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ORGANISATIONAL HAZARDS IN BIOTECHNOLOGY — TOWARDS A NEW RISK ASSESSMENT PROGRAM
Abstract
Great progress in the field of recombinant DNA technology has masked concern about the safety of the procedures involved. It seems that those carrying out oncogene research using these techniques may be exposed to considerable danger of contracting cancer. A thorough program to assess the risks involved is required to replace the complacency of ignorance which now exist, and it is required before rather than after damage is done.
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NOTES AND REFERENCES
For a description of this conference and the concerns prevalent at the time see Michael Rogers, ‘The Pandora's box congress’, Rolling Stone, June 1975, reprinted in James D. Watson and John Tooze (eds), The DNA Story: A Documentary History of Gene Cloning, Freeman, San Francisco, 1981, pp. 28–40.
This is evident in the editorial segments and the documents contained in Watson and Tooze, op. cit., note 1.
Robert Walgate, ‘Inquiry into laboratory's bone cancers’, Nature, 321, June 1986, p. 643; Anon., ‘Fears for gene engineers’, New Scientist, 12 June 1986, p. 19.
‘Pasteur Institute invites worldwide help to track recombinant DNA laboratory cancer risk’, Biotechnology Newswatch, 21 July 1986, pp. 1–2.
For an account of the political lobbying that led to a relaxation of the guidelines see Watson and Tooze, op. cit., note 1, chapter 6.
John Elkington, The Gene Factory: Inside the Biotechnology Business, Century, London, 1985; Joan Fujimura, ‘Constructing doable problems in cancer research’, Social Studies of Science (forthcoming).
Rogers, op. tit., note 1, quotation on p. 30.
Sherwood Gorbach, ‘Recombinant DNA: An infectious disease perspective’, Journal of Infectious Diseases, 137, May 1978, pp. 615–23.
Department of Health, Education and Welfare, ‘NIH-EMBO workshop to assess risks of recombinant DNA experiments involving the genomes of animal, plant and insect viruses’, Federal Register, 43, 63, 1978, pp. 13748–55.
H.W. Chan, M.A. Israel, C.F. Garon, W.P. Rowe and M.A. Martin, ‘Molecular cloning of polyoma virus DNA in E.coli: plasmid vector system’, Science, 203, March 1979, pp. 883–92; M.A. Israel, H.W. Chan, M.A. Martin and W.P. Rowe, ‘Molecular cloning of polyoma virus DNA in E.coli: oncogenicity testing in hamsters’, Science, 205, September 1979, pp. 1140–2.
Department of Health and Human Services, ‘Final plan for a program to assess the risks of recombinant DNA research’, Federal Register, 46, 111, 1981, pp. 30772–8. See in particular p. 30779.
‘Workshop on recombinant DNA risk assessment, Pasadena, California’, Recombinant DNA Technical Bulletin, 3, 3, 1980, pp. 111–28.
Stuart B. Levy and Bonnie Marshall, ‘Survival of E.coli host-vector systems in the human intestinal tract’, Recombinant DNA Technical Bulletin, 2, 2, 1979, pp. 77–80; Stuart B. Levy, Bonnie Marshall and Andrew Onderdonk, ‘Survival of E.coli host-vector systems in the mammalian intestine’, Science, 209, July 1980, pp. 391–4.
Susan Wright, ‘Recombinant DNA policy: from prevention to crisis intervention’, Environment, 21, 9, 1979, pp. 34–7.
Sheldon Krimsky, Genetic Alchemy: The Social History of the Recombinant DNA Controversy, MIT Press, Cambridge, 1982.
Barbara Rosenberg and Lee Simon, ‘Recombinant DNA: have recent experiments assessed all the risks?’, Nature, 282, December 1979, pp. 773–4.
Ditta Bartels, Hiroto Naora and Atuhiro Sibatani, ‘Oncogenes, processed genes and safety of genetic manipulation’, Trends in Biochemical Sciences, 8, 3, 1983, pp. 78–80.
Ditta Bartels, ‘Oncogenes: implications for the safety of recombinant DNA work’, Search, 14, 3/4, 1983, pp. 88–92; Ditta Bartels, “Occupational hazards in oncogene research’, Genewatch, 1, 5/6, 1984, pp. 6–8.
Tony Hunter, ‘The proteins of oncogenes’, Scientific American, 251, August 1984, pp. 60–9.
Robert A. Weinberg, ‘A molecular basis for cancer’, Scientific American, 250, November 1983, pp. 102–16.
C. Shih and R.A. Weinberg, ‘Isolation of a transforming sequence from a human bladder carcinoma cell line’, Cell, 29, 1982, pp. 161–9.
H. Land, L.F. Parada and R.A. Weinberg, ‘Tumorigenic conversion of primary embryo fibroblasts requires at least two co-operating oncogenes’, Nature, 304, August 1983, pp. 596–606.
Y.K.T. Fung, L.B. Crittenden, A.M. Fadly and H.J. Kung, ‘Tumor induction by direct injection of cloned v-src DNA into chickens’, Proceedings of the National Academy of Sciences USA, 80, January 1983, pp. 353–7.
For the sake of simplicity I have concentrated here on the effect of oncogene DNA per se. More recent work, particularly that conducted by Adams, Cory and their colleagues at the Walter and Eliza Hall Institute in Melbourne, shows that when certain genetic control elements (called enhancers) are linked to oncogenes, the combined sequence invariably leads to cancer in animals when embryos are injected with such combined sequences. These research findings, though exciting with regard to advances in the field, nevertheless point to additional safety problems for those who manipulate oncogene material. The relevant reference is J.M. Adams, A.W. Haris, C.A. Pinkert, L.M. Corcoran, W.S. Alexader, S. Cory, R.D. Palmiter and R.L. Brinster, ‘The c-myc oncogene driven by immunoglobulin enhancers induces lymphoid malignancy in transgenic mice’, Nature, 318, December 1985, pp. 533–8.
J.A. Lautenberger, D. Court and T.S. Papas, ‘High level expression in E.coli of the carboxy-terminal sequences of the avian myelocytomatosis virus (MC29) v-myc protein’, Gene, 23, 1983, pp. 75–84; J.A. Lautenberger, L. Ulsh, T.Y. Shih and T.S. Papas, ‘High level expression in E.coli of enzymatically active Harvey Sarcoma virus p21ras protein’, Science, 221, 1983, pp. 858–60.
Workshop on Recombinant DNA Risk Assessment, Pasadena, California, op. cit., note 12.
The various lines of argument are depicted in both the editorial comments and the documents found in Watson and Tooze, op. cit., note 1.
Indeed, as was noted before, it was reported recently that five molecular biologists who worked on cancer research at the Pasteur Institute became ill with cancer at the same time. See notes 3 and 4 above.
Michael Bishop J.. 1982. . ‘Oncogenes’. . Scientific American . , Vol. 246: March;: 69––78. .
Department of Health, Education and Welfare. . 1980. . ‘Guidelines for reseach involving recombinant DNA molecules’. . Federal Register . , Vol. 45((20)): 6732––8. .