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Prevalence of Financial Conflicts of Interest Among

Prevalence of Financial Conflicts of Interest Among

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Prevalence of financial conflicts of interest amongpanel members producing clinical practice guidelinesin Canada and United States: cross sectional study
Jennifer Neuman
, Deborah Korenstein
associate professor 
, Joseph S Ross
assistant professor 
, Salomeh Keyhani
assistant adjunct professor 
4 5
Departmentof Medicine, Mount Sinai School of Medicine, New York;
Section of General Internal Medicine, Department of Medicine, Yale University School ofMedicine and Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06520-8093, USA;
Division of GeneralInternalMedicine,UniversityofCaliforniaatSanFrancisco,SanFrancisco,CA,USA;
HSR&DResearchEnhancementAwardProgram,VAMedicalCenter, 4150 Clement Street, San Francisco, CA 94121
To determine the prevalence of financial conflicts of interestamong members of panels producing clinical practice guidelines onscreening, treatment, or both for hyperlipidaemia or diabetes.
Cross sectional study.
Relevant guidelines published by national organisations in theUnited States and Canada between 2000 and 2010.
Members of guideline panels.
Main outcome measures
Prevalence of financial conflicts of interestamong members of guideline panels and chairs of panels.
Fourteen guidelines met our search criteria, of which five hadno accompanying declaration of conflicts of interest by panel members.288 panel members had participated in the guideline developmentprocess. Among the 288 panel members, 138 (48%) reported conflictsof interest at the time of the publication of the guideline and 150 (52%)either stated that they had no such conflicts or did not have anopportunity to declare any. Among 73 panellists who formally declaredno conflicts, 8 (11%) were found to have one or more. Twelve of the 14guideline panels evaluated identified chairs, among whom six hadfinancial conflicts of interest. Overall, 150 (52%) panel members hadconflicts, of which 138 were declared and 12 were undeclared. Panelmembers from government sponsored guidelines were less likely tohave conflicts of interest compared with guidelines sponsored bynon-government sources (15/92 (16%)
135/196 (69%); P<0.001).
The prevalence of financial conflicts of interest and theirunder-reporting by members of panels producing clinical practiceguidelinesonhyperlipidaemiaordiabeteswashigh,andarelativelyhighproportion of guidelines did not have public disclosure of conflicts ofinterest.Organisationsthatproduceguidelinesshouldminimiseconflictsof interest among panel members to ensure the credibility and evidencebased nature of the guidelines' content.
The prevalence of financial conflicts of interest (COI) betweenclinicians and industry has been a topic of concern for themedical profession for more than two decades. The influenceof COI on medical research and publishing has had recentattention,
and the latest revelations about frequent and large“consultancy” payments to physicians, the practice of “ghostwriting” by drug company employees, and the prevalence of industryfunded“keyopinionleaders”inmedicineraiseconcernthatphysicians’financialrelationswithindustrymayunderminethepracticeandpromotionofhighqualityevidencebasedcare.
One area in which the presence of COI may be particularlyconcerning is the development of clinical practice guidelines.
Guidelines serve to standardise care, to inform evidence basedpractice, and ultimately to protect patients, so their freedomfrombiasisparticularlyimportant.
Overthepastdecade,mostorganisations that produce guidelines have adopted COIdisclosure policies for members of guideline panels. Someorganisations, such as the UK National Institute for Health andClinical Excellence (NICE), have gone further, excludingauthors with COI from relevant decision making.
In contrastto guidelines from centralised organisations such as NICE, USand Canadian guidelines are issued by medical specialtysocieties, non-profit organisations, government agencies, andprofessional associations, each with their own guidelinedevelopment processes and COI disclosure policies.
Correspondence to: J Neuman neuman.jennifer@gmail.comExtra material supplied by the author (seehttp://www.bmj.com/content/343/bmj.d5621/suppl/DC1)
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2011;343:d5621 doi: 10.1136/bmj.d5621 Page 1 of 8
Althoughmostorganisationsmandatesomeformofdisclosure,complete transparency is often not achieved,
13 14
and simpledisclosureofCOImaynotbeenoughtopreventpanelmembers’bias from influencing recommendations.
