English

How the Geneesmiddelenbulletin works

Introduction
Information on pharmaceutical products comes primarily from the industry. It has been estimated that in the Netherlands, the pharmaceutical industry spends about 10% of its budget on marketing, including advertisements, folders and mail-shots. A further 12,5% of the budget goes to the provision of 'scientific information and services'. These include medical representatives, scientific publications, congresses, educational tools and continuing education courses. It is the aim of independent bodies, such as the Farmacotherapeutisch Kompas and the Geneesmiddelenbulletin (Gebu), to provide impartial information for a fraction of the money laid out by the commercial sector.

The Geneesmiddelenbulletin Foundation publishes a monthly bulletin targeting everyone involved in the prescribing and provision of pharmaceuticals. Its intended purpose is to promote a more rational approach to pharmacotherapy. Its usefulness for day to day practice, for the local pharmacotherapy discussion groups of general practitioners and pharmacists and for the education in pharmacotherapy at the university are of primary importance. In the main articles and discussions on new products in particular, it strives to provide a picture as comprehensive as possible of all the relevant research so that readers, unimpeded by bias, can draw their own conclusions.

The Gebu tries to put the principals of evidence based medicine into practice as it adds to the value of the information it provides. It is against this backdrop of openness and verifiability, that the way in which the Gebu works will be explained. After a short historiography, its aims and basic principles will be dealt with. Subsequently those involved in the production of the magazine will be introduced and finally the procedures an article undergoes before it appears in print, will be explained.

History

The Gebu was first published in 1967 under the auspices of the Directorate of Public Health at the former Ministry of Social Affairs and Public Health. At that time the dynamic developments taking place in the field of pharmacotherapy and the lack of objective sources of information available, prompted a call from prescribers for independent information on pharmaceutical products. The American Medical Letter on Drugs and Therapeutics (1959) and the British Drug and Therapeutics Bulletin (1962) were used as models for the new journal. Originally the Gebu contained many articles translated from its English language co-journals but demand grew for articles more particularly relevant to the situation in the Netherlands. Suggestions relating to the use of antibiotics in the United States were not, for example, automatically applicable in the Netherlands.

In 1988 the Gebu was threatened with closure. This was not due to any criticism of the quality of the bulletin, but rather a consequence of cost-cutting proposals by the government. Combined action by many of those involved with the bulletin prevented its closure and the subject has never reared its ugly head again! The bulletin was privatised in 1990 and is now published by the independent Geneesmiddelenbulletin Foundation.

Aims and Basic Principles

Objectives and structure
According to its statutes, the aim of the Geneesmiddelenbulletin Foundation is the provision of independent and objective information about drug therapies to all those involved in their prescription and provision. To this end, the Foundation has a board of governors, an editorial board and an advisory council, each with its own part to play. The board of governors principally concerns itself with financial, organisational and personnel matters. The editorial board is responsible for the content of the journal. This is composed of seven people in total: general practitioners, pharmacists (both hospital-based and community) and several medical specialists. They meet monthly to discuss the ongoing publications. The editorial board is supported by an advisory council, which meets twice yearly and has seventeen members consisting of prescribing specialists, pharmacists, and general practitioners. The advisory council gives advice on the contents of the journal, the policy concerning articles, the choice of articles and also offers critical comments on each article. The preparatory and actual editorial work takes place in the editorial office, staffed by two scientific editors and three editorial assistants.

Independence
Maintaining the independence of the information is not uncomplicated. The Gebu wishes to protect its contents from any influence by the pharmaceutical industry or even the suspicion thereof. In order to guarantee its freedom, the bulletin is not financed by profit from advertising. This leaves the editors free to comment critically on issues such as new drugs, side-effects and promotional activities. The same holds true however, for its independence from government departments such as the registration authorities, the Health Inspectorate and the National Health Insurance Council, as well as professional and patient groups. There is no question of any of these groups having any influence on its contents.

Sources of income
The subsidy provided by the Ministry of Health, Welfare and Sports, is currently the most important source of income. It enables the bulletin to be distributed, free of charge, to all doctors, pharmacists and dentists who are members of their professional organisations. To save on postal charges, the Gebu is distributed along with the three journals of these three professional organisations. Those who do not receive these journals, can take out a subscription. This group makes up by far the largest part of the 1400 subscribers, who are also an important source of income. Final year medical and pharmacology students receive the Gebu free of charge. This brings the total circulation to more than 47000 copies.

