|
WHAT'S THIS?
|
Home
About us
Email sign up
Basics
Commentary
Viewpoints
Press releases
Resources
Directory
|
|
|
|
|
|
This is a freely accessible online resource for everyone involved in publication planning. Help us build the site into a valuable resource for, amongst others, medical writers and communications professionals, pharmaceutical industry managers, medical journal editors and publishers.
Please send your ideas, contributions and comments about the articles to the Editor of The Publication Plan, Mary Greenacre.
If you have any other comments about the service, the web site, or questions about advertising and sponsorship, please contact the Publisher, Peter Llewellyn.
|
|
|
Related Sites
|
|
BASICS << Good Publication Practice (GPP) – Frequently Asked Questions
|
Good Publication Practice (GPP) – Frequently Asked Questions
Published 26 November 2008, written by Andrea Cole
Good Publication Practice for pharmaceutical companies, or GPP for short, began life as an idea formed during a 1998 retreat organised by the Council of Biology Editors (now the Council of Science Editors [CSE]). Since then GPP has been formally written down as a set of guidelines in the seminal publication by Liz Wager et al1 in 2003, has its own dedicated website and has become common parlance in the world of pharmaceutical industry-sponsored publications. A decade on from its inception, GPP is on the brink of yet another major milestone: a new revised version, also known as GPP2, is on the horizon in collaboration with the International Society of Medical Publication Professionals (ISMPP).
What is GPP?
In simple terms, GPP is a set of guidelines to help ensure that publications from pharmaceutical industry-sponsored trials are produced in a responsible and ethical manner. By following GPP, results from all clinical trials should be published and presented accurately, objectively and in a balanced fashion.
Why is GPP necessary?
The publication practices of pharmaceutical companies have attracted the wrong sort of attention from journal editors, mass media and even law courts. In June 2004, the New York Attorney General alleged that GlaxoSmithKline withheld negative information about paroxetine (Seroxat®), a drug used to treat depression. As part of the settlement, GSK agreed to publicly disclose summaries of trial results on the company Web site. Pharmaceutical companies also started to examine their publication policies following the case against Pfizer-Warner-Lambert. This law suit claimed that the company illegally marketed its product, gabapentin (Neurontin®), for unapproved indications. The company’s publication strategy was said to “subsidize the production and dissemination of anecdotal reports favourable to off-label use of Neurontin," which were "of no scientific value." The media, on both sides of the Atlantic, picked up on these and many other news stories and headlines such as “Revealed: how drug firms 'hoodwink' medical journals. Pharmaceutical giants hire ghostwriters to produce articles - then put doctors' names on them” started to be commonplace.
GPP was, and still is, necessary to provide guidance to medical publication professionals, pharmaceutical companies and authors of industry-funded publications on how to produce publications in an ethical and responsible manner, and avoid the potentially negative consequences.
Who needs to know about GPP?
GPP is for use by commercial organisations that sponsor clinical trials and any companies or individuals who work on industry-sponsored publications. The guidelines cover publications in biomedical journals (both printed and electronic), oral/audiovisual presentations at scientific meetings, peer-reviewed and non-peer-reviewed publications
How does GPP link with other publication guidelines?
GPP does not replace existing guidelines, such as CONSORT2 or the newly revised International Committee of Medical Journal Editors (ICMJE) uniform requirements3, which should be used alongside GPP. In-depth knowledge of all relevant guidelines and policies is essential for a successful publication planner.
What does GPP say about the relationship between pharmaceutical companies and external investigators?
This particular topic is one of the core themes of GPP. It is widely acknowledged that the large, multi-centre clinical trials funded by pharmaceutical companies require close collaboration with many academic investigators. GPP advises that a contract, covering publication policies and ownership of data, should be agreed between the company and external investigators. The pharmaceutical companies maintain the right to be informed of any publication plans and review the manuscripts prior to submission. Successful publication of industry-sponsored trials relies on the intellectual and scientific contributions of all authors, whether internal pharmaceutical company employees or external investigators, and all authors should have access to the statistical reports and tables.
What is publication bias and how does GPP aim to prevent it?
Publication bias can appear in two guises: one is where negative or inconclusive results remain unpublished and the other is where positive results from a single trial are published in many different ways (known as redundant publication). Either way, publication bias gives the impression that the product has many more positive results than negative. Reducing publication bias is another core theme of GPP, and the guidelines suggest several ways in which to combat it:
1. Publish results from all clinical trials of marketed products
2. It is not acceptable to submit a paper to more than one journal at a time
3. Secondary publications should not precede the original publication
4. Full peer-reviewed publications should contain reference to all previous presentations of the data (e.g. abstracts)
5. Avoid repeat presentations of findings at major biomedical meetings unless guidelines for specific meetings allow this
6. A unique study identifier should be included in all publications to increase transparency
What about authorship – does GPP mention that?
