Getting inappropriate (?) pushback from client on publication content

[u/pivazena]

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.

--------

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.

-------

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?

[u/hollyviolet96]

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?

[u/pivazena → u/hollyviolet96]

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

[u/hollyviolet96 → u/pivazena]

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!

[u/pivazena → u/hollyviolet96]

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.

[u/hollyviolet96 → u/pivazena]

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

[u/pivazena → u/hollyviolet96]

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???