ISDB
The Gebu is an active participant in the International Society of Drug Bulletins (ISDB). This organisation unites more than fifty independent drug bulletins world-wide. One of ISDB’s activities is an intensive discussion with the European registration authorities with respect to the promotion of transparent procedures concerning the registration procedures for new drugs. The members of the ISDB also actively exchange articles, discuss editing methods and promote their mutual interests.

Consumer’s Association
There are regular meetings with the Dutch Consumer’s Association at which the contents of planned articles are discussed, with a view to re-printing a short summary of any articles of interest to the Consumer’s Association in their magazine.

The main article
Traditionally, the main article makes up the firts part of the bulletin - the basis of the Gebu. It usually deals with the treatment of a specific clinical condition, such as heart-failure or vaginal infection. The creation of a new group of drugs at the time when a second competitor comes onto the market, may also be an indication for a review article. An example of this in practice is the introduction of the new group of angiotensine II-antagonists. A third category into which main articles fall, is that of specific problems which arise in the prescribing of drugs, like the development of resistance, side-effects and interactions. The diversity of the target group and Gebu’s pretensions to be able to cover all aspects of developments in pharmaceuticals, results in a huge variety of subject matter. Rather specialised drugs are also sometimes dealt with.

Bulletin Board
The second section, the Bulletin Board, was introduced in 1991, specifically to distribute the most up-to-date information. The ‘New Drugs’ column discusses essentially all recently introduced drug therapies that contain a new active constituent. Exceptions are extremely specialised drugs aimed at a small patient group, e.g. growth hormones. We aim to review a drug as soon as possible after it has become generally available on prescription, and to provide clear information which will give it a place in the existing pharmacotherapeutic repertory. The key to this procedure being the comparison of the balance between effectivity and side-effects between the new drug and that of an existing standard therapy. This comparison can usually only be a provisional one, as good comparative studies are initially often unavailable. Moreover, on wider use of the drug, more side-effects, contra-indications and interactions may come to light, which were not recorded during clinical trials involving mostly only small groups of selected patients. Some recent examples of drugs taken off the market for this reason being mibefradil, sertindole and tolcapone.

The Bulletin Board also contains other items. ‘Variations’ looks at new indications for the use or administration of existing drugs. Under the heading ‘Watch Out!’ it reports on new findings in the areas of side-effects, contra-indications and interactions. Bulletin Board also devotes space to reviews and discussion of books and dissertations. Developments in the local pharmacotherapy discussion groups and news of drug registrations, the reimbursement system, drug costs and promotional activities all regularly make an appearance.

Editorial proceedings

Preparations
The editorial board formulates its editorial policy in consultation with the advisory council, and decides which subjects are to be dealt with. The main articles are usually written by external authors at the request of the editorial board. In the interests of impartiality we endeavour to opt for authors who are not associated with any particular pharmaceutical company. The potential author is sent articles of the randomised, double-blind and controlled trials published on the subject in question. Reports of these trials are obtained by the editorial office by systematic search operations in the Medline, Embase and Cochrane libraries. For the sake of transparency of the procedure, the aim is to give key search words at the beginning of each article. Information is also obtained, among others, from ISDB sister publications, review articles and text books.

How the main article is developed
The first draft received from the author(s) is checked on its content and adapted to the house-style by the editorial staff. In practice, this means that, if necessary, the construction is adapted. Some parts of the text may be condensed (e.g. pathology) and others may need to be augmented (e.g. results of clinical trials). The editors also look for uniform usage of medical terminology and literature listings, using the Vancouver rules.

The version of the article thus created, is then sent to the editorial board, the advisory council and to a minimum of five experts in the field (external referees) for peer review. A number of permanent referees are also asked for their views. These include representatives of the Farmacotherapeutisch Kompas (national formulary), the Dutch scientific associations of general practitioners and pharmacists, as well as professional specialist associations. This system ensures that every article is reviewed by at least twenty experts. The companies who make the products also get a chance to comment on the article. The name of the author is not printed on the draft article at this stage.

