Forum Bioethik |
Human Genetics Alert 8 July 2003 Contents 1. EU to Adopt Stem Cell Research Rules This Week 2. Science Friction: The growing--and dangerous--divide between scientists and the GOP. 3. The Independent Focus Part One: The science - Babymakers 4. The Independent Focus Part Two: The couple - Kylie wanted a baby. The clinic wanted eggs. They made a deal. If only life were so simple... 5. The Independent Focus Part Three: The debate - 'The lack of regulation really shocked me' Shelley Jofre says existing rules deny patients the protection they deserve 1. EU to Adopt Stem Cell Research Rules This Week 7 July, 2003 http://story.news.yahoo.com/news?tmpl=story&u=/nm/20030707/sc_nm/science_eu_ stemcells_dc_1 BRUSSELS (Reuters) - The European Commission (news - web sites) will adopt new guidelines this week regulating the use of embryos in EU-funded research in a move aimed at heading off a ban on the controversial technology, an EU spokesman said Monday. Since the start of the year, no European Union funds have been given to scientists involved in creating embryos to carry out stem cell research. "The research moratorium finishes at the end of 2003 and we want to have comprehensive guidelines in place," said European Commission Research spokesman, Fabio Fabbi. The EU executive is expected to adopt the proposal on Wednesday but it needs the approval of member states and the European Parliament to become law. This is expected for the end of the year, Fabbi said. Scientists say the research could yield cures for diabetes, Alzheimer's and Parkinson's disease. But opponents argue that the scientists are "playing God" and that the new technology will end in designer babies and human cloning. Stem cells are the master cells of the body, able to grow into other types of cells. One way of obtaining them is by therapeutic cloning -- creating embryos which can be mined for their stem cells. "The idea is not to encourage the creation of new embryos but the use of ones already existing," Fabbi said. When couples undergo fertility treatment, extra embryos are created to aid chances of pregnancy. The left-over embryos are either destroyed or frozen. The EU executive wants to encourage the use of such stored embryos rather than the creation of new ones. The current EU research budget is worth 17.5 billion euros but only a few million euros is spent on stem cell research, Fabbi said. ********************************************************************* 2. Science Friction: The growing--and dangerous--divide between scientists and the GOP. July 2003 http://www.washingtonmonthly.com/features/2003/0307.thompson.html By Nicholas Thompson Not long ago, President Bush asked a federal agency for evidence to support a course of action that many believe he had already chosen to take on a matter of grave national importance that had divided the country. When the government experts didn't provide the information the president was looking for, the White House sent them back to hunt for more. The agency returned with additional raw and highly qualified information, which the president ran with, announcing his historic decision on national television. Yet the evidence soon turned out to be illusory, and the entire policy was called into question. Weapons of mass destruction in Iraq, you say? Actually, the above scenario describes Bush's decision-making process on the issue of stem cell research. In August 2001, Bush was trying to resolve an issue he called "one of the most profound of our time." Biologists had discovered the potential of human embryonic stem cells--unspecialized cells that researchers can, in theory, induce to develop into virtually any type of human tissue. Medical researchers marveled at the possibility of producing treatments for medical conditions such as Parkinson's, Alzheimer's, and spinal cord injuries; religious conservatives quivered at the fact that these cells are derived from human embryos, either created in a laboratory or discarded from fertility clinics. Weighing those concerns, Bush announced that he would allow federal funding for research on 60-plus stem cell lines already taken from embryos, but that he would prohibit federal funding for research on new lines. Within days, basic inquiries from reporters revealed that there were far fewer than 60 viable lines. The National Institutes of Health (NIH) has so far confirmed only 11 available lines. What's more, most of the existing stem cell lines had been nurtured in a growth fluid containing mouse tumor cells, making the stem cells prone to carrying infections that could highly complicate human trials. Research was already underway in the summer of 2001 to find an alternative to the mouse feeder cells--research that has since proven successful. But because these newer clean lines were developed after Bush's decision, researchers using them are ineligible for federal funding. At the time of Bush's announcement, most scientists working in the field knew that although 60 lines might exist in some form somewhere, the number of robust and usable lines was much lower. Indeed, the NIH had published a report in July 2001 that explained the potential problems caused by the mouse feeder cells and estimated the total number of available lines at 30. Because that initial figure wasn't enough for the administration, according to Time magazine, Health and Human Services Secretary Tommy Thompson asked the NIH to see if more lines "might conceivably exist." When NIH representatives met with Bush a week before his speech with an estimate of 60 lines scattered around