April 18, 2025 • 29 mins
A report from the Partnership for Safe Medicine and the FDA show unauthorized and potentially harmful ingredients in knockoff weight loss drugs are pouring into the U.S. from foreign sources, bypassing FDA regulations. Experts warn that unsuspecting Americans are at risk, and immediate action is needed to stop these illegal imports. To learn the warning signs of illegally imported weight loss drugs, we're talking to George Karavetsos, former director of the FDA’s Office of Criminal Investigations.
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Episode Transcript
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Speaker 1 (00:06):
Welcome to Virginia Focus. I'm Rebecca Hughes of the Virginia
News Network. A report from the Partnership for Safe Medicine
and the FDA show unauthorized and potentially harmful ingredients and
knock off weight loss drugs are pouring into the US
from foreign sources bypassing FDA regulations. Experts warn that unsuspecting
Americans are at risk and immediate action is needed to
(00:28):
stop these illegal imports. To learn the warning signs of
illegally imported weight loss drugs, we're talking to George Cuttavesto's
former director of the FDA's Office of Criminal Investigations. Thank
you for coming on this show. I'm so glad that
we can talk about this important topic today. I know
these weight loss drugs are they seem to be everywhere nowadays.
Speaker 2 (00:51):
It is. It is true that we're seeing in an
explosion of interest, and unfortunately, what we've learned in the
anti counterfeiting space is that an explosion of interest also
then is followed by explosion of crime.
Speaker 1 (01:05):
Yeah, well, where the money is? You know what I'm saying.
Speaker 3 (01:11):
Money drives a lot of things, good and bad. So
what don't we start by why don't you tell us
about your organization and how you got to be the
head of it.
Speaker 2 (01:24):
So we are a coalition of everybody who handles medicine
and the supply chain, manufacturers, distributors, pharmacists, and patients, and
those four groups, especially in policy debates, almost agree on
nothing except our tiny mission, which is that counterfeit medicines
(01:44):
are danger to patients and everybody has an interest in
keeping them out. And so all the debates about everything
else you hear about drug policy fall away only on
our tiny little island of safety. And so that's what
we work on. Work on learning about how criminals do
crime in the drug counterfeiting space, and then educating healthcare professionals,
(02:09):
even drug manufacturers and patients of course, but how to
stay safe.
Speaker 1 (02:14):
Okay, So why don't we start with defining what a
counterfeit drug would be Because I mean, obviously, if I'm
Pheiser and I make a drug, I'm going to sell
it to any country that is willing to buy it.
So that's not what we're talking about though, right, Like
if I buy a Canadian Peiser drug a that I
(02:37):
get and it's more expensive in America, but it's still
drug a that's not what we're talking about, is it.
Speaker 2 (02:44):
Well, let's talk it. Let's flip that a little bit
and talk about what is a safe medicine. A safe
medicine is the medicine that was made for your country
by an entity that is licensed and inspected, and the
medicine is distributed and dispensed by also licensed individuals. Right.
(03:05):
So you know, if you get a medicine from another country,
it comes with a whole lot of risk. One of
those risks is that the people involved in the other
country aren't licensed, have no reason to actually give you
the real thing, and they're transacting perfect lookalike counterfeits. That's
why we actually end up having everybody in our supply
(03:28):
chain license. So it isn't actually safe. It may not
be a counterfeit, but it's certainly not safe to get
a medicine from a pharmacy in another country that's not
licensed by like let's say the Virginia Board of.
Speaker 1 (03:41):
Pharmacy, Okay, And basically the reason behind that would be
because it could be diluted, or it could be have
other medicines put in with it that you weren't expecting, correct.
Speaker 2 (03:55):
Yeah, I mean, once you are buying medicine from people
who aren't afraid of being drag into court for cutting
corners and giving you a fake. They will do that. Eventually.
People will cut corners and give you fakes because there's
no consequence. And so that's why even if you think, oh,
it looks just like the drug we have in the US,
(04:16):
you can't get it from another country. You just don't know.
And there's if they decide to cheat you, there's no consequences.
Speaker 1 (04:23):
For them, gotcha. I just want to clarify because I know,
at least in my mind's eye, and I tend to
be crazy with my creativity, you know, the idea of
a counterfeit drug is like, oh, some skivee person in
a back alley with a big pot and they're like
making drugs and forming it in a pill, and you know,
(04:44):
like that just seems so like far fetched, and it is,
I imagine, I.
Speaker 2 (04:49):
Mean it does. But you know, I've seen photos of
drug labs that make things like Liptour and other countries
and they are filthy, right, and by the time they
get done with their process that you know, the bottle
and the label all looks good and they put it
in there. But if you saw the conditions under which
(05:10):
they were made. You'd be like, I'm not putting that
in mind. I'm not putting that in my mouth. That
is never that is net, that would never be safe.
And you know it's I will say, especially in this
space to get back to the weight loss injectables. You're
injecting those right. So it is hard, It is really
really hard. We read inspections of compounding pharmacies and of
(05:34):
the drug manufacturers that are licensed by the FDA, like
Nova and Lily and others, and sterility is really challenging.
It's it is part of why the cost of the
medicine is expensive, and it's why we don't ever think
about quality issues too much in these medicines because so
much money is put into this difficult task.
Speaker 1 (05:56):
Okay, so back to your example, though, I have questions,
and so Liptor obviously is I don't know which company
owns that, but that's their brand. I mean, is that
the way that the drug supply chain works in other countries,
Like it's same medicine, but they don't have the same
(06:16):
safety protocols that the US has, and therein lives part
of the danger. I'm just trying to make sure, I understand.
