PAN DISCUSSION GROUP 

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First what’s in our Big Mac, Muck?

Fighting for the future of food : Deborah Koons Garcia's film documents how genetically engineered foods slipped into our supply

Carol Ness. San Francisco Chronicle. San Francisco, Calif.: Nov 7, 2004. pg. D.1

(Edited)

"Just about everybody is pretty serious about their chow," says Deborah Koons Garcia, enjoying the understatement. "Even if they don't eat good food, they're serious about their junk food."

No matter how serious they are, though, Garcia knows most people don't realize that genetically engineered foods have quietly slipped into much of the American food supply, mostly from corn and canola. They're in an estimated 60 percent of all processed foods.

She wants people to understand the risks, in her view, while there's still time.

"We are at a crossroads," says Garcia, fending off the wet affections of her three Dalmatians as she explains why she's spent the last three years and a chunk of what she calls her "Jerry money" making "The Future of Food," a documentary about GMO (genetically modified organism) foods. Though Garcia has made films all her life and runs her own production company, Lily Films, she is better known as the widow of Jerry Garcia, the legendary Grateful Dead lead singer and guitarist who died in 1995.

"Someone needed to make this film, because if this technology isn't challenged and if this corporatization of our whole food system isn't stopped, at some point it will be too late," says Garcia. "The Future of Food," finished in July, will get a special two- day screening at the Castro Theatre on Thursday and Friday.

First, she thought about doing a film on pesticides. But her research led her to the genetic revolution of agriculture. Biotech breakthroughs allowed the gene-splicing of plants from different species or even plants and animals to create crops that resist disease or can withstand pesticides, even the "terminator" gene that kills off crop seeds after one season.

"It became clear that GMOs are really a much bigger issue ... And it was really clear that there hadn't been a really good film that told the whole story from the cellular, from the microscopic level, all the way up to the global, which was a huge challenge -- but I just thought that's what people need to know," Garcia says.

Her 90-minute documentary feels more educational than polemic -- though it expresses a strong point of view against letting new life forms loose on the land without long-term testing of the health effects and real government controls, especially labeling of foods.

It's an issue with special resonance in California, where the economy depends on agriculture and GMO crops are gaining a toehold. Test fields of grapes, cotton, rapeseed, alfalfa, wheat, onions, corn, rice and other fruits and vegetables have won permits for California. Nationally, 100 million acres of GMO crops -- mostly corn, soy, canola and cotton -- were under cultivation by 2003, according to the film.

The issues are complicated and technically daunting -- one reason people have a hard time grasping them. But Garcia threads a clear path through the history, science and politics of GMO foods to a clear call for action.

She sets her stage with nostalgic, black-and-white shots of traditional farming, before the "green revolution" of fertilizers, chemical pest-killers and mono-cropping grew out of World War II weapons research. Agriculture became industry, and then recombinant DNA technology upped the ante in the 1990s. Chemical companies like Monsanto created Roundup Ready canola, and Bt corn with a spliced- in gene that makes its own insecticide.

Garcia leads carefully from one point to the next -- showing how the chemical companies have succeeded in first patenting their own GMO seeds, and then slapping patents on a huge number of crop seeds, patenting life forms for the first time without a vote of the people or Congress.

To make the point, Garcia goes to Saskatchewan grain farmer Percy Schmeiser to tell his story. He's one of hundreds of grain farmers sued by Monsanto after the company's Roundup Ready canola drifted into his field.

Monsanto accused Schmeiser of violating its Roundup Ready patent, even though Schmeiser never planted the GMO canola and didn't want it in his field. He fought the suit where many other farmers settled, but lost, and must pay Monsanto to plant his next crop from his own seed.

Garcia travels with UC Berkeley's Ignacio Chapela to Mexico, where hundreds of varieties of corn thrive in different climates and soils, to show how GMO crops threaten such biodiversity. It was here that Chapela found controversial evidence that genes of GMO corn had already jumped the border to contaminate native species.

The uncontrolled spread of genetically engineered plants -- recently proven again with tests of GMO grasses -- far beyond the fields where they were planted is one of the strongest arguments the film makes for introducing safeguards.

The film questions why the U.S. government hasn't required GMO foods to undergo the rigorous testing required of medicines created by recombinant DNA technology, and why it has resisted efforts to require GMO labeling on foods, as Europe does.

Suggesting an answer, the film ticks off all the government officials who have links to Monsanto, including Agriculture Secretary Ann Veneman and Attorney General John Ashcroft. It also briefly debunks claims that GMO foods are the answer to world starvation. Ultimately, the film is a call to action -- for people to think more about the consequences of their food choices and to use their consumer power to push for labeling and regulation. While some people are seeking to ban GMOs, Garcia thinks labeling would drive GMO foods off the market, as it has in Europe.

"I want people to watch the film and say we have to stop this," says Garcia.

Long gone are the days when Garcia believed "we could have our healthy foods over here, and they could have their food over there. You do your thing and I do mine."

With genetic engineering, she says, "You can't drop out anymore - - it'll come and get us."

But that’s Ok at least GMO’s are only in special controlled test sites aren’t they ..

No Foolproof Way Is Seen To Contain Altered Genes

Andrew Pollack. New York Times. (Late Edition (East Coast)). New York, N.Y.: Jan 21, 2004. pg. A.10

A new report commissioned by the government suggests that it will be difficult to completely prevent genetically engineered plants and animals from having unintended environmental and public health effects.

The report, released yesterday by the National Research Council of the National Academy of Sciences, says that while there are many techniques being developed to prevent genetically engineered organisms or their genes from escaping into the wild, most techniques are still in early development and none appear to be completely effective.

''One of our big messages throughout the whole report is that there are very few bioconfinement methods that are well developed,'' Anne R. Kapuscinski, a professor of fisheries, wildlife and conservation biology at the University of Minnesota and a member of the committee that wrote the report, said at a news conference in Washington yesterday.

Companies and scientists are now developing a wide range of genetically modified organisms: salmon that grow superfast, mosquitoes engineered not to transmit malaria, corn that produces pharmaceuticals and industrial chemicals.

One concern about these transgenic products is that their genes or the organisms could spread. Fast-growing fish, if they were to escape into the wild, might beat out regular salmon for food or mates, disrupting the ecological balance. Genes giving crops resistance to herbicides or insects might spread to weeds, making the weeds harder to eradicate. Pollen flow from corn engineered to produce a drug could allow the drug to get into corn destined for the food supply.

Much of the efforts to prevent these effects have involved physical containment, like growing fish in tanks rather than the ocean or growing crops in greenhouses. But the new report, commissioned by the Department of Agriculture, looks at biological methods of containment, which it calls bioconfinement. These include measures like inducing sterility by giving fish an extra set of chromosomes or exposing insects to radiation. Bacteria might be given ''suicide genes'' that would cause them to self-destruct if they escaped. Crop scientists are working on a variety of techniques, including putting the foreign genes into the chloroplasts rather than the nucleus because chloroplast genes usually do not get into the pollen.

In many cases, the report says, such bioconfinement will not be needed because the organisms will pose little risk. But it says that when it is needed, it might be useful to use more than one method at a time, since no single method is likely to be 100 percent effective. The report also says such bioconfinement methods are best considered early in the development of a genetically modified plant or animal rather than as an afterthought.

The panel's report could have some bearing on issues now before regulators. It recommends, for instance, that nonfood crops be sought for growing pharmaceuticals or chemicals that need to be kept out of the food supply.

This position is favored by many environmental and consumer groups and by food companies, which fear that a contamination incident would hurt sales and undermine public confidence in food safety. But the biotechnology industry has generally argued that it is most economical to use widely grown crops like corn and that these crops can be adequately isolated from crops grown for food.

The report also says there are weaknesses in the safeguards being taken by a company that is seeking Food and Drug Administration approval to sell salmon genetically engineered to grow faster.

The company, Aqua Bounty Technologies of Waltham, Mass., has said it would sell to fish farms only female fish that have been sterilized, thereby eliminating the possibility that the fish could reproduce should they escape into rivers or the ocean. But the report says those methods alone might not be sufficient, in part because sterilization does not always work. It says the fish should be grown only in special inland facilities, rather than in cages in the ocean from which they might escape. Joseph B. McGonigle, vice president of Aqua Bounty, said there were errors in the report. ''They clearly don't have a full grasp of both what we're proposing and how effective the technology is,'' Mr. McGonigle said. Consumer groups and the biotechnology industry differed on their interpretation of the report.

