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I for one applaud the use of email lists such as evidence-based-health to have a robust exchange of views. I just want to add, from the perspective of the list owner, that I am very keen to ensure that it is done in a a calm and respectful way at all times. I am not saying that any lines have been crossed recently, nor am I pointing the finger at anyone: my aim with this message is to let the list members know that although the list isn't moderated, I monitor all of the discussions and they can contribute in safety. In such matters I would always be guided by the consensus on netiquette. cheers Douglas On 12/08/2011 11:33, Jeremy Howick wrote: > Stephen is correct that it is, in a sense, unfair to target one source of > bias (industry bias) when there are others. At the same time, the fallacy > I pointed out stands: TWO WRONGS DO NOT MAKE A RIGHT. > > Moreover, Stephen's analogy between sources of bias (from industry, from > political points of view, etc.) and races, besides being polemical, does > not hold up. The police (and society at large) DO IN FACT wonder why > certain socio-economic and ethnic groups are more likely to commit crime. > They take steps to address these problems by implementing programs in > relevant areas. THEY ALSO DO OTHER THINGS IN OTHER AREAS! > > Here is another fallacy: > > (1) It is unfair to target industry when there are other sources of bias > (2) therefore, let's do nothing. > > Industry bias is a problem that SUPERCEDES THE PROBLEM OF "checking > outputs". The different results obtained in studies funded by industry and > those not funded by industry COULD NOT BE DETECTED BY "CHECKING OUTPUTS". > Therefore SOMETHING ELSE NEEDS TO BE DONE. > > > Jeremy > > > * please note my email address is now [log in to unmask] > -- > > Jeremy Howick PhD, MSc, PGCert, DipSoc, BA > MRC/ESRC Postdoctoral Fellow > Centre for Evidence-Based Medicine > University of Oxford > Oxford OX3 7LF > United Kingdom > www.cebm.net > www.primarycare.ox.ac.uk/dept_staff/jeremy-howick/ > eu.wiley.com/WileyCDA/WileyTitle/productCd-140519667X,descCd-authorInfo.htm > l > > > > > On 12/08/2011 11:07, "Stephen Senn"<[log in to unmask]> wrote: > >> The logical fallacy is surely Jeremy's. If a chief of police announced >> that we should do something about black crime and a journalist present >> said surely this is a dangerous policy because by concentrating on crimes >> perpetrated by one ethinc subgroup rather than by type of crime you could >> miss many serious offences, for example offences committed by whites, we >> surely would not accept as a reply 'you have to start somewhere'. >> >> The point I and others have been making is that many meta-analyses are >> misleading and this is a problem that has to be tackled in terms of >> checking output rather than motive. For example I have found Cochrane >> meta-analyses in which the same data have been counted twice. This it >> seems to me is a problem even though the authors are pure as driven snow. >> >> Regards >> Stephen >> >> >> Stephen Senn >> >> Professor of Statistics >> School of Mathematics and Statistics >> Direct line: +44 (0)141 330 5141 >> Fax: +44 (0)141 330 4814 >> Private Webpage: http://www.senns.demon.co.uk/home.html >> >> University of Glasgow >> 15 University Gardens >> Glasgow G12 8QW >> >> The University of Glasgow, charity number SC004401 >> ________________________________________ >> From: Evidence based health (EBH) [[log in to unmask]] >> On Behalf Of Jeremy Howick [[log in to unmask]] >> Sent: 12 August 2011 10:38 >> To: [log in to unmask] >> Subject: Ben Djulblegovic's evidence can resolve the debate over declared >> conflicts of interest >> >> Dear All, >> >> It strikes me that both Stephen Senn and Amy Price are committing the >> logical fallacy. It does not follow from: >> >> (1) industry bias is not the only bias >> >> to: >> >> (2) we should do nothing to reduce industry bias. >> >> That would be like saying, "allocation bias is not the only kind of bias, >> so we shouldn't require that reports of randomized trials report whether >> allocation was randomized and concealed". >> >> Reducing one major source of bias is better than not reducing any sources >> of bias. >> >> As an Evidence-Based discussion group, it is also useful for the debate >> to be based on evidence: there is a large body of evidence that drug >> sponsored trials provide misleading results: >> >> Bero, L., F. Oostvogel, P. Bacchetti, and K. Lee. 2007. Factors >> associated with findings of published trials of drug-drug comparisons: >> why some statins appear more efficacious than others. PLoS Med 4 (6):e184. >> Jorgensen, A. W., J. Hilden, and P. C. Gotzsche. 2006. Cochrane reviews >> compared with industry supported meta-analyses and other meta-analyses of >> the same drugs: systematic review. BMJ 333 (7572):782. >> Leopold, S. S., W. J. Warme, E. Fritz Braunlich, and S. Shott. 2003. >> Association between funding source and study outcome in orthopaedic >> research. Clin Orthop Relat Res (415):293-301. >> Lexchin, J., L. A. Bero, B. Djulbegovic, and O. Clark. 2003. >> Pharmaceutical industry sponsorship and research outcome and quality: >> systematic review. BMJ 326 (7400):1167-70. >> Schulz, K. F., D. G. Altman, and D. Moher. 