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"The need in science studies and anthropology for "Asian Biotech" would be hard to overstate. I was hungry for this book to use in my own teaching and writing, and the meal is as satisfying as I had anticipated. The theoretical framing is astute and generative, and the well-argued and diverse essays are thoroughly fleshed out historically and ethnographically. Nancy N. Chen, Aihwa Ong, and the contributors deserve our thanks. We have just run out of excuses for ongoing Western parochialism in science and technology studies and all of our kindred inquiries into biotechnology."--Donna Haraway, author of "When Species Meet"

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ASIAN BIOTECH

Duke University Press

Contents

Acknowledgments......................................................................................................................................viiIntroduction: An Analytics of Biotechnology and Ethics at Multiple Scales AIHWA ONG.................................................................1The Experimental Machinery of Global Clinical Trials: Case Studies from India KAUSHIK SUNDER RAJAN..................................................55Feeding the Nation: Chinese Biotechnology and Genetically Modified Foods NANCY N. CHEN..............................................................81Asian Regeneration? Nationalism and Internationalism in Stem Cell Research in South Korea and Singapore CHARIS THOMPSON.............................95Medical Tourism in Thailand ARA WILSON..............................................................................................................118Near-Liberalism: Global Corporate Citizenship and Pharmaceutical Marketing in India STEFAN ECKS.....................................................144Governing through Blood: Biology, Donation, and Exchange in Urban China VINCANNE ADAMS, KATHLEEN ERWIN, AND PHOUC V. LE.............................167Lifelines: The Ethics of Blood Banking for Family and Beyond AIHWA ONG..............................................................................190Embryo Controversies and Governing Stem Cell Research in Japan: How to Regulate Regenerative Futures MARGARET SLEEBOOM-FAULKNER.....................215Making Taiwanese (Stem Cells): Identity, Genetics, and Hybridity JENNIFER A. LIU....................................................................239Chinese dna: Genomics and Bionation WEN-CHING SUNG..................................................................................................263Afterword: Asia's Biotech Bloom NANCY N. CHEN.......................................................................................................293Bibliography.........................................................................................................................................301Contributors.........................................................................................................................................319Index................................................................................................................................................323

Chapter One

The Experimental Machinery of Global Clinical Trials | CASE STUDIES FROM INDIA

In earlier work, I have written about emergent systems of technoscientific production, value generation, and commodity circulation that concern the life sciences under the rubric of what might be called "biocapital," focusing on the sequencing of the human genome and the science of genomics that was emerging around this venture. The study of clinical trials is a necessary follow-up to the study of genomics in a project on biocapital.

This is because, first, within the biomedical process itself, clinical trials are often consequent to technologies such as genomics. Genomics is important to the drug discovery process-it potentially allows for the rational screening and identification of promising lead molecules that could conceivably have a therapeutic effect. This is the "upstream" or early-stage component of therapeutic development, but it is only distantly related, epistemologically and temporally, to the production of a therapeutic molecule. Clinical trials, on the other hand, constitute the "downstream" or drug development component of the process of therapeutic development. There is no way that any new drug molecule can come to market without a series of trials for safety and efficacy in animals and humans. Clinical trials therefore constitute the experimental machinery of biocapital: they are necessary to conduct before a drug comes to market, are particularly elaborate in the context of the U.S. regulatory framework, and are in themselves cost-intensive and high-risk with no guarantee of success.

Clinical trials constitute the set of practices required to certify a new drug molecule as safe and efficacious for the market. This set of practices serves in its rationale as a regulatory watchdog to prevent the market from being flooded with unsafe or spurious medication. In the United States, the clinical trials procedure is an elaborate one, occurring in four stages and contributing to the immense time, risk, and expense of the drug development process.

The stages of clinical trials are as follows: First, there is preclinical toxicological testing of a potential new drug molecule. This is usually performed on animals, in order to determine whether the molecule being tested is safe enough to put into a living system. This is followed by dosage studies, in order to come up with a metric that relates the dose of the drug being administered to safety and efficacy. Predictably, the efficacy of a drug increases with its dose, but so too does its toxicity, so the attempt is to find an optimum range of doses within which efficacy is maximized without compromising safety too much. If the drug is found too toxic to animals, the trial will not proceed any further, but if acceptable dose ranges can be determined within animals, then it proceeds to a three-phase trial in humans. Phase 1 trials are conducted on a small number of healthy volunteers to test the basic safety of the drug (since drugs that seem safe in animals may yet show adverse effects in humans). Phase ii involves scaled-up, larger, efficacy and safety trials on one hundred to three hundred patients. Phase iii trials are large-scale, randomized trials that may be conducted on a few thousand people, usually patients suffering from the ailment for which the therapy has been developed. These trials are usually coordinated across multiple centers, often (increasingly) globally.

Most trial sponsors are biotechnology or pharmaceutical companies because drug development in the United States (and in most parts of the world) is largely undertaken by the private sector. Universities and publicly funded laboratories in the States do play an enormous role in early-stage drug discovery-the identification of potential lead molecules and the conduct of early preclinical tests, but the institutional structure of drug development is such that they invariably license promising molecules to corporations in order to take them through clinical trials. This means that the biomedical and experimental rationales for clinical trials are completely entwined with the market value that these companies see from the drugs that eventually get developed, and with the market risk that attends the drug development process. Parenthetically, there is no epistemic reason why the drug development process should be so completely in the private sector, though this has become a naturalized facet of the biomedical economy, and is one of the factors that has allowed the seamless appropriation of health as an index whose value can be purely evaluated in terms set by the market. According to the Healthcare Financial Management Association's newsletter, "Twenty years ago, 80 percent of clinical research trials were conducted through academic medical centers. In 1998, estimates indicated the number of academic medical centers as investigator sites had dropped to less than half." Health research and production is thus progressively captured by...