Gregory Jaffe of the Center for Science in the Public Interest said the report's conclusion that there was no foolproof bioconfinement method suggested ''there is a need to have a better regulatory system that assesses whether there are any risks to begin with.''

But the Biotechnology Industry Organization said in a statement that the report concluded that ''technology providers have a variety of methods available to ensure confinement of organisms modified through biotechnology when risk warrants it.''

In another report issued yesterday, the National Research Council said urgent action was needed to preserve the Atlantic salmon in Maine, where the fish supply has been rapidly declining. The fish there constitute most of the Atlantic salmon population in the United States. A program of removing dams should start immediately, the report said.

And its not just corn and cows …

Science and Technology: Down in the forest, something stirs; Genetically modified arboriculture

The Economist. London: Jan 8, 2005.Vol. 374, Iss. 8408;  pg. 66

GM trees are on their way

IN SEPTEMBER 2004, a group of scientists from around the world announced that they had deciphered yet another genome. By and large, the world shrugged and ignored them. The organism in question was neither cuddly and furry, nor edible, nor dangerous, so no one cared. It was, in fact, the black cottonwood, a species of poplar tree, and its was the first arboreal genome to be unravelled. But perhaps the world should have paid attention, because unravelling a genome is a step towards tinkering with it. And that, in the end, could lead to genetically modified forests.

The black cottonwood was given the honour of being first tree because it and its relatives are fast-growing and therefore important in forestry. For some people, though, they do not grow fast enough. As America's Department of Energy, which sponsored and led the cottonwood genome project, puts it, the objective of the research was to provide insights that will lead to "faster growing trees, trees that produce more biomass for conversion to fuels, while also sequestering carbon from the atmosphere." It might also lead to trees with "phytoremediation traits that can be used to clean up hazardous waste sites."

It is also pretty sure to lead to a lot of environmental protest--hence, perhaps, the environmental emphasis of the energy department's mission statement. Given the argument about genetically modified field-crops that has taken place in some parts of the world, genetically modified forests are likely to provoke an incandescent response. Soya, maize, cotton and the like were already heavily modified for human use before biotechnologists got their hands on them. One result is that they do not do very well in the big, bad, competitive world outside the farmer's field. But trees, even the sorts favoured by foresters, are wild organisms. GM trees really might do well against their natural conspecifics.

The wood and the trees

Lofty mission statements aside, the principal commercial goals of arboreal genome research are faster growth and more useful wood. The advantage of the former is obvious: more timber more quickly. More useful wood, in this context, mainly means wood that is more useful to the paper industry, an enormous consumer of trees. In particular, this industry wants to reduce the amount of lignin in the wood it uses. Lignin is one of the structural elements in the walls of the cells of which wood is composed. Paper is made from another of those elements, cellulose. The lignin acts as a glue, binding the cellulose fibres together, so an enormous amount of chemical and mechanical effort has to be expended on removing it. The hope is that trees can be modified to make less lignin, and more cellulose.

In a lucky break, it looks as though it might be possible to achieve both goals simultaneously. A few years ago a group of researchers at Michigan Technological University, led by Vincent Chiang, started the ball rolling. They produced aspens, another species of poplar, that have 45% less lignin and 15% more cellulose than their wild brethren, and grow almost twice as fast, as well. The mixture the team achieved leaves the combined mass of lignin and cellulose in the trunk more or less unchanged and, contrary to the expectations of many critics, the resulting trees are as strong as unmodified ones.

The trick Dr Chiang and his colleagues used was to suppress the activity of one of the genes in the biochemical pathway that trees employ to make lignin. They did this using so-called "antisense" technology.

Antisense technology depends on the fact that the message carried by a gene is encoded in only one of the two strands of the famous DNA double helix. Because of the precise pairing between the components of the two strands, the other strand carries what can, in essence, be described as an "antimessage". The message itself is copied into a single-stranded messenger molecule which carries it to the protein-making parts of the cell, where it is translated. But if this messenger meets a single-stranded "antimessenger" before it arrives, the two will pair up. That silences the messenger. Dr Chiang therefore inserted into his aspens a gene that makes antimessengers to the lignin gene in question.

Wood can be improved in other ways, too. When it comes to papermaking, long fibres of cellulose are preferable to short ones. Thomas Moritz, of the Umea Plant Science Centre in Sweden, and his colleagues, have found out how to make hybrid poplars that reflect this industrial preference. In this case they did it by making a gene work overtime, rather than by suppressing its activity. The gene they chose is involved in the synthesis of a hormone called gibberellin and, once again, a side-effect of the alteration was to cause the trees to grow faster.

How such genetically modified trees would fit in with the natural environment is, of course, an important question--and it is important for two reasons. The first is political. The row about GM crops shows that people have to be persuaded that such technology will have no harmful effects before they will permit its introduction. But there is also a scientific reason. Trees have complex interactions with other species, some of which are necessary for their healthy growth.

Claire Halpin, of Dundee University in Scotland, and her colleagues have been looking into the question of environmental interactions using hybrid poplars that contain antisense versions of two other genes for enzymes involved in the production of lignin. The trees were grown for four years at two sites in France and England, in order to see how they fitted in with the local environment.

The trees and the bugs

The answer seems to be that they fitted in reasonably well. They grew normally and had normal diplomatic relations with the local insects and soil microbes. They also produced high-quality pulp.

A tree's interactions with soil microbes are often beneficial to it (the microbes provide nutrients) so this is an important result. But insects are frequently hostile, and some researchers are looking for ways to protect trees from them. Lynette Grace of Forest Research in Rotorua, New Zealand, for example, has taken an approach based on introducing the gene for Bacillus thuringiensis (Bt) toxin, a natural insecticide. This gene is already used to produce versions of crops such as cotton that do not require the application of synthetic insecticides. Dr Grace and her colleagues adapted it to the radiata pine, which is plagued by the caterpillars of the painted apple moth.

Genetic modifications based on Bt are environmentally controversial. On the one hand, they reduce the amount of pesticide needed. On the other, there is a fear that the gene might "escape" from crops into wild plants that form the foodstuffs of benign insects. In the case of trees it might not even be necessary for the gene to jump species. GM trees, with immunity to insect pests and faster growth rates than their unmodified competitors, might simply spread by the normal processes of natural selection. That really would be survival of the fittest.

An overview of stem cell research

Human Embryonic Stem Cell Research

An Overview By Margaret Doris

“I have made this decision with great care, and I pray it is the right one.”— George W. Bush, August 9, 2001

Many scientists believe that research on human embryonic stem cells, components of human embryos created in laboratories, will eventually yield cures to a number of devastating human conditions including juvenile diabetes, Parkinson’s disease and spinal cord injuries. On August 9, 2001, President George W. Bush announced he would permit federally funded research on existing stem cells lines derived from human embryos. He prohibited the federal funding of research on any cell lines created after that date.

According to Bush, his decision was based on the answers to two questions: “First, are these frozen embryos human life, and therefore, something precious to be protected? And second, if they're going to be destroyed anyway, shouldn't they be used for a greater good, for research that has the potential to save and improve other lives?”

“At its core,” Bush continued, “ this issue forces us to confront fundamental questions about the beginnings of life and the ends of science. It lies at a difficult moral intersection, juxtaposing the need to protect life in all its phases with the prospect of saving and improving life in all its stages.”

Bush defended his decision to limit federal funding to the 60 privately-created cell lines his advisers presumed were already in existence on the grounds that “[t]his allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line, by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life.” For the existing cell lines, Bush said, “the life and death decision has already been made.”

Bush’s announcement culminated years of debate that began in the mid-1960s, when scientists began working with embryonic stem cells in animal models. In 1995, Congress banned federal funding for destructive research using human embryos. Under the Clinton administration, however, federally funded scientists could conduct experiments on stem cell lines as long as they did not themselves participate in embryo destruction. That permission was largely moot, as it was not until the fall of 1998 that the first report of a successful isolation of human embryonic stem cells – done, of necessity, without federal support was published.

Legal, ethical and economic concerns have all been voiced in the debate over the use of human embryonic stem cells, as have religious considerations. The president indicated his own religious beliefs were central in his deliberations. “ My position on these issues is shaped by deeply held beliefs,” he told the American public. “[I] believe human life is a sacred gift from our creator.” However, other than implying that we are absolved from moral responsibility when the “life and death” decision has already been made, the president did not elaborate on his personal theology that shaped public policy. Most significantly, he did not directly address his own question: “Are these frozen embryos human life?”

