Speaker 1: Caveat injector there everywhere, diy peptides for losing, weight, building,
Speaker 1: muscle slowing, aging, getting tan, and general looksmaxing Inside a
Speaker 1: legally ambiguous and medically dubious global supply chain by Amanda Mole,
Speaker 1: Madison Muller, and Ashley Furlong, Read aloud by Mark Leidorf.
Speaker 1: In an industrial park a half hour outside Prague, Peter
Speaker 1: Magic finds himself at the center of a gold rush.
Speaker 1: In the fifteen years since he started his business as
Speaker 1: a teenager in his parents' garage in Slovakia, it's developed
Speaker 1: into a fast growing company with almost nine figures in
Speaker 1: annual revenue and an international clientele. He isn't training a
Speaker 1: new kind of agentic artificial intelligence that replaces your employer's
Speaker 1: legal department, or building the next online prediction market. His company,
Speaker 1: Janoshik Analytical, does purity and sterility testing for black market
Speaker 1: anabolic steroids, an obscure niche Magic found during his own
Speaker 1: foray into weightlifting. His search for other lifters online took
Speaker 1: him to four chan and read it, where many talked
Speaker 1: freely about their pharmaceutical experimentation, but fretted about what might
Speaker 1: be in their drugs. Magic figured testing steroid samples couldn't
Speaker 1: be that hard. It took a couple of years actually
Speaker 1: before we got all the processes perfected, because obviously, legally
Speaker 1: this is pretty.
Speaker 2: Thin ice, he says.
Speaker 1: Among connoisseurs, his testing has become the gold standard. Outside
Speaker 1: in his labs parking lot. He has the shimmering purple
Speaker 1: Ferrari to prove it. As it turns out, Magic's reputation
Speaker 1: for running a legitimate business evaluating illicit substances has positioned
Speaker 1: him perfectly for a new black market. The global trade
Speaker 1: in peptides. Injectable peptides are a loose cohort of amino
Speaker 1: acid based drugs that bond to receptors in the body
Speaker 1: to toggle various physiological processes.
Speaker 2: On and off.
Speaker 1: Some peptides are legal and widely used, including insulin and
Speaker 1: GLP one drugs. The pes for peptide in the early
Speaker 1: twenty twenties, as buzz about their weight loss capabilities moved
Speaker 1: beyond diabetics in doctor's offices, Ozembic and other GLP ones
Speaker 1: quickly grew popular among fringy fitness buffs, lookxmaxers, and Silicon
Speaker 1: Valley types to get weight loss drugs well outside of
Speaker 1: prescribing guidelines.
Speaker 2: Some turned to lenient.
Speaker 1: Telehealth providers and longevity clinics that were happy to welcome
Speaker 1: off label patients, the kind of clientele who are in
Speaker 1: turn happy to pay in cash. Exhilarated by the ease
Speaker 1: with which GLP ones help them get shredded, some of
Speaker 1: these users wanted to experiment further with the help of
Speaker 1: unconventional medical practitioners. These enhancement enthusiasts found more than a
Speaker 1: dozen other kinds of peptides. Most of these drugs weren't
Speaker 1: approved by the FDA and absent from the list of
Speaker 1: drug ingredients allowed to be used in compounding pharmacies, state
Speaker 1: regulated facilities that fill many gaps in the country's pharmaceutical
Speaker 1: supply by mixing customized medications. Some of these substances had
Speaker 1: been developed by traditional farmer companies but abandoned because of
Speaker 1: muddled efficacy results or lack of projected profitability. A few
Speaker 1: had hardly been tested in humans, and the potential long
Speaker 1: term side effects and safety of any of these peptides
Speaker 1: remain unknown. Their names consist of cryptic jumbles of letters
Speaker 1: BPC one F seven, CJC twelve ninety five, TB five
Speaker 1: hundred and promise all kinds of benefits. Want to sleep better,
Speaker 1: there's a peptide for that. How about helier tendinitis faster?
