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PUBLIC AVAILABILITY OF PHARMA POLICIES ON THEIR ROLE IN PEER-REVIEWED PUBLICATIONS Sarah Bartlett, Andrew Berrie, Hilary Davidson, Alice Choi Complete Medical Communications and Complete Medical Group, Macclesfield, UK

Figure 1 shows the relative level of detail that each of the four companies provide on key None of the four companies guarantee publication of all of their trial results in peer- ABSTRACT RESULTS aspects of publication policy and ethics. The two aspects of publication policy covered in detail reviewed journals. Table 3. Recognition of the role of professional medical writers. by all four of the companies were authorship and acknowledgments. All other aspects were Background: Cases of inappropriate publication practice and data disclosure have been highlighted in the GlaxoSmithKline, Merck & Co, and Pfizer state that they reserve the right to review proposed Company Acknowledgment required Comments Of the 20 companies considered within this analysis, only two (Daiichi Sankyo and Johnson & covered in varying degrees. past. Some pharmaceutical companies have developed statements/policies on their involvement in the manuscripts prior to submission; Merck & Co and Pfizer also state that they reserve the right Johnson) do not appear to have a publically available policy on the registration of clinical trials dissemination of company data in publications. Many such policies remain internal documents that are AstraZeneca and the disclosure of clinical trial results, nor on journal publication of company data (Table 1). Definition of ‘publication’, types of studies covered by policy, and the role to review proposed congress abstracts and associated presentations. GlaxoSmithKline and shared with investigators/authors and medical writers/agencies, but are not publically available. GlaxoSmithKline Professional medical writers may be of the company in publication Pfizer state that they do not suppress or veto submission of manuscripts. Objective: The objective of this survey was to establish which pharmaceutical companies had publication authors if contribution to manuscript meets policies available to the public and compare the content of these policies. The definition of ‘publication’ and the types of studies published are provided in Table 2. ICMJE criteria Table 1. Public availability of policies on clinical trial registration and results posting and on Access to data Methods: The websites of 20 pharmaceutical companies were accessed to obtain relevant policies and publication policy for 20 pharmaceutical companies. Merck these policies reviewed to assess similarities and differences. The four companies make data accessible to authors/investigators: Table 2. Defining ‘publication’ in policies and types of studies covered by the policies. Pfizer Professional medical writers may be Protocol registration Publication Protocol registration Publication Results: Most companies only mention their position on publications very briefly in the context of clinical trial – AstraZeneca: final protocol, statistical analysis plan, statistical tables, figures, and reports authors if contribution to manuscript meets registration and results disclosure. Merck & Co, GlaxoSmithKline, Pfizer, and AstraZeneca provide the most and results posting policy and results posting policy Company Description of publication Types of studies needed to prepare the publication ICMJE criteria comprehensive statements on publications in scientific journals. All four policies outline the companies’ Pfizer Abbott Laboratories authorship criteria and state professional medical writing support should be acknowledged. Other aspects AstraZeneca ‘publication in biomedical journals’ ‘all scientific, technical and medical – GlaxoSmithKline: summary of the overall trial results and if necessary, relevant reports, GlaxoSmithKline Bristol-Myers Squibb covered to greater/lesser extents by at least one of the policies include the role of the company in publications originated or sponsored by figures, or tables; the complete study database can be reviewed by request at a GSK site manuscript development/review, protection of intellectual property, and author access to data. Sanofi-aventis Amgen AstraZeneca’ or other mutually agreeable location Conclusions: The majority of major pharmaceutical companies do not publish their publication policies on Novartis Schering-Plough – : on request, review of the complete study database is permitted at the their corporate websites. Companies should be encouraged to consider making their policies publically GlaxoSmithKline ‘publish the results...in scientific ‘GSK-sponsored clinical trials that are Merck & Co CONCLUSIONS Roche Takeda and medical journals and in relevant for patient care irrespective of company facility