Good publication practice for communicating company sponsored medical research: the GPP2 guidelines
BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4330 (Published 30 November 2009) Cite this as: BMJ 2009;339:b4330
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Regardless of the specifics of Dr. Wilmshurst’s situation and the
number of publication-related guidances that exist, there are regrettably
still a number of parties or individuals that are not aware of or have not
adopted all of the elements of best publication practices today. However,
in response to Dr. Wilmshurst’s final question, we believe these
situations should neither undermine the need for guidelines to exist nor
serve to suggest that we think that the existence of guidelines alone
creates a state of utopia. Rather, we stand by the purpose of the GPP2
publication, an updated set of guidelines for publishing pharmaceutical
research, in serving as another key step in the ongoing effort that needs
to be made in raising publication standards.
As highlighted in a table in
the GPP2 guidelines (1), 16 different organizations have issued new codes
or updated existing documentation since 2003. Progress has been made, and
that progress should not be overlooked. In the United States, Senator
Grassley’s office recently issued a report calling for full transparency
in medical publications. We endorsed this call to our members but did
point out that the report was missing some of the more recent references
to current best practice documentation. At the same time, we recognize
that we must continue our efforts in education and advocacy to encourage
all parties, not only the pharmaceutical industry but all parties involved
in the publishing process, including authors, whether industry authors or
academicians, and publishers, in adopting and consistently adhering to
best publication practices to protect the integrity of medical research
and the interests of the public and patients.
1. Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM,
Ellison JM et al. Good publication practice for communicating company
sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330.
Competing interests:
I am employed by ISMPP, the non-profit organization affiliated with the GPP2 guidelines
Competing interests: No competing interests
These guidelines differ little from the existing standards, which are
honoured more in the breach than in observance by researchers, sponsors
and journals.
I was the principal cardiologist and co-principal investigator in the
Migraine Intervention with STARFlex© Technology (MIST) Trial.[1] NMT
Medical sponsored the trial. The resulting paper was published in
Circulation, the premier journal of the American Heart Association (AHA).
Circulation requires authors to sign a declaration that largely accords
with the proposed guidelines. Authors are required to sign that they have
approved the final version of the paper; that they have had sufficient
access to the data to verify the manuscript’s scientific integrity; that
they have made a significant contribution to conception and design of the
research, data acquisition and analysis, drafting the manuscript, etc;
that those who contributed to the research are appropriately acknowledged
and that nobody whose contribution should be acknowledged is omitted; and
that they assign copyright to the AHA. The copyright transfer specifically
states that the authors should be the sole authors of the work and
publication does not infringe the copyright, proprietary or personal
rights of a third party.
I sent an email to the other members of the steering committee saying
that I could not in conscience sign the declaration because:
1. Individuals involved in this research and instrumental in its
conception, design, execution, analysis and writing have been omitted in
favour of individuals who had less involvement.
2. The paper contained errors.
3. I could not in conscience agree to be an author of an article which
stated that “THE AUTHORS HAD FULL ACCESS TO THE DATA AND TAKE
RESPONSIBILITY FOR ITS INTEGRITY” because we did not have full access.
Another member of the steering committee, Dr Simon Nightingale, also
refused to sign the declaration.
Circulation did not question why two authors named in an earlier
version had disappeared from the final version and published the paper in
March 2008. I immediately wrote to the editor expressing my concerns. I
provided Circulation with hundreds of pages of documents to support a case
for publishing a correction. Eventually a 700 word correction, a four page
data supplement and a new version of the paper were published in September
2009. I know that the new version of the paper still has errors. I accept
that discussion of these errors may be controversial and that the BMJ may
be concerned about a libel action, so let us consider some unquestionable
facts.
1. One of the authors, Dr Rickards, died in May 2004.[2] He was not on the
trial design group and the protocol was not finished when he died. The
first author of the paper, Dr Dowson, was recruited to be my co-principal
investigator in August 2004. Ethics approval was obtained in November 2004
and patient recruitment started soon afterwards. Dr Rickards obviously did
not sign the author declaration. It is difficult to see how he qualifies
as an author. The correction still bears his name, although Circulation
knew at the time that he had died well before the trial commenced. His
death in May 2004 did not prevent his name appearing as an author of a
response to a letter about the trial early in 2009.[3] Why did Circulation
knowingly allow an individual to be an author when he did not satisfy the
journals authorship requirements?
