recommends a significant expansion in the number of conditions targeted by newborn screening (NBS) programs. 1 In this commentary we advocate a more cautious approach. NBS dates to the early 1960s, when the technology developed to conduct large-scale testing on dried blood spots for phenylketonuria (PKU). 2 PKU remains the paradigm condition for NBS because of features of the disease and its treatment, which are particularly advantageous to population screening. It is a condition that silently causes neurologic devastation but is amenable to early detection and effective prevention with a diet of moderate burden and complexity. 3 Many children affected with PKU and their families have benefited from state screening programs over the past 4 decades because of collaboration between health departments, families, primary care providers, and metabolic specialists.However, PKU screening is not an unmitigated success. 4,5 There was initial uncertainty about whether children with variant forms of hyperphenylalaninemia required treatment and about whether affected children require life-long dietary management. 6 Indeed, some children with benign conditions were seriously harmed from unnecessary restrictions in their diets. 5 In addition, long-term studies demonstrate decrements in cognitive function for affected children and adolescents who are not fully adherent to the diet, 7,8 yet adherence to the diet is challenging because of its poor palatability, high cost, and limits on insurance coverage in many policies. Affected women who are off the diet are at high risk of bearing severely neurologically impaired children. 9 Only recently have many programs begun tracking affected women to enable notification, education, and management. These difficulties by no means negate the value of NBS for PKU, but they highlight the problems with the successful implementation of a population-based screening program even when a model condition is targeted. NBS is a system with many elements from blood-spot acquisition to long-term management in the medical home. Any weak links in this chain will impair the efficacy of the program. State health departments continue to struggle to garner adequate resources and expertise to maintain current programs. 2 Other aspects of the NBS system, like insurance coverage for ongoing specialty care and special diets, are beyond health department control. It remains the case in medicine more broadly that population screening of asymptomatic individuals is rarely an effective approach to uncommon diseases.
A majority opinion seems to have emerged in scholarly analysis of the assortment of technologies that have been given the label "synthetic biology." According to this view, society should allow the technology to proceed and even provide it some financial support, while monitoring its progress and attempting to ensure that the development leads to good outcomes. 1 The near-consensus is captured by the U.S. Presidential Commission for the Study of Bioethical Issues (PCSBI) in its report New Directions: The Ethics of Synthetic Biology and Emerging Technologies, which arguably marked the end of a preliminary round of analysis about the ethical and policy questions raised by synthetic biology. Like a number of other, earlier documents issued by various groups around the world, the report called attention to questions about how the technology will be used; whether it might be misused; what sorts of accidents might happen along the way; the economic, environmental, and social impacts of the eventual applications; whether the very idea of "synthetic biology" should be troubling; and how the debate over all of these questions will be conducted. Also like most similar documents, however, while it called for careful monitoring and oversight of technology, it did not recommend any significant new constraints on its development and use. The commission's stance was that it would be "imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply 'let science rip,' regardless of the likely risks." 2 The questions that should be asked of synthetic biology have not been put to rest, of course, and cannot be put entirely to rest. Partly this is just because of factual uncertainties; the technology is still emerging, and the possible outcomes are still uncertain. Partly, too, it is because of conceptual uncertainties: how to articulate and how to address the questions also remain up for debate.In this report, we will take stock of the current consensus, comment on some of the major points of disagreement, and identify the next steps for the debate. In part I, we offer a brief overview of the research and applications commonly grouped together under the heading of synthetic biology, partly in order to set the stage for the rest of the discussion and partly because we want to highlight some conceptual problems that attend the very label given this field. In parts II, III, and IV, we take up, respectively, three broad classes of concerns that arise in the context of synthetic biology: concerns about the intrinsic or inherent value of doing synthetic biology, concerns about the concrete harms and benefits of doing synthetic biology, and concerns about justice. Addressing these concerns requires a method for bringing the public's values to bear on policy-making concerning emerging biotechnologies; in part V, we discuss the challenges in developing such a method.
As science learns more about how the brain works, and fails to work, the possibility for developing "cognition enhancers" becomes more plausible. And the demand for drugs that can help us think faster, remember more, and focus more keenly has already been demonstrated by the market success of drugs like Ritalin, which tames the attention span, and Prozac, which ups the competitive edge. The new drug Aricept, which improves memory, most likely will join them. Whether such drugs are good for individuals, or for society, is an open question, one that demands far more public discussion.
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