Speaker 2 (06:24):
So there's a there's a bunch of different dangers if
you take I'm trying to remember what the act of that,
the generic name of lipatory is. But if you take
sort of a generic lipertoire for another from another country,
you are basically putting your life in the hands of
the regulators of that company of that other country, right,
(06:45):
And so you don't know if it's coming from let's
say Turkey, if the Turkish FDA is as thorough as
the US FDA. And I will tell you that very
few agencies around the world are as thorough and as
well resource does the FDA, even if it's made in
the same factory. Right, a contract manufacturer that's making a
(07:08):
generic lipatoire for let's say Morocco, that batch may not
be as inspected as carefully as the one that is
being made for the US market. So you really want
a medicine that's made for the American market because you
know that will be inspected by the FDA's inspectors and
(07:31):
the FDA's regulation regime. It is not unusual to see
that the same factory will throw away a batch made
for the American market because it doesn't meet standards, but
will keep it for a different countries drug market, it's
definitely going to be a lower standard.
Speaker 1 (07:51):
And so a lot of these companies and you see
them all over social media, at least you do as
a woman. They're like, you know, hey, sign up for
I'm not gonna give any names because I don't want
to throw anybody completely under the bus, and I can't
think of any to be honest with you, but they're like, hey,
you know, we have this weight loss drug in that
weight loss drug and you don't even need a doctor's prescription.
(08:13):
Just sign up and you know, we'll send it to you.
How do we tell where that company is, where that
drug might be coming from, and if it's even remotely
something we're safe to do, or should we never entertain
that stuff?
Speaker 2 (08:33):
Well, there's definitely some warning signs that save you from
even having to look up the license. And one of
those would be if someone is offering a medicine that
is doesn't require a doctor's prescription. Right If you if
you see someone advertising a prescription medicine that normally you
would see other people require a doctor's prescription for, but
(08:56):
they say no prescription required, odds are good. That's not
safe right these most any prescription medicine requires some oversight
from a medical professional, unless you happen to be a
doctor who's treating yourself. It's just not safe to proceed
to take something that's going to pretty seriously affect your
(09:18):
health and not have someone else double checking all the details,
including like checking for cross interactions with other medicines you're taking.
So that's a warning sign. If it's too cheap to
be true, that's a warning sign. Generally. I will tell
you that when the National Associations of Board of Pharmacy
has surveyed Internet websites online pharmacies, they found that ninety
(09:44):
five percent of them are operating illegally. If you just
go a new Google online pharmacy, it's operating illegally. If
it tells you that it's in Canada or any other
country besides the US, it is operating illegally. Outright. There
is no Board of Pharmacy in any US state that
(10:04):
license a license is a pharmacy in other country. So
if it says it's Canadian, it's not safe. It's not
safe because Canadian pharmacies are unsafe. It's unsafe because nobody
has any idea what it really is gotcha, including your border.
Speaker 1 (10:19):
Farms, and that can include like we talked about ingredients
in something that has an interaction with something you may
be taking for blood pressure, right, exactly right.
Speaker 2 (10:33):
I don't take lipatour, but I've told that, I'm told
that certain certain things that affect your blood pressure interact
with other medicines. And you might not even think that
that's an interaction, but you would find out pretty quick
if you were taken of both, then nobody was supervising.
I will tell you that the safest thing you can
(10:54):
do is walking through your bricks and mortar pharmacy if
you have access to one, preferably an independent pharmacy, not
one that's run by a chain. And that person, that pharmacist,
if you're kind of them, you know, has a professional
(11:14):
oath to watch out for your health. And they will
talk to you about medicines you're taking, not even just
the first time, but they'll talk to you anytime you
go and get a medicine dispensed, about what else you're taking,
what kind of side effects you're experiencing. The They really
are healthcare professionals who spend more time in many cases
(11:35):
with patients than the doctors do.
Speaker 1 (11:38):
Yeah, I've discovered that myself. So let's say somebody goes
ahead and takes the risk and orders from an online pharmacy.
How in the world are they getting it into the country.
I mean, I thought we had all these checks and
balances so that things from outside that we deem dangerous
(11:59):
don't get inside of our borders.
Speaker 2 (12:03):
Well, in short, it's a form of smuggling. There's two
kinds of ways to get unapproved medicines into the country.
One of them is in the small package mail, and
there's about three million packages a day that come into
the US, and Customs and Border Protection and FDA do
(12:24):
an amazing job trying to inspect as many as possible,
but they are really quite often looking for a needle
in a haystack, and people will basically send things in
and sometimes they'll say it's medicine, and sometimes they won't.
But your fake online pharmacy will do that, hoping that
no one is going to grab that package from amongst
(12:46):
the other three million. The other way is sometimes larger shipments,
and this is what we just recently studied of freight
quantities of medicine that are worth more than eight hundred
dollars will come into the country and sometimes the lie
on the manifest about where they are. And the manifest
also requires for shipments that big to say where the
(13:08):
medicine was manufactured. And we have seen people completely lying
about these injectable GLP ones, claiming that they were made
in a JW. Marriott. We saw one shipment that was
claimed to have been manufactured in a Toronto high school,
another in a gym in British Columbia, and they just were,
(13:34):
they were just depending upon no one bothering to look.
