PUBLICATIONSM A N A G E M E N T T E A M

Company Authorship and Transparency in Pfizer-sponsored Manuscripts

LaVerne A. Mooney, Lorna Fay, and Angela Sykes Publications, Pfizer Medical, NY, 10017

AbstractConcern regarding transparency in authorship of Company-sponsored medical publications is often discussed in the scientific literature and press. The International Society of Medical Journal Editors (ICMJE) guidelines are endorsed by many journals and companies as the backbone of authorship criteria. Little data are available to evaluate whether company researchers are included as authors.

Objective: To determine what percentage of published manuscripts, sponsored by a specific company, had ≥1 company authors.

Research Design and Methods: Company-sponsored publications that were published or accepted (and not yet published) in 2009 were identified in Datavision, a publications management software application. Presence of Company authors, journal impact factor (IF) and type of manuscript were recorded. IF means, medians and ranges were calculated.

Results: Our original abstract included data on 393 Company-sponsored manuscripts. However, 3 were excluded from this analysis for reasons described in the Results section. Of the 390 Company-sponsored manuscripts published or accepted in 2009, 80% included ≥1 Company author and 16% were review articles. The percentage of review articles with ≥1 Company author was lower (44%) than observed for all manuscripts (80%). For reviews, median IF was 2.17 (range 0–7.22) compared with 3.01 (range 0–52.59) for all articles. Overall, median IFs were similar for manuscripts with or without Company authors, 3.13 and 2.52, respectively.

Conclusion: The presence of Company authors on over 80% of Company-sponsored scientific manuscripts published in peer-reviewed journals, suggests that, when Company employees meet authorship guidelines, they are appropriately named as authors. This systematic study of the prevalence of Pfizer authors on Company-sponsored publications is a step towards improving transparency in the peer-reviewed literature.

Methods• Pfizer US-sponsored manuscripts submitted through a PSC were tracked in Datavision

• Defined field in Datavision for each manuscript where Pfizer authorship is tracked. Pfizer author was determined from the Pfizer author (yes/no) field, which must be actively checked to yield a “yes”

• Report run to yield list of all manuscripts (abstracts and presentations excluded) accepted or published from January 1, 2009 through December 31, 2009

• Both marketed and unmarketed products were included

• Presence of a company author, journal IF and type of manuscript were recorded. Stratified by original data or review article

• Where Pfizer author field was not checked, the author list in the submitted manuscript was reviewed and compared to emails and/or affiliation listed in Datavision

• Manuscripts resulting from alliance partnerships (co-development or co-promote) that included an author from either sponsoring company were counted as having a Company author

• Supplements were removed from the study sample prior to assessment of authorship

• Pfizer US-sponsored manuscripts in this study did not include Wyeth publications

• Publications resulting from investigator-initiated grants were not in the scope of this study

Publication Sub-Committee (PSC) • PSC formed to manage the timely and scientifically accurate disclosure of Company-sponsored

clinical trial results via peer-reviewed literature (Figure 1)

• PSC is chaired by a medical or clinical colleague who is responsible for leading the development and implementation of the publication plan, based on clinical trial data and needs of the medical community, and for adherence to Pfizer’s publication policies and procedures

• The PSC Chair is ultimately responsible for ensuring the medical and scientific integrity of Pfizer publications and compliance with Pfizer policies regarding transparency, authorship and disclosure

• Supported by the Publication Specialist who oversees adherence to Pfizer policies and processes and is the subject matter expert on publication policies and procedures, directs operational management of the publication program, manages the publications agency and budget

Pfizer Publication Policy Public Disclosure and Authorship“Only those individuals who meet all of the ICMJE criteria should be named as authors on medical publications. All those who deserve authorship based on these criteria should be named in the byline and those who do not should be acknowledged elsewhere, if appropriate. These criteria apply to all research involved in the study publication. If a Pfizer employee meets the criteria for authorship, they should be listed as an author.”1

Pfizer policy requires:

• Mandatory publications policy and ICMJE guidelines training of Pfizer colleagues and agencies working on publications on Pfizer’s behalf

• Letter sent from Pfizer medical to external author requesting agreement to follow ICMJE guidelines

• Review of external author letter agreements and financial and editorial disclosures prior to submission of manuscript to journal

Figure 1: Publication Sub-Committee (PSC)

Core Members

PSC Chair (Medical or Clinical

colleague)

Overallresponsibility

for PSC

Medical /Clinical

Directors

OutcomesResearch

(OR)EditorialLead

(Agency)

Datavision maintenance, (send out ICMJE letters to

external authors, posting of final draft, submission if needed)

Administrative and editorial support,

manuscript editing, styling, drafting,

copyediting, figures, as requested

Review and QC data and check

statistical interpretation

Clinical, medical and OR expertise, trial knowledge /

perspective. Primary clinical

contact with external authors and investigators

Pfizer clinical trial data

and unmetclinical need

Biostatistics

PublicationSpecialists

Publication policy and training, compliance

Datavision access, management of

budget, PSC administration,

publication metrics

Ad hoc members may include legal/patents, regional medical directors, medical information, safety and risk management, project management, clinical study leads or managers.

