An Eye Opener on Risk in Our Brave New World

books:


	• Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet Denise Caruso Hybrid Vigor Press, 2006 - 272 pages average customer review:based on 15 reviews view larger image
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highly recommended

Intervention is fantastic

Denise Caruso brilliantly articulates issues around genetic engineering with clarity and insight in Intervention. Everyone who cares about issues of the 21st Century, needs to read this book. - Tiffany Shlain

An Eye Opener on Risk in Our Brave New World

This easy-to-read, cogent analysis of the bio-tech - including genetic engineering - industry serves a critical purpose in the world right now. Denise Caruso brings a diligent journalist ethic to a subject that should have most of us putting pressure on our leaders (business, scientific and political) to insist on more rigor in our decision making process in the better interests of humanity and the environment. While she grounds this in the bio-tech industry, Caruso's warnings and proposed solution (of an analytic deliberative process) are equally relevant to many other highly uncertain, risk-fraught, unfettered science domains. I highly recommend this book.

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A Book That Matters

Intervention in one of those books that wakes you up. Not only did I learn a tremendous amount about the potential risks of genetic engineering, I also gained a new understanding about the process of risk assessment itself. The book is a model of critical thinking, as Caruso questions in a fairminded, non-sensationalistic way fundamental assumptions surrounding the biotech industry and the way genetically engineered products are developed and marketed. As I read Intervention, I kept having "ahas" on two levels. The first involved a growing awareness of how we are increasingly all participants in what amounts to an ongoing series of lab experiments as genetically engineered products are introduced around the globe without fully comprehending what the consequences might be. The second concerned a new understanding of the field of risk assessment and the increasing need for collaborative, cross-disciplinary approaches to problem solving and decision making. This is a rich, engaging, thought provoking work that deserves widespread attention and discussion. I recommend it most highly.

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Asilomar was in 1975. Now what?

In Intervention, Denise Caruso, a columnist for the New York Times, has written an important and timely book. The set of people who need to read it include but are not limited to policymakers and voters in the US, in the affluent world, and in the developing world.

Intervention is mainly about transgenic organisms. One of the numerous unsolved problems people need to tackle this century is devising a workable regulatory framework for transgenic plants and animals, aka genetically modified organisms, aka organisms into which engineers have dropped pieces of DNA. In the US, the existing regulatory regime is a patchwork. The biggest part of the patchwork comes from at the dawn of recombinant DNA work at the Asilomar conference in 1975. Asilomar led directly to the "NIH guidelines". These guesstimated different levels of potential risk for different kinds of recombinant DNA experiments, mandated lab practices and levels of containment to conduct research at each level, and set up bodies for review and approval of experiments local to each university. Asilomar also brought about the establishment of an overarching national body, the Recombinant Advisory Committee (aka RAC) to rule on the appropriate level of containment for contested experiments, and established mechanisms by which levels of containment could be ratcheted up or down in response to information coming from new experiments, which in practice has led to sunset of most of the most burdensome regulations as the feared risks did not materialize. The regulatory framework affected experiments in universities funded by the US government, but was extended to commercial work via local communities. Individual cities caused, via their control of zoning, biotech firms to follow the NIH rules. Most of this "Asilomar framework" governs recombinant DNA research in lab organisms such as E. coli, yeast, and mice. In the US, use of recombinant DNA in people, for example in gene therapy, is regulated by the FDA, and release of an organism into the environment, for example a herbicide-resistant potato or an oil-eating bacterium, is regulated by the EPA.

Recombinant work is also regulated in other advanced countries, but in no country is there a system of local and national oversight as strong as that in the US. And the US framework, 32 years old, is fraying at the seams. It is showing its age by showing gaps. Many of the issues are due to the Moore's-law-like growth in the scope and power of the technologies, the democratization of the technical ability to hack DNA, the adoption of recombinant DNA methods by new classes of hackers , and the use of recombinant DNA to engineer different classes of organisms.

The Asilomar framework was designed to regulate research in universities and, extended by zoning regulations, in companies. The Asilomar framework was not designed for a world in which the number of people with basic training in recombinant DNA methods has increased from hundreds to tens or hundreds of thousands worldwide. For example, in most US localities, the only framework that governs recombinant DNA work by private citizens is that sometimes provided by local zoning regulations; and this at a time when affluent parents can and do outfit labs for their high school aged children.