available, as this may help with transparency and improve reputational issues within this field. ● Although most of the surveyed major pharmaceutical companies have made policies on AstraZeneca Bayer conference abstracts and whether the results are positive or – Pfizer: statistical tables, figures, and reports for the study at a designated Pfizer facility or clinical trial registration and data disclosure publically available, the majority do not Merck & Co Boehringer Ingelheim proceedings’ negative for GSK prescription medicines other mutually agreeable location. display detailed policies on their role in publications on their corporate websites. Johnson & Johnson Astellas and vaccines’ AstraZeneca and Merck & Co policies also specifically state that they will provide the study ● Where publically available policies exist, there was agreement that: Eli Lilly Novo Nordisk Merck ‘peer-reviewed papers; abstracts, ‘clinical trials sponsored and monitored INTRODUCTION protocol to the journal should it be requested. Wyeth Daiichi Sankyo posters or presentations at a by Merck – studies in which we collect – although companies will post study results of clinical trials on a publically accessible scientific meeting; or other and analyze data, including observational website, they cannot guarantee publication in a peer-reviewed journal The medical and lay press have reported a number of instances where pharmaceutical Protecting intellectual property communication of study results studies in which medically important – authorship should be in accordance with ICMJE and the contributions of professional companies have not fully disclosed clinical trial data related to marketed products. Policy and such as posting on the internet’ results warrant publication’ AstraZeneca, GlaxoSmithKline, and Pfizer all make statements regarding the protection of their Fourteen companies posted brief statements describing their policy on registration of studies medical writers should be acknowledged law have been introduced to provide a greater degree of clarity regarding the trials conducted intellectual property: by pharmaceutical companies and the data resulting from those trials: and public disclosure of results.3-16 Pfizer ‘scientific articles, posters, ‘Pfizer-sponsored studies conducted in – authors/investigators should be given access to the original data abstracts, and in online results patients or which have scientific or – AstraZeneca: ‘In order to protect intellectual property effectively, any collaboration between – In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that AstraZeneca, GlaxoSmithKline, Merck & Co, and Pfizer all provide comprehensive information on – pharma companies have a role in reviewing proposed publications and in protecting databases’ medical importance’ AstraZeneca and a third party will be subject to a formal agreement that will address member journals would require clinical trial registration in a public trials registry as a the companies’ positions regarding the publication of company data in peer-reviewed publications, intellectual property in a way that does not jeopardize the timeliness of the publication. 1 ownership and access to data.’ condition of consideration for publication. 17-21 as well as policies on registration of studies and public disclosure of results. ● Companies should be encouraged to consider making their policies on the publication of – In 2007, Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA; – GlaxoSmithKline: ‘On an exceptional basis, although not in line with WHO and ICMJE company product data available publically, as this may help with transparency and Public Law 110-85) mandated reporting of results for Phase II-IV trials of all US Food and requirements that all data elements should be disclosed at the outset of our trials, GSK improve reputational issues within the field. Drug Administration (FDA)-approved products and those that will be submitted to the FDA for Figure 1. Level of detail on different aspects of publication policy. may delay registration of certain data elements (compound, name, outcome measures, marketing approval.2 and/or the official title) relating to ongoing Phase I and Phase II trials. This is because early AstraZeneca GlaxoSmithKline Merck & Co Pfizer Peer-reviewed publication is considered by many to be the most complete form of data High disclosure of compound names and trial outcome measures could, in some circumstances, REFERENCES disclosure, and some pharmaceutical companies have developed policies regarding their prevent patentability or negatively impact innovation by reducing the incentive to invest in 1. International Committee of Medical Journal Editors. Available at: http://www.icmje.org. Accessed March 26, 2009. 2. Food and Drug Administration. