Book contents
- Frontmatter
- Contents
- Acknowledgments
- List of abbreviations
- 1 Introduction: gene transfer lost in translation
- 2 What is gene transfer?
- 3 Safety, values, and legitimacy: the protean nature of risk in translational trials
- 4 Taming uncertainty: risk and gene-transfer clinical research
- 5 Succor or suckers? Benefit, risk, and the therapeutic misconception
- 6 Looking backward: a model of value for translational trials
- 7 The chasm: the ethics of initiating first-in-human clinical trials
- 8 Tropic of cancers: gene transfer in resource-poor settings
- 9 Great Expectations and Hard Times: expectation management in gene transfer
- 10 Something in the sight adjusts itself: conclusions
- Epilogue
- Index
2 - What is gene transfer?
Published online by Cambridge University Press: 28 January 2010
- Frontmatter
- Contents
- Acknowledgments
- List of abbreviations
- 1 Introduction: gene transfer lost in translation
- 2 What is gene transfer?
- 3 Safety, values, and legitimacy: the protean nature of risk in translational trials
- 4 Taming uncertainty: risk and gene-transfer clinical research
- 5 Succor or suckers? Benefit, risk, and the therapeutic misconception
- 6 Looking backward: a model of value for translational trials
- 7 The chasm: the ethics of initiating first-in-human clinical trials
- 8 Tropic of cancers: gene transfer in resource-poor settings
- 9 Great Expectations and Hard Times: expectation management in gene transfer
- 10 Something in the sight adjusts itself: conclusions
- Epilogue
- Index
Summary
Introduction
Gene transfer researchers and others with historical inclinations like to describe an experiment performed by virologist Stanfield Rogers in the early 1970s as the first attempted gene transfer in human subjects.The Oak Ridge National Laboratories scientist had observed that Shope papilloma virus infections, which normally cause warts, also depress blood serum levels of the amino acid arginine in rabbits. Studies also showed that workers handling the virus also had lower serum arginine. Rogers then postulated that the virus contains a gene that codes for the enzyme arginase, which breaks down arginine
Around the same time the German physician H. G. Terheggen in Cologne encountered a series of patients with various neurological impairments due to a deficiency in the enzyme arginase. On learning of the report, Rogers contacted Terheggen and proposed administering the virus to patients with the enzyme deficiency. The study, notwithstanding its bold vision, proved unsuccessful in either improving disease symptoms or in producing biological insights. In fact, the virus used in the experiment “degenerat[ed]… in storage,” and much later studies revealed that in fact the virus did not encode arginase after all.
There is, of course, a sense in which the conceit behind contemporary gene transfer can find precedent in this episode. But Rogers's experiment predated recombinant DNA technologies, which emerged in the mid 1970s and enabled manipulation of genetic sequences. It also predated the development of a biotechnology industry, or the knowledge economy, or the emergence of the “triple helix” configuration of universities, the private sector, and the government.
- Type
- Chapter
- Information
- Gene Transfer and the Ethics of First-in-Human ResearchLost in Translation, pp. 8 - 30Publisher: Cambridge University PressPrint publication year: 2009