Draft monograph: Kisspeptin-10 — submissions
The 4 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
4 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
The absence of paediatric evidence is not stated where a reader would look for it
The respondent notes that the draft on Kisspeptin-10 rests largely on physiological studies rather than on clinical trials, and submits with that in view.
The population section describes the adult trial populations. Nothing states whether the compound has been studied in anyone under eighteen. For several compounds in this series it has not, and for one or two it has; the document does not let the reader tell which case applies.
The respondent proposes a standing row in the population table recording paediatric evidence as present, absent, or present in a named subpopulation only.
The secretariat accepts this submission. An unstated absence is indistinguishable from an unread section.
The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
The monograph should state what the compound costs
Having read the draft monograph on Kisspeptin-10, the respondent puts one point to the committee.
The respondent states that a reader deciding whether to pursue treatment needs to know what it costs, and that omitting price makes the assessment less useful than it could be.
The respondent proposes that a price range be recorded for each compound with the source and date.
The secretariat does not accept this submission. Price varies by jurisdiction, payer, presentation and date to a degree that no single figure could survive, and a stale price is worse than no price.
No price is recorded. The monograph records the presentations available and the regulatory status in each jurisdiction, which are the facts the Institute can verify and maintain. The submission remains published in full.
The monograph should not describe how the compound is supplied outside a regulated route
The respondent submits on the draft monograph for Kisspeptin-10. Reproductive-axis peptides act on a system with strong feedback, and a document that describes an effect without the feedback response describes half of it.
The respondent states that describing presentations observed in unregulated supply risks being read as a guide to obtaining them, and asks that the material be removed.
The respondent accepts that the information is accurate and objects to its presence rather than to its content.
The secretariat notes this submission and records the concern as a real one that the draft had already considered.
No amendment arises. The monograph describes what is supplied and names no supplier, price or route of acquisition, and it carries the standing statement that the Institute assesses evidence and does not recommend use. Describing a presentation a reader may already hold is the condition of being useful to that reader.
The document should not describe uses outside the approved indication
The respondent read the draft on Kisspeptin-10 and has confined this submission to a single matter.
The submission is made on behalf of a marketing-authorisation holder. It states that the draft describes uses of the compound that fall outside the approved indication, that such uses are not supported by the sponsor, and that describing them may be read as legitimising them.
The sponsor asks that the sections concerned be removed, or in the alternative that they carry a prominent statement that the sponsor does not support such use.
The secretariat does not accept this submission. The Institute records what is supplied and what is used, because a reader encountering a compound outside a regulated route is the reader most in need of an assessment of the evidence for it.
The sections remain. Every such section already states the regulatory status of the use described and states that the evidence for it is assessed separately from the evidence for the approved indication. The submission is published in full and identified as an industry submission.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
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