Speaker 1: Or lock in at work? There are peptides for that too,
Speaker 1: Need a tan sure. Then there are the stacks such
Speaker 1: as Wolverine, Klow, and Phoenix, combinations of peptides meant to
Speaker 1: max out user's results. Although most compounders stayed out of
Speaker 1: the peptide business, some were willing to fill prescriptions and
Speaker 1: risk the FDA warning letters that generally constitute the first
Speaker 1: phase of enforcement. As these peptides became mainstays of online
Speaker 1: chatter among Jim Bros and biohackers, and as their beliefs
Speaker 1: about peptides found even greater purchase among influential podcasters like
Speaker 1: Joe Rogan and Andrew Huberman, their popularity began to spread,
Speaker 1: alarming regulators. In August twenty twenty three, Jennifer Aniston told
Speaker 1: The Wall Street Journal that she swore by weekly peptide
Speaker 1: injections as part of her anti aging regimen. Weeks later,
Speaker 1: the Biden era of Food and Drug Administration changed the
Speaker 1: regulatory status of nineteen peptide drugs, effectively banning compounding pharmacies
Speaker 1: from producing them even with a valid prescription because of
Speaker 1: safety concerns. Filling these drugs was never really legal given
Speaker 1: their absence from the permitted list, but the change sent
Speaker 1: an explicit message to compounders about regulator's views. Many of
Speaker 1: the pharmacies that had been willing to test the boundaries
Speaker 1: took it as a wa warning shot and decided to
Speaker 1: drop the drugs entirely. Undeterred, peptide users simply went underground,
Speaker 1: where they found groups of fellow travelers on discord or telegram,
Speaker 1: or they formed groups of their own to track down
Speaker 1: the drugs they wanted to get them. These groups began
Speaker 1: to go straight to the source, ordering active ingredients in
Speaker 1: bulk from Chinese pharmaceutical manufacturers through wee chat, WhatsApp or
Speaker 1: other apps and paying in cryptocurrency. Suppliers then shipped the
Speaker 1: active pharmaceutical ingredients or API to buyers in little glass
Speaker 1: vials of white powder that can be reconstituted into an
Speaker 1: injectable liquid with a special type of sterile water. Labs
Speaker 1: such as Yanishik come in. When those vials arrived Stateside,
Speaker 1: buyers sent off a few to make sure they got
Speaker 1: what they paid for before divvying up the goods among
Speaker 1: group members. It wasn't long before some of these informal
Speaker 1: sourcing operations began to join a few existing peptide retailers
Speaker 1: in opening themselves to the public, which was becoming more
Speaker 1: peptide curious by the day. In spite of the FDA's
Speaker 1: safety warnings, importers expanded their orders and built ordinary looking
Speaker 1: e commerce sites, complete with advertising budgets and influencer partnerships.
Speaker 1: They believed they'd found a regulatory loophole that would allow
Speaker 1: them to sell to anyone with a credit card and
Speaker 1: sufficient risk tolerance. Like most prescription drugs, peptides aren't controlled
Speaker 1: substances that are inherently illegal to possess, but federal regulations
Speaker 1: govern what constitutes permissible trade depending.
Speaker 2: Who the buyers and sellers are.
Speaker 1: In particular, the sale of the raw materials used to
Speaker 1: make them isn't nearly as closely scrutinized as the sale
Speaker 1: of finished prescription drugs. As long as those raw materials
Speaker 1: are destined for use in a lab for research instead
Speaker 1: of in humans and animals, Sellers slapped for research use
Speaker 1: only on their websites and began filling orders for sometimes
Speaker 1: dozens of kinds of APIs, not only the controversial ones,
Speaker 1: but also those found in ozempic and zep bound, which
Speaker 1: appealed to millions of consumers.
Speaker 2: Desperate for the price use drugs.
Speaker 1: There's still really no way to know that your product
Speaker 1: is what even the testing company says it is unless
Speaker 1: you take it yourself, says a founder of Compound Sciences,
Speaker 1: a peptide site in Utah that's been around for less
Speaker 1: than a year, who asked not to be named so
Speaker 1: they could speak candidly. And you know, our families are
Speaker 1: on all of this product. He maintains that his business
Speaker 1: is careful to adhere to federal regulations around allowable marketing
Speaker 1: and packaging practices for research use API, which is where
Speaker 1: most sellers air. Interest in these substances has spread to
Speaker 1: the mainstream, and peptides are now commonly discussed online as
Speaker 1: treatment options for sagging skin and arthritis, pitched to menopausal
Speaker 1: suburban moms and offered to clients at a growing number
Speaker 1: of medspas as a casual add on to a botox
Speaker 1: touch up. Black markets, that is, sustained trade in goods
Speaker 1: that violate the law in some way are by nature
Speaker 1: difficult to measure, but there's plenty of evidence of increasing demand.
Speaker 1: There are so many many peptide sellers sending Yanoshik samples
Speaker 1: that from twenty twenty three to twenty twenty five, the
Speaker 1: volume of peptide tests the company processed increased more than
Speaker 1: twelve hundred percent, according to data it shared with Bloomberg BusinessWeek,
Speaker 1: during the first nine months of twenty twenty five, US
Speaker 1: Customs and Border Protection logged three hundred and twenty eight
Speaker 1: million dollars in active pharmaceutical ingredient imports for peptides, twice
Speaker 1: the amount imported during the same period the previous year.
Speaker 1: According to The New York Times, this included both material
Speaker 1: making its way to compound pharmacies for illegal use in
Speaker 1: medications and raw material headed to mercier destinations, but that
Speaker 1: number is likely just a fraction of the total. Importers
Speaker 1: increasingly employ more evasive maneuvers to skirt detection by customs officials,
Speaker 1: and that logged dollar amount is only the value of
Speaker 1: the imported raw material, which costs most large importers a
Speaker 1: few dollars per file, compared with the fifty dollars to
Speaker 1: three hundred dollars consumers are paying. The Compound signed Ens
Speaker 1: co founder says his company is a small business, bringing
Speaker 1: in about one hundred thousand dollars in revenue per month,
Speaker 1: with about half of that being profit that's.
Speaker 2: Purely from personal referrals.
