pp. 205- 209 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

Discussion on the Human Genome Project

: Now we have reached the middle of the conference, and we have a session on the Human genome Project. The co-chairman, Prof. Sakaki, has unavoidable business so he will be a little delayed and I will moderate. The first speaker is Dr Keyeux. We can only have one question.

Ivanov: Excuse my ignorance but what is ethnobotany?

Keyeux: Ethnobotany is the study of plants used in medicine or other health practices by indigenous peoples.

I.P. Singh: I was quite interested in the fears of the indigenous people, I would like to know what steps are being taken to reduce the fears of indigenous people?

Keyeux: Dialogue has started between indigenous people and Western society. I was referring to fears spread by the mass media, which are confusing for anyone. They pretend that we could make a weapon against indigenous people, but this is scientifically not correct. But is raises a lot of fears for the people because they perceive genetics as something which will manipulate and cause harm to them, and they overlook that genetics can also help to cure diseases. If we had not done research in this we could not have developed therapeutics in this, which we are now applying. It is helping a lot of people. Things have to be balanced.

Fujiki: Thank you, we must move to the next speaker, Prof. de Castro. We can have several questions.

Leavitt: Thank you for an interesting presentation. In January 1997 we were at a conference in Ahmednabad, India, and the focus was a similar message to your own, that indigenous people should benefit from the profits that are being made on their plants and animals and ideas, that are being exploited by big international companies. At this conference they brought some indigenous people, some farmers, and when the issue was discussed, and translated, the farmer said I do not really care about the profits others make because he had everything he wanted. I wonder how much these movements for indigenous personfs rights are initiated not by the indigenous people but by activists, bioethicists and people who may actually be imposing some of these Western liberal ideas on these people?

de Castro: That has always been a subject of discussion. I did not say that these groups should profit, I hate the use of that word, or the way you put it. It suggests some commercial interest. I did not mean that. I do not think it is correct to say that indigenous groups look at these things like that. If you have some problem and go to the indigenous persons and say you want to conduct research which may help others but not help their particular disease, you are looking at it from a perspective which is alien to them. They are interested in the particular diseases which have afflicted them. There is also the matter of not being entirely truthful to them. In many cases foreign medical missions have been coming to the Philippines telling the indigenous people that they are there to help them, and they collect samples from them, and in the process they may identify some illnesses or find ways to help them, but their real intentions are different. It has been the policy in the Philippines that foreign medical missions should seek the help of the Department of Health. In no case has the permission been given to collect genetic samples, however, we do know that genetic materials are stored in laboratories outside of the country. They are taken, even though the permission has been to conduct the medical missions for other purposes.

Roberts: When one has taken some material for examination and there is some left over. What would you suggest be done with the material? Should it be destroyed?

de Castro: Not necessarily, but that if the material is intended to be used for a particular purpose, that that purpose be made known to the sources of those material.

Roberts: But what I am saying is once that material has been used for those purposes, what can you do with what is left over. I am not sure?

de Castro: I suppose there can be some justification for further research, however, if it is used for some other purpose, or an unforeseen purpose, then the source of the material should be so informed.

Roberts: So you then have to go back?

de Castro: Yes.

Roberts: But what say it is not possible. Should every research project include travel funds for going back to obtain consent, for an infinite number of visits?

de Castro: Yes, I think so.

Fujiki: Thank you very much, we have to move to Dr. Verma. Unfortunately Dr Nasim is unable to come, so we do not have his talk. Thank you for a very useful presentation, and we have some time for comments.

Fluss: I was interested to learn of the new 1997 guidelines of the Indian Council of Medical Research, revised from 1980. Could you tell us whether there have been any cases of doctors undertaking unethical research under the 1980 guidelines? Did they provide sufficient safeguards and are there mechanism in place in case that physicians carry out unethical research?

Verma: I think we have had examples of unethical research. I do not know if you know the case at the beginning of 1997 where a Doctor in Assam transplanted a pigfs heart into a person. Eventually he was put in jail. Similarly there have been some complaints against research in Calcutta on using quinacrine as a contraceptive. Theoretically there are systems in place, but as you are in a large country these systems are not adequate. So certainly that system needs to be strengthened. For any complaint, someone has to file a written complaint, then the body will follow it up.

