Enriqueta Bond and Mohammad Reza Zali
The last decade has seen remarkable advances in our capacity to study molecular and cellular biological processes, to conduct stem cell research that leads to developing new medical therapies for debilitating diseases, and to explore fundamental questions of genetics as applied to medicine and even to cloning of selected animals. Technological advances permit screening and testing for an increasing number of genetic diseases. The mapping of the human genome provides new avenues for identifying and characterizing genes that may predispose to disease with the possibility of developing prevention and treatment strategies. However, these advances present society with numerous ethical and resource allocation challenges.
At the same time, the improved health of the citizens of the United States and Iran depends on the ability of these countries to provide health care that is based on the best available scientific knowledge that meets the needs of the population. The changing epidemiology of the disease burden, together with demographic changes such as the aging population in the United States and a growing cohort of youth in Iran, require rethinking investments in health care delivery systems, in organization of such systems, and in related research needs.
Both of these themes—ethical issues of medical genetics and the allocation of health care resources—were priority topics of discussion for the breakout group that also included James Childress, Sara Gray, and Hassan Tajbakhsh.
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Ethics in Medicine Enriqueta Bond and Mohammad Reza Zali The last decade has seen remarkable advances in our capacity to study molecular and cellular biological processes, to conduct stem cell research that leads to developing new medical therapies for debilitating diseases, and to explore fundamental questions of genetics as applied to medicine and even to cloning of selected animals. Technological advances permit screening and testing for an increasing number of genetic diseases. The mapping of the human genome provides new avenues for identifying and characterizing genes that may predispose to disease with the possibility of developing prevention and treatment strategies. However, these ad- vances present society with numerous ethical and resource allocation chal- lenges. At the same time, the improved health of the citizens of the United States and Iran depends on the ability of these countries to provide health care that is based on the best available scientific knowledge that meets the needs of the population. The changing epidemiology of the disease bur- den, together with demographic changes such as the aging population in the United States and a growing cohort of youth in Iran, require rethink- ing investments in health care delivery systems, in organization of such systems, and in related research needs. Both of these themes—ethical issues of medical genetics and the allo- cation of health care resources—were priority topics of discussion for the breakout group that also included James Childress, Sara Gray, and Hassan Tajbakhsh. 12
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13 ETHICS IN MEDICINE SIMILARITIES AND DIFFERENCES IN IRAN AND THE UNITED STATES IN DEFINING AND APPROACHING THE ISSUES The following subtopics were discussed under Ethical Issues in Medi- cal Genetics: • Criteria for the Requirements and Timing of Genetic Screening and Testing. There is no single federal regulation to govern screening in the United States, since screening and testing laws and regulations vary from state to state. Some states have mandatory screening, but in general the emphasis is on voluntary screening. Recently, considerable emphasis has been placed on nondirective counseling whereby physicians attempt to give patients facts about medical situations without suggesting one course of action over another. In the United States the decision to screen relies on at least two norms: (1) Is treatment available for the disease that is being screened? (2) Will the diagnosis provide the basis for reproductive decision making? Recently the ability to test for multifactorial complex diseases has become technically feasible. But such testing is predictive in nature, and the dis- ease may or may not emerge in the future. Also, the disease may be re- lated to both genetics and environmental conditions. There is, therefore, a reluctance to mandate predictive screening. In Iran screening technology is not as advanced, and there are fewer tests in use for genetic screening. Those that are available include Thalessemia and RHneg tests. Karyotyping is available on a limited basis for Downs syndrome or other chromosome abnormalities, and testing for Duchenne and for cystic fibrosis is also possible. As the number of tests available to Iranians increases, an important question is how to approach the cost/benefit analysis of deploying tests for diseases of limited burden or of low frequency. Similar to the situation in the United States, screen- ing in Iran is done on a voluntary basis. The decisions to screen rely heavily upon the patient/physician relationship. Professional societies are beginning to develop guidelines for screening, especially the pediatric and obstetrician-gynecological societies. One important aspect related to genetic screening in Iran is that a woman may have an abortion if the fetus has congenital malformation and she is able to obtain permission from her doctor and from a judge. • Education of Health Professionals and How They, in Turn, Edu- cate the Public. The American participants reported that it is often the medical so- cieties and volunteer associations that have taken the lead to educate the