The president’s reluctance to address this question does not mean that this and related questions are not proper topics for public debate. Among the moral and ethical questions human embryonic stem cell research raises are the following:

* When does a human embryo become a human life?

* If you accept that a human embryo is a “potential” life, whose rights are paramount: those of the potential human being, or those of the existing human beings whose lives might be improved by research on that embryo’s cells?

* Is there any difference between using “unwanted” embryos that might otherwise be discarded, and deliberately creating embryos for research?

* Who “owns” these embryos and their cells?

* Is commodification of human cellular life of theological concern?

* Is there a theological or moral distinction to be made between individually created embryos and cloned embryos?

Human embryonic stem cells cannot sustain themselves indefinitely. Typically, they are grown on and supported by embryonic mouse cells. Theoretically, there is the possibility of transfer of small bits of genetic material, or of cross-species viruses. Does this interaction with and nurturing of human cells by another species have ethical or moral implications?

While researchers are investigating adult stem cells as a less controversial and more readily available source of stem cells, they do not appear to possess the same potential embryonic stem cells do. Unlike an adult stem cell, a human fertilized egg is totipotent, meaning it has the potential to create all the specialized cells that make up a human being, as well as the intrauterine support structure necessary for fetal development. After approximately four days (and several cycles of cell division) the totipotent cells begin to specialize into a blastocyst. The outer layer of cells will go on to form support structures like the placenta. The inner cell mass will become the fetus. These cells are called pluripotent stem cells, because while they can form virtually every type of cell in the human body they cannot give rise to the cells necessary to support fetal development. Until about day 14, the inner cell mass has the potential to split, forming identical twins (in rare instances, the continue to split, forming identical triplets or quadruplets.) Eventually, these cells will diversify into the 220 types of cells necessary to form a complete human being. Scientists believe they can take these cells while they are still pluripotent, and coax them into become whatever type of cell they need. Such a procedure necessitates the destruction of the embryo.

Human embryonic stem cells are typically taken from unwanted embryos that were created in in vitro fertilization (IVF) clinics. It is also possible to deliberately create embryos for research purposes, using the same methods employed by IVF clinics.

Pluripotent stem cells have also been extracted from fetal tissue removed during elective abortions. The cells were retrieved from the areas of the fetus that would have developed into testes or ovaries. Researchers also theorize that it may be possible to clone human embryos, continuing the existence—or continually recreating the existence—of an individual embryonic cell line.

In its 1973 decision legalizing abortion, the U.S. Supreme Court decided embryos and fetuses are not "persons" nor are they entitled to legal protection until late in pregnancy. However, in 1999, the National Bioethics Advisory Commission acknowledged that most Americans believe “human embryos deserve respect as a form of human life.”

Bush would appear to believe that the embryo is, at first, merely possessed of potential. “Research on embryonic stem cells raises profound ethical questions, because extracting the stem cell destroys the embryo, and thus destroys its potential for life,” the president said in his address. “Like a snowflake, each of these embryos is unique, with the unique genetic potential of an individual human being.” However, after making these remarks he backtracks, posing first his unanswered question “are these frozen embryos human life?”, and then claiming human embryos “have at least [emphasis added] the potential for life.”

It is this respect for embryo’s potential, if not actual, human life, that led the president to restrict the federal funding to cell lines derived from embryos created in in vitro fertilization programs, and donated to research without financial inducements. It is morally acceptable to destroy these embryos, the president claims, because they will be “destroyed anyway.”

That is not actually the case. The vast majority of surplus embryos are not slated for deliberate destruction. Occasionally they are donated, as the president acknowledged, and implanted in another woman. Sometimes, usually as the result of a divorce settlement or clinic contract, they are deliberately thawed. But most are maintained indefinitely in a cryogenic limbo, where they may, at worst, be passively deteriorating.

“In recent weeks,” the president told the American public, “we learned that scientists have created human embryos in test tubes solely to experiment on them. This is deeply troubling, and a warning sign that should prompt all of us to think through these issues very carefully.” The president did not elaborate as to why he found this more troubling than the destruction of embryos originally slated for implantation. But by refusing to provide federal funds for the creation of research embryos, the president affords these embryos (or really, potential embryos) greater moral status and protection than those given embryos created in infertility treatment programs.

“Researchers are telling us the next step could be to clone human beings to create individual designer stem cells, essentially to grow another you, to be available in case you need another heart or lung or liver,” Bush said, without explaining how stems cells could create “another you.”

“I strongly oppose human cloning, as do most Americans. We recoil at the idea of growing human beings for spare body parts or creating life for our convenience.”

This opposition is difficult to understand. Cloning, after all, especially at the embryonic stage, is nothing more then twinning. And while the cloning of a developed human being certainly challenges our understanding of each individual as unique before God, embryonic cloning might actually reduce the number of embryos needed to create therapeutic stem cell lines. Scientists believe that embryonic stem cell lines will not be able to be perpetuated indefinitely; over time, each line will experience deterioration. However, if an embryo is cloned—perhaps repeatedly—then multiple identical cell lines can be perpetuated from a single embryo. It is even possible that one day cloning will obviate the need to destroy the original embryo. At present, scientists are able to take one cell from an early embryo and test it for a variety of genetic disorders. If it is disease- free it is allowed to continue its development implanted in a woman’s womb. It is possible that one day scientists may be able to adapt this technology, and allow embryos to “donate” a cell to stem cell research before they are implanted.

It appears that all of the human embryonic stem cell colonies approved for research funding under the Bush guidelines have been grown on top of embryonic mouse cells, known as "feeder" cells. The mouse cells provide an unidentified nutritional or growth factor that helps the human cells to continue to divide. Because they have been in close contact with mouse cells, it is possible either murine DNA or animal viruses have been transferred to the human cells. Under Food and Drug Administration xenotransplantation guidelines designed to minimize the risk of transferring potentially deadly animal viruses to humans, it would be difficult, though not impossible, to use the cells in human clinical trails of potential therapies.

Scientists are working on ways to grow human embryonic cell lines without using mouse cells, but any created after August 9 are ineligible for federal research money.

The potential integration of murine DNA into the human cells raises some interesting theological considerations as well. Scientists have already succeeded in grafting human neuronal cells into mice. What if mouse DNA is integrated into human bodies through the use of these stem cell lines? Does it somehow defile God’s human creation, which God has created in God’s image?

“As a result of private research, more than 60 genetically diverse stem cell lines already exist” according to Bush (Subsequent information suggests that as few as 10 of these lines may be actually useful for research. In addition, most of those are controlled by a University of Wisconsin foundation, which has acquired a patent on the stem cells. The foundation has already granted exclusive rights to develop the stem cells into the six most lucrative types of cells to a biotech company, Geron. In order to obtain access to these stem cells, the federal government must negotiate with the foundation.) “They were created from embryos that have already been destroyed, and they have the ability to regenerate themselves indefinitely, creating ongoing opportunities for research. I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life-and-death decision has already been made.”

Under the Bush plan, federally funded scientists, mostly working out of academic research institutions, would obtain cells derived from embryos destroyed with private money in private labs. These cell lines are controlled by a handful of companies and laboratories around the world, all of who have been busy filing patent applications on various aspects of stem cell technology. Researchers who obtain the cells may well find that the companies will retain potentially lucrative commercial rights to any future discoveries the scientists make.

“Federal dollars help attract the best and brightest scientists,” Bush said. “They ensure new discoveries are widely shared at the largest number of research facilities, and that the research is directed toward the greatest public good.” For some researchers, the federal support is not worth the accompanying federal restrictions. In December 2002, Stanford University announced plans to launch a new Institute of Cancer/Stem Cell Biology and Medicine. Headed by Dr. Irving Weissman, the first researcher to isolate stem cells, the new Institute says it may use private funds to create new human embryonic stem cell lines. Envisioning a day when stem cell research may provide treatment or cures for diseases ranging from juvenile diabetes to Parkinson’s Disease, Weissman asks, “How can someone be so morally superior as to say ‘The blastocyst counts, but the actual people, tough luck’?”

