The Institute of Medicine (IOM) defines conflict of interest as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest” 1).
Developmental incentives are fundamental to surgical progress, yet financial and professional incentives inherently create conflicts of interest (COI). Understanding how to manage COI held by neurosurgeons, industry, hospitals, and journal editors, without thwarting progress and innovation is critical.
COI are inherent to collaboration and innovation, and are therefore an unavoidable component of neurosurgery. The lack of a clear distinction between clinical practice and innovation, ability to use devices off-label, and unstandardized disclosure requirements create inconsistencies in the way that conflicts of interest are handled. Additionally, lack of requirements to compare innovation to the standard of care and inherent bias that affects study design and interpretation can have profound effects on the medical literature. Conflicts of interest can have both direct and downstream effects on neurosurgical practice, and it is possible to manage them while improving the quality of research and innovation.
Conflicts of interest are inherent to surgical innovation, and can be handled in an ethically sound manner. Neurosurgeons, device companies, hospitals, and medical journals can take steps to proactively confront bias and ensure patient autonomy and safety. These steps can preserve public trust and ultimately improve evidence-based neurosurgical practice 2).
Financial and nonfinancial relationships between pharmaceutical or medical device industry, physicians, investigators, and academic institutions are common and generally considered essential for development of new technology and advancement in medicine 3) 4).
However, these financial ties may at the same time create conflicts of interest: a set of circumstances that creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest 5).
The health care industry-manufacturers of drugs, devices, and medical equipment and its associated political and lobbying power, heavily influence strategic directions in clinical research. They may intervene, through experts with disclosed or silenced financial industry ties, in clinical guideline formation and dissemination, and may ultimately affect daily clinical practice.
The industry's interests are not necessarily aligned with the interests of patients and society and may lead to study participant injury or harm and also reduce the public's trust and confidence in clinical research.
It is obvious that the growing number of clinical trials conducted in vulnerable countries requires commitment from all stakeholders to ensure adherence to a core of internationally accepted ethical principles that reflect one of the basic ethical premises of the Declaration of Helsinki; that is, that the interests of science and society are not an excuse to conduct clinical trials in vulnerable countries.
Transnational clinical research should be controlled by internationally accredited ethical review boards, and research protocols rejected in one country should not be given permission to proceed elsewhere.
In addition, international human research monitoring agencies should have “…the power to sanction corporations and research groups that fail to respect universal standards”.
Surgeon-industry conflict of interest (COI) has become a source of considerable interest. Professional medical societies, industry, and policy makers have attempted to regulate potential COI without consideration for public opinion.
The objective of a study was to report on the opinions of individuals representing the general public regarding surgeon-industry consulting relationships.
Survey was administered using a “spine Web site,” and opinions are collected on surgeon-industry consulting and regulation. Associations among responses to similar questions were assessed to ensure validity and subgroup analysis performed for respondent age, sex, education, insurance, employment, and patient status.
Six hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort.
Despite the known potential negative impact of surgeon-industry COI on patient care, this study revealed that this does not seem to be reflected in the opinion of the general public. The respondents felt that disclosure is deemed one of the most important means of self-regulation and COI management, which is in agreement with current trends of most spine societies and journals that are increasing the stringency of disclosure policies 6).
We would not allow a physician fully employed by industry to make a scientific presentation or publish an article for a peer-reviewed journal related to his or her company’s device or drug, yet we know from previously released orthopedic surgeon related data that many physician lecturers and writers are receiving yearly “consulting fees” and “royalty arrangements” that greatly exceed what is paid to physicians employed by device manufacturers—many above $1 million/year 7) 8) 9).
If publicly reporting these numbers places some in an uncomfortable position, so be it. This information is critical in the analysis of the clarity, sanctity, and scientific integrity of information and data presented. Collaboration has been valuable, but full transparency is critical to open, unbiased scientific dialogue and exchange.