Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary (2014)

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1 Introduction and Overview1 Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated (DiMasi et al., 2003; IOM, 2014). This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Recent estimates suggest, for example, that bringing a new drug to market requires expenditures in excess of $1 billion and a time frame of more than 10 years (Paul et al., 2010). Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public–private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease out- comes or directed drug use. Partnerships can also reduce duplicative efforts and create a much more efficient, robust, and successful system for trans- lating discoveries into health care applications by sharing unique re- sources and expertise among participants. 1 The planning committee’s role was limited to planning the workshop, and the work- shop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Institute of Medicine, and they should not be construed as reflecting any group consensus. 1 

2 COI AND MEDICAL INNOVATION While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and man- aging any potential sources of conflict that could create bias in the re- search being performed together (Brennan et al., 2006). In 2009 the Institute of Medicine (IOM) Committee on Conflicts of Interest in Medi- cal Research, Education, and Practice defined conflict of interest as a relationship that may place primary interests (e.g., public well-being or research integrity) at risk of being improperly influenced by the second- ary, personal interests of the relationship (e.g., financial, professional, or intellectual gains) (IOM, 2009). For example, a researcher may be fo- cused on a specific area of research and this may influence the judgments the researcher makes. The committee’s 2009 report called for striking a balance between protecting against financial conflicts and advancing the generation of knowledge that benefits society. However, some public and private insti- tutions have adopted strict conflict of interest policies, leading to diffi- culties in establishing collaborative efforts, to challenges in gaining access to external scientific expertise, and to restricted interactions and communications between industry representatives and health care pro- viders (Zinner et al., 2010). Other institutions have sought to identify and manage conflicts of interest as a way of permitting research to continue while protecting the integrity of the research process and maintaining public trust (Lockhart et al., 2013). Challenges also exist in effectively communicating physician–industry relationships to patients so that the contexts as well as the benefits of these relationships are clear. Publicly available databases have been developed to disclose financial relation- ships but there is disagreement about the information they should contain and how the data should be presented to patients. To explore the appropriate balance between identifying and manag- ing conflicts of interest and advancing medical innovation, the Roundtable on Translating Genomic-Based Research for Health hosted a workshop in Washington, DC, on June 5, 2013, titled Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innova- tion in Medical Research. The Roundtable has examined a wide variety of issues involved in moving from basic scientific discoveries to clinical applications. Conflicts of interest are critical factors in many of these issues because of the collaborative nature of the translational process, said Sharon Terry, president and chief executive officer of Genetic Alli- ance. The intersection between conflicts of interest and innovation is 

INTRODUCTION AND OVERVIEW 3 where new ideas are generated, Terry said, and they provide opportuni- ties for growth and advancements in biomedical research. The goal of the workshop was to discuss conflicts of interest in the context of establish- ing best practices for facilitating innovation in medicine (see Box 1-1).2 A wide range of stakeholders, including government officials, pharma- ceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consum- ers, were invited to present their perspectives and participate in discus- sions during the workshop. All individuals and organizations have conflicts, regardless of the kind of work they are doing, said Allen Lichter, chief executive officer of the American Society of Clinical Oncology (ASCO). For that reason, conflict of interest can be a misleading term. ASCO has sought to recast its conflict of interest policies as “disclosures of relationships.” A rela- tionship may constitute a conflict in one context but not in another. Whether these relationships raise concerns or actual or apparent conflicts requires review of the circumstances surrounding the relationships be- cause the perceived conflict could be a matter of interpretation. As mul- tiple speakers pointed out during the workshop, conflicts of interest are inevitable in the development of medical treatments and devices and should not reflexively be seen as negative. Improvements to the way con- flict of interest is communicated with members of the public and patients could be helpful to ensure and maintain the trust of these groups. BOX 1-1 Workshop Objectives • To articulate and clarify current conflict of interest policies. • To examine and discuss the scope and goals of conflict of interest policies. • To examine the effect of current conflict of interest policies on medi- cal innovation. • To identify best practices and potential solutions for facilitating inno- vation under current conflict of interest policy implementation while still ensuring scientific integrity and public trust. 2 The workshop agenda, speaker biographical sketches, a full statement of task, and a list of registered attendees can be found in Appendixes A–D, respectively. 

4 COI AND MEDICAL INNOVATION THEMES OF THE WORKSHOP Chapter 2 provides an overview of the issues surrounding conflicts of interest from several different perspectives, including those of clini- cians, industry representatives, and government regulators. The meaning of conflict of interest is discussed, along with perceptions of the implemented policies, their goals, and impacts. Strategies for industry–academic part- nerships and an overview of government conflict of interest disclosure pol- icies are described. Chapter 3 explores the importance of transparency as it relates to disclosure of relationships and collaborative agreements. A discussion of issues that arise when serving on advisory committees and when recruiting consulting experts for government work is also ad- dressed. Chapter 4 examines how public descriptions of conflicts of in- terest, including reporting on the issue, shape the perceptions of policy makers, patients, and the broader public. This chapter also addresses the importance of communicating the context for conflicts of interest. Chapter 5 offers examples of how academic institutions are managing conflicts while balancing their objectives to encourage medical innovation. This chapter also examines the need for increased public knowledge of con- flicts of interest and emphasizes that effective conflict of interest policies support the institution’s primary goals of research and medical innova- tion, which is to improve the lives and health of patients.