Panel Discussion pp. 121-126 in Bioethics and the Impact of Human Genome Research in the 21st Century

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Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

Matsuda: I first will introduce the recently revised guidelines of the Japan Society of Human Genetics. Are there any questions.

Shinagawa: In your committee, Japanese abortion law is specifically contrary to most Euro-American countries. In other words, most Euro-American countries have two categories of induced abortion, that is "maternal indication" and "fetal indication". But in Japan there is no "fetal indication". Have you ever discussed on this regard?

Matsuda: Yes, it's a big problem. We have discussed so much about "maternal indication" and "fetal indication". I think very recently, Germany decided not to use the fetal condition, but only the mother's condition. In Japan we only consider the mother's condition. There are arguments to use fetal indications, but it is still being discussed. The general conclusion is that maternal condition is most important. If the fetus has some kind of disease, then the pregnant woman will be worried, which affects her health. So, maternal indication could include fetal condition, and then maybe it is not necessary to define both "maternal condition" and " fetal condition.

Shinagawa: Thank you, my understanding is almost the same.

Sivakami: You have stated that the genetic information should be protected by legal and ethical principles of confidentiality and it should not be disclosed to insurers or employers. It is particular in the case of people who migrate, or leave their countries on the basis of a contract to another country to be employed there, if they are known to be hypertension patients, I think the contract will be cancelled. Or if they are diabetes patients, also I think the contract will be cancelled. So I think I think it should be kept confidential, and should not be disclosed unless on demand of the person who undergoes the genetic testing.

Matsuda: Yes I understand that. We are only talking of the family. Especially in the family where they have danger to health and a high risk for the family, only in that case is it allowed to disclose the information to the family.

Wertz: Thank you Dr. Matsuda. I am delighted to see how closely the Japan Society of Human Genetics guidelines follow the draft proposed WHO guidelines of 1995, and the revised proposed WHO guidelines of 1998.

Matsuda: Dr. Wertz will next make her presentation. Are there any questions?

Minakshi: I did not understand the word blanket consent.

Wertz: A blanket covers everything. We talk about blanket agreements, blanket mortgages. Blanket consent means that you are consenting not only for a specific research project for which your blood is taken, but you are consenting for use of that sample in future research projects that researchers may not even be able to envision at all right now. We don't know what kind of genetic research will be done 7 or 8 years from now. So we can't ask you in advance for consent, but if you give a general consent that you allow your sample to be used for genetic research, then this removes the difficulty of going back and finding you in 7 or 8 years and asking you to give another consent

Sivakami: When you were talking about counseling, you said empathic and un-biased counseling. But in all counseling, I think the counselor corrupts the mind of the person who is taking a counseling, to move in the direction of making a particular decision. But you said that there is no responsibility on the part of the counselor, for whatever decision is made it is made only by the patient. But don't you think that he is actually encouraging my student to take up a subject. Am I not to accept some responsibility in the decision making?

Wertz: This is a very good question. You're pointing to the impossibility of completely un-biased counseling. I agree that people look at the counselor's gestures, they listen to their tone of voice - they're seeking direction, and it's very difficult to be un-biased. But the counselor should try to be as un-biased as possible. The counselor should avoid presenting biased information, as if it were scientific fact. Sometimes people make decisions with which the counselor disagrees. A counselor does not have to say whatever decision you make, I will give you emotional support and help you with that decision. In some countries like the U.S., that is a tenet of genetic counseling. You're supposed to support all decisions. The WHO guidelines say you don't have to, if there is something that the counselor really disagrees with, the patient is free to make that decision but you don't have to say "I will give you emotional support in what you're going to do". The counselor has a right not to support all decisions.

Ida: I have a very brief remark on your presentation, as chairperson of UNESCO International Bioethics Committee. I think UNESCO and WHO had difficulties. The UNESCO Declaration is rather from the viewpoint of research and science, and not from the viewpoint of medical practice. However the UNESCO declaration was adopted by the general conference of UNESCO, which means that governments adopted the UNESCO Declaration. On the other hand, WHO's guidelines are not adopted by governments. I understand this is an important document, but this is a document of experts in medical practice. So the two statements have difficulties, because the WHO guidelines are not always adopted by each member state of the WHO. I hope UNESCO and WHO will cooperate with each other.

