The importance of trust

Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(1):3-4.
DOI: 10.5639/gabij.2022.1103.014

Published in: Volume 11 / Year 2022 / Issue 3
Category: Editor's Letter
Page: 87-8
Visits: 890 total, 4 today

It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained human development, including our neighbours, teachers, the press, corporations, politicians, religious leaders, scientists, academic institutions, governments, and even the basic concepts of democracy. Lack of trust is posing a direct threat to our health by limiting acceptance the use of even the most well-proven, basic medical advances such as vaccines.

Lack of trust also appears to be at least one factor limiting the adoption of biosimilars discussed in the first Original Research in this issue; a study funded by Arnold Ventures, a philanthropy founded by  Laura and John Arnold, dedicated to tackling some of the most  pressing  problems  in the United States. The author of this data rich report, Professor James C Robinson, presents his review of the associations between variations in biosimilar adoption in different Italianand German regions and measures of social trust. His review included analyses of national data from 20 European countries that compared measures of social and political trust to the uptake of 20 biosimilar products used for chronic immunologic and acute cancer treatments. He found that adoption of biosimilars was directly related to social trust and trust in government, but  not  to  the use of economic incentives. He suggests that for incentives to be effective they should ‘ensure that the benefits accrue to the populations most affected’. Unfortunately, no data were presented that prove that such redirection of incentives is effective, no details  were  provided  of  how this would best be done, and it is unclear whether or how redirecting incentives would impact the underlying lack of trust. The manuscript includes a reference to the important work of Andersen and Griffith (Milbank Quarterly. June 2022. 1468-0009.12564) who have suggested ‘that the appropriate response to mistrust in healthcare organizations is not a doubling down on efforts to increase citizen trust but a redesign of those organizations to improve trustworthiness’. As past, current, and developing epidemics have demonstrated, a lack of trust is limiting the use and impact of both treatments and prevention methods that  have  been  proven to be effective. It appears, to this observer at least, that more research should be directed towards finding the most cost-effective ways to increase the trustworthiness of all our healthcare institutions.

Medical publications including GaBI Journal are not immune from issues of trust. This is because many potential and real conflicts of interest exist in the healthcare systems that generates manuscripts. The GaBI publication staff, including myself as well as our reviewers and readers, must evaluate such conflicts when a manuscript is evaluated or published. All medical publications, including ours, use peer-review processes that are designed to minimize the effects of real or potential conflicts of interest and increase trust. This need to evaluate the possible effects of bias is illustrated by the second Original Research in this issue. Possible bias on behalf of the authors, participants, reviewers, editors, and publication personnel all had to be considered during the evaluation of this manuscript.

The Alliance for Safe Biologic Medicines (ASBM), an organization that is financially supported by innovator and biosimilar producing pharmaceutical companies, sponsored the study reported here. The first author, Dr Ralph D McKibbin, is a practicing gastroenterologist who ‘provides disease state lectures’ for pharmaceutical companies that produce biosimilars and chairs the ASBM’s executive committee.

The third, Review Article by Dr Mihaela Buda from the European Pharmacopoeia Department, European Directorate for the Quality of Medicines & HealthCare describes the multi-stakeholder process that was used to develop the European Pharmacopoeia Commission’s Infliximab monograph. This was ‘a testcase for developing public standards for monoclonal antibodies’. The complex pharmacopoeia process described  was  designed to produce an informative, unbiased, product monograph for use by multiple stakeholders, including representatives of industry, practitioners, the public, and regulators. While the author cautions why the monograph ‘may therefore not be sufficient for a public standard’, the process and the monograph describe a method to develop unbiased, hopefully ‘trusted’, biological product evaluation information. This manuscript illustrates how conflicts of interest can influence medical publication. I am positively biased towards such a pharmacopoeia process because I spent 30 years as a volunteer member of the US Pharmacopoeia (USP). Readers, whether familiaror not with pharmacopoeias, should consider this potential bias when they read my comments, the Infliximab monograph, or this manuscript. I personally believe that if such monographs were both properly ‘marketed’ and modified to contain more information for lay readers, that both members of the public and practitioners might more often use such pharmacopoeia monographs as trusted sources of information when making decisions about therapeutic products.

The fourth and final Meeting Report by Mr Michael S Reilly and Professor Philip J Schneider describes the ASBM and GaBI co-sponsored, multi-stakeholder webinar. The webinar was funded by the ASBM. It was designed and conducted in collaboration with GaBI. The goals of the webinar included the uptake, physicians’ trust in prescribing and switching, European challenges, patients’ concerns, healthcare providers’ roles, and educational needs with respect to biosimilars. The manuscript describes in detail both the presentations given by experts and the content of panel discussions as well as specific questions posed by participants. These discussions included the role of trust in biosimilar acceptance and use in the USA, Europe, Canada, Australia, and developing countries. There were a variety of related issues discussed including the roles played by patient advocacy groups and biosimilar training programmes, attitudes towards and effects of forced substitution, the possibility of relaxing approval processes, and drug shortages. Readers are encouraged to consider both the material presented as well as any potential conflicts of interest that existed on behalf of either of the sponsors (ASBM or GaBI itself), the speakers, moderators, and even the participants. Whether or not there were potential, or even real conflicts, it is important to realize that data such as those presented during the webinar, as well as opinions expressed by participants, could be important resources to use when educating stakeholders.

As alluded to in my introductory comments about vaccines, some of the tragedies that have resulted from recent epidemics were the result of the ever-decreasing trust in both healthcare providers and our therapeutic products (including biosimilars). The lack of trust requires all stakeholders to search for ways to increase trust in both therapeutic products themselves and the information used to justify their use.

Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal

Disclosure of Conflict of Interest Statement is available upon request.

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