Egyptian soc2Clinical Practice and the Pharmaceutical Industry
Clinical Practice and thePharmaceutical Industry
Pharmaceutical industries &Sponsorship of Researches
fact that the pharmaceuticalindustry now spends more onmedical research than do theNational Institutes of Health inthe United States.
CongressThe report rejected a claim by critics of thepharmaceutical industry that drugcompanies spent more on advertising thanon research and development. Thereport found that drug makers spent muchmore on research. Last year,it saidcompanies spent $30.3bn on research anddevelopment and $19.1bn on all promotionactivities.including $2.7bn for advertisingaimed at consumers
Influences on general practitionersdecision to prescribe new drugs-theimportance of who says what.Prosser H, Almond S, Walley T.Prescribing Research Group, Department ofPharmacology and Therapeutics, The Infirmary, 70Pembroke Place, Liverpool L69 3GF and RoyalLiverpool University Hospital, Liverpool L7 8XP,UK.
Prescribing of new drugs is not simply related tobiomedical evaluation and critical appraisal but,more importantly, to the mode of exposure topharmacological information and socialinfluences on decision making. Viewed withinthis broad context, prescribing variationbecomes more understandable. Findings haveimplications for the implementation of evidence-based medicine, which requires a multifacetedapproach.
The methods of influence used include:B1. Gifts (reciprocal obligations)B2. Appeals to authorityB3. Social validation (Appeals to conformity)B4. Liking / friendshipB5. Commitment consistencyB6. ScarcityB7. Appeals to sympathyB8. Magic wordsB9. Images that appeal to desiresB10. Repetition for agenda setting
Rules and Guidelineson Doctors’ relationswith drug companiesElizabeth Wager
summaryCode of conduct & complaintProhibit inducementsCommercially funded research
summaryJournal condition Unsupressed dataGuidance and good publicationDialogue between the interestedparties
Pharmaceutical industry sponsorship and research outcome and quality: systematic review British Medical Journal 31may03
Joel Lexchin, associate professor1, Lisa A Bero,professor2, Benjamin Djulbegovic, associateprofessor3, Otavio Clark, chief of clinical oncologysection41 School of Health Policy and Management, York University,Toronto, ON, Canada M3J 1P3,2 Department of Clinical Pharmacy and Institute for Health PolicyStudies, University of California at San Francisco, San Francisco,CA 94118, USA,3 Interdisciplinary Oncology Program, H Lee Moffitt Cancer Centerand Research Institute, University of South Florida, Tampa, FL33612, USA,4 Instituto do Radium de Campinas, 13075-460 Campinas-SP, BrazilCorrespondence to: J Lexchin firstname.lastname@example.org
An increasing number of clinicaltrials at all stages in a products lifecycle are funded by thepharmaceutical industry
Possibility ofResults that are unfavourable to thesponsor—that is, trials that find adrug is less clinically effective orcost effective or less safe than otherdrugs used to treat the samecondition—can pose considerablefinancial risks to companies.
Exclusion ofPressure to show that the drugcauses a favourable outcome mayresult in biases in design, outcome,and reporting of industry sponsoredresearch.
Possible biases I. Clinical trials PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL (RCT). A. STATISTICAL CONSIDERATIONS B. ETHICAL CONSIDERATIONS C. STUDY POPULATIONS D. ENDPOINT ASSESSMENT E. ANALYSIS
recent systematic review of the impact of financial conflictson biomedical research found that studies financed byindustry, although as rigorous as other studies, alwaysfound outcomes favourable to the sponsoring company.However, this review looked for papers published only inEnglish, excluded reports in letters and abstracts, andlooked at studies funded by other industries.
ObjectiveTo investigate whether funding of drug studies bythe pharmaceutical industry is associated withoutcomes that are favourable to the funder andwhether the methods of trials funded bypharmaceutical companies differ from the methodsin trials with other sources of support.
MethodsMedline (January 1966 to December 2002) and Embase(January 1980 to December 2002) searches weresupplemented with material identified in the referencesand in the authors personal files. Data wereindependently abstracted by three of the authors anddisagreements were resolved by consensus.
Results30 studies were included. Research funded by drugcompanies was less likely to be published thanresearch funded by other sources. Studies sponsoredby pharmaceutical companies were more likely tohave outcomes favouring the sponsor than werestudies with other sponsors (odds ratio 4.05; 95%confidence interval 2.98 to 5.51; 18 comparisons).None of the 13 studies that analysed methods reportedthat studies funded by industry was of poorer quality.
ConclusionSystematic bias favours products whichare made by the company funding theresearch. Explanations include theselection of an inappropriatecomparator to the product beinginvestigated and publication bias.
