Gene Therapy and the Human Genome Project in Russia

- Vijay Kaushik, Ph.D. & Boris Yudin, Ph.D.

The Human Institute, Russian Academy of Sciences, Moscow, Russia

(Mail: Vijay Kaushik Post Office, Box-No.42, Moscow 113525, RUSSIA)


Eubios Journal of Asian and International Bioethics 7 (1997), 6-7.
In 1988 a group of researchers headed by Academician Bayev wrote a letter to Gorbachov asking for support and the initiation of the Human Genome Project (HGP) in Russia. After approval the scientific committee was organized and started functioning in an organized way. Since 1995, after Bayev's death, the committee has been led by Prof. Lev Kissilev of Engelhardt Institute of Molecular Biology.

At present there are three mutually connected approaches in the gene therapy section of the HGP - gene pathology, gene diagnostics and gene therapy proper. There are three major gene therapeutic projects in the current program:

1) The project headed by Prof. A. Zelenin of Engelhardt Institute and Prof. O. Evgrafov of Research Centre for Medical Genetics on Duchenne muscular dystrophy treatment.

2) Project supported by Ministry of Health for Researches on artherosclerosis treatment.

3) Project to prevent transformation of p53 gene (onco-genetic program) for treating cancer.

The gene therapy program in Russia is at the initial stage of development. Several genetic centres are engaged in the diagnostics of 23 hereditary diseases. At present the focus is on improving human health by studying the molecular and cellular aspects of the disease and establishing technology for carrying out somatic gene therapy treatment. No legislative norms have been framed for genetic screening and gene therapy so far. The Committee is engaged in formulating guidelines for protocols for clinical trials.

In January 1996 the Scientific Committee on HGP in Russia held the 5th Conference and discussed the progress made by various groups (1). In the framework of HGP research two grants exist for ethical aspects of gene therapy issues, headed by Prof. B. Yudin of Russian National Committee on Bioethics, and Prof. Trobnikov of Centre for Medical Health.

The Russian National Committee on Bioethics (RNCB) carried out a survey among the heads of projects on HGP (Russia) to seek what they thought were the most actual legal and ethical problems of this program for Russia. 120 survey copies were sent to experts and the results were analyzed (1). These experts said the most important issues were:

-safety of confidentiality of genetic information

-patents for human genes and genetic sequences

-possibilities of use of genetic tests data by insurance companies and employers

-safety of human rights by use of genetic techniques and its future consequences

-possibility of use of genetic engineering with a risk for human dignity and for genetic future of next generations

-use of genetic achievements for shaping human will and for changing human behaviour

The majority of these experts considered that Russian society has little information about potential risks and benefits of HGP research and about its use. So they suggest large scale information by the mass media and to include research problems of HGP in school and university curriculum.

More than one third of the experts answered that they discussed ethical and legal problems in conversation with their foreign colleagues. The majority of these experts consider legislative regulation of HGP research necessary, especially the use of its results. For this reason the Russian National Council on Bioethics of the Russian Academy of Sciences conducted an appraisal by experts of the draft Law on the states policies in the genetic engineering field. Conclusion of the draft had to be submitted to Committee of Science of Russian Parliament. RNCB also took part in working out of the bill on human genetic engineering, which was passed in 1996.

The survey showed these experts did not support eugenic projects. However, 25% agreed with compulsory sterilization, 34% with compulsory embryo abortion for genetic symptoms and 14% with selected combination of couples for reproduction of healthy offspring.

Under the framework of the RNCB sociological research was carried out with 1282 respondents, on the general public understanding of human genetic problems. Of these, 33% agreed with compulsory sterilization, 33% with compulsory embryo abortion for genetic symptoms, 10% with selected combination of couples for reproduction of healthy offspring, and 2% on the purposeful combination of the most gifted parents for making a national elite.

In the 1993 survey in the International Bioethics Survey (2, 3, N=446), some eugenic reasoning was suggested. There was very high support for government funded prenatal genetic screening (92% yes), and 80% of the respondents expressed willingness for such a test during their spouse's pregnancy. 87% of the respondents agreed with abortion of a 4 month old fetus with congenital abnormalities. Of the total respondents answering the question (in positive or negative manner) more than one tenth gave reasons such as "It will improve genes", the highest proportion among any of the countries. In Russia there was also the least number who cited fears of eugenics as a reason not to allow genetic screening (2).

The RNCB survey confirmed this, with responses to the following:

Q. Is their danger of physical degeneracy in Russia? Yes (56%), No (21%).

Q. Must the state accept the program for improvement of the Russian genepool? Yes (45%), No (19%).

On the whole the population doesn't support strict eugenic marriages, in response to further questions, only 2% would not consider restricting international marriage, 11% would restrict the reproductive activity of men with serious heredity disease, and only 6% considered the consequences of repression or wars as a serious danger for national genepool.

In the project framework two major directions of the present and future work of RNCB are planned:

1. Ethical and legal problems of genetic intervention in human reproduction.

2. Reappraisal of eugenics history and problems from the point of view of the current comprehension on the human genome and the research prospects in this field.

Keeping in view the importance of gene therapy for treatment of hereditary diseases and its widespread acceptance for cures, eugenic discussion is once again taking centre stage. These surveys provide some picture of the views of the Russian public attitudes to genetic screening, therapy and eugenics.

References

1. Yudin, B. Legal and ethical problems of research in the context of the Human Genome Program. The 5th Conference on the Human Genome, 1996, in memory of Academinan Bayev, 15-18 January, 1996, Moscow (In Russian).

2. Kaushik, V. & Macer, D. Bioethical reasoning in Russia, pp. 151-6 in D. Macer, Bioethics for the People by the People (Eubios Ethics Institute 1994).

3. Macer, D.R.J., Akiyama, S., Alora, A.T., Asada, Y., Azariah, J., Azariah, H., Boost, M.V., Chatwachirawong, P., Kato, Y., Kaushik, V., Leavitt, F.J., Macer, N.Y., Ong, C.C., Srinives, P. & Tsuzuki, M. (1995), "International perceptions and approval of gene therapy", Human Gene Therapy 6: 791-803.


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