Editorials

Disclosure UK: transparency should no longer be an optional extra

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i3730 (Published 06 July 2016) Cite this as: BMJ 2016;354:i3730
Read all the latest BMJ articles on Disclosure UK and view the linked infographics here.

Disclosing potential conflict of interests in 2016: state of the art in Italy

Over the past 30 years, medical journals have increasingly contributed to promoting the disclosure of potential conflict of interests (COI) in scientific articles. In this area, the first consensus document was released in 1993 by the Vancouver group. At that time, numerous authoritative medical journals adhered to this statement including the New England Journal of Medicine [1], the Lancet[2], The Annals of Internal Medicine[3] and the BMJ [4]. Richard Smith, Editor-in-Chief of the BMJ, observed that “the commoner remedy for conflict of interest is disclosure”[4]; in operational terms, he stated that “we plan as soon as possible to include the source of funding for a research study in all scientific papers, and we want authors and referees to let us know of any conflicts of interest they may have” [4].

After more than two decades, the observation that “the commoner remedy for conflict of interest is disclosure” remains entirely valid. However, there are still many countries (e.g. Italy) where the practice of disclosing COI still has a poor acceptance, particularly because this requirement is often felt to be a bureaucratic requirement rather than a form of scientific validation. At least in Italy, if one excludes the activities related to scientific publication where this practice is widespread, disclosing conflict of interest has fortunately become common practice also at the level of national institutions or national committees. On the other hand, this practice remains extremely uncommon in local committees such as those that, at regional level, make approval decisions on drugs or medical devices. Also scientific societies in the medical and pharmaceutical areas have proved to be extremely reluctant to request the disclosure of conflict of interest from their top members.

In the past, one practical reason that contributed to the bureaucratic nature of managing COI is that most scientific journals had their own COI form, which was specific to the specific journal; hence, different journals had different COI forms. Quite recently, however, the International Committee of Medical Journal Editors (ICMJE, formerly the Vancouver group) has undertaken a useful initiative in practical terms because a uniform COI form has been developed that remains the same across the different journals participating in the group [5]. While this uniformity of the form facilitates the submission of an article to a scientific journal, another advantage is that this form can also be used outside the field of scientific publishing. For example, the ICMJE form could be employed by the members of Drugs and Therapeutic Committees or by the members of scientific societies or by panel members producing clinical practice guidelines [6]. ICMJE has confirmed that there are no copyright restrictions if their COI form is employed for purposes other than medical publishing (Messori A, personal communication, 7 June 2016).

This Rapid Response is aimed at promoting a wider use of COI disclosure in Italy, at least at the level of regional Drugs and Therapeutic Committees. To understand the current relevance of this proposal, the question arises of how often this disclosure is currently practiced by the above mentioned committees. We have conducted a quick survey across 10 Italian regions. Two questions were asked: a) Is there any rule that obliges the Committee members to periodically fill a COI form? b) In the affirmative case, do these forms remain confidential or are they made publicly available?

In this sample of 10 regions, there were only 3 regions (Lazio, Emilia-Romagna, and Veneto) where filling the COI form proved to be mandatory. Among these 3 regions, only Lazio routinely makes these forms publicly available. Clearly, these results are disappointing and show that much work in this area is still to be done.

In conclusion, the comments presented in this Rapid Response are mainly aimed at emphasizing that, particularly in certain countries like Italy, wide areas of the health care system still have a poor application of the principles of COI disclosure. In this context, the availability of a uniform COI form like the one developed by ICMJE can be an important practical advantage.

ANDREA MESSORI (1), Pharm D, and ROBERTA RAMPAZZO (2), PharmD

(1) Unità di Health Technology Assessment, ESTAR Regione Toscana, 50100 Firenze

(2) Farmacia Ospedaliera, Ospedale di Camposampiero, Asl 15 Alta Padovana, Regione Veneto, 35012 Camposampiero (Padova)

CONFLICT OF INTEREST

The authors declare no conflict of interest

REFERENCES

1. Kassirer JP, Angell M. Financial conflicts of interest in biomedical research. N Engl J Med. 1993 Aug 19;329(8):570-1.

2. International Committee of Medical Journal Editors. Conflict of interest. Lancet 1993;341:E 742–3.

3. International Committee of Medical Journal Editors. Conflict of interest. Ann Intern Med. 1993 Apr 15;118(8):646-7.

4. Smith R. Conflict of interest and the BMJ. BMJ 1994;308:4

5. International Committee of Medical Journal Editors website. Conflicts of interest form. Available at http://www.icmje.org/conflicts-of-interest/ access 9 June 2016

6. Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ. 2011 Oct 11;343:d5621.

Competing interests: No competing interests

12 July 2016
Andrea Messori
HTA Unit
and Roberta Rampazzo (2), PharmD
(1) Unità di Health Technology Assessment, ESTAR Regione Toscana, 50100 Firenze and (2) Farmacia Ospedaliera, Ospedale di Camposampiero, Asl 15 Alta Padovana, Regione Veneto, 35012 Camposampiero (Padova)
Italy