H U M A N G E N E T H E R A P Y 1:49-54 (1990) Mary Ann Liebert, Inc., Publishers
H u m a n G e n e T h e r a p y , the Public, a n d Public Policy
THOMAS H. MURRAY
ABSTRACT The public's involvement in the debate over human gene therapy is used to illustrate two points. First, complex bioethical issues often come to the public's attention because of a scandal, in this case the Cline episode; enlightened discussion and public understanding are difficult to achieve under these conditions. Second, even with unfavorable circumstances at the outset, the debate can become channeled into politically responsible institutions which then can develop effective public policy. For gene therapy, four significant forums emerged: the President's Commission's Report Splicing Life, the 1982 Congressional Hearings, the O T A Report, and the R A C ' s Points to Consider document.
OVERVIEW S U M M A R Y Public involvement in the debate over human gene therapy has taken several forms. Public policy relating to emotional issues is seldom established by dispassionate discussion, and this has been true also for gene therapy. Murray points out that serious discussions began in earnest only after the unauthorized Cline experiment. There was also a great deal of rhetoric by Jeremy Rifkin and others. In spite of, or because of, the rhetoric, a reasonable and workable public policy has emerged.
I T is unlikely that any proposed medical therapy has ever received more public attention and prior scrutiny than that lavished on human gene therapy. Before launching a brief analysis of public involvement in the debate over human gene therapy, I want to propose a two-part thesis meant to be provocative. First, when complex bioethical issues such as human gene therapy come to public attention, they commonly do so in a form and in a forum unconducive to dispassionate discussion and deepened understanding. The second part may seem paradoxical: Despite the unfavorable circumstances under which these issues enter public debate, (or is it because of the unfavorable circumstances?) debate and decision making get channeled into politically responsi-
Center for Biomedical Ethics, Case Western Reserve University School of Medicine, Cleveland, O H 44106. 49
MURRAY ble (if not necessarily politically responsive) institutions. With human gene therapy as the case study, let us begin with part one of the thesis—that it came before the public in a manner unfavorable to informed, rational debate. The beginnings were certainly inauspicious enough. In keeping with the recent practice in matters bioethical, h u m a n gene therapy came to the fore thanks to a scandal—Martin Cline's premature, unapproved experiment.(1) (The National Commission that had been established to suggest ways of protecting the h u m a n subjects of research had itself been set up as a response to a scandal involving apparently unethical research in this country that had recently c o m e to light. Cline had run afoul of the regulations growing out of that Commission's work.) Scandals are very effective at getting the public's attention, but not so useful for informing them or fostering enlightened discussion and decisions. B y tarnishing the image of scientific researchers, and establishing an association between shady, illicit dealings and the idea of h u m a n gene therapy, the Cline affair could have done little good for public understanding of the ethical issues in h u m a n gene therapy. But, it did succeed in bringing the prospect of such genetic manipulation in humans out ofthe realm of science fiction and into the public consciousness as a plausible, not-too-distant perhaps, reality. O n June 20,1980, the General Secretaries ofthe National Council of Churches, the Synogogue Council of America, and the United States Catholic Conference—main-line organizations representing the three most populous religious groups in the country—wrote a letter to then-President Carter expressing a number of concerns at the prospect of an explosion in genetic engineering, including intervention into the h u m a n genome.(2) Their concerns included the possible misuse of these n e w powers in the n a m e of eugenics, the inadequacy ofthe profit motive for constructing just social policies, and the need to have public interests represented as key decisions are m a d e about the future uses of recombinant D N A . This letter prompted the President to ask the newly established President's Commission to investigate these issues, leading in November, 1982, to the report Splicing Life. Along with such carefully modulated efforts by religious organizations came additional calls for attention and action. A number of people, including a small but influential group of scientists, attempted to arouse public interest in genetic engineering generally and h u m a n gene therapy in particular. In all probability, the person most successful in that endeavor has been Jeremy Rifkin, w h o has combined legal maneuvers with an u n c o m m o n ability to create headlines. T i m e and again, Rifkin has managed to attract the interest of