Report - Norway

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Dec 3, 2012 (4 years and 9 months ago)

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A Trans
-
Atlantic Dialogue on Genetics and Health:

Research Frontiers and Ethical, Economic, Legal, and Social Issues


A Symposium Co
-
hosted by The Royal Norwegian Embassy, Washington D.C. through its
Norwegian Research and Technology Forum in the U.S./Cana
da and

The Center for Strategic and International Studies



Executive Summary


The genomic era has introduced an explosion of biotechnological advances with implications for
health, including genetic tests, microarrays, pharmacogenomics, pre
-
implantation
genetic
diagnosis, and the promise of embryonic stem cells. Has our public policy kept up with this rapid
pace of scientific progress? How do we deliberate about the ethical, legal, and social
implications of new genetic technologies within our pluralisti
c societies? Furthermore, how can
we promote further advances while ensuring the ethical acceptability of the findings, especially
when there is a stark divergence of views across Europe and the United States? What are
appropriate policy frameworks for d
ealing with the wide divergence in national legislations?
These questions were addressed in "A Trans
-
Atlantic Dialogue on Genetics and Health:
Research Frontiers and Ethical, Economic, Legal, and Social Issues," a symposium co
-
hosted by
The Royal Norwegia
n Embassy and the Center for Strategic and International Studies (CSIS) on
May 16, 2003.


The seminar opened with remarks by Charles A. Sanders, former CEO of Glaxo Inc, and trustee
of CSIS, and Knut Vollebaek, Ambassador of Norway to the US. The Honorable

Kjell Magne
Bondevik, Prime Minister of Norway, gave the Keynote Address. The presenters that followed
represented a wide variety of topics, backgrounds and perspectives. They presented the new
scientific, ethical, and policy challenges introduced by pha
rmacogenomics, regenerative
medicine, and pre
-
implantation genetic diagnosis. While pharmacogenomics promises to offer
patients personalized therapies, this new application of genetic knowledge may complicate
clinical trial design and be challenging for
physicians to incorporate. In addition,
pharmacogenomics may heighten concerns about genetic discrimination and privacy. New
techniques in the field of regenerative medicine might extend the life span, but the cost of health
care for an aging populace wi
ll increase as a result of these technologies. Parents desperate to
overcome infertility or avoid a disease that has devastated their family will have increasing
options to do so, but these individual choices have significant implications for society and

may
conflict with ethical guidelines. Representatives from Norway described the advantages that
this nation offers for biotechnology research and international collaboration. Speakers promoted
the progress that can be made with creative partnerships am
ong different disciplines.


All of the seminar participants expressed a firm belief that the new technologies represent an
exciting potential for the relief of human suffering; however, they would have to be developed
within acceptable legal, moral and soc
ial norms. Within this broad area of agreement, the
symposium participants expressed marked differences in emphasis. Some would prefer minimal
regulation in order not to impede scientific progress, whereas others would prefer that scientific
and technologi
cal development should only proceed within strict regulatory limits. Examples of

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such differences in national legislations were presented. Prime Minister Bondevik gave an
overview of the recent legislation introduced in Norway, providing an example of a v
ery strict
regulatory context. Other seminar participants expressed sharp disagreement with this model,
arguing that it would impede scientific progress. The different viewpoints presented during the
symposium made it quite clear that one must accept a di
versity of viewpoints in this
controversial area of policy. Even though the Prime Minister represented a country where social
and political values exemplified a strict regulatory approach, he also stressed the value of
tolerance and respect for the choices

of other countries, providing a possible framework for
resolving the tensions among different national approaches.


Several issues for future discussion emerged from the symposium. For example, how can one
develop mechanisms and frameworks to foster an
atmosphere of mutual understanding, while
accepting the right of countries to make their own choices and the right of countries to have their
choices respected by others? It would be important to develop clear international regulations
before agreement ca
n be reached about particular topics, such as human reproductive cloning. In
areas where there is a need for further discussion before reaching international agreements,
mechanisms and frameworks for dialogue will have to be developed. These mechanisms f
or
dialogue will be essential for collaborative research to be possible in the context of what might
otherwise appear to be mutually exclusive policies. Finally, policy
-
makers must be mindful that
genetic information is truly global. One must bear in min
d that policies also will affect those
countries that are not yet developing genetic technologies. Furthermore, one must consider how
everyone, both in the developed and the developing worlds, can have access to the benefits of
these genomic developments.

The symposium posed these as the main challenges for the future
in the area of international science policy.




