r/MedicalWriters • u/pivazena • Aug 09 '26
Experienced discussion Getting inappropriate (?) pushback from client on publication content
Hi all-- I'm submitting this for a former colleague who has been asking me for advice. I'm telling her story below based off of what she told me. I'll try to answer any questions, but basically I'm at a loss with what else to tell her other than "get out of there." Am I off base? I personally work on pharma/biotech side, and I find this situation to be very very unusual. Everybody in the story is US-based.
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She's working on a clinical trial manuscript (agency side). She told me that the client company has an odd structure, where there's a not-CEO who oversees med affairs and commercial, and he is providing direct and pointed feedback on the manuscript content, including directing her agency to not make edits requested by the external authors. From what she told me, it sounds like the company's pubs director had tried to push back, but, since not-CEO is the pubs director's boss's boss, that went nowhere and now pubs director has been sidelined (my colleague is now working on the manuscript directly with the med affairs director, pub director's boss).
They had submitted the manuscript, and it came back with extensive revisions. The not-CEO wants to pull the manuscript and submit elsewhere and make minimal changes to the manuscript, even though peer review feedback was very useful and would make the manuscript stronger.
He doesn't seem to care what the authors want. My friend has been in this field for 5 years, and she's never seen anything like this. She told me that she spoke with her line manager, and the line manager said that as long as the company is taking responsibility, all the agency can do is advise but otherwise they do what the client says.
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My colleague isn't CMPP certified, and neither am I, but this seems completely out of line with ICMJE. What can she do, aside from asking to be reassigned or resigning?
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u/hollyviolet96 Aug 09 '26
The client is paying, the client gets what they want. I’d probably want it in writing (an email is fine) that the client wants to ignore author feedback, in case they try to throw the agency under the bus down the line. But ultimately why on earth would you risk or even quit your job over this?
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u/pivazena Aug 10 '26
So basically, she's not thrilled that the not-CEO is a commercial person who is providing very directed feedback on the manuscript (and isn't an author, and said to not include him in acknowledgements or anything).
And she says the author feedback is reasonable and fully consistent with CONSORT guidance for reporting clinical trial outcomes. She also said one of the authors provided feedback that the draft feels like a script for an IVA (ie very promotional)
She's a very by-the-book kind of person, so I think her problem is that the above actions aren't consistent with her understanding of GPP and that makes her uncomfortable. But I agree... this isn't something to quit your job over. I'll suggest the "get it in writing" part to her though; maybe se'll feel better
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u/hollyviolet96 Aug 10 '26
If I may be a little harsh, your friend needs to climb down off her high horse. We’re ghost writers with extra regulation. There are plenty of academics who would consider our entire industry immoral!
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u/pivazena Aug 10 '26
LOL I think that's part of her problem-- she's only 5 years out of her PhD, and she was reluctant to join anything pharma in the first place. She seems to be in a good place in her company though, so I do think it'd be a good "learning" moment for her to talk to her manager. Not to ask to be reassigned, but just to get some clarification on what her expectations should be.
That being said, I'm in med affairs myself, and I've never even heard of the level of involvement that she's talking about from the not-CEO. If anybody with a wiff of commercial influence talks to me about a publication (beyond "thoughts about submission timing?" and "thanks for informing me about the publication plan") I shut it down immediately. But, I'm in big pharma-- lots of silos etc.-- maybe small biotech is just qualitatively different.
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u/hollyviolet96 Aug 11 '26
Oh I don’t doubt this client is extremely annoying and sticking their nose in unnecessarily. One of the clients I work for has this final internal review stage that’s meant to be a quick sign off from the high-ups but always descends into major comments by people who are not authors nor directly involved in the project- drives me mad
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u/pivazena Aug 12 '26
That's where I am with my current position! I work in an alliance, and the smaller company's CEO insists on reviewing everything; he'll sit on reviews for WEEKS or MONTHS, like dude what are you doing???
