Articles

This article was written an account of a scandal in Russia over the use of fetal tissue for experimentation and for profit. The authors discuss the scandal in the context of present Russian medical practice, and of the role of the National Committee on Bioethics.

The section continues with the latest draft of the Council of Europe's proposed European Convention on Bioethics, and ends with reports of two recent meetings – one about genetic screening of children, and the other about mental incapacity.
 

Developing ethical awareness in a society that was until recently totalitarian, and might become so again, presents some special challenges. The authors consider some general issues in the light of a major scandal that erupted in January 1996 over the use of fetal tissue.

Genesis of the problem

When starting bioethics in Russia we were motivated by the idea of democratising our society on a basic micro-social level. The country was swift enough to take several important steps in this direction on the macro-social level – to adopt a new constitution with guarantees of human rights and rights of ownership of private property, and to elect a Parliament and the President. But all this modernisation of Russia’s political facade didn't change the internal structure of society sufficiently, the web of every day relationships in families, work, schools, hospitals and other places. One of the most brilliant philosophers of the Russian ‘silver age’, L. S. Frank, wrote at the beginning of the century that the tyrannical state (in his time the czarist state) grows out of tyrannical interpersonal relationships. Political revolution that is not grounded in social evolution at the basic level of satisfaction of ‘simple’ human economic, physical and psychological needs could only reproduce the same totalitarian pattern under a new ideological label. This is exactly what has happened during the Bolshevik revolution in 1917, and this is exactly what could happen today in Russia.

In the development of democratic procedures in health care we are meeting numerous problems. Having some knowledge and experience in American and Western European bioethics we were frustrated because the range of ethical ‘answers’ that we could borrow from our Western colleagues did not then, and sometimes still does not now match the range of ‘questions’ that are recognised by the Russian public as morally valid in health care.

For example, until the beginning of the 90s the problem of abortion existed in Soviet society not as a question of the moral status of fetuses and women’s rights, but as a problem of the recognition that women having abortions were normal patients. Abortion was and is the most popular means of contraception in Russia, but from the official Communist point of view it was a kind of social deviation. Women were disobedient if they refused to create individuals to be soldiers and part of the state labour force. Consequently in the USSR abortion as a medical procedure was also used as a form of political punishment. It was performed in the great majority of cases without anaesthesia. A rude, unceremonious, and offensive attitude of physicians towards their clients was normal in these cases. That is why the problem of abortion was interpreted at that time as the problem of humane treatment of women as ordinary patients. They were not concerned about their human rights and were ready to depend on paternalist physicians. We were sure that this wouldn’t solve the problem. Without recognition by the medical profession of basic patient rights, no improvement could be achieved in this field, or in other areas of Russian medicine. But how could one change the way the public feels about and perceives a problem? Public mentality is very conservative and it is extremely difficult to change it from one way of perceiving problems to another, and to introduce new ways of reasoning.

We discussed this problem on several occasions with our Eastern European colleagues. One such discussion took place in Moscow in 1991. Our Hungarian friend and colleague Bela Blasszauer offered a solution that seemed at first glance rather inappropriate in ethics. He said: ‘What you need is a good scandal. This is the only thing that could threaten the self-confidence of medical professionals, and attract public attention to your problems’. There are theoretical objections for such a remedy.[1] But events in Moscow at the beginning of this year seemed to show the wisdom of Bela Blasszauer’s recommendation. The furious scandal that broke on the Eve of the Russian Orthodox Christmas helped to bring into public consciousness the problem of abortion in new way, with emphasis on the moral status of fetuses and women’s rights to control their own bodies.

The Moscow fetal transplant scandal

There is an old Russian saying; ‘It is better to see once than to hear ten times’. “In Russia, where abortion is still the most popular kind of contraception, legislation on abortion is the most liberal in the world, and the lives of two out of three conceived fetuses are usually terminated, there was an outburst of indignation after seeing only one abortion on television.”[2] This happened on 7 January, 1996 – Christmas Eve. The news programme ‘Itogy’ (Summaries) of Independent Russian Television presented a report prepared by the German company ‘Spiegel TV’. The programme was a collage of documentary pictures of a woman crying and in pain while having an abortion without anaesthesia, of a disembowelled body of a foetus on a morgue table, of a high tech medical laboratory harvesting fetal tissue, and of poor orphanage residents. This was accompanied by a narrative about the dubious commercial activities of The International Institute of Biological Medicine (IIBМ) in a joint venture with The Scientific Centre of Obstetrics, Gynaecology and Perinatology (SCOGP).