Relationships Between Authors ofClinical Practice Guidelines and thePharmaceutical IndustryNiteesh K. Choudhry, MD, FRCPC; HenryThomas Stelfox, MD, FRCPC; Allan S.Detsky, MD, PhD, FRCPC JAMA. 2002;287:612-617
Eighty-seven percent 87 % of authors had someform of interaction with the pharmaceutical industry.Fifty-eight percent 58 % had received financialsupport to perform research and38% had served as employees or consultants for apharmaceutical company. JAMA. 2002;287:612- 617
CPG authors interacted with 10.5 differentcompanies. Overall, an average of 81% (95%confidence interval, 70%-92%) of authors per CPGhad interactions. Similarly, all of the CPGs for 7 of the 10 diseasesincluded in our study had at least 1 author whohad some interaction. Fifty-nine 59% percent had relationships withcompanies whose drugs were considered in theguideline they authored, and of these authors, 96% had relationships thatpredated the guideline creation process. JAMA. 2002;287:612-617
Fifty-five percent of respondents indicated that theguideline process with which they were involvedhad no formal process for declaring theserelationships. In published versions of the CPGs,specific declarations regarding the personalfinancial interactions of individual authors withthe pharmaceutical industry were made in only 2cases. Seven percent thought that their ownrelationships with the pharmaceutical industryinfluenced the recommendations and 19% thought that their coauthorsrecommendations were influenced by theirrelationships. JAMA. 2002;287:612-617
Interpretation biasUKPDSSeeing what you want to seein randomised controlledtrialsJames McCormack and Trisha Greenhalgh, BMJ 2000;320:1720-1723 ( 24 June)
UKPDSSeeing what you want to see in randomised controlled trialsJames McCormack and Trisha Greenhalgh Nevertheless, many authors, journal editors, and the wider scientific community interpreted the study as providing evidence of the benefit of intensive glucose control
Why Consider Economic ResearchType of Funds •Alone research by Pharmaceutical Lab •Total Funds of scientific research •Share witn others
ECONOMIC EVALUATIONS: REAL OR IMAGINED? Correspondence to:Michael Drummond Marco Barbieri EconomicsCentre for Health EconomicsHealth Centre forYork University of York University ofY010 5DD,UKHeslington, York Y010 5DD, UK Heslington, YorkTel: +44 1904 433709 Tel: +44 1904434264Fax: +44 1904 433644 Fax: +441904 433644e-mail: email@example.com e-mail: firstname.lastname@example.org
Stelfox et al. (1998) Review of English-language medicalliterature (1995-1996) about the safety ofcalcium channel antagonists. 70 articles found: 30 supportive of calcium-channels antagonist, 17 neutral, 23 critical.96% of the supportive authors had financialrelationship with manufacturers of calcium-channel antagonists, as compared with 60%of neutral and 37 of the critical authors. Theassociation was statistically significant.
Cho and Bero (1996)Comparison of drug studies published insymposium proceedings that aresponsored by drug companies witharticles published in their parentmedical journals.The percentage in favour of the drug ofinterest was 98% for articles with drugcompanies support and 79% for articleswithout drug companies support. Thedifference was statistically significant.
Davidson RA (1986)Review of randomised clinical trials indifferent areas.107 published trials were analysed. 71% oftrials favoured new therapies ; 43% of thesewere funded by pharmaceutical firms. Of31% of trials favouring the traditionaltherapy, only four (13%) were supported bydrug companies. There was a statisticallysignificant association between the sourceof funding and the outcome of the study.
Rochon et al. (1994)Review of publications ofmanufactures-supported trial ofNSAIDs (1987-1990)52 publications representing 56 trialswere found. In all 56 trials themanufacturer-associated drug wasreported as comparable (71.4%) orsuperior (28.6%) to the comparisondrug.
Gazzaniga and Garattini (1992)Review of 7 pharmacoeconomic studies oncholesterol-lowering agentsLack of methodological rigour in some partof the analyses, but this is not necessarylinked to industrial sponsorship. The role ofsponsor played by drug companies in 5 ofthe 7 studies did not seem to havesignificantly affected the quality of theresults.
Sacristan et al. (1997)Review of economic studies published overthe period 1988 to 1994 . Analysis ofpublication bias.22 out of 24 studies (83%) published inPharmacoEconomics reported positiveresults, with 83% of them sponsored by drugcompanies. 34 out of 69 studies (49%)published in general medical journalsreported positive findings, with 74% of themsponsored by government agencies. Thedifference in percentage of positive resultsbetween PharmacoEconomics and generalmedical journals was statistically significant.
Drummond et al. (1997)Survey of decision-makers’ atitudes toeconomic evaluation conducted in the UK.59% of responders cited the lack ofcredibility of industry-sponsored studiesas an obstacle to the use of the study,with 8% of respondents identifying this asthe most important obstacle. By contrast,the possibility that government studieswere not credible was identified as aproblem by only 9% of respondents, withless than 1% identifying this as the mostimportant.
Azimi and Welch (1998)Comparison of cost-effectivenessanalyses sponsored by drug companieswith those sponsored by non-profitorganisationsIndustry-financed cost-effectivenessanalyses were more likely to supportadditional expenditures withinvestigational drugs than standardtreatments.
ECONOMIC EVALUATIONS:REAL OR IMAGINED? This publication bias can only be addressed by increasing the funding for economic evaluations of medicines from other, mainly public, sources.
National Codes, Associattion ofBritish Pharmaceutical industry(ABPI), Medicines Australia andPharmaceutical Research andManufacturers of America
France, legal code de la santePublique (article L4113-6) ProhibitPhysician from receiving benefitsmore than 30 euros (illegal payments)sanction 75 000 euros and a two yearsprison sentence