Conflicts of Interest in Clinical Practice

ECU is committed to supporting collaborations with Industry and other external entities. Preserving these relationships is essential to advancing ECU’s mission of providing, promoting, and supporting high quality and cutting-edge clinical service, research, and medical education.

By their very nature, such collaborations can create real or perceived conflicts of interest that may compromise integrity, independence, leadership, exercise of professional judgment, or the reputation of the University.  The University regulation on Conflicts of Interest, Commitment, and External Activities for Pay sets forth parameters for reporting and managing conflicts of interest as well as identifying activities that are not allowable under any circumstances.

Brody School of Medicine (BSOM) has published a Standard Operating Procedure that complements existing University policies by addressing BSOM employees’ interactions with industry. This SOP, Conflicts of Interest Regarding Interactions with Industry expands University regulations on the acceptance of gifts and specifically addresses ghostwriting.

Gifts

BSOM employees are prohibited from accepting gifts from industry representatives (defined as any item, product, or service, regardless of the nature, purpose or value).  Industry-supplied food or drink are defined as personal gifts and applies to setting both on campus and off campus.  Employees may not participate in industry-sponsored dinner programs, hospitality events, symposia, and meals in clinical settings or associated conference settings, product theaters and similar events that are held independent of professionally organized activities.   Exceptions are as follows:

  • When provided as part of attendance at independent medical education programs compliant with the requirements of the Accreditation Council for Continuing Medical Education or other nationally recognized accrediting bodies
  • When provided as part of attendance at scientific or professional society meetings where the gift is provided to all attendees of the meeting

Ghostwriting

Employees may not participate in ghost authorship, i.e., cause or allow any material to be published under their name when the material is principally authored by another individual(s) without including that that individual(s)’ name and, as applicable, relationship to any vendor relevant to the material published.

From “Conflicts of Interest in Clinical Practice” by Mark Tonelli:

Conflicts of interest, ubiquitous in medicine, occur when the interests of clinicians do not align with the interests of their patients. When systemic and institutionalized, such conflicts become particularly problematic, not only creating risks for individual patients but also undermining the integrity of the medical profession. Financial conflicts of interest arise when the reimbursement of clinicians appears to encourage decisions and actions that are unlikely to be in the best interest of individual patients. More insidiously, the influence of the pharmaceutical and medical device industry on clinicians, whether through gift giving, support of continuing medical education, or guideline development, creates conflicts of interest that may go unrecognized. Recognition and acknowledgment are the first steps in ameliorating conflicts of interest, which can then be disclosed and potentially eliminated.

The American Medical Association’s Statement on Conflicts of Interest in Patient Care

Code of Medical Ethics Opinion 11.2.2:

The primary objective of the medical profession is to render service to humanity; reward or financial gain
is a subordinate consideration. Under no circumstances may physicians place their own financial interests above the welfare of their patients.

Treatment or hospitalization that is willfully excessive or inadequate constitutes unethical practice.
Physicians should not provide wasteful and unnecessary treatment that may cause needless expense solely for the physician’s financial benefit or for the benefit of a hospital or other health care organization with which the physician is affiliated.

Where the economic interests of the hospital, health care organization, or other entity are in conflict with patient welfare, patient welfare takes priority.

Physician Payment Sunshine Rule – Open Payments

The Sunshine Rule is a provision of the Affordable Care Act that requires the public reporting by applicable manufacturers and Group Purchasing Organizations (GPO) of defined transfers of value to physicians and teaching hospitals.

The Act also requires applicable manufacturers and GPOs to report designated physician ownership and investment interests in their entities. Reporting only applies to manufacturers and GPOs of drugs, devices, biologicals or medical supplies in which payment is available under Medicare, Medicaid or CHIP and, which requires a prescription to be dispensed. While physicians and teaching hospitals have no reporting obligations under this regulation, they do have the right to review and dispute all required information being reported about them by the applicable entity prior to this information being placed on a public website.  The Sunshine reporting regulations do not negate the responsibility of physicians to report their financial interests or relationships with industry sponsors in accordance with the University conflicts of interest regulation.

CMS Open Payments Database
CMS Open Payments Overview

 

Resources for Clinicians

For further reading for Conflicts of Interest and Compliance: