Transcription
Open accessThe new standard for pharma publications23 October 2020
Make your company a leader in transparencyBECAUSE you can make a differenceWhat open access means for pharmaand stakeholders in healthcareActions for you and your company to taketo help drive change AccessibilityGlobal reachLeadershipEquityScientific exchange VisibilityPatient centricityInclusionTransparencyOpportunitiesTrust Build: develop infrastructure that increasesaccessibility and discoverabilityEngage: listen to academics, prescribers, patientsand the public to know what they wantCampaign: ask publishers for what you want andshow that it is in their interests tooAdvocate: unite the community to insist thatjournals offer open accessUnderstand: master the details to be credible indiscussionsStandardise: mandate open access thoughpublication policiesEducate: discuss as a team the benefits ofpublishing open access whenever possibleImproved patient care2
ContentsThe case for open access in pharmaOpen science, transparency and pharmaWhat open access means to key stakeholdersThe impact of open access and how to overcome barriersMandating open access in pharmaThe open access position statement
The case for open access in pharma
An uncomfortable questionPublishers have committed to makingCOVID-19 research open access1Should all life-changing and life-savingresearch be made freely available?But is this enough?Too many doctors and patientsare making decisions without the benefitof the latest research.2– Barack Obama2009 address to the American Medical Association1. Wellcome. Available online: nd-reusable (Accessed 24 August 2020); 2. The right to research coalition. Available index.shtml (Accessed 14 September 2020)5
Paywalls mean that our research cannot be readby those who need itPatients and families(especially strongly engaged patients, such asmany people with rare diseases)Academic researchersPolicymakers(comprehensive journal access isincreasingly rare, especially at theless wealthy institutions)(with huge influence butsometimes without access tothe gold standard evidence)Healthcare professionalsJournalists, bloggers, industry critics(many doctors, nurses, social workers,pharmacists, psychologists, counsellors,volunteers do not have institutional access tosubscription journals)(communicators with a wide reach but whoseinformation is often several steps removed fromthe primary source)Patient advocates(partnering with pharma to give input on researchproposals and reimbursement decisions,summarizing research for patients andconducting/co-authoring research)6
The impact of paywalls on our stakeholdersReasons why research behind a paywallmay not be read There is no subscription Institution has terminated theirsubscription1,2 Login details are incorrect, or remoteworking does not enable login3 There is limited access in low- andmiddle-income countries4 One-time access fee is too expensiveWhat are the consequences? A reader must rely solely on the abstractfor information or on what others say theresearch says This may give an incomplete orinaccurate picture0to work from Some people may turn to illegal sourcesto access researchAre we content with this?1. Nature. Available online: d41586-019-00758-x/d41586-019-00758-x.pdf (Accessed 25 August 2020); 2. The Scientist. Available online r-journals—64522 (Accessed 25 August 2020); 3. Costa-Pereira R. Braz J Biol 2020;80:697; 4. Boudry C et al. Peer J 2019; doi: 10.7717/peerj.7850;5. Collins C. Available online: lves-into-the-science-of-a-condition/ (Accessed 25 August 2020).7
Why are we content to leave our life-saving andlife-changing research stuck behind paywalls? to build author’s bibliographies?Or should we be ensuring thatour research is disclosed andcommunicated widely? to support journal business models?Is that our job?Can we find a way to support all aims?8
What open access means for our key stakeholdersAccessibilityScientific exchangeEquityInclusionTransparencyImproved patient care9
What open access means for pharmaGlobal nitiesTrust10
A road map to universal open diseEducateGreen openaccess repository,data sharingplatformsResearch, focusgroups, outreachOpen Pharmaposition statementoutreachCovering lettersNews, twitter,blogs, conferencesIpsen, Shire,Takeda, Plan S,White HouseSlides, webinars,one-pagers,podcastsLet’s make iteasy for peopleto find ourresearchLet’s understandwhat ourstakeholderswantLet’s ask forwhat we wantLet’s persuadejournals to offerus open accessLet’s master thedetails to becredible indiscussionsLet’s mandate allresearch to beopen accessLet’s publishopen accesswhenever wecan Author accepted version on repository Open access embargo up to 12 monthsIncreasingly stringent definitionof open access Version of record on journal website Immediate open access (no embargo)11
The move towards open scienceis already happeningIPSENWileyBOAIF1000The Budapest Open AccessInitiativeWellcome TrustHoward HughesMedical InstituteBill & MelindaGates FoundationWorld HealthOrganizationUKRIBerlin DeclarationPlan SCANCERRESEARCHUKShireOASPAOpen Access Scholarly Publishing AssociationNational ScienceBethesda StatementFoundationNational InstitutescOAlitionSof HealthGalápagosU.S. DepartmentEuropean Commissionof DefenseARTHRITISRESEARCH UKHorizon 2020Future Science GroupJiscPLOS
Even the best ideas remain just that until they are shared, until they can beutilized by others. The more people that can access and build upon the latestresearch, the more valuable that research becomes and the more likely we areto benefit as a society. More eyes make for smaller problems.1131. SPARC. https://sparcopen.org/open-access/ (accessed 24 August 2020).
