Over the years scientific research has led to major changes in the way we
lead our lives. The discovery of Penicillin and the vaccines against smallpox
and polio, for example, revolutionized the way we treat infectious disease
and saved countless lives. We have learned to look forward to these discoveries
and anxiously await the next developments in treating cancer, and other life
threatening diseases. Now recent developments in the technology of the study
of human cells have created an international trend of great importance that
crosses business, political, social and religious lines. In 1997, scientists
in Scotland were able to create a sheep cloned from its mother. From the time
announcement of this groundbreaking work was made, the public began to realize
the tremendous implications of stem cell research. We now know that the technology
is there to “grow” cells that have the “ability to divide
for indefinite periods in culture and to give rise to specialized cells”
which have the potential to perform critical roles in curing medical conditions
such as cancer and birth defects which are caused by abnormal cell specialization
and cell division. (“Stem cells”)
This research on ‘stem cells’ may also bring about the possibility
of replacing damaged organs with new ones cloned from a person’s own
cells. This is welcome news to the field of health care and gives hope for
many who are suffering from debilitating conditions. The National Institutes
of Health states in “Stem cells: A Primer” that “There is
almost no realm of medicine that might not be touched by this innovation.”
Biotech companies are spending millions on research in the race for commercial
success. Industrialized nations are in the process of setting guidelines which
are necessary for two main reasons: first, the technology involves destruction
of the embryos, which has raised religious and ethical concerns; second, the
issue of how far to go must be resolved; the same technology that can replace
human tissue may also be used to create a human being from a cloned embryo.
This is quite a leap from curing disease to cloning a loved one from a piece
of tissue.
The world has faced ethical dilemmas with scientific discoveries before. The
use of atomic weapons, for example, continues to threaten the international
community, and its use will be debated for years to come. Stem cell research,
however, has the potential for great good in relieving the suffering of so
many people. Decisions must be made regarding where and how it is conducted,
who funds it, and what the role of government will be. This paper will show
how various governments are addressing the legal and ethical issues of stem
cell research, how the political environment is affecting the profession of
research and medicine, and finally, how the United Kingdom is becoming a world
leader by making early decisions that will draw the research and the resulting
commerce to its shores.
Embryonic stem cells research has emerged in recent years as the one of the
most promising and at the same time, one of the most controversial fields
of medicine. The public announcement of the birth of Dolly, the sheep cloned
from its mother in Scotland in 1997, was enough to prompt worldwide concern.
Although DNA research had been going on for about 40 years using non-human
cells, this was the first time it was shown that an animal could be produced
from the DNA of only one parent. It was only a matter of time before the technology
was applied to human cells. In November 1998 James Thomson, a University of
Wisconsin researcher, was the first to succeed at “culling stem cells
from surplus embryos created at fertility clinics”, keeping them “alive
and reproducing indefinitely” (Golden 27). This opened the door for
the possibility of replacing cells for Alzheimer’s and Parkinson’s,
spinal paralysis, and a host of other life threatening conditions. Since these
specialized cells have the potential to form tissue for any part of the body,
therapeutic use of stem cells would have widespread support except that the
process involves destruction of the embryos themselves. In response to Thompson’s
new developments, President Clinton asked the National Bioethics Advisory
Commission to report and make recommendations on human cloning research. He
directed the National Institutes of Health to continue a moratorium on funding
for human cloning research, a ban that was in place since 1994 (Greene 4).
The NBAC concluded that the “inefficiency and risk of cloning research
made current human research inappropriate.” They also urged private
companies to comply with the ban voluntarily (Greene 4).
With the largest medical research budget in the world (Ross), the United States
has long been at the forefront of medical research. The human genome project,
a 13 year effort to identify all the human genes in human DNA was one such
scientific success coordinated and funded by the U.S.(Human). However, in
January, 2001, The United Kingdom became the first country to legalize cloning
for the purpose of therapeutic stem cell research. This controversial decision
was certain to attract commercial possibilities to a less restricted setting.
Reaction in the United Kingdom to the most liberal research law Parliament
has approved so far was strongly negative from church heads and right-to-life
groups, but the public was largely non-critical. A negative article in the
London Spectator states that the “British political, medical and pharmaceutical
establishments presented a united front to the public” when the issue
of legalizing stem cell research was being debated last year (Johnson). Religious
leaders complained that their concerns were ignored by the Blair government
in its haste to speed the legislation through (Johnson).
