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EVIDENCE-BASED-HEALTH  August 2011

EVIDENCE-BASED-HEALTH August 2011

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Subject:

List etiquette

From:

Douglas Badenoch <[log in to unmask]>

Reply-To:

Douglas Badenoch <[log in to unmask]>

Date:

Fri, 12 Aug 2011 12:26:09 +0100

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (482 lines)

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 Œcherry 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 Š 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

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