The evidence for the newly approved peptides, and the names of the FDA advisory panel members who have a financial interest in the votes they just cast to approve them.
Let me get this straight….for years Kennedy has railed against the FDA for being in the pockets of big pharma. So when he gets the levers of power he sets up a committee of peptide investors to vote on peptides and ignore the scientific community ?! It’s ludicrous! You know what never happened? Big pharma voting on the approval of their own products.
The conflicts of interest are quite bad. The apparent attitude among the people creating them may be even worse because it seems premised on the belief that the public is too ignorant or unworthy to deserve otherwise.
I’ve known several people experimenting with peptides for injury recovery, weight loss, vitality, and other goals. What concerns me is the level of confidence many place in them despite how little human evidence exists. The answers are also hard to interpret because peptides are often combined with testosterone or other compounds, so it becomes difficult to know what is actually producing the result. This piece helped clarify concerns I was already beginning to have, and I’ll keep watching the evidence closely.
Nathan, I'm glad this article is helpful. There’sNathan, I'm glad this article is helpful. There's a lot of misinformation out there about peptides. One thing no one knows is what long-term impact they may have, positive or negative. Let's hope it's only positive…
If there was a there there, I’m pretty sure pharma companies would be conducting and publishing safety and efficacy trials, and getting candidates on the road to regulatory approval. Feels like a very dangerous position.
Dr. Thyer, thanks for making this point. Could it be the case that big pharma isn’t pursuing peptide RCTs because there are barriers too costly or too temporally large to make them a good choice for such shareholder-run companies? I’m just trying to think of the best alt-reason these companies wouldn’t be in the game.
True. Pharma can't patent a natural molecule, so they can't recoup the cost. The compounding industry can profit from selling unproven versions, and the wellness industry doesn't need proof to sell.
So, we are left with vague, unproven claims of efficacy and no safety data. Demand increases and physicians don’t have a legitimate path to prescribe. We (physicians) see this as a reason not to recommend, but consumers looking for health fixes don’t necessarily interpret the signals the same way.
What is fascinating is the justifications used by the pro peptide community which have glaring deficits in logic. Limited testing, safety or dosage data be damned, they would rather attack the messenger than consider they could be deluding and harming themselves. The few people that have come out and reported adverse reactions on sites like Reddit or discuss lack of human testing get viciously attacked for being stupid and making the community look bad. Maybe if you allow them to be compounded the discussion can move to the need for human trials. Right now the issue is so politicized, you can’t have a rational discussion and influencers are using their lack of availability to create more hype and demand.
Alice, no doubt there is too much political posturing and not nearly enough evidence-based discussion about peptides—as there is about (pick your topic) these days. I wasn't aware that Reddit was as bad as, say, Twitter/X, on the intolerance scale. The enjoyable, respectful discussions I've had about peptides tend to be in person, with people that hold a wide range of opinions and/or direct experience. One thing no one can rationally argue: the long-term effects of using these peptides remains a mystery. So caveat utilitor.
As a public health scientist with a background in systematic reviews I appreciate the research summary. This strikes me as pretty terrifying and concerning - how the hell what seems like pretty much zero (in evidence pyramid terms, no human trials) evidence for efficacy and safety for humans?
Six of eight new panel members sell peptides. The votes may be nonbinding but the conflict of interest is not. Appreciate the research breakdown, this is exactly the kind of context the headlines skip.
It is admittedly, a difficult task to staff advisory boards of this type, completely with people that do not have industry experience, and conflict of interest or the appearance of that. It has always seemed like a simple fix to this: you simply recuse yourself from voting where you may have a conflict of interest or even the appearance of a conflict of interest. So in this case, maybe only six people would have votes.
The trouble on the other side of it is, people should be able to voluntarily try just about Any supplement or procedure that will not impact people beyond themselves.
Anecdotally, I do know several people who have used peptides to help recovery for hips, knees, and shoulders with what appears to be astounding success. As you know, it may be short-term and there may be some side effects that have not come to Light yet.