But perhaps the most public change since Asilomar is the increase in the number of different engineered organisms intended to be used outside of the lab. Here, agriculture has emerged as a flashpoint. Last year most of the dollar value of the US corn, soybean, and cotton crops came from transgenic plants. Although introduction of recombinant crops in Europe is stalled, due in part to old fashioned trade protectionism, worldwide, farmers are planting them everywhere they can, from Brasil, where the Lula regime retroactively legalized herbicide resistant soybean seed in the face of the fact that farmers were enthusiastically smuggling in metric tons of the stuff from Argentina and Paraguay, to China and India, where genetically modified insect-resistant rice seed, probably made by multiple independent firms, has been sold since at least 2005. In agriculture, without outright prohibition, the spread of genetically engineered plants and animals is likely to continue until most species of economic importance have been engineered. But even though farmers may love the stuff, it turns out that people tend to view technologies such the recombinant DNA that enables transgenic plants as affecting their lives. Moreover, many may feel that the changes the technologies are bringing are occurring without their understanding or consent.

In Intervention, Caruso uses this steady increase in the contribution of genetic engineering to the economy as a test case, an example to consider how new technologies might be regulated. The book requires the reader to face the question of what an international regulatory framework for recombinant DNA work and genetic engineering of organisms should look like.

Caruso does not lay out solutions, but she does describes processes for involving larger numbers of stakeholders in decisionmaking, promising tactics to provide additional ways for societies to get a handle on the pace of technical change.

Intervention is not horatory, it is not prescriptive. Caruso raises issues and suggests mechanisms that might help address them, but does not provide a ten point set of solutions. I find this aspect of the book to be a strength, although as a consequence the book leaves the reader with many more questions than answers. Here, I will mention two.

First, at the moment, in the US, a new technology is typically regulated only after has been shown to cause harm, and, by law, the degree of regulation is based on assessed risk, and the assessment of risk is supposed to be based on the best science available. Overall, at least for recombinant DNA, I believe that this conceptual framework for regulation has worked pretty well (To my knowledge there has only been one death directly attributable by recombinant DNA (the child Jesse Gelsinger, who died during an experimental gene therapy trial in the 1990s from a dose of a gene therapy vector that should never have been allowed by the local review committee)). But there are other ideas on which regulation can be based. Should the US exchange this basis for regulation for that used in the EU, grounded in "precautionary principle", derived from German Social Democratic legal theory in the 1930s, even if to do so were to carry a cost of delaying the benefits new technologies might bring?

Second, in part because of the science-based risk assessment mandated in the US, people who feel uneasy about a new technology or who simply dislike it are almost always required to assert that their opposition or unease is due to the fact that the technology presents a risk. Why always talk piously about risk if the real issue that one finds some work of engineering distasteful (Caruso even has a term for this, the "ugh factor")? In a democracy, should widespread dislike, by itself, ever constitute grounds for regulating or even prohibiting a technology? If not, why not?

I hope that the publication Denise Caruso's Intervention marks the start of a broader discussion, one that might help societies gain better control of technical change and its consequences.

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We need more books like this

I am not familiar with genetics, genomics, post genomics and all this stuff, but I read Intervention with a lot of interest, as a guide into the unknown.
I would feel more confident if more scientists understood the problems it raises.
Caruso develops an aproach that, I am convinced, we should encourage. An atitude of openness and cautiousness in front of what's changing and that we don't know. Be there, participate with a critical mind might be the smartest way of entering the future as we make it happen. Be open to all stakeholders knowledge and understanding might be the safest way to move forward.
This is one of the most difficult thing I can think of. But Caruso is of considerable help with the processes she suggests we should adopt.

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reviews: page 1, 2, 3

Recipient of a Silver Medal for science writing in the 2007 Independent Publishers Book Awards, INTERVENTION challenges two of the most sacred tenets of modern society, innovation and technology, from the perspective of the unique risks they present. Using genetic engineering as its model, it paints a vivid picture of the scientific uncertainties that biotech risk evaluations dismiss or ignore, and lays bare the power and money conflicts between academia, industry and regulators that have sped these risky innovations to the market. 'Intervention' champions an alternative method for assessing the risks of technology, developed by the world's top risk experts, that can eliminate such conflicts, help regain public trust in science and government, and drive research and development toward more useful, safer products.

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