the press, creating a flurry of news reports about some aspects of recombinant D N A . H e has even, on occasion, managed to obstruct specific projects. H u m a n gene therapy has not escaped his attention. In June, 1983, Rifkin's Foundation for Economic Trends released a resolution signed by a remarkable variety of over 50 religious leaders (from Jerry Falwell to officials of m a n y mainstream Jewish, Catholic, and Protestant religious organizations) and a handful of scientists. The resolution concluded: "Resolved, That efforts to engineer specific genetic traits into the germline ofthe h u m a n species should not be attempted. "(3) The language of the resolution itself is fairly temperate, making statements such as "no individual, group of individuals, or institutions can legitimately claim the right or authority to m a k e such decisions on behalf of the rest of the species alive today or for future generations." The same cannot be said for the document accompanying the resolution, a paper with the portentous title, "The Theological Letter Concerning the Moral Arguments Against Genetic Engineering of the H u m a n Germline Cells." With no attribution of authorship, the "letter" is a mixture of cogent 50
PUBLIC POLICY arguments and bald rhetoric. For example, the spectre of Nazi eugenic programs is raised and we are warned that "[w]hile professional ethicists watch out the front door for tell tale signs of a resurrection of the Nazi nightmare, eugenics doctrine has quietly slipped in the back door. The n e w eugenics is commercial not social. In place ofthe shrill eugenic cries for racial purity, the n e w commercial eugenics talks in pragmatic terms of medical benefits and improvement in the quality of life. The old eugenics was steeped in political ideology and motivated by fear and hate. The n e w eugenics is grounded in medical advance and the spectre of extending the h u m a n life span."(4) O n careful reading, this passage dissolves into incoherence. For one thing, it skipsrightover the distinction between positive and negative eugenics m a d e earlier in the same paper. For another, it introduces the notion of "commercial" eugenics, with the negative connotation commercialism has had in m u c h of the debate over recombinant D N A . But what is commercial about using gene therapy to treat a disease? Or, at least, h o w is it any more commercial than other medical therapies, and w h y is it any more objectionable in the context of gene therapy? Consider another passage: "Today the ultimate exercise of political power is within our grasp; the ability to control the future lives of h u m a n beings by engineering their characteristics in advance; making them a hostage of their o w n architecturally designed blueprints."(5) This is surely a gross exaggeration of any reasonable prospect of the powers of gene therapy in the foreseeable future. I agree that it is a horrendous scenario. But to invoke it when the issues before us have to do with questions such as whether to promote research that might lead to gene therapy to cure Huntingdon's disease does nothing to advance the discussion. A n d yet, the variety of people and events that have caught the public's attention have, I think, served a useful purpose. The ethical issues in h u m a n gene therapy are complex, and it is difficult to imagine that the public would give them m u c h thought had they not appeared in the dramatic garb of scandal or heated rhetoric. At worst, the debate becomes frozen into misleading categories. Fortunately, that seems not to have happened in the case of h u m a n gene therapy. Instead, the response of those w h o believe in the value of gene therapy has been to open the issues up for discussion, and to introduce a more considered tone into the debate. H a d there not been scandals, were there not a Jeremy Rifkin to generate heat, w e might have seen very little n e w light as well. Aroused public interest on these issues has forced supporters of gene therapy to create public forums where open, rational debate could flourish. Without the dramatic spurs, it is not at all clear that as m u c h or as careful discussion would ever have taken place. The second part of m y thesis was the assumption ofthe debate by public agencies. This includes the efforts by various governmental and quasi-governmental agencies to examine the moral issues surrounding h u m a n gene therapy as well as to regulate its practice. There have been at least four important efforts of this sort. Undoubtedly the most sustained and thorough analysis ofthe ethics of h u m a n gene therapy by an "official" body was the report Splicing Life issued by the President's Commission for the Study of Ethical Issues in Medicine and Biomedical and Behavioral Research.(6) In tone, Splicing Life is a mixture of enthusiasm for the science, calling it a "celebration of h u m a n creativity,"(7) alternating with concerns about the moral and social consequences of a too-fervent embrace of genetic engineering, reminding us "that great powers imply great responsibility."(8) The report sketches the importance of the distinction between changing somatic cells and germ cells, although it does not see the distinction as quite the watershed others appear to believe it to be. It portrays somatic-cell gene therapy as akin to standard medical interventions, except that it "involves an inherent and probably permanent change in the body rather than requiring repeated 51