Curious to know if anyone in here has firsthand experience with these peptides? Or more anecdotal cases of their success or detriments. I have a long-term rotator cuff issue that has had me considering something along these lines to try to bring it back.
Matt, I agree that industry experience isn't disqualifying for FDA panel voters deciding whether to allow pharmacies nationwide to compound unproven peptides. I do think having a direct commercial interest in exponentially increasing access to an unproven drug should disqualify anyone from having a say in the decision. Especially when the non-appointed, career scientists at FDA, who don't have a commercial interest in the subject, strongly recommended against doing so.
Like you, I know people who say BPC-157 helped them heal from injuries, or just made them feel better/stronger. The thing that stops me the most is: what if I unknowingly fed a small tumor with peptides that helped it become a big tumor in 5, 10...20 years? The fact is, we don't know. The science isn't there to say so. So for me, these peptides represent walking into a dark room and hoping there's not a plank missing.
I like your analogy about walking into a dark room that might have a missing plank. I don’t necessarily think it’s bad if someone that has an interest in something is on a board of this type, they are welcome to advocate things, they just shouldn’t be able to vote. Someone who’s just loaded with conflict of interest should not be allowed on the board.
I understand your concern about peptides, possibly feeding something you don’t want fed, but the argument you’re making could put a 15 to 20 year lag on the application of any drug.
What are your thoughts about people waiving liability in order to be test subjects for things like this??
I don't think my argument comprises the need to hold up drug applications for years. My argument is that research should have a credible verdict on drugs approved for mass consumption, unless there's a critically urgent need to distribute them without it. These peptides don't have that verdict. Thus, you're walking into a dark room with no evidence the floor is solid and clean, or rickety and roach-infested.
I don't have informed, well-marinated thoughts on waiving liability. But generally, people can decide to subject themselves to whatever they want, as long as it doesn't harm others.
I said the 15-20 years because you said this “The thing that stops me the most is: what if I unknowingly fed a small tumor with peptides that helped it become a big tumor in 5, 10...20 years?”. Sorry if I was conflating your ideas. Totally agree with giving people the autonomy to try things that don’t raise risk for others. I am a big believer in the idea that individuals all have their own separate risk profile for the choices they make about healthcare treatments.
Yes, although there isn't all that much scientifically documented positive evidence (or negative evidence). And it's always good to differentiate between evidence in the petri dish or in worms or mice versus evidence in humans, of which there is very little beyond what your friends and my friends are telling us each
Good question. BPC-157 went into human trials in Europe years ago under a code name, PL 14736, run by the Croatian drug maker Pliva. The company took it through an early safety study in healthy volunteers and then a mid-stage trial in patients with ulcerative colitis, a serious bowel disease. The trial reportedly showed some benefit with no obvious harm. But Pliva never published the full results, so no outside researcher could check the work. Then the program was shelved.
Pliva was later absorbed by Teva Pharmaceutical (the world's largest maker of generic drugs. It had bought Barr Pharmaceuticals in 2008, and Barr then bought Pliva in 2006. So through those deals, BPC-157 ended up inside a giant generics company that had little interest in pushing an unproven peptide through the rest of clinical testing, and it got shelved). BPC-157 never won approval anywhere, and it resurfaced as the gray-market injectable people buy today.
Another safety trial registered in 2015 but cancelled the next year, again with nothing published.
Jenny, the New York Times article quotes an FDA panel member named Dr. Kim (if memory serves correctly about his last name) who voted no, and made the point that in one study, 30% of people who received a placebo peptide reported noticeable improvements, so the jury is definitely still out on peptides. But, like you, I know several people who swear by them.
Wow, the gatekeepers are up in arms over losing control. This entire article reveals the underlying turf war between people wishing to maintain an ecosystem of milking customers similar to the sildenafil model where everyone in the chain gets to have a cut vs what’s happening with peptides. The buttfurt from overpaid grifters is off the charts
Thank you! Peptides are an exciting area of biomedical research as they can act as highly specific signaling molecules, potentially influencing pathways involved in tissue repair, metabolism, inflammation, and aging. But the growing popularity of longevity peptides also makes careful interpretation especially important.
