compounders, I says, are mostly governed by state regulations.
Speaker 5 (11:44):
The states are checking to see if they're following protocols, right,
you know, if their protocols around cleanliness, protocols, around what
sort of testing they're supposed to be doing, what sort
of records they're supposed to be keeping. But the states
are not going and you know, checking to make sure
that the drugs work.
Speaker 3 (11:59):
Even still, some state investigators have found some pretty worrying things,
like unsterile conditions at a compounder pharmacy in Arizona and
insufficient testing at one in Louisiana. But Bloomberg Health reporter
Madison Muller says that tracing any ill effects back to
compounders can be really difficult.
Speaker 4 (12:17):
Even when a patient says I got so and so reaction,
you know, I had stomach issues or my skin broke
out in hives or whatever from a compounded drug, it's
extremely difficult to actually prove that it was from the
compounded medication and that there was an issue with the
compounded medication versus any other drug. There isn't really the
(12:40):
same level of adverse event tracking that happens with branded medications.
Speaker 3 (12:46):
And Ike says that the worrying thing for doctors wasn't
necessarily wrongdoing at these compounders.
Speaker 5 (12:51):
I spoke with several doctors, and I think they were
in general more concerned with the lack of evidence than
evidence of wrongdoing or widespread bad quality or something like that.
You know, they were talking about the lack of clinical trials.
They were talking about the lack of peer reviewed studies.
There are a lot of questions that they have that
(13:12):
they're looking for answers for about the effectiveness of these
compounded medicines.
Speaker 3 (13:17):
And it's not just doctors who are worried about compounders.
The big pharmaceutical companies behind these drugs are also concerned,
like Novo Nordisk, which makes ozepic and we goo v
and Eli Lilly which makes zep bound.
Speaker 4 (13:30):
Yeah, so Novo Nordisk and Eli Lilly are both very
worried about the compounding that's going on. They say that
it's not necessarily from a competitive perspective. They are making
as much of these drugs as they can, and you know,
as we've seen, they're making a lot of money off
of these drugs as well, So they say that it's
not necessarily a competitive risk, but they are worried about
(13:54):
reputational issues. Both drug makers say that they've tested the
drugs and you know, we haven't seen the results of
those tests, but they say that there are you know,
impurity issues. In some cases, the drugs are no more
than like sugar water basically, and so they're filing a
lot of lawsuits, dozens of lawsuits against some of these
medical spas compounding pharmacies to try to limit and crack
(14:17):
down on some of this.
Speaker 3 (14:19):
But Ike says, many of these pharma company lawsuits aren't
focused on the safety of the compounders, but on the
way they're marketing their products.
Speaker 5 (14:26):
So there's a lot of issues that these companies are
taking with how you know, a website might describe the
drug as as opposed to concerns about whether the drug
is harmful to patients or not.
Speaker 3 (14:40):
Even with the lawsuits and the issues reported by patients
like Lindsay Posey, Ike says, it's important to remember that
compounders can serve an important role in the market, particularly
when there are drug shortages.
Speaker 5 (14:52):
These drugs can be safe and you know, can be
made properly as long as they're made you know, at
high quality pharmacies.
Speaker 3 (15:00):
But the problem is it's very hard for a regular
consumer to know just which pharmacies are high quality and
which ones might have issues, and that's left people like
Lindsay struggling to get answers on just what it is
they're taking and how to stay safe.
Speaker 1 (15:15):
It just kind of seems like.
Speaker 2 (15:19):
No matter which avenue you talk to, it's always someone else.
It could be a bad batch, you know, or it
could be time temperature abused or got overheated and shipping,
you know. It could be a lot of things, and
it's not very comforting.
Speaker 3 (15:38):
Which is why she says that if companies like Novo
Nordisk and Eli Lilly can eventually manufacture enough drugs to
meet the demand, there's still this issue of insurance and cost.
As long as the price of these drugs remain high,
people are going to look for cheaper, potentially less safe options.
Speaker 8 (15:57):
I feel as though, you know, we wouldn't have to
go down this route that you could potentially be unsafe
if these insurance companies started caring it for people like me.
Speaker 3 (16:14):
That's it for this episode of The Big Take from
Bloomberg News. I'm Sarah Holder. This episode was produced by
Adrianna Tapia and Jessica Beck. It was edited by Aaron
Edwards and Cynthia Koons. It was fact checked by Thomas
lu It was mixed by Robert Williams. Our senior producers
are Naomi Shaven and Kim Gettelson. Our senior editor is
(16:35):
Elizabeth Ponso. Nicole beamsterbor is our executive producer. Say Bowman
is Bloomberg's head of podcasts. If you liked this episode,
make sure to subscribe and review The Big Take wherever
you listen to podcasts. It helps people find the show.
Thank you so much for listening. We'll be back tomorrow
Hosts And Creators
Sarah Holder
Saleha Mohsin
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