And in two of those cases, those shipments were allowed
because well I don't know why, but I assume it's
because FDA and CVP didn't have the manpower to actually
look at the manifest and refuse the shipment. But that's
actually a big issue. In our research. We found over
(13:57):
the last two years, you know, over one hundred and
almost two hundred shipments of some agnatide and trizepetite, the
two major ingredients for weight loss injectables that made it
into the US, that were on their face completely not legal.
They were manufactured in factories that the FDA didn't even
(14:17):
know existed, Oh.
Speaker 1 (14:19):
My gosh, and it probably said creepy basement on the description, right,
it shut up.
Speaker 2 (14:27):
What's really disturbing is that some of them said ingredient
for compounding. And so, you know, we have some concerns
about where people who compound medicine are getting their ingredients
because for the most part, everybody agrees that those manufacturers
are not in the US. And we looked at these
shipments to say, are these shipments that are clearly not
(14:51):
being made in FDA known factories coming into the US
for compounding and we did find we did find se
several instances where they were coming in for marked for compounding.
They were not in an FDA inspected factory, and we
don't know where they went because that information is not public,
so I can't tell you if it was a legal
(15:13):
or an illegal compounder. But they were definitely intended to
be used in compounded injectable weightless medicines.
Speaker 1 (15:20):
Wow. Now these medicines, My understanding is that they became
popular because of celebrities, And I mean, would they have
been guilty of potentially getting these medicines from somewhere other
than the US or I mean, does that does that
(15:41):
is that something that happens I assume it is. I
mean we see it in movies.
Speaker 2 (15:46):
Yeah, I mean, I think if you cast your mind
back a little bit, you know, it was Prince who
his heartbreaking death was caused by a fake pill made
with fentanyl. So celebrity are not immune from breaking the
drug supply chain, right like they have. The money is
not the issue for them. It's just do they know
someone who can get them get them medicine. And the
(16:10):
truth is, I don't know if celebrities, uh you know,
get this medicine from compounded sources, legal or illegal sources,
or they get like them you know, Rio Loo's up
In and Maunjaro, But they certainly have the money to
get their real product. But we're we're all at risk,
right that That Prince's death shows that no one is
(16:32):
really immune from the dangers of stepping out of the
legitimate drug supply of your corner drug store.
Speaker 1 (16:38):
Yeah, for sure. And just to clarify, like the little
medical weight loss place at the local strip mall, as
long as that's a doctor running that, that's usually pretty safe, right.
Speaker 2 (16:56):
No, a lot of those have been. I mean, I'll
tell you why, from a purely principal concept, why it's
not super safe. You've got a physician who's in business
only to treat you for issues of weight loss. Maybe
you see the position, maybe you don't, But that physician
(17:17):
is not your regular doctor. They don't know your history,
they don't know what other issues you struggle with historically,
and so it's not as good as going to your
regular general practitioner to get a weight loss medicine. And
so I don't think that that's a good idea. In addition, medspas,
(17:39):
and it depends on the state because the regulation is
different all over the place. Medspas, maybe you're being supplied
by a pharmacy, you know, perhaps in some cases they're
being supplied by a doctor who does compounding that's allowed
in their state, but they're not considered to be safe
dispensers of prescription medicine right not. Their history, their history
(18:01):
is other techniques of beauty. And so I would not
go to a med spa, you know. And there have
been plenty of stories of medspas who've been, you know,
notified by law enforcement that they're violating the law, and
so I think that that's not the place you want
to go for safe medication.
Speaker 1 (18:21):
Gotcha, gotcha? Because I mean weight losses. I mean, it's
been a big business as long as I can remember,
especially well.
Speaker 2 (18:31):
And you know, you asked why these drugs became popular,
and they became popular because they work, They produce under
medical supervision, They produce life changing results, literally life changing results.
There was just a Wall Street Journal reporter who wrote
an article about his journey with the zempic and how
(18:52):
he lost I think it was forty pounds or sixty pounds,
and then another twenty after he went off it. Because
while he was losing, he had the motivation to really
change his life habits and he could not have pulled
this off without the medicine. But now he's a very
(19:12):
different person with very different habits, and he's really conquered
this weight issue which plagued him his whole life. And
so you know, they really work, right they are. I mean,
I cannot tell you what it means for someone I'm
fifty seven. I've seen a lifetime of diet and fad
diet culture. To see something that actually works, I mean,
(19:36):
I think these medicines are amazing and I'm really excited
to see all the good they can do.
Speaker 1 (19:42):
Yeah, and it's my understanding that they not only do
they help with weight loss, but supposedly they help with
other things, is that right.
Speaker 2 (19:52):
I mean, they're being studied for other things, such as
at various addiction issues. But you know, I don't think
that there's nothing approved as far as I know, it's
only approved for diabetes and obesity and weight loss. They're
not approved for, you know, helping with addiction. But you know,
(20:12):
this is an area which is we're still in the
infancy of understanding these drugs, understanding what they're capable of,
and even figuring out what is the most effective formulation.
There are still in the pipeline various formulations of these
drugs that have not been approved yet that could be
more effective with less side effects. You know, it's just
(20:34):
super exciting to be here at this moment in the history.
Speaker 1 (20:37):
Yeah, for sure. And I mean, obviously, people there's been
a huge movement towards reducing the amount of chemicals in
food and particularly processed foods, and you know the PFA
PF essays, and you know, the microplastics all that kind
of stuff. But like you said, the fact that this
(20:59):
works is just kind of gangbusters. If you were to
advise somebody who's interested, but hasn't taken the leap yet,
just either PCP or would you recommend them go to
a specialist? What do you what are your thoughts?