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws &docid=f:publ085.110.pdf. Accessed involvement in the dissemination of company data through peer-reviewed journals and novel ways of assessing the effects of investigational medicines and vaccines.’ March 26, 2009. 3. Abbott. Available at: http://www.abbott.com/global/url/content/en_US/40.30.10:10/general_content/General_Content_00266.htm. Accessed March 26, 2009. scientific/medical congresses. – Pfizer: ‘In rare cases, it may be necessary to delay publication or other public disclosures 4. Amgen. Available at: http://www.amgentrials.com/medpro_policy.cfm. Accessed March 26, 2009. 5. Astellas. Available at: http://www.astellas.com/en/corporate/disclosure/clinicalstudies.html. Accessed March 26, 2009. Medium for a short time to protect intellectual property.’ 6. Bayer. Available at: http://www.bayerhealthcare.com/scripts/pages/en/research_development/clinical_trials/ The objective of this survey was to compare the content of pharmaceutical companies’ disclosure_policy/index.php. Accessed March 26, 2009. publication policies that are made available to the public through their corporate websites. 7. Boehringer Ingelheim. Available at: http://trials.boehringer-ingelheim.com/com/Home/News/OurPosition/index.htm. Accessed March 26, 2009. Authorship and professional medical writers 8. Bristol-Myers Squibb. Available at: http://www.bms.com/clinical_trials/pages/disclosure.aspx. Accessed March 26, 2009. 9. Eli Lilly. Available at: http://www.lillytrials.com/docs/ctr_policy.pdf. Accessed March 26, 2009. 10. Novartis. Available at: http://www.novartis.com/research/clinical-trial.shtml. Accessed March 26, 2009. All four policies reference the ICMJE Uniform Requirements for Manuscripts Submitted to 11. Novo Nordisk. Available at: http://www.novonordisk-trials.com/website/content/publicationofct.aspx. Accessed March 26, 2009. Level of detail Low Biomedical Journals1 and outline their authorship criteria, which in all cases are consistent 12. Roche. Available at: http://www.roche.com/global_policy_on_registration_of_clinical_trial_protocols.pdf. Accessed March 26, 2009. METHODS 13. Sanofi-aventis. Available at: http://en.sanofi-aventis.com/binaries/050106_release_en_tcm28-21769.pdf. Accessed March 26, 2009. with the requirements of the ICMJE: 14. Schering-Plough. Available at: http://www.schering-plough.com/research-development/clinical-research.aspx#0. Accessed March 26, 2009. 15. Takeda. Available at: http://www.takeda.com/press/article_1121.html. Accessed March 26, 2009. 16. Wyeth. Available at: http://www.wyeth.com/ClinicalTrialResults. Accessed March 26, 2009. The websites of the top 20 pharmaceutical companies based on 2007 prescription revenues 1. substantial contributions to conception and design, or acquisition of data, or analysis and 17. AstraZeneca. Available at: http://www.astrazeneca.com/_mshost3690701/content/resources/media/publications-policy-may-2008.pdf. Accessed March 26, 2009. (Pfizer, GlaxoSmithKline, sanofi-aventis, Novartis, Roche, AstraZeneca, Merck & Co, Johnson & interpretation of data and 18. GlaxoSmithKline. Available at: http://www.gsk.com/responsibility/downloads/GSK-Public-Policy-on-Disclosure-of-Clinical-Trial-Information.pdf. Accessed March 26, 2009. None 19. GlaxoSmithKline. Available at: http://www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf. Accessed March 26, 2009. Johnson, Eli Lilly, Wyeth, Abbott Laboratories, Bristol-Myers Squibb, Amgen, Schering-Plough, 20. Merck & Co. Available at: http://www.merck.com/mrl/swf/clinical_trial_publication_guidelines.swf. Accessed March 26, 2009. r 21. Pfizer. Available at: http://www.pfizer.com/research/science_policy/registration_disclosure_authorship.jsp. Accessed March 26, 2009. ed rty 2. drafting the article or revising it critically for important intellectual content and Takeda, Bayer, Boehringer Ingelheim, Astellas, Novo Nordisk, and Daiichi Sankyo) were ship rite r ation r c ope al w ove r c ation c cy Disclaimer accessed to obtain relevant publication policies. Autho c company in ess to data 3. final approval of the version to be published. edi Definition of ations tual p tion M poli c cc c c The authors are not implying that the lack of information on any aspect of publication policy in the public domain means that the knowledgment publi Studiesby A ote c Role ofpubli peed of publi pr company does not adhere to ‘industry standards’ or that internal company-confidential policies do not exist. These publically available policies (current as of March 2009) were reviewed to assess content a S Intelle Policy regarding recognition of the contributions of professional medical writers is described and compared for similarities and differences. in Table 3. Presented at the ISMPP 5th Annual Meeting, Philadelphia, PA, USA, April 20-22, 2009.

Contact: Sarah Bartlett ([email protected])