Speaker 1: He says Compound Sciences doesn't buy ads or work with influencers,
Speaker 1: noting that he knows of larger operations that he believes
Speaker 1: bring in as much as two million dollars per month
Speaker 1: in gross sales. Investors within the industry say the black
Speaker 1: market is anywhere from one to three billion dollars. Now,
Speaker 1: this already booming economy is preparing to emerge from the shadows.
Speaker 1: Under instruction from US Secretary of Health and Human Services
Speaker 1: and self professed peptide fan Robert F. Kennedy Junior, an
Speaker 1: FDA committee is expected to recommend that seven peptides be
Speaker 1: added to the list of substances available for legal use
Speaker 1: in compounding pharmacies, with another five to be considered for
Speaker 1: inclusion by early twenty twenty seven. Such a move would
Speaker 1: help clear the way for compounding pharmacies to fill prescriptions
Speaker 1: of these medications, which, as Kennedy said in an ex
Speaker 1: post in April, would divert demand away from a dangerous
Speaker 1: black market that puts Americans at risk. It would also
Speaker 1: make a number of hyped peptides that lack rigorous scientific
Speaker 1: backing and that could have side effects.
Speaker 2: As risky as severe allergic.
Speaker 1: Reactions, liver or kidney damage, and sped up tumor growth
Speaker 1: much more palatable to the buying public. In some ways,
Speaker 1: this would be a shocking turn of events, upending the
Speaker 1: system of drug development and regulation in the US as
Speaker 1: we know it. In other ways, it's just the most
Speaker 1: recent step in the long march toward a fully consumerized
Speaker 1: healthcare system in which customers transact directly with companies marketing
Speaker 1: medications with limited interference from peski doctors and regulators, along
Speaker 1: with entrepreneurs and investors getting in position to cash in.
Speaker 1: Many existing healthcare workers stand to profit from swelling consumer demand.
Speaker 1: Telehealth companies, compounding pharmacies, medspas, testing labs, Chinese drug manufacturers.
Speaker 1: There's one industry, though, that's been caught flat footed, big pharma.
Speaker 1: It's responsible both for the peptide consumer craze and the
Speaker 1: original development of almost all of the drugs now popular
Speaker 1: on the black market. For traditional pharmaceutical companies. The growing
Speaker 1: popularity of these peptides threatens to siphon off potential customers
Speaker 1: and undermined incentives to invest in costly clinical research and
Speaker 1: drug development. Meanwhile, entrepreneurs like Nathan Gravell, the chief executive
Speaker 1: officer of longevity telehealth platform Jevity Health, are getting ready
Speaker 1: to pounce. Our pharmacy partners are already preparing for these
Speaker 1: to be legal.
Speaker 2: The twenty seven year old says.
Speaker 1: They are pre planning for a lot of volume, a
Speaker 1: lot of demand. Christy Turner is not a hobbyist, bodybuilder,
Speaker 1: or an aspiring wellness influencer or someone with a deep
Speaker 1: distrust of mainstream medicine. She's a therapist in suburban Indianapolis
Speaker 1: with a husband and two grown kids, and she's been
Speaker 1: trying to lose weight for as long as she can remember.
Speaker 1: In May twenty twenty four, Turner took her her first
Speaker 1: dose of Eli Lilly's zepbound a GLP one and felt
Speaker 1: her life change within a matter of hours. We were
Speaker 1: going with my son and his fiancee to dinner, and
Speaker 1: that was five hours later, and I realized the food
Speaker 1: noise was gone. She describes it as a magical experience.
Speaker 1: That since helped her lose almost two hundred pounds. Turner
Speaker 1: began taking zepbound after becoming a patient at Mochi Health,
Speaker 1: a San Francisco telehealth startup founded in twenty twenty two,
Speaker 1: a boom time for online medical startups thanks to the pandemic,
Speaker 1: loosened regulations, and a spike in demand for ozempic prescriptions.
Speaker 1: At Mochi, Turner met doctor Laura Rice, a functional medical
Speaker 1: practitioner and osteopath, who prescribed that first dose. Eventually, Turner
Speaker 1: canceled her Mochi subscription and continued to see Rice at
Speaker 1: her independent practice.
Speaker 2: I followed her like a little groupie.
Speaker 1: Turner says, she's the one who's opened the world of
Speaker 1: peptides to me to help with post weight loss skin sagging.
Speaker 1: Rice recommended Turner take ghkcu, a peptide the FDA has
Speaker 1: excluded from compounding in its injectable form. Turner is also
Speaker 1: on glutathione, a legal peptide for its purported immune boosting properties,
Speaker 1: which she first heard about after joining a live stream
Speaker 1: with Rice, who said it was a favorite among her
Speaker 1: other patients. My boys are twenty two and nineteen, and
Speaker 1: they make fun of me. Turner says, they're like you're
Speaker 1: turning into a gem bro. You're getting your stacks. Doctors
Speaker 1: who are willing to recommend restricted peptides to patients are
Speaker 1: usually in specialties functional and integrative medicine, longevity, anti aging
Speaker 1: that offer a broad range of therapies lacking in a
Speaker 1: rigorous scientific backing. Depending on the doctor, that can include
Speaker 1: relatively uncontroversial treatments such as acupuncture or massage, as well
Speaker 1: as more esoteric options like complex protocols of nutritional supplements.
