After removing the nucleus of the egg, scientists will insert a cell to clone an
animal. How long before they turn to humans?
Wearing Tony Blair masks, activists protest cloning outside a European Union summit
in December 2000.
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How
to clone à la Dolly
“Therapeutic”
or adult DNA cloning are just nice ways of referring to the fabrication of human
embryos by somatic cell nuclear transfer (SCNT), which is how that famous sheep Dolly
was created. SCNT involves a few basic steps. First, take a human egg and remove
the nucleus (which contains its DNA or genetic material) and insert a single healthy
cell of a patient. Then pass an electric current to fuse the two and the egg acts
as if it was fertilized. You now have a tiny ball of cells which some like to refer
to as a pre-embryo. But this is just another euphemism used to calm public fear.
That little cluster is indeed an embryo and could theoretically grow into the patient’s
clone if it were implanted into a woman’s uterus and if all went well. Note the ifs,
for as Dolly and her ilk remind us, the chances of actually producing a healthy human
clone are extremely remote. But this may be beside the point, for the embryos in
question will be destroyed within 14 days, when the first signs of neural development
appear.
Why go to so much trouble? Between the fifth and seventh day after fertilizaton,
a batch of 20 to 30 cells appear that are worth gold for scientists and patients
suffering from a wide range of degenerative diseases and conditions. Embryonic stem
cells (ES cells) have the potential to develop into any kind of cell in the human
body. Although there are several kinds and sources of stem cells—such as those found
in the bone marrow of adults—none so far seem to have the malleability of ES cells,
which can also be kept and grown in laboratories for long periods of time. The great
hope is that researchers will learn to direct ES cells into becoming any part of
the body—cells, tissue or maybe even organs—required by a patient. For example, someone
suffering from heart disease might be able to “grow” genetically identical cardiac
tissue in a laboratory that could then be transplanted with little risk of rejection.
Yet there may be alternative routes to the same goal. Researchers at PPL Therapeutics,
which is part of the team that produced Dolly, recently announced that they were
able to transform adult skin cells back into stem cells and then into beating heart
cells. This type of work might initially require embryo research but in the long
term it could offer a way out of cloning.
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While
it is politically risky to claim the embryo itself, there are plenty of backdoors
to exert
control over it. |
By
creating embryos through cloning, we may also find a treasure trove for treating
disease. But in the rush to profit, we may sell short the very stuff that makes us
human, a sense of dignity.
A
theoretical
speck in a Petri dish has a veritable mob straining for a better view across the
industrialized world and beyond: men and women in white coats and religious robes
jostle beside parliamentary lords, scruffy environmentalists and patients trembling
with Parkinson’s disease. The mystery in question is none other than the human embryo
cloned à la Dolly. The aim is not to produce people. Through “therapeutic”
cloning, scientists would create embryos to harvest stem cells, which may hold the
key to treating a wide range of disease. But like most passionate debates, the real
issue—commercialization—sits quietly in the background of the emotional din.
Human
respect or cellular sludge?
The
debate erupted across the industrially advanced world on January 22nd, when Britain
became the first European country to legalize the creation of cloned human embryos.
Members of the European Parliament almost immediately expressed their shock and condemned
the decision. Yet in many ways, the new law is a logical extension of rules dating
back over a decade. Since 1990, UK researchers could create and use embryos for limited
research purposes, namely to treat infertility and detect birth defects. The new
law widens the field of study to include stem cells, which experts say could revolutionize
medicine, offering the possibility of transplants to treat scores of illnesses from
Parkinson’s disease to diabetes (see box). No one has yet applied for a license to
perform such experiments, according to the Human Fertilisation and Embryology Authority,
which will carefully screen each request. No other uses of cloning would be allowed
and a new law has been promised to explicitly ban reproductive cloning.
As expected, the most rigid opposition has come from the Catholic Church, which considers
the embryo to be a living person from the moment of conception. Cloning aside, even
research involving “spare” embryos (created for infertility treatments but not used)
is condemned because it is morally wrong to use a person for the benefit of someone
else.
At the opposite end of the spectrum lie the hardcore utilitarians of science and
business, who are generally astute enough not to announce their politically incorrect
views: namely that the embryo is just another batch of cellular sludge that can and
should be used like any other biological resource in the pursuit of medical research.
Somewhere between these two poles lies the famous middle ground, for which there
is no clear road map but a general principle: respect for human dignity, a touchstone
of French and European law. “The very fact of being human automatically entails the
right to a certain respect or dignity. It is what separates us from other animals,”
says Noëlle Lenoir, president of the European Group on Ethics and justice on
the French Constitutional Court. The seeds of this notion rest in the major monotheistic
religions, says Lenoir, but the principle effectively took root in international
law following the Second World War and the eugenic brutality of the Nazis.
Finding
biological clues
The
embryo is not legally considered a person but rather “a human being in the true sense
of the word, meaning it exists and its nature is human,” according to Bernard Mathieu,
a French professor at the Sorbonne. This protects the embryo from being reduced to
a commercial resource without intruding upon a woman’s right to protect her health
and control her fertility. Such an understanding of human dignity underlies the decision
by many European countries to strictly limit or prohibit embryo research in general.
But the UK’s green light to therapeutic cloning reflects a very different interpretation
of the same principle, according to Alastair Campbell, a professor and member of
the UK expert committee which recommended that Parliament approve the research. The
traditional categories of vocabulary for distinguishing between respect for human
life and that of persons are too clumsy, says Campbell. Instead, he turns to biology
for clues in defining ethical limits. Basically, the embryo is treated with increasing
moral seriousness or protection as it develops. This is why it is forbidden to experiment
on any embryo—cloned or not—after 14 days, when the “primitive streak” or the first
signs of an emerging nervous system appear.