MURRAY applications of an outside force or substance."(9) It sees organ transplantation as the closest analogy. While alluding to germ-cell gene therapy as a form of "eugenics," Splicing Life does not actually call for a ban on it, preferring instead to say that "the technical uncertainties, the ethical implications, and the low probability of actually treating an affected person are strong contraindications against therapy of fertilized eggs or embryos becoming a useful clinical option in the near future."(10) The report emphasizes the need for public education and involvement in policy making on recombinant D N A , and on the need for oversight bodies well-informed and unbeholden to self-interested powers. The second route for official public examination of h u m a n gene therapy has been via Congressional Hearings, such as were held in November, 1982, before the House Subcommittee chaired by then-Congressman (now Senator) Albert Gore, Jr/1 n O n e ofthe outcomes from those hearings and in part shaped by Splicing Life was legislation proposing to establish an official Commission that would examine social and ethical issues in h u m a n gene therapy/12) Although adopted as part ofthe National Institute of Health (NIH) bill in the last Congress, the Commission fell victim to President Reagan's veto ofthe entire N I H legislation. Since then, a n e w bill has been passed and signed into law establishing a "Biomedical Ethics Board" and a "Biomedical Ethics Advisory Committee. "(13) The Board is a bipartisan body comprised of three Democrats and three Republicans from the House and the same from the Senate. The Advisory Committee is to consist of scientists, health care providers, people "distinguished" in a number of fields, and citizen representatives. Although given a broad mandate to examine "ethical issues arising from the delivery of health care and biomedical and behavioral research . .," the Board is explicitly ordered to prepare a "report on research and developments in genetic engineering . . . which have implications for h u m a n genetic engineering" within 18 months of its appointment/14) The fate of the Biomedical Ethics Board and its Advisory Committee is a reflection of an unfortunate recent tendency. Like state bioethics commissions in N e w York and N e w Jersey, the federal Biomedical Ethics Board became a target ofright-to-lifegroups. Unlike their state counterparts w h o have been able to function, though, the Biomedical Ethics Board has floundered completely. With a Congressional membership balanced equally between those supporting a right-to-life position and those not, the Board has been paralyzed. It has been unable to appoint a fourteenth m e m b e r ofthe Advisory Committee (to replace a m e m b e r w h o had died), or to elect a chair and vice-chair. Until it does those three things, it is forbidden to spend any of the money appropriated for it. (At last word, its appropriation also had been slashed by three-quarters.) While the Board and Advisory Committee are not yet dead, they are moribund. A third quasi-governmental actor figuring in the h u m a n gene therapy debate has been the U.S. Congress Office of Technology Assessment ( O T A ) which in December, 1984, released a background paper on the subject/15) The O T A paper made m u c h of the distinction between somatic and germ-cell therapy, emphasizing that somatic cell therapy will probably develop slowly, is ethically unproblematic, and will not have m u c h impact on the frequencies of genes in the population. Agreeing with the conclusions of the President's Commission on germ-cell therapy, the O T A paper argues that "inherited alterations ... are unlikely . . in the near future because they are technically too difficult, are perceived as ethically problematic, and m a y not prove superior to existing technologies."(16) The paper's generally reassuring tone, though, does not preclude some worries over h o w public policy shall be made. After citing opposing opinions about gene therapy, the paper notes "Such conflicting views cannot be assuaged by empty 52