11 15 16
Emphasising theimportance of having unbiased recommendations to guideclinical practice, the Institute of Medicine recently publishedrecommendations on management of COI among authors of clinical practice guidelines.
These recommendations call forthe exclusion of panel members with financial COI, theappointmentofachairwithoutCOI,andanendtodirectfundingof guidelines by industry. They also recommend full disclosureof the COI policy of each guideline panel, along with thepotential COI of all panel members. Lastly, they recommendthat if appointing panellists with COI is unavoidable, theirpresence should be limited to a minority and they should beprohibited from voting.Using the Institute of Medicine’s recommendations as aframework, we determined the prevalence of financial COIamongguidelinepanellistsfromorganisationsconsideredlikelyto reflect best clinical practice and influence behaviour. Weevaluated guidelines produced over the past decade by nationalorganisations in the United States and Canada that coveredscreening for and treatment of diabetes and hyperlipidaemia.We hypothesised that a substantial proportion of members of guideline panels would have COI. We chose hyperlipidaemiaand diabetes as representative disease categories because of thehigh prevalence of both diseases in the population. In addition,the drugs used to treat these diseases account for the largestshareofprescriptiondrugexpenditureswithintheUSMedicarepopulation and some of the highest spending on prescriptiondrugs worldwide.
WedidacrosssectionalstudytoexaminetheextentoffinancialCOI among members of guideline panels who participated inthedevelopmentofguidelinesonhyperlipidaemiaanddiabetesbetween 2000 and 2010.
We identified guidelines by searching the National GuidelineClearinghouse, MDConsult, UpToDate, and the websites of organisations with a potential interest in hyperlipidaemia anddiabetes(suchastheAmericanDiabetesAssociation,AmericanHeart Association, and American College of Physicians). Weused the search terms “hyperlipidemia,” “cholesterol,” and“diabetes” to identify potential guidelines. We selectedguidelines if they were issued by national organisations(governmentsponsored,medicalspecialtysocieties,professionalassociations, and non-profit organisations) in North America(UnitedStatesandCanada),between2000and2010andcoveredscreening, treatment, or both for hyperlipidaemia or diabetes inthe general population. We classified each organisation exactlyas listed on the National Guidelines Clearinghouse website,exceptfortheCanadianDiabetesAssociationandtheCanadianCardiovascular Association, which were not included on thiswebsite.WeusedthedesignationsoftheUSorganisationsmostsimilar to them—the American Diabetes Association and theAmericanHeartAssociation.WeexcludedguidelinesaffiliatedtoaUSstateorCanadianprovinceandthosecoveringscreeningand management for particular subgroups of disease (forexample, management of diabetes in patients with HIV) (table1). We determined industry sponsorship of a guideline fromacknowledgments in the guideline itself. The web appendixgives references for all the guidelines included.
Main outcome measure
We defined financial COI as the direct compensation of aguideline panellist by a manufacturer of a drug used to treat thedisease of interest in the guideline, in the form of grants(including research), speakers’ fees, honorariums,consultant/adviser/employeerelationships,andstockownership.We classified COI into three categories: declared in theguideline; undeclared in the guideline but identified throughour search strategy; and no opportunity to declare COI in theguideline but identified COI by our search strategy.
Identification of COI
WesearchedeachguidelinefordeclarationofCOIbythepanelmembers. If no conflict was declared in the guideline or in anaccompanying document, we searched Medline to identifyfinancial COI. We searched all publications of each panelmember in the two years before publication and the year of publicationoftheguidelinefordataonCOI.Weusedtwoyearsas the cut-off because organisations vary in the length of timethey consider COI to be relevant. NICE considers COI to berelevant 12 months before participation on a committee,
whereas the World Health Organization considers COI to berelevant within four years of participation.