A
lurking trade in stem cells
Dr
Donald Bruce of the Church of Scotland reluctantly agrees that certain forms of research
may be justified on “spare” embryos. However, the recent UK decision crosses a major
ethical threshold, says the director of the Church’s Society, Religion and Technology
Project. “Instead of treating embryos as a whole,” says Bruce, “we now see them as
a source of parts.” The UK has moved from a policy of “no and less”—which only permits
the use of embryos when there are no alternatives for understanding very serious
problems—to a “yes, provided” approach—which opens the floodgates provided that certain
conditions are met.
There is also a practical side to this ethical dilemma. Imagine that we do take the
cloning route to harvest stem cells: doctors would require at least one egg, but
probably a dozen or more, to treat each patient. Hence Bruce’s recommendation that
research should explore all the options before embarking upon therapeutic cloning
(see box).
Not only is the recent UK decision too wide for critics, but it could lead to the
slippery slope of reproductive cloning—whereby people are created by cloning. British
law clearly forbids this scientifically remote possibility, yet the problem ultimately
lies in the globalized medical community, says Bruce. Sects, businessmen and more
recently a group of maverick scientists have trumpeted their intentions to clone
people, despite the extraordinary risks of deformity. What will prevent them from
setting up shop in a genetic safe haven, a country where bioethical legislation doesn’t
apply or exist?
But in the shadows of these theoretical discussions lurks the largest threat: the
future trade in embryos and stem cells. Every expert cited in this paper, including
Prof. Campbell who supports the research, has joined a host of others deeply concerned
about commercialization. In particular, there appear to be too many loopholes in
patent rules, especially in the U.S. but also in Europe and industrialized countries
like Australia, Canada and Japan.
Consider the genesis of Dolly the sheep, who was born in 1996 at the Roslin Institute
in Scotland. An American company, Geron, bought the commercial arm of the institute
and received a license to two UK patents that shocked many in Europe and the U.S.
The first patent basically covered the cloning technique and the second the covered
“products” of that process. This can be read to mean that Geron owns products like
cloned human embryos in the early stage of development.
European
doublespeak
Geron
then sent a similar set of applications to the European Patent Office (EPO), which
initially approved them before striking off the right to human embryos upon a second
reading, according to Christoph Then, a genetic research expert for Greenpeace Germany.
The decision marks a step in the right direction, says Then. But it also reflects
the split personality of the European Union: while liberalizing trade rules to compete
with the U.S. biotech market, it tries to squat the moral high ground of genetic
research to serve as a beacon for the rest of the world.
So we find strong principled statements ringing in the European Parliament and proud
reminders of the Union’s Charter, which prohibits “making the human body and its
parts as such a source of financial gain.” Yet at the same time, member states are
supposed to be integrating a very controversial directive on genetic patenting, which
is meant to balance ethical and commercial concerns. On the one hand, “processes
for human cloning” are not considered patentable, nor are “uses of human embryos
for industrial or commercial purposes.” Nevertheless, a company can control (receive
a patent for) “an element isolated from the human body or otherwise produced by means
of a technical process.” This is a dazzling bit of doublespeak, but don’t believe
anyone who tries to tell you exactly what it means. Instead look to recent trends
in gene patenting for key clues as to what we might expect in the near future.
In theory, patents are supposed to reward inventions, not just the discovery of elements
already existing in nature. You can, however, be awarded a patent for developing
a novel use for an element, like a gene. But look at the human genome—the genetic
map of our species—and you’ll find a trail of lawyers scurrying for a patent almost
every time a scientist, or rather a computer, suspects a gene may be lurking. They
cannot even fully identify it, let alone understand its function, yet they claim
it as their own. This basically means that anyone else who looks to use that gene
to develop a new drug or to treat a related disease must pay for the view.
This same commercial race is heading straight for the human embryo via therapeutic
cloning. According to Then of Greenpeace, the number of patent applications directed
at human embryos is dramatically increasing. Last year, two biotech companies, from
Australia and the U.S., applied for and received a European patent on cloned human
and animal embryos as well as mixed species embryos from pigs and humans. But after
a major public uproar stoked in Germany by Greenpeace, the Munich-based EPO said
it was a “mistake” and the companies admitted they had gone too far and promised
not to include human embryos in their patents anywhere in the world.
While it is politically risky to claim the embryo itself, there are plenty of backdoors
to exert control over it. A company may receive broad powers over simply retrieving
embryonic stem cells or culturing and guiding them in a particular direction. This
is not to suggest that such feats don’t require ingenuity. Yet depending upon the
scope of the patent awarded, we could see a re-run of the same abusive pay-per-view
approach taken with genes.
More
than just a sum
So
far only four countries have implemented the patent directive. France and Germany
have both expressed opposition and the Netherlands, supported by Italy and Norway,
has challenged the directive in Europe’s Court of Justice. Outside of officialdom,
groups like Greenpeace are turning on the pressure to reopen the negotiations.
This is usually the point where journalists and experts sign off with a vague but
earnest call for public debate. But the exchange is already underway—in the media,
religious halls, universities and the corridors of hospitals, where doctors, patients
and the families speak and think quietly. This appears to be a step forward, yet
there is a new trend among some scientists and bioethicists to denigrate this kind
of discussion, especially if it reaches an emotional timbre. Opposition is ascribed
to “confusion” over the issues and to the damage done by the false but pervasive
belief that “we are the sum of our genes.” Genes are just molecules and early embryos
are microscopic balls of cells. Yet they both hold an iconic power which stems not
from confusion, but a gut instinct to respect human dignity. |