Speaker 2: Or energy healing.
Speaker 1: I got out of mainstream medicine because I was very disillusioned.
Speaker 1: Rice says, though she still commonly prescribes statins and other
Speaker 1: FDA approved medications at her own practice, she has more
Speaker 1: latitude in how much regulatory and scientific risks she's willing
Speaker 1: to offer to patients, including through peptides that aren't supposed
Speaker 1: to be available from compounding pharmacies. She's been able to
Speaker 1: find willing compounders for the forbidden drugs anyway, including for
Speaker 1: Turner's GHKCU, which Rice is able to get from a
Speaker 1: pharmacy in Texas. The potential risk is a little bit scary,
Speaker 1: Turner admits, but she trusts her doctor to keep her safe.
Speaker 1: Doctor Rice does her research. As Rice sees it, her
Speaker 1: role is twofold to help patients in ways she doesn't
Speaker 1: think mainstream medicine can, and to blunt the safety risks
Speaker 1: that some of them are already taking after trying treatments
Speaker 1: they've heard about on Reddit or TikTok. The hard part
Speaker 1: is patients are asking for these medicines because they're seeing
Speaker 1: them online, but as physicians, we're carrying all the risk,
Speaker 1: Rice says, though she and her practice also actively promote
Speaker 1: the use of these drugs online. We're carrying sourcing sterility, potency,
Speaker 1: informed consent, state board scrutiny, malpractice. I mean, it's a
Speaker 1: huge risk, but I've also taken that risk conservatively, and
Speaker 1: probably only a small percentage of my patients are on
Speaker 1: some of the more gray area peptides. She mentions BPC
Speaker 1: one fifty seven for musculoskeletal healing, which is incredibly popular
Speaker 1: online and listed prominently on her practice's website, though it's
Speaker 1: banned from compounding pharmacies and there's almost no clinical research
Speaker 1: showing its safety or efficacy in humans. I've used that
Speaker 1: for patients, she says, is the data there to support
Speaker 1: it absolutely not. Among rice's patients taking BPC one fifty
Speaker 1: seven is Hassan Slayman, a forty five year old roofing
Speaker 1: contractor in Michigan. Slayman didn't know much about peptides, but
Speaker 1: he'd begun to worry about his health after spending much
Speaker 1: of his life ignoring it. He smoked about a pack
Speaker 1: and a half of cigarettes a day, and before construction,
Speaker 1: he'd spent years working as a bouncer and a fourty,
Speaker 1: all of which had taken a toll on his body.
Speaker 1: Nine previous surgeries and other nagging injuries kept him in pain.
Speaker 1: He found RICE through his best friend, whose transformation under
Speaker 1: the doctor he says has been incredible. Slayman's has Rice
Speaker 1: started him on terzepetide, the active ingredient in zep bound,
Speaker 1: as well as BPC one fifty seven, and he felt
Speaker 1: pretty good, even though he hadn't really changed his habits.
Speaker 1: More broadly, Now, he says he's on a stack of
Speaker 1: seven peptides, terzepetide and BPC one fifty seven, plus MOTSC
Speaker 1: for collagen production, glutethione for detoxification, and TB five hundred
Speaker 1: KPV and GHKCU for old injuries and skin quality. With
Speaker 1: the exceptions of terzepetide and gluetethione, all these drugs are
Speaker 1: currently banned from use in injectable medications by US compounding pharmacies.
Speaker 1: Slayman says he feels incredible and his health has improved
Speaker 1: enough to make his work less painful and running after
Speaker 1: his nine year old more fun. He started carrying around
Speaker 1: Rice's business cards so that when people ask what he's doing,
Speaker 1: he can send them her way. He likens it to
Speaker 1: the way he promotes his faith. Why would he gatekeep
Speaker 1: something that can help people? Most people don't even know
Speaker 1: where to start, he says. For many patients, feeling comfortable
Speaker 1: injecting a dubiously sourced medication at home didn't just materialize overnight.
Speaker 1: Often it starts with safe, legal, legitimately prescribed, and extremely
Speaker 1: effective medications. The GLP one's. They pulled the entire peptide
Speaker 1: market up there along with them, says Magic, the Janoshik founder.
Speaker 1: Some twelve percent of Americans are taking a GLP one,
Speaker 1: according to a recent survey from the health policy organization KFF.