PUBLIC POLICY assurances, and public policy decisions will typically be made without consensus." Mentioning the factual ambiguities, O T A continues by warning that "[p]ublic policy will be decided amidst great uncertainty."(17) The most fine-grained analysis of the ethics of human gene therapy has been offered by the Recombinant D N A Advisory Committee's Working Group on H u m a n Gene Therapy. In the modestly titled "Points to Consider . ." the R A C ' s Working Group laid out a series of concerns that ought to be addressed by scientists contemplating experimental gene therapy in humans/18) B y n o w the distinction between somatic- and germ-cell lines seems almost second nature, although some of the questions focus on whether, in attempting to alter somatic cells, w e might inadvertently affect the genetic material of germ cells, or transmit the altered material to other persons. Interestingly, the Working Group (now called the H u m a n Gene Therapy Subcommittee) shows its cognizance ofthe importance of openness in the early trials of human gene therapy when it says it "would prefer that the first proposals submitted for R A C review contain no proprietary information or trade secrets, enabling all aspects of the review to be open to the public."(19) A newly revised "Points to Consider . " has just been completed by the Subcommittee. [Ed.: See p. 93, this issue.] This m a y be the lasting contribution made by all the participants in the human gene therapy debate. O n e does not have to have a knee-jerk belief in the efficacy of public discussion to acknowledge that it is vitally important that a technology with the potential, eventually, for dramatic impact on h u m a n life be given careful, open scrutiny. This is so for a number of reasons. S o m e have to do with probable consequences. It is likely that research will be done with greater care, and that the human subjects of that research will be well protected. In this way, w e also minimize the possibility of scandal and the resulting mistrust of science, and the threat of an irrational public reaction causing research to be halted. But there are also reasons not limited to consequences. In a democracy, it isrightthat potentially radical alterations in our relations with ourselves and each other be dealt with openly and in detail, not furtively or by an isolated elite, however virtuous their intentions. Scientists m a y feel annoyed, convinced that public debate just slows d o w n their work as they must deal with one after another objection. But the response ought to be to work on m a n y levels to foster a more scientifically literate public, so that this and future debates can be carried out on a more sophisticated level. This will not be easy, yet few tasks loom as more important to those of us committed to both science and democracy. A n d w e o w e at least some small thanks to those w h o have insisted on raising the issues, even if w e disagree with them on substance. O n M a y 22, 1989, the first approved research protocol using genetically modified human cells began. N o gene therapy per se was involved. T o the tumor infiltrating lymphocytes was added a bacterial gene that conferred resistance to the antibiotic Neomycin. This was to serve as a marker for the cells when they were reintroduced into research participants. Thus far, results indicate that the marker gene has functioned as hoped/20)
NOTES 1. Sun, M. (1981). Cline loses two NIH grants. Science 214, 1220. 2. Claire Randall, Rabbi Bernard Mandelbaum, and Bishop Thomas Kelly, June 20,1980. The text of this letter is reproduced in President's Commission for the Study of Ethical Problems in Medicine and 53
MURRAY Biomedical and Behavioral Research. (1982). Splicing Life, (Washington, DC: Government Printing Office). The letter appears as Appendix C 3. The text of the Resolution appeared as part of a press release from the Foundation on Economic Trends, June 8, 1983. That same package included "The Theological Letter Concerning the Moral Arguments Against Genetic Engineering of the H u m a n Germline Cells." 4. "Theological Letter," p. 7. 5. Ibid., p. 9. 6. President's Commission, Splicing Life. See Footnote 2 for full citation. 7. Ibid., p. 2 8. Ibid., p. 3. 9. Ibid., p. 45. 10. Ibid., p. 48. 11. U S House of Representatives. (1982). Hearings on H u m a n Genetic Engineering Before the Subcommittee on Investigations and Oversight ofthe Committee on Science and Technology, 97th Congress, 2d session, No. 170. (Washington, D C : Government Printing Office). 12. The bill introduced by Congressman Gore was H.R. 2788, "To establish the President's Commission on the Human Applications of Genetic Engineering." 98th Congress, 1st session, April 27, 1983. 13. The Biomedical Ethics Board was established under Section 11 of P.L. 99-158, "The Health Research Extension Act of 1985." 14. Ibid., Congressional Record—House, October 11, 1985, p. H8766. 15. Congress of the U S Office of Technology Assessment, H u m a n Gene Therapy—A Background Paper. (Washington, D C : Government Printing Office) (OTA-BP-BA-32), December, 1984. 16. Ibid., p. 1. 17. Ibid., p. 30. 18. National Institutes of Health Working Group on Human Gene Therapy NIH Recombinant D N A Advisory Committee, "Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols," manuscript dated September 23, 1985. 19. Ibid., p. A. 20. Culliton, B.J. (1989). Gene transfer test: So far, so good. Science 245, 1325-1326. Address reprint requests to: Dr. Thomas H . Murray Center for Biomedical Ethics Case Western Reserve University School of Medicine 2119 Abington R o a d Cleveland, O H 44106 Received for publication October 23, 1989; accepted November 8, 1989.