In July, 2001, the U.S. House of Representatives passed the human Cloning
Prohibition Act of 2001 in response to an announcement that a Massachusetts
biotech company, Advanced Cell Technologies, planned to begin human cloning
to produce embryonic stem cells (“Send In”). By a vote of 251
to 176, the House rejected an amendment favored by advocates of cloning human
embryos for therapeutic purposes (Weiss “House”). Rep. James Greenwood,
who sponsored the less restrictive measure, claimed that the House vote had
“no basis in science” and “cell therapy is the wave of the
future.” (“Hysteria”) More criticism of the House vote came
from the scientific community. The American Society for Reproductive Medicine
called the bill an “irresponsible, over-reaching restriction on scientific
research” and Carl Feldbaum, president of the Biotechnology Industry
Organization said the group was going to call on the Senate to “reflect
more carefully” and separate the reproductive from the therapeutic cloning
technologies (Weiss “House”).
The pressure was great for a U.S. decision on exactly which types of research
would be funded. Bush’s dilemma was how to balance the “hopes
of research against the moral imperative that the government should not be
funding the destruction of human life” (Lacayo 19). After consulting
experts in the field and even the Pope, President Bush announced in August,
2001 that funding will be approved for research only on existing cell lines
that were leftover from embryos used in-vitro fertilization use and would
be destroyed anyway. The National Institutes of Health claim that 65 of these
cell lines exist worldwide. (Lacayo18). With this decision Bush was attempting
to find the political middle ground that “allowed him to claim he had
not stood in the way of promising medical investigations” while keeping
his promise to the Republican right not to fund new stem cell research (Lacayo
19). Technically, the NIH may fund research using stem cells, but its guidelines
prohibit the use of federal dollars to derive the stem cells; this has been
illegal since 1996 (“NIH”).
In the U.S., conservative philosophy is traditionally pro-business and usually
promotes unrestricted business growth. However, the religious right is a heavy
influence on President Bush and he will be depending on their support for
reelection. His decision on federal funding limitations for this research
represents a compromise in which Bush is “trying to distance himself
from the destruction of the embryos” (Lacayo19). Indeed, the U.S. Conference
of Catholic Bishops and some hard line conservative Christian groups have
condemned any use of embryos. However, many right-to-life groups are expressing
satisfaction with Bush’s decision regarding funding and are concentrating
their efforts in halting reproductive cloning. The National Right to Life
Committee, The Christian Coalition, and the Moral Majority have all expressed
support for Bush’s position (Goodstein). Some pro-life legislators are
even questioning the assumption that the embryos used in the extraction of
stem cells are actually human. Senator Orrin Hatch supports funding of stem
cell research claiming that “a frozen embryo is more akin to a frozen
unfertilized egg than to a fetus naturally developing in the body of a mother”
(MarwickMost of the industrialized nations are following Bush’s lead
in establishing guidelines for research, but regulations vary widely from
country to country. Nine European Union member states have passed laws banning
research on stem cells and human embryos. The European Commission has decided
not to fund any projects involving cloning or stem cell research for the next
four years, and Germany and France are petitioning the United Nations to draft
new legislation to ban such research (“European”). France, whose
population is 76.3% Roman Catholic (Encyclopedia Britannica) has been very
outspoken in condemning human cloning for reproduction and has recently drafted
legislation to be voted on next year that will specifically ban human cloning
for reproduction. The Minister of Health, Bernard Kouchner has referred to
the process as “photocopying” human beings and states that it
is “morally unacceptable to create life while hijacking its very meaning”
(Erlanger). However, Germany is probably the most vocal opponent of stem cell
research in the European Union. The government had banned all genetic research
since the fall of Hitler. The memory of his atrocious experiments on Jews,
Gypsies, and handicapped groups has kept the country behind until about five
years ago when some techniques in genetic research were permitted for development
of pharmaceuticals (Komarow). Germany is home to large medical companies such
as Schering and Bayer, who stand to gain from more liberal laws. Work on adult
stem cells is progressing, but current German law allows use of embryos only
for in vitro fertilization (Komarow).
According to CNN.com, Japan approved guidelines similar to the U.S. in August,
and will begin studies on cells discarded from fertility treatments only.
Israel has no laws restricting stem cell research and little public opposition;
they have succeeded in growing heart cells from human stem cells. In 1999
a law was passed in Israel banning human cloning for five years (“Stem
Cell Research”). Canada has drafted guidelines that would permit use
of existing cell lines and new cell lines created from fertility treatment
donors (Bueckert). In Australia, there is no nationwide policy to date; they
could not reach consensus on stem cell research. In China, only study of stem
cells drawn from afterbirth and umbilical cord is permitted. However, regulation
is somewhat lax (CNN). India has set up a bioethics panel to draft guidelines
for the collection and use of embryonic stem cells drawing on the existing
guidelines from the Indian Council of Medical Research (Mudur). In India there
is very little objection to abortion, and two of their research centers are
holding human stem cells that are eligible for research under Bush’s
plan (Mudur).