Speaker 1: Helping convince millions of users and the many people who've
Speaker 1: watched their transformation that the key to health, beauty, and
Speaker 1: longevity might come in a syringe. The widespread use of
Speaker 1: cosmetic injectables such as botox and lip filler, now easily
Speaker 1: jabbed at a StripMap medspa near you, has bolstered the
Speaker 1: belief that injectable drugs are an easy, low risk option
Speaker 1: providing quick, visible results. Pursuit of GLP ones and the
Speaker 1: insurance denials, high cash prices, shortages, and prescribing restrictions that
Speaker 1: have commonly come with them have also pushed patients toward
Speaker 1: medical practitioners and drug sources they might have previously issued,
Speaker 1: or maybe hadn't even heard of. Patients turned to the
Speaker 1: Internet for guidance on how to find better prices, just
Speaker 1: like they do with everything else they buy. Wherever they
Speaker 1: look for advice, Reddit, Instagram, TikTok, Facebook groups, people are
Speaker 1: ready to guide them to the black market. For patients
Speaker 1: who arrive in these corners of the Internet where cheap
Speaker 1: research chemicals proliferate, it can feel like alice going through
Speaker 1: the looking glass. What if that thirteen hundred dollars medication
Speaker 1: you desperately needed was really cheap all along? Why hadn't
Speaker 1: anyone told you the truth. It's not a coincidence that
Speaker 1: some of the most vocal research peptide users, though far
Speaker 1: from all of them, are vaccine skeptics who think that
Speaker 1: common immunizations lack sufficient scientific evidence. As these users see it,
Speaker 1: vaccines and other things are foisted upon them by the
Speaker 1: government and big pharma in pursuit of control and profit. Peptides, meanwhile,
Speaker 1: are the secret key to free your personal health from
Speaker 1: institutional control. Those buying research grade chemicals effectively become impromptu pharmacists,
Speaker 1: a job most are not qualified to do. They have
Speaker 1: to turn powdered active ingredients into injectable drugs, which requires
Speaker 1: reconstituting them with bacteriostatic water, itself a sterile prescription product
Speaker 1: that customers are sourcing bootleg versions of online. Powders are
Speaker 1: sold by weight, but dosages are measured in volume. That
Speaker 1: means users who want to experiment need to understand how
Speaker 1: to combine the powdered and liquid ingredients to make a
Speaker 1: particular concentration, which some brands of syringes will then measure
Speaker 1: in milli liters, while others simply show units About a
Speaker 1: year ago new the patients of the telehealth platform ivim
Speaker 1: Health began showing up to their intake appointments mentioning that
Speaker 1: they were on reta truetide, Lily's new unapproved GLP one
Speaker 1: that in research use form is now the most popular
Speaker 1: drug among peptide buyers. When asked how much they were taking,
Speaker 1: they had no idea. When we're on those video conferences
Speaker 1: with patients, will ask them like show us the vial
Speaker 1: and show us the injection instructions, says Taylor Canter, ivem's
Speaker 1: co founder and chief medical officer. Usually they just have
Speaker 1: the vile shipping research peptides with instructions for dosage and injection.
Speaker 1: After all, would risk sellers acknowledging that they're selling to
Speaker 1: individual patients for human use. The regulatory changes the FDA
Speaker 1: is considering would be the first step in moving access
Speaker 1: to at least some of these substances into compounding pharmacies,
Speaker 1: which would reduce some of the risks that come with
Speaker 1: consumers acting as kitchen table chemists. Because retaitrutide is currently
Speaker 1: in phase three clinical trials, it wouldn't be included. Compounders
Speaker 1: operate licensed, state regulated, and sterile facilities that would ship
Speaker 1: peptides in ready to inject vials of liquid that include
Speaker 1: dosing and injection instructions. These kinds of pharmacies have been
Speaker 1: around as long as doctors have been writing prescriptions, but
Speaker 1: the COVID nineteen era boom in telehealth usage and massive
Speaker 1: shortages of name brand GLP ones suddenly put them front
Speaker 1: and center with consumers. You saw one telehealth company run
Speaker 1: a Super Bowl ad advertising compounded drugs, says Scott Brunner,
Speaker 1: a pharmacist and the CEO of the Alliance for Pharmacy Compounding,
Speaker 1: a US trade group, that would have been unheard of
Speaker 1: ten years ago. As a result, many of the country's
Speaker 1: thousands of licensed compounders have dramatically expanded their capacity to
Speaker 1: make peptides in the past few years.
Speaker 2: Although the vast.
Speaker 1: Majority of compounding pharmacies won't touch the currently unpermitted peptides,
Speaker 1: some of them, including those rice sources from for patients,
Speaker 1: have continued to fill prescriptions for the drugs anyway, even
Speaker 1: after the Biden era changes reinforced that they weren't authorized
Speaker 1: to do so. Now that there's a peptide friendly administration
Speaker 1: in the White House, some pharmacies and practitioners alike, especially
Speaker 1: those in red states, appear even more comfortable gambling that
Speaker 1: regulatory clearance is more likely than targeted enforcement for those
Speaker 1: who get into the peptide business.
Speaker 2: A little bit early.
Speaker 1: Among prescribers, the practice has become so widespread that in
Speaker 1: early June, the Alabama Board of Medical Examiners issued an
Speaker 1: official notice warning the state's practitioners that prescribing or recommending
Speaker 1: research grade medications is prohibited by law, even if patients
Speaker 1: sign a waiver advising them of the risks. That some
Speaker 1: compounders already demonstrated a willingness to play fast and loose
Speaker 1: with the rules during the heady days of the GLP
Speaker 1: one boom, worries Brunner, the Pharmacy Trade Group head, about
Speaker 1: what might be ahead. There are telehealth platforms that are
Speaker 1: members of our organization and our model citizens, but there
Speaker 1: are some that you know they didn't exist in twenty
Speaker 1: twenty three, He says, I'm concerned about that kind of opportunism,
Speaker 1: which I suspect in a universe where these peptides are authorized,
Speaker 1: will repeat itself. We'll be right back with Caveat injector.