Wertz: It was not WHO's intention that member states adopt these. These are simply for reference by public health departments, many of whom have no experience with genetics in general medicine. Thank you for your comment. The next speaker is Dr. Webb from the Human Genetics Commission in the UK. Are there any questions?

Takebe: Recently we learnt from newspaper articles that Huntington's disease testing has just been approved for use by insurance companies in the UK. As you know, Huntington's disease is a most controversial disease because of its late onset and very serious outcome. Has your committee already discussed this issue, or do you have any plan to discuss this in the future?

Webb: Insurance is one of the big concerns of many people. The government two years ago, could see that this was becoming more and more of a concern to the public and set up a separate group called the Genetics and Insurance Committee. This committee has been looking at, and working with, the insurance companies to firstly insure that if genetic testing is to be used, then it is done on an equitable basis. They are currently looking at seven genetic tests that the insurance companies have said they wish to use. They are looking at those to see whether or not those seven tests actually give useful information that could be considered by insurance companies. Huntington's was the first test that they have looked at and they have decided that it does give valuable information about somebody's future health because of the high penetrance. They decided that it can only be used if the test has already been carried out. The insurance company cannot ask an individual to take a genetic test. But if an individual has taken such a test, then the insurance company is entitled to seek that information.

Macer: What is the relationship to the European Commission and has there been any consideration of the possibility that people who may reject your advice or limits on the provisions of genetic service, would appeal to the European Human Rights Declaration for example for access. The second question is that I heard there was a difference in the patent protection given to the nuclear transfer techniques used to produce Dolly in England compared to European patent office. Is there a difference and is your commission going to touch on any intellectual property issues?

Webb: As regards the European situation, officials from the Department of Health who provide the secretariat to the Human Genetics Commission regularly meet with their counterparts in Europe and I have also been involved in the OECD initiative to look at genetic testing which involved people from Japan and many other countries. There are regular exchanges of views. What the Human Genetics Commission can do is to regulate genetics in the UK, but we are very much aware that if people want to order tests over the Internet for example, then they are free to do so. We can only set regulations within the UK. As regards the patent situation, I'm not aware of any fundamental differences in what is patentable within UK and Europe; I believe they are the same. There are differences between patent systems, particularly between Europe and the USA, but I'm not aware what is patentable in the UK would be considered un-patentable in Europe.

Kneller: The European Directive 98-44 leaves open the possibility that member states can make their own laws with respect to living animals and plants. I believe patenting of a complete animal is still not possible in certain European state, where as it is in the US. I am not sure about the UK. What the Dolly inventors may have done is patented the complete animal in a country like the US. Certainly the basic techniques for embryo implantation in cloning would probably be patented identically in Europe, US and probably Japan, too.

Wertz: The next paper is from Dr. Vogel in Germany. Thank you for an excellent presentation, on premature use of law. Are there any questions?

Shinagawa: Once upon a time, 1920s and 1930s, eugenics and Social Darwinism opened the door to euthanasia, etc. As far as I understand, antenatal diagnosis of many congenital anomalies has opened another door to the globalized termination of fetus and embryos. In Germany, you have the recent Embryo Protection Law, but since 1933 you have another law. Probably there has been much discussion of these issues in Germany. Would you kindly introduce some to us?

Vogel: I think what you have said is very important also to get a better understanding on the very restrictive policy in my country regarding also to prenatal and preimplantation diagnosis. All of us in Germany have history in mind; the history of the Germanic law, and the history of euthanasia, etc. This makes the public and the politicians, and everybody, much more reluctant concerning acceptance of recent progress than in any other country. I do understand this very well, but it is my opinion that we should now proceed with a policy that helps people in the present situation. But the historical situation is exactly what you have described. This makes the attitude of politicians or journalists or the general public, understandable.

Shinagawa: Social Darwinism was adopted not only in Germany and Japan, but many Scandinavian countries and many states of the USA also. I would like to ask Dr. Wertz and Dr. Webb, how is this problem in the USA and UK?