Open science, transparency and pharma
Open Science:what does it mean? and where do disclosure andtransparency fit in?Providing researchers with the skills and competencies they need to practise Open Science - Report of the Working Group on Education and Skills under Open Science, 2017. Available from: nce/ (Accessed 17 January 2020)15
Who do people trust?Doctors?Researchers?Governments?Pharma?16
Why do we need research transparency?Around 59% of the public trust researchby university scientists ‘completely’ or‘a great deal’ but only 32% of the public trustresearch carried out by thepharmaceutical industry ‘completely’or ‘a great deal’ 17Ipsos MORI. Wellcome Trust Monitor, Wave 3. London: Wellcome Trust, 2016. Available from: doi 10.6084/m9.figshare.3145744 (Accessed 20 March 2019)
Pharma companies now disclose the resultsof nearly all their clinical trialsAll industry sponsorsAll sponsorsNon-industry sponsorsProportion of trials reported 4201518Baronikova S et al. BMJ Evidence-Based Medicine 2019;24:177–184
Is disclosure of results alone enough?We need to be able toaccess clinical research All stakeholders wanttransparent science in a timely manner19
What open access means to keystakeholders
Reuse rights affect medical educationPharma companies can be denied use of a figure or table – eventheir own – by a journal that holds copyrightYou could face a 100 000 bill for permission to reproducecopyrighted material1 You might choose instead not to present a fair, balanced andcomprehensive view of the treatment landscapeThe CC BY licence favoured by Plan S allows reuse of any kind,only an attribution is neededThis is rarely available at prestigious medical journals unlessyour organisation has a mandate that requires it1. True story from a single symposium in 2019, personal communication. Multiple clients and medical communications staff report that broad digital rights for a single figure permission can cost 10 000.21
What open access means to healthcareprofessionals?Equality“An adult pulmonary/critical carespecialist said, “I won't pay,because it's so expensive. I'mnever going to pay 45 for anarticle. I just do without.”1TreatmentTrust“As free access toinformation on the internethas become the norm, theexpectation that researchresults (papers) shouldalso be open hasfollowed.”2“ help take healthcommunication “upstream”to policy-makers, programmanagers and other publichealth decision-makers.”31. Maggio LA et al. BMJ Open 2016;6:e012846. doi: 10.1136/bmjopen-2016-012846; 2. International Society for Medical Publication Professionals white /White Papers/ISMPP OA White Paper.pdf; 3. Moorhead LL et al. PLoS One 2015;10:e0129708. doi: 10.1371/journal.pone.012970822
What can open access mean to patients?Equality“I was pleased to be at theadvisory board butI was the only person whohadn’t seen the paper. Itmade me feel like asecond-class citizen.”TreatmentTrust“A paywall may restrict thenumber of readers andthis might NOT help thereputation of thepharmaceutical industry(the mindset of it being abit secretive).”“It’s not practical fordoctors to spend a lot oftime learning abouta syndrome that they maysee only once in theircareers . parents willmake the time to learneverything they can.”23Personal communications from patient advocates
Open access mattersI recently met a physician from Southern Africaengaged in perinatal HIV prevention, whose primary accessto information was abstracts posted on the Internet. Based ona single abstract, they had altered their perinatal HIVprevention programme from an effective therapy to one withlesser efficacy.Had they read the full-text article they would haveundoubtedly realized that the study results were based onshort-term follow-up, a small pivotal group [and] incompletedata, and [were] unlikely to be applicable to their country’ssituation. Their decision to alter treatment based solely onthe abstract's conclusions may have resulted in increasedperinatal HIV transmission.Professor Arthur Ammann, Co-founder of Global Strategies for HIV Prevention24HIV, human immunodeficiency virus
The impact of open access and how toovercome barriers
How can we overcome the barriers?Barriers The option to publish researchOA is not always available tocommercial research funders(e.g. OA under a CC BY licenceis not always available forindustry-sponsored publications) Many journals only allow articlesto be made OA following anembargo period of up to12 months after publication Cost of OA fees Requiring OA may restrictauthors’ choice of journalSteps to take Choose a journal that allowscommercially funded researchto be published OA Select the least restrictive OAlicence available Choose a journal that makesarticles OA immediately or witha minimal embargo period Calculate current OA costsand decide whether the currentOA budget should beincreased to pay for OA witha Creative Commons licencebased on the potential increasein reach and impact of articlesOutcomes Guaranteed free-to-readpublications Some published content canbe reused without restrictions Publications available witha minimal embargo period Increased budget allocationfor OA Increased access to researchfor the scientific and medicalcommunity as well as patients26BY, Attribution; OA, open access