Opening Remarks


Charles A. Sanders

Former CEO, Glaxo Inc. and Trustee, CSIS, Symposium Chair

--

Knut Vollebaek

Ambassador of Norway to the U
.S., Forum Chair

--

Keynote Address


Kjell Magne Bondevik

Prime Minister of Norway


Speakers


Rita Colwell

Director, US National Science Foundation

--



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Steve Fodor

Chairman and CEO, Affymetrix, Inc

--

Sandy Thomas

Director, Nuffield Council on Bioethics

-
-

William Haseltine

President and CEO, Human Genome Sciences

--

Richard Jackson

Adjunct Fellow, CSIS Global Aging Initiative

--

Mark Hughes

Professor and Director, Center for Molecular Medicine and Genetics, Wayne State University
School of Medicine

--

Ola

Didrik Saugstad

Professor in Pediatrics, Department of Pediatric Research, The National Hospital in Norway

--

Anne McLaren

Principle Research Associate at Wellcome/CRC Institute, University of Cambridge, Member of
European Group of Life Sciences (EGLS) an
d the

European Group on Ethics (EGE)


Panelists


Torleiv Ole Rognum

Professor, Institute of Forensic Medicine, University of Oslo, and member of the Norwegian
Biotechnology Advisory Board

--

Barbara Rhode

Head of Unit on Ethics, Science and Society, Direc
torate General Research, EU Commission

--

Alex MacKenzie

Professor of Pediatrics, University of Ottawa, and Vice President of Research, Genome Canada

--

Thomas H. Murray

President, The Hastings Center





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Scientific Progress and Ethics: Galileo’s Telescop
e and the Stars that Guide Us


The Honorable Kjell Magne Bondevik, the Prime Minister of Norway, clearly delineated the
research priorities, goals, and ethical implications of biotechnology in Norway today. His
opening address, highlighting the crucial ne
ed for ethical guidance especially in the area of
assisted reproductive technologies, provided a sharp contrast to points made later in the morning
promoting the promise of genetics. This divergence in perspectives created the theme for the
morning: altho
ugh policy
-
makers, ethicists, scientists and physicians differed in their ideas of
which technologies should be pursued and which might require more oversight, all agreed that
open deliberation will be the only way to achieve real progress.


“The rapid an
d impressive advances in research and development provide us with unprecedented
opportunities for human, social and economic progress, not just in our respective countries, not
just in the industrialized world, but indeed on the global stage,” introduced M
r. Bondevik. “At
the same time, these advances also raise fundamental political and ethical challenges and
dilemmas.” Bondevik provided an analogy between the current state of biotechnological
progress and the attitudes of the early 17
th

century in Galil
eo’s Rome: genetic progress today
represents the “telescope” that we should not turn away from in ignorance but should instead
embrace. Biotechnology could provide “food for the hungry and cure for the sick…[giving] us
expectations for a better life for p
eople all over the world.” However, it is necessary to devote
attention to ethics, or as Bondevik articulated, we must look
through

the lenses of technology to
see the guiding stars of “the common good of mankind” and the “sanctity of human life.”


Bondev
ik’s convictions about the sanctity of life, from conception to a natural death, imbued his
proposed policies toward biotechnology. Believing that life is a common good, he opposes
patenting of human genes, microorganisms, microbes, plants, or animals. F
urther, he insists that
the wealth created from biotechnology should be shared throughout the world, and especially in
those countries that provide the source of the discoveries. In a new bill proposed to the
Norwegian Parliament on April 11, 2003, the Go
vernment outlines how the dignity of human life
can be preserved through strict regulation of genetic technologies. Opposing prenatal diagnosis
used to prevent the birth of babies with disabilities, Bondevik instead emphasizes treating
illnesses through o
ther means. The proposed bill also would impose regulations on in
-
vitro
fertilization (IVF), requiring that supernumerary embryos not be produced at all and that only
one fertilized egg be implanted in a woman’s uterus. The Government also opposes pre
-
imp
lantation genetic diagnosis (PGD) and plans to regulate the use of ultrasound to diagnose
fetal abnormalities. Finally, the Government believes that using embryos to create stem cells,
whether in excess from IVF or created anew, is wrong, and thus will no
t allow any research with
embryonic stem cells in Norway.


“We cannot reduce public policy to a matter of economic cost
-
benefit calculations only. That is
simply inhuman.”
-

Norwegian Prime Minister Kjell Magne Bondevik


Mr. Bondevik proposed that there
be international discourse on these crucially important issues.
Indeed, the symposium opened such trans
-
Atlantic dialogue. William Haseltine, President and
CEO of Human Genome Sciences, Inc., and former Harvard University professor, took up the

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challenge
, arguing that the policies of Norway might hamper scientific progress there. He
introduced the question of whether the Government’s too
-
rigorous opposition to stem cell
research might impede research, “preventing Galileo from building his telescope in th
e first
place.” Furthermore, he argued that intellectual property controls through patenting drive
research progress; without such protections and incentives, research might come to a halt. It is
evident that there needs to be a balance between scientifi
c progress and commercial interests on
the one hand and ethics on the other, but exactly where the fulcrum should be placed is unclear.
Alex MacKenzie, a Canadian pediatrician and Vice President of Research at Genome Canada,
described the complex relation
ship between commercialization and ethical concerns: “[New
biotechnology] is humane, but is informed by necessity by commercial interests.” Although the
conflict between commercial interests and regulatory guidance was pronounced, with each
speaker in the

symposium acknowledging the importance of discourse, it is evident that these
issues are beginning to be discussed with the transparency required to move forward.