By denying federally funded researchers the right to develop their own cells lines, and by allowing private ownership of the most public of resources, our DNA, the government has made it almost certain that the greatest public good will not be done.

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An example of recycling your own stem cells – Nan’s cousins had this procedure

First Patient to Get Stem Cell Treatment for Crohn's in Remission

By Peggy Peck

WebMD Medical News

Reviewed By Gary Vogin, MD

Aug. 10, 2001 -- Joy Weiss treated herself to a Big Mac for lunch on Friday and then considered whether she should top off the meal with a salad, some fruit, or both. For most 20-somethings, that doesn't sound like an extraordinary lunch choice, but for Weiss it's a miracle meal.

The miracle in this case is a controversial, experimental medical procedure that involves stem cells harvested from a patient's own bone marrow.

Ten weeks ago, Weiss became the first person to undergo the stem cell infusion for treatment of Crohn's disease, a condition in which the body's immune system attacks the patient's digestive tract. On Monday, researchers at Chicago's Northwestern Memorial Hospital completed a second such treatment in another Crohn's patient. The second patient, reportedly a 16-year old male, has requested anonymity, says Richard Burt, MD, lead researcher in the pilot study. Burt says, however, that the second patient is doing well.

For years, Weiss did not know a single day without pain, the gut-wrenching pain caused by Crohn's disease. "Until I was 19 I could never get my weight up above 90 pounds," says the 22-year-old Weiss. Dairy foods, salad, fruit, nuts, fried foods -- all were dietary no-no's for Weiss, who was diagnosed with Crohn's disease when she was 11.

Over the years of treatment for the condition, Weiss suffered through as many as 10 daily attacks of painful diarrhea characterized by watery, bloody stools.

Treating the Crohn's symptoms required the powerful steroid prednisone, which helped quiet the inflammation caused by the disease but also weakened other tissues in her body. Moreover, years of intestinal disease plus steroid therapy impaired her body's ability to absorb calcium, so she has developed osteoporosis, the bone-wasting disease normally associated with old age.

Two years ago, Weiss' doctor began using IV tubes to deliver "night feeds so that I could get some nutrients." Her gastroenterologist recommended her for a colostomy, a procedure in which a large part of the colon is removed and the patient wears an external bag for waste. But after examining her, "my surgeon said that although my body was ready for a colostomy, I wasn't ready psychologically, so he said he would look for other alternatives."

The surgeon turned to the Internet, and there he found an article about Burt's proposal to treat Crohn's disease with an experimental procedure that required a stem cell transplant, using cells harvested from the patient's own bone marrow. This type of transplant is used to treat leukemia and other cancers.

Burt and his co-investigator Robert Craig, MD, had been waiting for about three years for the "right patient for this procedure," says Craig, a professor of medicine at Northwestern University Medical School.

The pilot study in which Weiss was the first patient will eventually include 10 Crohn's patients who have "failed all other accepted therapies," says Burt. Craig tells WebMD the patients not only "will have failed all other therapies, but they also must convince me that they are willing to take the risks associated with stem cell transplant."

Stem cell transplant is an experimental procedure that definitely carries its own risks. First, the cells are harvested from the patient's bone marrow, and then the patient is treated with powerful chemotherapy drugs, which are used to destroy the patient's immune system. After the immune system is destroyed, the patient's stem cells are injected back into the body and the patient is kept in a sterile environment for two weeks so that the "new" immune system can develop. During this time, any infection can pose fatal risks.

Because Crohn's disease is usually not fatal, some researchers are questioning the advisability of treating the disease with such a risky procedure.

In a statement released Thursday, the Crohn's and Colitis Foundation of America said "We are not certain that the benefits of stem cell transplants in Crohn's disease patients outweigh the risks. ... Scientists have yet to determine whether stem cell transplant can initiate a long-term remission in people with Crohn's disease. In addition, the potential benefits of this therapy must be weighed against the risk of infection. While Crohn's patients have an altered immune system, researchers have not yet determined whether Crohn's can be qualified solely as an autoimmune disease. Until those questions are answered through carefully monitored, long-term clinical studies, stem cell transplant in Crohn's disease patients remains an investigational therapy."

Craig tells WebMD, "I agree with the CCFA. Believe me, a patient has to convince me that this is the absolute right thing for him or her." He says that he worries "about the possibility that I will lose a patient to this therapy."

The type of caution expressed by Craig is well placed, says Richard MacDermott, MD, head of gastroenterology and immunology at Albany Medical College in New York. "This is obviously a truly investigational procedure at the very beginning of the investigational ladder. It has a long, long way to go," MacDermott tells WebMD.

"I don't personally know the [rate of sickness and death] associated with stem cell transplant, but it has got to be significant," says MacDermott, who is a trustee of the Crohn's and Colitis Foundation of America.

Burt says the procedure "wasn't done in a cavalier or relaxed manner -- the procedure was approved by the FDA." He says, too, that the chemotherapy used in his stem cell protocol is not as toxic as earlier stem cell transplant experiments. "The only complication that we had was a two-day fever," says Burt, who adds that tests done during that two-day period turned up no evidence of infection.

From her perspective, Weiss says she underwent two cycles of chemotherapy and neither was "as bad as my worst days with Crohn's." She says that she started feeling better "almost right away. All the pain didn't leave but it started getting better right away. This is the first time I have had a Crohn's remission in 11 years."

Weiss spent about two and half months in Chicago undergoing pretreatment screening, treatment, and immediate follow-up. She is expected back in Chicago on Aug. 18 for a follow-up exam and then will return again at six months, nine months, and 12 months for follow-up. After 12 months, "I'll go back every year for five years," says Weiss. Craig says that it will take at least five years to confirm a true remission of disease.

Meanwhile, at her home in Mariaville, Maine, population 500, Weiss is enjoying the "first summer of my life." Always interested in horses, Weiss is anticipating applying to college to study "equine science. I have a mare here and now I am able to go out and walk the mare. It is a miracle."

Some stuff on the ethics of messing with little proto- humans….

Neither Person Nor Property

By Paul Lauritzen

In his testimony before the National Bioethics Advisory Commission on

stem cell research, Gilbert Meilaender urged the commission to be

honest in its recommendations. If you endorse federal funding of stem

cell research, he said, don’t do so by pretending that an unimplanted

embryo is not an embryo. Don’t rely on the sophistry that talks of

“pre-embryos” or “pre-implantation embryos.” Meilaender’s advice to the

commission was wise and points to the difficulty of thinking clearly

about the early embryo when considering the morality of the rapidly

expanding possibilities of embryo research.

From preimplantation genetic diagnosis to stem cell research,

scientific interventions in the reproductive process are forcing us to

consider the nature of the early embryo and to answer the question:

What is the early embryo? Unfortunately, when that question has been

asked in debates about embryo research, the answers have typically been

framed in terms reminiscent of debates about abortion, where the

extreme positions dominate. Either the fetus is a person with a full

set of rights, or it is nothing but a clump of cells with little or no

moral claim on us at all. In short, the embryo is either a person or it

is a kind of property. In my view, when applied to embryo research,

neither extreme is plausible, and to advocate either is in fact morally

irresponsible. If we are to think and speak truthfully about embryo

research, we must repudiate the extremes and find a middle ground.

The Two Extremes

At one end of the spectrum of views on the status of the embryo is the

view that, from conception, the embryo is fully a person with all the rights any person has—most notably the right to life. Although magisterial teaching is not definitive on this point, the common perception and the public posture of Catholic teaching on the status of the embryo accords with this extreme view. We see this, for example, in the Instruction Donum Vitae, issued by the Vatican’s Congregation for the Doctrine of the Faith in 1987, where we read: “The human being is to be respected and treated as a person from the moment of conception; and therefore from the same moment his rights as a person must be recognized, among which in the first place is the inviolable right of every innocent being to life.”

The implication of this view of the fetus for Catholic teaching on abortion has long been clear: abortion is an abominable crime. In Donum Vitae, however, the C.D.F. draws out the implications of this view of the fetus for embryo research as well. “No objective,” the C.D.F. writes, “can in any way justify experimentation on living human embryos or fetuses, whether viable or not, either inside or outside the mother’s womb.” Indeed, this has been the consistent response of the Catholic Church to every new development in reproductive technology that involves manipulating early embryos. Whether the issue is in vitro fertilization (I.V.F.) or embryo freezing, preimplantation genetic diagnosis or embryonic stem cell research, all are wrong—indeed, the suggestion is that all are murderous—because all typically involve the destruction of a living person.