Speaker 2 (21:20):
I would I would start with a primary care physician
just as you would suggest, and talk to them about this,
talk to them about getting access to this medicine if
if your insurance doesn't cover it. Both companies have direct
to patient programs that if you're if you're in the
(21:40):
business of paying cash that are significantly less than what
you might end up paying, you know, buying buying buying
the medicine cash from a local pharmacy. A local pharmacist
is always best. But if you can get you go
to your primary care doctor and get the prescription, you
can take it odd to one of these direct direct
(22:01):
sales and you know, have that conversation. Right long term
you you're you're you're doing this for your long term health, right,
You're you want to you want to lose weight so
that you're no longer obese or overweight for your long
term health. That requires the involvement of your long term physician.
(22:22):
So I would do that. And even if you if
you are with a big healthcare system, you know those
doctors are going to have your ongoing electronic medical record,
even if it's not the same doctor every you know,
after two years you're there's you're still going to have
a long term focus on your health and then they'll
(22:43):
help you.
Speaker 1 (22:44):
Okay, so we might see some new versions of these
coming out in the future, is what you're saying or
one of the things I'm hearing you say. Do we
know anything about that?
Speaker 2 (22:55):
We're not even at the end. We are not even
at the end of this innovation cycle.
Speaker 1 (22:59):
Oh okay, all right, so we need to be watching
for that. Then why don't you answered this question for me?
I'm just curious and you're the expert. Is there anything
the audience needs to know that I just didn't know
that I needed to ask you about it?
Speaker 2 (23:20):
I mean, I think the most important thing to understand
is that when you're out looking for access to these medicines,
there are three categories that you need to understand. There's
the patented or branded medicine that's like the woman the
name like gozump pick with a catchy jingle. There's generic
(23:43):
versions which don't exist yet, but often a medicine that
is got a brand name, after a time, it will
go off patent and become generic. There are no generic
versions of these medicines yet, so it's not safe to
take something that someone tells you as a generic version
of a zepic. It doesn't exist. So that's really important
(24:06):
thing to know now. And then the compounded medicines, and
this is what most people don't understand. Compounded medicines are
not FDA approved, and the FDA states to patients that
they do not test them for safety or efficacy, and
I think that's a really important point. You know, usually
compounded medicines are let's say, oncology drug that is in
(24:31):
shortage before you start your cancer treatment, and in that case,
you take that medicine because the alternative is that you
don't start your cancer treatment, and that's terrible. But in
this case, you know, if you are faced with an
option of taking a compounded weight loss medication, the time
(24:53):
at which you start is not is not the same
risk benefit ratio of starting cancer treatment, and you know
you don't want to take that risk if you can
avoid it, even for a legally compounded medicine, I would
definitely go to the direct sales channel from Lillie or
Novo to get that medicine because you know it's actually
(25:13):
coming from a manufacturer who's inspected, and that's an FDA
approved drug. All the compounded medicines are not FDA approved,
and that's even for the legal ones. You know, there
are illegally compounded medicines out there being made by pharmacies
with no license at all, and those are also wildly unsafe.
And then the last thing I would say is, if
(25:37):
you can believe it, there are an enormous rash of
look alike, perfect lookalike counterfeits of a zebic and other
weight loss injectables. They look like the real thing. They've
got the real box, or it looks like the real box,
but they're completely vake. And that's what you'll get if
(25:59):
you go online from a foreign pharmacy and try and
order a zempic.
Speaker 1 (26:04):
And so don't ever do that, Okay, And I thought
of my question, do you think that these medications are
going to have a significant effect on the realm of
bariatric surgery?
Speaker 2 (26:21):
Yeah, I think it could. I think it'd be really interesting.
I think that there's people who haven't had bariatric surgery
who might have been thinking about it, but but might
now decide to try one of the injectable GLP one drugs,
and I think that that is very exciting obviously if
you are not thrilled about having surgery.
Speaker 1 (26:42):
Yeah, definitely. And do you think they'll come out with
an oral version for people who don't like shots?
Speaker 2 (26:50):
They are actually experimenting. There is already an oral version
of some aglaetide, and they continue to refine in this
space an other oral versions that might be more effective.
Right now, the injectables are more effective and result in
more weight loss than the oral dose versions. But again,
(27:10):
we're at the beginning of this innovation cycle. We're not
even we don't even know where this is going to end.
And I think there's better oral versions that they're going
to discover and really and get approved by the FDA.
Speaker 1 (27:23):
Okay, can you point us to a website where we
can learn more about this?
Speaker 2 (27:29):
Yeah? So, our website has a whole bunch of consumer
resources for people who want to learn about counterfeits, and
you can go to www Dot safemedicines dot org. We
have advice on how to buy safely, how to buy
safely online. Most of that advice is don't do that,
and how to identify and spot warning signs for counterfeit
(27:52):
medicines wonderful.
Speaker 1 (27:54):
Well, I think we've come to the end of our time,
but I just want to tell you I am so
grateful that you came on the show and shared this
information with us and answered my questions and hopefully I
was able to think of questions that people you know
listening would want to ask and so I can answer
their questions.
Speaker 2 (28:15):
Well, I'm glad to be here. You know. Drug safety
is a passion of mine. It's why we've existed for
twenty three years, and anything we can do to help
people make safer choices is important for us most definitely.
