Objective and context
The objective of the Geneesmiddelenbulletin Foundation is to promote the rational therapeutic use of drugs and medical devices. Rational therapeutic use is defined as use based on the principles of Evidence Based Medicine, an approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research.1 By rational use we mean the prescription or use, based on scientific evidence, of the most appropriate drug or medical device for an individual patient or a population where this is necessary or clinically relevant, based on the most suitable profile in terms of efficacy, adverse effects and costs.
In its publications and articles, Ge-Bu tries to maintain a maximum degree of independence, which involves various aspects. On the one hand, Ge-Bu aims to safeguard its contents as much as possible from any influence of the pharmaceutical and medical devices industries or even any semblance of such influence. In order to guarantee its independence in this respect, the bulletin is not financed by advertising profits. This leaves the editors completely free to comment critically on issues such as newly introduced drugs, adverse effects and promotional activities. On the other hand, the same is true for its independence from government-related institutions such as the Medicines Evaluation Board (CBG, the Dutch registration authority)1, the Health Inspectorate (IGJ)2, the Pharmaceuticals & Medical Technology Department of the Ministry of Health, Welfare and Sport3, and the Dutch National Health Care Institute (formerly National Health Insurance Council)4, as well as professional and patient societies. There is no question of any of these parties having any influence on Ge-Bu opinions or publications.
Sources of Income
The main source of income for Ge-Bu is the subsidy it receives from the Dutch Ministry of Health, Welfare and Sports.
Ge-Bu exclusively publishes articles by invited authors, and does not accept uninvited manuscripts for publication. After the editorial team has established the importance of publishing an article about a particular topic, it looks for internal or external experts to author it. By and large, articles come in two types: Reviews, which are relatively long thematic articles, and Concise Reports, usually concerning topical subjects and studies recently published elsewhere. Each article features a narrative abstract, combined with a Ge-Bu Positioning Statement which indicates Ge-Bu’s assessment of the article discussed and its possible consequences for medical practice in general, and for patients in particular.
The editor-in-chief formulates the editorial policy, in consultation with the editorial team, the editorial board and the scientific advisory council, and decides which subjects are to be dealt with and when. The feature articles are usually written by external authors at the request of the editorial board. In the interest of impartiality, we endeavour to invite only authors for the articles who have no ties with any particular pharmaceutical or medical device company.
Stages of manuscript development
The first draft received from the author(s) is checked for content by the editorial team and adapted to the house-style, uniform usage of medical terminology and literature references. In practice, this may mean that parts of the text may be condensed or added.
The draft version of the article thus created is then sent to the editorial board, to the scientific advisory council, to external experts and to permanent reviewers, including representatives of organisations like the editorial board of the Farmacotherapeutisch Kompas5, the Dutch College of General Practitioners (NHG)6 the scientific institute of pharmacists (WINAp) of the Royal Dutch Pharmacists Association (KNMP)7 and the Netherlands Pharmacovigilance Centre (Lareb)8, as well as representatives of scientific associations of general practitioners, medical specialists and dentists. This system ensures that every article is reviewed by an average of 30 to 40 experts. The name of the author is not printed on the draft article, in order to ensure an objective judgement by all reviewers.
The editorial team collect and consider the comments made by the reviewers and if necessary perform a further literature search. A proposal for processing the comments made by the reviewers is formulated by the editorial team and laid before the editorial board. At its monthly meetings, the board decides which suggestions for adjustment and improvement will be submitted to the author. The blinded comments and text suggestions are then discussed with the author, usually in person.
If necessary, the resulting second draft of the article is often returned once more to a number of the above reviewers, selected for their expertise, and submitted to the companies whose drugs or devices are mentioned in the text. They have another chance to suggest changes, should they wish to do so. After being evaluated by the editorial team, such suggestions are again sent to the author if necessary, while at the same time the final textual corrections are made. Finally, the latest version of the manuscript is, if applicable, submitted for comment to the companies whose drugs or devices are mentioned in the text. It is only after these comments too have been evaluated and if necessary incorporated, which is usually about four to six months after the delivery of the first draft, that the editor-in-chief decides to publish the manuscript as an article. The long time that elapses until the moment of publication is inherent to the laborious process, in which the arguments of as many experts as possible are taken into consideration, all of whom have the right to hear and be heard as much as possible. This is because the Reviews in particular are intended to offer guidance for a number of years to come. The production period for the Concise Reports is usually not as long, enabling them to respond somewhat sooner to current developments.
Offering independent and objective information about the rational therapeutic use of drugs or medical devices, which always involves assessing the balance between effectiveness and adverse effects, requires high-quality research whose outcomes have been published in peer-reviewed journals. Double-blind randomised studies form the gold standard, especially for proving the effectiveness of an intervention, whereas this type of study design can hardly ever be used to identify an infrequently occurring adverse effect, or to detect a differences in adverse effects of an intervention. By definition, adverse effects are rare, so observational studies (cohort studies, case-control studies and cross-sectional studies) are usually the best that can be achieved for this aspect.
As regards the reporting of randomised studies, Ge-Bu subscribes to the ‘Consolidation of the standards of reporting trials’ (CONSORT) guidelines for reporting on randomised clinical studies and hence on the effectiveness of drugs (Ge-Bu 2009; 43: 111-113 and 2), and checks the articles against these guidelines.
As regards the reporting of observational studies (cohort studies, case-control studies and cross-sectional studies), which are usually studies into the adverse effects of drugs, Ge-Bu subscribes to the ‘strengthening the reporting of observational studies in epidemiology’ (STROBE) guidelines.2
Ge-Bu also makes use of systematic reviews of both randomised and observational studies reported in accordance with the ‘Preferred Reporting Items for Systematic Reviews and Meta-Analyses’ (PRISMA) guidelines.2
Ge-Bu checks the information from the literature against the clinical guidelines prevailing in the Netherlands.
Ge-Bu does not use research results that are only available in the form of abstracts, conference posters, data on file and expert reports, as such materials have usually not been reviewed by independent reviewers. It has often happened that when articles based on these studies are later submitted for publication, they are rejected by the journal editors, or are found to contain slightly different data. In addition, the information provided by such sources is often too brief to allow a reliable interpretation of the results. Also, apart from some very rare breakthroughs, it is hard to conceive that a doctor would want to prescribe a drug for which no reliable documentation is to be found in the literature. Only in cases where absolutely no reliable published information is available and an assessment of the drug in question is nevertheless essential, will Ge-Bu make use of less verifiable information. This will then always be explicitly mentioned in the article.