A social science framework for the analysis of health technology regulation: the risks and benefits of innovative pharmaceuticals in a comparative context

This article proposes a social scientific methodology for the investigation of the regulation of the risks (and benefits) of pharmaceuticals in an international comparative context. To do this, it examines the philosophical presuppositions that are necessary for the production of social scientific knowledge; the relationships between epistemology, concept formation and empirical research design; and the generation of hypotheses and selection of research methods, by reference to the ontological status of the research object. It is concluded that objectivist realism provides a philosophically coherent framework for empirical social scientific research on the regulation of technological risks, which can be useful to citizenship and public health without being instrumentally technocratic, whereas relativism is philosophically self-defeating and can only be useful in spite of itself

The Effects of Heparins on the Liver: Application of Mechanistic Serum Biomarkers in a Randomized Study in Healthy Volunteers

Heparins have been reported to cause elevations in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) but have not been associated with clinically significant liver injury. The mechanisms underlying these benign laboratory abnormalities are unknown. Forty-eight healthy men were randomized to receive subcutaneous injections of unfractionated heparin (UFH; 150 U/kg), enoxaparin sodium (1 mg/kg), dalteparin sodium (120 IU/kg), or adomiparin sodium (125 IU/kg; a novel heparin) every 12 h for 4.5 days. Asymptomatic elevations in serum ALT or AST were observed in >90% of the subjects. Elevations were also observed in the levels of serum sorbitol dehydrogenase (SDH), glutamate dehydrogenase (GLDH), miR-122, high-mobility group box-1 protein (including the acetylated form), full-length keratin 18, and DNA. Keratin 18 fragments, which are apoptosis biomarkers, were not detected. Biomarker profiles did not differ significantly across heparin treatments. We conclude that heparins as a class cause self-limited and mild hepatocyte necrosis with secondary activation of an innate immune response