At the other end of the spectrum stands the view that the early embryo

is little more than cellular material, which demands little, if

anything, of us morally. Although such a view of the fetus is rarely

openly admitted, it is, I believe, more pervasive than many liberals

would care to admit. Reductionistic views of the fetus are often found,

for example, in the writings of those whose moral views are shaped by

the law.

Consider the work of the well-known and influential legal scholar John

Robertson. Although Robertson would probably dispute the characterization of his view as the extreme one that embryos are merely biological material, the way he frames his discussion of embryo research and the uses of the embryos that he sanctions indicates that his view is extreme. For Robertson, the real question in the debate about embryo research is whether the reproductive freedom that justifies assisted reproduction also justifies embryo research. Thus, in his book, Children of Choice, Robertson tells us that the fundamental question is this: “Does procreative liberty entitle people to use their reproductive capacity to produce products or material to serve nonreproductive ends?” Once the question is framed in this way, the only real reason to oppose embryo research is that it may involve a kind of symbolic harm to embryos, and this harm will almost always be outweighed by the potential benefits of embryo research. So where the Catholic Church opposes most non-therapeutic embryo research as profoundly wrong, Robertson endorses most forms of embryo research, because for him the loss of embryonic life is profoundly insignificant.

A Problem With the Extremes

What should we make of these extreme views? Although I cannot here develop the detailed arguments that would demonstrate the inadequacy of the two extreme positions, let me note a general problem for both views. I will then conclude with some comments about how we might make progress on this issue. The problem is that for neither position does the rhetoric match the reality of moral practice. If we took seriously, for example, the rhetoric of many pro-life advocates about embryo research, we ought to be in the streets fighting not merely to restrict such research but to shut down every I.V.F. clinic in the country. To describe I.V.F. and embryo research as murdering children, as former

Republican presidential candidate Gary Bauer has done, is implicitly to issue a call for tireless social action to halt the carnage. Yet no such effort has been made to halt I.V.F., nor is there likely to be one; because most people recognize that however morally problematic destroying early embryos is, it is not murder. At the same time, however, the view that the early embryo is merely

cellular material is equally implausible. In recent years, Leon Kass has spoken of the “wisdom of repugnance” in relation to cloning, but over 20 years ago Kass demonstrated this point dramatically in considering the status of the early embryo. If you are inclined to think that the embryo is just so much biological stuff, he said, try to imagine your reaction to the prospect of eating the blastocyst as a kind of human caviar ( Toward a More Natural Science). The revulsion we feel at this prospect should be enough to show us that the embryo, even the earliest embryo, is not nothing. It is life, indeed human life, which deserves respect.

That the rhetoric of those who dismiss the embryo’s status as insignificant does not match their moral practice is suggested by the fact that even so staunch a supporter of procreative liberty as John Robertson does not believe that  anything goes. Although, as we saw, Robertson talks about the creation of “products or material,” and although the chapter in which he uses such language is entitled “Farming the Uterus,” Robertson does not endorse all forms of embryo

research. Indeed, even Robertson’s rhetoric is sometimes curbed, as when he talks about the embryo deserving respect.

An Alternative Approach

If it is a mistake to think of the early embryo either as a person or merely as a clump of cells, how should we think of the embryo? Let me take a suggestion from the legal philosopher Ronald Dworkin. In his book Life’s Dominion, Dworkin has argued that the problem with debates about abortion is that they have mostly been conducted as if the fundamental question is whether the fetus or embryo is a person. Framing the debate in this way inevitably leads to the sort of extreme

positions that we have just noted. Instead of arguing about whether the fetus is a person—a debate that is polarizing precisely because it invites a yes-or-no answer—Dworkin notes that the actions of both camps suggest common ground. “The truth,” Dworkin writes, “is that liberal opinion, like the conservative view, presupposes that human life has intrinsic moral significance, so that it is in principle wrong to terminate a life even when no one’s interests are at stake.”

My suggestion, then, is that we abandon the rhetoric that gives us the choice: either person or property. Instead, let us highlight the awe and reverence that nearly everyone feels at the miracle of life. If the embryo is not a person, it is certainly a developing form of human life and as such deserves respect. It seems to me that Leon Kass got it right all those years ago when he wrote: “In the blastocyst, even in the zygote, we face a mysterious and awesome power, a power governed by an immanent plan that may produce an indisputably and fully human being. It deserves our respect not because it has rights or claims to

sentience but because of what it is, now and prospectively.”

Such a view of the embryo may not seem far removed from Catholic teaching; certainly it is closer to church teaching than the view of someone like John Robertson. Yet to speak of the sanctity of human life, even the absolute obligation of respecting the life of the early embryo, is importantly different from speaking of an absolute obligation not to conduct embryo research. Such a view will not sanction talk of categorical evil or of murder or of killing children when discussing embryo research. Instead, celebrating the wonder that

is human life, from its earliest moments to its last, will lead to a moral presumption against embryo research.  Concretely, this means that the burden of proof rests on those who wish to conduct such research. It also means that we need to develop criteria by which we will determine if the burden has been met.

Articulating and defending appropriate criteria is beyond the scope of this essay. Nevertheless, let me in closing suggest three possible tests. Borrowing from just war theory, we might insist that there be a just cause for any proposed research involving the embryo and that such research be both  proportionate and of last resort. If we were to develop these three conditions carefully, I suspect that we would find that many proposed forms of embryo research fail the test.

Consider, for example, the case of embryonic stem cell research in light of the condition of last resort. In a letter to the National Institutes of Health Office of Science Policy, the general secretary for the N.C.C.B./U.S.C.C., the then Msgr. Dennis Schnurr, pointed out on behalf of the American bishops that the promising work being done on adult stem cells eliminates the need for embryonic stem cell research. “The existence of such startling new alternatives [as adult stem research], which may be much more amenable to clinical use and do not require any destruction of human life,” he wrote, “poses a significant

new issue for ethics and public policy”(www.nccbuscc.org/prolife/issues/bioethic/comments.htm).

Although Bishop Schnurr does not name the issue as that of last resort, his point is surely that advocates of embryonic stem cell research have not demonstrated that embryo research is the only possible avenue to the many promised clinical benefits of stem cell research. Indeed, they have not even tried. Yet, if we are to respect the value of embryonic life, it is not unreasonable to insist that every alternative to embryo research be exhausted before we consider the possibility of destroying even one embryo.

I began my comments by noting Gilbert Meilaender’s insistence that we think and speak truthfully in discussing embryo research. Meilaender also says that if we proceed with stem cell research we should “scrap” any talk of respect for the embryo as inherently deceitful. About this last point I believe Meilaender is mistaken. Although respect for the early embryo will certainly restrict the circumstances under which embryo research may properly be conducted, and although it may preclude research in some—perhaps in many—cases, respecting the embryo is not inherently incompatible with embryo research. Unfortunately, as long as the debate about embryo research is framed in terms of the personhood/property dichotomy, we will make little progress in articulating precisely what respect for the embryo requires of us morally.

Paul Lauritzen is chairperson of the department of religious studies and director of the program in applied ethics at John Carroll University in Cleveland, Ohio

*********************************************************************

And finally a religious view point

Sacred body? Stem cell research and human cloning

Heinrich Bedford-Strohm

Reading the "signs of the times" demands Christians' vivid attention to the public debate. As a consequence of the call to witness the gospel in our times, it also needs passionate participation in this debate. There is hardly an issue these days for which this is more true than that of bioethics.

In this area, the developments are so rapid that the ethical debate has already moved on when the newest textbook is printed. In spring 2000 a professor would tell students about the Human Genom Project (HUGO) and about its ambitious endeavour to decipher the genetic code of humanity by the year 2005. Half a year later his script would have been ready for recycling: on 25 June 2000, the American President Bill Clinton and the two leading researchers gave a press conference in which they announced that the project was nearly completed. The news conference was broadcast worldwide and surrounded by the aura of a historic event. No wonder that theological language was used to underline its importance: "Today we are learning the language in which God created life," said the American president. The church's participation in the debate is virtually forced, when the main actors speak in a vocabulary which contains theological terms such as "God" and "creation".

