Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, 10 January 2018
Authors: Steven Joffe, Holly Fernandez Lynch
“Though popular with the public and supported by politicians from both parties, the legislation has been widely criticized by policy experts. In isolation, its impact would probably be limited, since the bill was substantially hollowed out to secure the necessary votes. Nonetheless, the motivation behind the proposed legislation threatens to weaken the FDA’s ability to pursue its public health mission.”
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Makers of Nurofen ran ‘misleading and deceptive’ campaign against Panadol: court

SMH, 11 January 2018
Author: Stephanie Gardiner
“Nurofen is better than paracetamol for common headaches,” declared the advertisements in women’s lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle.”
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The Ebola clinical trials: a precedent for research ethics in disasters

Journal of Medical Ethics 2018;44:3-8.
Author: P Calain
“The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel’s recommendations have challenged conventional thinking about therapeutic development and clinical research ethics.”
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A Federal Ban on Making Lethal Viruses Is Lifted

NYT, 19 December 2017
Author: Donald G McNeil Jr
“Federal officials on Tuesday ended a moratorium imposed three years ago on funding research that alters germs to make them more lethal. Such work can now proceed, said Dr. Francis S. Collins, the head of the National Institutes of Health, but only if a scientific panel decides that the benefits justify the risks.”
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