Speaker 1 (28:28):
So yeah, thank you for your time, and maybe we
can have you back on the show another time. Love
to I hope you've enjoyed today's show. Thanks for tuning
into the show on your favorite local radio station. You
can now listen to this show or past shows through
the iheartapp or on iHeart dot com. Just search for
Virginia Focus under podcasts. I'm Rebecca Hughes with a Virginia
(28:49):
news network, and I'll be here next week on Virginia Focus.
Welcome to Virginia Focus. I'm Rebecca Hughes of the Virginia
News Network. A report from the Partnership for Safe Medicine
and the FDA show unauthorized and potentially harmful ingredients and
knock off weight loss drugs are pouring into the US
from foreign sources bypassing FDA regulations. Experts warn that unsuspecting
Americans are at risk and immediate action is needed to
(00:28):
stop these illegal imports. To learn the warning signs of
illegally imported weight loss drugs, we're talking to George Cuttavesto's
former director of the FDA's Office of Criminal Investigations. Thank
you for coming on this show. I'm so glad that
we can talk about this important topic today. I know
these weight loss drugs are they seem to be everywhere nowadays.
Speaker 2 (00:51):
It is. It is true that we're seeing in an
explosion of interest, and unfortunately, what we've learned in the
anti counterfeiting space is that an explosion of interest also
then is followed by explosion of crime.
Speaker 1 (01:05):
Yeah, well, where the money is? You know what I'm saying.
Speaker 3 (01:11):
Money drives a lot of things, good and bad. So
what don't we start by why don't you tell us
about your organization and how you got to be the
head of it.
Speaker 2 (01:24):
So we are a coalition of everybody who handles medicine
and the supply chain, manufacturers, distributors, pharmacists, and patients, and
those four groups, especially in policy debates, almost agree on
nothing except our tiny mission, which is that counterfeit medicines
(01:44):
are danger to patients and everybody has an interest in
keeping them out. And so all the debates about everything
else you hear about drug policy fall away only on
our tiny little island of safety. And so that's what
we work on. Work on learning about how criminals do
crime in the drug counterfeiting space, and then educating healthcare professionals,
(02:09):
even drug manufacturers and patients of course, but how to
stay safe.
Speaker 1 (02:14):
Okay, So why don't we start with defining what a
counterfeit drug would be Because I mean, obviously, if I'm
Pheiser and I make a drug, I'm going to sell
it to any country that is willing to buy it.
So that's not what we're talking about though, right, Like
if I buy a Canadian Peiser drug a that I
(02:37):
get and it's more expensive in America, but it's still
drug a that's not what we're talking about, is it.
Speaker 2 (02:44):
Well, let's talk it. Let's flip that a little bit
and talk about what is a safe medicine. A safe
medicine is the medicine that was made for your country
by an entity that is licensed and inspected, and the
medicine is distributed and dispensed by also licensed individuals. Right.
(03:05):
So you know, if you get a medicine from another country,
it comes with a whole lot of risk. One of
those risks is that the people involved in the other
country aren't licensed, have no reason to actually give you
the real thing, and they're transacting perfect lookalike counterfeits. That's
why we actually end up having everybody in our supply
(03:28):
chain license. So it isn't actually safe. It may not
be a counterfeit, but it's certainly not safe to get
a medicine from a pharmacy in another country that's not
licensed by like let's say the Virginia Board of.
Speaker 1 (03:41):
Pharmacy, Okay, And basically the reason behind that would be
because it could be diluted, or it could be have
other medicines put in with it that you weren't expecting, correct.
Speaker 2 (03:55):
Yeah, I mean, once you are buying medicine from people
who aren't afraid of being drag into court for cutting
corners and giving you a fake. They will do that. Eventually.
People will cut corners and give you fakes because there's
no consequence. And so that's why even if you think, oh,
it looks just like the drug we have in the US,
(04:16):
you can't get it from another country. You just don't know.
And there's if they decide to cheat you, there's no consequences.
Speaker 1 (04:23):
For them, gotcha. I just want to clarify because I know,
at least in my mind's eye, and I tend to
be crazy with my creativity, you know, the idea of
a counterfeit drug is like, oh, some skivee person in
a back alley with a big pot and they're like
making drugs and forming it in a pill, and you know,
(04:44):
like that just seems so like far fetched, and it is,
I imagine, I.
Speaker 2 (04:49):
Mean it does. But you know, I've seen photos of
drug labs that make things like Liptour and other countries
and they are filthy, right, and by the time they
get done with their process that you know, the bottle
and the label all looks good and they put it
in there. But if you saw the conditions under which
(05:10):
they were made. You'd be like, I'm not putting that
in mind. I'm not putting that in my mouth. That
is never that is net, that would never be safe.
And you know it's I will say, especially in this
space to get back to the weight loss injectables. You're
injecting those right. So it is hard, It is really
really hard. We read inspections of compounding pharmacies and of
(05:34):
the drug manufacturers that are licensed by the FDA, like
Nova and Lily and others, and sterility is really challenging.
It's it is part of why the cost of the
medicine is expensive, and it's why we don't ever think
about quality issues too much in these medicines because so
much money is put into this difficult task.
Speaker 1 (05:56):
Okay, so back to your example, though, I have questions,
and so Liptor obviously is I don't know which company
owns that, but that's their brand. I mean, is that
the way that the drug supply chain works in other countries,
Like it's same medicine, but they don't have the same
(06:16):
safety protocols that the US has, and therein lives part
of the danger. I'm just trying to make sure, I understand.