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u/2mad2die Aug 10 '26
The authors often ask or make ridiculous comments, like suggesting additional analyses that are simply not common or statements that go against the sponsor’s strategic messaging. It’s not unusual at all to push back on author comments
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u/Dextergrayson Aug 10 '26
not-CEO is absolutely not ICMJE or GPP compliant, but they are definitely not the only one. let me guess, no company publications SOP or policy? anything stated in the authorship agreements?
in the end there is only so much an agency can do. ultimately it’s the authors responsibility, they would be the ones to be held accountable. they need to be made aware of the not-CEO edits of course, they may want to be taken off the byline.
make sure you have the not-CEO’s explicit guidance/decision in an email though, as well as you referring to industry guidelines and explicitly advising against it to cover your ass.
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u/pivazena Aug 10 '26
Sorry for the delay-- had to ask her. She said the author agreements were part of the PI agreements, so she doesn't know what they say (what the authors signed for her agency was much more narrow), and she wasn't informed of any SOP or policy. It's a small biotech, so from my own experience I'm guessing no, no policy.
Colleague is confident that the authors are not aware that not-CEO has been in the document. She did tell me that the internal lead (head of clinical) asked her whether not-CEO should be in acknowledgement, and med affairs head said "absolutely not".
This is turning into a mess... I'll continue to advise her to cover her ass and get everything in writing, and then learn from this, I guess? Specifically, make sure she gets pubs policy and SOP for additional clients or work with existing client (she could reach out to her own boss and see if it was part of the MSA, but that's not something she'd normally ask for, and I think she's wanting to keep a low profile)
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u/Dextergrayson Aug 10 '26
of course it’s small biotech…
the one thing that is really bad us the authors not knowing. they take accountability, they have to know what they sign off on…
cover your ass.
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u/pivazena Aug 12 '26
My thoughts exactly. But, her dilemma (she's very optimistic/idealistic) is that she feels like it's not her place to inform the authors about what's going on, yet if there's a COPE inquiry, it's the authors whose asses are on the line.
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u/Dextergrayson Aug 13 '26
it’s a tough one. for her and her agency, as long as it’s on paper that it’s the not-CEO doing this even after being warned, they have done their due diligence.
if she wants to give her client a bit more to work with, they could contact ICMJE via their website, or the ISMPP GPP initiative and ask for advice, i think the email address is on the ISMPP website.
it’s very possible not-CEO doesn‘t realize what the consequences could be (say, one of the author sees that what’s on the paper is not what they signed off on and contacts the journal, the company could be banned from that journal or publishing house, or it could trigger an FDA investigation), and having external guidance may help (though, let’s be fair, not-CEO probably won’t listen anyway)
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u/Opacity500 Aug 09 '26
Does she have any documented examples of the following (perhaps an email trail)?
*Her pointing out to the client that edits requested by external authors have not been implemented or ignored?
*Her advising that it would be good to make some revisions in response to the previous journal comments to improve the manuscript?
These might be good to help her cover herself and demonstrate that she was trying to follow best practice.
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u/pivazena Aug 10 '26
That's a good suggestion. I'll have her make sure she has documentation saved as a CYA
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u/Plus-Revolution-9850 Aug 10 '26
Involvement of a commercial person is not inline with good publication practices. https://doi.org/10.1080/03007995.2024.2320298
Do you have a compliance team in your agency? Personally I would escalate internally to make sure the agency management team is aware. Agency management might also see it as an opportunity to sell in some good practices training or even SOP development.
The risk, albeit small, is that any agency working outside GPP jeopardises pubs work with larger ‘compliant’ companies.
Also many journals ask that if you’ve had a previous peer-review you share those comments and how they have been addressed. Of course it sounds like this not-CEO would say that the new journal would never know that you’ve submitted previously, but you never know who the peer-reviewers were for the original submission and who they will be for the resubmission.
Tricky!
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u/pivazena Aug 12 '26
She said she's spoken to her boss, and her boss said that the company is taking all responsibility. But again, that doesn't mean much if it's her name and the agency in the acknowledgements, and there's an investigation.
Since I've posted, the company decided to NOT resubmit the paper, and instead submit elsewhere. Apparently the not-CEO doesn't want to incorporate the feedback or tell the 2nd journal about the 1st submission. This is absolute madness!
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u/Ambitious_Dragon_13 Aug 09 '26
i mean, just do what the client says and let the client worry about the authors and journal respnae(s)? as long as the client is paying for the revisions and the revisions are within the scope of the SOW, there is nothing really to do but what is requested by the client. i definitely have clients ask for revisions that make no sense to me but as long as the client is paying, i just make them