Medical Affairs Departments Editing and Proofreading Services

A consultant emails to ask whether anyone has used your drug in patients on dialysis. It is not an indication, there is no labelling for it, and there are four small papers and some unpublished data. Answering fully is scientific exchange. Answering enthusiastically is promotion of an unlicensed use. The line between them lives in the wording of a letter that somebody has to write this afternoon.

We edit what medical affairs functions produce — responses to unsolicited medical information requests, standard response documents and their approval records, scientific exchange and field medical materials, medical information letters and their references, publication plans and manuscript support documentation, advisory board briefs and outputs, congress and symposium material, medical education grant documentation, evidence generation plans, and internal guidance on the promotional boundary for field teams. Our editors work on the letter that answers a question about unapproved use.

The unsolicited request response is where medical affairs demonstrates its independence or quietly loses it, and its failure is tone rather than content. The same three papers can be presented as an honest answer to a question or as a case for using the drug, and the difference is in what surrounds them. We work through these so the response opens by stating what is and is not approved, since a reader must be able to locate the answer relative to the label before reading anything else; so the evidence is presented completely, including studies that were negative, small or of poor quality, because selective citation is what converts information into promotion; so each study is described with what it actually was — the design, the number of patients, the endpoint — rather than with its conclusion, given that a favourable conclusion from eleven patients should read like eleven patients; so the response does not recommend, suggest or imply a course of action, and language such as "may be considered" is removed; so unpublished data is either provided with its limitations or withheld consistently by policy rather than case by case; so the response is the same whoever asks and is recorded as such; and so the closing offers further information rather than follow-up contact. Responses written this way are read as science, which is the only thing that makes them valuable.

Everything you send is treated in confidence, including unpublished data, responses and internal guidance. We are editors rather than medical, regulatory or compliance advisers, and we offer no view on the promotional boundary, evidence or clinical practice. What we can do is keep an answer from becoming an argument.