No one doubts that the issues involved are so fundamental that they touch religious concerns. There is, however, deep disagreement about the conclusions to be drawn. Many scientists share the ethical reservations voiced by religious traditions towards the new technological possibilities. Other leading scientists have explicitly attacked such reservations. The American Nobel Prize winner James Watson explicitly addresses those who believe that all human life is a mirror of God and who attribute, therefore, a sanctity to human life which excludes any human attempt to use it for ends such as medical research. Watson himself affirms that life is not created by God but is the product of an evolutionary process which follows Darwin's principles of natural selection. Religiously motivated laws which, for example, enforce the birth of genetically disabled children, says Watson, create unnecessary suffering for their parents. In the long run--thus the Nobel Prize winner--these religious voices will be isolated and their views will be ignored.

Watson's argument shows that in the current debate on the new possibilities of modern biotechnology there is more at stake than just the pros and contras of a certain scientific method or procedure. It has, in fact, to do with a possible change in ethical culture, questioning the validity of fundamental ethical values which have so far been embedded in a broad societal consensus.

This brings us to the contribution of the churches. In cultures strongly influenced by the Christian tradition, even those who do not share the churches' religious heritage acknowledge their important contributions to the fundamental ethical structure of society. In the debate about questions of modern biotechnology, as in questions concerning the development of the global economy, the churches have a special quality: they are globally organized and share their heritage across national, racial, ethnic and cultural borders. But they are, at the same time, deeply rooted in the local context, living their faith in their local parishes, always feeling connected in faith to people continents away. These qualities make the churches ideal actors in global civil society, and their contributions are especially important in issues which transcend national contexts and which can only be addressed globally.

The ecumenical movement, from its very roots and long before the term "civil society" was used for this activity, has seen participation in global civil society as an integrative part of its call. This was true in regard to questions of genetic engineering at a very early stage.

The ecumenical movement and biotechnology (1)

Already in 1970, the WCC convened scientists from all over the world to discuss the rapid development of science and the ethical implications of it. At the conference on "Technology, Faith and the Future of Man" in Geneva in 1970, the topic of biotechnology was intensively discussed. Science, said German biologist Ernst von Weizsacker, makes more and more progress in tracing the fundamental molecular mechanisms, of our genetic equipment and of our bodily functions, and develops the capacity to intervene: first it copies, then it corrects and, in the end, it constructs. With these words von Weizsacker accurately described what would happen in the decades to come. Since the WCC recognized the urgency of the issue, it initiated a five-year-study-process which resulted in a document published under the title "Genetics and the Quality of Life". The topic was taken up at the large ecumenical conference at the Massachusetts Institute of Technology in Cambridge, USA, in 1979, which devoted one section to the ethical questions related to the biological manipulation of human life. In 1981, the WCC's Sub-Unit on Church and Society established a working group which published a report in 1982 under the title Manipulating Life--Ethical Issues in Genetic Engineering. It took many years, however, until the bio-ethical debate was continued with a major consultation. This led to a document which was officially adopted by the central committee Of the WCC in 1989.

This document is, to this very day, the last official statement of the WCC on questions of biotechnology. It walks a fine line between a fundamental critique of the genetic manipulation of human life and the instrumentalization of early human life on the one hand, and on the other the hope for new possibilities of healing currently incurable diseases and thus the prospect of the alleviation of human suffering. The document mirrors the fact that the ethical discourses in the national contexts of the various member churches are quite different. Nevertheless, there is a common basic understanding of the dangers of misuse of the new scientific possibilities. The WCC calls for a ban on using genetic diagnosis for selecting gender, and warns against using genetics as a basis for discrimination at the work place and in the insurance industry. At the same time, it leaves certain doors open. It calls for a ban of germ line gene therapy "at the present time". Considering the fact that germ line gene therapy means manipulating genes which influence the genetic basis of future generations--and is therefore the basis for designing future human beings--this wording shows that the WCC's critique of genetic manipulation of life in 1989 was rather cautious.

A similar conclusion can be drawn from the statement which the document makes concerning the use of human embryos for research. If we admit, says the document, that the potential of a human embryo to become one or more persons demands our respect, then we are obliged not to experiment with such an embryo at all (or, at least, only if there are grave reasons to do so). Then the document names such reasons: grave genetic diseases, or research to cure lethal illnesses. As a, consequence the WCC advises governments to ban research with human embryos. If there are exceptions then the governments are to define the conditions very clearly.

This brief look at the only elaborated WCC policy document on questions of biotechnology shows that the WCC expresses a clear ethical reservation against modern biotechnology. But it does not absolutely condemn genetic manipulation and the use of embryos for research.

Since 1989, the development in biotechnology has been rapid. Some of the techniques which are at the centre of the current ethical and political debate had not even been discovered then. Therefore, an intense discussion on biotechnology has to be at the very top of the ecumenical agenda. Not only the scientific community, but also the political actors in the global community need to know what the churches have to say on these urgent issues concerning fundamental questions of life. The international ecumenical working group on bio-ethics, which was established in 2001, needs the full institutional support of the WCC in order to reach its conclusions as quickly as possible.

Two of the most burning issues not yet treated in the 1989 document, but which are presently undergoing ethical and political discussion in various countries, will be examined more thoroughly in this article: the use of embryonic stem cells for research and the cloning of human embryos.

Human stem cell research

Human embryonic stem cells have come more and more to be the "objects of desire" for scientists engaged in research in the field of medical genetics. Tremendous hopes are connected with these cells, which can be found in human embryos in their earliest stages of development. Doctors hope to find therapies for diseases such as Parkinson's, Alzheimer's or multiple sclerosis, which have so far been incurable. The idea is that stem cells can be used as a "fire-brigade" in the human body. Where human cells degenerate and therefore lead to such diseases, stem cells could be injected into the body and help rejuvenate it by stimulating the growth of new, healthy cells.

Embryonic stem cells are so interesting for this task because they are not defined in their function. In the early stage of the embryo they are still "pluripotent"--that is, they can still develop into any kind of body tissue, be it brain tissue, heart tissue or kidney tissue. For lay observers, the development of an embryo from a conglomerate of a few cells into a more and more differentiated organism is a miracle. If scientists succeeded in exploiting this miracle by understanding the mechanisms which make embryonic cells develop into different types of tissue, they would have found the key to replacing any kind of defective tissue in the patient's body. New organs could even be grown--a prospect which would revolutionize medicine, since the lack of new organs is a major barrier in helping many patients who have a very short life expectancy.

If these new medical techniques can cure grave diseases, what is the ethical problem? At this stage, embryonic stem cells are not "totipotent" which means that these cells cannot each develop into an embryo any more. The ethical problem lies in the generation of these cells. They grow in the first few days after fertilization in the developing embryo. For researchers to isolate and use these stem cells, the embryo must die. Evidently, if the embryo is seen as a human being from the very beginning of its life, the ethical question arises whether it is legitimate to kill human life in order to gain stem cells, even if the goal is the cure of diseases.

Thus for the ethical assessment of human embryonic stem cell research a fundamental factor is how the early stages of human life are understood. If we look at the different national contexts in Europe, three levels of protection for life at these earliest stages can be identified. A first group of countries forbids any research with embryos and only allows treatments which enhance the prospect of life for the treated embryo. These countries are Ireland, Luxembourg, Austria, Switzerland, Norway, Italy and Germany. A second group of countries allows research with an embryo even if it does not serve this specific embryo; but such research must serve the development of medical methods for protecting embryos in general. That is, it has to serve the future well-being of embryos, for example in the case of artificial insemination. Denmark, France and Sweden are some of the countries that belong to this second group. A third group of countries allows research with embryos without the limitations mentioned above, as long as it occurs within the first 14 days after fertilization: Finland, Greece, Great Britain, the Netherlands and Spain are part of this third group. Given this heterogeneous picture it is not surprising that Europe's 1996 Convention on Human Rights and Biomedicine does not categorically ban research with human embryos.

In the other continents of the world, the situation is hard to classify. In many countries there is no legal rule in this issue at all. In Australia, Israel and the United States, liberal legal standards allow intensive research with embryonic stem cells. The limitation of stem cell research which the American President George Bush advocates and which is presently being debated in the United States only applies to public funding. Research possibilities by privately financed institutions remain untouched. The political process concerning rules on human cloning is still open. The house of representatives has banned all forms of human cloning, while the leading proposal in the senate would allow therapeutic cloning and only ban the implantation of a cloned embryo to create a baby.

