In his letter, PD Dr. Haas calls for the introduction of a financial threshold to help define a conflict of interest. He points to the colleagues in den US and refers to a guideline of the American Heart Association (1). In this guideline, all amounts exceeding USD 10 000 are classed as significant. However, smaller amounts must be declared as well—they are classed as modest.
There is no lower limit to the influence exerted by gifts—this has been proven by scientific studies about reciprocity (2). Therefore, we hold the opinion that authors should be asked to declare benefits regardless of the amount. By virtue of the principle of reciprocity we feel obliged to repay favors, gifts, invitations and the like. This is used by pharmaceutical companies to influence the prescription behavior of physicians. The rule of reciprocity works almost independently of the value of what has been given. There is no threshold value below which an influencing effect becomes less likely or can be excluded. As a matter of fact, persons who think that they cannot be influenced are even more susceptible to being influenced: The illusion of invulnerability leads to inadequate resistance to attempts of manipulation.
When dealing with conflicts of interest, it is essential to document them in the first place; then they should be evaluated by a third party and finally, and most importantly, the detection of a conflict of interest must have consequences. In the United States, the rules regarding the transparency of financial relationships between pharmaceutical companies and physicians are particularly strict. For example, based on the provisions of the Physician Payment Sunshine Act, as of September 2014 any benefits provided by pharmaceutical manufacturers or manufacturers of medical devices to physicians and teaching hospitals in excess of 10 dollars in value are published (www.cms.gov/openpayments/), including consultancy and lecture fees, financial support for research and teaching, travel and entertainment expenses, shares and dividends. In Germany, the Code of Transparency of the Association of Voluntary Self-Control of the Pharmaceutical Industry (FSA, Verein Freiwillige Selbstkontrolle für die Arzneimittelindustrie e. V.) is effective (www.fsa-pharma.de/). Pursuant to this code, as of 2016, any non-cash benefits provided to physicians and other healthcare professionals are to be published; however, unlike in the US where there is one central website, it is expected that these benefits will be posted on the respective company websites. In contrast to the United States, in Germany physicians have to agree to this information being published.
We like to thank Prof. Dr. Lempert for his valuable additional information on key developments in the handling of conflicts of interest in the context of the creation of guidelines in the United States. Proposals for how to deal with conflicts of interest have been made in the US for other areas of medicine as well, including research and basic and advanced training and continuing medical education (3). These have been a source of inspiration to the discussion in Germany (4, 5) and led, for example, to the introduction of rules regarding the handling of conflicts of interest by the Drug Commission of the German Medical Association (www.akdae.de/Kommission/Organisation/Statuten/Interessenkonflikte/Regeln.pdf).
What we have to do now is to follow these rules and make certain that declared conflicts of interest have consequences—to ensure optimum care for patients.
Dr. med. Gisela Schott, MPH
Arzneimittelkommission der deutschen Ärzteschaft
Conflict of interest statement
The authors of all contributions declare that no conflict of interest exists.
|1.||Giglia TM, Massicotte MP, Tweddell JS, et al.: Prevention and treatment of thrombosis in pediatric and congenital heart disease: a scientific statement from the American Heart Association. Circulation 2013; 128: 2622–2703 CrossRef MEDLINE|
|2.||Klemperer D: Interessenkonflikte: Gefahr für das ärztliche Urteilsvermögen. Dtsch Arztebl 2008; 105: A 2098–100 VOLLTEXT|
|3.||Committee on Conflict of Interest in Medical Research, Education, and Practice, Institute of Medicine: Lo B, Field MJ, (eds.): Conflict of interest in medical research, education, and practice. 1st edition, Washington D.C.: National Academies Press 2009.|
|4.||Lieb K, Klemperer D, Ludwig WD (eds.): Interessenkonflikte in der Medizin: Hintergründe und Lösungsmöglichkeiten. Berlin, Heidelberg: Springer-Verlag 2011 CrossRef|
|5.||Schott G, Lieb K, König J, et al.: Declaration and handling of conflicts of interest in guidelines—a study of S1 guidelines from German specialist societies from 2010–2013. Dtsch Arztebl Int 2015; 112: 445–51 VOLLTEXT|