Scientific coordinator of “Focus Farmacovigilanza”, FV regional Center of Lombardia, Milan, Italy
Editorial coordinator of “Focus Farmacovigilanza”, Zadig Scientific Publisher, Milan, Italy
The bulletin “Focus Farmacovigilanza” has always been particularly sensitive to the conflict of interest issue, to the point of reporting to the reader even the possible conflicts concerning the sources used in the various articles. It’s worth reminding that “Focus Farmacovigilanza” is not a journal that publishes original research articles or reviews, but a bulletin that disseminates news and comments in the field of pharmacovigilance. It is therefore a tertiary literature journal aiming to disseminate medical-scientific information. The conflict of interest issue doesn’t concern the authors of our articles alone, but the authors of the articles published in the scientific literature as well (see the rules defined by the International Committee of Medical Journal Editors - ICMJE). We realize that conflicts of interest may influence the results of research, but pretending to solve the matter by creating a veil of merely apparent virginity (the sentence "none of us have conflicts of interest" is at least hypocritical given their nature is not only economic, but also academic, intellectual, political and religious, etc. etc.) is not a solution. Instead, we strongly believe in the opposite attitude: unearthing the conflicts and making them obvious. Such belief is shared with all main international scientific journals, which do not avoid publishing articles by researchers with conflicts of interest, but require they are explicitly declared and made clear. As far as it concerns “Focus Farmacovigilanza”, editor, scientific coordinator, editorial coordinator and editorial board must not have any conflict of interest (by this meaning they should not receive any research funds, whereas the publisher should not advertise drug companies either). Its external authors, instead, are mostly clinicians or pharmacologists or clinical pharmacologists who, starting from scientific literature, provide synthesis or news in the field of pharmacovigilance and they must clearly indicate the presence or absence of conflicts of interest in the used sources.
We strongly believe that proposing to "downgrade" the bulletins featuring authors with conflicts of interest is out of time with respect to the discussions regarding the issue, which are currently going on worldwide in scientific-medical literature; and worst still, it is unenforceable (Is there any clinician or researcher with no conflict of interest at all?) without giving up important scientific contributions, which in some areas are essential.
Instead, we consider imperative to raise awareness among readers on the issue of conflicts of interest and let them understand their relevance by making the conflicts clear.
In this sense there should be:
- a declaration of conflict of interest for every member of the editorial staff, to be stored and updated;
- a declaration of conflict of interest by the authors of the articles, which indicates whether they have conflicts with respect to the treated subject;
- an indication of the existence of any declared conflicts of interest regarding each item of the bibliography and, in case, their level.
This last point, which among all ISDB bulletins is carried out only by “Focus Farmacovigilanza”, is the real news for a dissemination journal such ours, because it allows readers to have a critical attitude towards what is read and to form opinions which are not merely based on what the authors write, but also on how solid and not affected by conflicts of interest the cited sources are.
The fact that a considerable number of ISDB bulletins / journals would be downgraded to second class publications should not be underestimated!
Conflict of interest policy
The policy of ISDB on conflict of interest (CoI) was discussed. All members agreed that the editorial team of a bulletin must be free from any CoI with pharmaceutical and healthcare related companies as stated in the ISDB constitution (article 2a). Some ISDB bulletins are able to use in-house editors to prepare all their articles and therefore can be considered to be completely free from CoI. Other bulletins commission external authors to contribute to articles and, in this case, CoI may arise when external authors have CoI. The majority of Committee members agreed that external authors should be free from CoI as well. A question was raised about institutions that publish bulletins and also undertake research sponsored by pharmaceutical companies, but the issue was not discussed in depth. There was discussion about whether the General Assembly should vote on an amendment to the constitution to state that to be granted full membership bulletins should not use external authors with potential CoI. Concern was expressed that a vote could split ISDB. The Committee voted in favour (seven for, three against) of holding a vote at the General Assembly. Therefore the Committee will put a resolution to the 2015 General Assembly proposing an amendment to the ISDB constitutions in the following terms:
• External authors should be free from CoI for the bulletin to be granted full membership.
• There will be a three-year period for full members to adjust to this new situation.
• The three-year adjustment period will not apply to new members.
When the new regulations come into effect, bulletins that have external authors with CoI or directly undertake sponsored research will be granted associate membership. These bulletins will be allowed to use an ‘ISDB Associate Member’ logo. In the coming months the Committee will discuss ways to reinforce and promote an active role of associate members within the ISDB.
In addition, the Committee will explore how to expand the network and liaise more closely with other organisations that also produce information on drugs and therapeutics (blogs and similar platforms) but not necessarily bulletins as such, and enquire about their interest in becoming associate members.
ISDB Newsletter - Vol. 29 No. 2 November 2014