Dr. Leon's reputation as a clinical trials clinical investigator and participant was therefore permanently disadvantaged.
Training and Presentation in Medical Conferences
Physicians such as Dr. Smathers participate in colloquia and congresses, and present teaching seminars about the use of medical devices and new pharmaceutical regimens. A concern of some is that this representation of the company can result in an endorsement of the company. A second concern is that the physician may allow his or her judgment to be compromised by their relationship with the company.
On the first concern, there is a pressing need for experienced physicians to teach others how to improve their practice. The rules (as above for clinical trials) are strict about what is presented, and how it is presented. The physician must present all sides, supported by clinical evidence, with a clear indication of side-effects and contraindications.
On the second concern, there may be an effect on the physician's prescribing behavior if he/she believes in the product. There is, by law, no direct relationship between the prescription of drugs or medical devices and pharmaceutical products and physician remuneration. Even the conversations between physicians and "drug reps" are carefully scripted, and bounded by the need to disclose negative and positive points of a drug or device.
Additional Reasons for Dr. Smather's Concerns
Dr. Smathers is bound by peer review, reputation and the conditions of her Hippocratic Oath. She may have been taken aback by our request for her to file an affidavit certifying that she is not "a crook" (a la Richard Nixon). This negative assertion would, in Dr. Smather's mind, be already covered...
Smathers' role with our company is on a part-time basis for relatively benign medical treatments. She may regard her service to our company as a public service, rather than a necessary major component of her compensation. Maintaining the services of a well-reputed physician is in the interests of our company.
Recommendation
We make the assumption that all our employees, consultants and suppliers operate in an ethical manner. All of us are susceptible to forms of bribery, theft or malfeasance. While we rely on the criminal justice system and personal morality to prevent such occurrences, these actions can happen from time to time. As managers, we agree that the incidence of such transgressions is low. In Dr. Smathers' case, she is additionally bound by oath, peer review and reputation which she would not want to besmirch by accepting untoward gifts from medical suppliers.
Bibliography
CDISD. "Clinical Data." CDISD. 2007. http://www.cdisc.org / (Accessed November 21, 2007).
NEJM. "Understanding Financial Conflicts of Interest." New England Journal of Medicine, 1993: 573-576.
Wolfe, S. "Testimony Before FDA Advisory Committee Concerning the Protocol for Biopure's Blood Substitute HBOC-201 (HRG Publication #1795)." Public Citizen. December 14, 2006. http://www.citizen.org/publications/release.cfm?ID=7492 (Accessed November 21, 2007).
Wood, S. "NEJM bars Martin Leon from reviewing research or authoring reviews and editorials post-COURAGE embargo breach." The Heart, April 20, 2007: n.p.
Medical Memo - Results of Requested Research on Medical Ethics Concerns