As a physician-scientist, I think the key distinction is between a peptide being biologically interesting and being clinically validated. Preclinical findings can provide compelling mechanistic rationale, but we still need robust human data on efficacy, pharmacokinetics, dosing, long-term safety, and meaningful clinical outcomes.
I would also be cautious with the phrase “FDA cleared” when discussing therapeutics. FDA approval, clearance, and regulatory status are not interchangeable, and the specific indication and formulation matter enormously. Regulatory language should be precise, particularly when patients may interpret it as proof of efficacy or safety.
The field is undoubtedly promising, but the real opportunity is to move peptide-based interventions from exciting hypotheses to evidence-based medicine, where we know not only what a peptide does, but who benefits, at what dose, for how long, and with what long-term risks…
There is nothing especially exciting about peptides as an area of deug development. Insulin has been used since the 1920s and there are many examples of approved peptide drugs along the way. See https://www.sciencedirect.com/science/article/pii/S0968089617310222 . The only thing new here is the reckless expansion of access to untested treatments. A smart, honest and un-conflicted government would invest in randomized controlled trials of each before approval. It is shocking how we don't invest in testing all the supplements and folk medicines that people administer to themselves.
Robert, it's hard to argue that RCTs of each peptide are what good science & good government demand before essentially giving the drugs' sellers the green light to "have at it, folks!" I think of the number of people who, by sheer odds, based on the number of dollar-driven shortcuts that we can expect some peptide purveyors to take, will legally buy and use contaminated, research-grade peptides fit for worms or cells in a petri dish, but not a mom or dad trying to heal themselves on the fly. I hope I'm wrong.
Let me get this straight….for years Kennedy has railed against the FDA for being in the pockets of big pharma. So when he gets the levers of power he sets up a committee of peptide investors to vote on peptides and ignore the scientific community ?! It’s ludicrous! You know what never happened? Big pharma voting on the approval of their own products.
The conflicts of interest are quite bad. The apparent attitude among the people creating them may be even worse because it seems premised on the belief that the public is too ignorant or unworthy to deserve otherwise.
I’ve known several people experimenting with peptides for injury recovery, weight loss, vitality, and other goals. What concerns me is the level of confidence many place in them despite how little human evidence exists. The answers are also hard to interpret because peptides are often combined with testosterone or other compounds, so it becomes difficult to know what is actually producing the result. This piece helped clarify concerns I was already beginning to have, and I’ll keep watching the evidence closely.
Nathan, I'm glad this article is helpful. There’sNathan, I'm glad this article is helpful. There's a lot of misinformation out there about peptides. One thing no one knows is what long-term impact they may have, positive or negative. Let's hope it's only positive…
If there was a there there, I’m pretty sure pharma companies would be conducting and publishing safety and efficacy trials, and getting candidates on the road to regulatory approval. Feels like a very dangerous position.
Dr. Thyer, thanks for making this point. Could it be the case that big pharma isn’t pursuing peptide RCTs because there are barriers too costly or too temporally large to make them a good choice for such shareholder-run companies? I’m just trying to think of the best alt-reason these companies wouldn’t be in the game.
True. Pharma can't patent a natural molecule, so they can't recoup the cost. The compounding industry can profit from selling unproven versions, and the wellness industry doesn't need proof to sell.
So, we are left with vague, unproven claims of efficacy and no safety data. Demand increases and physicians don’t have a legitimate path to prescribe. We (physicians) see this as a reason not to recommend, but consumers looking for health fixes don’t necessarily interpret the signals the same way.
What is fascinating is the justifications used by the pro peptide community which have glaring deficits in logic. Limited testing, safety or dosage data be damned, they would rather attack the messenger than consider they could be deluding and harming themselves. The few people that have come out and reported adverse reactions on sites like Reddit or discuss lack of human testing get viciously attacked for being stupid and making the community look bad. Maybe if you allow them to be compounded the discussion can move to the need for human trials. Right now the issue is so politicized, you can’t have a rational discussion and influencers are using their lack of availability to create more hype and demand.
