The term "gene therapy" encompasses at least four types of application of genetic engineering for the insertion of genes into humans. The scientific requirements and the ethical issues associated with each type are discussed. Somatic cell gene therapy is technically the simplest and ethically the least controversial. The first clinical trials will probably be undertaken within the next year. Germ line gene therapy will require major advances in our present knowledge and it raises ethical issues that are now being debated. In order to provide guidelines for determining when germ line gene therapy would be ethical, the author presents three criteria which should be satisfied prior to the time that a clinical protocol is attempted in humans. Enhancement genetic engineering presents significant, and troubling, ethical concerns. Except where this type of therapy can be justified on the grounds of preventive medicine, enhancement engineering should not be performed. The fourth type, eugenic genetic engineering, is impossible at present and will probably remain so for the foreseeable future, despite the widespread media attention it has received. There are four potential levels of the application of genetic engineering for the insertion of gene into a human being. Somatic cell therapy: this would result in correcting a genetic defect in the somatic (i.e.,body) cells of a patient. Germ line gene therapy: this would require the insertion of the gene into the reproductive tissue of the patient in such a way that the disorder in his or her offspring would also be corrected. Enhancement genetic engineering: this would involve the insertion of a gene to try to "enhance" a known characteristic; for example, the placing of an additional growth hormone gene into a normal child. Eugenic genetic engineering: this is defined as the attempt to alter or "improve" complex human traits each of which is coded by a large number of genes; for example, personality, intelligence, character, formation of body organs, and so on.
{"title":"Human gene therapy: scientific and ethical considerations.","authors":"W F Anderson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The term \"gene therapy\" encompasses at least four types of application of genetic engineering for the insertion of genes into humans. The scientific requirements and the ethical issues associated with each type are discussed. Somatic cell gene therapy is technically the simplest and ethically the least controversial. The first clinical trials will probably be undertaken within the next year. Germ line gene therapy will require major advances in our present knowledge and it raises ethical issues that are now being debated. In order to provide guidelines for determining when germ line gene therapy would be ethical, the author presents three criteria which should be satisfied prior to the time that a clinical protocol is attempted in humans. Enhancement genetic engineering presents significant, and troubling, ethical concerns. Except where this type of therapy can be justified on the grounds of preventive medicine, enhancement engineering should not be performed. The fourth type, eugenic genetic engineering, is impossible at present and will probably remain so for the foreseeable future, despite the widespread media attention it has received. There are four potential levels of the application of genetic engineering for the insertion of gene into a human being. Somatic cell therapy: this would result in correcting a genetic defect in the somatic (i.e.,body) cells of a patient. Germ line gene therapy: this would require the insertion of the gene into the reproductive tissue of the patient in such a way that the disorder in his or her offspring would also be corrected. Enhancement genetic engineering: this would involve the insertion of a gene to try to \"enhance\" a known characteristic; for example, the placing of an additional growth hormone gene into a normal child. Eugenic genetic engineering: this is defined as the attempt to alter or \"improve\" complex human traits each of which is coded by a large number of genes; for example, personality, intelligence, character, formation of body organs, and so on.</p>","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 2","pages":"55-63"},"PeriodicalIF":0.0,"publicationDate":"1985-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14977551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Location of topics in NIH Guidelines for Research involving recombinant DNA molecules.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 2","pages":"76-8"},"PeriodicalIF":0.0,"publicationDate":"1985-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14977552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Overall, the risk assessment data have shown not only that recombinant DNA research using E. coli strains is safe but also that E. coli strains, in general, including K-12 strains, can colonize the mammalian colon in individuals undergoing antibiotic treatment. However, very little is known about how E. coli colonizes the mammalian colon and it is possible that different strains use different adhesins and different colonic receptors in the process. Through the approach described here it has been possible to begin to identify both E. coli adhesins and colonic receptors which may play an important role in the colonization process. Hopefully, continued research into the molecular basis of E. coli colonic colonization will lead to the development of healthy E. coli strains for recombinant DNA research which are unable to colonize the human colon under any circumstance.
{"title":"E. coli colonization of the mammalian colon: understanding the process.","authors":"P S Cohen, D C Laux","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Overall, the risk assessment data have shown not only that recombinant DNA research using E. coli strains is safe but also that E. coli strains, in general, including K-12 strains, can colonize the mammalian colon in individuals undergoing antibiotic treatment. However, very little is known about how E. coli colonizes the mammalian colon and it is possible that different strains use different adhesins and different colonic receptors in the process. Through the approach described here it has been possible to begin to identify both E. coli adhesins and colonic receptors which may play an important role in the colonization process. Hopefully, continued research into the molecular basis of E. coli colonic colonization will lead to the development of healthy E. coli strains for recombinant DNA research which are unable to colonize the human colon under any circumstance.</p>","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 2","pages":"51-4"},"PeriodicalIF":0.0,"publicationDate":"1985-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14001378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Location of topics in NIH guidelines for research involving recombinant DNA molecules.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 1","pages":"32-4"},"PeriodicalIF":0.0,"publicationDate":"1985-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"15115654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Congressional hearing on the adequacy of current statutes and scientific knowledge for the regulation of biotechnology.","authors":"E Milewski","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 1","pages":"7-16"},"PeriodicalIF":0.0,"publicationDate":"1985-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14974285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Legal and regulatory considerations in environmental biotechnology applications.","authors":"T O McGarity","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"1985-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14974283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Proposed addition of prohibited experiments to the NIH guidelines.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 1","pages":"17-28"},"PeriodicalIF":0.0,"publicationDate":"1985-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14974284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Points to consider in the design and submission of human somatic cell gene therapy protocols.","authors":"","doi":"10.1089/blr.1985.4.176","DOIUrl":"https://doi.org/10.1089/blr.1985.4.176","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"8 4 1","pages":"181-6"},"PeriodicalIF":0.0,"publicationDate":"1985-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1089/blr.1985.4.176","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"60840231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Senate hearing on the potential environmental consequences of genetic engineering.","authors":"E Milweski","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77777,"journal":{"name":"Recombinant DNA technical bulletin","volume":"7 4","pages":"189-203"},"PeriodicalIF":0.0,"publicationDate":"1984-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17654664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}