In Russia and in China, the information we have does not allow a clear picture, but also implies extended research activities. Recent news, however, suggests that a leading scientist in China, Lu Guangxiu of the Xiangya school of medicine in southern China's Hunan province, has cloned more than 30 human embryos. These embryos are said to have been grown to a 200-cell stage, large enough to harvest embryonic stem cells. Up to now cloned embryos had been grown only to a 6-cell stage. At least five laboratories in China are known to be engaged in the research and all are said to have made great progress, due in part to the lack of any legal barriers.

This brief overview shows that the situation is very different in the various national contexts. This underlines the necessity of a global dialogue on this issue. The ethical questions at stake are clear: Can human life in its first days of existence be considered equally worthy of protection as in later stages? Does the affirmation of human dignity, supported by a broad global consensus, have concrete consequences for the ethical and legal assessment of embryonic stem cell research? Can the good ends for which this research is conducted outweigh the ethical reservation one might have against it? And what is it, exactly, that we call "human dignity"?

These questions are even more urgent if we look at the other issue which is presently at the centre of bio-ethical debate: cloning. Here we must distinguish two types of cloning: While in reproductive cloning it is intended to create an embryo which is actually to be born and to grow up, in therapeutic cloning the cloning technique is used only for the purpose of generating human embryonic stem cells.

Reproductive cloning

The reproductive cloning of human beings has for a long time been a favourite subject of science fiction movies. We now know that it is not science fiction any more, even though no one knows exactly the extent of cloning experiments already going on. The news media regularly reports about efforts of this kind. The Italian doctor Severino Antinori has announced that he has begun the procedure necessary for producing a cloned baby; the same has been reported about the American religious sect "Clone Aid", which expects the "new creation" to arrive through cloning technology. None of these groups or persons have a basis in the professional medical world. But there is also hardly any doubt that they have access to the technology and the knowledge to perform the procedure which could lead to a cloned human being, even though this procedure is still connected with a high risk of failure.

What are we actually talking about when we speak about cloning? The technology at the centre of the debate works like the procedure which Ian Wilmuth, of Edinburgh's Roslin Institute, used to create the famous cloned sheep "Dolly": First you remove the nucleus from an egg, then take a body cell from the person you want to clone and extract the nucleus from it. Then you inject this nucleus into the first egg cell, replacing its original nucleus. Then you stimulate this cell through electric impulses until it starts dividing as an embryo. Since the cell nucleus contains the complete set of genetic information, the developing embryo is genetically identical to the donor of the body cell. In the case of the cloned sheep Dolly, there were hundreds of failures before the procedure worked and experts say that in the case of human beings the medical risks, and the probability of "misfits", are even higher, Ian Wilmuth himself has become one of those who warn most fervently against transferring the technology which he used for animals to human beings. However, since the technology exists, one has to deal with the possibility of its use and further development for application to human beings.

Most people have an intuitive reaction against such efforts to clone human beings. But what is the ethical basis of such a reaction? Genetically speaking, cloned human beings are the same as identical twins. The intuitive reaction against cloning is, nevertheless, very appropriate because there is one major difference between identical twins and cloned human beings: while twins have come into existence as genetically identical human beings by coincidence or--from a religious standpoint, by the will of God --cloned human beings are produced by other human beings according to the latter's own personal will. Thus cloning violates the dignity of the human person because a cloned person is not an end in itself, but in its genetic design is completely predetermined (and therefore instrumentalized) by somebody else. Horrific visions of an army of genetically optimized cloned human beings, as we know them from films, are only the tip of the iceberg of the possible uses of the cloning technology. The more immediately probable uses might be, for example, desperate parents who loose a child and try to regain this child through cloning technology.

News of ongoing efforts to clone human beings has alarmed the churches worldwide. The Society, Religion and Technology Project of the Church of Scotland--to name just one institution--has been in the forefront of ethical debate on cloning since Dolly hit the headlines in 1997. Its director, Donald Bruce, has been in dialogue with the Roslin scientists since 1994. Thanks to this intensive dialogue and discussion process the Church of Scotland, in its statement in 1997, was among the first bodies in the world to call for legislation to ban human reproductive cloning. It has also consistently stressed the immense dangers of applying to human beings a procedure which has caused so many problems in animals.

Meanwhile, credible efforts to clone human beings have also alarmed governments and led to a diplomatic initiative, started by Germany and France, to achieve a legally binding international ban on human reproductive cloning. It has already generated a resolution of the United Nations general assembly (no. 56/93) which was cosponsored by fifty delegations from all regions and was adopted unanimously, laying the ground for a negotiating process. The goal is to achieve a legally binding convention before the end of the year 2003.

   Binding universal norms [said Christian Much, Germany's representative, in

   his statement at the UN on 26 February 2002] are an effective tool to

   combat serious threats to human dignity ... Reproductive cloning of human

   beings poses a threat to human dignity. We think that only an international

   binding global norm, with its legal and moral power, is the appropriate

   answer. It will enable us to prevent dishonest competition among

   researchers and research institutions in the field of reproductive cloning.

His statement led to a call to action: "We must win the race against those who want to perform reproductive cloning of human beings and we can win it."

But while the consensus on the ethical questionability of human reproductive cloning is wide, the other way of using the cloning technology is not unanimously rejected by the international community, and not even by the worldwide church community.

Therapeutic cloning

The immediate cause for a wide international discussion on therapeutic cloning was a decision of the British parliament. On 19 December 2000, the House of Commons, after an intense and emotional debate, passed a law which, for the first time anywhere, allowed the cloning of human beings for the purpose of gaining human embryonic stem cells. As we have noted, the decisive difference between therapeutic cloning and reproductive cloning is the fact that the former never intends to lead to the birth of a cloned human being. Rather, therapeutic cloning promises to remedy one big disadvantage of the human embryonic stem cell technique. As with any organ transplantation, the injection of stem cells in a patient's body in order to restore his or her healthy cell growth runs a certain risk: since the genetic code of the injected stem cells is not identical with the patient's genetic code, the injection of these cells can lead to an anti-immune reaction by the patient. Knowing that this problem is the main risk in organ transplantation and that it requires the use of strong medication in order to stop the rejection of the new organ by the patient's body, one can understand why the prospect of overcoming this risk is so tempting. This is exactly what the technique of therapeutic cloning should be able to do, once it is sufficiently developed.

By analogy with the reproductive cloning technique, the cell nucleus of a patient's cell is injected into an egg cell whose nucleus has been removed. The embryo which begins to grow after electric stimulation therefore contains the patient's genetic code. After a few days the embryo produces stem cells which also carry that identical genetic code, and therefore no anti-immune reaction will occur.

The potential of this technique is obvious. It could be used not only for the injection of stem cells into, for example, a damaged brain; it also could lead to the production of organs to replace damaged ones, with no risk of anti-immune reactions. No wonder that experts see a multi-billion-dollar market in the future use of this technique.

However, medical scientists have emphasized that the medical prospects of therapeutic cloning are quite unclear, and may be realizable only in 20-30 years. Others have pointed towards a serious problem in its practical application for many patients: as we have seen, female egg cells are needed for the cloning technique. If only 10 percent of Germany's Parkinson patients were treated with this technique, 25,000 human clones would be necessary. As the experience with the cloning of animals has shown, hundreds of egg cells are necessary to produce just one clone. Thus, millions of female egg cells would be necessary to treat just a small portion of all patients who would be eligible for this therapy. It does not require much imagination to see how unrealistic this is. A look at the internet homepages of North American reproduction clinics shows that prices for donated egg cells range between 6000 and 17,000 dollars. But more important than the financial limitations is the troubling prospect of women being humiliated as mass donors of egg cells.

Scientists look therefore for alternatives to therapeutic cloning, but also to embryonic stem cell therapy in general. The most promising path towards alternatives which are ethically less problematic is the exploration of the potential of "adult stem cells". Adult stem cells exist in adult organisms only in small numbers. They are also less promising in their potential development than embryonic stem cells. But, in principle, they can be used for the same therapeutic purposes without carrying the ethical burden of existing only at the expense of a sacrificed embryo. However, if what leading medical scientists say is true, it cannot be denied that work with embryonic stem cells would lead to practicable therapies more quickly than comparable work with adult stem cells.

The ethical dilemma concerning both embryonic stem cell research and the related technique of therapeutic cloning is, therefore, not resolved simply by pointing towards possible alternatives. If, by stopping a certain line of research, suffering patients must wait longer for a cure or run a greater risk of never being cured, there have to be good ethical reasons for that.

