pp. 271-277 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.

8.3. Gene Therapy: Professionals will go further away from public opinion

Yasuko Shirai.

National Institute of Mental Health, Chiba, Japan

1. Introduction

Dramatic advances in the Human Genome Project may open the door for gene therapy not only for genetic disorders but also for some kinds of cancer and other common diseases. The first step toward human gene therapy in Japan was made when an Expert Committee on Gene Therapy was initiated at the Health Science Council in October, 1991. After some deliberations, the Expert Committee prepared "an Interim Report on Gene Therapy" in June, 1992. The two main points of the Interim Report were as follows: (1)gene therapy was considered as a possibly important treatment method not only for genetic disorders, cancer and AIDS but also for so-called adult diseases. (2)In order to promote gene therapy clinical research, they proposed the planning of priority research projects, the organization of a system of review, the preparation of guidelines, and so on. Based upon this report, the Health Science Council issued "Guidelines on Clinical Trials for Gene Therapy" in April, 1993. These guidelines were authorized by the Ministry of Health and Welfare in February, 1994(1). In August, 1995, the first clinical research of gene therapy in Japan was used to treat a five-year-old boy with ADA at Hokkaido University Hospital. It was reported that the main procedures of this trial were successfully finished in Octover, 1997. Many Japanese doctors have pursued similar goals targetting cancer and AIDS.

This has been our first experience to provide guidelines and a reviewing system prior to beginning clinical trials with advanced medical technologies. However, the structured paternalism of Japanese society (3) was functioning, again; no public hearings or forums were held through out the process of preparing the guidelines. Many people around the world have expected that gene therapy offers the possibility of an epoch-making treatment method for diseases currently without effective treatment. Therefore, it is very important to share information and exchange opinions between so-called experts and ordinary people for reaching mutual agreement on the medical use of the outcomes of genome research. To raise the awareness of the benefits of having a wider forum, the present author conducted two opinion surveys which demonstrated attitudinal differences between experts and lay persons concerning the clinical use of advanced medical technologies.

2. Methods

A survey of experts was carried out in July, 1994 with the cooperation of the Japanese Society of Human Genetics(whose total current membership is 1,321) and the Japanese Society of Inherited Metabolic Disease(whose total current membership is 615). Through a random sampling method, 600 members from the first group and 100 members form the second group were selected as respondents. Seven hundred questionnaires were distributed by mail, and a total of 358 responses were received(a response rate of 51.1%).

The survey of lay persons was carried out from October through November, 1996, with the cooperation of the Sentensei Shishi-syogaiji Fubo-no-kai(the Parents' Association of Children with Malformations in Extremities), two groups of parents with children of Down syndrome, and Kyoto Iryo Hiroba (a medical consumers' self-help group in Kyoto). 330 couples from the three parents groups and 150 members from Kyoto Iryo Hiroba composed the group of lay persons. 810 questionnaires were distributed by mail, and a total of 350 responses were received(a response rate of 43.2%).

The main issues of the two opinion surveys were prenatal diagnosis and abortion, assisted reproduction, gene therapy and preimplantation diagnosis. In this paper, I report the attitudinal comparisons between the so-called experts and the lay persons concerning specific applications of gene therapy for six cases (To cure a usually fatal disease, to reduce the risk of developing a fatal disease later in life, to stop children from inheriting a usually fatal genetic disease, to stop children from inheriting a nonfatal birth defect, to improve the intelligence level that a child would inherit, to improve the physical characteristics that a child would inherit).

3. Results

3.1 Sample Characteristics

Table 1 lists the characteristics of the respondents of the two groups. Among the expert group, the age of the respondents ranged from 23 to 87 years old; the average age was 43.2 years old (SD=11.7). More than 80% of the respondents were male medical doctors. The valid answers of a total of 356 respondents were used in the following analysis. Among the group of lay persons, the age of the respondents ranged from 19 to 72 years old, and the average age was 40.5 years old (SD=9.8). About 39% of the total respondents were male, and residual 61% were female respondents. Nearly 60% of the female respondents in this group were housewives, and more than half of the male respondents were businessmen.

Table 1: Sample characteristics

Expert group in 1994 survey

Concerned lay persons group in 1996 survey

N

358

N

350

% Female

18.2%

% Female

61.4%

Age: Under 35 years

32.4%

Age: Under 35 years

31.7%

36-49 years

40.0%

36-49 years

48.9%

50-59 years

15.4%

50-59 years

14.0%

60+ years

11.4%

60+ years

4.9%

Speciality   Occupation  
Medicine

Natural Science

Uncertain

84.4%

13.7%

12.0%

Business

Self-employed

Civil service

Housewife

Other

23.1%

4.6%

8.6%

36.6%

27.7%

3.2 Attitude toward gene therapy for a usually fatal genetic disease

Figure 1 presents the respondents' attitudes toward gene therapy for a usually fatal genetic disease. Among the expert group, more than 80% of the total respondents were in favor of the gene therapy used for this case. About 9% were opposed, and 8.7% abstained. There was no significant attitudinal difference between the male and the female experts. Among the group of lay persons, 69% of the male respondents agreed with the gene therapy used in this case. 18% were opposed, and 13% abstained. Whereas among the female lay persons, less than half were in favor of this use of gene therapy, 23% were opposed, and 29% abstained. There was thus a significant attitudinal difference between the male and the female lay persons in this case(p<0.001 by chi-square test). A large opinion discrepancy between the expert group and the group of lay persons was revealed (p<0.0001 by chi-square test).