“My view…is that the patenting directive [a new European Union regulation of inte
llectual
property rights] goes too far and may lead to less research and development, rather than the
opposite. Legal forms of ownership in human genes, microorganisms, microbes, plants, or
animals is deeply problematic from an ethical perspective. I hav
e therefore…questioned the
right to give permission to scientists and commercial enterprises to patent living forms and
organisms.”


Norwegian Prime Minister Kjell Magne Bondevik

--

“Without patent protection, the investment for research would be too grea
t. One cannot just say
that life is life and can never be patented.”


Dr. William Haseltine



For Biotechnology, Norway Offers Opportunities but Must Overcome Obstacles


Mr. Bondevik described many key advantages that Norway can offer for biotechnologica
l
research and development. The nation’s evident devotion to ethics and public discourse make
Norway an attractive partner for research, as these issues are already such a part of public
consciousness. Further, as Torleiv Ole Rognum, a Norwegian professo
r, stated, the population is
highly educated about biotechnology and has relatively positive attitudes toward its biomedical
applications. In addition, Norway offers the following opportunities for biomedical research:




National birth, death, and disease
registers as well as a bioregistries for access to human
biological material



A homogenous population convenient for genetic research



High ratings in research in neuroscience, cancer research, and microbiology, including
advances in imaging research, skin c
ancer therapies, and a newly launched program on
functional genomics (FUGE)



A re
-
organized health care system, with increased devotion to clinical research



A Government emphasis on research with adult stem cells



Biomarine resources available for biopro
specting




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However, as Mr. Rognum made clear, there are some obstacles that must be overcome before
Norway can become an international power in the biotech field. There has so far been reluctance
in Norway to spend much money on research, with oil and gas

dominating most of their trade.
There has been a poor tradition translating research discoveries into commercial products.
However, there are some promising research developments in Norway: Norway produces half of
the world’s fish vaccines and her exten
sive natural resources provide the potential for drug
discoveries through bioprospecting. Mr. Rognum concluded that it is imperative that Norway
develop a new biotech industry in the post
-
oil era, and that Norway presents many opportunities
for internatio
nal collaborations, as long as “partners respect [Norway’s] ethical and social
conditions.”



Convergent Technologies for Interdisciplinary Progress


Dr. Rita Colwell, the director of the National Science Foundation, presented the major scientific
achieve
ments in recent years, from the genetic sequencing of simple bacterium to the sequencing
of the human genome. She emphasized the important role that the technological revolution has
played in the revolution of bioscience. Biotechnological progress depend
s on the contribution of
many disciplines. In oceanography, convergence zones form when multiple water masses
intersect, and these areas are where nutrients concentrate. Similarly, discoveries aggregate in
such “hyphenated zones,” when seemingly disparat
e disciplines of the biological, physical, and
social sciences intersect. Examples of such beneficial convergences include: adaptive optics,
when astronomy techniques were applied to the human eye; developing control strategies for the
SARS virus using ma
thematical models; use of nanotechnology to create images of proteins in
drug design; and the study of human cognition using computer technologies. Such
multidisciplinary research is the key to developing new therapies.


The major priority areas for resea
rch in the 21
st

century include studies of biocomplexity,
nanoscale science and engineering, information technology research, mathematical sciences, and
the human and social sciences. In particular, Dr. Colwell stressed the study of biocomplexity to
under
stand the relationships of living things and their environment. These relationships must be
studied on multiple scales, from the levels of the atom, cells, tissues, community, ecosystem,
globe, and universe.


“Where research meets and explores the unknown
, the ideas and technologies of life science,
physical science, and information science are converging. At those fields of intersection and
exchange, interdisciplinary research is accelerating and deepening our knowledge.”



Dr. Rita Colwell



Pharmacoge
nomics: Medical Promises and Ethical Challenges


“While the current treatment paradigm is that everyone with a given diagnosis in the population
gets the same treatment, what we’d like to go to is use human genome data to …provide
information about individ
ual differences, allowing us to know which individuals will respond
well to a given drug, who will not respond, and who will have an adverse effect,” explained Dr.

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Steve Fodor, Chairman and CEO of Affymetrix. The application of genetic information into
dr
ug therapies, or pharmacogenomics, is one of the most promising applications of the human
genome project. While there are significant benefits likely from this field, there are also novel
ethical challenges that must be addressed.


Affymetrix, Inc, a Cali
fornia
-
based biotech company, developed microarray technology, chips
that allow the simultaneous analysis of sequence variability (DNA variation) and expression
variability (analysis of mRNA activation). These DNA chips are used in basic and clinical
rese
arch, and have broad commercial applications. Current chips can examine nearly 40,000
transcripts simultaneously. This technology has enormous potential for studying diseases. For
instance, using microarrays, scientists differentiated between three leuk
emia subtypes at the
molecular level. The cellular responses to treatment of patients with leukemia can be studied
using microarrays. In HIV, the activity of genes can be observed using microarrays to assess
what systems are upregulated in response to th
e presence of the virus.