54
H u m a n G e n e T h e r a p y , the Public, a n d Public Policy
THOMAS H. MURRAY
ABSTRACT The public's involvement in the debate over human gene therapy is used to illustrate two points. First, complex bioethical issues often come to the public's attention because of a scandal, in this case the Cline episode; enlightened discussion and public understanding are difficult to achieve under these conditions. Second, even with unfavorable circumstances at the outset, the debate can become channeled into politically responsible institutions which then can develop effective public policy. For gene therapy, four significant forums emerged: the President's Commission's Report Splicing Life, the 1982 Congressional Hearings, the O T A Report, and the R A C ' s Points to Consider document.
OVERVIEW S U M M A R Y Public involvement in the debate over human gene therapy has taken several forms. Public policy relating to emotional issues is seldom established by dispassionate discussion, and this has been true also for gene therapy. Murray points out that serious discussions began in earnest only after the unauthorized Cline experiment. There was also a great deal of rhetoric by Jeremy Rifkin and others. In spite of, or because of, the rhetoric, a reasonable and workable public policy has emerged.
I T is unlikely that any proposed medical therapy has ever received more public attention and prior scrutiny than that lavished on human gene therapy. Before launching a brief analysis of public involvement in the debate over human gene therapy, I want to propose a two-part thesis meant to be provocative. First, when complex bioethical issues such as human gene therapy come to public attention, they commonly do so in a form and in a forum unconducive to dispassionate discussion and deepened understanding. The second part may seem paradoxical: Despite the unfavorable circumstances under which these issues enter public debate, (or is it because of the unfavorable circumstances?) debate and decision making get channeled into politically responsi-
Center for Biomedical Ethics, Case Western Reserve University School of Medicine, Cleveland, O H 44106. 49
MURRAY ble (if not necessarily politically responsive) institutions. With human gene therapy as the case study, let us begin with part one of the thesis—that it came before the public in a manner unfavorable to informed, rational debate. The beginnings were certainly inauspicious enough. In keeping with the recent practice in matters bioethical, h u m a n gene therapy came to the fore thanks to a scandal—Martin Cline's premature, unapproved experiment.(1) (The National Commission that had been established to suggest ways of protecting the h u m a n subjects of research had itself been set up as a response to a scandal involving apparently unethical research in this country that had recently c o m e to light. Cline had run afoul of the regulations growing out of that Commission's work.) Scandals are very effective at getting the public's attention, but not so useful for informing them or fostering enlightened discussion and decisions. B y tarnishing the image of scientific researchers, and establishing an association between shady, illicit dealings and the idea of h u m a n gene therapy, the Cline affair could have done little good for public understanding of the ethical issues in h u m a n gene therapy. But, it did succeed in bringing the prospect of such genetic manipulation in humans out ofthe realm of science fiction and into the public consciousness as a plausible, not-too-distant perhaps, reality. O n June 20,1980, the General Secretaries ofthe National Council of Churches, the Synogogue Council of America, and the United States Catholic Conference—main-line organizations representing the three most populous religious groups in the country—wrote a letter to then-President Carter expressing a number of concerns at the prospect of an explosion in genetic engineering, including intervention into the h u m a n genome.(2) Their concerns included the possible misuse of these n e w powers in the n a m e of eugenics, the inadequacy ofthe profit motive for constructing just social policies, and the need to have public interests represented as key decisions are m a d e about the future uses of recombinant D N A . This letter prompted the President to ask the newly established President's Commission to investigate these issues, leading in November, 1982, to the report Splicing Life. Along with such carefully modulated efforts by religious organizations came additional calls for attention and action. A number of people, including a small but influential group of scientists, attempted to arouse public interest in genetic engineering generally and h u m a n gene therapy in particular. In all probability, the person most successful in that endeavor has been Jeremy Rifkin, w h o has combined legal maneuvers with an u n c o m m o n ability to create headlines. T i m e and again, Rifkin has managed to attract the interest of the press, creating a flurry of news reports about some aspects of