Leavitt: Could we focus on the point that all papers this morning have discussed, what is wrong about using samples, whether it be blood samples or a piece of hair or anonymized medical records, for a purpose other than what it was given. if I give my blood for a medical examination for my own illness, what is wrong if you take that sample and use it later for epidemiological study?

Verma: Basically when we took the sample from a person you told them you are taking for this purpose, and then later you change the purpose. It is only right that the person be consulted. You do not need to travel, you can write to the person and say, gThese samples we took from you, we would now like to use for this studyh. I think this is only fair, because any result which comes out with commercial benefit, they should be given some proportion of it. Secondly, it may be misunderstood that you have misguided them. That you took the samples for one purpose but actually you wanted them for another. They should not be destroyed, but people must be told.

Shapiro: Thank you for a very lucid account of the Indian situation. Could I make a general point, that many of these problems are not specific to India, developing countries. A whole range of problems are raised. What does one do with a sample that you want to use for another research project from which it was gathered for. Of course in developed countries we have this as an everyday problem, and the alternative to going back is to say to the person at the beginning when giving the sample, that we are taking it for this purpose but we hope that you will also allow us, as our research moves on, to use it for other research as well. Our experience, is that most people can understand this, and I think this is a good alternative.

Verma: I think that you are right. In the ICMR guidelines we revised, we borrowed heavily from the WHO document, on Guidelines for Genetic Research and Genetic Services, as well as the ones prepared by the Nuffield Foundation. As you said, on the consent form, we include that the person agrees for the sample to be used for other types of research. But if the new research yields you information which is subsequently used for commercial purposes, we must pass on some of the benefits to the people even if it is not written there in the first document. What would you say to this?

Shapiro: I think we have all tended to exaggerate the benefits that come from this type of use. If you take the John Moore case, which is where this notion of gEl Doradoh genes began, we learn that there arenft generally. It would be much fairer to tell people that there is value from research but it is a slow process, a diffuse process, and the business of trying to attribute minor rewards to individuals would not be cost effective administratively. I think you should say to people you should be altruistic.

Roberts: I would like to pick up on two points. One is the change in sex ratio since the beginning of the century. The greatest change in the sex ratio occurred in the first half of this century, and since we developed the capability for prenatal sexing, the trend has not continued and may have even reversed. The second point is the interesting case you presented with prenatal diagnosis of spina bifida, and you were asked to give directive counseling. I think you did yourself an injustice, as you gave the impression it is either all non-directive or directive, but from my knowledge of you, you are too good a clinician for that to happen. I am sure you would have discussed the problems that the parents may face with a child with spina bifida, and support, locomotion, and in essence you elucidated the parentsf wishes.

Verma: Regarding the sex ratio, if we ignore prenatal sexing, at birth there is naturally an excess of males, but in life males are more prone to accidents and diseases. But in India and in developing countries there is a neglect of the female, the female gets less food, less medical care, less likely to be taken to the hospital for some minor illness, so there is more and more mortality in the female. So the sex ratio which was at birth, letfs say 104 males to 100 females, keeps on increasing. So females are becoming less. Amniocentesis extended the discrimination to before birth. Often we do find reports, of some infanticide, which is punishable by imprisonment, but it does go on. This again aggravates the issue. It is the continuous ill treatment of females and low status, always getting less. Regarding spina bifida, we still may be more directive then in the West. I remember Dr Carter, the British geneticist, who said in the later part of his life said he should have been more directive in his counseling. What he expected the people to do, they were not doing. Families with severe diseases were still having more children. But what I do, is to say, what other couples in your position would do.

Manickavel: My question is whether the directive counseling you are talking about is linked to paternalism, and is it goal oriented.

Verma: For people who understand genetics I do not give them directive counseling, even though they sometimes want me to say what they should do. I say they must make their own decision because this concerns reproduction and abortion. But to some people who are illiterate, and do not explain, what is autosomal recessive or dominant. What I do is put it as what most people would do.