Such microarray technology has application in pharmacogenetics. Pharmaceuticals range in their
efficacy from 10% to 50% and also have a range of adverse effects associated with them.
Individual differences on the genomic le
vel appear to predict the response. The cytochrome
p450 genes are involved in the metabolism of 90% of the commercially available drugs, and
polymorphisms within these genes confer differences in people’s metabolism of and toxicity of
these drugs. Thus,
genetic tests or microarray technology could be used to predict individuals’
rate of metabolism of particular drugs. Dr. Fodor emphasized that pharmacogenetics should not
be considered some distant technological advance, instead, “it is really happening n
ow and it will
be on us before you can blink your eye.” It is therefore imperative to consider the new ethical
challenges that pharmacogenetics introduces as it begins to be integrated into clinical practice.
Dr. Fodor described three major ethical issue
s in pharmacogenomics: concerns about privacy and
discrimination, issues related to fair access to genetics information, and evolving concepts of
social group identities.


In response to the progress made in pharmacogenetics, the Nuffield Council on Bioeth
ics, an
independent body in the United Kingdom that contributes to policy
-
making and stimulates
debate of ethical issues, has developed a report to give an account of the likely effects of
pharmacogenetics on clinical medicine and explore the ethical impli
cations. The report will be
published in September 2003. Dr. Sandy Thomas, the Chairman of the Nuffield Council,
provided some highlights of the report.


While the proponents of pharmacogenetics claim that this technology will provide the ‘right
medicine

for the right patient at the right dose’, there have been few applications of
pharmacogenetic testing so far and thus it is unclear whether and to what extent these
applications will be realized. There are constraints imposed by the complexity of human
r
esponses to medicines and by the current systems of health care delivery. Many factors will
influence the extent of the benefits of pharmacogenetics, including the economic influences of
the pharmaceutical industry, regulatory frameworks, cost
-
benefit con
straints of health
-
care
providers, and the impact on the patient
-
physician relationship.




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Dr. Thomas described two areas of potential benefit of pharmacogenetics, benefits to research
and benefits to treatment. Application of pharmacogenetic testing in r
esearch trials of
experimental therapeutics might protect participants who would have adverse drug effects.
Moreover, this could make the research process more efficient by excluding those patients who
would complicate the interpretation of the results, l
eading to a refinement in the process of
developing new medicines. In the treatment context, pharmacogenetic testing has the important
inherent benefit of reducing adverse reactions and improving efficacy. Physicians’ prescription
practices would be impr
oved, as they would be able to predict which drugs would work best for
which patients. In addition to these potential benefits, however, there are also significant issues
that must be considered in the areas of research and development, public policy, cli
nical practice,
and general concerns about the use of genetic information.


In the research context, pharmacogenetics will have an impact on many aspects of clinical trials,
including subjects’ consent, trial design, costs, and storage of data and sample
s. This application
will also raise legal issues. For example, if pharmacogenetic testing is not used as a safeguard in
a clinical drug trial, will a subject who experiences an adverse effect be able to raise liability
issues? This is an important que
stion that must be considered as pharmacogenetic testing begins
wider use in research. Furthermore, patients will be stratified into groups based on their reaction
to drugs. Such stratification will have implications toward existing medicines and even
me
dicines that have been withdrawn as unsuccessful in previous clinical trials


should such
unsuccessful therapies be reconsidered with the application of pharmacogenetics? What are the
implications of patients being divided into groups based on their respo
nse to medicines
(informed by polymorphisms in the cytochrome p450 genes) or based on features of their disease
(such as gene expression of tumors)? As Dr. Fodor suggested and Dr. Thomas asserted, these
new divisions in society based on pharmacogenetic in
formation might challenge people’s
understanding of social identity and race. In addition, there may be patients who are neglected
from potentially beneficial pharmacogenetic research. For instance, there may be little incentive
to conduct pharmacogeneti
c research for patients with very rare “orphan” diseases.


There are also important public policy issues to consider with pharmacogenetics. There needs to
be appropriate regulation not only of pharmaceuticals but also of genetic tests, regulation that ha
s
so far been lacking. Furthermore, the appropriate method of provision of tests is unclear. Will
people have access to these tests only through health care professionals? Or should they have
direct access to these tests, over
-
the
-
counter, or through th
e Internet? How should resources be
allocated toward pharmacogenetics? These policy issues are applicable to genetic technologies
in general, but have increasing significance when considering the potential for the widespread
integration of pharmacogeneti
c medicine into general clinical care.


Within clinical practice, pharmacogenetics raises issues about demands on physicians’ already
-
constrained time, the appropriate training in genetics that would be required to integrate testing
into standard clinical
care, and concerns about patient decision
-
making. Results of
pharmacogenetic testing are likely to be in the form of uncertain probabilities that a given patient
may or may not tolerate a drug. Patients and physicians have difficulty understanding and
co
mmunicating such probabilistic information, with consequences for the quality of patients’
decisions to pursue testing and their appreciation of the results.



