This study looks at trial reports and concludes that certain people appear all too often. Is Prof G one of them?
Do not read if you easily get offended.
Coles A. Authorship of phase 3 trials in multiple sclerosis. Ann Neurol. 2018 Mar 8. doi: 10.1002/ana.25203. [Epub ahead of print]
But the question is
Which letter of the alphabet is ProfG? As he is surely on the list
Can we guess who they are?
As a basic-scientist who has to sweat and toil for grant monies, slave to produce the work (OK the guys in the lab do the slaving), write the papers, which I enjoy, then slog with the peer-review process for an “impact factor pants” paper, this article may be an eye opener that shocks.
Yep…I’m mean my clinical colleagues.
They live a different lifestyle, incase you haven’t realised this.
Trips to meetings, corporate-branded posters that someone designs, prints and puts up, slide decks and yep even ghost-writers…or more recently real writers from companies.
It seems that Prof C from Cambridge, who is a principled man, who went on sabbatical rather than be tainted by pharma during the licencing process and commercial launch of his drug, wants to get something off his chest.
So perhaps, this paper is a result of personal experience about pharma meddling in clinical trial write-ups. I can see a few familar names on the alemtuzumab trial papers that could feature in the top ten.
However, companies have to be very careful about what is written. There are rules what they can say. This is one of the reasons why trial reports are often so bland and are often written by professional writers aware of these rules.
Such papers have demographics (this really should be supplementary data), efficacy and side-effects.
Yes but it could be said that if get your papers in certain Journals, work in certain Institutions, have certain mates in influential places then your career can be promoted, there are more ways to do this and being involved in clinical trials is not the only way to do this.
Yep, for example Cambridge University will received millions to create a Chair (Professorship) after the phase III success:-).
Oh my God! Have I made Prof G a guest author?
For the record, Prof G was instrumental in the licensing of process for alemtuzumab and Barts was a major recruting site, but anyway. Back to the story.
Authorship has always been an thorny issue for papers and is true whether or not they are phase III trial papers, I would put money that there are thousands of authors that get a relative free-lunch every single day, where they are on publications but didn’t do too much except be boss of the lab. However, keeping the lab running is important.
However, If that isn’t bad enough
Just like we can see who are on grant panels and then who get the grants.
Likewise, there are names that appear time and time again on academic projects. This may be because they are the best scientists, but could be they are good science politicians.
Is this Prof G again?. As one of a small group of neurologists I must admit I see him on telecoms and we know he goes to plenty of advisory board meeting to advise pharma…so what’s his letter in the list?
Well to me the tenor of the piece would seem to suggest exactly that.
“Nor would they misrepresent or influence the primary trial outcome; the methods of collection and analysis of this key result is appropriately pre-determined and overseen”.
This is true, but studies of information on clinical trials.gov have shown that the endpoints get changed after the studies are reported as finished
Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study
Company sponsorship has been reduced due to the introduction of new rules.
Is this why ECTRIMS is a day shorter this year?
“It would be naïve to imagine that this does not influence the relationship between author and sponsor”.
“yet this is potentially undermined by the situation in which a small group of people are repeatedly asked to lead writing committees by sponsoring companies”.
If you applied this to all publications, you wouldn’t have the Research Assessment Exercise/Research Excellence framework in the UK. This costs tens of millions to say Oxford & Cambridge are ace:-(
I wonder also if certain names were removed from papers…would we still have the dogmas that can be a hindrance to effective treatment?
These papers would get rejected and the Lemming effect, where scientist all follow the same idea and sometimes say the wrong thing, would not occur.
This is an interesting one, however it means that you would be in the hands of the journal and their biases. It takes months to go through data. We got our hands on the CARE-MS trial data and focused our reporting on potential safety issues…not mentioned in the original trial reports.
“Structures could be created for investigators to report concerns about biases in trial reporting, free from reprisal”.
Surely this could be done now anyway, if you are an author and you are not happy with content, you can address issues during the writing process. If you are not satisfied you can remove yourself from the paper, you can write to editors once submitted and you can write reviews to set the record straight.
However, I doubt anything would be free of consequences if unwelcome reports are made. Many people provide paid service to the companies and if the companies don’t like the service they get they will go elsewhere. It;s simple economics. Likewise, if they like the advice they comeback for more. I guess the ten speak words of wisdom.
Maybe he’ll smack my wrists for the suggestion:-( , but science is the freedom to say things and then to expect people to challenge them.
Is this the beginning of the end of professional trialist?
I doubt it.
Does Prof C get a knighthood or has he really put the cat among the pigeons with his colleagues?
Is this issue just an MS issue?…….I doubt it.
- Honorary and ghost authorship are prevalent.
- Medical writers are employed commonly to assist with reporting of commercially sponsored clinical trials.
- We identified honorary authorship in 33% of the trials analysed, compared with 9–19% reported previously.
- Assistance of medical writers was only identified in reports of commercially sponsored trials.
- A statistician should always be included as an author to ensure accountability on the statistical analysis.
There is a rejoinder to Prof Coles’s article in the same journal (which will be the subject of a post here) that attempts to rebut the concerns made plain in his piece which perhaps shows that this article has really ruffled a few feathers. Well done to Prof Coles for that and for raising the subject it’s certainly got people talking and it’s nice to see people putting their heads above the parapet, even if they risk having their heads shot off.
What do you think?