Speaker 1: Welcome back to Caveat injector. Tucked away at the back
Speaker 1: of a cafe at a five star hotel in London's
Speaker 1: ritzy Notting Hill.
Speaker 2: Mansi Houkmani is fresh from.
Speaker 1: The gym and sipping on carrot juice. The Belize native
Speaker 1: moved to London about six months ago after a stint
Speaker 1: in New York, but it's hard to say where she'll
Speaker 1: be on any given day. She travels back to the
Speaker 1: US frequently and flits between far flung locales such as
Speaker 1: Dubai and Panama at the behest of her clients. About
Speaker 1: a year and a half ago, after leaving her career
Speaker 1: developing branding and growth strategies for tech startups, she started
Speaker 1: a wellness focused substack newsletter called Chief Longevity Officer. It
Speaker 1: didn't take long for something she'd written about pepti to
Speaker 1: make the rounds. I started getting invited a lot to
Speaker 1: these biohacker meetups in New York, literally going to people's
Speaker 1: high rise lofts in Tribeca and seeing people inject themselves.
Speaker 1: The opportunity in peptides, she says, quickly became obvious. A
Speaker 1: lot of people who start companies and dole out investment
Speaker 1: dollars had suddenly become interested in experimenting in a sector
Speaker 1: that most of them didn't know much about, and so
Speaker 1: Houkmani has become one of a small but growing cohort
Speaker 1: of advisors, fixers, and consultants who help people with money
Speaker 1: figure out how to put it into the peptide market.
Speaker 1: Houkmani's sprawling network of friends and associates includes Max marcione,
Speaker 1: a founder of San Francisco based Superpower Health, which until
Speaker 1: recently was just a blood testing startup for people who
Speaker 1: want to self monitor their biomarkers.
Speaker 2: Marcioni first became.
Speaker 1: Aware of peptides in twenty twenty four when his co
Speaker 1: founder looked at Marcioni's stack of nutritional supplements and told
Speaker 1: him he needed to give peptides a try. Initially, Marcioni
Speaker 1: says he was spooted to self inject the drugs, but
Speaker 1: he got over it, and in the past six months
Speaker 1: or so he's remade Superpower, acquiring technology from a biotech
Speaker 1: company that will allow it to customize its peptide formulations.
Speaker 1: The goal, he says, is to begin selling immediately when
Speaker 1: the FDA's regulatory changes hit, and for Superpower to become
Speaker 1: the biggest peptide company in the world. Not everyone will
Speaker 1: be able to move as swiftly if the FDA flips
Speaker 1: a switch runner. The CEO at the Pharmacy Compounding Trade
Speaker 1: Group says he's worried that the group's member companies will
Speaker 1: be inundated with prescriptions they can't fill and angry customers
Speaker 1: they'll have to turn away. To comply with quality regulations,
Speaker 1: Compounding pharmacies can't just WhatsApp a Chinese supplier, send over
Speaker 1: some Bitcoin and start filling prescriptions once the API powder
Speaker 1: clears customs. Most estimates I hear are between three and
Speaker 1: nine months, he says, for a pharmacy to establish regulatorially
Speaker 1: sound sourcing for the ingredients necessary to compound many currently
Speaker 1: banned peptides. If that happens, he fears that some compounders
Speaker 1: might be tempted to turn to substances that are below
Speaker 1: pharmaceutical grade to meet the demand. Hukmani, who says she's
Speaker 1: currently advising a firm that's looking to bring peptide manufacturing
Speaker 1: to the US, describe the issue a little more succinctly.
Speaker 1: It's not even America that really controls the peptide and
Speaker 1: GLP one infrastructure. It's like effing China to manufacture peptides
Speaker 1: profitably requires economies of scale. The facilities and equipment are
Speaker 1: too expensive and technically complex for opportunists to enter the
Speaker 1: market overnight or for manufacturing capacity to be spun up
Speaker 1: quickly in the US, Europe has a few big manufacturers that,
Speaker 1: along with highly reputable Chinese suppliers, mostly deal with high
Speaker 1: end drug companies and large, well funded research laboratories. For
Speaker 1: pretty much everyone else, smaller pharma companies, compounding pharmacies less
Speaker 1: sophisticated research labs, the active ingredient is imported from one
Speaker 1: of many other Chinese chemicals manufacturers. It's generally these manufacturers
Speaker 1: that also directly or indirectly supply the black market for
Speaker 1: research chemicals. Though in China it's illegal to export pharmaceutical
Speaker 1: grade ingredients without a permit, some take the risk of
Speaker 1: filling the vials themselves. For other manufacturers, their participation is
Speaker 1: unwitting or at least plausibly deniable. Local middlemen set up
Speaker 1: front companies that claim to be ordering bulk peptide ingredients
Speaker 1: for legal uses, and the front companies handle the work
Speaker 1: of processing and packaging those ingredients into dosage specific vials
Speaker 1: For consumers overseas. When a BusinessWeek reporter visited Yanishik's check
Speaker 1: testing facility in April, two employees were hauling a big
Speaker 1: blue Ikia bag full of testing samples into the company's lab.