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Finally, the introduction of pharmacogenetics re
-
emphasizes ethical, legal, and social
implicatio
ns already well
-
considered with regard to the use of genetic information in other
contexts, such as prenatal screening and predictive genetic testing for late
-
onset disease. These
concerns include sample collection and storage, informed consent to genetic

testing, privacy and
confidentiality, access to genetic information for patients, family
-
members, and insurers, and
genetic exceptionalism. As Dr. Thomas posed, “Is genetic information any different from the
information obtained from, say, a cholesterol
test?” While it is unclear what the impact of
pharmacogenetic testing will be, it is evident that the multitude of issues that this technology
introduces should be considered now.


“Where we’d like to go to is to be able to really look at the data coming

out of the human
genome to begin to understand the right drug at the right dose for the right patient.”



Dr. Steve Fodor

--

“Claims of the ‘right medicine for the right patient at the right dose’ may be over
-
optimistic.”




Dr. Sandy Thomas



Regenera
tive Medicine and Aging


“We have begun to have the ability to use the process that nature uses to build our bodies, to
surpass what nature does,” said Dr. William Haseltine, describing the field of regenerative
medicine. Like pharmacogenetics, regenerati
ve medicine introduces important ethical questions;
in particular, one must consider the social and economic costs of extending human life.


As scientists have begun to understand the natural processes the body uses to regenerate itself,
applying these mec
hanisms toward medicine has become possible. Medicine has already
successfully incorporated human products into treatments; for example, we regularly use insulin
produced from cells, and perform transfusions, bone marrow transplants, and organ transplants
.
Regenerative medicine will take these applications further, using knowledge of genetics and
immunology to refine and improve therapies. Embryonic or adult stem cells also hold
tremendous promise for regenerative medicine. However, ethical constraints
might limit
research on embryonic stem cells, and it is impossible to know what value these cells might have
in advance of such research.


As new biotechnology products, such as stem cell therapies, are introduced into medical care in
the future, who will
pay for the rising costs of health care? Political differences exist between
health care payers, consumers, and those companies that provide pharmaceuticals and other
devices. As Dr. Haseltine pointed out, “the resolution of these policy and political is
sues will
largely determine the shape of medicine in the future.” Haseltine insists that a market approach
to research and development is necessary for progress in research to continue.


Dr. Richard Jackson, Adjunct Fellow for CSIS’s Global Aging Initiat
ive, provided a commentary
on the challenges inherent in increasing longevity, introducing his talk by saying that “his self
-
appointed role is to rain on the parade.” Indeed, his commentary provided a sobering perspective
on the demographics of an increas
ingly aging society. Like Haseltine, Jackson questioned how

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society will pay for all the advances in biotechnology, especially for the rising elderly population
group. The average health care costs for the elderly in the United States are currently about

12%
of the Gross Domestic Product, and these costs are expected to rise to an average of 24% by the
year 2040. These costs will become more extreme because the elderly population’s health care
needs will become greater.


One might think that as life expe
ctancy rises through the aid of biotechnology, everyone will
become healthier, health disparities will be reduced, and medical costs will be stable. However,
this does not appear to be the case. Instead, as life expectancy rises in some groups, there
con
tinue to be striking disparities among groups worldwide. In addition, it is unreasonable to
expect that the rising group of elderly will have “unlimited access to modern medicine,” as
Jackson emphasized, considering the extreme costs of health care. Any
health care reform
efforts must consider that the elderly consume 3 to 5 times more health services per capita than
the young, and the fastest growing group is the most elderly. While the elderly may have a lower
incidence of disability as a result of mod
ern medicine, they will not necessarily be any healthier
than in the past. People’s expectations about health care are becoming more inflated as more
technologies are introduced; people begin to expect health care services to cure, as opposed to
treat, di
sease. However, as one illness becomes ameliorated through biotechnology, health care
costs will need to cover the next illness that emerges in the increasingly older population. In
addition, new technologies, in particular the customized genetic technol
ogies previously
discussed, are likely to add to the overall costs of health care.


Jackson concluded his talk by evoking the global differences in policies toward biotechnology, a
continuing theme of the symposium. Jackson stated that discussion should b
e focused not on
forbidding certain technologies but instead on deciding which will be publicly subsidized and
which will be assumed by the private sector. He emphasized that policy
-
makers must consider
the significant cultural differences among nations w
hen planning policy guidelines; for instance,
the United States, Japan, and countries in Europe will respond very differently to imposed
limitations on biomedical research and practice. Balancing the demands for international
collaboration and internation
al guidelines with culturally
-
specific attitudes and priorities will
remain a challenge for the future.




“Our aging societies will have to abandon the fantasy that every citizen can be guaranteed
unlimited access to modern medicine.”


