Health Care Ethics Case Study 9E.

Dr. Smith is the PI for a phase II, randomized, placebo-controlled, double blind study with approval for research by the FDA for a particular primary indication. The sponsor of the study is Drug Company Z- a large pharmaceutical company whose stock is publicly traded. Dr. Smith is interested in seeing the drug through its approval phase, as it is a drug for a disease for which no current therapy exists. Although Dr.Smith has worked as a consultant for the sponsor of the study regarding the development protocols for large cooperative studies, she has not done so for this particular study or drug, In this advisory role, Dr.Smith has received annual compensation in the amount of $10,000 and also sits in a voluntary capacity on the sponsors scientific advisory board. Dr.Smith also serves as a clinical research advisor for a number of competing drug companies and as such feels the potential for conflict of interest to negatively affect this protocol is limited to nonexistent. Dr. Smith has no stock interest in the company nor does she have any patents or personal interest in the drug other than the potential benefit for her patients.

In this case study, Dr. Smith has a financial interest in the sponsor of the study, albiet $10,000. Given that the study is randomized placebo controlled and double blinded, do you see any potential for conflict of interst negatively affecting the clinical research? What factors might either change your decision or further reinforce your determination? Would changing the scenario in the following ways alter your decision?

Case Study 9e modification A: What if Dr. Smith received $100,000 a year for her work with Drug Company Z, and this was her primary source of income as she rarely sees patients any longer and largely serves as a consultant?

Modification B: What if drug company Z was founded in part by Dr. Smith? What if it was a small, private company, a hopeful startup, and this Phase II drug was its leading source of potential revenue for years to come?

Using case study 9E Answer the question as to whether Dr. Smith has any potential conflict of interest that could negatively affect the clinical research. How do the changes (modifications A and B) change the scenario? What is the threshold at which there exists a conflict of interest that would be unethical?