Case Study 5: A Study Evaluating the Use of Traditional Medicines A plant common to South Asia, "thankuni" (Hydrocotyle asiatica), when dried, ground up, and added to water is reported to be effective in the treatment of bloody diarrhea. One paper suggesting that "thankuni" has an affect on decreasing bloody diarrhea, has appeared in an unrefereed journal from an institute of traditional medicine in India. "Thankuni" is the only ingredient of a popular traditional medicine, "Ajorno", which is produced by a local company, is widely available, very popular, and quite inexpensive. No clinical studies have been conducted on this product and the specific chemical composition has not been determined. An investigator at an international research institution in Bangladesh is intrigued by this product and wishes to evaluate its clinical effectiveness. The present treatment for dysentery (by far the most common cause of bloody diarrhea in the country) is fluid and ampicillin, an antibiotic that is clinically effective and bacteriocidal. Ampicillin, however, is often unavailable outside the major cities (80%) of the population is rural and when available is too expensive for most people. The investigator reasons that if the traditional medicine prove effective, therapy will be more accessible to everyone because of availability and cost. He submits a protocol to the study committee of the institute for a well-designed double-blind study that compares the clinical effectiveness and bacteriacidal properties of "Ajorno" against ampicillin. Adult patients admitted or seen on an outpatient basis with a history of dysentery will be randomly assigned to one of the treatment groups after a rectal swab has been taken for a bacteriological diagnosis. "Ajorno", which is in a powdered form will be put into a gelatin capsule so that it is indistinguishable from the antibiotic. The study committee meets and votes not to approve the protocol for the following reasons: (1) the specific chemical composition of "Ajorno" is not known; (2) the prior reports of effectiveness has been for "bloody diarrhea" which might include any number of diagnoses including dysentery and amoebiasis; and (3) there are no studies reported in referenced journals that have indicated that the traditional medicine is effective or have suggested a mechanism for its reported effectiveness. The investigator notes that would be next to impossible to define all the ingredients of this traditional medicine and if done would be a costly undertaking. Besides, he argues, it is the interaction of the different ingredients that probably are the reason for he drug's reported effectiveness. Lastly he suggests that those on the review panel who voted against approval are biased against traditional medicines, are denigrating the indigenous science of the country, and trying to impose their own "Western" biases on scientific research. Comment on the ethics of this study. The following questions should be considered: Was the committee correct in its assessment? Is the investigator correct in his accusation that those voting no are showing "Western" bias in their decision? If the study was approved would the committee be using a double-standard in its assessment of the ethics of the design? Name: Email: Response: Please type or paste your response over this text. Note: Cases are fictional, but based on real events. All organization and individual names have been changed. For more information on the Program on Ethical Issues in International Health Research, click here!