Clinical Advances in Hematology & Oncology

July 2019 - Volume 17, Issue 7

Improving the Disclosure of Conflicts of Interest in Medicine

Dirk Arnold, MD, PhD

Director, Asklepios Tumor Center Hamburg
Professor of Medicine
Head of Oncology, Hematology, and Palliative Care
AK Altona
Hamburg, Germany

 

H&O  How would you define a conflict of interest?

DA  In the medical community, a conflict of interest can be defined as a situation in which a relationship has the potential to influence an objective interpretation of scientific data. Conflicts of interest can be both perceived and real, and may arise from relationships among physicians, research societies, and pharmaceutical companies, for example.

H&O  Are there any relationships with industry that do not need to be disclosed?

DA  As a general rule, all relationships between physicians and industry should be disclosed. There may be certain interactions that do not bear the potential for conflict, owing to the nature of the interaction. When considering invitations and gestures of hospitality, for example, it is probably not necessary for a physician to report a discussion with an industry representative that involves the gift of a cup of coffee. However, there may be different interpretations of the same situation. It is not always easy to identify whether there is a conflict.

H&O  Are there types of conflicts that physicians tend to overlook when submitting a disclosure?

DA  Physicians may overlook a potential conflict of interest that lacks financial remuneration. For example, doctors performing research on behalf of a company might not receive any money to do this research. However, they do have the interest that their research is recognized by the community and/or published. In contrast, the industry’s interest might be to use the data for reasons such as marketing or premarketing.

H&O  What percentage of hematologists/oncologists have relationships with industry?

DA  I would say nearly 100% if a relationship includes any type of interaction, including a situation in which a pharmaceutical representative brings some information and small gifts, such as a bar of chocolate. At some point, however, we have to conclude that some interactions are indeed too narrow to represent a conflict. If the definition of conflict of interest starts with financial remuneration, travel support, or accepting invitations to attend meetings, then the percentage of physicians likely ranges from 10% to 20%.

H&O  What do studies suggest about how relationships with industry impact physicians’ behavior?

DA  There is always the risk that a close relationship with industry might lead to an overly optimistic view of a company’s position regarding a particular treatment.

H&O  Why is it important for physicians to disclose any potential conflicts of interest?

DA  Physicians who perform industry-sponsored studies should report on their research in an objective way. Physicians must prescribe treatment that is in the best interest of their patients. It should be made clear that these interests are the physician’s primary concern. 

H&O  Does Europe have a standard process by which doctors disclose any conflicts of interest? 

DA  Transparency reporting procedures are brought into place by the “giver,” for example, a pharmaceutical company, publisher, or institution, rather than by the “taker,” for example, a physician. Therefore, I believe that disclosure by doctors is usually based on the policy of each organization rather than by regulations or laws. Since organizations or companies are generally acting globally, policies are similar in Europe and the United States.

H&O  What is your view of the Physician Payments Sunshine Act?

DA  The Sunshine Act is very ambitious, in a positive way. The act attempts to capture everything that could bear a potential conflict of interest. In most European countries, it is generally thought that the Sunshine Act may be overregulating and perhaps requires too much detail. It is a good instrument. However, it is necessary to be realistic and use a reasonable reporting system.

H&O  What steps can institutions take to facilitate the disclosure of their employees’ conflicts of interest?

DA  Institutions must recognize that their employees may have conflicts of interest. They should encourage honest reporting, which can protect them from legal consequences. There is sometimes a sense of shame involved in the declaration of conflicts of interest; it can be viewed as an indication that one is working too closely with industry. This perception can lead to underreporting. However, there is no general shame in these interactions. Experts in a particular field often must work closely with industry to facilitate the development of new treatments. Therefore, it is necessary to honestly recognize that interactions between industry and physicians are part of the process of scientific innovation. It is not inherently harmful to have a conflict of interest.

H&O  Do you have any other recommendations on how to improve disclosure of conflicts of interest? 

DA  At the European Society for Medical Oncology, we are taking several steps. First, we ask our members to recognize that conflicts of interest exist, and that there is no shame in having them. Disclosure is a declaration of honesty. Second, we recommend that institutions take measures to assess their members’ potential conflicts. There should be an overview that follows a hierarchical process to ensure that conflicts of interest are properly declared. For example, a scientific director of a congress should ensure the accuracy of disclosures submitted by the leaders of each scientific track. The leaders of the scientific tracks, in turn, should ensure that their speakers have submitted proper disclosures. That being said, it is of course not possible to “police” and/or to evaluate the financial records of institutions or physicians. However, it is possible to highlight the importance of full disclosure and take steps to ensure accuracy.

Disclosure

Dr Arnold has received honoraria for advisory boards, consulting, and presentations from Bayer Healthcare. He has received honoraria for presentations from Amgen, Sanofi, Astellas, Biocompatibles, and Sirtex, as well as the CME providers Art Tempi Media, prIME Oncology, and TRM Oncology. He has received honoraria for presentations and provided educational events for Servier and Roche. He has received honoraria for advisory boards from Merck Sharp & Dohme, Merck Serono, Eli Lilly, Bristol-Myers Squibb, Servier, Roche, Sirtex, and Boston Scientific. He has received support for congress travel from Bristol-Myers Squibb, Roche, and Sanofi. He has received honoraria for advisory boards and presentations from Terumo. He is a member of the consulting board for IQVIA/Quintiles, with honoraria paid to his institution.

Suggested Readings

Jang S, Chae YK, Majhail NS. Financial conflicts of interest in economic analyses in oncology. Am J Clin Oncol. 2011;34(5):524-528.

Moraes FY, Mendez LC, Taunk NK, et al. Funding source, conflict of interest and positive conclusions in neuro-oncology clinical trials. J Neurooncol. 2018;136(3):585-593.

Prasad V, Rajkumar SV. Conflict of interest in academic oncology: moving beyond the blame game and forging a path forward. Blood Cancer J. 2016;6(11):e489

Torjesen I. Oncology trial authors don’t fully disclose financial conflicts of interests, analysis finds [published online August 30, 2018]. BMJ. doi:10.1136/bmj.k3749.

Wayant C, Turner E, Meyer C, Sinnett P, Vassar M. Financial conflicts of interest among oncologist authors of reports of clinical drug trials. JAMA Oncol. 2018;4(10):1426-1428.