2. The published paper and the amended version each mention the roles
played by the trial design group and the steering committee, but the
members of those committees are not named. The members of the trial safety
committee are named, though they had a less demanding role than the other
two committees. I was on the trial design group, but not one of the
authors was a member. Dr Nightingale and I were 2 of the 5 clinical
members of the steering committee. Two other members were from the
sponsoring company, and they are both acknowledged in the paper. Failure
to acknowledge our roles might prevent questions about why Dr Nightingale
and I were not authors. Dr Nightingale and I worked at the centre that did
the most patient visits in the trial - over 600 out of 2000 - more than
30% of all patient visits. Dr Nightingale and I wrote an early draft of
the paper and contributed to subsequent drafts. Some “authors”, who had no
role in conception, design, management, data analysis or writing did as
few as 8 patient visits to qualify as an author. Not surprisingly, some
authors had no idea about the controversy within the steering committee
over inaccuracies in the paper, which were subsequently confirmed by
publication of the correction. When Circulation has a stated policy on
acknowledgement of contributions, why has the journal failed to ensure
adequate acknowledgement of the roles of Dr Nightingale and me in the
corrected version?
3. Circulation has failed to respond to my communications since the
correction was published. Is that an appropriate way for an ethical
journal to behave?
4. I have provided Circulation with incontrovertible evidence that I also
wrote part of the protocol for another trial sponsored by NMT Medical, the
BEST Trial. My contribution to that trial has not been acknowledged.[4]
What value is there in guidelines when they are ignored, unless their
sole purpose is to mislead the public into believing that publication of
research has integrity?
References
1. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe
SL, Rees T, De Giovanni JV, Morrison WL, Hildick-Smith D, Elrington G,
Hillis WS, Malik IS, Rickards A. Migraine Intervention with STARFlex
Technology (MIST) Trial: a prospective, multicenter, double-blind, sham-
controlled trial to evaluate the effectiveness of patent foramen ovale
closure with STARFlex septal repair implant to resolve refractory migraine
headache. Circulation 2008;117:1397-1404.
2. Anthony Francis Rickards – Obituary. BMJ 2004;329:234.
3. Dowson A, Mullen MJ, Khan AA, Rickards A, Peatfield R, Muir K,
Wells C, Lipscombe SL, Hildick-Smith D, Rees T, De Giovanni JV, Morrison
WL, Elrington G, Hillis WS, Malik IS. Response to letter regarding
article, “Migraine Intervention with STARFlex Technology (MIST) Trial.
Circulation 2009;119:e194.
4. Mullen MJ, Hildick-Smith D, De Giovanni JV, Duke C, Hillis WS
Morrison WL, Jux C. BioSTAR Evaluation Study (BEST). A prospective,
multicentre, phase 1 clinical trial to evaluate the feasibility, efficacy,
and safety of the BioSTAR bioabsorbable septal repair implant for the
closure of atrial-level shunts. Circulation 2006;114:1962-7.
Competing interests:
I was co-principal investigator in the MIST Trial. I refused to be an author of the resulting publication in Circulation, because it was inaccurate and because important information had been omitted. Circulation subsequently published a 700 word correction, a four page data supplement and a new version of the paper. I maintain that the correction is incorrect. I am currently being sued for libel by NMT Medical Inc, the sponsor of the trial, for speaking about my concerns about the trial. I am defending the action.
Competing interests: No competing interests
GPP2’s recommendations [1], when considered in their entirety and in
conjunction with GPP2’s checklists, will help authors, contributors and
sponsors to collaborate responsibly and appropriately.
GPP2 agrees with Poses [2], Jacobs and Baldwin [3] that guest and
ghost authors are unacceptable. GPP2 requires “Honest attribution of
authorship” [1]. ‘Who did the work?’ should be answered by an honest list
of all authors and acknowledged contributors. All qualifying authors and
contributors should be listed, including contributing individuals employed
or contracted by the sponsor. Contributorship statements to describe
exactly who did what should be used.
We disagree with Poses that the GPP2 guidelines “obfuscate who is
responsible and accountable for a clinical trial.”
