The Body Hunters: Testing New Drugs on the World's Poorest Patients
http://www.100md.com
《新英格兰医药杂志》
Clinical and translational research has all the right material for great stories. Heroines and heroes strive for truth and fame and fortune. The foe, whether disease, death, or suffering, gives urgency to these quests. Yet there are myriad obstacles to success, including false paths, competition, and sometimes enormous costs, including, most critically, the human costs sometimes paid by the participants in research. While stories of success in such pursuits tend to be celebrated in the pages of professional journals and textbooks, in classrooms, and sometimes in the popular media, stories of failure may find even broader reach, whether journalistic or fictional. Telling and hearing such stories — whether they emphasize good or evil — has merit, since there can be a lot to learn about how to improve our approach to clinical and translational research. Nonetheless, these stories can be harmful if the facts are wrong or if alternative perspectives are not considered.
In The Body Hunters, Sonia Shah tells a range of stories regarding multinational drug testing. Shah's title, perhaps borrowed from an earlier Washington Post exposé concerning research ethics, is not subtle. In her view, those who fund and conduct clinical and translational research do not merely recruit participants but, rather, "hunt" for "bodies." Her chapter titles are similarly intriguing — take, for example, "Growing the Pharma Monolith" and "Uncaging the Guinea Pig." There are, of course, risks and benefits associated with producing such a sensationalized account. On the one hand, it may attract readers, pique interest, and sell books. On the other hand, it may alienate some readers who are engaged in the research enterprise and who therefore stand to benefit from a comprehensive understanding of how the field is viewed, an understanding that would help them determine what problems exist and what changes should be made to solve them.
The Body Hunters is an accessible account of what are largely recent troubles in medical research involving human participants. It is based on a range of sources, including published scientific and governmental reports, interviews, transcripts, and press releases. Shah first provides an overview of the globalization of drug development, describing tensions related to conducting trials across borders between countries for which there may be substantial disparities in resources. She next examines the use of placebo controls in clinical trials, focusing predominantly on cases in which their use has been considered by some to be problematic. To place these issues in context, she sketches the growth and development of the pharmaceutical industry and the regulatory approaches that govern it, touching on seminal cases that are now familiar to anyone with training in research ethics, such as the egregious Nazi medical experiments; the study of the natural history of syphilis conducted in Tuskegee, Alabama; and the potential hazards of inadequate research, as exemplified by the use of thalidomide during pregnancy. Shah then gives considerable attention to research on HIV infection that has created heated international debates, especially those about the appropriateness of using placebo controls in trials addressing the prevention of vertical transmission (from mother to infant) of HIV and about the political situation in South Africa, which has greatly affected research programs and drug availability for HIV. She then describes aspects of the research enterprise in India, the recent changes in ethical codes for research, and the potential limitations of informed consent in the research setting. Shah concludes by offering some suggestions for improvement.
The Body Hunters provides an interesting set of stories about multinational drug development. The stories Shah has selected are important and derive from a rich set of resources; they are powerful and therefore likely to play a role in the shaping of policy and attitudes toward clinical research. It is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories. It is also critical to recognize that these stories should not be read from any single point of view, since that would be insufficient, especially for those who bear the awesome responsibility of protecting research participants and bringing safe and effective products to the clinic.
Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University
Baltimore, MD 21205(By Sonia Shah. 242 pp. Ne)
In The Body Hunters, Sonia Shah tells a range of stories regarding multinational drug testing. Shah's title, perhaps borrowed from an earlier Washington Post exposé concerning research ethics, is not subtle. In her view, those who fund and conduct clinical and translational research do not merely recruit participants but, rather, "hunt" for "bodies." Her chapter titles are similarly intriguing — take, for example, "Growing the Pharma Monolith" and "Uncaging the Guinea Pig." There are, of course, risks and benefits associated with producing such a sensationalized account. On the one hand, it may attract readers, pique interest, and sell books. On the other hand, it may alienate some readers who are engaged in the research enterprise and who therefore stand to benefit from a comprehensive understanding of how the field is viewed, an understanding that would help them determine what problems exist and what changes should be made to solve them.
The Body Hunters is an accessible account of what are largely recent troubles in medical research involving human participants. It is based on a range of sources, including published scientific and governmental reports, interviews, transcripts, and press releases. Shah first provides an overview of the globalization of drug development, describing tensions related to conducting trials across borders between countries for which there may be substantial disparities in resources. She next examines the use of placebo controls in clinical trials, focusing predominantly on cases in which their use has been considered by some to be problematic. To place these issues in context, she sketches the growth and development of the pharmaceutical industry and the regulatory approaches that govern it, touching on seminal cases that are now familiar to anyone with training in research ethics, such as the egregious Nazi medical experiments; the study of the natural history of syphilis conducted in Tuskegee, Alabama; and the potential hazards of inadequate research, as exemplified by the use of thalidomide during pregnancy. Shah then gives considerable attention to research on HIV infection that has created heated international debates, especially those about the appropriateness of using placebo controls in trials addressing the prevention of vertical transmission (from mother to infant) of HIV and about the political situation in South Africa, which has greatly affected research programs and drug availability for HIV. She then describes aspects of the research enterprise in India, the recent changes in ethical codes for research, and the potential limitations of informed consent in the research setting. Shah concludes by offering some suggestions for improvement.
The Body Hunters provides an interesting set of stories about multinational drug development. The stories Shah has selected are important and derive from a rich set of resources; they are powerful and therefore likely to play a role in the shaping of policy and attitudes toward clinical research. It is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories. It is also critical to recognize that these stories should not be read from any single point of view, since that would be insufficient, especially for those who bear the awesome responsibility of protecting research participants and bringing safe and effective products to the clinic.
Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University
Baltimore, MD 21205(By Sonia Shah. 242 pp. Ne)