Manickavel: Is it possible to explain to them the severity of diseases and the karma principle, and leave the decision to them?

Verma: I always leave the decision to them. But it is like whether you say a glass is half full or half empty. The counselor, changes the name depending on what they think is right for them. It is not really a paternalistic view, in India abortion is undertaken for very minor things, so generally I try to dissuade them from abortion. A lady will come who has taken some drug, and some doctor may have recommended an abortion, but I have saved many lives arguing that they should not, and that there is no risk.

Fujiki: We can continue some discussion of this in Fukui. The next speaker is Dr. Macer. Now we can have some discussion.

Mauron: Thank you for the very exciting presentation which opens many questions, and in fact we have already discussed sampling practices, commercial pressures, the respect for informed consent of people, but I would like to shift to another aspect which has not been discussed, namely genetic studies as sources of knowledge that would be possibly troubling to traditional worldviewfs of indigenous peoples, and how to solve those sorts of dilemmas. In a sense, science is tangentially troubling to tradition, in its very nature and history, and how can we at the same time articulate legitimate concerns for a respect for dealing with traditional worldviews without going over to a post-modern relativist view which would in effect allow knowledge to be suppressed as soon as it is disturbing to someonefs worldview? How can this dilemma be solved and how your committee can have an input on that.

Macer: This clash of worldviews is a central issue to indigenous groups, and is something which is still taking some researchers time to understand. Because some of the other issues, like return of research benefits, do not seem to be so central. When I met with indigenous people from all continents of the world and discussed with some of these protest groups, I found often they were happy to give their samples to science for the research, but some of them have had abuse in the past. The point is that they want to say, leave us alone. At least in the Colombian projects, and in the HGDP, the researchers have agreed that if people do not give genuinely free consent they will leave them alone. The problem is other researchers may not, and in fact they go on continuing to collect samples, and there has been a great confusion about which groups of researchers are doing what. Coming to the second problem, I believe they have a right not to know the research results, so that their world view would not be challenged, if that is what they really want. However, the latest plan for the population genetics research is to look at a large number of genes in a small number of individuals and the individuals may be accessed at any large international university campus. These individuals would have a world view that is similar to the researcher, and they would say, Yes, here is my blood, please put my population group into your database. This is not the community consent, but it is difficult.

Ivinson: The idea of a committee that would listen to complaints or concerns that indigenous groups or scientists seeking to conduct the studies, sounds very sensible and appropriate. Would that committee aim to adjudicate, and parties going into the committee would agree to abide by the decision? Secondly, you say that there is a problem of funding. Is there an example in the past where a committee has, in an informal way, gathered to listen to some concerns and has obtained a reasonable outcome. When people hear of another committee, they may say no money for another committee. Are there some positive outcomes that you can hold up and show that it works?

Macer: The problem with the committee has been the funding. It was interesting, that we have a committee acceptable to all parties, and the HGDP organizers have said that they would be willing for our ethics committee to be an ethics committee for the HGDP, as originally proposed by HUGO. The HGDP organizers are sensitive to this, and they have said that they would leave out any sampling or data that did not meet the ethical criteria. For that project therefore it may be OK, but otherwise it would be up to researchers, there is no way to enforce decisions. It is difficult to think of an example of a committee working effectively like this, though Dr. Crawley suggested the UNAIDS Committee has been one successful model. The United Nations is the most appropriate body for such a committee, but we could only expect voluntary cooperation, and perhaps you could have a blacklist, but it would not have binding powers. You would need to have national ethics committees or funding bodies that would agree to the recommendations and stop the funding.

Shapiro: I think that we should not be too despairing about the lack of sanctions. These projects and this type of research all need funding, and the major funding bodies, both governments and foundations, cannot afford to be seen to be funding research that is generally deemed to be unethical. I think that one can expect a general requirement for ethical approval, and speaking of the developed world no foundation can afford to be seen financing research that lacks ethical approval. I think a similar pressure can be applied to governments and multinational pharmaceutical companies.

Leavitt: I agree with Mr. Shapiro, but I think the recent case of the funding of a chair in Cambridge by cigarette manufacturers points out that funding is not always ethically controlled.