If the Medline search identified no COI, we used Google tosearch the internet, combining each panellist’s name with thename of each of the major manufacturers that develop andmarket drugs for hyperlipidaemia and diabetes. We searchedfor any relevant relations that occurred in the two years beforerelease of the guideline. We identified drug companies bysearching the
Tarascon Pocket Pharmacopoeia
2010 editionfor all drugs listed for the treatment of hyperlipidaemia anddiabetesandidentifyingtheirmanufacturerbyaninternetsearch.We reviewed the first 50 search results for each panellist-drugcompany pair for reported financial relations with the drugindustry. We chose a threshold of 50 results because searchresults became less relevant after this threshold. When weidentified COI, we confirmed the identity of the panel memberofinterestbymatchinghisorherreportedinstitutionalaffiliationwith the one documented in the guideline. One author (JN)identified COI, and another (SK) verified the presence of COI.
Statistical analysis
We report the percentage of panel members with financial COIandwhetherthechairofthepanelhadCOI.Wereportthetypesof compensation received by panellists but distinguish grantfunding from other types of compensation, as it presumably isintended to support research efforts whereas other forms of compensationgenerallysupportpersonalincome.Inasecondaryanalysis, we dichotomised guidelines into several categories,including sponsorship (government versus other), disease(hyperlipidaemiaversusdiabetes),andcountryoforigin(UnitedStates versus Canada). We created these categories to examinethe effect of the characteristics of the organisation sponsoringtheguidelinesontheprevalenceofreportedCOI.Wecomparedthe proportion of COI in each guideline category overall and ina secondary sensitivity analysis, limiting the sample toguidelineswithdeclarationsofCOItoaccountforpossiblebiasrelated to opportunity for disclosure. We examined differencesbetween each category by using a two sided, 0.05 level χ
testof significance. We used Stata statistical software for allstatistical analyses.
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2011;343:d5621 doi: 10.1136/bmj.d5621 Page 2 of 8
Characteristics of guidelines
We identified 14 guidelines that met our search criteria: sevenfor diabetes and seven for hyperlipidaemia (table 1). Four of the guidelines were published by medical specialty societies,two were from professional associations, six were fromgovernment sponsored organisations, and two were publishedbyprivatenon-profitorganisations.ThreeguidelineswerefromCanadaand11fromtheUnitedStates.Twoguidelineproducingorganisations had drug industry sponsorship (one from Canadaand one from the United States). Among the 14 guidelineproducing organisations, nine provided a document listing theCOIofpanellists.FiveguidelinesdidnotprovideanopportunityforpanelliststopubliclydeclarefinancialCOI,andfourofthesewere sponsored by the government.
Panel size
The size of panels ranged from nine to 93, with a median sizeof 15 panellists per guideline. A total of 288 panel members,representing 265 different people, participated in the 14guidelines. Twenty-three panel members participated in twoguidelines. Of these panel members, five had COI that werecounted for both guidelines, two had COI that counted for onlyone of the guidelines, and 16 had no COI. Among the 23panellists who were counted twice, 17 had no opportunity topublicly declare COI.
Prevalence of financial COI
Of the 288 panel members (chairs included), 48% (n=138)reported COI at the time of the publication of the guideline and52% (150) either stated that they had no COI (73) or did nothave an opportunity to declare COI (77) (table 1). Of thosewho declared conflicts, 93% (128) reported receivinghonorariums, speakers’ fees, employee/adviser/consultancypayments, or stock ownership from drug manufacturers of interest. The remaining 7% (10) reported receiving fundingexclusively for research.Ofthe211panellistswhohadanopportunitytopubliclydeclareCOI, 73 stated that they had no COI, among whom 11% (n=8)had undeclared COI identified through our search strategy (fig1).All73panelmembersreceivedspeakers’fees,honorariums,or employee/adviser/consultancy payments or held stock ownership. Among the 77 panel members who did not have anopportunity to publicly declare COI, we found 5% (4) to haveCOI through our search strategy (fig 1). Of the 12 undeclaredCOI,wefoundonethroughourGooglesearchandtheremainderthrough our Medline search. In summary, among 288 membersof guideline panels, 52% (n=150) had COI, of which 138 weredeclared and 12 undeclared. Four undeclared conflicts wereamong panel members of guidelines without an opportunity todeclare COI.Ofthe14guidelines,12identifiedachair.Ofthese12,wefoundsix to have COI, all of which were declared. Among guidelinesthat provided public declarations of COI, six of seven chairsreported COI (table 1).
