The Challenge of Conflict of Interest in Medicine

As the relationships between industry and medicine increase, the primary goals of medicine, -- high quality research, responsible patient care and excellent medical education -- are at risk of being compromised by the undue pursuit of financial gain. Conflict of interest policies and procedures are designed to reduce that risk. This article seeks to clarify the concept of conflict of interest, counter the most common objections to its use, and describe the various methods of regulating conflict of interest.


The Challenge of Conflict of Interest in Medicine
Dennis F. Thompson * HARVARD UNIVERSITY Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) 103 (2009) [136][137][138][139][140] The expanding relationships between industry and medicine have produced great benefits. [1] [2] Industry support for medical research has led to important therapeutic breakthroughs. Such support has helped medical education at all levels. Academic research, in turn, has provided industry with many basic ideas that lead to the development of new drugs and medical devices. However, as these relationships have grown, the conflict between the financial goals of industry and the professional goals of medicine is creating significant risks for not only the profession but also the public. [3] [4] [5] What should be the primary goals of medicine-high quality research, responsible patient care and excellent medical education-may be compromised by the undue pursuit of financial gain. That tension is what policies for regulating conflicts of interests should be designed to control.

The Concept of Conflict of Interest
A conflict of interest is a set of circumstances that are reasonably believed to create a substantial risk that professional judgment of a primary interest will be unduly influenced by a secondary interest. [6] [7] The primary interest refers to the purpose of the professional activity, such as the welfare of patients or the quality of research. The secondary interest is typically financial gain. The belief about the risk of the effects of the conflict is based on past experience in other relevant cases.
To avoid common misunderstandings of the concept that can lead to misplaced and ultimately ineffective policies, it is important to appreciate the sig- Secondary interests include the desire for professional advancement, recognition for personal achievement, favors to friends and family, assistance to one's students and colleagues, and most saliently financial gain. Conflict of interest rules typically focus on financial gain, not because it is more corrupting than the other interests but because it is relatively more objective, fungible, and quantifiable. It is therefore more effectively and fairly regulated than other secondary interests. Most secondary interests including financial gain are perfectly -2 -legitimate (even desirable) goals within limits. The secondary interests are objectionable only when they have greater weight than the primary interest in professional decisions.
The conflict is not an occurrence but a set of circumstances that create or increase a risk that primary interests will be compromised as a result of the pursuit of secondary interests. The claim that there is a conflict of interest expresses a tendency. It is based on common past experience: we have learned that under certain circumstances professional judgment about a primary interest is at risk of being unduly influenced by a secondary interest. Rules that control this danger, even if the threat is actualized in relatively few cases, are intended to protect against this risk. Therefore, a conflict of interest exists whether or not a particular individual or institution is actually unduly influenced by the secondary interest. In any particular case, individuals may be said to have a conflict of interest even though their decisions do not actually impede primary professional goals or violate primary professional obligations.

The Purposes of Conflict of Interest Policies
Institutions, professional organizations, and governments on behalf of the public establish policies to address the problem of conflict of interest. The policies try to ensure that professional decisions are made on the basis of primary, not secondary interests. To the extent that they are effective in this general goal, they serve two more specific purposes.
First, the policies help maintain the integrity of professional judgment. [8] [9] Bias is the most salient way in which integrity can be compromised [10] [11]. Violations of other standards of professional practice such as timely publication of research, fair treatment of students and post-docs, and openness with patients are also risks. The policies do not assume that any particular professional will necessarily let financial gain influence his or her judgment. The policies seek to minimize the risk of undue influence by secondary interests, most prominently personal financial gain, that should be irrelevant to the merits of decisions about the conduct of research, teaching, and patient care.
Second, the policies help sustain public confidence in professional judgment. [12] Here the point is to minimize or eliminate circumstances that would cause reasonable persons to suspect that professional judgment has been improperly influenced, whether or not it has. The public includes not only patient and research subjects, who may have other concerns on their mind, but legislators, foundation heads, editorial writers and other opinion leaders. To the extent that the public and public officials distrust the profession, they are likely to demand greater external regulation, and to supply fewer resources for its primary activities. When an individual professional acts in ways that lead to distrust, the consequences may affect colleagues, patients, and the institution as a whole. Similarly, institutional practices can be the source of distrust, with effects that may be even more damaging than those of individuals. Once trust is lost, it is difficult to restore.

