1
Research Design and Methods: The Monitoring the External Publications
Environment (MEPE) task force was commissioned by our Scientific Affairs Medical
Writing department to identify, summarize, and communicate significant policy
changes, issues, and trends related to publications and authorship in the
scientific/medical literature. It also monitors important publication-related
developments in the lay press as an indicator of public opinion.
Results: The MEPE task force initiated processes to identify publication-related
developments with potential business impact. We have robust assessment and review
procedures that allow us to triage, assess, summarize, and report this information to
senior internal leadership within one week via periodic-focused email updates. In the
past year, we have provided four updates, which were evaluated as “very” or
“moderately” useful by 96% of survey respondents.
Conclusions: The MEPE task force has provided value to key stakeholders by
identifying, summarizing, and communicating publication-related external events,
trends, and issues with potential business impact.
INTRODUCTION
• Rapid changes in the field of medical communications include issues of
medical ghostwriting and authorship contribution, protocol submissions,
potential financial conflicts of interest, and publication bias
• Industry-sponsored publications in particular have come under increased
scrutiny
• Medical journals and professional societies have made changes to their
editorial policies in response
• In light of the negative perception/mistrust of industry involvement in
clinical publications, pharmaceutical companies need to maintain
awareness of current developments in medical publishing to help with
related decision-making and anticipate needed process/policy changes
• To that end, the creation of a dedicated workstream to proactively identify
and rapidly communicate updates may be useful
• MEPE tracks trending issues in medical publications issued by:
– Journals
– Universities
– Medical centers
– Industry groups (eg, PhRMA, EFPIA, IFPMA)
• Through RSS feeds of journal tables of contents and news sources:
– Medical press
– Lay press
– Blogs/lobby groups
• Active participation in publication societies and professional organizations
– ISMPP
– American Medical Writers Association (AMWA)
– Council of Science Editors (CSE)
• Ad hoc updates from colleagues in medical publishing
• Google Alerts are assigned to team members for daily monitoring
(Table 1)
Medical ghostwriting
Publication bias
Medical publication acknowledgements
Medical writing support
Scientific publication acknowledgements
Pharmaceutical industry publications
Pharmaceutical industry [support OR sponsor]
OBJECTIVES
• Monitor the medical publishing global environment
• Review, summarize, and rapidly communicate to internal stakeholders:
– Significant developments in journal publication policies
– New or updated guidelines disseminated by professional organizations
such as the International Committee of Medical Journal Editors (ICMJE),
International Society for Medical Publication Professionals (ISMPP),
Pharmaceutical Research and Manufacturers of America (PhRMA)
– Updates to academic policies of authorship and publication ethics
– Trending issues or concerns regarding medical publishing in the
medical press and lay press
Figure 1. Process Map
Ideal Timeline
Event
Identification
End
Team Review
and Triage for
Novelty and
Significance
No
MEPE Team Member
or Other
1 Day
Yes
Write Summary
Person(s) Responsible
1 to 2 Days
Team Review
of Summary
2 Days
Executive
Review and
Approval
2 to 3 Days
MEPE Team
MEPE Team Member
Assigned as Writer
MEPE Team
Department and
Functional Area Heads
Medical publications transparency
Pharmaceutical Research and Manufacturers of America (PhRMA)
Good Publication Practice 2 (GPP2)
Certified Medical Publication Professional (CMPP)
International Council of Medical Journal Editors (ICMJE)
*Other search terms may be added on an as-needed basis
NS
Four Updates on Key Developing Issues Were Prepared by
the MEPE Task Force Over the Past Year
1. Merck amends publication policy to proactively provide study
protocols for journal review
In July 2011, Merck & Co. Inc. updated their publication policy to
provide increased transparency regarding reporting of clinical trial
results.11 In a press release, the pharma company indicated that they
would proactively provide full copies of the study protocol and
statistical analysis plan with all journal submissions resulting from
studies of investigational or approved products.
2. Recent articles call for increased transparency in the role of
medical writers in pharmaceutical industry-sponsored
publications
In July and August 2011, two articles suggested that ICMJE authorship criteria were being misused to keep medical writers who provide
substantive input into publications off the author byline.12,13 The
articles proposed specific changes to standards of practice, including
the requirement that medical writers be listed as authors on the byline.