Conflicts of interest by guidelines’characteristics
COI were significantly less common among guideline panelssponsored by the government than among panels sponsored byotherorganisations(16%
69%;P<0.001)(table2).COIwerehighly prevalent among panel members of guidelines producedby Canadian specialty societies and US specialty societies butwere significantly higher among Canadian panels (83%
58%;P<0.001).WefoundnostatisticallysignificantdifferenceintheprevalenceofCOIamongpanelmembersofdiabetescomparedwith hyperlipidaemia guidelines (56%
44%; P=0.06). In asensitivity analysis limited to guidelines for which panellistshad the opportunity to publicly declare conflicts, we found thatCOIwerestillsignificantlylesscommonamongguidelinepanelssponsored by the government compared with panels sponsoredby other organisations (46%
72%; P=0.01) (table 2). COIwere significantly more common among Canadian than USpanels(83%
68%;P=0.04),andagainwefoundnostatisticallysignificant difference in the prevalence of COI among panelmembersofdiabetescomparedwithhyperlipidaemiaguidelines(table 2).
For diabetes and hyperlipidaemia, we found that conflicts of interest (COI) were present for the vast majority of guidelinepanels reviewed. We also found that among panels that hadchairs,halfofthesehadCOI.Inaddition,amongpanellistswithan opportunity to publicly report COI, one out of nine reportedno COI but were found to have undeclared COI. Our dataillustratethepervasivenessofCOIamongmembersofguidelinepanels and may raise questions about the independence andobjectivity of the guideline development process in the UnitedStates and Canada.A recent study of COI for members of cardiovascular guidelinepanelsalsofoundthatCOIwerecommon.
However,thisstudywas limited to guidelines produced by the American Collegeof Cardiology/American Heart Association, an organisationwhose guideline development process has previously beenscrutinised for influence by industry.
Our study includes awide range of guideline producing organisations and can beapplied to the general guideline development process in theUnited States and Canada. Furthermore, our study exposes theproblem of incomplete disclosure and highlights the importantrelationbetweensponsorshipofguidelinesandpresenceofCOI.Our results are similar to those of a study done more than adecade ago, which found that 59% of authors of guidelinesadmittedtohavingreceivedfundingfrommanufacturerswhoseproductswereincludedorconsideredintheguideline.However,only two of 44 guidelines studied at that time had publiclyavailabledisclosuredocuments,andCOIweredocumentedonlythroughselfreport.
Ourstudyshowsthatinspiteofincreasingrequirements for disclosure of COI by guideline panellists therate of COI remains similar, suggesting that mandatingtransparencymaynottranslateintodecreasedCOIonguidelinepanels.Among guideline sponsoring organisations with publicdisclosure of COI, we found that government sponsored panelshad significantly fewer panel members with COI, suggestingthatexpertpanelscanbeconvenedfrommemberspredominantlywithout COI. However, although our sample included sixgovernment sponsored guidelines, only two of them (oneCanadian and one US) included a public statement on the COIof panel members. The remaining four were produced by theVeterans Administration and the US Preventive Services Task Force (USPSTF). The USPSTF is the main governmentsponsored body in the United States that issues guidelines onscreening and has a strict policy of managing its members’conflictsofinterest.
However,taskforcepanelmembers’COIdisclosurescanbeviewedonlyafterarequestundertheFreedomof Information Act is filed with the government. This processis unnecessarily cumbersome and does not lend itself to easy
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2011;343:d5621 doi: 10.1136/bmj.d5621 Page 3 of 8

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