Question $21$

$($Adapted from WHO Casebook, # $57)$

An Asian pharmaceutical company has developed a promising new antipsychotic medication for the treatment of schizophrenia. Sales analysts predict the drug could earn the company a significant profit within $4$ years. The study drug has already been tested on several thousand volunteers in Asia. During this testing, however, some study participants developed cardiac arrhythmias. Consequently, the responsible regulatory agency issued a $$not approvable$$ letter, which requires the drug company to do more tests of the drug on human beings before it can be considered for approval again.

In response, the company contracts a state hospital in Eastern Europe to complete the needed tests. The hospital is a long$-$term facility for mentally ill patients; it is overcrowded, and most patients have been in the facility for many years with no hope of being discharged. Often they have to wait for several months before they get an opportunity to see a doctor. Many patients do not have any next of kin or relatives who visit them regularly or at all.

Facility doctors determine whether a patient is competent to enter a study before obtaining informed consent for their participation. They are paid a fee for each patient who is recruited. The information sheet given to patients states that the drug $$has been tested in thousands of patients and the results of these studies are being reviewed by authorities in Asia, Europe, and the United States of America$.$ It also notes that the drug $$appeared to slightly affect the electrical activity of the heart in some people$.$ It contains no other mention of cardiac problems or arrhythmias. The company did not inform the country$$s regulators of the Asian regulatory agency$$s action; the laws of this country do not require such reporting and thus the company contends that it $$adheres to the laws of each country in which research is conducted$.$

This study raises a number of ethical issues. Amongst other things, you are concerned about the payment of $$finder$$s fees$$ to facility doctors for each patient recruited. Which of the following statements is TRUE?

The payment of a fee for the recruitment of patients is not a conflict of interest since it is normal that physicians should want to receive payment for work that they do$.$

The payment of finders$$ fees to those who recruit patients into clinical trials is a conflict of interest that can be managed, for example, by ensuring that the amount paid to physicians is not disproportionate to their usual revenue.

The payment of a finder$$s fee is a significant conflict of interest that cannot be managed in any way. As such this aspect of the project is unacceptable.