Open access can provide sustainable publishingbusiness models Academic publishers add value to the healthcare environmentand are valued by pharma–––Distribution of informationQuality-adding and quality assurance (peer review, in-house editors)Honest broker role between pharma and doctors Driven by competition, demand and mandates, fully open accessjournals are thriving and publishers are transitioning traditionaljournals to open access Pharma business is important to publishers, and also to themedical societies who own many of the journals–– Pharma is used to paying for:subscriptions, page charges,open access article processingcharges, permissions, reprints,supplements enhanced media,advertising and more Publishers and journals that adapt to provide greater benefits andefficiency will thriveRead and publish agreements may provide more predictablerevenue streams with less administration and better value27
Open access publication enhances impactArticle citationsSocial media activityYoung F et al. Presented at the 2018 ISMPP, 30 April–2 May 2018) [poster 29]. Available from: d 28 April 2018)28
The open access advantage is greatestfor highly cited articles9Impact factorOA87Strength of correlation Shown here is the importance of twofactors in determining citations, froma multivariate regression Open access was a significant predictor ofcitations, especially for highly cited articles Open access did not increase citations ofarticles with low citation counts For other publications, open access wasalmost as important as journal impactfactor and more important for highly citedpublications65432101–4 citationsvs 05–9 citations 10–19 citations 20 citationsvs 1–4vs 1–4vs 1–429Ottaviani J. PLOS ONE 2016;11(8):e0159614
Open access journals have higher citationmetricsAn analysis of the difference between medical open access and non-open access journalsfound significant differences (p 0.001) in the following indices:Open accessNon-open accessScholarly output157205Citescore1.191.06Percent cited52%48%SNIP0.7060.617SNIP, source normalized impact per paperAlRyalat SA et al. F1000 Research 2019;8:26630
Full open access increases HCP downloadsof publicationsP 0.0110Papers downloaded per month Given access to a clinical summaryservice, UpToDate, one-third (34%) ofphysicians preferred looking at thefull text article Among this one-third, physiciansdownloaded twice as many papers whenalso given full open access1286420Normal accessFull open access31Moorhead, LL. et al. PLOS ONE 2015;10
Mandating open access in pharma
Benefits of an open access mandateAdvantagesRisk mitigation Avoid accusations of hiding publicationswhile publicly funded bodies mandateopenness, and of cherry-picking studies No need for reprints and associatedtransfer of value reportingCCClear terms of use and reuse, understoodby the academic communityBroader knowledge and trust fromall stakeholders in healthcareStrengthened scientific exchange, replacingoutdated promotional channelsCCBYWith CC BY, more balancededucational content becauseno more figure permissions33BY, Attribution; CC, Creative Commons
What are pharma companies doing?ShireIPSENGalápagosGSKCompany policy1(effective from January 2018)Company policy2(effective from January 2019)Company policy3(effective from November 2020)Company positionShire Plc (now part of Takeda)implemented a policy requiringthe submission of allShire-supported researchto journals that offer publicavailability via open accessIpsen implemented a policyrequiring all Ipsen-affiliatedresearch to be published openaccess, meaning articles willbe openly accessible onlineand free of costGalápagos implemented apolicy committing to providingonline barrier-free access tocompany-funded researchpublished in peer-reviewedjournalsGSK and other pharmacompanies stronglyrecommend that its fundedresearch is publishedopen ory/story-overview/59034
Proportion of open access publications (%)Pharmaceutical companies can achieve up to80% open access by encouraging it 10080608440586120172019200Good Pharma Scorecard1Jan–Sep 2019GSK2351. Macdonald S, Koder T. Presented at ISMPP, January 21–22, 2020, London, UK; 2. Mysore S et al. Poster presented at ISMPP, January 21–22, 2020, London, UK
and up to 100% by mandating open accessProportion of open access publications (%)100806040586120172019100918480Jan–Sep 2019Jan–Dec 201775200Jan–Sep 2018Before policyGood PharmaScorecard1GSK2After policyShire3Jan 2013–Dec 2017Before policyJan–Sep 2019After policyIpsen41. Macdonald S, Koder T. Presented at ISMPP, January 21–22, 2020, London, UK; 2. Mysore S et al. Poster presented at ISMPP, January 21–22, 2020, London, UK; 3. Philippon V et al. Poster presented at ISMPP,January 21–22, 2020, London, UK; 4. Page S et al. Poster presented at ISMPP, January 21–22, 2020, London, UK36
The open access position statement
