Ethical Issue, decision

[Roxanita]

Q- A schizophrenic outpatient comes to visit his doctor to ask for advice. He states that he has been experiencing many negative side effects from the Haloperidol he is taking. He is experiencing tardive dyskinesia. He asks his doctor if it would be all right if he entered a double blind study on the effects of a new schizophrenic drug. One group would not receive any treatment and the other group would receive the experimental drug. What would you say to this patient?

[Roxanita]

The study would be too risky considering his current condition. Look at alternative drugs with less side effects until the new drug has been tested.

The patient is a schizophrenic and cannot risk not taking his medicine while on the study because he doesn’t know if he would be placed in the group with medicine or the group without. Therefore as a physician, one needs to be aware of that risk.

In addition, according to medical rules, the patient who is incompetent or who is psychotic and dysfunctional as is this patient, has the right to refuse a medical treatment but it must be through a surrogate.
When a surrogate makes decisions for a patient, they should use the following criteria:
a) Subjective standard-actual intent, advance directive
b) Substitutive judgment- who best represents the patient
c) Best interest standard-burdens vs. benefits and interests of patient, not preferences of the decision-maker

The patient is not considered competent and therefore cannot make the best decision.
In addition, the patient is upset about the side effects. Therefore, it should not be forced on him if he does not like the side effects, because this will also lead to a risky response due to his aversion of the side effects (he may not take the medicine as often as he should).

A physician should not advise a patient to go into a medically threatening situation, especially a double blind study in which neither the investigators nor the patient know if he is getting any treatment.

A participant of a double blind study must sign a form of consent stating that they will not take any medicine while on the study and they accept the responsibility of their decision.