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14 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS public. There is also some relevant instruction in the kindergarten-grade 12 system. Iran also relies on the kindergarten-grade 12 system in addressing health issues, but it has a much stronger governmental presence in public education, as the Ministry of Health is responsible for public education. The ministry funds the universities and research centers and therefore is well positioned to lead in medical ethics education. The role of educa- tional technology in this effort is not yet well developed. • Regulation of Laboratory Diagnostic Tests. In the United States much stress is placed on the regulation of speci- ficity and sensitivity of laboratory tests. The issue of testing for carrier status of a gene in infancy raises concerns. For example, a patient with the sickle trait may not have the disease but may be labeled as “sick” by the test. The Iranian participants stressed the basic need of deployment and access to laboratory tests and suggested an exchange with the United States of scientific information on best practices. • Privacy and Confidentiality Issues of Data Repositories Including Appropriate Consent Both for Research and During Clinical Trials. The issue of data or tissue repositories for study and perhaps even- tual use in clinical trials brought to light some interesting differences be- tween Iran and the United States. For the United States, the concept of privacy is very important. In this regard, the legal bounds of consent are being tested for research on stored tissue. Often the ability to do research with repositories depends on the anonymity of the subjects. When deal- ing with samples in the United States, the scientist must also be aware of possible property rights of the sample’s originator. In contrast, in Iran the samples are generally viewed as the property of the investigators, and the consent given by a patient in Iran is usually more encompassing than the consent a patient gives in the United States. • Social Responses to Medical Genetics Ethical Issues Such as Sex Selec- tion, In vitro Fertilization, and the Relevance of Religion and Philosophy. Looking at societal approaches on sex selection, neither Iran nor the United States has evidence that this regularly occurs. The United States does not prohibit abortion for sex selection, yet sex selection is not apparent except for sex-linked genetic conditions. Underlying factors in- clude the opposition of professional and religious societies to sex selec- tion and the espousal of a commitment to gender equality. Sex selection is not regularly practiced in Iran, due partially to the fact that abortion is not allowed under most circumstances. While in vitro fertilization is allowed, the Iranian participants have seen no evidence of this being used to select sex. In Iran the cultural importance placed on having children and having a large family opposes the idea of discarding a child of one sex. Iran would most likely have the framework to regulate or
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15 ETHICS IN MEDICINE ban sex selection if it were to come into practice, given the example of the Iranian parliament’s current discussion on donor sperm and eggs. The final topics concerned cloning and gene therapy. Due to the his- tory in the United States of freedom of choice regarding reproductive tech- nologies, the U.S. federal government is finding it difficult to ban new technologies, even those regarded as harmful. There are some regula- tions regarding gene therapy and stem cell research, but at this point only a few states have banned cloning. Professional societies on the whole are opposed to reproductive cloning. Iran has not yet developed the techni- cal capability for reproductive cloning; however, Iran seems better equipped than the United States to deal with the technology when it is available since Iran already has investigated related issues. Regarding allocation of health care resources, the group made the fol- lowing observations. • The Changing Burden of Disease, Epidemiology of Diseases, and Priorities for Health Care. Some of the problems Iran and the United States share are chang- ing demographics, a change in morbidity from communicable diseases to noncommunicable diseases, new and re-emerging diseases, and multi- drug resistance in diseases. Iran and the United States also face similar challenges in providing health services to growing immigrant or refugee populations. Finally, the Iranians stressed that obesity was a burgeoning health problem as it is in the United States. Iran differs from the United States in the technology area. It just now realizes the importance of high-tech and expensive procedures for health protection and is seeking direction on the best way to deploy ad- vanced technologies. Iran’s human capital, technology, and financial re- sources are limited compared to those of the United States. Meanwhile, the impact of urbanization on health (changing diets, pollution, and stress) is seen as a large problem. On the positive side, Iran has historically had a responsive national health care system as exemplified by its primary health care system. This system needs guidance from scientists, however, in responding to the changing epidemiology of the disease burden. Another issue is the dis- ease burden related to Iran’s high population growth. The government in Iran supports population control through birth control. Family support for aging family members remains intact, but mores are changing and portend the need to develop new approaches to care in the future. Inju- ries and accidents are the greatest causes of death and injury, likely due to the large youth populations.