Speaker 2 (06:24):
So there's a there's a bunch of different dangers if
you take I'm trying to remember what the act of that,
the generic name of lipatory is. But if you take
sort of a generic lipertoire for another from another country,
you are basically putting your life in the hands of
the regulators of that company of that other country, right,
(06:45):
And so you don't know if it's coming from let's
say Turkey, if the Turkish FDA is as thorough as
the US FDA. And I will tell you that very
few agencies around the world are as thorough and as
well resource does the FDA, even if it's made in
the same factory. Right, a contract manufacturer that's making a
(07:08):
generic lipatoire for let's say Morocco, that batch may not
be as inspected as carefully as the one that is
being made for the US market. So you really want
a medicine that's made for the American market because you
know that will be inspected by the FDA's inspectors and
(07:31):
the FDA's regulation regime. It is not unusual to see
that the same factory will throw away a batch made
for the American market because it doesn't meet standards, but
will keep it for a different countries drug market, it's
definitely going to be a lower standard.
Speaker 1 (07:51):
And so a lot of these companies and you see
them all over social media, at least you do as
a woman. They're like, you know, hey, sign up for
I'm not gonna give any names because I don't want
to throw anybody completely under the bus, and I can't
think of any to be honest with you, but they're like, hey,
you know, we have this weight loss drug in that
weight loss drug and you don't even need a doctor's prescription.
(08:13):
Just sign up and you know, we'll send it to you.
How do we tell where that company is, where that
drug might be coming from, and if it's even remotely
something we're safe to do, or should we never entertain
that stuff?
Speaker 2 (08:33):
Well, there's definitely some warning signs that save you from
even having to look up the license. And one of
those would be if someone is offering a medicine that
is doesn't require a doctor's prescription. Right If you if
you see someone advertising a prescription medicine that normally you
would see other people require a doctor's prescription for, but
(08:56):
they say no prescription required, odds are good. That's not
safe right these most any prescription medicine requires some oversight
from a medical professional, unless you happen to be a
doctor who's treating yourself. It's just not safe to proceed
to take something that's going to pretty seriously affect your
(09:18):
health and not have someone else double checking all the details,
including like checking for cross interactions with other medicines you're taking.
So that's a warning sign. If it's too cheap to
be true, that's a warning sign. Generally. I will tell
you that when the National Associations of Board of Pharmacy
has surveyed Internet websites online pharmacies, they found that ninety
(09:44):
five percent of them are operating illegally. If you just
go a new Google online pharmacy, it's operating illegally. If
it tells you that it's in Canada or any other
country besides the US, it is operating illegally. Outright. There
is no Board of Pharmacy in any US state that
(10:04):
license a license is a pharmacy in other country. So
if it says it's Canadian, it's not safe. It's not
safe because Canadian pharmacies are unsafe. It's unsafe because nobody
has any idea what it really is gotcha, including your border.
Speaker 1 (10:19):
Farms, and that can include like we talked about ingredients
in something that has an interaction with something you may
be taking for blood pressure, right, exactly right.
Speaker 2 (10:33):
I don't take lipatour, but I've told that, I'm told
that certain certain things that affect your blood pressure interact
with other medicines. And you might not even think that
that's an interaction, but you would find out pretty quick
if you were taken of both, then nobody was supervising.
I will tell you that the safest thing you can
(10:54):
do is walking through your bricks and mortar pharmacy if
you have access to one, preferably an independent pharmacy, not
one that's run by a chain. And that person, that pharmacist,
if you're kind of them, you know, has a professional
(11:14):
oath to watch out for your health. And they will
talk to you about medicines you're taking, not even just
the first time, but they'll talk to you anytime you
go and get a medicine dispensed, about what else you're taking,
what kind of side effects you're experiencing. The They really
are healthcare professionals who spend more time in many cases
(11:35):
with patients than the doctors do.
Speaker 1 (11:38):
Yeah, I've discovered that myself. So let's say somebody goes
ahead and takes the risk and orders from an online pharmacy.
How in the world are they getting it into the country.
I mean, I thought we had all these checks and
balances so that things from outside that we deem dangerous
(11:59):
don't get inside of our borders.
Speaker 2 (12:03):
Well, in short, it's a form of smuggling. There's two
kinds of ways to get unapproved medicines into the country.
One of them is in the small package mail, and
there's about three million packages a day that come into
the US, and Customs and Border Protection and FDA do
(12:24):
an amazing job trying to inspect as many as possible,
but they are really quite often looking for a needle
in a haystack, and people will basically send things in
and sometimes they'll say it's medicine, and sometimes they won't.
But your fake online pharmacy will do that, hoping that
no one is going to grab that package from amongst
(12:46):
the other three million. The other way is sometimes larger shipments,
and this is what we just recently studied of freight
quantities of medicine that are worth more than eight hundred
dollars will come into the country and sometimes the lie
on the manifest about where they are. And the manifest
also requires for shipments that big to say where the
(13:08):
medicine was manufactured. And we have seen people completely lying
about these injectable GLP ones, claiming that they were made
in a JW. Marriott. We saw one shipment that was
claimed to have been manufactured in a Toronto high school,
another in a gym in British Columbia, and they just were,
(13:34):
they were just depending upon no one bothering to look.
And in two of those cases, those shipments were allowed
because well I don't know why, but I assume it's
because FDA and CVP didn't have the manpower to actually
look at the manifest and refuse the shipment. But that's
actually a big issue. In our research. We found over
(13:57):
the last two years, you know, over one hundred and
almost two hundred shipments of some agnatide and trizepetite, the
two major ingredients for weight loss injectables that made it
into the US, that were on their face completely not legal.
