Hospital and Confidentiality

Confidentiality Hospital and Confidentiality RCT: Dr. L's dilemma In this particular ethical dilemma, patient Bruce W. is taking a placebo during a drug trial for a drug which is beginning to show promising results. Dr. L's dilemma is a common one for physicians involved in randomized clinical trials. Dr. L must weigh the value of the experimental method and his duty as a scientist with his duty as a physician. As a physician, Dr. L's ultimate responsibility is to his patient.

He has an ethical obligation to keep the patient fully informed about treatment options and the risks and the benefits of the medications and treatments administered while the patient is under his care. But as a scientist participating in an experiment with a 'control' group, he has an ethical obligation to keep his patient in the dark about the patient's status as a control group participant. If the drug is promising -- as it seems to be -- Bruce W.

could have a longer lifespan if he takes the drug than if he remains 'as is,' but the better the research on the drug, the more apt it is to be approved the FDA for a large number of people. Without a control group in a RCT, the improvement witnessed in the group under study could simply be due to reasons that correlated with the use of the drug, rather than were caused by it.

Indeed, the fact that 24 of the 36 patients on placebos and only 15 of those receiving the new drug died seems to support use of the drug is based on the comparison between the placebo group and the experimental group. Still, there may need to reevaluate the existence of control groups in all forms of medical research. Perhaps in some instances they should not be used -- or should be discontinued mid-way through the study when illnesses are sufficiently life-threatening and the drugs are sufficiently promising.

At present, the drug in question does seem to have shown efficacy for an illness that has a 70% likelihood of fatality. Patients are likely to be willing to take a risk to improve their chances of extending their life spans. Regarding the first aspect of Dr. L's dilemma, little utilitarian benefit would accrue if the doctor broke his confidentiality and informed Bruce W. Of the fact Bruce was taking a placebo.

At best, Bruce would feel anxious and upset to know he was getting no real treatment and this would likely compromise the effectiveness of the study, since Bruce would perceive no benefits and not act as an effective control in the study. The placebo effect has been measured and is 'real,' and must be taken into consideration when comparing the results in the experimental group and the control group, and Dr. L secretly coming forward will merely taint the results.

Whatever the ethical obligation he perceives towards his patient, he knew when the patient agreed to the trial the doctor knew he would be ethically bound not to inform Bruce of his status as a control group participant. The court case of Tarasoff v. Regents supports.