The goal of this book in one sentence:
This volume reveals the major challenges involved in securing populations pharmaceutically and explores how governments are designing extensive new medical countermeasure regimes to overcome those challenges. At the heart of this pharmaceutical turn in security policy, I argue, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in—including the way we now imagine and practice security.The author explains the pharmaceutical defenses for a global pandemic, and specially describes the case of Tamiflu.
The idea of “medical countermeasures” is also fascinating, secondly, because of the terminology it musters. The concept textually embodies the progressive epistemic fusion of the two professional fields of medicine (“medical”) and security (“countermeasures”), attempting to seamlessly blend key vocabularies from both communities into a single notion. Here the term begins to form a fascinating intersection, or bridge, between these two different social fields, giving rise in the process to a fascinating new and interdisciplinary policy space where the respective concerns of pharmaceuticals and security begin to interpenetrate each other, and can also come into direct tension with one another.The chapter 4 is specially of interest: The Margin Call for Regulatory Agencies and explains what was done in the Tamiflu case.
A cursory review of the FDA approval processes for Tamiflu paints a fairly uneventful picture. In fact, the sequence of events leading up to FDA approval for Tamiflu can be quickly summarized. A month after the Swiss approval, on 27 October 1999, the FDA approved Tamiflu for “the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than 2 days” (FDA 1999b). This marketing approval process unfolded rapidly according to the priority review procedure—within six months—following Roche’s initial application for FDA approval on 29 April 1999.
Again, the case of Tamiflu has been highly instructive. It showed that this new pharmaceutical intervention could only be designed after scientists had first gained a much better understanding of the precise molecular processes involved in viral replication unfolding inside the human body—especially the role played by the influenza virus’s surface proteins such as neuraminidase. Once scientists had understood the vital role played by the neuraminidase and decoded its precise molecular structure, they discovered a “static” site that could form the basis for a new drug target. Scientists could then set about the task of deliberately designing an “artificial” molecule that would bind to that critical site in the neuraminidase and that could inhibit its key role in the process of viral replication. In that sense, our technical ability to develop new pharmaceutical defenses is itself dependent upon a prior—and deeper—scientific understanding of the life processes unfolding at the scale of the molecular.The case of covid-19 began without any countermeasure, because molecular knowledge started mid-January once it was sequenced. Nowadays, we can only wait for a successful vaccine and therapy.