They were manufactured in factories that the FDA didn't even
(14:17):
know existed, Oh.
Speaker 1 (14:19):
My gosh, and it probably said creepy basement on the description, right,
it shut up.
Speaker 2 (14:27):
What's really disturbing is that some of them said ingredient
for compounding. And so, you know, we have some concerns
about where people who compound medicine are getting their ingredients
because for the most part, everybody agrees that those manufacturers
are not in the US. And we looked at these
shipments to say, are these shipments that are clearly not
(14:51):
being made in FDA known factories coming into the US
for compounding and we did find we did find se
several instances where they were coming in for marked for compounding.
They were not in an FDA inspected factory, and we
don't know where they went because that information is not public,
so I can't tell you if it was a legal
(15:13):
or an illegal compounder. But they were definitely intended to
be used in compounded injectable weightless medicines.
Speaker 1 (15:20):
Wow. Now these medicines, My understanding is that they became
popular because of celebrities, And I mean, would they have
been guilty of potentially getting these medicines from somewhere other
than the US or I mean, does that does that
(15:41):
is that something that happens I assume it is. I
mean we see it in movies.
Speaker 2 (15:46):
Yeah, I mean, I think if you cast your mind
back a little bit, you know, it was Prince who
his heartbreaking death was caused by a fake pill made
with fentanyl. So celebrity are not immune from breaking the
drug supply chain, right like they have. The money is
not the issue for them. It's just do they know
someone who can get them get them medicine. And the
(16:10):
truth is, I don't know if celebrities, uh you know,
get this medicine from compounded sources, legal or illegal sources,
or they get like them you know, Rio Loo's up
In and Maunjaro, But they certainly have the money to
get their real product. But we're we're all at risk,
right that That Prince's death shows that no one is
(16:32):
really immune from the dangers of stepping out of the
legitimate drug supply of your corner drug store.
Speaker 1 (16:38):
Yeah, for sure. And just to clarify, like the little
medical weight loss place at the local strip mall, as
long as that's a doctor running that, that's usually pretty safe, right.
Speaker 2 (16:56):
No, a lot of those have been. I mean, I'll
tell you why, from a purely principal concept, why it's
not super safe. You've got a physician who's in business
only to treat you for issues of weight loss. Maybe
you see the position, maybe you don't, But that physician
(17:17):
is not your regular doctor. They don't know your history,
they don't know what other issues you struggle with historically,
and so it's not as good as going to your
regular general practitioner to get a weight loss medicine. And
so I don't think that that's a good idea. In addition, medspas,
(17:39):
and it depends on the state because the regulation is
different all over the place. Medspas, maybe you're being supplied
by a pharmacy, you know, perhaps in some cases they're
being supplied by a doctor who does compounding that's allowed
in their state, but they're not considered to be safe
dispensers of prescription medicine right not. Their history, their history
(18:01):
is other techniques of beauty. And so I would not
go to a med spa, you know. And there have
been plenty of stories of medspas who've been, you know,
notified by law enforcement that they're violating the law, and
so I think that that's not the place you want
to go for safe medication.
Speaker 1 (18:21):
Gotcha, gotcha? Because I mean weight losses. I mean, it's
been a big business as long as I can remember,
especially well.
Speaker 2 (18:31):
And you know, you asked why these drugs became popular,
and they became popular because they work, They produce under
medical supervision, They produce life changing results, literally life changing results.
There was just a Wall Street Journal reporter who wrote
an article about his journey with the zempic and how
(18:52):
he lost I think it was forty pounds or sixty pounds,
and then another twenty after he went off it. Because
while he was losing, he had the motivation to really
change his life habits and he could not have pulled
this off without the medicine. But now he's a very
(19:12):
different person with very different habits, and he's really conquered
this weight issue which plagued him his whole life. And
so you know, they really work, right they are. I mean,
I cannot tell you what it means for someone I'm
fifty seven. I've seen a lifetime of diet and fad
diet culture. To see something that actually works, I mean,
(19:36):
I think these medicines are amazing and I'm really excited
to see all the good they can do.
Speaker 1 (19:42):
Yeah, and it's my understanding that they not only do
they help with weight loss, but supposedly they help with
other things, is that right.
Speaker 2 (19:52):
I mean, they're being studied for other things, such as
at various addiction issues. But you know, I don't think
that there's nothing approved as far as I know, it's
only approved for diabetes and obesity and weight loss. They're
not approved for, you know, helping with addiction. But you know,
(20:12):
this is an area which is we're still in the
infancy of understanding these drugs, understanding what they're capable of,
and even figuring out what is the most effective formulation.
There are still in the pipeline various formulations of these
drugs that have not been approved yet that could be
more effective with less side effects. You know, it's just
(20:34):
super exciting to be here at this moment in the history.
Speaker 1 (20:37):
Yeah, for sure. And I mean, obviously, people there's been
a huge movement towards reducing the amount of chemicals in
food and particularly processed foods, and you know the PFA
PF essays, and you know, the microplastics all that kind
of stuff. But like you said, the fact that this
(20:59):
works is just kind of gangbusters. If you were to
advise somebody who's interested, but hasn't taken the leap yet,
just either PCP or would you recommend them go to
a specialist? What do you what are your thoughts?