Shapiro: I think Cambridge University has taken tremendous criticism over that episode and will certainly not repeat its behaviour.

Fujiki: Thank you we have to stop, we ask Dr. Nukaga to talk. Thank you. We have to move to the next speaker, let me introduce the co-chair, Prof. Sakaki.

Sakaki: I am sorry I could only arrive here now from Tokyo. The next speaker is Prof. Penchaszadeh. Thank you we can have some discussion.

Leavitt: I have a remark, is you said there was a Chinese belief that drawing amniotic fluid might weaken the body and possibly draw harm, and you interpreted this as an obstacle. But I wonder if these things can be seen as some foreign cultural belief. Sometimes if you translate them into medical terms, these people can be right. There is data that drawing amniotic fluid causes harm to some fetuses. Secondly, I have read that there is in the USA an Office of Alternative Medicine, that is trying to encourage alternative and Asian medicine. Could you please explain if this has any impact on your work? To what extent does traditional Chinese medicine alter the use of modern medicine in New York Chinese community.

Penchaszadeh: A belief doesnft necessarily have to be true. Sometimes beliefs are based in experience, and yes, amniocentesis can produce complications. Perhaps you may be right in that my use of the word obstacle is too exclusive, rather the paper was to give ideas of the concerns which come from the own culture of patients. They maybe grounded in experience or not, but we should not be dismissed by those providing the services. The _ XE gNIHh _ has for several years had an Office of Alternative Medicine, whose role is to analyze scientifically what alternative medicine is. This takes into account the reality that alternative medicine is very much practiced, not only by immigrant groups, or people with their own culture, but across all cultures and socio-economic groups, especially for conditions which are not curable by Western scientific medicine. There is no connection between that initiative and our own experience, because they have not yet looked at genetic practices, but are looking at herbal medicine, acupuncture, medication, for specific treatments or amelioration of a condition.

Verma: How much was the demand for asking for sex of the fetus, and how did you answer these?

Penchaszadeh: That is an important point, among the Chinese in America there is a similar preference for males as you discussed in India. However, the prevailing attitude of most geneticists in the USA is they would not condone fetal sexing, except for sex-linked diseases. Our unit would never perform a diagnosis if that was a stated reason, but it is probably going on in a number of places. Prenatal diagnosis is being used to do that among some people in the USA, and in our own community, according to some of our data. This is not stated overtly, but is used for other indications and we cannot quantify but not put on the table by the patients.

Elwyn: Could you explain in more detail the types of ethical problems in the clash between the traditional Chinese oriented family view and the family as a legitimate part of the decision making process, and where you might be obligated as a physician to talk with the family, versus the legal ideas in North America and the Western view of the doctor and the patient in direct conversation, and against disclosure to family.

Penchaszadeh: We have learnt through experience that we must involve the family because the patient will request it. Our genetic counseling sessions, and in general among Latino patients also, our sessions have to go to a larger room, because it is not only the pregnant woman, or the couple, but the in-laws, sisters or brothers. We have not really had any clash accepting that. We always say that the unit of care is the family, and in genetics that is clear, so we accept involvement of the extended family. Sometimes it may represent a problem if one of the family member may not be available, and the patients will postpone decision-making until they consult in-laws, or the oldest member of the family, but it has not been a significant problem. There are no legal restrictions on this.

Manickavel: This is a comment from the point Dr Verma raised. There is one incident which came to the media in Canada 5-6 years ago, due to the strict law against prenatal sex diagnosis there. In Western Canada, and across the border in Seattle, Washington, a company advertised in Canadian newspapers in ethnic newspapers in Hindi and Punjabi, to attract patients from Canada to cross the border and have prenatal sex diagnosis, as well as abortion.

Fujiki: Thank you, we must move to the last talk. I introduce Prof. Sakaki who is Director of the next five yearfs Human Genome Project in Japan. Thank you for a broad and comprehensive overview. Our time is very short, so please continue discussion this afternoon and during the reception tonight.

Please send comments to Email < asianbioethics@yahoo.co.nz >.

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