the world in unknown condition, the White House thought it had what it wanted. In his announcement, Bush proclaimed, without qualification, that there were "more than 60 genetically diverse stem cell lines." After his speech, then-White House Counselor Karen Hughes said, "This is an issue that I think almost everyone who works at the White House, the president asked them their opinion at some point or another." However, Bush didn't seek the advice of Rosina Bierbaum, then-director of the White House's Office of Science and Technology Policy (OSTP). Hughes claimed that Bush had consulted other top federal scientists, including former NIH director Harold Varmus. That was partly true, but the conversation with Varmus, for example, took place during a few informal minutes at a Yale graduation ceremony. Later press reports made much of Bush's conversations with bioethicists Leon Kass and Daniel Callahan. Yet neither is a practicing scientist, and both were widely known to oppose stem-cell research. Evan Snyder, director of the stem-cell program at the Burnham Institute in La Jolla, Calif., says, "I don't think science entered into Bush's decision at all." The administration's stem-cell stand is just one of many examples, from climate change to abstinence-only sex-education programs, in which the White House has made policies that defy widely accepted scientific opinion. Why this administration feels unbound by the consensus of academic scientists can be gleaned, in part, from a telling anecdote in Nicholas Lemann's recent New Yorker profile of Karl Rove. When asked by Lemann to define a Democrat, Bush's chief political strategist replied, "Somebody with a doctorate." Lemann noted, "This he said with perhaps the suggestion of a smirk." Fundamentally, much of today's GOP, like Rove, seems to smirkingly equate academics, including scientists, with liberals. In this regard, the White House is not necessarily wrong. Most scientists today do lean Democratic, just as most of the uniformed military votes Republican--much to the annoyance of Democrats. And like the latter cultural divide, the former can cause the country real problems. The mutual incomprehension and distrust between the Pentagon and the Clinton White House, especially in its early years, led to such debacles as Somalia and the clash over allowing gays to serve openly in the military. The Bush administration's dismissiveness toward scientists could also have serious consequences, from delaying vital new medical therapies to eroding America's general lead in science. The Clinton administration quickly felt the sting of the military's hostility and worked to repair the relationship. It's not clear, however, that the Bush administration cares to reach out to scientists--or even knows it has a problem. Mad Scientists The GOP has not always been the anti-science party. Republican Abraham Lincoln created the National Academy of Sciences in 1863. William McKinley, a president much admired by Karl Rove, won two presidential victories over the creationist Democrat William Jennings Bryan, and supported the creation of the Bureau of Standards, forerunner of today's National Institutes of Science and Technology. Perhaps the most pro-science president of the last century was Republican Dwight D. Eisenhower, a former West Point mathematics and engineering student, and later president of Columbia University. Eisenhower established the post of White House science adviser, allowed top researchers to wander in and out of the West Wing, and oversaw such critical scientific advances as the development of the U2 spy plane and federally funded programs to put more science teachers in public schools. At one point, he even said that he wanted to foster an attitude in America toward science that paralleled the country's embrace of competitive sports. Scientists returned the affection, leaning slightly in favor of the GOP in the 1960 election. The split between the GOP and the scientific community began during the administration of Richard Nixon. In the late 1960s and early 1970s, protests against the Vietnam War captured the sympathy of the liberal academic community, including many scientists, whose opposition to the war turned them against Nixon. The president characteristically lashed back and, in 1973, abolished the entire White House science advisory team by executive order, fuming that they were all Democrats. Later, he was caught ranting on one of his tapes about a push, led by his science adviser, to spend more money on scientific research in the crucial electoral state of California. Nixon complained, "Their only argument is that we're going to lose the support of the scientific community. We will never have their support." The GOP further alienated scientists with its "Southern strategy," an effort to broaden the party's appeal to white conservative Southerners. Many scientists were turned off by the increasing evangelical slant of Republicans and what many saw as coded appeals to white racists. Scientists also tended to agree with Democrats' increasingly pro-environmental and consumer-protection stances, movements which both originated in academia. Gradually, as John Judis and Ruy Teixeira show in their recent book The Emerging Democratic Majority, professionals, the group of highly skilled workers that includes scientists, moved from the Republican camp to the Democratic. Yet that transition took a while, in large part because most professionals were still fiscally conservative, few sided with pro-union Democrats, and the Republican Party had not yet been overtaken