The editorial office inventorises and considers the reviews of the article and then performs a further literature search. Suggestions on processing of reviews are laid before the editorial committee. At its monthly meetings, the committee decides which suggestions to submit to the author. The summarised and undesignated comments and text suggestions are then discussed with the author personally.

The resulting second revised version of the article is returned to the referees and drug companies with an accompanying explanation of the revisions. They again have the chance to review and comment, should they wish to do so. It is only then, usually about six months after the delivery of the first draft, that the article is considered ready for publication. Sometimes, even more time is necessary. This is an inherently laborious process, as it involves the opinions and arguments of many experts who all have the right to hear and be heard. The main articles are meant to serve as guides for a number of years.

Bulletin Board
Unlike the creation of the main article, the Bulletin Board is written by a number of regular, unnamed authors, including staff at the editorial office. There is a close cooperation with the Farmacotherapeutisch Kompas, the Netherlands Pharmacovigilance Foundation (Lareb), the section Drug Surveillance at the Inspectorate of Public Health, the Dutch Medicines Evaluation Board and the scientific institute of pharmacists. Another difference is that the texts concerning new drugs, variations and side-effects at present are sent to the referees and drug companies for review only once. This results in a shorter production time and enables the Bulletin Board section to provide more recent information.

Sources of Literature
The Gebu uses standard and consensus texts as its literature sources, providing of course that these are available on the subject in question. The consensus of opinion is however, not always arrived at independently of the pharmaceutical companies and a standard work is sometimes in need of revision. For this reason the Gebu always tries to draw independent conclusions. To this end we use only trials which have been well-structured and competently carried out and whose results are published in journals who practice a system of peer review. In principle, the Gebu does not publish results gained from abstracts, posters, papers read at conferences, data on file and expert’s reports, as this material has not been checked by independent reviewers. More than once it has happened that an abstract subsequently submitted as an article, has not been able to withstand a journal’s editorial review. Moreover, in many cases the information provided is insufficient for the adequate interpretation of results. With the exception of a very rare breakthrough, it is difficult to imagine why a doctor would want to prescribe a drug which has no back-up in pharmacotherapeutic literature. Only in cases where there is no source of reliable, published information whatsoever, will the Gebu use the less well reviewed information. This is always pointed out explicitely in the article.

Reader’s letters
Letters from readers are always answered personally, but are not placed in the bulletin. Most of the letters concern matters which have already been discussed and considered by the broad field of experts prior to publishing. It is quite possible however that small discrepancies may occur in the interpretation of research results. Naturally any mistakes will always be rectified. Sometimes letters will form the basis for a further article.

Looking to the future

Recently we have let carrie out a survey, in which we divided our readership by profession, into six focus groups. We asked for suggestions on improving the contents and layout of the bulletin. Their feedback of ideas and suggestions has formed the basis of a number of changes we are making. One of these is the introduction of our own website on Internet which will be making its appearance this year. As well as the complete electronic publication of the bulletin, we are planning to provide an index connecting to the complete collection of articles published in recent years. We are also intending to produce articles specifically aimed at patients, summaries of articles in the English language and links to related websites.

Summary and conclusion

The Geneesmiddelenbulletin Foundation is an a impartial organisation, independent of third parties such as the pharmaceutical industry, government departments, professional organisations and patient groups. Articles are only published after extensive consultation with various experts. The conclusions are based as much as possible on the published and therefore verifiable results of randomised, clinical trials with adequate control groups. It is considered essential that new drugs should be compared with those already existing in the field before they are allotted a place in the pharmacotherapeutic repertory.

References

Jong-van den Berg LTW de, Buurma H. Communicatie rond geneesmiddelen. In: Buurma H, Jong-van den Berg LTW de, Leufkens HGM (red). Het geneesmiddel. Utrecht: Wetenschapppelijke uitgeverij Bunge, 1996: 216-244.
How Drug and Therapeutics Bulletin produces articles. DTB 1997; 35: 73-74.
Hoen E ’t. ISDB: dedicated to ensuring reliable drug information. WHO Essential Drugs Monitor 1997; 24: 11.
Abbasi K, Herxheimer A. The European Medicines Evaluation Agency: open to criticism, transparency must be coupled with greater rigour. BMJ 1998; 317: 898.