The Importance of Conflicts of Interest in Medicine
Many physicians play more than one role in the health care industry. While most physicians provide some level of direct patient care, some will also teach residents or other physicians, be leaders in medical organizations, serve as administrators, or conduct research. While often harmonious, at times the demands of these various roles can sometimes be in conflict with each other. For instance, a physician who is doing research in her specialty may be paid by a drug company to act as a consultant. That same physician may be prescribing the drug company’s medication to patients. This can present a conflict for the physician. While most conflicts are financial, some are related to professional advancement or recognition. Financial conflicts do not only involve personal gain. Physician administrators who make decisions about contracts and purchasing can have conflicts between cost containment for their organization and providing quality care to patients. Conflicts such as these can be a significant source of moral distress for physicians. At ProNobis Health, we understand the discomfort that can arise out of conflicts, and we can help you think about them and work toward their resolution.
Two of the most important ethical values of medicine are professional integrity and public trust. In making treatment recommendations, individual patients and the public in general need to be sure that the recommendations are based on objective scientific evaluations that take into consideration the moral promise to do good and to not harm. One of the most basic levels of trust that exists between physicians and patients is that the physician is not biased in prescribing a treatment, particularly if that bias stems from personal or corporate gain. The same is true in evaluating the integrity of scientific research, the objectivity of medical education, or the loyalty of a physician to a professional society. In all these cases, the relationship involves a fundamental trust that the physician is unbiased, that his recommendations are objective.
It is important to note that just because a conflict exists does not necessarily mean that the physician has been biased or has acted unethically. A medical device company may have made a large donation to a residency program, but that does not necessarily mean that the residents will be biased in using that device and not evaluating other similar devices. It does, however, mean that there is a risk of such bias. Part of evaluating conflicts of interest involves assessing both that risk and the harm that could arise if bias is introduced. An important consideration in considering harm is the damage to public trust that can arise from conflicts of interest. There have been several high profile examples of physicians involved in conflicts of interest. Whether or not actual bias was introduced, the incidents caused public scandal, which eroded patient and public trust. Essentially, there was an unacceptable risk that decisions would be made by the physician that would be unduly influenced by factors that were not relevant.
Many conflicts of interest involve relationships between physicians and biotechnology, drug, or medical device companies. It is essential to note that these relationships exist mainly to further scientific discovery and improve patient care. There is nothing intrinsically unethical when a physician, hospital, or academic medical center forges a relationship with the biomedical industry. Many of these relationships have led to important discoveries and major advances in treating disease and promoting health. These relationships can be mutually beneficial as long as safeguards are put into place that protect the integrity of patient care, research, and education, as well as maintain public trust.
Identifying and Assessing Conflicts of Interest
Broadly speaking, conflicts of interest arise when there is a risk that one interest, such as provision of beneficial and non-harmful medical care, will be unduly influenced by another interest, like personal financial gain. It is important to parse this out further and explore what we mean by interest as well as conflict.
Interests can be thought of as primary and secondary. Primary interests are the main commitments of the individual based on his or her professional role. For physicians, our primary interest may be provision of beneficial and non-harmful medical treatment, scientifically rigorous research, and/or high-quality medical education. Primary interests represent values, obligations, loyalties, and duties and are judged by integrity, rigor, and quality. Sometimes primary interests can be in conflict, such as when a public health physician treats individual patients during an epidemic or a transplant surgeon considers the allocation of an organ. In both cases, the physician has a legitimate primary interest in helping and not harming patients, but her desire to help her own patient may be in conflict with her desire to help many patients. Similarly, conflicts of commitment may exist in which a physician has two equally worthy primary commitments. These conflicts often involve an individual’s distribution of time and effort, rather than direct or indirect gain. An example is a surgeon who is also president of the local medical society. There may be concern that she is not devoting sufficient attention to her surgical responsibilities, in light of her duties in the medical society. In this case, there is no secondary interest, but rather two conflicting commitments.
Secondary interests are those interests beyond the physician’s primary obligation that are at risk of influencing or biasing the primary interest. Most often, secondary interests are financial, but that is not necessary. Studies suggest that even a meager financial gain can bias decision-making. Furthermore, the individual may not even be fully conscious of the extent of influence that has been exerted. Because of the potential bias that a personal financial interest introduces, disclosure is almost universally required in any patient care, research, or educational activity. Disclosure is not an end in itself, but rather it allows for investigation of the extent of the conflict, and recommendations about how the conflict can be ethically resolved.
In some ways, personal financial interests are among the easier conflicts of interest to consider since they are objective and easy to quantify and assess. Secondary interests beyond personal financial gain are much more complicated in terms of disclosure, investigation, and resolution. Things like professional advancement and recognition—whether it is personal, for a family member, or for a student or trainee—can unduly influence primary interests. Furthermore, for physicians who hold administrative roles, conflicts of interest may be present when they make decisions that financially benefit the hospital or group, but also compromise some aspect of patient care. In and of themselves, secondary interests may be legitimate goals. Personal financial gain, helping a family member or trainee, and professional advancement are all desirable goals that only become ethically problematic when they supersede a physician’s primary interests in professional decision-making.
