Is BPC 157 legit or snake oil or jury's still out?
September 18, 2023 4:04 PM Subscribe
Someone recommended something called BPC 157 which is apparently a peptide, which doesn't mean a lot to me, for IBS. If you google it, it comes up as a solution for various unrelated things and comes up in the same search as colloidal silver, which I understand to be not only wholly ineffective but harmful, so I'm skepty. On the other hand there's an NHI article that says BPC 157 is at least harmless. Anyone know more about it?
Best answer: Examine.com is a reputable online supplement encyclopedia. Their BPC-157 page says there's no evidence (yet) that it is either safe or that it has any benefits, unless you happen to be a rat who's suffered surgical trauma.
posted by Mr.Know-it-some at 7:04 PM on September 18, 2023 [2 favorites]
posted by Mr.Know-it-some at 7:04 PM on September 18, 2023 [2 favorites]
As a former clinical trials Coordinator at an academic medical school, the scandal of unpublished clinical medical studies is well known to both the clinical sites (academic doctors) and the sponsors which are typically a pharmaceutical or medical device company. There are some self-funded trials in academic centers (though not with new and unapproved drugs or devices) but the cost of high-quality human trials is so high that these independent studies are extremely few and far between.
All pharma trial sponsors insist on confidentiality agreements and will provide data to a select group of physician researchers to write an article at the study's conclusion if the study result is positive for the article studied. There is unbelievably intense competitiveness among physician researchers to publish "important" papers, and it is impossible to imagine any of them lining up to say that something they invested a lot of time and effort studying was ineffective or unsafe. The sponsor controls the data and would have no incentive to allow an article saying such a thing to be published. On occasion the FDA will halt a study in process if harm occurs to subjects, as the sponsors must submit reports regularly for minor side effects, and immediately about serious injuries or deaths. Still, there is no requirement to publish even in that circumstance.
Articles are published if the drug or device tested is shown to be safe or effective - the end point depends on the phase of the study. There is no requirement that negative studies are published or that the data is ever shared - it belongs to the sponsor. Theoretically, different researchers could study the same subject because they have no idea someone else did this previously. This is frustrating and idiotic at the minimum, not to mention the cost of labor and human subjects participating not knowing that the drug or device was previously studied. The doctors who participate in the studies and enroll patients know the statistics of the study, but they all signed confidentiality agreements and can't tell anyone without the sponsor's permission that whatever it was that was studied did not perform as expected. And the lack of academically published articles on negative results keeps the docs in the dark, too.
Phase 1 trials are designed to prove only that a drug or device is safe. That the the Phase 1 trial lulu68 mentions above was not published can be assumed to have been a negative study. As I said above, nobody publishes about failures.
posted by citygirl at 7:19 PM on September 18, 2023 [5 favorites]
All pharma trial sponsors insist on confidentiality agreements and will provide data to a select group of physician researchers to write an article at the study's conclusion if the study result is positive for the article studied. There is unbelievably intense competitiveness among physician researchers to publish "important" papers, and it is impossible to imagine any of them lining up to say that something they invested a lot of time and effort studying was ineffective or unsafe. The sponsor controls the data and would have no incentive to allow an article saying such a thing to be published. On occasion the FDA will halt a study in process if harm occurs to subjects, as the sponsors must submit reports regularly for minor side effects, and immediately about serious injuries or deaths. Still, there is no requirement to publish even in that circumstance.
Articles are published if the drug or device tested is shown to be safe or effective - the end point depends on the phase of the study. There is no requirement that negative studies are published or that the data is ever shared - it belongs to the sponsor. Theoretically, different researchers could study the same subject because they have no idea someone else did this previously. This is frustrating and idiotic at the minimum, not to mention the cost of labor and human subjects participating not knowing that the drug or device was previously studied. The doctors who participate in the studies and enroll patients know the statistics of the study, but they all signed confidentiality agreements and can't tell anyone without the sponsor's permission that whatever it was that was studied did not perform as expected. And the lack of academically published articles on negative results keeps the docs in the dark, too.
