I would be willing to submit a rapid response as below...please edit me as I am new at this and would only want to say what would accurately represent the issue. I suggest we all send in something as the more rapid responses that are well written the better it will be. Perhaps this could be followed up with a paper dealing with this question to the BMJ by those most qualified to do so?
My vote is no because a ban does not solve the core problems and it is like shutting the barn door after the cows have left the premises.
Publication bias, (file drawer effect) happens when research results are suppressed/disregarded. In meta analysis sources of bias are not controlled by the method. Exclusive reliance on published studies could artificially inflate study effect size as could the quality or emphasis of studies chosen. One way to mitigate this could be for journals to insist that all studies rejected and accepted for review be disclosed upon request to any subscriber so the study could be replicated. This could include pharmaceutical industry/medical device raw data.
Deliberate publication bias can be the result of financial, legal, political or cultural agendas and the use of influence to bias the study by ‘cherry picking’ where studies failing to produce the desired bias are rejected regardless of validity. A declaration of conflict of interest and a subsequent ban is not going to solve the problem. The Simpson's paradox/ Yule-Simpson effect may erroneously reverse success rates when groups are combined with inappropriate causal interpretation of frequency data, systematic formal analysis without publication bias and public statistical awareness of this element may mitigate this issue.
Unified rejection from the scientific community, mandatory journal article retractions and withdrawal of funding for meta analysis/systematic review authors and organization who consistently show bias would be more effective than epidemiologists grandstanding by sending cherry picking/junk science letters to the editor without doing a shred of work other than citing their own papers in the complaint.
Other strategies include choosing studies from journals respected for their objectivity and training students to follow suit. Universal/standardised methods with agreement on coding, weighting, and combining results whether by a fixed or random model could mitigate unintentional bias as could adding in quality unpublished research even with non significant results such as is available from universities and laboratories. Sometimes what doesn’t show significance and why is just as important as studies that push all the right numbers buttons.
For example recently a study on iPS cells show by DNA that these are not replicated stem cells capable of function but rather in the cytoskeleton there are critical regulatory factors missing. I asked several scientists in this field did you not even look? The answer was yes but the findings were not publishable in our eyes. I asked what about cultured stem cells and was told that this was covered by using stem like cells rather than stem cells in publishing. What this shows me is that although those in the industry could navigate to truth it is highly unlikely that those outside of the field even when well educated could do so.
Language matters. This is a serious question for concern in this age of multi-disciplinary research. In conclusion ethics, diligence, and the standards of Evidence Based Medicine matter. Let each of us do our part to uphold them and celebrate with support those who are standing with us to fight this good fight.
Best Regards,
Amy
Amy Price
Building Brain Potential
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Michael Bennett
Sent: 11 August 2011 08:10 PM
To: [log in to unmask]
Subject: Re: Turning the tide on conflicts of interest
I too would say no to this proposition … after much introspection and consideration. Jo and Stephen make very good points and I will not rehash those.
I would be much more excited by the proposition that journals no longer publish clinical trials (full reports of all data and outcomes published on-line), but concentrate on evaluating those trials using the appropriate methodologies of which this list is so aware. I think this was suggested by Smith? Will try and dig out the reference..
Mike
Mike Bennett
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Stephen Senn
Sent: Thursday, 11 August 2011 22:08
To: [log in to unmask]
Subject: Re: Turning the tide on conflicts of interest
As a sinner with many ties to industry (I maintain a declaration of interest at http://www.senns.demon.co.uk/Declaration_Interest.htm ) I would say "no" to Ash Paul's question. Part of the problem with this approach is that it does not go far enough. "Trust nobody" should be the motto not "mistrust some". It is checkability that matters. I agree with Jo that others have axes to grind. Epidemiologists, just like journalists (remember them and phone hacking?) further their careers by bringing bad news.
As an instance of the dangers of concentrating on the pharma dimension consider the chapter "Is Mainstream Medicine Evil? " in Ben Goldacre's otherwise excellent Bad Science. He describes a number of ways that you can massage your results without acknowledging that the drug regulatory framework with its emphasis on declared protocols and statistical analysis plans, not to mention re-analysis of results by regulators has a much tighter control of this than does medical publishing.
Coincidentally, this morning on the Allstat list, Allun Reese drew attention to work by Keith Baggerly and Kevin Coombes and their work on forensic bioinformatics and how they have discovered that it is often very difficult to reproduce published results.
I usually add to my declaration of interest, 'the author is an academic whose career is furthered by publishing' but journals often remove it.
By the way, next year is the centenary of Piltdown Man.
Stephen
Stephen Senn
Professor of Statistics
School of Mathematics and Statistics
Direct line: +44 (0)141 330 5141
Fax: +44 (0)141 330 4814
University of Glasgow
15 University Gardens
Glasgow G12 8QW
The University of Glasgow, charity number SC004401
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of jo kirkpatrick
Sent: 11 August 2011 12:35
To: [log in to unmask]
Subject: Re: Turning the tide on conflicts of interest
I completely agree with Ash and Fiona Godlee regarding COI. I also agree that there should be absolute openness and transparency over any ties to industry; and I assume this includes commerce and any potential source of benefits. The reader should always know if and how writers could benefit but I am slightly nervous about the use of a total ban. This ban would really only target writers who have already declared their conflicting interests. How do we know who else has ties to industry if they do not declare them, or if they actively conceal these.
However it isn't only money, how can we tell what other axes writers might have to grind apart from financial gain? Eg If you agree with my dodgy findings, I will agree with yours. What does the term 'ties to industry' actually mean it is a bit ambiguous so exactly how would we define this? If it is too broad it could include anyone with any remote tie to any industry, and if it is too narrow people will wriggle through. So where would a ban start and end? Is there not a better way to deal with the whole COI problem? In the meanwhile I will continue to apply a large pinch of salt when I am reading reviews and reports of findings.
Fiona Godlee has written a great Editorial in this week's BMJ:
Turning the Tide on Conflicts of Interest
Cite this as: BMJ 2011;343:d5147
At the end of the Editorial, she has posed this question to everybody: ..... should the BMJ repeat the NEJM’s experiment and ban editorials and clinical reviews from authors with ties to industry? I’d welcome your views in rapid responses.
Could I please request members of this group to give their views to the BMJ in rapid responses. COI issues are inextricably linked to the ultimate success or failure of EBM, and we, in this group, should have the moral courage to make our voices heard to the BMJ.
Dr Ash Paul
Medical Director
NHS Bedfordshire