The National Institutes of Health claims that there are a total of 64 stem
cell lines in existence, 24 of them in Sweden. At the University of Goteberg,
scientists are more cautious about the number and admit that the program is
quite new. Since their cell lines meet Bush’s requirements, their program
is generating quite a bit of interest (McNeil). Some smaller countries are
seeking to relax their controls on embryo research hoping to have their biotech
companies take the lead in commercial success (“Overexcitement”).
Singapore, for example, hopes to become a world power in stem cell research
by benefiting from unhindered and essentially unregulated research. They claim
that a native scientist, Ariff Bongso’s mating studies paved the way
for the Thompson team’s success at University of Wisconsin. Dr. Bongso’s
group owns 6 of the cell lines and with the help of Australian financial backers,
has established a company to supply cell lines to U.S. scientists (Frank).
The New York Times describes Singapore along with Australia, Sweden and India
as “an unexpected new order of world powers” in stem cell research
(Wade 8/28). It seems that these countries are taking advantage of their lack
of regulation while the usual “powerhouses of biomedical research in
the United States and Europe are being held back by political and ethical
debate”(Wade 8/28).
The wide range of opinion even within conservative political thought shows
that it is by no means certain that therapeutic human cloning will be banned
in the United States. Since the Senate has not taken up the question yet,
a new statement from the National Academy of Sciences may affect future Senate
debate. NAS is an “independent organization chartered by Congress to
advise the government on scientific issues” (Weiss “Broader”).
Just one month after Bush’s announcement, they have come out with recommendations
that ask for funding for research on new cell lines, which they report will
be necessary for therapeutic research as the existing cell lines become “compromised
by age” (Weiss “Broader”). This puts the key science group
in disagreement with Bush’s policy. The report also expresses concern
about the lack of ethical oversight in the private sector and called for an
“oversight body whose members would include experts in science, ethics,
theology and law to keep tabs on the field of embryonic stem cell research”
(Weiss “Broader”).
If the U.S. continues its present policy, it may stand to lose significantly
in the race for leadership in the commercial phase of the research. Even if
all nations agreed on the same regulations, which would be ideal, restrictions
on research will be difficult to enforce internationally. No government has
the power to alter the course of technology, and few countries want to miss
out on a potentially lucrative business (Bookman). The George Washington University
Law Review states “due to the role of the United States as a leader
in biotechnology, an international regulatory body cannot legitimately be
formed without U.S. support”. They suggest that the U.S. show this leadership
by initiating an international agency to regulate research (Greene). Every
country dealing with the question of how much research to permit is affected
by its own history, politics and government, and the balance of power may
shift dramatically as different aspects of the research are legalized.
As world leaders weigh in with opinions and legislative bodies debate the
issues, the political situation becomes crucial to the decision-making. Private
companies are moving ahead with stem cell research and seeking the best political
climate to give them the freedom they need to proceed with the work. The conservative
Republican administration in the U.S. seems to be a hindrance to their plans,
which is causing dissent within the ranks on the position. Hardliners on the
religious right are pitted against moderates who favor the medical industry
and the possible commercial success of new advances in medicine. Bush’s
decision may be interpreted as an attempt at compromise to head off possible
liberal legislation from the majorities in both houses who support embryonic
stem cell research (Lacayo 19). The House legislation was a blow to the future
of research in the U.S. because it rejected an amendment that would have allowed
private companies to develop therapies from created human embryos. However,
it remains to be seen whether the Senate will pass the legislation as well.
If the ban is upheld in the Senate, privately funded stem cell research in
the United States as well as other important research such as the human genome
project could be compromised. (“Hysteria”) Advanced Cell Technologies
has just announced that they have succeeded in creating “the first human
embryos ever produced by cloning” (Kolata). This announcement has brought
new attention to the controversy and may speed up the Senate debate. Bush
is urging the Senate to pass the House legislation as a result of this “crossing
of the line” by Advanced Cell Technology (Carter). The company’s
CEO, Michael West, insists that he has no interest in cloning human babies
and that his goal is to find a method to create embryos that could provide
stem cells to cure disease (Kolata). The announcement may have been an attempt
to keep the funding debate in the news, since the researchers were not actually
successful at retrieving stem cells from the embryos. The company’s
research is privately funded, which does raise the question of whether “science
is moving ahead of public policy” (Kolata)
According to The Wall Street Journal, “the battle over the future of
embryonic stem-cell research is shifting to a critical new front: the 60 stem-cell
lines President Bush says can be studied by U.S. scientists supported by federal
funds” The companies who supply these lines, identified by the National
Institutes of Health, will be making agreements with federally funded researchers
for a share of the rights (Ragalado). Scientists says there are difficulties
growing the lines and the existing ones may lose their value over time. Dr.