Dr. Richard Jack
son



Pre
-
implantation Genetic Diagnosis and ART


Using genetic biotechnology to extend life is evidently fraught with complexities on the societal
level, raising questions about how society can afford to support an increasingly aging population.
On the o
ther end of the spectrum, genetic technologies can offer parents opportunities to make
decisions that will affect the quality of the next generation, raising questions about the limits of
parental autonomy. Modern assisted reproductive technology has ari
sen from a history tainted
by eugenics, when knowledge about genetics was used not to improve lives, but to justify
immoral practices. As Dr. Mark Hughes, director of the Center for Molecular Medicine and

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Genetics at Wayne State University School of Medic
ine, described, “Genetics may save lives,
but it has also historically been used in very cruel and terrible ways.” Regulatory guidance over
assisted reproductive technologies may be needed to avoid societal harms, but at what cost to
parents wishing only

to avoid a dreadful illness in their children? This was the central question
explored in Dr. Hughes’ presentation.


Potential parents with a family history of inherited disease have limited reproductive options.
They can choose not to have children at a
ll; they can adopt, an increasingly economically
difficult option; they can undergo artificial insemination or egg donation with unrelated donors;
or they can choose to “roll the genetic dice” and risk having a child with a disease that has
already devasta
ted the family. If parents choose to become pregnant, they could use such
prenatal screening tools as amniocentesis or chlorionic villi sampling (CVS). Each technique,
however, carries a risk to a healthy pregnancy; further, termination of the pregnancy
remains the
only option if parents decide not to carry a child with the familial disease, a prospect associated
with significant ethical and psychological repercussions.


Assisted reproductive technology (ART) might give at
-
risk parents the opportunity t
o have a
healthy pregnancy. In vitro fertilization (IVF) has been used over the last 25 years, with one
million babies born through this technique. IVF has a low success rate, however, and will not
guarantee that resulting infants will be free of the dis
ease that runs in the family. Pre
-
implantation genetic diagnosis (PGD), on the other hand, allows the opportunity to screen for a
given genetic disease before pregnancy begins. Dr. Hughes described the possibilities of using
PGD to avoid babies born with

such illnesses as Fragile X disease and myotonic dystrophy. The
use of this technology becomes more ethically complex when considering adult
-
onset diseases,
such as Huntington disease or cancer. In contrast to the dominant ethos in bioethics that oppose
s
the use of PGD for adult
-
onset diseases, Dr. Hughes provocatively asked why we should
not

strive for a pregnancy that will be free of cancer, thus ending a terrible history of familial
cancers?


“How can we not offer high
-
risk families an alternative to
‘throwing the genetic dice’?”



Dr. Mark Hughes



Hughes described the even more demanding ethical challenge of using PGD not simply to screen
for disease, but to choose an embryo that has a particular non
-
disease related characteristic.
Where do we draw

the line? In the case of a family he treated, the parents wanted to choose an
embryo to implant that was not only free of SCID (Severe Combined Immunodeficiency
Disease) but was also immunologically compatible with an older child who had SCID, to serve
a
s a bone marrow donor. This case raises the ethical issue of using one child as a means to an
end. Ultimately, Hughes was convinced to perform the technique for these parents. The couple
insisted they would love their infant regardless; furthermore, Hug
hes argued that they knew more
about the impact of the disease they sought to avoid than any physician, policy
-
maker, or
bioethicist.


Hughes’ comments reinforced the challenge of making ethically appropriate decisions in a
pluralistic society. Parents st
rive to have healthy children who are genetically
-
related to

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themselves, and using assisted reproductive technology to do so will become increasingly
accepted. However, there is a danger that families might feel socially pressured to pursue
genetic screen
ing, or that they might feel blamed if they do not. The challenge to make
appropriate decisions is exacerbated when considering the global context. As Mr. Bondevik
conveyed, he opposes the use of PGD in Norway. However, given the fierce parental desires

that Hughes described, denying such parents these reproductive opportunities will be a difficult
policy to implement.


Dr. Ola Didrik Saugstad, a Norwegian pediatrician, fleshed out some additional challenges of
PGD, including those of particular signific
ance in the international context. He described the
international conflict in guidelines about the creation of supernumerary embryos. He also
described some problems that arise as a result of the involvement of commercial interests. Even
while some nati
ons might prohibit PGD, there is an international market for these technologies.
He cited the example of letters posted on the Internet requesting assistance for PGD. There is no
coherent international consensus on the limits that might be set on the use

of PGD beyond
families at
-
risk for disease, such as using the technologies to screen for traits. Finally, there are
legal consequences of PGD; parents might sue if an unhealthy embryo was implanted, contrary
to the parents’ expectations. A child’s res
ulting disability after PGD might be considered
damage from the “wrongful act.”