The report stated that physicians from IIBM forced pregnant women to have late term abortions without anaesthesia. ‘Nalador 500’, produced by a German pharmaceutical company, Schering, but not licensed in Germany, was used for this purpose. After special treatment, tissues of aborted foetuses were sold abroad or used for experimentation on orphans or abandoned children with Down’s syndrome. It was also alleged that experiments involving transplantation of fetal tissue were performed by an American doctor, E. M. Molner, whose license had been suspended in the USA because of malpractice in cosmetic surgery.

The public reaction was so horrified, that the Prime Minister, V. Chernomyrdin, ordered a commission to investigate the case the next day. By January 11 the Commission headed by the Deputy Minister of Health Care, N. Vaganov, had come to the conclusion that the whole story presented by ‘Itogy’ was biased and inaccurate. All the accusations were refuted. Dr. E. M. Molner had a license to practice in California and physicians from IIBM had never participated in performing abortions. Abortions were always performed with anaesthesia by physicians of SCOGP. Tissues of aborted fetuses were handed over to IIBM for research purposes and never sold to anyone, especially not abroad. ‘Nolador 500’ and ‘Prostin-15M’ (Upjohn, USA), used for abortions, were permitted in Russia and most European countries (including Germany). Treatment of children with Down’s syndrome was not experimental but a transplant procedure approved by the Russian Ministry of Health Care and Medical Industry.

Abortions were done and fetal tissues were used for transplantation only with oral or written consent of the pregnant women. The consent form was designed by the Hospital Ethics Committee of SCOGP and included a section for women to agree to the use of fetal tissues for ‘scientific and practical purposes’. The Commission made special note of the innovative character and high scientific level of research done by IIBM.

The findings could have meant a happy end to the scandal. However, the Russian public and mass media were not happy with the conclusions of the official Commission. Tens of publications in the most popular dailies, weeklies, and magazines, and several reports on Russian television have since appeared. Even now, after half a year of intense public debate, it is too early to cross the last ‘t’ in the story.

What is wrong with the official conclusion

During public debates a number of significant contradictions in the official statements of the Commission were revealed, along with unresolved moral and legal problems. We summarise only the most important:

– most of the comments suggested the Commission was biased. Amongst its ten members only Boris Yudin from the Russian National Committee on Bioethics (RNCB) was not a representative of the Russian medical elite. His ‘special opinion’ in the official statement of the Commission irritated other members. The chairman of the Commission, N. Vaganov, as a deputy minister of health care was the person who had authorised the activities of IIВМ and SCOGP in an official ministry letter in 1992. Three other members are directors of medical research centres where IIВМ had applied its innovative technologies of fetal transplantation. These techniques were used for the treatment of patients not only with Down’s syndrome, but also those with male impotence, diabetes, menopause and other conditions. No women, or representatives of the Russian Orthodox Church were included in the commission;

– the legal status of transplantation of fetal tissues in Russia is not established.[3] The special law of the Russian Federation on transplantation of organs and tissues lists all kinds of tissues and organs that are permitted for transplantation, but fetal tissues are not mentioned. The letter of deputy minister N. Vaganov giving permission for IIВМ to go ahead with its research and practice had no legal power. In addition it contradicts the existing administrative policy of the ministry that permits use of any new method of treatment only after approval by the Presidium of the Medical Academy of Sciences. [4] The latter has not been done, because the president of IIВМ, Professor G. T. Sukhih, recognised that researchers did not have enough clinical data to apply for approval by the Presidium.[5] Such a recognition makes the Commission conclusion that fetal transplantation was not experimental appear suspicious;

