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MENUBPC-157 (Body Protective Compound 157) is not recognized by the Food and Drug Administration as being safe or effective. Nonetheless there are many within the pharmaceutical compounding industry, who claim that it is a virtual wonder-drug, able to cure everything from leaky gut syndrome to traumatic bone and muscle injuries. The Coalition for Responsible Compounding has therefore reviewed the available scientific literature on BPC-157 identified 5 areas of concern
The US National Academies of Science defines a "conflict of interest" in scientific research as a situation in which an individual has an interest in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance, compromise the integrity of the research. This is the situation which exists when the same individual is involved in competing interests, one of which may potentially corrupt the other and introduce bias in his or her professional judgement. For example, the inventor, patent-holder, or owner of a drug who is personally involved in laboratory work or clinical studies examining the safety or efficacy of the drug in question, would be said to have a conflict of interest.
As of April 14, 2024, there are 183 published studies mentioning BPC-157, each of which are indexed by the National Institute of Health. Of those 183 studies, 158 studies have been authored by Predrag Sikiric, who is found listed on multiple patents for BPC-157. Sven Seiwerth, another inventor named on multiple BPC-157 patents, is responsible for coauthoring 146 of the 183 published articles. Rudolf Rucman is named as the solo inventor on a BPC-157 patent, while also being listed as the author of 47 published scientific papers on the substance. Rucman has had a lifetime total of 50 papers indexed by the NIH. In reviewing the literature on BPC-157, nearly every paper (certainly every primary work) has been written by at least one author (and often half a dozen or more) with a vested interest in the outcome of the paper, and thus a conflict of interest.
Conflicts of interest do not, standing alone, invalidate scientific work. The main problem with conflicts of interest is not that they exist per se, but rather stems from their nondisclosure. When scientists have vested interests in the outcome of a given paper and fail to disclose that interest, readers are not provided with adequate information to make informed judgments about the credibility of the work.
No published BPC-157 articles reviewed by the Coalition for Responsible Compounding disclose that any of the authors are inventors of the substance or listed on the related patents. Many of those articles expressly state that no conflicts of interest exist for any of the authors.
Clustering occurs when research in a given field or into a given substance is overly homogenous. For example, one study on BPC-157 lists 21 authors, but when examining their institutional affiliations, they are actually all from the University of Zagreb Department of Pharmacology (note that many of these authors are also the inventors of the compound as well). Another study cites primarily its own authors BPC-157 work in the references (one author is cited 14 times for as many papers).
Clustering is a problem because it gives the appearance of widespread consensus on a given substance, when in reality, closer examination may reveal that the same group is responsible for nearly 100% of the "consensus," either by having written all of the papers, or by having contributed to most of the citations.
Impact Factor is a scientometric index metric based on the yearly mean number of citations of articles published by a given journal over the past two years. In basic terms, this is a proxy measurement for the importance of a given scientific journal. The British Medical Journal has an impact factor of 107.7. The World Journal of Gastroenterology, a journal in which one of the most recent BPC-157 studies was published, has an impact factor of 4.7. Current Pharmaceutical Design, another journal which has published a more recent BPC-157 paper, has an impact factor of 2.8. The Journal of the American Medical Association has an impact factor of 120.7.
This information should not be construed to imply that sound and important research is not published in these journals (or journals with similar impact factors). But we must view the research on BPC-157 critically, when weighing the fact that it is claimed by some to be a miracle-drug, yet has been relegated exclusively to low impact journals.
A 2019 paper summed up the current state on BPC-157 research as follows: "[T]o date, the majority of studies have been performed on small rodent models and the efficacy of BPC 157 is yet to be confirmed in humans. Further, over the past two decades, only a handful of research groups have performed in-depth studies regarding this peptide."
A review of the currently available literature reveals no high quality studies (placebo controlled double blind, in humans, with sufficient participation to reach statistical significance) to suggest that it is either safe or effective. The sole clinical trial on record at ClinicalTrials.gov was sponsored by PharmaCotherapia, and was slated to be performed on healthy volunteers in Tijuana, Mexico. That clinical trial is currently designated as having been cancelled with an"unknown" status.
Due to the aforementioned and undisclosed conflicts of interest, the clustering, low impact of the published research, and the lack of human data, the Coalition for Responsible Compounding is compelled to agree with the FDA's assessment of BPC-157 as not sufficiently proven to be safe or effective, and to support a Category 2 designation.