Whereas PGD has begun to be used at certain clinics and by certain physicians in the United
States, Europe has divergent policies toward the technique. Although public opinio
n about PGD
in Norway is variable, as Mr. Bondevik’s comments made clear, the use of PGD in Norway will
be rejected. The Government cites the claim that parents do not have the right to choose the
qualities and traits of their children. In France, PGD is

restricted only to families at risk for
severe, non
-
treatable, disease. In Germany, any diagnostic technologies before the 8
-
cell stage
are prohibited. In Sweden, PGD is accepted, but there is no specific regulation on the issue. The
Swedish Parliament

has recommended that the technique only be used when there is serious
progressive inherited disease. In Denmark, PGD can be performed when there is a known
increased risk that a child will have a disease or can be used to detect a chromosomal
abnormality

during IVF. European Union guidelines on PGD are in formation.



Transatlantic Differences: Divergent Policies or Common Ground?


Anne McLaren used her perspective as a member of the European Union’s European Group on
Ethics (EGE), a group organized t
o advise the European Commission on ethical issues related to
science and new technologies, to comment on differences in European policies toward
biotechnology. While Dr. Saugstad described the divergence in opinions on PGD, Dr. McLaren
described the Euro
pean policies toward stem cell research and patenting, two of the contentious
issues discussed in the symposium.


Despite conflicts with policies in some member states, the European Commission supports stem
cell research, and EGE has concluded that researc
h in both adult and embryonic stem cells
should be pursued. Creation of embryos by somatic cell nuclear transfer (SCNT), however, is
not encouraged at this time. The EGE concluded that European Union funding should be

13

available for research on existing e
mbryonic stem cell lines as well as adult stem cell research,
but only in those Member States that authorize regulated human embryo research. Research use
of embryonic stem cells from supernumerary embryos is allowed in the United Kingdom,
Netherlands, Be
lgium, Sweden, Finland and Greece; it is prohibited in Germany, Austria,
Ireland, Denmark, and France; and there is no ruling on the issue in Spain, Italy, Portugal or
Luxembourg.


This issue of stem cell research is quite complicated in the European Uni
on context because of
the complexities related to research funding. Germany, in particular, did not believe that EU
money should go towards funding research on embryonic stem cells because Germany did not
want money used for that purpose. In response, Mc
Laren clarified that the European
Commission believes that to honor the pluralism of the EU, “individual countries cannot dictate
the use of European money in nations where research is permitted and regulated toward worthy
ends.”


With regard to the patent
ing issue, the European Commission recognizes the importance of
patents for research productivity. In general, they support the ethical acceptability of patents for
treatments or mechanisms, as long as they fulfill the requirements of novelty, inventivene
ss, and
industrial application.


Dr. Barbara Rhode, the head of the unit on Ethics, Science and Society of the EU Commission,
continued to describe the European context of biotechnology. She reinforced the complexity of
the EU system, wherein funding deci
sions might clash with individual member countries’ ethical
regulations.


Rhode described the most important issues in bioethics today, reiterating some of the comments
from throughout the symposium. First she described cloning, both for reproductive and
therapeutic uses, which brings up ethical issues of human dignity. All EU nations are in favor of
banning reproductive cloning, with some countries attempting to link such a ban to therapeutic
cloning. Second, she described using human embryos in researc
h, bringing up the ethical issue
of the moral status of embryos. She emphasized the role open dialogue can play in policy
-
making, discussing a recent EU seminar on supernumerary embryos. Third, she described issues
related to genetic testing and biobanki
ng, bringing up concerns about selection, privacy, and
discrimination. These issues have been discussed in a working group of industry, academia, and
non
-
governmental organization leaders with a draft report due in June 2003. Finally, she
emphasized the
importance of distributive justice worldwide. She described increasing interest
in global responsibility, citing recent activities at the National Institutes of Health and other
groups to research and educate about standards of ethics in research conducte
d in the developing
world.


Rhode’s comments provided important policy guidance for the future. She cited several steps
that must be undertaken to reach consensus, both within Europe and in trans
-
Atlantic
discussions. While some fundamental issues might
be regulated worldwide, it is necessary to
consider the particular cultural features of each country involved. She also described the
importance of designating authorities to assess the communication process. In addition, research
endeavors should be pur
sued, to clarify uncertain elements of the science and inform policies

14

with data. The public must be educated about the issues and involved in the discussions. Finally,
policy
-
makers must take responsibility for those countries that have not yet developed

genetic
technologies.


Dr. Tom Murray, director of the Hastings Center, the foremost bioethics think tank in the United
States, agreed that there needs to be international dialogue. He expressed special concerns about
the use of genetic information, the
powers of genetic manipulation (including but not limited to
gene therapy), and the dangers of the genetic apology, using genetics to explain differences
between populations, thus justifying harmful discrimination. Like other speakers before him, he
descr
ibed the necessity of achieving a balance between the public good and private ownership.