recombinant D N A . H e has even, on occasion, managed to obstruct specific projects. H u m a n gene therapy has not escaped his attention. In June, 1983, Rifkin's Foundation for Economic Trends released a resolution signed by a remarkable variety of over 50 religious leaders (from Jerry Falwell to officials of m a n y mainstream Jewish, Catholic, and Protestant religious organizations) and a handful of scientists. The resolution concluded: "Resolved, That efforts to engineer specific genetic traits into the germline ofthe h u m a n species should not be attempted. "(3) The language of the resolution itself is fairly temperate, making statements such as "no individual, group of individuals, or institutions can legitimately claim the right or authority to m a k e such decisions on behalf of the rest of the species alive today or for future generations." The same cannot be said for the document accompanying the resolution, a paper with the portentous title, "The Theological Letter Concerning the Moral Arguments Against Genetic Engineering of the H u m a n Germline Cells." With no attribution of authorship, the "letter" is a mixture of cogent 50
PUBLIC POLICY arguments and bald rhetoric. For example, the spectre of Nazi eugenic programs is raised and we are warned that "[w]hile professional ethicists watch out the front door for tell tale signs of a resurrection of the Nazi nightmare, eugenics doctrine has quietly slipped in the back door. The n e w eugenics is commercial not social. In place ofthe shrill eugenic cries for racial purity, the n e w commercial eugenics talks in pragmatic terms of medical benefits and improvement in the quality of life. The old eugenics was steeped in political ideology and motivated by fear and hate. The n e w eugenics is grounded in medical advance and the spectre of extending the h u m a n life span."(4) O n careful reading, this passage dissolves into incoherence. For one thing, it skipsrightover the distinction between positive and negative eugenics m a d e earlier in the same paper. For another, it introduces the notion of "commercial" eugenics, with the negative connotation commercialism has had in m u c h of the debate over recombinant D N A . But what is commercial about using gene therapy to treat a disease? Or, at least, h o w is it any more commercial than other medical therapies, and w h y is it any more objectionable in the context of gene therapy? Consider another passage: "Today the ultimate exercise of political power is within our grasp; the ability to control the future lives of h u m a n beings by engineering their characteristics in advance; making them a hostage of their o w n architecturally designed blueprints."(5) This is surely a gross exaggeration of any reasonable prospect of the powers of gene therapy in the foreseeable future. I agree that it is a horrendous scenario. But to invoke it when the issues before us have to do with questions such as whether to promote research that might lead to gene therapy to cure Huntingdon's disease does nothing to advance the discussion. A n d yet, the variety of people and events that have caught the public's attention have, I think, served a useful purpose. The ethical issues in h u m a n gene therapy are complex, and it is difficult to imagine that the public would give them m u c h thought had they not appeared in the dramatic garb of scandal or heated rhetoric. At worst, the debate becomes frozen into misleading categories. Fortunately, that seems not to have happened in the case of h u m a n gene therapy. Instead, the response of those w h o believe in the value of gene therapy has been to open the issues up for discussion, and to introduce a more considered tone into the debate. H a d there not been scandals, were there not a Jeremy Rifkin to generate heat, w e might have seen very little n e w light as well. Aroused public interest on these issues has forced supporters of gene therapy to create public forums where open, rational debate could flourish. Without the dramatic spurs, it is not at all clear that as m u c h or as careful discussion would ever have taken place. The second part of m y thesis was the assumption ofthe debate by public agencies. This includes the efforts by various governmental and quasi-governmental agencies to examine the moral issues surrounding h u m a n gene therapy as well as to regulate its practice. There have been at least four important efforts of this sort. Undoubtedly the most sustained and thorough analysis ofthe ethics of h u m a n gene therapy by an "official" body was the report Splicing Life issued by the President's Commission for the Study of Ethical Issues in Medicine and Biomedical and Behavioral Research.(6) In tone, Splicing Life is a mixture of enthusiasm for the science, calling it a "celebration of h u m a n creativity,"(7) alternating with concerns about the moral and social consequences of a too-fervent embrace of genetic engineering, reminding us "that great powers imply great responsibility."(8) The report sketches the importance of the distinction between changing somatic cells and germ cells, although it does not see the distinction as quite the watershed others appear to believe it to be. It portrays somatic-cell gene therapy as akin to standard medical interventions, except that it "involves an inherent and probably permanent change in the body rather than requiring repeated 51
