Researching safety and cost-effectiveness in the life cycle of nanomedicine

Nanotechnology is rapidly emerging as a transformational influence on many industry sectors. This is particularly true of medicines and medical devices. This article argues that, as policy interest in devising an appropriate regulatory framework for nanotherapeutics escalates, it will be important for public health to ensure that a broad life-cycle approach to both safety and cost-effectiveness is adopted. It charts some of the most important issues likely to be faced and begins to map how they can best be addressed.     

Federal Deficits, Debt and Interest Costs

Current federal government deficits are of a size unprecedented since World War II. While budget surpluses have been infrequent, deficits before 1982 were small enough that the federal debt shrunk in relation to the size of the economy. Now, however, the federal deficit is stuck at about 5 percent of gross national product, and the ratio of federal debt to gross national product (GNP) is growing rapidly. These large deficits are driving up interest rates, hurting American exports, turning the United States into a debtor nation, and causing government interest outlays to spiral. The possibilities are limited for lowering interest costs through directly reducing interest rates or introducing new Treasury debt management strategies. The only way to cage the interest monster is to enact a substantial package of tax increases and cuts in noninterest spending. We list some possible elements of such a package and show how they might be combined to tame the growth of debt.     

AmpFlSTR profiler Plus short tandem repeat DNA analysis of casework samples, mixture samples, and nonhuman DNA samples amplified under reduced PCR volume conditions (25 microL)

As part of the validation of the AmpFlSTR Profiler Plus short tandem repeat (STR) system, under reduced polymerase chain reaction (PCR) volume conditions (i.e., 25 microL), a total of 275 casework samples were processed. Examples of profiles are presented along with amplification conditions to improve the odds of obtaining balanced and complete profiles for samples showing partial results or profiles with a descending slope. Data collected and used to develop our interpretation guidelines are included. From the mixture studies, full profiles were obtained for minor contributors, using 2 ng of DNA, with ratios of 10:1 or 1:20 and using 1 ng of DNA, with ratios of 10:1 and 1:8. The specificity of the Profiler Plus amplification reaction performed in 25 microL was examined and confirmed using a large spectrum of nonhuman DNAs. This report supports the use of the AmpFlSTR Profiler Plus STR system for casework DNA typing under reduced PCR volume conditions.     

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.     

Reviews

Rita Felski, The Gender of Modernity (Harvard University Press) Cambridge, MA, 1995.

Katie Holmes, Spaces in Her Day: Australian Women's Diaries 1920s‐1930s (Allen & Unwin) St Leonards, NSW, 1995.

Ros Pesman, Duty Free: Australian Women Abroad (Oxford University Press) Melbourne, 1996.

Frances Porter and Charlotte Macdonald (eds), ’My Hand Will Write What My Heart Dictates’ (Auckland University Press with Bridget Williams Books) Auckland, 1996.

Lucy Bland, Banishing the Beast: English Feminism & Sexual Morality 1885–1914 (Penguin) Harmondsworth, 1995.

Margaret Thornton, Dissonance and Distrust: Women in the Legal Profession (Oxford University Press) Melbourne, 1996.

Diane Bell and Renate Klein (eds), Radically Speaking: Feminism Reclaimed (Spinifex Press) North Melbourne, 1996.

Rye Senjen and Jane Guthrey, The Internet for Women (Spinifex Press) North Melbourne, 1996.     

Creating capacities for peacebuilding citizenship: history and social studies curricula in Bangladesh,Canada, Colombia,and México

Public education is one influence on how young people learn to navigate social conflicts and to contribute to building democratic peace, including their sense of hope or powerlessness. Social studies curricula, in particular, introduce core concerns, geographies, governance and civil society, and participation skills and norms. History education narratives frame identity, (dis)trust or peaceful coexistence, and provide exemplars of how social conflicts and injustice have been handled in the past. To shed light on these peacebuilding and peace-blocking choices, this paper examines government-sanctioned social studies and history curricula in contrasting contexts of violent conflict and peace: Bangladesh, Colombia, México, and (Ontario) Canada. Our comparative analysis shows how these official curricula (de)normalize violence and militarism, present national identities as hegemonic/exclusive or plural/inclusive, and create opportunities for teaching/learning peacebuilding citizenship competencies such as conflict dialog, human rights awareness, and engagement in collective processes of civil society and governance.     

Application of forward‐looking infrared (FLIR) imaging from an unmanned aerial platform in the search for decomposing remains

Traditional methods of cadaver detection in outdoor environments include manual ground search, cadaver dogs, and manned aerial reconnaissance during daylight. These methods have limitations; however, a potential low‐cost alternative may be to employ thermal imaging equipment mounted on an unmanned aerial vehicle (UAV) to detect heat emitted by insect and bacterial activity on the decomposing remains. No studies have addressed the influence of wrappings on detection of maggot mass thermal signatures nor assessed thermal detection of smaller body fragments. We addressed these knowledge gaps by utilizing a two‐phase experimental approach to explore thermal detection of carcasses using UAV‐mounted infrared imaging. In Phase 1, pig body fragments were deposited on the surface or shallow buried. In Phase 2, whole pig carcasses were deposited in four conditions: on the surface uncovered, wrapped in plastic or carpet, or buried. Our results demonstrated that observable heat emissions from remains corresponded to peak insect activity during active decay and could be readily detected in uncovered whole carcasses and fragments. Although plastic and carpet wrappings partly impeded detection of insect heat signatures, these materials were clearly detectable themselves because of their contrast to the background ground surface. Thermal signatures of buried partial remains and disturbed gravesoil were also observed; however, the buried whole carcass transitioned to adipocere prior to the decay stage and without any insect colonization or heat signature. These data can inform operational implementation of this technique to complement existing search strategies to offer a robust, low‐cost alternative for use where scene characteristics allow.