Kristin Hagen

The role of means and goals in technology acceptance. A differentiated landscape of public perceptions of pharming.

Most pharmaceuticals are either chemically synthesized small molecules or are derived directly from natural sources such as plants and human blood. An increasing number of drugs comprising recombinant proteins, antibodies and nucleic acids are also produced in living organisms that have been genetically engineered for the purpose (Walsh, 2006). In parallel to this growing market of so‐called biopharmaceuticals (Lawrence, 2007; Ledford, 2006), research has focused on the development of improved production platforms, notably genetically modified plants and animals. Recombinant biopharmaceuticals have, for example, been expressed in maize kernels, tobacco leaves, goats milk and chicken eggs (Giddings et al , 2000; Dove, 2000). The production of recombinant pharmaceutical proteins in higher organisms is termed ‘pharming’, a portmanteau of pharmaceuticals and farming, which reflects the combination of ‘red’ (biomedical and/or pharmaceutical) and ‘green’ (agricultural and/or food) biotechnology. The idea behind pharming is that it will enable the faster, more flexible and cost‐effective production of pharmaceuticals compared with current synthetic production processes. The use of recombinant DNA technology to alter organisms for a specific purpose has raised its fair share of controversy. While initial public resistance to producing biopharmaceuticals in lower organisms has largely disappeared—for instance, synthesizing human insulin in bacteria—there is still considerable opposition to genetically modified higher organisms and their use in agriculture or medicine. In light of the often hostile public reaction to other applications of biotechnology, a better understanding of the publics views and attitudes to pharming might help to guide the interaction of the research community and industry with the public at large. > …a better understanding of the publics views and attitudes to pharming might help to guide the interaction of the research community and industry with the public at large Here, we present public perceptions of plant and animal pharming in 15 advanced industrial societies—12 European …

Synthetic Biology: Public Perceptions of an Emergent Field

We analyze some of the issues that synthetic biology raises for the social sciences within the “public perceptions of science” framework. The changing roles of public perceptions in policy making are described in relation with changes in the institutional and cultural contexts of science. We take a closer look at the available empirical evidence about public views on synthetic biology against the background of what is known about public perceptions of biotechnology more generally. Many vectors influence public attitudes to biotechnology, notably risk perceptions, tradeoffs between goals and means, ethical views, and trust in science and regulatory institutions. Attitudes are also associated with frames, symbols and worldviews. One of the central worldviews that affects subsets of the life sciences is the current vision of nature: many people are aware of problematic aspects of economic growth that makes intensive use of science and technology, and there is therefore sensitivity to scientific progress that further challenges the boundaries of “natural” processes and objects. Synthetic biology has components in potential conflict with the public’s preference for “naturalness” in many areas, although this is at present dormant due to the low salience of synthetic biology in the media and public.

The technology of pharming

In 1977 scientists succeeded in introducing the first human gene into a microorganism in order to produce a genetically engineered human protein. This “advent of biotechnology” took place only one decade after the discovery of the genetic code, which describes the connection between genes and the formation of proteins. The production of proteins by genetic engineering involves the incorporation of a foreign (often human) gene into an organism’s or a cell’s own genome. The genetically modified living system can then express so-called ‘recombinant’ proteins – it becomes a living “protein expression system”. Well-established expression systems for pharmaceutical proteins include fermenter-grown genetically modified Escherichia coli, baker’s yeasts (Saccharomyces cerevisiae) or Chinese hamster ovary (CHO) cell cultures. Proteins are linear chains of amino acids. Information about the sequence of each protein is encoded by the DNA of a gene. Expression of a protein commences when a gene is copied (transcribed) from a point termed the promoter, producing a messenger molecule or RNA. RNA is then processed to remove the non-coding regions or introns, and transported to the protein synthesis machinery. Here it is read (translated) and determines the amino acids added to a new protein molecule. Different cells require different proteins and therefore express different genes. The expression of a particular gene is controlled by the interaction of factors within the cell and DNA sequences associated with the gene. These regulatory elements include the promoter and others termed enhancers (see figure 2.1).

The New Worlds of Synthetic Biology—Synopsis

Synthetic biology is a young and heterogeneous field that is constantly on the move. This makes societal evaluation of synthetic biology a challenging task and prone to misunderstandings. Confusions arise not only on the level of what part of synthetic biology the discussion is on, but also on the level of the underlying concepts in use: concepts, for example, of life or artificiality. Instead of directly reviewing the field as a whole, in the first step we therefore focus on characteristic features of synthetic biology that are relevant to the societal discussion. Some of these features apply only to parts of synthetic biology, whereas others might be relevant for synthetic biology as a whole. In the next step we evaluate these new features with respect to the different areas of synthetic biology: do we have the right words and categories to talk about these new features? In the third step we scrutinize traditional concepts like “life” and “artificiality” with regard to their discriminatory power. Lastly, we utilize this refined view for ethical evaluation, risk assessment, analysis of public perception and legal evaluation. This approach will help to differentiate the discussion on synthetic biology. By this we will come to terms with the societal impact of synthetic biology.

Editorial: Ambivalences in Societal and Philosophical Dimensions of Synthetic Biology

In this editorial, we situate the 17 chapters of the book in the context of ambivalences of synthetic biology: the uses of the label, the significance of the associated metaphors and visions, critical and public engagement, and reasons for unease. Hype and metaphors in synthetic biology may sometimes skew the debate, but they should nevertheless not be ignored: a balanced, realistic view of synthetic biology includes acknowledgment of the variety of research agendas and visions. The goals and agendas underlying engagement and evaluative activities are important aspects, too: in some cases, they are designed to increase acceptance. This can be a source of unease. Another major source of persistent unease is that synthetic biology takes to further extremes the worldview that allows humans to put life under their disposal. Is quoting grand visions for synthetic biology a good way to begin a book about its societal implications? Metaphors such as “living machines” and “digitizing life” have been ubiquitous in synthetic biology, but with ambivalent effects. For synthetic biology, on the one hand, futuristic—even biblical—visions have helped to establish the field and secure funding. On the other hand, the field needs to deliver; and vivid metaphors as well as “newness” make it an obvious subject for critical voices and regulatory initiatives. Beyond this political dimension, hype and metaphors of synthetic biology—including the label itself—have been inspiring for more nuanced evaluative efforts.

Legal problems of pharming

The regulatory framework of pharming is highly complex. As regards the sources of regulation, one must distinguish between European and national levels. The various phases of pharming, from the initial development to the authorization procedure to final manufacturing, are partly subject to different legal rules. In addition, the various regulatory issues at the relevant stages are addressed by different pieces of regulation. The following text is organized so as to follow the “life cycle” of pharming products. When appropriate, the phases are further divided into segments according to the regulatory issues arising and the type of regulation concerned. The following overview provides an initial orientation.