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Protected to death?
The U.S. Food and Drug Administration is taking steps to encourage drug testing research on pregnant women and children, recognizing the surprising lack of good information about both drug dosages and side effects when drugs are prescribed for these large subsets of the population. Pediatricians argue that itís long overdue that we realize that children are not just smaller versions of adult patients, and obstetricians welcome accurate information about drugs risks for pregnant women and the fetuses they carry. But the process to gain improved information means more research on pregnant women and children, requiring more research subjects from these groups and more risk to individuals who participate in research. How much risk is acceptable for pregnant women and children in the name of drug testing? How should we best balance these risks against the information yielded by such research?
A history of protection
Early human research policies in the U.S. were created in the context of numerous highly publicized cases of the misuse of subjects, ranging from deceptive recruitment practices of impoverished men with syphilis in the so-called Tuskegee Syphilis Study, to questionable informed-consent practices in research on institutionalized children at the Willowbrook State School in New York. This social context led to special protections for various research populations who were viewed as particularly vulnerable to exploitation, such as children. It also reflected the political realities and commitments of the day, such as protecting the unborn.
That meant that no risky research could be performed on children unless there was the potential for direct medical benefit to the subjects themselves -- thus excluding the possibility of early phase drug trials involving children. Pregnant women were excluded from all research participation in an effort to prevent harm to fetuses, and that policy was often expanded in practice to exclude not only pregnant women, but women of childbearing capacity generally.
A shift to inclusion
By the late 1980s, the work of advocacy organizations supporting more research on diseases such as AIDS and cancer prompted different thinking about research participation and its benefits. Rather than focusing on protection from exploitation and the risks of research participation, emphasis shifted to assuring access by groups and individuals to the benefits that research has to offer. This resulted in changes in federal policy to require the inclusion of members of particular groups as subjects in research, starting with requirements to include women and minorities, in 1993. More recent moves to carry out drug testing on pregnant women and children represent a continuation of the shifting emphasis towards inclusion.
Balancing protection and access
But the appropriate emphasis on inclusion must be balanced with the need to protect the subjects of research. We know from many studies that the process of informed consent in research doesnít live up to our high-minded rhetoric about fully informed and fully free participants. Subjects are often confused by the complexity of technical information for proposed research. They may misunderstand the fact that research is meant to help answer a scientific question rather than to offer them a specific therapeutic benefit. So we must make sure that the benefits of research arenít won at the expense of subjectsí trust and understanding, or worse -- at the cost of their physical well-being.
The problem with research is that individual subjects always bear the risks of research, while the benefits will be enjoyed mostly by others. We must allow the pendulum to swing farther towards emphasizing the benefits of research, while at the same time assuring that the rights and interests of subjects are adequately protected. The history of protecting particular groups of subjects from potential exploitation was well-intentioned, but had the unfortunate effect of excluding large parts of the population from the fruits of biomedical research -- effectively protecting them to death. It is a testament to the FDA that it is learning from this history rather than repeating it.
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.
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