Speaker 1: Yanishik's peptide sampling room is filled with tiny vials that
Speaker 1: have been cataloged, weighed, and sometimes shaken or heated, depending
Speaker 1: on the substance. An employee feeds samples into one of
Speaker 1: the liquid chromatography mass spectrometry machines. The business is growing
Speaker 1: so fast Yanishik has ballooned from ten to almost forty
Speaker 1: employees since last year. The machines are labeled with mythological
Speaker 1: characters and superheroes to help its many new staffers discern
Speaker 1: one from another. This is Sith, a Nordic goddess, and
Speaker 1: this one is Thor Magic, says, pointing to two of
Speaker 1: the machines. Yanishek and its clients, typically peptide sellers in
Speaker 1: the US or private sourcing groups, can then look up
Speaker 1: the batch numbers printed on their fials to see if
Speaker 1: what's inside is what it claims to be. Only about
Speaker 1: five percent of samples don't pass, a percentage that's consistent
Speaker 1: across other testing labs. Magic is careful to note that
Speaker 1: Yanishik can detect contaminants such as heavy metals or indotoxins,
Speaker 1: but can't determine whether the substance is safe to inject
Speaker 1: on a pharmacological level.
Speaker 2: But still, as the.
Speaker 1: Ranks of black market consumers have grown, those buyers have
Speaker 1: begun to demand evidence of third party testing from other
Speaker 1: types of suppliers, including licensed compounding pharmacies who'd never received
Speaker 1: such requests from patients in the past. This Magic, says,
Speaker 1: is a completely new frontier for his business, and he's
Speaker 1: negotiating a deal with an American lab that would expand
Speaker 1: the Yanishik name stateside. In other areas of the market,
Speaker 1: entrepreneurs are looking for more ways to rush in. At
Speaker 1: the inaugural meeting of the California Peptide Club in April,
Speaker 1: held at a hilltop San Francisco mansion, conversation among the
Speaker 1: one hundred and fifty attendees centered on what business opportunities
Speaker 1: might be available to founders and investors. In New York,
Speaker 1: wellness influencer Delphine Legrand recently introduced The Protocol, an online
Speaker 1: subscription service that lets members, primarily women, by premium grade
Speaker 1: peptides with physician oversight.
Speaker 2: She says.
Speaker 1: Investors were initially reluctant to fund her company, but given
Speaker 1: the expected change in regulation in the last few months,
Speaker 1: we've seen a huge, huge shift where every institutional investor
Speaker 1: is trying to form their thesis on this space. Rare Capital,
Speaker 1: a private investment firms in Nashville that was bullish on
Speaker 1: peptide startups even before the prospect of legalization, led protocols
Speaker 1: six million dollar seed round in April. To Rachel Schau,
Speaker 1: the fund's co founder, it was obvious just how mainstream
Speaker 1: the demand already was wherever she went. A country music
Speaker 1: concert in Florida, her Minnesota hometown, the luxurious haunts of
Speaker 1: Los Angeles' wealthy residents, hangouts with her teacher friends, people
Speaker 1: were buzzing about peptides. The middle of the US is
Speaker 1: all talking about it, she says. Other investors, including Daisy Wolf,
Speaker 1: a partner at Andres and Horowitz, are intrigued.
Speaker 2: But skeptical.
Speaker 1: Demand is clearly huge, and many of the GLP one
Speaker 1: drugs are exciting, Wolf says, but she says she's worried
Speaker 1: about a lack of oversight and safety data around.
Speaker 2: A lot of what's out there. Anyone selling reta.
Speaker 1: Truetide right now is just like a flat out criminal,
Speaker 1: and it's scary that people are in jecting themselves with
Speaker 1: black market drugs, she says. Pharma companies seem stunned that
Speaker 1: over the course of just a few years, American consumers
Speaker 1: have found a way to get their hands on substances
Speaker 1: that are too experimental for them to legally market, or
Speaker 1: that they gave up on developing years ago. But in
Speaker 1: the age of social media and DIY wellness, these drugs
Speaker 1: have found a second life with consumers willing to experiment
Speaker 1: on themselves. This new dynamic presents a problem for the
Speaker 1: future of drug development. Drug companies are generally willing to
Speaker 1: pay for the expensive trial and error because patent laws
Speaker 1: then allow them to reap huge profits on drugs that succeed.
Speaker 1: If the FDA is prepared to accept overwhelming consumer demand
Speaker 1: as a justification for curtailing those patent rights, then the
Speaker 1: financial calculus for drug makers changes in ways that could
Speaker 1: fundamentally alter the future of pharmaceuticals. Obesity drug upstarts such
Speaker 1: as Structure Therapeutics are already bracing for potential copycats to
Speaker 1: flood the market years before they even have an approved drug.
Speaker 1: It's obviously a risk to innovation and Reason's Wolf says,
Speaker 1: why should biotechs and scientists billions of dollars in inventing
Speaker 1: new drugs that can change humanity save lives if they're
Speaker 1: just going to be ripped off immediately and there's going
Speaker 1: to be no protection. Not Surprisingly, Dave Rix, CEO of
Speaker 1: Lily and one of the most powerful people in the
Speaker 1: pharmaceutical industry, agrees, people don't have a biochemistry lab in
Speaker 1: their basement and those medicines haven't been tested in clinical
Speaker 1: trials like.