Phase 1 trials are designed to prove only that a drug or device is safe. That the the Phase 1 trial lulu68 mentions above was not published can be assumed to have been a negative study. As I said above, nobody publishes about failures.
posted by citygirl at 7:19 PM on September 18, 2023 [5 favorites]
Response by poster: Thanks, that answers that!
posted by less-of-course at 7:27 PM on September 18, 2023
posted by less-of-course at 7:27 PM on September 18, 2023
Please note that if you do a web search and you get hits from the "NIH" they are probably simply papers going to PubMed, which is an attempt by the NIH to improve access to papers (esp. those that are the result of public funding.) It wouldn't imply anything about the quality of the paper and definitely not
Proteins and peptides are both made up of amino acids; peptides are just arbitrarily short. So, many proteins are 300 or 500 amino acids long, whereas BPC-157 is only 15 amino acids. Both tend to get chewed up in your digestive system and are thus useless if you take them orally, though at least one paper claims BPC-157 is stable in "gastric juices" (a simulation of the gut).
nthing that there's nothing demonstrating it's efficacious and no sign of serious or well funded study to show either safety or efficacy.
Phase 1 trials are designed to prove only that a drug or device is safe. That the the Phase 1 trial lulu68 mentions above was not published can be assumed to have been a negative study
I can't comment with authority on purely hospital/academic studies, but from the pharma side the suggestion that not publishing a Phase I means lack of safety is unwarranted. One reason is the most common cause of failure in Phase I isn't lack of safety, but bad pharmacokinetics: The drug doesn't get absorbed by the body, or is chewed up so quickly it doesn't have any possibility of doing any good.
But also a Phase I for a new drug, is generally neither interesting on its own, nor so big or specialized we need to work with academics with the publish/perish imperative. This silence is a little selfish: publishing such an early success doesn't impress anyone and simply provides competitive intelligence for other companies. By the time we have something to publish, we'd be doing it on larger Phase II studies. (IME we are in fact more likely to publish on a compounds that failed due to toxicity, as it's potentially scientifically interesting and, in many cases, will kill a project and free up scientists to write it up.)
Papers based on Phase I studies on an existing approved drug are more interesting and more likely to fit the publish-if-successful mold.
posted by mark k at 8:46 PM on September 18, 2023 [4 favorites]
Proteins and peptides are both made up of amino acids; peptides are just arbitrarily short. So, many proteins are 300 or 500 amino acids long, whereas BPC-157 is only 15 amino acids. Both tend to get chewed up in your digestive system and are thus useless if you take them orally, though at least one paper claims BPC-157 is stable in "gastric juices" (a simulation of the gut).
nthing that there's nothing demonstrating it's efficacious and no sign of serious or well funded study to show either safety or efficacy.
Phase 1 trials are designed to prove only that a drug or device is safe. That the the Phase 1 trial lulu68 mentions above was not published can be assumed to have been a negative study
I can't comment with authority on purely hospital/academic studies, but from the pharma side the suggestion that not publishing a Phase I means lack of safety is unwarranted. One reason is the most common cause of failure in Phase I isn't lack of safety, but bad pharmacokinetics: The drug doesn't get absorbed by the body, or is chewed up so quickly it doesn't have any possibility of doing any good.
But also a Phase I for a new drug, is generally neither interesting on its own, nor so big or specialized we need to work with academics with the publish/perish imperative. This silence is a little selfish: publishing such an early success doesn't impress anyone and simply provides competitive intelligence for other companies. By the time we have something to publish, we'd be doing it on larger Phase II studies. (IME we are in fact more likely to publish on a compounds that failed due to toxicity, as it's potentially scientifically interesting and, in many cases, will kill a project and free up scientists to write it up.)
Papers based on Phase I studies on an existing approved drug are more interesting and more likely to fit the publish-if-successful mold.
posted by mark k at 8:46 PM on September 18, 2023 [4 favorites]
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Also: "Therapeutically, the synthetically produced peptide BPC-157 is not currently approved for use as a human drug. It is an experimental compound that has been investigated for inflammatory bowel disease and soft tissue healing, although there is a concerning lack of published clinical trial data because studies appear to have been cancelled or stopped without any published conclusions."
Also, from the Mayo Clinic: "Taking colloidal silver by mouth is not thought to be safe or effective for any of the health claims that many manufacturers make. Silver is not an essential mineral, as some sellers of silver products say."
Finally, from clinicaltrials.gov (where are trials are required to be registered; unpublishable if not), this Phase 1 study from 2015 (42 patients, completed in 2016) was never published. You can learn more about trial phases here, but basically a Phase 1 trial is just to see if something is safe - not to see if it works.
posted by lulu68 at 5:14 PM on September 18, 2023