Ethical reflection

Most Christian churches oppose research with embryos because they see the dignity of the human person violated when embryos are sacrificed for reasons outside themselves, as good as those reasons might be. If there are thoughts of liberalizing this ethical opposition, they relate to embryos which are "left over" from artificial insemination procedures and do not have in any case a realistic prospect of being born from a mother. The production of embryos with the goal of then sacrificing them in order to gain stem cells, as is the case with therapeutic cloning, is almost unanimously opposed.

There is one church in Europe, however, which takes a different stand on this issue. The Church of Scotland, which we have already mentioned for its clear condemnation of reproductive cloning, issued a statement at its 2001 general assembly in which it opposed the use of embryos from artificial insemination procedures for any other purpose than for human reproduction research, but declared "that human embryos created by cell nuclear transfer [that is to say, for therapeutic cloning] may be used in medical research and therapy, subject to the 14-day limit".

Insofar as God--argued the Scottish church--created human embryos for the end of human reproduction, such embryos, within the 14-day period, should only be used for research serving human reproduction. But since embryos created by therapeutic cloning have never served the end of reproduction, they can be used for medical research and the production of embryonic stem cells.

This controversial position makes it all the more necessary to look more thoroughly at the ethical questions which underlie the debate on the application of biotechnological possibilities.

The fundamental importance of human dignity

It has often been affirmed that it is pointless to invoke the principle of human dignity in the bio-ethical debate because this principle is as uncontroversial as it is empty. There are, however, good reasons to disagree with this assessment. This becomes clear if we look at the German philosopher Immanuel Kant's classical definition of human dignity: reasonable beings all have the obligation to see and treat each other never only as a means to another end, but always as an end in itself. If human life at its beginning is seen as subject to the principle of human dignity, then it is hard not to see the tension between this ethical principle and the practice of embryonic stem cell research or, even more so, of therapeutic cloning. To gain human embryonic stem cells, the embryo has to be sacrificed. It has to die for the good end of developing therapies for people who otherwise have to suffer--but it is still not being treated as an end in itself, but as a means to another end. This is even more true for therapeutic cloning, where embryos are called into existence for no other reason than to be sacrificed for other ends. The argument of the Scottish church is not convincing, because the fact that human life has been called into existence by human action solely for the purpose of generating stem cells does not justify depriving this life of its God-given dignity.

The closeness of Kant's philosophical argument to biblical thinking has often been shown. The biblical option for the poor, as well as the golden rule (Matt. 17:12) and the "love commandment" (John 13:34), can be understood as ethical barriers against the reduction of human beings to an instrument for someone else's ends. There is a distinctively theological argument which can further develop what is meant by the dignity of the human person. From a theological standpoint, this dignity is not based on the nature of humans as reasonable beings, as in Kant's thinking, but it is rooted in the relationship which God establishes with the human being. The biblical affirmation that humans are created in the image of God has often been understood as something which humans have to prove themselves "worthy" of. Sin was then understood, by some, as destroying the status of human beings as beings created in the image of God. This is why it is so important to affirm the emphasis of the New Testament on the unconditional acceptance of the sinner by God. The love of God, as Jesus describes it in the parable of the prodigal son, reaches beyond the empirical "worthiness" of God's creatures. Neither moral merit, nor physical ability, are the basis of God's relationship to human beings, but exclusively God's own love and joy in the face of life. Thus it is God who makes human beings an end in themselves and if human beings take the right to decide about the worthiness of human life, then they forget that life receives its dignity from God.

This argument also has consequences for the other ethical question that is at stake in the bio-ethical debate: What is the status of human life in its earliest beginnings?

The status of early human life

The landscape of the ethical discussion on this issue can be described in terms of five positions.

The weakest position has been publicly discussed in connection with the theses of the Australian ethicist Peter Singer, now teaching at Princeton University. This position links the full protection of life, and its personal status, to the empirical existence of certain characteristics such as sensitivity to rationality, consciousness and self-esteem. For Singer human beings deserve this protection only a few weeks after birth. The second position sees the act of birth as constitutive for the attribute of human dignity and its protection. A third position is based on the high estimation of reason and wants to protect fully human life beginning with the fifth week after fertilization, when the brain starts to develop in the embryo. A fourth position affirms the 14-day period which we have already mentioned. This is based on the fact that until the end of this period there is a possibility that the embryo will divide into twins, and therefore the individuality of the embryo is seen as beginning only after this period. (The other reason given for the 14-day period is the nidation of the embryo in the womb of the mother which takes place within this period.) Finally, the fifth and strongest position affirms that the embryo is a human being from the very beginning, and therefore also deserves full protection from the moment of fertilization of the egg cell on. This position is not only affirmed in many church statements. It has also entered legal codices such as the German embryo protection law.

This fifth position might trouble women who are involved in the discussion on the issue of abortion, and are rightly suspicious of any ethical views which ignore the conflicts faced by women in this question. And, indeed, the bio-ethics discussion touches many questions which are also discussed in dealing with the issue of abortion. Nevertheless, there are also clear differences. While in the issue of abortion issue we are dealing with a conflict within the body of a woman, in the biotechnology debate we are talking about methods which objectify human life and therefore pose the danger of leaving such human life without any protection. Therefore it actually makes sense to establish especially strict standards for human life in laboratories, while refusing the temptation to draw any direct conclusions for the debate on abortion.

With this proviso in mind, there are good reasons to see the fifth position as the one which is ethically most convincing. The first reason for this assessment has gained plausibility especially through the knowledge developed through genetic research in recent decades. We know today that with fertilization, all the genetic information which is the biological basis of the development of a human person is existant. Nothing is added later on, no matter whether the embryo divides into twins or not, his or her developing body exists from the beginning without limitation. Therefore it is appropriate to say: the embryo does not develop into a human being, but develops as a human being.

The second reason for the validity of the fifth position is a consequence of the theological reflexion in which we have engaged. If human dignity is something which cannot be rooted in any empirical characteristic of a human being, but is something attributed to a human being through a relationship established by God, then this cannot be without consequences for the status of early human life. It means that human dignity cannot be based on reaching a certain state of biological development, be it the exclusion of development as twins, or the development of a brain, or the beginning of consciousness.

Therefore in deciding when human life is worthy of protection, the only approach which is not arbitrary is to take fertilization at the point in time at which the new human being comes into existence. We have seen that there are also theological reasons which must not to be neglected and which lead to this conclusion.

Accepting the finiteness of human existence

Our ethical reflection on human embryonic stem cell research and therapeutic cloning leads to the conclusion that these new techniques are in conflict with ethical norms, because they use early human life as a means to achieve an external end. This conclusion does not deny the good ethical reasons which can be named in favour of such techniques. Certainly there can be no doubt about the high ethical value that medical efforts to alleviate human suffering enjoy. Indeed, in the biblical tradition, human beings are never simply called to accept passively their fate, but rather to shape it with the abilities which God has given them.

This vocation of human beings as shapers of their existence, however, becomes destructive if they neglect the ethical "points of orientation" which God has also given them. The story of the tower of Babel is the best example of this danger. The affirmation of human dignity has come to be a widely accepted point of ethical orientation, serving as a barrier against the all-too destructive human desire for power. This ethical perspective received many of its impulses from the Judeo-Christian tradition. Therefore it is more than appropriate if the Christian churches watch carefully how culture deals with ethics, and lift up their voices whenever they see human life treated as a goods in a medical and technological market, rather than as an end in and of itself.

The temptation to overcome human finiteness by any available means seems to have accompanied humanity from the very beginning. The biblical creation story describes Adam and Eve neglecting the prohibition of eating from the tree of the knowledge of good and evil. There is a second tree in this story: the tree of life. It is often overlooked that the tree of life is the reason why God drives Adam and Eve out of the garden Eden and places the cherubim at its entrance:

   Then the LORD God said, "See, the man has become like one of us, knowing

   good and evil; and now, he might reach out his hand and take also from the

   tree of life, and eat, and live forever." Therefore the LORD God sent him

   forth from the garden of Eden, to till the ground from which he was taken.

   He drove out the man; and at the east of the garden of Eden he placed the

   cherubim, and a sword flaming and turning to guard the way to the tree of

   life (Gen. 3:22f.).