Wertz: It is true that we had a history of social Darwinism, which really was economic Darwinism rather than genetic Darwinism, for the most part. We also have a eugenic history of sterilization of people with mental retardation or for social deviance. But it has not affected our public consciousness, the way the Holocaust has affected public consciousness in Germany. For most people in the US, it's more of a historical curiosity; something that was done mostly in the 1930s, though the sterilization laws remained on the books till 1970s, and there were sterilizations after the Second World War. But this is not really affecting policies about genetics.

Vogel: The different might be partially due to the fact that the policies in the 1930s in Germany were much more extreme. Of course there were certain eugenics movements in the UK and the USA, as is well known, however this did not lead to the inhumane consequences, which we had in Germany. Therefore it is understandable that the public conscience in my country is touchy, more reluctant to accept progress. But still I believe that our population has to benefit from the recent progress of science. The general rules of WHO and other committees are also the general rules that are being followed by the scientific community in our country.

Webb: I'm not aware of any particular hang-ups that we have in the UK about genetics. I'm sure there have been things that we have done in the past that we now would look back on and say that we shouldn't have done. However I've been involved in the development of genetic tests for sale across Europe, and there are very noticeable difference between selling genetic tests in the UK and selling them in Germany. However, I believe that conferences of this nature and guidelines that various organizations will be putting out will cause people to rethink. Whilst we have some issues and public awareness rising up now in the UK about genetics, there are serious concerns, but I do believe that the government has thought ahead and now has the human genetics commission to discuss the issues, as soon as they become apparent rather than always reacting.

Wertz: The next speaker is Dr. Mao from the UK. Thank you for presenting on a topic that is seldom discussed, but has important implications for prenatal diagnosis. Are there any questions?

Matsuda: I have a comment. In Japan up to now more than 30 million new born babies have been screened by mass screening system, for which Dr. Hisashige has calculated the cost benefit ratio. During the last 20 years we saved 5 billion yen. But in that case, only for PKU and hypothyroidism, two diseases, is it cost effective because of their higher incidence, but the other four diseases screened are negative in those terms. So, cost effectiveness should be related to, and considered with respect to the incidence of the disease itself. So we cannot compare only the basis of the disease itself.

Williams: I spent some time studying managed care systems, health care systems in the US. Parts of the basis of them is that they are motivated by, supposedly at least, by saving money. That has lead to some problems, because saving money is important but it is not a good proxy for measuring lots of kinds of things that are important in the provision of health care. The cheapest solution isn't the always the best one in health care. Because economic analysis is important, I'm wondering if you could comment on the appropriate place of genetic testing in health care.

Mao: As I said, economic issues of genetics is discussed little, simply because to discuss money is some sort of shame, because there are a lot of social issues you need to address. But practically, for this sort of project there are a lot of factors that need to be integrated, but we need to make ethics the basis of economic analysis. I think there is mutual interaction, because if you simply talk about the ethical issues, the principle is there. But how then do you practice? You need to present the detailed data and convince the general public. Also you need to convince the scientific community using the scientific data. This is why this sort of thing is important.

Vogel: As we already talked about after my talk, in my country Germany, history plays a very important role also in present discussions. Therefore economic consequences are allowed to be discussed, let's say for PKU testing, since therapy is available from the early development. However, it is completely impossible to discuss the same things for Down's syndrome, and the cost effectiveness of pregnancy termination in all these cases. Interestingly, the official groups and the government are not very honest in this point. Of course when we got additional resources for prenatal diagnosis, for example for Down's syndrome and other genetic diseases in the early 1970s, the government did ask us about possible economic benefits for the population. But this was never published, and never talked about in public. You are regarded as an inhumane eugenicist if you argue these things in the public or the press. I think we should also learn to be a little bit more honest in these things, and this was a very honest presentation.

Matsuda: I have a comment. Especially in the newborn mass screening, we use government money. In that case we have to consider about cost benefit, otherwise people won't agree with that. But in the case of Down's syndrome screening in Japan we cannot use government money. So we cannot use the same evaluation for all cases; do we use the government's money or do we use individual money? I think this is the most important aspect when you discuss about economic state.