Speaker 2: A Lily medicine.
Speaker 1: Rix says, when you buy a Lily medicine, you know
Speaker 1: what's in it and you know is tested. The question
Speaker 1: of how to regulate such a market will be central
Speaker 1: when the FDA convenes at its campus in White Oak, Maryland,
Speaker 1: in July. Over two days, the agency's Pharmacy Compounding Advisory Committee,
Speaker 1: or PCAC, will consider whether compounding pharmacies should be allowed
Speaker 1: to legally make a handful of popular peptides. The agenda
Speaker 1: includes BPC one fifty seven for ulcerative colitis, a disease
Speaker 1: that causes painful ulcers in large intestine, TB five hundred
Speaker 1: for wound healing, and MOTSC for obesity, among others. The
Speaker 1: problem is that there aren't large scale clinical trials in
Speaker 1: humans proving the safety or effectiveness of most of these compounds,
Speaker 1: evidence that PCAC, a group that currently has only three
Speaker 1: voting members as opposed to its statutorily required ten, historically
Speaker 1: requires before making an affirmative recommendation. Beyond that, little information
Speaker 1: has been released about the meeting, and the FDA has
Speaker 1: been roiled by recent staff changes. The prevalence of these
Speaker 1: substances on the black market and growing consumer awareness do
Speaker 1: not change FDA scientific or regulatory standards, HHS Press Secretary
Speaker 1: Emily Hilliard said in an emailed statement. At the upcoming
Speaker 1: PCAC meeting, independent experts will evaluate the available scientific evidence
Speaker 1: for each substance, including clinical, pharmacological safety.
Speaker 2: And other relevant data.
Speaker 1: Despite the chaos, and despite the further FDA rulemaking that
Speaker 1: would be necessary to permit compounding more peptides, preparations for
Speaker 1: Peptide Liberation Day continue. Businesses that already offer certain legal
Speaker 1: peptides are getting ready to add even more, While some
Speaker 1: compounding pharmacies have gotten a jump on the month's long
Speaker 1: process of securing their supply chains. Ivems Canter, whose telehealth
Speaker 1: company already offers GLP ones and the peptide sur Morellan,
Speaker 1: which can be compounded legally, says its pharmacy partners are
Speaker 1: going through the testing phase to ensure quality and safety
Speaker 1: thresholds are met. It's also trying to figure out which
Speaker 1: peptides it will be able to offer, and is conducting
Speaker 1: peptide focused training sessions with its practitioners. Other telehealths are
Speaker 1: trying to strike a more cautious tone with the public.
Speaker 1: Hymn's and Hers Health with Jones of peptide manufacturing facility
Speaker 1: in California, says it isn't planning to rush into the market.
Speaker 1: The six point four billion dollar company, which recently roused
Speaker 1: the ire of federal regulators over its aggressive GLP one marketing,
Speaker 1: says it won't expand its peptide lineup for consumers until
Speaker 1: it's confident and its ability to meet the very high
Speaker 1: standards that we believe everyone should be meeting.
Speaker 2: A spokesperson says.
Speaker 1: If the FDA does expand access to certain peptides, the
Speaker 1: patient experience must include a rigorous intake process, consistent provider
Speaker 1: involvement and a commitment to advancing reliable learnings about safety
Speaker 1: and efficacy. If regulators decide to open the door to
Speaker 1: more kinds of peptides, there will also be a market shakeout.
Speaker 1: Businesses that sell research grade chemicals tend to lose some customers,
Speaker 1: and even a peptide friendly FDA might crack down on
Speaker 1: those suppliers once a more regulated option exists. At Utah's
Speaker 1: Compound Sciences, the founders say they'd be sorry to see
Speaker 1: the revenue stream go if the FDA tightened its screws
Speaker 1: on research use retailers.
Speaker 2: But they wouldn't lose sleep.
Speaker 1: Their long game, the co founder says, is elsewhere. He
Speaker 1: and his partner also own licensed compounding pharmacies. Our real
Speaker 1: goal in this is to move peptides into the compounding pharmacy,
Speaker 1: he says, which already fills to zeppetide prescriptions for telehealth companies.
Speaker 1: Not only would the proposed regulatory changes likely help more
Speaker 1: patients feel comfortable trying the drugs.
Speaker 2: But the company also wouldn't have to.
Speaker 1: Deal with some of the headaches of operating on the
Speaker 1: black market, such as breaking up import shipments into smaller
Speaker 1: packages to avoid confiscation and dealing with overpriced payment processors
Speaker 1: who are willing to handle credit and debit transactions for
Speaker 1: high risk businesses. At the moment, though, the headaches are
Speaker 1: worth it. It's not a nice way of explaining it.
Speaker 1: But the research only side is our side. Chick, the
Speaker 1: co founder, says. Right now, the side Chick is tremendously successful.
Speaker 1: She's the one we're putting on our arm with Ambertong
Speaker 1: and brody Ford.