GPP2 states “Authors … are responsible for how medical research is
interpreted and communicated” [1]. GPP2 reflects ICMJE guidance that “Each
author should have participated sufficiently in the work to take public
responsibility for appropriate portions of the content” [4]. GPP2
recommends that investigators as well as “members of the study steering
committee and the protocol development team” [1] (i.e. the principal
investigators or individuals who designed the study) should comprise the
publication steering committee. GPP2 states “members of the publication
steering committee may become authors, but membership of the committee
does not automatically confer authorship” [1] because authorship should
depend on actual contributions made to the publication.
GPP2’s recommendation for a named “guarantor” reflects ICMJE guidance
[4]. One of the principal investigators would likely be guarantor and
probably lead author on at least the primary publication(s) from a study.
In the US, Europe and elsewhere sponsors are now legally required or
obliged to post clinical trial results on a publicly-accessible internet
registry regardless of outcome [5,6]. Particularly for these trials GPP2
recommends “Making public or publishing results regardless of outcome”
[1]. Sponsors should endeavour to publish, to avoid publication bias from
unpublished negative results.
References
1. Graf C, Battisti WP, Bridges D et al. Good publication practice
for communicating company sponsored medical research: the GPP2 guidelines.
BMJ 2009;339:b4330
2. http://www.bmj.com/cgi/eletters/339/nov27_1/
b4330#226987
3. http://www.bmj.com/cgi/eletters/339/nov27_1/
b4330#227612
4. International Committee of Medical Journal Editors. Uniform
requirements for manuscripts submitted to biomedical journals.
www.icmje.org.
5. Food and Drug Administration Amendments Act of 2007.
www.fda.gov/RegulatoryInformation/Legislation/Federal
FoodDrugandCosmeticActFDCAct/SignificantAmendmentsto
theFDCAct/FoodandDrugAdministrationAmendmentsActof2007
/default.htm
6. International Federation of Pharmaceutical Manufacturers and
Associations, European Federation of Pharmaceutical Industries and
Associations, Japan Pharmaceutical Manufacturers Association,
Pharmaceutical Research and Manufacturers of America. Joint position on
the disclosure of clinical trial information via clinical trial registries
and databases. Updated November 10, 2009.
http://clinicaltrials.ifpma.org/fileadmin/files/pdfs/EN/
November_10_2009_Updated_Joint_Position_on_the_Disclosure
_of_Clinical_Trial_Information_via_Clinical_Trial_
Registries_and_Databases.pdf
Competing interests:
The authors' competing interests are disclosed in full in GPP2 (BMJ 2009;339:b4330).
Competing interests: No competing interests
We are pleased that the publication of GPP2 [1] has given further
prominence to the importance of ethics in biomedical publications. We are
particularly pleased that the guidelines recognise the role of
professional medical writers and make clear the important distinction
between professional medical writers, who have a legitimate and ethical
role to play in publications, and ghostwriters, who do not. We believe
that the guidelines contain much good advice that should help to promote
high ethical standards.
However, there are two points in the new guidelines that give us
cause for concern, and we would be grateful if the authors of GPP2 could
clarify their intentions in those areas.
First, the original GPP guidelines [2] contained the recommendation
“Companies should endeavour to publish the results from all of their
clinical trials of marketed products.” This recommendation appears to be
absent from GPP2. We believe strongly that both positive and negative
results should be published to avoid the serious problem of publication
bias. Do the GPP2 authors agree that it is still important to publish the
results of all trials?
Second, the precise role of the publication steering committee as
described in GPP2 seems unclear. The guidelines appear to allow for the
possibility that employees of the sponsor company could be members of the
publication steering committee without being authors of the publication.
That sounds dangerously close to ghost authorship. Do the GPP2 authors
agree that it is important to ensure that sponsor employees should either
be named authors of a paper or, if they are not named authors, should have
no influence on the content of the publication?
References
1. Graf C et al. Good publication practice for communicating company
sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330
2. Wager E, Field EA, Grossman L. Good publication practice for
pharmaceutical companies. Curr Med Res Opin 2003;19:149-54
Competing interests:
AJ and HB are both officers of EMWA, which represents professional medical writers throughout Europe. Their roles as press officer and president are both unpaid positions. For their day jobs, AJ is the director of Dianthus Medical Limited, and HB is the director of Scinopsis. Both Dianthus Medical Limited and Scinopsis provide professional medical writing services to pharmaceutical companies.