Alice, no doubt there is too much political posturing and not nearly enough evidence-based discussion about peptides—as there is about (pick your topic) these days. I wasn't aware that Reddit was as bad as, say, Twitter/X, on the intolerance scale. The enjoyable, respectful discussions I've had about peptides tend to be in person, with people that hold a wide range of opinions and/or direct experience. One thing no one can rationally argue: the long-term effects of using these peptides remains a mystery. So caveat utilitor.
As a public health scientist with a background in systematic reviews I appreciate the research summary. This strikes me as pretty terrifying and concerning - how the hell what seems like pretty much zero (in evidence pyramid terms, no human trials) evidence for efficacy and safety for humans?
Nic, how the hell, indeed. Hopefully we get more information on that question soon.
Six of eight new panel members sell peptides. The votes may be nonbinding but the conflict of interest is not. Appreciate the research breakdown, this is exactly the kind of context the headlines skip.
David, I'm glad this is useful to you. Thanks for letting me know. More to come....
Superior analysis. Thank you!!
Roger, thank you. I'm glad it is useful to you.
Excellent summary, hope you continue to focus on the topic
AJ, do I have a choice?
Paul, I love this topic.
It is admittedly, a difficult task to staff advisory boards of this type, completely with people that do not have industry experience, and conflict of interest or the appearance of that. It has always seemed like a simple fix to this: you simply recuse yourself from voting where you may have a conflict of interest or even the appearance of a conflict of interest. So in this case, maybe only six people would have votes.
The trouble on the other side of it is, people should be able to voluntarily try just about Any supplement or procedure that will not impact people beyond themselves.
Anecdotally, I do know several people who have used peptides to help recovery for hips, knees, and shoulders with what appears to be astounding success. As you know, it may be short-term and there may be some side effects that have not come to Light yet.
Curious to know if anyone in here has firsthand experience with these peptides? Or more anecdotal cases of their success or detriments. I have a long-term rotator cuff issue that has had me considering something along these lines to try to bring it back.
Matt, I agree that industry experience isn't disqualifying for FDA panel voters deciding whether to allow pharmacies nationwide to compound unproven peptides. I do think having a direct commercial interest in exponentially increasing access to an unproven drug should disqualify anyone from having a say in the decision. Especially when the non-appointed, career scientists at FDA, who don't have a commercial interest in the subject, strongly recommended against doing so.
Like you, I know people who say BPC-157 helped them heal from injuries, or just made them feel better/stronger. The thing that stops me the most is: what if I unknowingly fed a small tumor with peptides that helped it become a big tumor in 5, 10...20 years? The fact is, we don't know. The science isn't there to say so. So for me, these peptides represent walking into a dark room and hoping there's not a plank missing.
I like your analogy about walking into a dark room that might have a missing plank. I don’t necessarily think it’s bad if someone that has an interest in something is on a board of this type, they are welcome to advocate things, they just shouldn’t be able to vote. Someone who’s just loaded with conflict of interest should not be allowed on the board.
I understand your concern about peptides, possibly feeding something you don’t want fed, but the argument you’re making could put a 15 to 20 year lag on the application of any drug.
What are your thoughts about people waiving liability in order to be test subjects for things like this??
I don't think my argument comprises the need to hold up drug applications for years. My argument is that research should have a credible verdict on drugs approved for mass consumption, unless there's a critically urgent need to distribute them without it. These peptides don't have that verdict. Thus, you're walking into a dark room with no evidence the floor is solid and clean, or rickety and roach-infested.
I don't have informed, well-marinated thoughts on waiving liability. But generally, people can decide to subject themselves to whatever they want, as long as it doesn't harm others.
I said the 15-20 years because you said this “The thing that stops me the most is: what if I unknowingly fed a small tumor with peptides that helped it become a big tumor in 5, 10...20 years?”. Sorry if I was conflating your ideas. Totally agree with giving people the autonomy to try things that don’t raise risk for others. I am a big believer in the idea that individuals all have their own separate risk profile for the choices they make about healthcare treatments.