Distribution to
Management
Total approximately
1 week
Summary of Task Force Updates and Their Impact
• We summarize the four updates issued from the task force over the past
year and provide an assessment of the impact of the publications via
journal readership metrics and via an internal survey of update recipients
– External validation – assessment of journal readership metrics
• The subjects for two of the updates were publications in PLoS
Medicine
• PLoS Medicine provides metadata for citations and page views for
their publications
• We compared total, HTML only, and PDF only page views for the
first three months after publication for the three articles included in
our updates with those for the PLoS Medicine “Ghostwriting
Collection” of related articles1-10
– Internal validation – survey of MEPE update recipients
• Recipients of the MEPE update issued in December 2011 were
queried regarding the impact of the updates to their
publication-related decision-making
3. Recent article reports the prevalence of honorary and ghost
authorship in six high impact biomedical journals
In October 2011, four senior JAMA editorial staff published results
from an author survey on the prevalence of honorary and ghost
authors in six leading general biomedical journals.14 They reported a
statistically significant decrease in ghost authorship from 12% in 1996
to 8% in 2008, and a non-significant decline in honorary (guest)
authorship from 19% in 1996 to 18% in 2008.
4. Legal remedies proposed against guest authors of ghostwritten
medical publications
A pair of articles published in PLoS Medicine in August 2011 and
January 2012 proposed legal remedies for guest authors who signed
on as authors for medical journal articles that were ghostwritten with
industry support.15,16 Possible legal actions included litigation based
on personal injury or wrongful death based on fraudulent or
misleading information contained in the article, class action under the
False Claims Act for reimbursement based on off-label information or
for diminishment of journal subscription value, charges based on the
Anti-Kickback Statute if authors were found to have received
payments or other goods or services of value in exchange for their
authorship duties.
UR
E
INF
O
SUMMARY
Figure 2. The Articles That Were the Subjects of the Updates
Had Comparable External Impact to Similar Articles
Published in the Same Venue
14000
12000
10000
8000
6000
4000
2000
Total
HTML
(HTML + PDF)
Types of Article Views
PDF
PLoS Medical Ghostwriting Collection
Ghostwriting Collection
Legal Remedies
(Stern and Lemmens)
Honorary/Ghost Author Prevalence
(Matheson, et al.)
Legal Remedies
(Bosch, et al.)
• PLoS publications selected for executive attention by the MEPE task
force had similar numbers of HTML and PDF page views compared with
those for all PLoS publications related to medical ghostwriting
Figure 3. MEPE Updates Were Rated “Very Useful” by a
Majority of Recipients
• Recipients of the December 2011 update were surveyed for their
response to the question:
“How useful are the periodic MEPE updates to your work,
particularly in regard to your understanding of the publishing
environment and decision-making surrounding medical
publications?”
70
67%
• The MEPE task force, through identification and summarization of select
articles and online communications, continues to raise awareness that
informs medical publishing decision making across our company
REFERENCES
1. Wilkes M, Johns M. Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients
Off-Label Prescriptions. PLoS Med. 5(11):e223.doi:10.1371/journal.pmed.0050223. Published November 11,
2008.
2. Lacasse JR, Leo J. Ghostwriting at Elite Academic Medical Centers in the United States. PLoS Med.
7(2):e1000230.doi:10.1371/journal.pmed.1000230. Published February 2, 2010.
3. Fugh-Berman AJ. The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. PLoS Med.
7(9):e1000335.doi:10.1371/journal.pmed.1000335. Published September 7, 2010.
4. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. Ghost Authorship in
Industry-Initiated Randomised Trials. PLoS Med. 4(1):e19.doi:10.1371/journal.pmed.0040019. Published
January 16, 2007.
5. McPartland JM. Obesity, the Endocannabinoid System, and Bias Arising from Pharmaceutical Sponsorship.
PLoS ONE. 4(3):e5092.doi:10.1371/journal.pone.0005092. Published March 31, 2009.
6. Wager E. Authors, Ghosts, Damned Lies, and Statisticians. PLoS Med. 4(1):e34.doi:10.1371/
journal.pmed.0040034. Published January 16, 2007.
