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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.
Here is a lightly edited transcript of the conversation:
Lindsay Posey: I am a single parent. I'm a widow. My husband was in the military, and he died in the line of duty, uh, years ago. So it's just me. So if something happens to me, you know, I think about my kids.
Sarah Holder: Lindsay Posey is a 38 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 Ozempic or Mounjaro.
Posey: I told him that I was like, yeah, I would love to, but my insurance isn't going to cover it.
Holder: 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.
Posey: So I, you know, started going on Reddit researching different places, Googling, and I came across telehealth companies.
Holder: 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 vial she received seemed to work – lowering her desire for food – but then the second vial seemed to have no effect.
Posey: 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.
Holder: Then, Lindsay opened her third vial of medicine.
Posey: And, you know, within a week of starting it, my face just kind of started to break out. Within two weeks, it was getting really bad. I think I did three weeks of that vial before I had gone through every avenue and process of elimination, trying to figure out what is causing this.
Holder: Lindsay stopped applying a new moisturizer she’d been using. She modified her diet.
Posey: You know, I really, I couldn't find an answer. So I thought it has to be this. So I ended up throwing the rest of that vial away.
Holder: Lindsay eventually got a replacement vial from the compounding pharmacy.
Posey: 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?
Holder: Lindsay says the experience made her wonder just where these vials were coming from.
Posey: It’s kind of scary, you know, 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 digging and you're like, okay, well, is that the truth?
Holder: Today on the show, how the skyrocketing demand for weight-loss drugs like Zepbound, Ozempic and Wegovy is sending Americans into a $1 billion shadow industry that could be putting their health in danger.
I’m Sarah Holder and this is the Big Take from Bloomberg News.
Madison Muller: Last year when you would Google Ozempic or Wegovy, most of the things that would come up online were news articles or, you know, so and so celebrity is taking Ozempic.
Holder: Madison Muller is a health reporter at Bloomberg. She mostly covers Ozempic, Wegovy and other weight loss drugs. And she says over the past year, she’s noticed different results starting to show up on Google.
Muller: It's crazy. I mean, if you type Ozempic into Google search, like, all of the advertisements are for telehealth companies that are selling compounded drugs.
Holder: You might have seen these results too for telehealth companies like Hims & Hers, or Ro, that sometimes advertise cheaper copycat meds. Madison got to work compiling all of the results she found for companies that said they sold those sought-after weight loss drugs.
Muller: I mean, I think there were like 60 companies or something at the time. And I was like, there is something going on here. And so Ike and I started looking into this.
Holder: Ike Swetlitz 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. They’re something else entirely.
Swetlitz: 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, you know, mixed together some chemicals and gave it to you in whatever sort of format you needed it. So that was, that was how you got medicines.
Holder: 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.
Swetlitz: But compounders still had a role making some medicines. Mostly medicines for people who might have been, 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.
Holder: 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.
Swetlitz: 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.
Holder: Ike says this worked for a while, until 2012 when dozens of people died from contaminated drugs made at a compounding center in Massachusetts.
News Archival: State officials here in Massachusetts say they found a leaking boiler, dirty floor mats, even black specks visible to the naked eyes in sealed vials at the New England compounding center.
Holder: That led to a national meningitis outbreak and, in 2013, 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.
Muller: 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, Ozempic, Wegovy, Mounjaro, Zepbound 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 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.
Holder: Even if you’ve been prescribed Ozempic or another semaglutide drug, it can often be very difficult to find a pharmacy with the medicine in stock.
Muller: 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 that also helps telehealth companies and other businesses that have sort of built up a business around prescribing these drugs to patients.
Holder: Are they using the same active ingredients as Ozempic and Wegovy and Mounjaro?
Swetlitz: So if the, if the compounders are doing what they're supposed to do and, and following the rules, then yes, they should be using the same active ingredients.
Holder: But sometimes, patients might be confused about exactly what drug they're getting.
Muller: 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, um, you know, smiling patients on it and says that it's selling Ozempic. Like, oh, it probably is. So I think that that's sort of the challenge is in this, you know, world of misinformation and, 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.
Holder: Other times, Madison says, patients are in fact seeking out the cheaper, compounded version of the drug.
Muller: And that’s one of the things, I mean, especially on, like, on social media, the compounded drugs have really taken off, especially on TikTok.
Archival TikTok: Alright so in this bag, I have alcohol swabs to prep for your skin, I also have the needles that you use for injection, and then this little vial right here is the compounded medication - you can see it.
Muller: A lot of TikTok influencers and, 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.
Archival TikTok: With the compounded version, as long as there’s a shortage, I am going to get my medication.
Holder: Ike says these compounding pharmacies are growing rapidly – partially to meet demand, and partially because there’s a lot of money to be made.
Swetlitz: 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 in gold-plated Bentleys because of the profits from some of these compounding medicines.
Holder: Bankers told Ike that annual sales of compounded weight-loss drugs could ultimately be as high as $1 billion. So, there’s demand – and there’s potentially billions of dollars in revenue. But there's also one big asterisk.
Holder: So, Madison, now for the million dollar question. Are compounded weight loss drugs safe to use?
Muller: Yeah. I mean, that's our million dollar question, too, is are these drugs safe to use? And, and in the course of our reporting, that's something that has been very difficult to determine.
Holder: The safety of knockoff Ozempic...that's coming up after the break.
Holder: 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 reporter Ike Swetlitz told me.
Swetlitz: So I think that the biggest 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 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.
Holder: Compounders, Ike says, are mostly governed by state regulations.
Swetlitz: The states are checking to see if they're following protocols, right? You know, if they're 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, and, you know, checking to make sure that the drugs work.
Holder: 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.
Muller: 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 same level of adverse event tracking that happens with branded medications.
Holder: And Ike says that the worrying thing for doctors wasn’t necessarily wrongdoing at these compounders.
Swetlitz: 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. 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 they're looking for answers for about the effectiveness of these compounded medicines.
Holder: 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 Ozempic and Wegovy, and Eli Lilly, which makes Zepbound.
Muller: 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, they say that it's not necessarily a competitive risk, but they are worried about 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 down on some of this.
Holder: 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.
Swetlitz: So there’s a lot of issues that these companies are taking with how a website might describe the drug as opposed to concerns about whether the drug is harmful to patients or not.
Holder: 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.
Swetlitz: These drugs can be safe and, you know, can be made properly, as long as they're made, you know, at, at high-quality pharmacies.
Holder: 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.
Posey: It just kind of seems like 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 in shipping, you know, it could be a lot of things. And it's not very comforting.
Holder: 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.
Posey: I feel as though, you know, we wouldn't have to go down this route that's, you know, could potentially be unsafe if these insurance companies started carrying it for people like me.
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