3.3 Attitude toward gene therapy for reduction of the risk of developing a fatal disease later in life

Figure 2 illustrates the respondents' attitudes toward gene therapy for reduction of the risk of developing a fatal disease later in life. Among the expert group, 69% of total respondents favored gene therapy used for this case. About 12% were opposed, and 19% abstained. There was no significant attitudinal difference between the male and female experts. Among the group of lay persons, 61% of the male respondents approved of the gene therapy in this case, 22% were opposed, and 17% abstained. Among the female lay persons, only 46% were in favor, 26% were opposed, and 28% abstained. A significant attitudinal difference was indicated between the male and female lay persons (p<0.05 by chi-square test). In this situation, a large opinion discrepancy between the expert group and the group of lay persons was also demonstrated (p<0.0001 by chi-square test).

3.4 Attitude toward gene therapy for stopping children from inheriting a usually fatal genetic disease

Figure 3 presents the respondents' attitudes toward gene therapy for stopping children from inheriting a usually fatal genetic disease. Among the expert group, 66% of the total respondents agreed with the gene therapy used in this case. About 22% were opposed, and 12% abstained. In the comparison of male and female respondents' attitudes, no significant difference was revealed. Among the lay persons, 64% of the male respondents favored the gene therapy, 22% were opposed, and 14% abstained. Among the female lay persons, less than half were in favor, 24% were opposed, and 28% abstained, indicating a significant attitudinal difference between the male and female lay persons (p<0.01 by chi-square test). A large opinion discrepancy between the expert group and the lay group was revealed (p<0.005 by chi-square test).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1: Attitude toward gene therapy for a fatal genetic disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 2: Attitude toward gene therapy for reduction of the risk of developing a fatal disease later in life

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 3: Attitude toward gene therapy for stopping children from inheriting a fatal genetic disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 4: Attitude toward gene therapy to stop children from inheriting a non-fatal birth defect

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 5: Attitude toward gene therapy for improvement of the intelligence level that a child would inherit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 6: Attitude toward gene therapy for improvement of the physical characteristics that a child would inherit

3.5 Attitude toward gene therapy for stopping children from inheriting a non-fatal birth defect

Figure 4 indicates the attitudes toward gene therapy used for stopping children from inheriting a non-fatal birth defect. Among the expert group, about half of the total respondents favored the gene therapy for this case. A quarter were opposed, and 26% abstained. There was no significant attitudinal difference between the male and female respondents. Among the group of lay persons, 55% of the male respondents were in favor of this use of gene therapy; 30% were opposed, and 26% abstained. Among the female lay persons, only 31% favored gene therapy in the case; 37% were opposed, and 32% abstained. There was a significant attitudinal difference between the male and female lay persons (p<0.0001 by chi-square test). A slight attitudinal difference between the expert group and the group of lay persons was suggested (.05< P <.10 by chi-square test).

3.6 Attitude toward gene therapy for an improvement of the intelligence level that a child would inherit

Figure 5 indicates the respondents' attitudes toward gene therapy for an improvement of the intelligence level that a child would inherit. Among the expert group, only 10.5% of the total respondents were in favor of the gene therapy used for this case; 73.4% were opposed, and 16.1% abstained. The male and female respondents had quite similar attitudes on this matter. Among the group of lay persons, 11.5% of the male respondents favored the gene therapy, 67.7% were opposed, and 20.8% abstained. Less than 5% of the female lay persons agreed with this use of gene therapy, 79.8% were opposed, and 15.6% abstained. A significant attitudinal difference was present between the male and female lay persons(p<0.05 by chi-square test). In this case, no opinion discrepancy was shown between the expert group and the group of lay persons.

3.7 Attitude toward gene therapy for an improvement of the physical characteristics that a child would inherit

Figure 6 illustrates the respondents' attitudes toward gene therapy for an improvement of the physical characteristics that a child would inherit. Among the expert group, only 11% of the total respondents were in favor of this gene therapy, 71% were opposed, and 18% abstained. Among the group of lay persons, 15% of the male respondents agreed with the gene therapy in this case, 68% were opposed, and 17% abstained. Among the female lay persons, 10% approved, 67% were opposed, and 23% abstained. There were no significant attitudinal differences between the male and female respondents in each group, or between the expert group and the group of lay persons. It is noteworthy that this case was the only one in which no attitudinal differences were indicated among the four subgroups.