7. Logdberg L. Being the Ghost in the Machine: A Medical Ghostwriter's Personal View. PLoS Med.
8(8):e1001071.doi:10.1371/journal.pmed.1001071. Published August 9, 2011.
8. Sismondo S. Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the
Pharmaceutical Industry? PLoS Med. 4(9):e286.doi:10.1371/journal.pmed.0040286. Published September 25,
2007.
9. Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC. Conflicts of Interest at Medical Journals: The
Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study.
PLoS Med. 7(10):e1000354.doi:10.1371/journal.pmed.1000354. Published March 26, 2010.
10. Kesselheim AS, Mello MM, Studdert DM. Strategies and Practices in Off-Label Marketing of Pharmaceuticals:
A Retrospective Analysis of Whistleblower Complaints. PLoS Med. 8(4):e1000431.doi:10.1371/
journal.pmed.1000431. Published September 10, 2010.
60
11. Merck Guidelines for Publication of Clinical Trials and Related Works
http://www.merck.com/research/discovery-and-development/clinical-development/Merck-Guidelines-forPublication-of-Clinical-Trials-and-Related-Works.pdf.
50
40
12. Leo J, Lacasse J, Cimino A. Why does academic medicine allow ghostwriting? A Prescription for reform.
Society. 2011;48:DOI 10.1007/s12115-011-9455-2.
29%
30
13. Matheson A. How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be
Revised. PLoS Med. 8(8):e1001072.doi:10.1371/journal.pmed.1001072. Published August 9, 2011.
20
10
0
• The rapidly changing environment of medical publishing requires that
companies relying on journal publications to communicate science-based
findings from their research activities keep aware of updates to
publication policies and current publication-related issues
• Our company has made use of a dedicated task force to rapidly identify
critical issues in medical publishing and communicate them to senior
management with a planned turnaround time of approximately one week
• A sampling of PLoS Medicine publications chosen by the task force for
escalation to internal stakeholders was comparable in terms of external
interest to that of similar publications in that journal
• The periodic updates produced by the task force were rated as “very” or
“moderately” useful in terms of business impact by 96% of survey
respondents, with no respondents rating them as “not useful”
CONCLUSION
0
Yes
Clinical trial posting
Medical plagiarism
1
Amgen Inc., Thousand Oaks, CA, USA; Amgen (Europe) GmbH, Zug, Switzerland
Publication planning
Guest authorship
1
RESULTS
No
Table 1. Google Alert Search Terms*
2
2
METHODS
Task Force Standard Review and Assessment Procedures
1
3-month Page Views (Mean/SD)
Objective: Knowledge of medical publication policies, issues, and trends is critical for
pharmaceutical executives and research and development personnel in the drug and
device industries who provide input on industry-sponsored publications. A poster
presentation at ISMPP 2011 outlined our company’s efforts to provide such updates to
internal stakeholders by means of a dedicated task force. Our task force is now
entering its third year of service.
1
Percentage of Respondents (%)
ABSTRACT
1
M
1
MEPE
E
1
Excellence
In Medical
Publishing
A
R
Geoff Smith, Jon Nilsen, Shawn Lee, Mee Rhan Kim, Dikran Toroser, Erica Rockabrand, Lucy Hyatt, Larry Kovalick, Juli Clark
1
ITOR
N
MO
E
LYZ
NA
Monitoring the External Publication Environment (MEPE): Identifying and Communicating Significant Developments to
Key Stakeholders in a Corporate Setting
4%
Very Useful
Moderately
Useful
Neutral
14. Wislar JS, Flanagin A, Fontanarosa PB, DeAngelis CD. Honorary and ghost authorship in high impact
biomedical journals: a cross sectional survey. BMJ. 2011;343:d6128 doi:10.1136/bmj.d6128.
0%
Not Useful
15. Stern S, Lemmens T. Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of
Ghostwritten Articles. PLoS Med. 8(8):e1001070.doi:10.1371/journal.pmed.1001070. Published August 2, 2011.
16. Bosch X, Esfandiari B, McHenry L. Challenging Medical Ghostwriting in US Courts. PLoS Med.
9(1):e1001163.doi:10.1371/journal.pmed.1001163. Published January 24, 2012.
n = 24 from a total of 117 recipients
© 2012 Amgen Inc.
International Society for Medical Publication Professionals, Baltimore, MD; April 23–25, 2012