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Published online by Cambridge University Press: 17 May 2016
Though not the first attempt to ameliorate a human genetic disease by modifying somatic cells, the experiments performed by Dr. Martin J. Cline on two women suffering from thalassemia (one in Jerusalem, the other in Naples) were the first and still the only ones to use rDNA techniques.1 In some respects the criticism and censure of Cline by the NIH resembles the case of Dr. Ian T. Kennedy.2 Both Cline and Kennedy were found guilty of having violated the NIH Guidelines for Research Involving Recombinant DNA Molecules, but there is a crucial difference between the two cases. Cline attempted to implant genetically altered cells into human beings. Consequently, his work involved moral issues concerning the use of human subjects in biomedical experiments which go beyond the usual concerns over safety and control in rDNA research. In fact, I shall argue that the rDNA aspect of the Cline affair was relatively minor compared with the moral reasoning which guided the actions and judgments of Cline and his critics. Despite its importance for understanding the behavior of the participants, this ethical dimension does not receive adequate emphasis in Robin and Markle's account of the Cline episode within the framework of their four sociological perspectives (substantive, network, organizational, societal).
1. In 1970 two West German girls suffering from hyperargininemia were deliberately infected with Shope papilloma virus (Schmeck, Jr., 1970). It was believed that the virus might contain a gene for the enzyme arginase. It is now thought that virus does not code for the enzyme but merely stimulates the production of arginase in cells that already possess the capacity to produce it. The experiment was a controversial failure. The patients (ages 2 and 7) were too young to give their informed consent—the disease had already caused mental retardation and other serious health problems in the elder girl—and its scientific rationale was questionable.Google Scholar
2. See the issues of Science of September 5, 1980; September 26, 1980; and April 3, 1981. See also New Scientist, March 26, 1981.Google Scholar
3. According to Cline, the University Poly Clinic in Naples “used a more informal procedure [than that employed by the Hadassah Hospital in Jerusalem]' but still took steps to insure that the patient was informed of risks and that the potential benefits outweighed any possible harm” (Jacobs, , 1980).Google Scholar
4. This has since been changed. Section III-A-4 of the NIH Guidelines for Research Involving Recombinant DNA Molecules now requires RAC review for all experiments that involve the “deliberate transfer of recombinant DNA or DNA derived from recombinant DNA into human subjects.” The RAC added the second disjunct in order to cover experiments like Cline's original protocol where the DNA would be cleaved from its vector before being introduced into the human subject, and hence no longer qualify as “recombinant DNA” (Recombinant DNA Research, 1985).Google Scholar
5. Anderson, (1984) notes that the plasmid-based, calcium phosphate procedure has still not been shown to be an effective delivery system, though the risk of harm now appears to be slight. Many researchers now favor alternative delivery systems such as modified retroviruses. Because of the complexity of the regulatory system which controls the expression of beta-globin genes, attention is now focussed on Lesch-Nyhan disease and immunodeficiency disorders (Schmeck, Jr., 1984).Google Scholar