2010. CONSORT 2010 statement: >> updated guidelines for reporting parallel group randomised trials. PLoS >> Med 7 (3):e1000251. >> Yaphe, J., R. Edman, B. Knishkowy, and J. Herman.2001. The association >> between funding by commercial interests and study outcome in randomized >> controlled drug trials. Fam Pract 18 (6):565-8. >> To cite just one example from a common and thoughtful contributor to this >> list (Ben Djulblegovic), "Research funded by drug companies was less >> likely to be published than research funded by other sources. Studies >> sponsored by pharmaceutical companies were more likely to have outcomes >> favouring the sponsor than were studies with other sponsors (odds ratio >> 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons)." >> (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC156458/) >> >> Jeremy >> >> ps: Stephen Send should be applauded and I'm being completely sincere >> for being so open about his list of potential conflicts of interest with >> industry (he has consulted for over 50 pharmaceutical companies and >> receive grants from a dozen of them: >> www.senns.demon.co.uk/Declaration_Interest.htm) >> >> * please note my email address is now [log in to unmask] >> -- >> >> Jeremy Howick PhD, MSc, PGCert, DipSoc, BA >> MRC/ESRC Postdoctoral Fellow >> Centre for Evidence-Based Medicine >> University of Oxford >> Oxford OX3 7LF >> United Kingdom >> www.cebm.net >> www.primarycare.ox.ac.uk/dept_staff/jeremy-howick/ >> eu.wiley.com/WileyCDA/WileyTitle/productCd-140519667X,descCd-authorInfo.ht >> ml >> >> From: Ash Paul<[log in to unmask]<mailto:[log in to unmask]>> >> Reply-To: Ash Paul<[log in to unmask]<mailto:[log in to unmask]>> >> Date: Fri, 12 Aug 2011 08:28:42 +0100 >> To: >> "[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI >> L.AC.UK>" >> <[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI >> L.AC.UK>> >> Subject: Re: Turning the tide on conflicts of interest >> >> Dear Jacob, >> In a tangential but related development, here's the press release issued >> today by PLOS Medical Journals: >> Authorship Rules For Medical Journals Flouted By Pharma Industry >> http://www.redorbit.com/news/science/2093981/authorship_rules_for_medical_ >> journals_flouted_by_pharma_industry/index.html? >> There's also a reference to the following two PLOS articles: >> http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.10 >> 01072 >> and >> http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.10 >> 01071 >> Regards, >> Ash >> >> >> Ash >> Dr Ash Paul >> Medical Director >> NHS Bedfordshire >> 21 Kimbolton Road >> Bedford >> MK40 2AW >> Tel no: 01234897224 >> Email: [log in to unmask]<mailto:[log in to unmask]> >> >> >> >> From: Jacob Puliyel<[log in to unmask]<mailto:[log in to unmask]>> >> To: >> [log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL >> .AC.UK> >> Sent: Friday, 12 August 2011, 6:00 >> Subject: Re: Turning the tide on conflicts of interest >> >> Dear Jo and Others on the List >> Jo you wrote >> 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. >> >> Are we allowing the best to be the enemy of the good? >> >> We can tackle undeclared conflicts as the next step. Let us deal with the >> obvious declared conflicts of interest first. >> >> I see little point in just publishing the declaration of conflict of >> interests. It is editorial cop out. >> By publishing declarations of conflicts of interests, the Editor is >> saying simply, "This author has declared that he has conflicts of >> interest when writing this review/editorial. With all the resources I >> have at my disposal, I am unable to state that this has/has not biased >> his/her judgment. You, as the reader, must make that judgment. If you >> think that the conflict of interest has biased him/her, please disregard >> this review/editorial that we are publishing." >> >> Jacob Puliyel >> Head of Pediatrics >> St Stephens Hospital >> Delhi >> [log in to unmask]<mailto:[log in to unmask]> >> >> >> On Fri, Aug 12, 2011 at 7:42 AM, Dr. Amy Price >> <[log in to unmask]<mailto:[log in to unmask]>> wrote: >> 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 pickingı 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 doesnıt 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 >> Http://empower2go.org<http://empower2go.org/> >> Building Brain Potential >> >> >> >> >> >> From: Evidence based health (EBH) >> [mailto:[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@ >> JISCMAIL.AC.UK>] On Behalf Of Michael Bennett >> Sent: 11 August 2011 08:10 PM >> To: >> [log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL >> .AC.UK> >> 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]<mailto:EVIDENCE-BASED-HEALTH@ >> JISCMAIL.AC.UK>] On Behalf Of Stephen Senn >> Sent: Thursday, 11 August 2011 22:08 >> To: >> [log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL >> .AC.UK> >> 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 >> Private Webpage: http://www.senns.demon.co.uk/home.html >> >> 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]<mailto:EVIDENCE-BASED-HEALTH@ >> JISCMAIL.AC.UK>] On Behalf Of jo kirkpatrick >> Sent: 11 August 2011 12:35 >> To: >> [log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL >> .AC.UK> >> Subject: Re: Turning the tide on conflicts of interest >> >> Dear Ash and EBH >> 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. >> >> Best wishes ,Jo >> >> From: Ash Paul<[log in to unmask]<mailto:[log in to unmask]>> >> To: >> [log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL >> .AC.UK> >> Sent: Thu, 11 August, 2011 8:34:15 >> Subject: Turning the tide on conflicts of interest >> Dear colleagues, >> 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 NEJMıs experiment and ban editorials and >> clinical reviews from authors with ties to industry? Iıd 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. >> >> Regards, >> >> Ash >> Dr Ash Paul >> Medical Director >> NHS Bedfordshire >> 21 Kimbolton Road >> Bedford >> MK40 2AW >> Tel no: 01234897224 >> Email: [log in to unmask]<mailto:[log in to unmask]> >> >> >> >> >> -- Mr Douglas Badenoch Director, Minervation Ltd ------------------------- 23 Bonaly Grove Edinburgh EH13 0QB ------------------------- Tel: +44 131 441 4699 Web: www.minervation.com ------------------------- Minervation is a limited company registered in England and Wales Registered number: 4135916 VAT number: 792674384 Registered Office: Salter's Boat Yard, Folly Bridge, Abingdon Road, Oxford, OX1 4LB United Kingdom