Speaker 2 (21:20):
I would I would start with a primary care physician
just as you would suggest, and talk to them about this,
talk to them about getting access to this medicine if
if your insurance doesn't cover it. Both companies have direct
to patient programs that if you're if you're in the
(21:40):
business of paying cash that are significantly less than what
you might end up paying, you know, buying buying buying
the medicine cash from a local pharmacy. A local pharmacist
is always best. But if you can get you go
to your primary care doctor and get the prescription, you
can take it odd to one of these direct direct
(22:01):
sales and you know, have that conversation. Right long term
you you're you're you're doing this for your long term health, right,
You're you want to you want to lose weight so
that you're no longer obese or overweight for your long
term health. That requires the involvement of your long term physician.
(22:22):
So I would do that. And even if you if
you are with a big healthcare system, you know those
doctors are going to have your ongoing electronic medical record,
even if it's not the same doctor every you know,
after two years you're there's you're still going to have
a long term focus on your health and then they'll
(22:43):
help you.
Speaker 1 (22:44):
Okay, so we might see some new versions of these
coming out in the future, is what you're saying or
one of the things I'm hearing you say. Do we
know anything about that?
Speaker 2 (22:55):
We're not even at the end. We are not even
at the end of this innovation cycle.
Speaker 1 (22:59):
Oh okay, all right, so we need to be watching
for that. Then why don't you answered this question for me?
I'm just curious and you're the expert. Is there anything
the audience needs to know that I just didn't know
that I needed to ask you about it?
Speaker 2 (23:20):
I mean, I think the most important thing to understand
is that when you're out looking for access to these medicines,
there are three categories that you need to understand. There's
the patented or branded medicine that's like the woman the
name like gozump pick with a catchy jingle. There's generic
(23:43):
versions which don't exist yet, but often a medicine that
is got a brand name, after a time, it will
go off patent and become generic. There are no generic
versions of these medicines yet, so it's not safe to
take something that someone tells you as a generic version
of a zepic. It doesn't exist. So that's really important
(24:06):
thing to know now. And then the compounded medicines, and
this is what most people don't understand. Compounded medicines are
not FDA approved, and the FDA states to patients that
they do not test them for safety or efficacy, and
I think that's a really important point. You know, usually
compounded medicines are let's say, oncology drug that is in
(24:31):
shortage before you start your cancer treatment, and in that case,
you take that medicine because the alternative is that you
don't start your cancer treatment, and that's terrible. But in
this case, you know, if you are faced with an
option of taking a compounded weight loss medication, the time
(24:53):
at which you start is not is not the same
risk benefit ratio of starting cancer treatment, and you know
you don't want to take that risk if you can
avoid it, even for a legally compounded medicine, I would
definitely go to the direct sales channel from Lillie or
Novo to get that medicine because you know it's actually
(25:13):
coming from a manufacturer who's inspected, and that's an FDA
approved drug. All the compounded medicines are not FDA approved,
and that's even for the legal ones. You know, there
are illegally compounded medicines out there being made by pharmacies
with no license at all, and those are also wildly unsafe.
And then the last thing I would say is, if
(25:37):
you can believe it, there are an enormous rash of
look alike, perfect lookalike counterfeits of a zebic and other
weight loss injectables. They look like the real thing. They've
got the real box, or it looks like the real box,
but they're completely vake. And that's what you'll get if
(25:59):
you go online from a foreign pharmacy and try and
order a zempic.
Speaker 1 (26:04):
And so don't ever do that, Okay, And I thought
of my question, do you think that these medications are
going to have a significant effect on the realm of
bariatric surgery?
Speaker 2 (26:21):
Yeah, I think it could. I think it'd be really interesting.
I think that there's people who haven't had bariatric surgery
who might have been thinking about it, but but might
now decide to try one of the injectable GLP one drugs,
and I think that that is very exciting obviously if
you are not thrilled about having surgery.
Speaker 1 (26:42):
Yeah, definitely. And do you think they'll come out with
an oral version for people who don't like shots?
Speaker 2 (26:50):
They are actually experimenting. There is already an oral version
of some aglaetide, and they continue to refine in this
space an other oral versions that might be more effective.
Right now, the injectables are more effective and result in
more weight loss than the oral dose versions. But again,
(27:10):
we're at the beginning of this innovation cycle. We're not
even we don't even know where this is going to end.
And I think there's better oral versions that they're going
to discover and really and get approved by the FDA.
Speaker 1 (27:23):
Okay, can you point us to a website where we
can learn more about this?
Speaker 2 (27:29):
Yeah? So, our website has a whole bunch of consumer
resources for people who want to learn about counterfeits, and
you can go to www Dot safemedicines dot org. We
have advice on how to buy safely, how to buy
safely online. Most of that advice is don't do that,
and how to identify and spot warning signs for counterfeit
(27:52):
medicines wonderful.
Speaker 1 (27:54):
Well, I think we've come to the end of our time,
but I just want to tell you I am so
grateful that you came on the show and shared this
information with us and answered my questions and hopefully I
was able to think of questions that people you know
listening would want to ask and so I can answer
their questions.
Speaker 2 (28:15):
Well, I'm glad to be here. You know. Drug safety
is a passion of mine. It's why we've existed for
twenty three years, and anything we can do to help
people make safer choices is important for us most definitely.
Speaker 1 (28:28):
So yeah, thank you for your time, and maybe we
can have you back on the show another time. Love
to I hope you've enjoyed today's show. Thanks for tuning
into the show on your favorite local radio station. You
can now listen to this show or past shows through
the iheartapp or on iHeart dot com. Just search for
Virginia Focus under podcasts. I'm Rebecca Hughes with a Virginia
(28:49):
news network, and I'll be here next week on Virginia Focus.
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