Competing interests: No competing interests
We applaud Graf and co-authors for developing the GPP2 guidelines and
The British Medical Journal for publishing them. By addressing the
interests of all stakeholders and defining the roles and responsibilities
of each, the guidelines provide clear instructions for exorcising the
ghosts that have been haunting professional medical communication. For
example, the GPP2 guidelines distinguish between ghostwriting, which is
unethical, and professional medical communication. As stated by the
Association of American Medical Colleges and as noted in GPP2,
“Transparent writing collaboration with attribution between academic and
industry investigators, medical writers, and/or technical experts is not
ghostwriting” (1). This distinction is particularly relevant for authors
in academic and health care settings where guidance on legitimate and
ethical writing collaboration had previously been lacking. We urge all
contributors to medical journal articles and presentations at scientific
congresses to familiarize themselves with and adhere to the GPP2
guidelines.
1. Association of American Medical Colleges. Industry funding of
medical education. Report of an AAMC task force. June 2008. Available at:
http://services.aamc.org/publications/showfile.cfm?
file=version114.pdf&prd_id=232
Competing interests:
Thomas Gegeny is employed as a scientific team lead with Envision Scientific Solutions, a medical publications agency that works with pharmaceutical companies.
Melanie Fridl Ross is Director/Sr Medical Writer-Editor at the University of Florida Health Science Center News & Communications.
Mary Royer and Cindy Hamilton are freelance medical writers.
Judith Pepin is an employee of The Procter & Gamble Co.
Competing interests: No competing interests
These guidelines seem to obfuscate who is responsible and accountable
for a particular clinical trial, and for articles written reporting on
such a trial.
The guidelines ignore the time-honored concept of a "principal
investigator" who is responsible for the entirety of a research project.
Instead they allow for each manuscript arising from a clinical trial to
have both a lead author and a "guarantor." The latter is envisioned as
having "overall responsibility for the integrity of a study and its
report." Then who appoints the guarantor? Who is responsible for the
integrity prior to his or her appointment? When a trial generates more
than one manuscript, would they necessarily have the same guarantor? If
not, who would ultimately be responsible, and how would disagreements be
resolved?
The guidelines prevent understanding of who ought to be the authors
of a manuscript, what their responsibilities should be, and how
accountable they are for the manuscript. The distinctions among
"contributors," "authors," "investigators," "sponsor employees," and
"individuals contracted by the sponsor" are unclear.
In particular, the guidelines seem to condone ghost authorship. They
would not prevent a professional medical writer from writing an initial
outline, the first draft, and all subsequent drafts. including the final
draft of a paper. Yet that writer would not necessarily be an author,
since only if if he or she is willing to "take public responsibility for
relevant portions of the content" then he or she may be in a position to
meet the remaining ICMJE criteria for authorship. Of course, this would
allow a professional writer to simply be unwilling to take such
responsibility in order to avoid being listed as an author.
In my opinion, these guidelines do little to increase confidence in
the integrity of commercially sponsored clinical research.
Note: the above was derived from a longer commentary on the blog
Health Care Renewal (http://hcrenewal.blogspot.com) which is available
here:
http://hcrenewal.blogspot.com/2009/11/how-industry-
views-research-it
-sponsors.html
Competing interests:
None declared
Competing interests: No competing interests
The GPP2 states that if a medical writer is willing to “take public
responsibility for relevant portions of the content” [ICMJE] then he or
she may be in a position to meet the remaining ICMJE criteria for
authorship.”
In a Nov. 30, 2009, blog post, “How Industry Views the Research It
Sponsors” at Health Care Renewal (http://hcrenewal.blogspot.com), Roy M.
Poses, MD, states, “Presumably, a professional writer could dodge
authorship by simply being ‘unwilling’ to take such public responsibility.
So the guidelines apparently condone nearly all functions commonly assumed
to be those of an author to be performed by a professional writer paid
directly by the sponsor, without the writer being listed as an author.
The guidelines thus appear to condone ghost-[authoring] in its most
pernicious form.”
