Author + information
- Christopher M. O’Connor, MD, FACC, Editor-in-Chief, JACC: Heart Failure∗ ()
- ↵∗Address for correspondence:
Dr. Christopher M. O’Connor, Editor-in-Chief, JACC: Heart Failure, Heart House, 2400 N Street NW, Washington, DC 20037.
There are occasions when doctors and hospitals have financial relationships with pharmaceutical and healthcare companies. These relationships may be for a variety of work, ranging from research activities, consulting, and advising, to speaking fees, gifts, travel, and meals. The Sunshine Act requires the Centers for Medicare and Medicaid Services collect information from manufacturers, including purchasing organizations regarding financial relationships between these entities and hospitals or physicians. The Open Payments Program makes these relationships public. The Sunshine Act suggests that there is a direct linear relationship between behavior and financial compensation for the aforementioned transactions. Conflict comes in many forms and varieties. These include accepting and presenting material, educational presentations, or publications controlled by industry; consulting arrangements not in the form of written contracts; interaction with industry representatives to promote their agenda or product; and conducting marketing practices presented as clinical research. Although all of us employ increased transparency in the effort to reduce conflict, it is important to recognize that the wrong presentation of financial relationships without context can be misleading.
For example, one physician was portrayed as receiving millions of dollars in consulting and speaking compensation; yet, this was the result of a patent payout from years prior. In addition, equating financial compensation for service on data safety monitoring boards and clinical end point committees, core laboratory activities, and safety surveillance compared with non−continuing medical education speaking engagements and non−research-related activity provides the public with a misaligned view of physician activities.
Do we really not want physicians involved in data safety monitoring boards and therapeutic development of new agents? Recently, a drug development program was guided by a group of scientists without medical degrees. A safety signal emerged that was not recognized until significant harm had occurred to patients. In reviewing this case, I wonder if this would have been the case had physicians been in the position of providing the safety surveillance for the early development of this novel drug therapy. There are a number of noncardiovascular products, particularly for diabetes and oncology, that are being monitored for cardiovascular events as a safety risk. Cardiologists reviewing these cases are being reported as having a conflict for participating on committees that are reviewing these events. Is it really the intent of the Sunshine Act to stop these physicians from providing safety surveillance? Currently, health organizations have conflict of interest policies that require physicians to report on a regular basis, and management plans are put in place for areas of potential and perceived conflict. Professional societies have provided important guidelines for conflict of interest. I believe that we should be reporting conflict of interest in a fashion that is transparent and honest. We should grade the conflict with an ordinal scale in which the purpose is well understood. We should have transparency around what the influence of payments may be, distinguishing whether it is to endorse a particular product or it is for the advancement of trials and development for which someone is paid. I believe strongly that the academic community should provide guidance to interpret these open and transparent data in the new era. We should work together to realign the headlights.
- American College of Cardiology Foundation