Evan Snyder from Harvard University calls Bush’s decision “scientific
naïve” because some of the existing lines appear to have lost their
usefulness and many more populations of cells will be needed to treat diseases
(Regalado).
In addition to Advanced Cell Technologies, there are key institutions and
companies conducting stem cell research now. The Wisconsin Alumni Research
Foundation, which is a for-profit affiliate of the University of Wisconsin
holds the patent for James Thompson’s groundbreaking research and stands
to profit handsomely from his work. The patent is expected to be challenged
in the courts, but work is going ahead funded by Geron, a California based
biotech company, which owns the key commercial rights (Regalado). Thomson
himself is somewhat disappointed by the restrictions posed by Bush’s
decision, but is continuing work under arrangement with the alumni association,
thus freeing himself from the federal restrictions and avoiding conflicts
with the university’s government-funded research (Golden). Other U.S.
researchers are already making plans to move their research abroad in anticipation
of the restrictions on federally financed research. Roger Pederson, a leading
U.S. scientist in stem cell research has already moved his work to the University
of Cambridge in the United Kingdom (Pezzella). Advanced Cell Technologies
plans to move if the Senate votes in favor of the ban. Geron Corporation has
acquired a firm in Scotland to assure what the CEO describes as “complete
freedom to operate”, and a Massachusetts company, Bio-Transplant, purchased
part of an Australian firm (Shadid). If other companies follow, the United
States stands to lose the lead in a potentially lucrative field due to the
conservative political climate.
Some international companies are already going public with their research
findings. In Australia, BresaGen is working on turning stem cells into nerve
cells to treat Parkinson’s disease. National University, Singapore,
Monash University Australia, Hadassah Medical Centre, Israel and Humbrecht
Laboratory, The Netherlands have teamed to form ES Cell International which
is funding research and supplying stem cells to others. Rambam Medical Center
in Israel is “growing the precursors of heart cells and pancreatic tissue”
and has sent supplies of stem cells to top laboratories at Harvard and MIT
(Regalado).
The difficult questions of where to draw the line are being debated in the
editorial pages both here and abroad. Some of the more radically conservative
editorial responses were prompted by the announcement of some rather shocking
testimony before a recent special cloning symposium by the National Academy
of Sciences. Severino Antinori, an Italian gynacologist and infertility specialist,
and Panayiotis Zavos of the University of Kentucky announced plans to set
up a cloning clinic to produce the world’s first cloned baby. Also the
Raelins, a controversial religious group, testified that they intended to
clone the cells of a dead baby in the hopes of bringing him back to life.
They claim to have a lab, scientists and volunteers to carry the baby to term.
Biotechnology specialists agree that cloning a human will be possible in a
few years, and they fear that research may be proceeding underground now (Gibbs
48). These announcements not only call attention to the lack of international
regulation, but also stir up hysterical reactions from religious leaders and
conservative politicians who are worried that one line of research may impede
another, thus reducing the chances of finding cures. According to Tony Perry,
a Rockefeller University cloning expert, a shocking breakthrough in human
cloning would cause “an overcompensatory response by legislators that
could be disasterous” and cost the lives of those suffering from diseases
who might be helped by the research (Gibbs 49)
It was not a coincidence that the Roslin Institute in Scotland engineered
the birth of “Dolly”, alerting the world to the possibilities
of stem cell research. Although the institute’s goal was to create livestock
that would be able to produce human medicines in their milk, they had been
doing genetic research on animals for a long time (Greene 3). The United Kingdom
has long been a leader in reproductive science. In 1978, they were the first
to produce a “test tube baby”, thus beginning the practice of
in vitro fertilization that has become accepted internationally to help infertile
couples conceive. This scientific achievement spurred Parliament to debate
the ethical decisions of reproduction for the next ten years. The Human Fertilization
and Embryology Authority, an agency that licenses fertility clinics and research
institutions, was set up by parliament in 1991 to regulate all research on
human embryos. From that time on, researchers in the United Kingdom have been
working under a less restrictive system allowing them to create human embryos
for research purposes . “The agency has permitted five categories of
research with human embryos, all related to human fertility”(Wade 8/14).