MURRAY applications of an outside force or substance."(9) It sees organ transplantation as the closest analogy. While alluding to germ-cell gene therapy as a form of "eugenics," Splicing Life does not actually call for a ban on it, preferring instead to say that "the technical uncertainties, the ethical implications, and the low probability of actually treating an affected person are strong contraindications against therapy of fertilized eggs or embryos becoming a useful clinical option in the near future."(10) The report emphasizes the need for public education and involvement in policy making on recombinant D N A , and on the need for oversight bodies well-informed and unbeholden to self-interested powers. The second route for official public examination of h u m a n gene therapy has been via Congressional Hearings, such as were held in November, 1982, before the House Subcommittee chaired by then-Congressman (now Senator) Albert Gore, Jr/1 n O n e ofthe outcomes from those hearings and in part shaped by Splicing Life was legislation proposing to establish an official Commission that would examine social and ethical issues in h u m a n gene therapy/12) Although adopted as part ofthe National Institute of Health (NIH) bill in the last Congress, the Commission fell victim to President Reagan's veto ofthe entire N I H legislation. Since then, a n e w bill has been passed and signed into law establishing a "Biomedical Ethics Board" and a "Biomedical Ethics Advisory Committee. "(13) The Board is a bipartisan body comprised of three Democrats and three Republicans from the House and the same from the Senate. The Advisory Committee is to consist of scientists, health care providers, people "distinguished" in a number of fields, and citizen representatives. Although given a broad mandate to examine "ethical issues arising from the delivery of health care and biomedical and behavioral research . .," the Board is explicitly ordered to prepare a "report on research and developments in genetic engineering . . . which have implications for h u m a n genetic engineering" within 18 months of its appointment/14) The fate of the Biomedical Ethics Board and its Advisory Committee is a reflection of an unfortunate recent tendency. Like state bioethics commissions in N e w York and N e w Jersey, the federal Biomedical Ethics Board became a target ofright-to-lifegroups. Unlike their state counterparts w h o have been able to function, though, the Biomedical Ethics Board has floundered completely. With a Congressional membership balanced equally between those supporting a right-to-life position and those not, the Board has been paralyzed. It has been unable to appoint a fourteenth m e m b e r ofthe Advisory Committee (to replace a m e m b e r w h o had died), or to elect a chair and vice-chair. Until it does those three things, it is forbidden to spend any of the money appropriated for it. (At last word, its appropriation also had been slashed by three-quarters.) While the Board and Advisory Committee are not yet dead, they are moribund. A third quasi-governmental actor figuring in the h u m a n gene therapy debate has been the U.S. Congress Office of Technology Assessment ( O T A ) which in December, 1984, released a background paper on the subject/15) The O T A paper made m u c h of the distinction between somatic and germ-cell therapy, emphasizing that somatic cell therapy will probably develop slowly, is ethically unproblematic, and will not have m u c h impact on the frequencies of genes in the population. Agreeing with the conclusions of the President's Commission on germ-cell therapy, the O T A paper argues that "inherited alterations ... are unlikely . . in the near future because they are technically too difficult, are perceived as ethically problematic, and m a y not prove superior to existing technologies."(16) The paper's generally reassuring tone, though, does not preclude some worries over h o w public policy shall be made. After citing opposing opinions about gene therapy, the paper notes "Such conflicting views cannot be assuaged by empty 52