The GPP guidelines refer readers to the ICMJE uniform requirements3 as a good starting point to determine qualification as an author. The ICMJE recommend that authors meet all three of the following criteria:
1. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data
2. Drafting the article or revising it critically for important intellectual content
3. Final approval of the version to be published.
It is important, therefore, to ensure that all authors fulfil these criteria and also that no authors who meet the criteria are omitted.
Increasingly, however, biomedical journals are adopting the contributorship model of authorship (for example, The Lancet) so it is important to check and respect the individual requirements of each journal.
What is the guidance from GPP on the contributions of medical writers?
Much of the bad press surrounding the alleged unethical publication practices of pharmaceutical companies focused on the use of “ghostwriters”. These shadowy figures are believed to devise and write all the content of an article at the pharmaceutical companies’ request, with their final job being to find a healthcare professional to put their name to the manuscript. While some people thought that the involvement of professional medical writers should be discouraged or banned altogether, the team behind the GPP guidelines felt that increasing transparency around the role of professional medical writers was a better option. The benefits of involving a professional medical writer often include improvements in both the quality and timeliness of industry-sponsored publications. And where there is complete transparency about the involvement of a professional medical writer, there can be no allegations of ghostwriting.
The guidance provided by GPP on the role of professional medical writers is very clear:
1. The named author(s) must determine the content of the publication and retain responsibility for it
2. The medical writer should agree on an outline of the paper with the named author(s) before beginning to write and should keep in close and frequent contact with the author(s)
3. The named author(s) must be given adequate time to comment on all drafts of the manuscript
4. The named author(s) should approve the final version of the manuscript before it is submitted, and it is the lead author’s responsibility to submit the manuscript and be the primary contact for the journal
5. The contribution of the medical writer should be acknowledged
Do medical writers meet the criteria for authorship?
A common question from medical writers is whether they meet the three ICMJE criteria for authorship and should therefore be listed as an author. While a professional medical writer may be involved in drafting a manuscript and thereby fulfil criteria 2, it is unlikely that they would be involved in making substantial contributions to conception and design of the trial, acquisition of data, or analysis and interpretation of data. Furthermore, as mentioned above, it is the named authors’ responsibility to approve the final version of a manuscript, and therefore a medical writer would not meet that criterion either. A few journals, however, are changing their editorial policy so that medical writers can be listed as authors; the individual journal guidelines will provide more details on whether this is a possibility.
Who is responsible for implementing GPP?
Everyone involved with publication planning should be familiar with these guidelines and appropriate management structures should be in place to implement them. In a medical communication agency, this could include creation of a compliance team that has responsibility for ensuring internal compliance with GPP, all other applicable laws and guidelines, and client contracts. Internal compliance guidelines, backed up with on-going training, are needed for staff education and reference. Understanding of compliance regulations should be included in all staff objectives and measured. The role of healthcare communication agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals has been detailed in a recent publication.4
What’s next for GPP?
Publication planners are eagerly awaiting GPP2. A press release about GPP2 was posted on this site earlier in the year which described how GPP2 will follow the mission laid out by the original GPP authors. GPP2 will encompass the many new codes and guidelines that have been developed or updated since the previous GPP document and their implications for medical publications, including the Food and Drugs Administration Amendments Act (FDAAA) and the posting of clinical trial results, updated ICMJE guidelines, and updated Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) codes.
The group responsible for developing GPP2 will send out a draft to more than 170 external reviewers in mid-December 2008. These reviewers include pharmaceutical/biotech/device companies, professional societies (e.g., European Medical Writers Association and CSE), journal editors and publishers and agencies.
References
1. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149-154.
2. Begg C, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-639 (also available on http://www.consort-statement.org; last accessed 20/11/08)
3. Uniform requirements for manuscripts submitted to biomedical journals and separate statements from the International Committee of Medical Journal Editors. http://www.icmje.org (last accessed 20/11/08)
4. Cairns, A, Yarker YE. The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals. CMRO 2008;24(5):1371-8.
About the author:
Andrea Cole is VP, Medical & Scientific Services at Gardiner-Caldwell Communications, part of the KnowledgePoint360 Group.
|
Feedback: Do you have any comments about this article? Contact the Editor, Mary Greenacre.
|
|
|