Evoking Dr. Colwell’s message, Murray stressed that genetic information should not be
considered in isolation, as single genes on a chromosome, or “beans in a bean
-
ba
g,” but as an
ecosystem, considering the contributions of the environment and the implications of the
information towards the family, community, and society. Furthermore, genetic information
should not be viewed as something different to be feared (geneti
c exceptionalism), but as just
another type of medical information. Finally, as was appropriate for this international and trans
-
Atlantic event, Murray emphasized that we must be mindful of fair and just access to the
products that result from the human g
enome project.


“We need to work toward fair access to the fruits of the genome and biotechnology.”



Dr. Thomas Murray



Conclusions and Future Directions


In a summary statement, Dr. Alex MacKenzie said, “It seems that what we
can

do has surpassed
what
we know about what we ought to do.” The pessimistic sentiment that our technology has
outpaced public policy was evoked several times throughout the symposium. However, the
participants’ evident dedication to pursuing dialogue toward the development of i
nclusive public
policies justifies optimism for the future. The presenters described the challenges of developing
public policy, both within nations and across international boundaries, but consistently
emphasized that public policy guidance is imperativ
e to move forward with the innovations
resulting from genomic research. All of the seminar participants expressed a firm belief that the
new technologies represent an exciting potential for the relief of human suffering; however, they
would have to be de
veloped within acceptable legal, moral and social norms. There were
striking differences among participants with regard to the degree to which regulation is
acceptable. The different viewpoints presented during the symposium made it quite clear that
one
will have to accept a diversity of viewpoints in this controversial area of policy.


While Norway represented a country where social and political values exemplified a strict
regulatory approach, Norwegian representatives also stressed the value of open d
eliberation,
tolerance, and respect for the choices of other countries, providing a possible framework for
resolving the tensions between different national approaches. A major challenge for the future
is developing mechanisms and frameworks to foster an

atmosphere of mutual understanding,
while accepting the right of countries to make their own choices and the right of countries to

15

have their choices respected by others. It would be important to develop clear international
regulations before agreement
can be reached about particular topics, such as human reproductive
cloning. In areas where there is a need for further discussion before reaching international
agreements, mechanisms and frameworks for dialogue will have to be developed. Further trans
-
At
lantic dialogue, with an emphasis on including public perspectives, should continue into the
future. Such mechanisms for dialogue will be essential for collaborative research to be possible
in the context of what might otherwise appear to be mutually excl
usive policies. Finally, one
must be mindful that genetic information is truly global. Public policy should consider the
impact of genetic technologies even on those countries that are not yet developing research in
this field. Public policy must work
toward ensuring that everyone will have access to the
promises of genomics.


16



Genetics and Health Glossary


Assisted Reproductive Technology (ART).
This term refers to medical techniques employed
with the goal of producing a healthy pregnancy, and inclu
des
IVF

or
PGD
.

Biocomplexity.
Term referring to the dynamic web of relationships of living things interacting
with the environment.

Bioprospecting.
Hunting for new pharmaceutical components within natural resources. (For
example, a new cancer drug that

induces cell death has been created from a diatom discovered in
a Norwegian fjord.)

Embryonic stem cells.
Cells removed from embryos that might be induced to produce a range
of cellular types and tissues, with the hope for medical applications. These ce
lls differ from
adult stem cells

which are those cells that are harvested from adults instead of embryos and
might have similar promise to produce a range of tissue types.


Genetic exceptionalism.
The notion that genetics is different from other medical i
nformation
and thus demands increased oversight by virtue of its being genetic.

In
-
vitro fertilization (IVF).
The twenty
-
five year
-
old practice of creating embryos from donor
egg and sperm; fertilized embryos are then implanted into a woman’s uterus.

Mic
roarray technology.
Also called a
DNA chip
, this technology allows researchers to
examine the activity (in the form of mRNA expression) of thousands of genes at once.

Pharmacogenomics.
A field that uses molecular techniques to explore genome sequences a
nd
gene activity to determine individual differences in drug responses.

Pre
-
implantation genetic diagnosis (PGD).
A technique that uses in
-
vitro fertilization along
with genetic analysis of a single cell of the fertilized embryo in the 8
-
cell stage. For

example,
PGD can allow a specific embryo that is free of a particular genetic disease to be implanted into
a woman’s uterus.

Prenatal diagnosis.
The use of fetal diagnostic technologies, whether amniocentesis, chlorionic
villi sampling, or ultrasound, to

identify abnormalities or other characteristics in the developing
fetus. Some people are critical of prenatal diagnosis, claiming that the availability of these
technologies to identify and abort fetuses with disabilities contradicts the movement for soc
ial
integration and improvement of quality of life of those living with disabilities.

Regenerative medicine.
Using the power of the body to regenerate itself in medical
applications to improve the quality of or extend life.

Supernumerary embryos.
Those e
mbryos produced through IVF or other reproductive
technologies in excess of clinical need that are not implanted in a woman’s uterus.

Somatic cell nuclear transfer (SCNT).
The process by which a species may be “cloned,” by
transferring the genetic materia
l of a non
-
gamete cell to an egg; activation of this complex will
produce an embryo with the identical genome as the donor cell.