Defining Conflict of Interest - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Defining Conflict of Interest
The divide between innovation and conflict of interest in medical research is not so clear.


Pharmaceutical Technology
Volume 36, Issue 3, pp. 38

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here