– the statement of the Commission that this treatment is not an experimental procedure is in direct contradiction with another statement of the Commission that was put two lines below it: – ‘Because we are at the very beginning of the collection of empirical data on the clinical results of fetal tissue transplantation, this question should be discussed later at a special session of The Presidium of The Medical Academy of Sciences’;[6]

– in the conclusion of the Commission there is a statement that researchers selected only those patients with Down’s syndrome (children younger than 6 months) whose relatives were interested in treatment of their child. But journalists’ investigations showed that all five patients were orphans or abandoned by parents and left by other relatives in an orphanage. No surrogate consent on their behalf was established;[7]

– in one place the Commission insists that aborted fetuses were handed over by SCOGP to IIВМ only for research purposes, and then recognises in another paragraph that about 30% of all transplantations were done by IIBM for profit;

– the decision of women to abort fetuses late in pregnancy at SCOGP could not be treated as voluntary. In most other hospitals providing free abortions they are usually done without anaesthesia. The documentary pictures shown by ‘Spiegel TV’ of an abortion were probably from one such hospital. In most places anaesthesia is offered at additional cost. An opportunity to have a free abortion with anaesthesia in a good medical institution like SCOGP may arguably be coercive for a lot of women needing abortions;[8]

– the statement that fetal tissues were never sold is regarded sceptically by the mass media because IIВМ has a large number of contracts with commercial and state medical institutions, including the Central Clinical Hospital of the President’s Administration, where most transplantations were done for profit.[9] Such suspicions were strengthened by a statement of one official representative of the ministry suggesting this scandal was provoked by rivals of Russian doctors who are trying to stop them promoting their services in international markets. What kind of commodities were they going to offer on these markets? At this moment only the German pharmaceutical company ‘Schering’ is disadvantaged by the scandal. The company decided to withdraw ‘Nolador 500’ from Russia because of the risk that it was being misused.[10] That meant that American ‘Prostin-15M’ (Upjohn) has been left without competitors on the Russian market of 2-3 million abortions a year.

In addition, in most of the media, it was emphasised that there is an acute necessity to impose legal limitations on the practice of abortion in Russia. Existing laws in this country are extremely liberal. Abortion can be performed for social reasons until the 22nd week of pregnancy, and for medical reasons up to term. The list of medical and social reasons for justifying late term abortions established by the Ministry and adopted by the Government is so broad that there are virtually no limitations on abortion at any stage of fetal development.

In the public debate, there was strong agreement that fetuses shouldn’t be treated as ‘raw material’ for modern biomedical technologies and that they should have a special moral status, and social protection. It is right to use tissues of an aborted fetus for transplantation in order to help sick people (with, for example, Alzheimer’s disease), but it is wrong to transform them into a kind of private property to be used for profit. The recognition of a special moral status of fetuses has caused another standard bioethical problem – ‘what are the limits of women’s rights to exercise power over the lives of their unborn chil­dren?’. There is well-established agreement that it is necessary to minimise late term abortions so they are performed only when the mother’s life is threatened, that abortion is not an appropriate form of contraception, and that modern technologies of birth control should be implemented throughout state programmes of family planning.

It is necessary to consider the special cultural context of the discussion. Traditionally conservative on issues of abortion, the Russian Orthodox Church now enjoys a growing influence on public opinion and the opinions of the Russian political elite. The Church is not so powerful as in Poland, but together with other Christian churches, Jews, Muslims and Buddhists it controls a large part of the population. If its influence is added to that of a growing number of ‘pro-life’ organisations, it is reasonable to say that the ultra liberal policies of the Russian medical authorities do not match the more conservative standing of the Russian population on this issue. Even publications in favour of programmes to develop transplantation of fetal tissue recognise that existing levels of abortion should be minimised, and that abortion itself is a matter of significant moral concern.