In an ISMPP teleconference about the GPP2, I posted a question
seeking a reaction to Dr. Poses’ comments from presenter Chris Graf, first
author of the GPP2. The teleconference did not get to my question.
However, when Mr. Graf discussed the role of professional medical
writers, he said, “if they [medical writers] can be [authors] maybe they
should be.”
Sadly, “The guidelines thus appear to condone ghost-[authoring] in
its most pernicious form.”
Competing interests:
I am a medical writer-editor who provides services to individuals and organizations.
Competing interests: No competing interests
I welcome the publication of GPP2 and congratulate the team on their
work and, in particular, for achieving far wider consultation than we
attempted for the original version.
When we started work on the first version of GPP (in 1999) many
companies were unwilling to make a commitment to publish the results of
all trials of their marketed products and many companies (and industry
associations) were opposed to trial registration. Progress has been made
towards ensuring comprehensive registration and results disclosure but
concerns about transparency and responsible reporting remain.
In my contacts with pharmaceutical companies I often hear complaints
that trust has been lost in company-sponsored publications. I suggest that
one small step towards restoring that trust would be for companies to
endorse GPP2 publicly. The next step would be to make sure they are
following the guidelines.
Competing interests:
I was an author of the original GPP guidelines
Competing interests: No competing interests
Congratulations to members of the GPP2 Steering Committee for having
the expertise and endurance required to put GPP2 on the map. Will GPP2
alone prompt industry critics to say ‘you have arrived at your
destination’ (ie, the ethical production of publications and presentations
of industry-sponsored medical research)? No, nor should it. Even with a
GPS system, the ignorant and the arrogant still get lost. We need to
educate the ignorant about GPP2 and stop the arrogant from taking
unethical routes to prepare presentations and publications. We can all do
our part to support GPP2, but I really look forward to hearing from
journal editors and congress organisers as to if and how they will
actively support GPP2. I guess I’m asking for directions…
A/Professor Karen Woolley, PhD
Competing interests:
My company provides medical writing training courses and services to academic, biotechnology, and pharmaceutical clients.
Competing interests: No competing interests
Re:Debating good publication practice
I am disappointed in the reply, "Debating good publication practice"
(January 12, 2010) from Chris Graf, lead author of the GPP2 guidelines,
and the GPP2 coauthors.
Their reply goes to great lengths to emphasize that all authors
should be noted as authors. The reply states, "'Who did the work?' should
be answered by an honest list of all authors and acknowledged
contributors. All qualifying authors and contributors should be listed,
including contributing individuals employed or contracted by the sponsor."
Thus, this reply restates that one of the characteristics of
integrity, according to the GPP2 article's checklist for articles and
presentations, is "honest attribution of authorship."
But the GPP2 authors do not address the criticisms from Roy M. Poses,
MD, and from me, which are based in part on the following from the GPP2
article: "Professional medical writers, depending on the contributions
they make, may qualify for authorship. For example, if a medical writer
contributed extensive literature searches and summarised the literature
discovered, and by doing so helped define the scope of a review article,
AND IF HE OR SHE IS WILLING [emphasis added] to 'take public
responsibility for relevant portions of the content' [ICMJE;
www.icmje.org] then he or she may be in a position to meet the remaining
ICMJE criteria for authorship."
Furthermore, I pointed out that Mr. Graf stated in an ISMPP
teleconference about the GPP2, "if they [medical writers] can be [authors]
MAYBE THEY SHOULD BE [emphasis added]." Again, the reply from Mr. Graf
and the GPP2 coauthors does not reply to Mr. Graf's stated contradiction
with the rest of the GPP2 guidelines.
So according to the GPP2 guidelines and Mr. Graf, should medical
writers who qualify for authorship be included as authors? I encourage Mr.
Graf and the GPP2 coauthors to reply to the internal inconsistency of the
GPP2 guidelines and to Mr. Graf's answer this question.
It seems to me that GPP2 guidelines and Mr. Graf in his separate
statement would have it either way. Consequently and regrettably, the GPP2
guidelines fail as good publication practice guidelines. The explanation
of the development of the GPP2 guidelines demonstrates a well-thought
procedure.
Competing interests: I am a medical writer-editor who provides services to individuals and organizations.