Has BPC-157 been tested in Europe?
So basically, when I’m taking from your article is all positive results of using this peptide or anecdotal correct?
Yes, although there isn't all that much scientifically documented positive evidence (or negative evidence). And it's always good to differentiate between evidence in the petri dish or in worms or mice versus evidence in humans, of which there is very little beyond what your friends and my friends are telling us each
Good question. BPC-157 went into human trials in Europe years ago under a code name, PL 14736, run by the Croatian drug maker Pliva. The company took it through an early safety study in healthy volunteers and then a mid-stage trial in patients with ulcerative colitis, a serious bowel disease. The trial reportedly showed some benefit with no obvious harm. But Pliva never published the full results, so no outside researcher could check the work. Then the program was shelved.
Pliva was later absorbed by Teva Pharmaceutical (the world's largest maker of generic drugs. It had bought Barr Pharmaceuticals in 2008, and Barr then bought Pliva in 2006. So through those deals, BPC-157 ended up inside a giant generics company that had little interest in pushing an unproven peptide through the rest of clinical testing, and it got shelved). BPC-157 never won approval anywhere, and it resurfaced as the gray-market injectable people buy today.
Another safety trial registered in 2015 but cancelled the next year, again with nothing published.
Thanks, Paul. Great summary and facts. I’ll keep it in my back pocket for the next person who tells me injected peptides are amazing.
Jenny, the New York Times article quotes an FDA panel member named Dr. Kim (if memory serves correctly about his last name) who voted no, and made the point that in one study, 30% of people who received a placebo peptide reported noticeable improvements, so the jury is definitely still out on peptides. But, like you, I know several people who swear by them.
Wow, the gatekeepers are up in arms over losing control. This entire article reveals the underlying turf war between people wishing to maintain an ecosystem of milking customers similar to the sildenafil model where everyone in the chain gets to have a cut vs what’s happening with peptides. The buttfurt from overpaid grifters is off the charts
Thank you! Peptides are an exciting area of biomedical research as they can act as highly specific signaling molecules, potentially influencing pathways involved in tissue repair, metabolism, inflammation, and aging. But the growing popularity of longevity peptides also makes careful interpretation especially important.
As a physician-scientist, I think the key distinction is between a peptide being biologically interesting and being clinically validated. Preclinical findings can provide compelling mechanistic rationale, but we still need robust human data on efficacy, pharmacokinetics, dosing, long-term safety, and meaningful clinical outcomes.
I would also be cautious with the phrase “FDA cleared” when discussing therapeutics. FDA approval, clearance, and regulatory status are not interchangeable, and the specific indication and formulation matter enormously. Regulatory language should be precise, particularly when patients may interpret it as proof of efficacy or safety.
The field is undoubtedly promising, but the real opportunity is to move peptide-based interventions from exciting hypotheses to evidence-based medicine, where we know not only what a peptide does, but who benefits, at what dose, for how long, and with what long-term risks…
Keeping my fingers crossed 🤞 thanks again!
There is nothing especially exciting about peptides as an area of deug development. Insulin has been used since the 1920s and there are many examples of approved peptide drugs along the way. See https://www.sciencedirect.com/science/article/pii/S0968089617310222 . The only thing new here is the reckless expansion of access to untested treatments. A smart, honest and un-conflicted government would invest in randomized controlled trials of each before approval. It is shocking how we don't invest in testing all the supplements and folk medicines that people administer to themselves.
Robert, it's hard to argue that RCTs of each peptide are what good science & good government demand before essentially giving the drugs' sellers the green light to "have at it, folks!" I think of the number of people who, by sheer odds, based on the number of dollar-driven shortcuts that we can expect some peptide purveyors to take, will legally buy and use contaminated, research-grade peptides fit for worms or cells in a petri dish, but not a mom or dad trying to heal themselves on the fly. I hope I'm wrong.