The Authority has the confidence of the public and has the power to regulate
not only the details of clinical practice, but also deals with ethical issues
such as whether a couple can choose the sex of their baby (Wade 8/14). Reproductive
cloning is not permitted by the Authority. That question will be decided by
legislation as was the decision to allow therapeutic cloning in December,
2000. How far to go with stem cell research is controversial legally and ethically
because of the slippery slope leading to cloning human beings, and this is
a concern to the U.K. government. A bill to ban reproductive cloning is pending
in Parliament now. The current decision is to permit research on human embryos
until they are 14 days old. At this age, the embryos are thought to be in
a more “recognizable structure” (Wade 8/14). This law is far more
liberal than the U.S. House of Representatives legislation, which banned all
research on new embryos. The U.K. decision is also a break from the recommendations
of the European Union and has prompted much editorial comment suggesting worldwide
concern.
One reason for the less restrictive reproductive legislation in Britain is
that Parliament acts with little opposition from pro-life forces (Wade 8/14).
The United Kingdom was among the first countries to legalize abortion (Johnson),
and the extreme religious conservatism that exists in the United States does
not have the same kind of impact on British politics. The public has confidence
in scientists and the agencies that oversee them (Wade). One must also consider
Prime Minister Tony Blair and his Labour Party’s control of parliament
for a second consecutive term. His party is pro-business and anxious to provide
a free atmosphere for the commercial success of stem cell research. Nearly
$28 million has been spent on stem cell research by the Biological Sciences
Research Council since 1989, and the amount is likely to increase due to the
liberalized laws (Capell). The United Kingdom has a long history as an economically
and politically stable world power, and is a leader in finance and industry,
being an active participant in the formation of the European Union and a major
international trading power (“Background”).
The government is now in the planning stages of the world’s first embryo
stem cell bank, which could give U.K. scientists a “significant edge
over their U.S. counterparts in the race to develop new techniques for tissue
transplantation” (Naik) According to Dr. Robert Lovell-Badge, an embryologist
at the Medical Research Council, the stem cell bank should be set up in about
a year. It would serve as a repository for master stem cells from human embryos
around the world, which would have the ability to develop into many kinds
of tissue including brain, heart and nerve (Naik). Dr. R. Alta Chara, a United
States law and ethics professor, feels that the United Kingdom has used “carefully,
sequential decision making and have created probably the best research environment
globally” (Wade 8/14). The biggest advantage the United Kingdom has
now in the race to be the center of commerce in this research is that Parliament
made the decision fairly early to put together a flexible legislative framework
for embryo research which can be adjusted to accommodate advances in biological
science (Naik). For example, a loophole in the 1990 Human Fertilisation and
Embryology Act was recently revealed by a lawsuit against the government by
the ProLife Alliance, a British anti-abortion group. Britain’s high
court ruled that cloning humans was not illegal. Emergency legislation is
being rushed through both legislative houses now to close the legal loophole
(“Emergency”). Ruth Deech, chairwoman of the embryology agency
since 1994, believes that it can never really be resolved, so “in a
typical British fashion, we have reached a compromise that embryos may have
research carried out on them” (Wade).
The United Kingdom would like to draw more research to its more liberated
atmosphere, and companies and academic institutions that need stem cells for
independent research will be able to obtain them from the bank, which is backed
by major scientific groups and governmental institutions. According to the
Guardian, American scientists will be looking more to Britain for “science
unconstrained by political compromises…” (Klotzko).
It might be said that recent developments in stem cell research have opened
the door to the genetic destiny of man. The possibility now exists that quadriplegics
will walk again and victims of Parkinson’s will live to old age. It
may also be possible to produce designer babies and create clones of famous
people or your beloved dog, and it is this possibility that is causing the
greatest alarm.
Stem cell research is forcing governments to deal with the issues of science
as public policy, and the extent and nature of governmental control will be
crucial to the research. The balance of power in this lucrative field will
shift to the countries that provide the most freedom to pioneering scientific
institutions and biotech companies and at the same time have clear, established
guidelines to avoid abuse.
According to the George Washington Law Review, “Human cloning has become
a nearly inevitable prospect.” It is important that the distinction
between therapeutic cloning and reproductive cloning be made in any efforts
by a regulatory body. It appears that while a majority of countries object
to creating humans, the medical use of stem cells in the fight to conquer
disease and disability is more acceptable. If these two types of research
are considered separately, the crucial therapeutic research may be able to
proceed in a less political atmosphere. Even so, it will not be easy to sort
out the religious, political and legal issues surrounding stem cell research,
but it is imperative that the international community continues to do so.
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