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16 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS • The Need to Shift the Health Care Paradigm From Treatment of Disease to Prevention of Disease. Promotion of health is of great importance in both countries. The role of the individual is critical in disease prevention, thus shifting the locus of decision making from the physician to the individual. • Evidence-Based Medicine and Use of Best Practices to Improve the Quality and Safety of Health Care. Both countries lack an overall system of health priorities, and there is weakness in the public health systems. Oregon is the only state in the United States that has established medical priorities, and it has done so only in reference to the Medicaid program. Also, the anthrax incidents in the United States have brought to light weaknesses in the public health infrastructure. • Quality of Care and Direction of Resources to Health Care Priorities. There are incentives and payment policies in both countries that foster continued inequality in access to health care and an excessive em- phasis on acute care rather than care for chronic diseases. Another re- source issue is the problem of ensuring access to basic services while at the same time rationing investments in expensive services and tertiary care in ways that maximize the use of resources to best ensure a healthy population. OPPORTUNITIES FOR INTERNATIONAL COOPERATION The group offered recommendations for possible collaboration be- tween the academies in the two countries. • Providing U.S. Reports on an Ongoing Basis to Counterpart Acad- emies in Iran, Especially Online. Many reports produced in the United States could be useful in sup- porting Iranian science and technology transfer activities. • Facilitating Access to Journals and to the National Library of Medicine’s Resources. Iranian scientists and medical professionals would benefit from free access to journals and other relevant literature. • Development of a Special Website to Facilitate Exchange of Infor- mation. A website is currently under development at the U.S. National Academies for the Internet Message Access Protocol that could have a section specifically dedicated to interacademy collaboration. • Promotion and Implementation of a Variety of U.S.-Iran Exchanges. As a first step, the Iranian side could identify centers of excellence and topics for possible collaboration. A “sister” or “twinning” approach could
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17 ETHICS IN MEDICINE match universities, hospitals, professional societies, cities, or government agencies. The Centers for Disease Control and Prevention, for example, have an international fellowship program that might be of particular interest. • Iranian Participation on Committees of the U.S. National Acad- emies. • A Frontiers of Science Program that Convenes Young Scientists from Different Fields to Consider Cutting-Edge Research. A first step for the U.S. National Academies is to invite an Iranian observer to a Frontiers program to explore the feasibility of a more formal interaction. • Iranian Use of the Institute of Medicine’s Reports on Injury Preven- tion and Iranian Sharing of Data Collected on Accidents in Iran. The increase in death from accidents and injuries suggests a pos- sible role for the Iranian academy to undertake an injury prevention study in which it could make recommendations to the government agencies such as the Ministry of Health or Ministry of Transportation and Roads. This would be similar to a study of the Institute of Medicine that influenced the founding of an injury prevention branch of the Centers for Disease Control and Prevention. • Meetings to Explore Approaches to the Transfer of Medical Science and Technology of Interest in Iran. • Interacademy Collaboration Using Global Surveillance Techniques for Monitoring Infectious Diseases and Emerging Infections. • Research Devoted to the Changing Demographic Descriptors and Epidemiology of Disease, with Possible Associations to the World Health Organization (WHO). WHO has studied the epidemiological shift to chronic disease and is in the process of updating a major study on health burden in different countries. While heart disease has received considerable attention from WHO, with special study groups in different countries, less attention has been given to cancer. • A Workshop or Project on Food-Borne Diseases and Food Safety. • An Interacademy Cross Cultural Study on Obesity Examining the Differences and Similarities of the Two Countries and Cultures. Areas of interest include eating patterns; exercise; dietary compo- nents; genetics; disease patterns; and societal issues. Finally, the breakout group selected the proposed workshop on food- borne diseases and food safety as a natural next step in collaboration. Not only are there concerns about microbiological contamination of food but there are issues related to feeding hormones and antibiotics to animals. Also, the introduction of genetically modified food has raised controversy in some international venues. Iran has considerable expertise in zoonosis
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18 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS and emerging concerns about the use of hormones and antibiotics in ani- mals as well as genetically modified foods. The United States has become more aware of food safety issues in the context of bioterrorism. The project might address epidemiology, surveillance, and monitoring; bur- den of disease; approaches to prevention; a future research agenda; and a case study regarding animal health and zoonosis.