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The divide between innovation and conflict of interest in medical research is not so clear.
What is a conflict of interest? Gilbert's Law Dictionary says that a conflict of interest (COI) arises when private interests clash with one's duty to serve the public interest. Prejudicial interest refers to having an interest in a topic that may affect one's ability to fairly and objectively consider the subject. Equipoise is a scientific concept by which a researcher believes in a hypothesis, yet no factual proof yet exists. Equipoise becomes conflict when medical professionals convince themselves they are right despite evidence to the contrary because of their own self-interests. When that happens, an ethical line in the sand is crossed. It can be hard to tell when that line gets crossed, no matter how rigorously a decision, affiliation, or financial arrangement is examined.
There are a panoply of new standards, rules, and guidelines relating to COI for medical research. The Physician Payment Sunshine provisions under the Patient Protection and Affordable Care Act mandate medical product and device companies to report any kind of transfer of value to physicians and post it in a public database. A half dozen states, with more likely to follow, have rules governing conduct for pharmaceutical and medical-device manufacturers that require reporting, prohibit, or impose restrictions on a wide array of physician–industry activities ranging from free meals to continuing medical education courses. At the federal level, rules under the National Institutes of Health (NIH) require medical researchers receiving federal grants to disclose any industry payments over $5000 and allow a university's NIH grants to be withdrawn for egregious violations or lack of oversight.
In the private sector, medical researchers are required by some medical publications to fill out standardized forms that enumerate payments from consulting work, honoraria, expert testimony, grants, commissioned manuscripts, intellectual property rights, royalties, stock holdings, and advisory boards. The American Medical Students Association ranks medical schools annually based on their COI polices, and the Pew Prescription Project and Yale University both have conducted recent surveys of patient attitudes regarding physician ties to pharmaceutical companies.
Why the brouhaha? In part, it is because of the media's attention to this type of story. A recent example reported in MedPage Today concerned Thomas Zdeblick, chair of the Department of Orthopedics at the University of Wisconsin–Madison, which according to the article, received more than $25 million in royalties since 2003 from Medtronic, a firm that sells spinal devices. Reportedly, this funding occurred while the hospital affiliated with the university spent $27 million on Medtronic spinal products from 2004–2010. Zdeblick also received more than $1 million in compensation from the university in 2010, according to the article (1).
But is this a case of COI? In this particular case, the selection of implant devices was done by a review committee. Moreover, Zbedlick's influence on residents and fellows was mitigated by the fact that they work with multiple surgeons who have differing views and preferences for various devices, and students are told about the royalties Zdeblick receives. The entire management plan, under which he operates, is a shared responsibility of the doctor, the department, and the dean's office.
That brings us full circle to definitions of COI and equipoise. The foundation of medical research is the state of clinical equipoise, which is met when there is genuine uncertainty within the expert medical community—not necessarily on the part of the individual investigator—about the preferred treatment (2). It is a shared responsibility. Implementing a just and workable system of COI monitoring is not something that can be achieved by simply legislating against bad acts. Rather than developing a system that prevents bad acts, legislation often creates a chilling effect—an inhibition or discouragement of legitimate expression, such as innovation.
Curbing innovation is the last thing we can afford in biomedical R&D. The turnover rate of researchers who have not submitted an investigational new drug application since 2006 is 35% (3). While NIH biomedical research funding has flatlined for the last several years, the number of doctors applying for NIH grants has flatlined for the last few decades. The average age of first-time biomedical grantees has risen six years to 42 years old (4).
Cures for cancer and neurodegenerative disease are elusive and costly as are the solutions to the crushing debt of biomedical education. There is a strong need for translational approaches in R&D, creation of interdisciplinary MD–PhD research teams, and cross-fertilization of private and public sector resources. These are conflicts of the public interest and that is where change should focus.
1. J. Fauber, "Financial Conflicts Taint 'Ivory Tower'," Milwaukee Journal Sentinel, Dec. 27, 2011, www.medpagetoday.com, accessed Feb. 13, 2012.
2. B. Freedman, NEJM 317 (3), 141–145 (1987).
3. B. Gwinn, presentation at the Summit for Clinical Ops Executives (Feb. 7, 2012, Miami).
4. K. Matthews et al., PLoS ONE 6 (12), online, Doi:10.1371/journal.pone.0029738, Dec. 28, 2011.