The authors collectively control decisions regarding the publication including:• Content• Target journal • Type of publication• Order of names on the bylineAuthors responsible for:• Adhering to congress and

journal guidelines • Disclosing any potential

conflicts of interest to the congress or journal

• Acknowledging in the publication the individuals who provide editorial support and the funding source, as well as the author’s relationship with Pfizer

In general, Pfizer does not compensate authors for work associated with the development of publications.

All individuals providing editorial support must work under the direction of the authors

Results• 393 manuscripts were identified across all Pfizer products including 42 different

compounds

• 3 manuscripts were excluded for the following reasons: 1 was published in 2008, 1 was an investigator-initiated manuscript, 1 was incomplete record that could not be verified

• Of the 390 manuscripts:

• 80% had ≥1 Pfizer author,

• 64 (16%) were review articles, and

• 326 (84%) were comprised of primary, secondary, PK/PD, and other research articles

• For the sub-groups of manuscripts:

• 87% of original data articles had ≥1 Pfizer author

• 44% of reviews had ≥1 Pfizer author

• The maximum IF for reviews was substantially lower than that for all manuscripts and original data articles; the median IF of reviews was slightly lower, see Table 1

Limitations• Although not necessarily a direct limitation of this study, casual observations of published manuscripts have shown that, while we may be effective at including appropriate affiliations and disclosures in the version of the manuscript that is submitted, all of this information is sometimes not included in the published article. Possible reasons include space constraints, journal format or policy, or changes made prior to publication

• The Pfizer author field does not specify the number or the placement of the author in the byline

Future Work• Author affiliations will be confirmed when each publication is verified by a literature search and the actual publication is reviewed

• We will assess the first and last authorship positions for all 390 manuscripts when we validate the citations

Conclusions• In this study of all Pfizer US-funded manuscripts published or accepted in 2009, 16% of the sample consisted of review articles. The majority of manuscripts described primary research, secondary, OR, PK/PD results and pre-clinical work

• As expected, Company colleagues were more frequently found as authors of original research manuscripts (80% with ≥1 Pfizer author) than review articles (44% with ≥1 Pfizer author)

• The median IF of journals that published data with Pfizer authors was not substantially different than that of journals that published research without Company authors

• Management of Company-sponsored publications through a central database and a PSC allows oversight of disclosures and assessment of Pfizer colleague participation in authorship

Table 2: Manuscripts by Type and Impact Factor

Figure 2: Manuscripts by Type and Pfizer Author

Manuscript Category Mean Median Min Max n

Percent with Company Authors

All Pfizer-sponsored manuscripts 3.81 3.01 0 52.59 390

No Pfizer author 3.10 2.52 0 14.60 79

(≥1) Pfizer author 3.99 3.13 0 52.59 311 80

All reviews 2.41 2.17 0 7.22 64

No Pfizer author 2.56 2.19 0 6.63 36

(≥1) Pfizer author 2.24 2.01 0 7.22 28 44

Excluding reviews 4.08 3.13 0 52.59 326

No Pfizer author 3.56 2.70 0 14.60 43

(≥1) Pfizer author 4.16 3.13 0 52.59 283 87

Impact Factor Statistics

3 excluded due to: • 1 published in 2008 • 1 investigator initiated • 1 incomplete record not verified

N = 393 Manuscripts listed in Datavision report as accepted

or published in 2009

N =390 unique manuscripts

Mean IF=3.81Range (0_52.59)

ReviewsN=64 (16%)

Mean IF=2.41Range (0_7.22)

Excluding reviews:Original research manuscripts

(primary, PK/PD, OR, secondary,preclinical, meta analyses)

N=326 (84%)Mean IF= 4.08

Range (0_52.59)

No Pfizer Author N=36

Mean IF= 2.56Range (0_6.63)

≥1 Pfizer AuthorN=28

Mean IF=2.24Range (0_7.22)

No Pfizer Author N=43

Mean IF= 3.56Range (0_14.60)

≥1 Pfizer AuthorN=283

Mean IF=4.16Range (0_52.59)

Author Responsibilities

1 www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship.jsp. Accessed November 8, 2011.