Let’s consider an example. Dr. Jones is a primary care doctor in a community training program for residents. She typically sends her patients to Green Memorial Hospital (GMH) when they need to be admitted. She has a lot of experience with GMH and thinks it is a better hospital than the other facility in town, Blue Memorial Hospital (BMH). Dr. Jones’ resident is graduating this year and has applied for a staff position at BMH. Dr. Jones likes her resident and wants to help her get the job. An administrator from BMH called Dr. Jones as a reference for her resident. He mentions that he would really appreciate it if Dr. Jones would start referring her patients to BMH. In this case, the primary interest is Dr. Jones’ obligation to provide what she judges to be the best care for her patients. Her secondary interest is in helping her resident get a job. Had the administrator offered Dr. Jones a $1000 fee for every patient she referred to BMH, one can see that it would be more straightforward to assess the conflict.
The conflict itself must also be considered in identifying and assessing conflicts of interest. Essentially the conflict is the set of circumstances or relationships that increase the risk that a primary interest would be abandoned in favor of a secondary interest. The conflict exists whether or not the primary interests are actually neglected in favor of the secondary. Just because a conflict exists does not mean that the individual is unethical; it does mean that a conflict has been identified that needs to be assessed and resolved in an ethically acceptable manner. This is where judgment comes into play. The extent of influence exerted by the conflict must be considered when assessing the conflict and determining its resolution.
Ethical Test of Conflict of Interest
Physicians play many diverse roles: caring for patients, educating, and researching. Additionally, there are multiple diverse relationships between physicians, academic institutions, biotechnology, and industry. Many of these relationships lead to improvement in patient care and advances in medicine. However, because of the diversity of roles and relationships, there is the potential that a secondary interest will unduly influence a primary interest. Once the primary and secondary interests, as well as the conflict itself, have been identified, the next step is to apply an ethical test to the conflict.
As suggested by the report by the Institute of Medicine Committee on Conflict of Interest, ethical tests of conflicts of interest aim to assess two things: first, the risk or likelihood that a secondary interest will influence a primary interest; and second, the extent or seriousness of harm that would result if a secondary interest were to influence a primary interest. In testing a conflict of interest, it is important to remember that conflicts are not binary; they are not either present or absent. They exist in varying levels of risk of influence and seriousness of harm were an influence to occur. The model proposed here and by the Institute of Medicine is a template for deliberation about conflicts of interest, but does not offer recommendations for their resolution. As noted previously, the existence of a conflict of interest does not imply that anyone is unethical or that some wrong has occurred. Rather, it points to a need for assessment in order to reach an ethical resolution.
Severity of the Conflict
The first assessment of the severity of the conflict is the likelihood that a primary interest would be influenced by a secondary interest. Here, three questions help to determine how much influence a secondary interest has the potential to exert over a primary interest.
What is the value of the secondary interest? While the secondary interest may be financial, it may also be in terms of advanced professional status or position, affecting the individual directly or indirectly by affecting a family member or trainee. In general, the larger the value, the greater the influence, but this is not always true. Smaller value secondary interests can certainly exert an influence. One way of assessing the value, particularly if it is financial, is by determining whether it is proportionate and reasonable based on expected compensation to that professional class. For instance, a consulting fee that reimburses at a rate ten times greater than the physician would receive for that same amount of clinical work could be more likely to influence a primary interest than one which paid half the normal rate for clinical work. As well, payments made to an individual for his or her own benefit may be more likely to influence a primary interest than those made to a department or institution.
What is the scope of the relationship? The scope refers to the duration and depth of the relationship. In general, longer invested relationships have the potential to influence primary interests more than briefer superficial relationships. An example is being invited to be a onetime speaker as opposed to be a member of the board of directors.
What is the extent of discretion? Discretion here pertains to latitude in decision-making. Having more power in making important decisions could correlate with greater potential for a secondary interest influencing a primary. The president of a medical group typically has more decision-making latitude regarding the group than does a junior physician.
The second assessment of the severity of the conflict is the seriousness of harm that could result from such an influence. The three questions below help to assess the extent of harm that could result should the secondary interest influence the primary.
What is the value of the primary interest? The value here refers to what duty, goal, or obligation exists in the primary interest. For the physician caring for patients, this is to deliver the highest quality care while avoiding harm. For the researcher, it is the integrity of the scientific data she publishes. For the educator, it is objectivity in the information he teaches. Another way of elucidating the value is to ask what is at risk in the conflict itself; what about the primary interest is at risk?
What is the scope of the consequences? The scope refers to the impact, roughly measured by how many individuals could be affected, if the secondary interest were to influence the primary. If a physician teaching a small group of first year medical students were to be unduly biased in favor of a drug to treat hypertension based on receiving speaking fees from the pharmaceutical company, the extent of harm that could result is less than if he were drafting clinical practice guidelines to be disseminated by the American Heart Association.
What is the extent of accountability? When the physician involved in the conflict has less accountability or oversight, the harm that could result from an influence is typically greater. This is not to say that without regulation individuals will act unethically. Rather, independent oversight helps to mitigate potential harm that could result from an undue influence.
Resolving Conflicts of Interest
After the conflict is disclosed and assessed, and the severity in terms of likeliness of influence and seriousness of harm has been identified, the next step is to determine a resolution to the conflict. Overall, judgment will determine the course of action. Conflicts with the lowest likelihood of influence and the least seriousness of potential harm can often be resolved by disclosure alone. Those with greater risk of influence and more serious harm may require recusal, divestment, or additional oversight. Some conflicts are incompatible and the resolution involves choosing either the primary or the secondary interest. Conflicts involving patient care, in particular, should be closely scrutinized so as to be certain that bias is not introduced and that public trust is maintained. Often institutional policy will determine how to address a conflict of interest. When there is no policy, or when the conflict to be addressed falls outside the stated policy, the ethical test of severity can gauge the seriousness of the conflict and serve as a foundation for its resolution.