Science and Social Context

Science and Social Context: The Regulation of Recombinant Bovine Growth Hormone in North America

Copyright Date: 2002
Pages: 224
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  • Book Info
    Science and Social Context
    Book Description:

    She examines the decision-making processes at Monsanto that led to their making the drug available and discusses corporate, academic, and regulatory decision-making in the context of a restructured global political economy for agriculture. Mills shows that there was consensus about the scientific evidence but interpretation of that evidence differed depending on the context from which it was viewed. Scientists who analysed it for regulatory bodies interpreted it differently than scientists in corporate or academic institutions, and scientists in Canada and Europe interpreted it differently than those in the United States. In the United States it was assumed that any problems arising from its use could be taken care of within the existing dairy system; in Canada and Europe these problems were regarded as legitimate animal welfare issues. While all regulatory bodies agreed that human health problems were unlikely, in Canada the Health Protection Branch questioned this, but ultimately rejected the drug on animal health grounds.

    eISBN: 978-0-7735-7027-6
    Subjects: General Science

Table of Contents

  1. Front Matter
    (pp. i-iv)
  2. Table of Contents
    (pp. v-vi)
  3. Acknowledgments
    (pp. vii-viii)
  4. Chronology
    (pp. ix-xii)
  5. Acronyms
    (pp. xiii-2)
  6. 1 Overview
    (pp. 3-16)

    On 14 January 1999 Health Canada rejected Monsanto’s application to license recombinant bovine growth hormone (rbGH) in Canada. (The drug is also known as recombinant bovine somatotropin (rbST) or simply as bovine somatotropin (bST)).¹ The product is developed using recombinant DNA (rDNA) technology, a form of biotechnology. When injected into lactating dairy cows, the product results in a 10 to 15 percent increase in milk production.² In the early 1980s four multinational chemical and pharmaceutical companies competed to bring the product to market — Monsanto, a chemical corporation turned biotechnology company based in St Louis, Missouri; Elanco, the animal products division...

  7. 2 The Economic Context: The Political Economy of Agricultural Biotechnology
    (pp. 17-52)

    The purposes of this chapter are threefold. First, it sets out the economic context by providing an overview of the development of the biotechnology industry in the United States, and its facilitation by government policies. The success of the biotechnology industry was regarded as crucial to the United States’ economic future. Although government policy fostered the creation of the industry in the 1990s, agricultural biotechnology came to be dominated by multinational corporations such as Monsanto that were exporting their innovations and investing in seed companies and biotechnology firms located around the globe. However, protests by the environmental movement and subsequent...

  8. 3 The Political Context in the United States
    (pp. 53-76)

    In 1993 the Food and Drug Administration in the United States concluded that rbGH was safe for cows and for the humans who drink their milk; any indirect risk to human health from animal health problems could be managed within the existing milk monitoring system. The reasoning behind this decision is explored in chapter 5; the purpose of this chapter is to outline the context in which the FDA conducted its evaluation of rbGH.

    During the period of the evaluation, the FDA was subject to two major pressures. The manufacturers of the product were eager to have it approved because,...

  9. 4 The Political Context in Canada
    (pp. 77-102)

    In Canada, the Bureau of Veterinary Drugs within Health Canada rejected the drug rbGH on animal health grounds. Canadian regulators, like their u.s. counterparts, found that the drug did not represent a threat to human safety. However, scientists within the bureau who had not been involved in the human health review questioned this decision. As will be explored further in chapter 5, these scientists were concerned that there was insufficient evidence on which to base the human health decision and that some of the data contradicted the conclusions on which the decision had been based. The internal - and external...

  10. 5 The Scientific Debate
    (pp. 103-142)

    Since the late 1980s, the public debate about rbGH has focused on safety issues. Would milk from treated cows be safe to drink? Would its consumption lead to an increased risk of breast or other cancers? If animals become sick when treated with rbGH, will people consuming their milk also be affected?

    In spite of the ferocity with which these issues were argued, there was a surprising degree of consensus about the scientific issues involved.¹ It was agreed that the evidence showed little likelihood of risk to human health; however, it was also argued that the existing data were insufficient...

  11. 6 Conclusion
    (pp. 143-160)

    In assessing the scientific evidence regarding the safety and effectiveness of rbGH, scientists within the company, the FDA, Health Canada, and the universities operated on the basis of existing scientific knowledge when assessing both animal and human health. The approval of the drug in the United States can best be explained as the result of a regulatory system in which the studies requested and the interpretation of the data were derived from a conventional scientific framework. I am using the term “conventional” here in Thomas Kuhn’s sense to refer to science that has been accepted by an established scientific community...

  12. Notes
    (pp. 161-172)
  13. Bibliography
    (pp. 173-204)
  14. Index
    (pp. 205-207)