Standards for Assessing Conflicts of Interest
Conflicts are not binary. They can be more or less severe. The severity of a conflict depends on (1) the likelihood that professional decisions in the relevant circumstances tend to be unduly influenced by a secondary interest; and (2) the seriousness of the harm or wrong that could result from such influence. Both of these assessment are based not mainly on the particular case in question, but on other cases in similar circumstances.

Procedures for Dealing with Conflicts of Interest
The standards should guide the choice of procedures and the way in which they are deployed. In general, the more severe the conflict, the more rigorous the procedures should be. Three major types of procedure are commonly used to deal with conflicts of interest: disclosure, management and prohibition.

Disclosure
Disclosure is intended to give people who may be af- Although each of the procedures may be used alone, they are usually, and more effectively, combined in various ways. For example, even when disclosure is not sufficient -as is often the case-it may be still be essential as part of a comprehensive policy. Some level of disclosure is necessary for both management and prohibition of conflicts of interests.

Conclusion
Medicine today faces many difficult challenges-high costs of treatment, lack of availability of insurance, The problem of institutional conflicts has not received as much attention as individual conflicts, but * The distinction between institutional and individual conflicts of interest is not the same as the distinction between institutional and individual corruption. In the discussion of conflicts, the terms (institutional/individual) refer to the agents whose interests are in question, whereas in the discussion of corruption the terms refer to the forms that the influence takes. Thus, individual conflicts can be instances of institutional corruption (as when an individual researcher receives support from a corporation for research in his lab rather than for his personal profit).  [18] Because no decision maker in an institution is fully free of conflict in the case of institutional conflicts, it is not possible to establish a fully independent process for assessing such conflicts. That difficulty has led some to suggest that more rigorous regulation by government is necessary. But such regulation has its own familiar difficulties. It is by no means clear that the government officials are better positioned to understand the primary mission of these institutions, and to strike the delicate balance between encouraging commercial relationships between industry and health care institutions, and protecting the integrity of research, practice and education.
Although there is no perfect solution, the most suitable authority for making judgments about institutional conflicts is the board of trustees, or the equivalent governing body. In their fiduciary role, members of the board are responsible for giving priority to the longer term interests of the institution.
Standing at greater distance from the day to day pressures of decision making, they can more judiciously assess the impact of the financial interests on the institution's core mission. They have access to more comprehensive information about the finances of the institution, some of which may be confiden-tial. They are also better positioned to help the chief executive resolve disputes about conflict of interest between schools and other units within the institution.
(The school of public health, for example, may think that investments in certain products create a more serious risk to the whole institution than does say the business school.) More generally, the decisions of a Board are more salient within and beyond the institution.
When the Board takes up an issue, the concerned public is more likely to take notice.
Boards are more likely to take seriously their responsibility for institutional conflicts if their members have direct responsibility for ensuring that these conflicts do not undermine the long term primary interests of the institution. They should establish their own committee, partially on the model of the audit committee, charged with regularly reviewing the impact of the institution's financial relationships on its core mission. The committee should include members who do not themselves have any conflicts, and at least one person who is completely independent of the board and the institution.
The committee should submit a formal report to the board each year, analyzing the institution's financial relationships that may affect the institution's core activities, and the ways in which the institution is managing any conflicts. The report should be made available to the public, to the extent consistent with the requirements of confidentiality. In large institutions, the committee may find it helpful to have the assistance of a working committee, composed of professionals and staff within the institution, which would conduct more frequent reviews and special investigations. Such a committee should report directly to the Board's committee.