Gene Therapy

Advances in genetic technology, including the use of the polymerase chain reaction (PCR) and restriction fragment-length polymorphism, have facilitated the precise diagnosis of genetic disease(56). A portion of the embryo, i.e. one blastomere or its nucleus, can now be removed and analysed for a specific gene defect(44). More than 6000 heritable diseases have been identified in human(57). The diagnosis of human genetic diseases before implantation has been proven to prevent the transmission of genetic abnormalities in high risk couples  Gifro et al., (1998) reported on the successful outcome with day 4 embryo transfer after PGD for genetically transmitted diseases(58). Future development in this field can be expected as knowledge of the human genome increases(56). An important development is the introduction and the application of gene therapy for correcting genetic defects in the embryo before its transfer in the uterus.

French Anderson introduced four well known categories of human gene therapy in the scientific literature in 1990(59). This categorization has been acknowledged by many workers such as Lebo and Golbus for being helpful to delineate and focus the ethical gene therapy discussion(60). These four categories are the somatic cell gene therapy, the germ line gene therapy, enhancement genetic engineering and the eugenic genetic engineering.

The somatic cell gene therapy refers to a situation when a genetic defect in the somatic cells or body cells of the patient are corrected. The germ-line gene therapy is when a genetic defect in the germ or reproductive cells of the patient namely the egg, sperm or the early embryo are corrected so that the offsprings of the patient would not suffer from this defect. The enhancement genetic engineering is when a gene is being inserted in order to try to enhance or improve a specific characteristic as increasing the height. The fourth human gene therapy is eugenic genetic engineering when genes are inserted in order to try to alter or improve complex human traits that depend on a large number of genes as well as extensive interactions with the environment such as personality, character, intelligence or others(59).

Other workers as LeRoy Walters have suggested that there are really five basic categories. He subdivides enhancement genetic engineering into somatic cell enhancement genetic engineering and germ-line enhancement genetic engineering(61).

The core of concern about germ line gene therapy is "the slippery slope" leading to attempts at germ-line enhancement that causes all of us to question whether a strict prohibition at the germ-line might not be the safest course. As long as we are able to clearly distinguish therapy from enhancement engineering, some workers would seem to support germ line gene therapy. However the line between ethical and unethical genetic intervention is clearly to be sought in the distinction between what is therapy and what is not therapy(62).

There is no doubt that the rather general approval which somatic cell gene therapy receives, does not exist regarding germ-line therapy. It might even look as though there were almost a consensus to the contrary, that is about the non-acceptability of germ-line therapy in the European medical research councils(63).

The work group on human gene therapy at the Inuyama CIOMS conference of 1990 goes on to say that "germ-cell therapy should be broadly discussed before it is upon us, although it is not an immediate prospect. Before germ line therapy is undertaken, its safety must be very well established, for changes in germ-cells would affect the descendants of patients"(19).

De Wachter in his conclusion on the topic of ethical aspects of human germ-line gene therapy stated that ethics has not been able to solve the dilemmas of germ-line gene therapy. On the one hand, it is difficult to reject summarily all forms and types, past, present and future, of human germ-line gene therapy, specially in cases where only germ-line therapy would do the therapeutic job(63).

Genetic manipulation is desirable to remedy genetic defects. Serious ethical questions begin to arise at the borderline cases when the aim of genetic manipulation shifts from therapy to the creation of new human types(64). The importance of clear moral guidelines in the conduct of gene therapy is understood by reports of secretive use of recombinant DNA and cloning techniques on patients in otherwise enlightened nations. This unacceptable research is initiated by the perception that it is necessary to stay ahead of international competition in biotechnology and to avoid strong public protest. The slippery slope of the utilitarian is a grave danger when business and utility rather than ethics, drive the application of medical knowledge scientific or otherwise(65).

From a Muslim perspective, human gene therapy should be restricted only to therapeutic indications. Somatic cell gene therapy is encouraged as it involves remedy and alleviation of human sufferings. However, enhancement genetic engineering or eugenic genetic engineering would involve change in the creation of God which may lead to imbalance of the whole universe and should be prohibited. Gene therapy to manipulate hereditary traits such as intelligence, stupidity, stature, beauty, ugliness, sterility or fertility is a serious attempt as it might imbalance the life of man(21).

If any germ line gene therapy is practiced it should be solely restricted to therapeutic purposes. A pre-requisite for this application is that scientists should be absolutely certain that such manipulation will not affect the descendants of patients, in an unforeseen pattern which is, with the present state of the art, almost impossible(66-67).

Certainly with the expected wider application of human genome therapy in future there are several ethical questions to be answered. Some of these questions are :

a- What are the criteria for approval of human gene therapy protocols ?

b- How should we select patients without discrimination ?

c- What is  the social control mechanism ?

d- How is it possible to respect medical confidentiality and patient’s autonomy ?

e- How resources are to be allocated ?

More extensive ethical debate is required on these extremely sensitive ethical issues. However, one must bear in mind differences in the ethical percepts of different societies(66-67).

Consent to treatment and experimentation should be a free and an informed consent. It should be a free one without coercion. The subject of treatment or experimentation should not be under any subjudation. The consent is obtained after proper counselling. During this counselling, the individual subjects should understand and agree to treatment and reasons for experimentation. In large community surveys, the community must also agree to the study. The counselling should not be restricted to information counselling only where the physician or the researcher provides information, it should include implication and supportive counselling. In developing countries, where the level of illiteracy is very high the value of written consent is very questionable. Great emphasis should be made on verbal personal counselling and consent should be witnessed(68-69).

Volunteers for medical experimentation should be drawn with free informed consent equally from among groups who can potentially benefit later on from the outcome of experimentation(9). Special attention is needed when experimentation subjects are subordinate to the investigators eg : Students and nurses or in the case of prisoners. Participation should be completely voluntary. Financial or other benefits as sort of incentives should not distort the process of free informed choice. The ethical principle of respect implies during implementation of the treatment or experimentation, the patients should be able to withdraw their consent at any time without loosing any benefit.

In embryo and genetic research the increase in the predictive potential of genetic screening is likely to have consequences for the extent to which genetic data are used. These data can be used within the context of health care which does not represent an ethical problem. However, these data can also be used outside the framework of care of the individual, in particular, in the domain of employment or insurance. Whether genetic data is similar to medical data or not, is a matter of controversy. If it is so, then access to genetic data may result in selectivity and possibility of exclusion from access to work or private insurance on the basis of genetic information. This could have considerable consequences at the level of the individual and of society(70).

The serious normative discussion of possible applications of this new knowledge should be systematically pursued. The decision to resort to screening has to be made individually, in the context of the patient - doctor relationship, and strictly for therapeutic purposes. The genetic health care policies must be based on an open conception of man and the recognition of human solidarity, beyond individual genetic differences.

Finally, the researchers and health care worker's responsbility in this matter has to be taken on in the perspective of a democratic debate. From a Muslim perspective every effort should be taken to protect the Muslim woman and her family from the adverse effects of advanced technology and from improperly planned researches without depriving her of its benefits.