Some publishers prevent pharma from publishingunrestricted open access1/21(5%)20/21(95%) In a study of 35 medical journals witha high impact factor, 21 (60%) offeredan immediate open access option witha Creative Commons licence Only one of these 21 journalspotentially offered immediate openaccess under a CC BY licence toauthors, irrespective of theirfunding sourceJournals only offering CC BY open access for researchfunded by specific non-commercial organizationsJournals offering CC BY open access to organizationsthat require itBY, attribution; CC, Creative CommonsEllison T et al. BMJ Open 2019;9:e028655. doi: 10.1136/bmjopen-2018-02865538
The Open Pharma open access goalWe believe that pharmaceutical company-funded research should be published in a way that istransparentaccessibletimelyefficient and sustainable39
We, as Open Pharma, a group of pharmaceutical companies and otherresearch funders, alongside healthcare professionals, regulators, patients,publishers and other stakeholders in healthcare, recognize the importanceof publishing research with open access, where papers can be readwithout payment of a one-off access charge or subscriptionOpen Pharma position statement on open access40
Open access position statement1 – key detailsOur long-term goalOur immediate priority Secure authors publishing company-fundedresearch the same right to publish openaccess as authors publishing researchfunded by other sources Free to read – and reuse – from the dateof publicationAll research to be made free to readfrom the date of publicationCCAny variant of Creative Commonsor equivalent licenceBY, Attribution; CC, Creative Commons1. Open Pharma. Available online: -access/Secure authors publishing company-fundedresearch the same terms as authorspublishing research funded by other sourcesCCBYSustainable use of CC BY41
Endorsements from individuals, organizations,pharmaceutical companies and publishers1809 publisher endorsementsendorsementsBetasciencepress PublishingFrontiers Media SAMDPIecancerFuture Science GroupPLOSF1000 Research LtdHindawiWiley31 endorsements from other organizationsAIX ConsultancyInternational Kidney Cancer CoalitionPedalling4ACureAtaxia and MeInside STEMSCN2A AustraliaAutoinflammatory UKIpsenScott Pharma SolutionsCambridge Rare Disease NetworkKAN Consulting MON. I.K.EScriva medical CommunicationsCanadian Organization for Rare DisordersKidney Research UKSequoia Medical Communications LtdCentro Español de Investigación FarmacoepidemiológicaM-CM NetworkSolanum Medical Communications LtdCinclus Pharma Holding ABM-SpectiveSUDEP ActionDSL Consulting, LLCObservational and Pragmatic Research Institute Pte LtdThe Aarskog FoundationEpi-FitOutcomes Positive, IncThinkSCIENCE, Inc.Galápagos NVOxford Health Policy ForumZimbabwe Evidence-Informed Policy NetworkOxford PharmaGenesis1–2 endorsements3–5 endorsements6–30 endorsements31 endorsementsCorrect as of 20 October 2020M-CM, macrocephaly-capillary malformation; MDPI, Multidisciplinary Digital Publishing Institute; PLOS, Public Library of Science; SUDEP, sudden unexpected death in epilepsy42
Reach of the position statement43
Comments from individual endorsers“If we are committed to ‘doing the right thing“A vital element of open access is ‘knowledge mobilization’ – bringingfor patients’, then we must all support openas many relevant stakeholders to engage with published research aspossible to maximize its reuse and impact. Open access offers a way access and transparency.”to maximize contact with multiple audiences, spark new ideas and–John Gonzalez, Solanum Medical Communications Ltdunderstanding, and ensure new interventions and treatments can“Science should be open. Research cannot bereach those that need them as soon as possible.”–Rebecca Lawrence, F1000Research kept locked for access to a limited few. It’scontrary to the principles of doing clinicalresearch. We make volunteer participants give“One of the persistent challenges facing various stakeholders inus valuable results and then block the endthe health sector in Zimbabwe and other low- to middle-incomeusers from using the same to help thesecountries is physical and cognitive access to relevant crediblevolunteers.”evidence to use in identifying research priorities, doing the–Alban Sigamani, Narayana Healthresearch, develop policy and in making programme“Important step in enabling patient groups andinterventions to ensure universal health coverage, posingcharities to share relevant information with thea serious threat for the health sector.”community and build an informed society.”–Ronald Munatsi, Zimbabwe Evidence Informed Policy Network–Alan Thomas, Ataxia and Me44
Engage with the position statementHelp us to share the news!Let’s work together Sign our position statement today!https://openpharma.blog/ Get involved in the conversation@ OpenPharmaPlease reuse and share these slides however you wish, to advocate for open access and the open sciencemovement, and please remember to acknowledge Open Pharma and encourage more people get involvedAvailable to download: https://doi.org/10.6084/m9.figshare.1307317445
Patient centricity Opportunities Trust. Contents The case for open access in pharma Open science, transparency and pharma What open access means to key stakeholders . perinatal HIV transmission. Professor Arthur Ammann, Co-founder of Global Strategies for HIV Prevention HIV, human immunodeficiency virus .