Position of the RNCB

The Russian National Committee on Bioethics (RNCB) is a non-governmental, non-commercial organisation housed in the Russian National Academy of Sciences. From the very beginning of the abortion scandal, representatives of RNCB were actively involved in public discussions on the issue.[11] Its position is summarised in several statements:

1. The main cause of the scandal is the traditional authoritarian and paternalistic desire of the medical establishment to decide for the whole society what is for the common good in health care, to interpret and evaluate cornerstone concepts of medicine like ‘death’, ‘life’, ‘normal’, ‘pathological’, ‘person’, ‘fetus’ etc. Such a position was characteristic of the activity of professional groups within the ‘closed’ totalitarian Soviet society. In an open, democratic society such basic concepts (their interpretation and evaluation), should be developed through public debates and recognised democratic procedures. The notion of aborted fetuses as a kind of raw material (shared by the medical establishment) that could be used for the development of profitable methods of treatment has no public support. The feeling of public distrust towards the ‘fetal business’, and the medical profession in general, that was demonstrated during the scandal shows the necessity of establishing a kind of informed consent from the public before implementing any new biomedical technologies in practice.

2. Creation of the national system of independent ethics review bodies (like LRECs in the UK) as mechanisms of public control of biomedical scientific research and clinical testing of new methods of treatment, could be a sufficient step towards the prevention and resolution of possible conflicts between the general population and Russian medical science. Ethics committees that now exist in some medical research institutions are heavily dependent on hospital authorities and couldn’t function as independent ethics review bodies. For example the consent form that was amended by the ethics committee of the SCOGP doesn’t provide women with any information about the goals and the character of the procedure of late term abortion, about risks to their health, or about how the tissues of her fetus will be used. Such a document has only symbolic value, and doesn’t protect women’s safety and autonomy.

3. New legal regulations and institutional policies should be developed in order to disconnect financial links between medical teams that are performing abortions and establishing that fetuses are dead, i.e. teams that are harvesting fetal tissues, and teams that are developing transplantation of those tissues for profit. There is an acute need to develop a legally established and publicly recognised concept of death in fetuses, and to develop publicly controlled institutional policies regarding the therapeutic and research use made of aborted fetuses.

4. Development of profitable programmes of transplantation of foetal tissues will increase demand for late term abortions and that is why they should be limited as much as possible.

At the same time we must acknowledge that in the modern economic and political situation in Russia, offering commercial services is the only way for many medical institutions to survive. Medicine in this country is traditionally underpaid. And even these limited resources are usually provided only in part and with significant delays. Low social status and financial reimbursement of medical professionals, and their significant power as distributors of vitally important limited resources of health care makes this professional group vulnerable to different forms of corruption.12 Highly profitable businesses in the transplantation of fetal tissues that are of doubtful legality are just one example from a great number. We are reluctant to give any moral justification to any form of corruption because of the poor financial conditions of physicians, but without changes in the social status of the medical profession no real moral improvement in this field can be achieved. Until

society is ready to provide medical doctors with just financial reimbursement., we as individuals pay the 'saved' money in other ways or an even greater amount of money on the ' shadow market' of medical services.

A fuller version of this article was published in Cambridge Quarterly of Healthcare Ethics vol.6, no. l, winter 1997.
 

References

[1] Tishchenko, Pavel. The individual and healthcare in the New Russia. Cambridge Quarterly  of Healthcare Ethics (1995) 4, 75-79.

[2] Melnikov, Alexander. TV programme forced Government to become involved in complicated problems of medical ethics. Izvestija. January 11, 1996.

[3] Feodorina, Maria. Physicians with limited responsibility. Moskovskij Komsomoletz. January 22, 1996.

[4] Sadkovskaja, Tatijana. Sensation of ‘Spiegel TV’ had burst, but fatal problems of fetal therapy remain. Rossijskije Vesty. January 19, 1996.

[5] Feodorina, Maria. Op. cit.

[6] Ibid.

[7] Feodorina, Maria. Op. cit.; Chukurov, Alexy. Business on unborn. Pravda, January 13, 1996.

[8] Sadkovskaja, Tatijana. Op. cit.

[9] Chukurov, Alexy. Op. cit.

[10] Sadkovskaja, Tatijana. Op. cit.

[11] Yudin, Boris. We should respect dignity of fetuses. Nezavisimaja gazeta, January 17, 1996.