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Early ethical debate on germ-line genetic interventions:

1984 - the Council for Science and Society in the United Kingdom advised a working rule for ethical debate on new technologies

"...refrain from moral judgement on unverifiable possiblities as notational cases rooted neither in the reality of experience nor in a specific context."

In the early 1970's physician-philosopher Leon Kass evaluated prospects and consequences of "limitless self modification" of such interventions, he wrote that: "...it may...mark the end of human life as we and all other humans have known it. It is possible that the nonhuman life which may take our place will be superior, but I think it most unlikely and certainly not demonstrable."

Paul Ramsey viewed germline gene therapy as a temptation with hellish consequences:

"...to know fully who a fellowman essentially is, which should be known only to God and on record in his counsels. Before us then opens up the dizzy absysmal prospect that men can be present where the foundations of the world were laid. Piece by piece of information may destroy our sense that, for all the genetic corruption, God made the world and the human creature and they are good."

Joseph Fletcher countered the above dark view with:

"The Cassandras and Jeremiahs and Gloomy Guses are a part of the problem, not of its solution. Technology, whether of the "hard" physical kind of the "soft" biological kind, is man's creation and man's hallmark... To be civilized is to be artificial, and to object that something is artificial only condemns it in the eyes of subrational nature lovers or natural-law mystics."

In 1980, leading religious leaders brought their concerns about DNA technology and human gene therapy to the President's Commisiion for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Interrupting its planned agenda, the Commission responded to their appeal to consider the social, legal and ethical implications of DNA research and its uses with human beings. The Commission's subsequent report, "Splicing Life", strongly defended the continuation of DNA research. The commission recommended that experiments in somatic cell therapy be done, but only after approval by a broadened Recombinant DNA Advisory Commitee (RAC) of the National Institutes of Health (NIH), which was accomplished by creating a Human Gene Therapy Subcommittee in 1984.

The current position of the RAC and its Human Gene Therapy Subcommittee is that it:

"...will not at present entertain proposals for germline alterations but will consider for approval protocols involving somatic cell gene therapy. The purpose of somatic cell gene therapy is to treat an individual patient, e.g., by inserting a properly functioning gene into a patient's somatic cells. In germ-line alterations, a specific attempt is made to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed on to the individual's offspring."

Similar guidelines were adopted in the United Kingdom by the Joint Medical Research Council and the Royal College of Obstetricians and Gynaecologists Interim Licensing Authority, which:

"...will consider research projects on a case by case basis but certain types will not be approved, e.g., modification of the genetic constitution of a prembryo: the placing of a human pre-embryo in the uterus of another species for gestation: cloning of pre-embryos by nuclear substitution."

The Human Gene Therapy Subcommittee will be the first national body to consider the scientific and ethical aspects of human germ-line gene therapy.

Also, more religious leaders are open to germ-line therapy for serious genetic disorders and distinguish it from "Enhancement". For example, Gregorius, Metropolitan Greek Orthodox Bishop of Delhi, comments that from his theological perspective:

"...one cannot see anything intrinsically forbidden or evil in gene therapy, whether somatic or germ-line. Infinite possiblities of power are open to humanity. The ethical problem is not in the acquistion of this power, but in its wise use."

"Three criteria must be satisfied before attempting germ-line gene therapy in human embryos. The first is extensive experience with somatic cell gene therapy that demonstrates its effectiveness and safety. This process may take several years, in terms of the numbers and types of patients needed. Second, there should be adequate animal studies of the reproducibility, reliability, and safety of germ-line therapy, with the same vectors and procedures to be used in human embryos. If corrected germ-line cells will be, or are intended to be, inherited by progeny of the treated individual, these progeny should benefit by the absence of the corrected disorder and not be harmed by any unintended side effects, such as cancer or retroviral infection...the third is that a solid societal consensus should undergird the first attempts at germline gene therapy. This therapy will affect future generations. Its social impact is immeasurably larger than somatic cell therapy. The gene pool is a joint possession of all members of society."

"Human gene therapy is a symbol of hope in a vast sea of human suffering due to heredity. What is the extent of this suffering? About 22 percent of newborn deaths in developed nations are due to congenital malformations or genetic disorders. About one-third of children admitted to pediatric units in Western nations need treatment for the complications of genetic disorders, congenital defects, or mental retardation. New information about hereditary factors in some types of cancer is coming to light; cancer is now best understood as a genetic disease."

"Restoration of restricted research in the federal sector now blocked due to links with abortion or loss of embryos needs to be accomplished. Echoing Walter' paper, we see these obstacles as a "Taboo" subject. To remove them is more difficult than it is to open a new debate o germ-line therapy. How can effective ethical and social debate on human germ-line gene therapy n pre-embryos really occur without prior attention to the ethics of embryo research and federal support of such research?"

(ref. Germline Gene Therapy: A New Stage of Debate - John C. Fletcher and W. French Anderson Law, Medicine & Health Care vol 20:1-2,spring-summer 1992)

"How active should the profession be indisseminating public information and in taking policy positions? The council for Responsible Genetic manipulations of sperm, oocytes, or embryos (CRG Takes Stand, 1992). The subcommittee can consider whether the ACMG should take positions on alternatives that have been suggested by policy makers, such as the NIH policy of not entertaining proposals involving germ-line gene therapy."

"Preimplantation genetics is set against a unique history of keen public interest and governmental withdrawal that places greater-than-usual responsibilities on practitioners. If preimplantation diagnosis proceeds, it must be alongside a set of rules that establishes a habit of caution and excellence rigorous enough to oversee preimplantation therapy. This goal can be achieved by moving slowly, with respect for less burdensome alternatives, and with a policy mapped out and in place in which geneticists have played a leadership role. Genome mapping and sequencing are not the only areas where markers need to be placed and unknown areas need to be deciphered in this modern era of molecular genetics."

American Journal of Medical Genetics 52:151-157 (1994) Preimplantation Genetics: A case of prospective action - Eugene Pergament and Andrea Bonnicksen

"There have been regulations and legislation brought in which oppose the use of germ-line manipulation. Some of the restrictions apply only to procedures other than to cure a hereditary disorder, but others are more general. The British Human Fertilization and Embryology Bill would outlaw germ-line gene therapy on embryos. The European Council has passed a recommendation stating that every new individual has the right to a genetic constitution that has not been interfered with. In 1988 the European Medical Research Councils issued a joint statement stating that "germline gene therapy should not be contemplated", neither should enhancement genetic engineering (EMRC 1988). In the USA germline gene therapy is not considered yet, but maybe so at a later stage. The National Health and Medical Council of Australia Report stated that germ cell gene therapy is ethically unacceptable. In the state of Victoria, Australia, it would be illegal. The reaction against germ-line manipulation has been widespread. The International Organization of Scientists for Social Responsibility has proposed that the United Nations add an article to the Human Rights articles, saying that a human genetic inheritance should not be modified, except by somatic cell gene therapy."

Shaping Genes - Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture. Darryl R. J. Macer, Ph.D. Eubios Ethics Institute 1990.

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