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Assuring the ethical conduct of clinical cancer trials in the developing world

Few practicing physicians, clinical investigators, or bioethicists would argue with the statement that the publication of an article by Beecher in 1966 fundamentally altered the opinion of most that “unethical clinical research” activity was limited to those countries and societies with “deranged political systems. ” In this landmark article, Beecher described several studies conducted in the U.S. that would not satisfy any objective standard of ethical research, including the intentional inoculation of institutionalized, mentally disabled children with the hepatitis virus; the administration of “live cancer cells” to human volunteers not told of the origin of this material; and the “transplantation” of melanoma cells from a patient to her mother (who subsequently died of metastatic melanoma). Quite appropriately, the Beecher study is, and should remain, a centerpiece of formal clinical research training programs for all individuals participating in research involving human subjects. A recently published article in the same journal may someday find itself discussed alongside the seminal effort by Beecher as one of the critically significant documents that awakened the international research community to the potential for the exploitation of citizens in the developing world who are being “asked to participate” in clinical trials. This profoundly disturbing piece, written by Drs. Nundy and Gulhati, both of whom are Indian physicians, describes clearly how women and men in India are, in the words of Kant, being used as a means (sometimes solely for the financial benefit of others), rather then being treated as an ends themselves. Descriptions of the lack of ethical oversight for clinical trials (e.g., investigators do not seek nor do they provide any information regarding conflicts of interest), sponsor indifference to the welfare of individual study participants (e.g., the absence of statements that patients responding to an experimental agent will be permitted to continue treatment when the formal study is completed), and potentially inappropriate direct inducements to encourage entry into the study of those living in abject poverty (e.g., paying workers more money per month to participate in a study than they would earn at work, or by providing medication that is worth more than their annual salary) provide a powerful reminder that we must remain vigilant and stand united against the behavior of those clinicians who do not appear to understand that the term “human subject” refers to all human beings, 1