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.
References
1. J. Fauber, "Financial Conflicts Taint 'Ivory Tower'," Milwaukee Journal Sentinel, Dec. 27, 2011,
http://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.
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