Mao: As I said in my introduction, in the past, the social economy had a huge impact in the Western eugenics movement. So it is basically uneasy to talk about economic issues of genetics beyond ethics now. There should be parallel discussion, because you have the ethical framework but you need to do some sort of calculation. Otherwise you cannot convince people. This could be the platform to exchange different ideas and for discussion in multiple dimensions among people in all walks of life.

Matsuda: Thank you, the next paper is by Dr. Verma from India. Are there any questions?

Takaku: I have two short questions. You mentioned that prenatal diagnosis for sex selection is permitted in case of diagnosing the X-linked diseases. Is it permitted in preimplantation diagnosis?

Verma: Sex selection for X-linked diseases both in prenatal and preimplantation diagnosis is permitted.

Takaku: The second question is that you are permitting IVF for treatment as well as for research. Are you permitting IVF only for research?

Verma: It is not clearly stated about IVF and embryo research but the implication is that it is permitted up to 14 days post conception, which is until the formation of the primitive streak.

Takaku: You are permitted to use embryos until 14 days but is it permitted to do IVF only to create embryos for research?

Verma: No

Leavitt: You mentioned that no drug trials are required for herbs if they are to be used in Ayurvedic medicine. I've been very interested in the fact that many types of non-Western medicine are now attracting great international interest, there have been progress in the scientific evaluation, but I see very little impact of the bioethics movement there. My question is whether this aspect of the law is simply an oversight or is there a conscious decision to respect long Ayurvedic experience as being sufficient, so consequently no clinical trials are required.

Verma: They are permitted not to have any clinical trials if one of our ancient books on Ayurveda states that it is useful for this disease. That is a respect for old knowledge. If it is stated, it doesn't come under the perview of drug control of India. Otherwise the drug controller must approve every drug.

Leavitt: That sounds very reasonable. I also read that in Western medicine, that 60% of drugs have never undergone clinical trials, but experience is a form of clinical trial.

Minakshi: You talked about the national program on human genome diversity. What kind of rules do you follow for benefit sharing of, for example, for the ethnic groups from whom you take the blood samples from.

Verma: So far the research is still in the early stages. So they are collecting the data and studying many polymorphisms. Some work is also done with disease associations. The idea is that they said that those people who participate should receive some benefit, but so far it has not come to the level of how much and how it will be ensured.

Minakshi: What I understand from the national program on human genome diversity is more related to human genome diversity project. Is it so?

Verma: It is not linked with the international project. It is an independent national project. It's been funded by the Department of Biotechnology in different parts of India.

Minakshi: What is the specific position of the Indian Council of Medical Research on the human genome project on the whole?

Verma: It is supported and permitted so it should be carried out.

Matsuda: The next speaker is Dr. Williams, from the Foundation of Genetic Medicine. Are there any questions?

Vogel: I want to make one simple point regarding benefits of populations participating in certain studies. In South East Asia and Africa, intestinal worms in children are very common. A research worker who brings drugs against intestinal worms to a population, is normally very popular in this population, and will get all the blood samples he wants to have. This is a thing we do not think about, but knowing the local conditions in a certain population, this very simple device might be very helpful for the population and for the researcher.

Williams: I definitely agree. When asked, "How do you find out what's important to local communities? How can researchers possibly know what people want?", my answer is usually to say "You ask them".

Wertz: In developing our statement in benefit sharing, the Human Genome Organization Ethics Committee had the problem of defining community. It's easy to define community if you're thinking of an American Indian tribe living on a reservation. But what if you have people who ordinarily don't think of themselves as community. For instance, people with heart disease randomly selected from all over the US. How do you share benefits?

Williams: I don't claim to have every answer. But in that kind of a situation, that research is conducted among people who are not part of a self recognized group, it might be helpful to take a survey sampling. Then we could ask about people generally with that condition what kinds of things might be beneficial for them. We could proceed in that way. This is my opinion so you are free to disagree, but I do not think that benefits that are shared should necessarily flow back only to the specific individuals that contribute. I think it's OK to define things more broadly.