PUBLIC POLICY assurances, and public policy decisions will typically be made without consensus." Mentioning the factual ambiguities, O T A continues by warning that "[p]ublic policy will be decided amidst great uncertainty."(17) The most fine-grained analysis of the ethics of human gene therapy has been offered by the Recombinant D N A Advisory Committee's Working Group on H u m a n Gene Therapy. In the modestly titled "Points to Consider . ." the R A C ' s Working Group laid out a series of concerns that ought to be addressed by scientists contemplating experimental gene therapy in humans/18) B y n o w the distinction between somatic- and germ-cell lines seems almost second nature, although some of the questions focus on whether, in attempting to alter somatic cells, w e might inadvertently affect the genetic material of germ cells, or transmit the altered material to other persons. Interestingly, the Working Group (now called the H u m a n Gene Therapy Subcommittee) shows its cognizance ofthe importance of openness in the early trials of human gene therapy when it says it "would prefer that the first proposals submitted for R A C review contain no proprietary information or trade secrets, enabling all aspects of the review to be open to the public."(19) A newly revised "Points to Consider . " has just been completed by the Subcommittee. [Ed.: See p. 93, this issue.] This m a y be the lasting contribution made by all the participants in the human gene therapy debate. O n e does not have to have a knee-jerk belief in the efficacy of public discussion to acknowledge that it is vitally important that a technology with the potential, eventually, for dramatic impact on h u m a n life be given careful, open scrutiny. This is so for a number of reasons. S o m e have to do with probable consequences. It is likely that research will be done with greater care, and that the human subjects of that research will be well protected. In this way, w e also minimize the possibility of scandal and the resulting mistrust of science, and the threat of an irrational public reaction causing research to be halted. But there are also reasons not limited to consequences. In a democracy, it isrightthat potentially radical alterations in our relations with ourselves and each other be dealt with openly and in detail, not furtively or by an isolated elite, however virtuous their intentions. Scientists m a y feel annoyed, convinced that public debate just slows d o w n their work as they must deal with one after another objection. But the response ought to be to work on m a n y levels to foster a more scientifically literate public, so that this and future debates can be carried out on a more sophisticated level. This will not be easy, yet few tasks loom as more important to those of us committed to both science and democracy. A n d w e o w e at least some small thanks to those w h o have insisted on raising the issues, even if w e disagree with them on substance. O n M a y 22, 1989, the first approved research protocol using genetically modified human cells began. N o gene therapy per se was involved. T o the tumor infiltrating lymphocytes was added a bacterial gene that conferred resistance to the antibiotic Neomycin. This was to serve as a marker for the cells when they were reintroduced into research participants. Thus far, results indicate that the marker gene has functioned as hoped/20)
NOTES 1. Sun, M. (1981). Cline loses two NIH grants. Science 214, 1220. 2. Claire Randall, Rabbi Bernard Mandelbaum, and Bishop Thomas Kelly, June 20,1980. The text of this letter is reproduced in President's Commission for the Study of Ethical Problems in Medicine and 53
MURRAY Biomedical and Behavioral Research. (1982). Splicing Life, (Washington, DC: Government Printing Office). The letter appears as Appendix C 3. The text of the Resolution appeared as part of a press release from the Foundation on Economic Trends, June 8, 1983. That same package included "The Theological Letter Concerning the Moral Arguments Against Genetic Engineering of the H u m a n Germline Cells." 4. "Theological Letter," p. 7. 5. Ibid., p. 9. 6. President's Commission, Splicing Life. See Footnote 2 for full citation. 7. Ibid., p. 2 8. Ibid., p. 3. 9. Ibid., p. 45. 10. Ibid., p. 48. 11. U S House of Representatives. (1982). Hearings on H u m a n Genetic Engineering Before the Subcommittee on Investigations and Oversight ofthe Committee on Science and Technology, 97th Congress, 2d session, No. 170. (Washington, D C : Government Printing Office). 12. The bill introduced by Congressman Gore was H.R. 2788, "To establish the President's Commission on the Human Applications of Genetic Engineering." 98th Congress, 1st session, April 27, 1983. 13. The Biomedical Ethics Board was established under Section 11 of P.L. 99-158, "The Health Research Extension Act of 1985." 14. Ibid., Congressional Record—House, October 11, 1985, p. H8766. 15. Congress of the U S Office of Technology Assessment, H u m a n Gene Therapy—A Background Paper. (Washington, D C : Government Printing Office) (OTA-BP-BA-32), December, 1984. 16. Ibid., p. 1. 17. Ibid., p. 30. 18. National Institutes of Health Working Group on Human Gene Therapy NIH Recombinant D N A Advisory Committee, "Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols," manuscript dated September 23, 1985. 19. Ibid., p. A. 20. Culliton, B.J. (1989). Gene transfer test: So far, so good. Science 245, 1325-1326. Address reprint requests to: Dr. Thomas H . Murray Center for Biomedical Ethics Case Western Reserve University School of Medicine 2119 Abington R o a d Cleveland, O H 44106 Received for publication October 23, 1989; accepted November 8, 1989.
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