US-based journal Science has published a paper in which experts have cautioned that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve.
Carnegie Mellon University's Alex John London joined McGill University's Jonathan Kimmelman and Marina Emborg of University of Wisconsin-Madison and Wisconsin National Primate Research Center to examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time. According to their report, scientists and regulators tend to focus on how individual patients should be protected from risks, and as a result, overlook how medical advance itself can be adversely affected by poorly designed clinical trials. London and his co-authors argue that debates over access neglect key ethical issues.
To safeguard the advancement of medical research, the authors suggest that four key questions must be answered when researchers propose human studies of new therapies. These include: Did animal experiments show reliable effects on disease?; are the animal models similar enough to human beings that favorable results are to also occur in human trials?; to what extent are researchers justified in believing that observations in animals will hold up in human beings?; and will clinical trials apply the exact conditions that were used in successful animal studies? The authors suggest that there are instances when human trials are initiated despite unsatisfactory answers to these questions.
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