Kawashima: What is the definition of care and cure in the US?

Williams: I cannot speak on behalf of the entire US, but I will try to give my definition. I would think "care" would be types of provision of services or types of things that help people to feel good, safe or happy. For "cure" there is a medical definition which is getting rid of disease, but I personally don't lean towards that. I like looking at cure more in terms of a system approach and trying to correct whatever causes there are in a person's life if that is possible.

Matsuda: The next speaker is Dr. Takebe. Are there any questions?

Azariah: I have been reading some things about the "karma" in Hinduism and Japan. As far as my reading goes, in Indian literature, Buddha is the first person to stand against karma and the caste. How is it that the concept of karma is continued in Buddhism if Buddha was against karma?

Takebe: I asked several Chinese and Indian colleagues and they said they can find some of the old literature explaining karma, maybe coming from very original Buddhism concept. Also even from Israel, my Jewish friends said in Israel such a concept still exists. Maybe it originated from India and spread to all the world, not necessarily limited to Eastern parts of Asia.

Becker: From a viewpoint of a scholar of religion, we need to distinguish between karma that is transmitted through a family, from karma which one individual brings from a past life to a present life to a future life. Both this question and the presentation tend to confuse these. The Jewish conception and the Hindu conception and many religious conceptions are the karma that runs with a family, from father to son to grandson. Where as the Buddhist conception is that there are impulses of consciousness, which affect future consciousness, mainly of the individual of that consciousness, and they also impact on the environment and the environment comes back to the individual "Ingaouhou" but this is not in the family in traditional Buddhism, it's for the individual.

Takebe: I completely agree. I have also asked many leading Buddhist people and they explain that way. But the common people's understanding is rather different. For example, I have my own experience. When I was young, one of the neighbor boys had a bad leg, and that was said to be because his grandmother kicked a dog and that was the cause of a bad leg. That kind of karma has been very common in Japanese society for many years.

Unidentified man: I think Buddhism is the first Indian culture, which directly came into Japan. Not only the religion of Buddha, but also the background or the concept of the Indian culture came as one. So we Japanese tend to think almost all those traditional Indian thoughts are the same as Buddhism. I think there is misunderstandings.

Takebe: The old written literature, Kojiki, was published in 712. But the story even in that book has much relation to Indian or Chinese philosophy.

Matsuda: The next speaker, is Dr. Ida. Are there any questions?

Simon: I am at the Stockholm International Peace Research Institute. Has the IBC looked at all at plans to look in the future at the issue of biological warfare, and the possible applicability of these new technologies to warfare purposes? Maybe in the context of international cooperation, because I know that in the past, fears that this technology could be used for warfare purposes has been an obstacle to cooperation.

Ida: I should say that IBC has many and various problems ahead and we are rather focusing on the bioethics on the human being and not directly to the biotechnology. Because if you enter into the biotechnology problem, we should extend the field of discussion to all the problems, concerning the development of biosciences. Even in the bioethics just concerning human beings, we have many subjects to discuss. I have already mentioned some points we have discussed, and we have many other subjects to be discussed, for example, xenotransplantation or some other embryonic stem cell research or the post genomic phase. So we are very aware of the biotechnology problems, which are related to bioethics, but we cannot do all the things at once. The problem for us is that we meet only once a year, and we have only two working groups a year. The budget is limited. Of course I may ask all the governments to give us money. This is an economics problem.

Matsuda: The last paper is by Dr. Fujiki. I would like to ask Dr. Wertz to make some concluding remarks.

Wertz: I find it very heartening to see the amount of agreement among nations on the basic ethical issues in human genetics, and how they should be resolved. We have heard now detailed codes of ethics from several different quarters. We heard of medical codes of ethics from Japan, from India and from WHO, and I am amazed to see the amount of agreement. There are areas of difference, but the areas of agreement far exceed these. We've also heard from the UK, from Germany, and I really begin to think that the world is reaching a consensus on what should be done on the area of human genetics. I hope that we have further discussion perhaps in Fukui in succeeding years, to carry the areas of agreement yet further. I want to thank Prof. Fujiki for organizing such a wonderful array of representatives.


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