A good friend of mine posted this link on my Facebook wall the other day. For several years, this embarrassing illustration of the consequences of bioethical inadequacy has haunted the pharmaceutical giant. Much of the focus of the Pfizer debacle has centered on the unethical conduct of the clinical trial in Kano. I contend that focus should lie not primarily with the procedural and infrastructural problems that allowed such ethical misconduct in the first place. We should equally focus on the deep seated issues of scarcity of resources and lack of access to medical care that make clinical trials the only alternative for so many in developed world to obtain drugs for treatment- therapeutic or otherwise.
Charles Lidz and Paul Appelbaum defined and extensively researched what they call the Therapeutic Misconception. They contend that it "occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attirubutes therapeutic intent to research procedures." The developing world is faced with a quandary whereby access to clinical trials and other research may be the only means for obtaining treatment, even though the treatment may not prove beneficial to the patient/subject. Patients and subjects become conflated, while the objectives of the investigator and clinician remain separately defined. For many, participation in clinical trials without a full appreciation of the risks, benefits and alternatives results in inadequate consent for participation. For others, the guarantee of study drugs, therapeutic or not, is incentive enough. How should one balance ethical obligations with the need for advancement of science and technology, and sound data? The line separating coercion and incentive has all but blurred with the increase in outsourced clinical trials. How do we reconcile this? I argue that bioethics and public health must form an integrated discourse by which we address practical public health issues incorporating bioethical theories and ideas. Logical? Practical? What are your thoughts?
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