Draft monograph: BPC-157
Consultation on the draft monograph for BPC-157. The draft records that the Institute identified no completed randomised controlled trial in humans reporting a clinical outcome, and grades the principal assessed outcome at very low certainty on that basis…
§1Consultation and window
§1.1Window
- Opened
- 7 January 2024
- Closed
- 7 March 2024
- Duration
- 60 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: BPC-157
- Submissions received
- 8
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the very low certainty rating correctly drawn, and is the distinction between an absent and a conflicting evidence base made clearly enough on the face of the document?
- Is the preclinical literature summarised proportionately, given that it is extensive and that none of it is a clinical outcome?
- Is the analytical section proportionate to what a reader would need in order to interpret a certificate for a pentadecapeptide supplied outside a regulated route?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The monograph was amended before ratification. The absence of clinical trial evidence is now stated in the abstract rather than reached in section 4, and the preclinical summary was shortened and given a standing statement that an animal result is not a clinical outcome.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.