3.8 Summary of the results of statistical comparisons concerning the affirmative attitudes on specific applications of gene therapy

Table 2 is a summary of the results of the statistical comparison concerning affirmative attitudes on specific applications of gene therapy among the four subgroups. As shown in the table, the expert group had more affirmative attitudes toward the first four uses of gene therapy than did the group of lay persons. In contrast, the two groups had definitively negative attitudes toward the other two uses(cases 5 and 6), the so-called non-medical uses of gene therapy. As mentioned above, among the expert group, the male and female respondents held quite similar attitudes toward gene therapy for all six cases, whereas among the group of lay persons, significant attitudinal differences were shown between the male and female respondents toward five uses of gene therapy except for the last case.

After a careful examination of the attitudes among the four subgroups, it was revealed that the main cause of the attitudinal differences between the expert group and the group of lay persons stemmed from the large opinion discrepancies between the male experts and female lay persons toward these matters.

Table 2: Summary of the results of statistical comparisons concerning positive attitudes on specific applications of gene therapy

Case

Experts vs. Lay persons

Male v. Female

Male expert

 

overall

male

female

expert

Lay

v. female laypersons

Cure a usually fatal disease

*****

E>L

**

E>L

***

E>L

ns

****

M>F

*****

E>L

Reduce the risk of developing a fatal disease later in life

*****

E>L

*

E>L

+

E>L

ns

*

M>F

*****

E>L

Stop children from inheriting a usually fatal genetic disease

***

E>L

ns

ns

ns

**

M>F

*****

E>L

Stop children from inheriting a nonfatal birth defect

+

E>L

ns

+

E>L

ns

*****

M>F

****

E>L

Improve the intelligence level that a child would inherit

ns

ns

ns

ns

*

M>F

*

E>L

Improve the physical characterist-ics that a child would inherit

ns

ns

ns

ns

ns

ns

The number of astericks in the box indicates the significance level by Chi-Square test,

***** P<0.0001; **** P<0.001; *** P<0.005; **P<0.01; * P<0.05; + P<0.1;

ns = no significant difference

4. Comparisons with other surveys and groups

There have been only a few surveys on attitudes toward gene therapy in Japan (2, 5-8). The results of the present survey reveal a high level of support of gene therapy among the experts compared to the groups in those surveys. Compared to the public attitudes reported in those survey, however, the present group of lay persons indicated a similar level of support. In the OTA survey (4), a strong majority of Americans approved of human gene therapy. In contrast to the OTA survey, the lay persons in the present study more often declined to express definitely affirmative attitudes toward gene therapy.

 

5. Discussion and Conclusion

Based on the results of the present survey, the following points are suggested.

1) There were significant attitudinal differences between the experts and the lay persons concerning gene therapy.

2) The experts and the lay persons shared negative attitudes toward gene therapy used for non-medical purposes.

3) The main cause of the attitudinal differences between the experts and lay persons stemmed from the large opinion discrepancies between the male experts and female lay persons.

In Japan, genetic disorders are always a serious family problem. In the traditional way of thinking, genetic disorders were regarded as a shameful occurrence to be hidden from society. The traditional religious teaching in our society contributed to as idea that genetic disorders were the results of misconduct in a previous generation of the family. Although such ideas have rapidly diminished in its impact, there are still implicit discrimination and prejudice against those who have genetic disorders and/or those who have a family history related to it. A person and his/her family with genetic problems are almost always faced with not only medical problems but also psycho-social problems and ethical dilemma.

These findings suggest that a wider open forum is indispensable to consider a fruitful future of gene therapy in our society. When forums and/or working groups on this matter are organized and the members are choosen for them, it is also necessary to give serious consideration to the attitudinal differences caused by the factors of gender and expertise.

References

1. Health Science Council: Guidelines for Gene Therapy Clinical research. Health Science Annual Report, 1994. pp.362-373.

2. Macer, D. Attitudes to Genetic Engineering: Japanese and international comparisons. Eubios Ethics Institute, 1992.

3. Macer, D Bioethics may transform public policy in Japan. Politics & Life Sci. 13: 89-90, 1994.

4. OTA: U.S. Congress Office of Technology Assessment, New Development in Biotechnology, 2: Public Perceptions of Biotechnology-Background Paper (OTA-BA-350). Washington, D.C.: U.S.G.P.O., 1987.

5. Prime Minister's Office: Life Science. Monthly Public Opinion Survey April 1986: 53-99 (in Japanese).

6. Prime Minister's Office: Medical ethics in practice. Monthly Public Opinion Survey May 1991: 24-52 (in Japanese).

7. Macer, D. (1992). "Public acceptance of human gene therapy and perceptions of human genetic manipulation." Human Gene Therapy 3: 511-8.

8. Macer, D.R.J., et al. (1995), "International perceptions and approval of gene therapy", Human Gene Therapy 6: 791-803.


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