by its more socially conservative factions. In the mid 1970s, for example, Republican President Gerald Ford showed a moderate streak while in the White House and reinstated the Office of Science and Technology Policy. Ronald Reagan oversaw a widening gulf between the Republican Party and academic scientists. During the 1980 campaign, he refused to endorse evolution, a touchstone issue among scientists, saying, "Well, [evolution] is a theory--it is a scientific theory only, and it has in recent years been challenged in the world of science and is not yet believed in the scientific community to be as infallible as it was once believed." Though he aggressively funded research for military development, he alienated many in academia with his rush to build a missile defense system that most scientists thought unworkable. George H.W. Bush tried to walk the tightrope. He pushed the Human Genome Project forward and elevated the position of chief science adviser from a special assistant to assistant. Yet he served during an acrimonious public debate about global warming, an issue that drove a wedge between academic scientists and the interests of the oil and gas industry--an increasingly powerful ally of the GOP. He generally sided with the oil industry and dismissed environmentalists' appeals for the most costly reforms. Yet he also tried to appease moderates by signing the landmark Framework Convention on Climate Change in Rio de Janeiro and helping pass the Clean Air Act, which aimed to reduce smog and acid rain. In the end, his compromising did him little good; environmentalists attacked him, and his rapprochement with liberal academic elites won him few friends with social conservatives. Bush faced a surprisingly tough primary challenge from Pat Buchanan in the 1992 election campaign, saw his support among evangelicals in the general election decline compared with 1988, and lost to the Democratic underdog Bill Clinton. Newt Gingrich didn't make the same mistakes. When he became the House Speaker in 1995, Gingrich worked vigorously to cut budgets in areas with Democratic constituents--and he knew that by the time he came to office most scientists were supporting Democrats. The speaker took aim at research organizations such as the U.S. Geological Survey and National Biological Survey and dismissed action on global warming. He even abolished the Congressional Office of Technology Assessment, which served as the main scientific research arm of Capitol Hill. Gingrich claimed that OTA was too slow to keep up with congressional debates; agency defenders argued that the cut was fueled by partisan dislike of an agency perceived as a Democratic stronghold. Indeed, several years prior, OTA had published a report harshly critical of the predominantly GOP-backed missile defense project, the Strategic Defense Initiative. By the mid 1990s, the GOP had firmly adopted a new paradigm for dismissing scientists as liberals. Gingrich believed, as Nixon did, that most scientists weren't going to support him politically. "Scientists tend to have an agenda, and it tends to be a liberal political agenda," explains Gingrich's close associate former Rep. Robert Walker (R-Pa.), the former chairman of the House Science Committee. In 1995, Rep. Dana Rohrabacher (R-Calif.), then-chairman of the House committee dealing with global warming, called climate change a "liberal claptrap." In interviews with The Washington Post in 2001, Texas Republican Tom DeLay dismissed evolution as unproven, said that we shouldn't need an EPA because "God charges us to be good stewards of the Earth," and denigrated scientific Nobel Prize winners as "liberal and extremist." Ph.D. Phobia George W. Bush embodies the modern GOP's attitude toward science. He hails from a segment of the energy industry that, when it comes to global warming, considers science an obstacle to growth. He is strongly partisan, deeply religious, and also tied to evangelical supporters. And, like Reagan, he has refused to endorse the scientific principle of evolution. During the 2000 campaign, a New York Times reporter asked whether he believed in evolution. Bush equivocated, leading the Times to write that he "believes the jury is still out." Bush has also learned from his father's experience that siding with scientists gains him little politically, and often alienates conservatives. Bush and Rove have tried to woo portions of other groups that traditionally trend Democratic--steel tariffs for unions, faith-based grants for African-American ministers--but scientists are different. They aren't a big voting bloc. They are generally affluent, but not enough so to be major donors. They are capable of organizing under the auspices of a university to lobby for specific grants, but they aren't organized politically in a general way. In short, scientists aren't likely to cause the GOP problems if they are completely alienated. Scientists have almost never turned themselves into anything like a political force. Even Al Gore, the apotheosis of many scientists' political hopes, received little formal support from them during the 2000 campaign. Consequently, the White House seems to have pushed scientific concerns down toward the bottom of its list of priorities. Bush, for instance, has half as many Ph.D.s in his cabinet as Clinton had two years into his term. Among the White House inner circle, Condoleezza Rice's doctorate distinguishes her as much as her race and more than her sex. Consider also the length of time the administration left top scientific positions vacant. It took 20 months to choose an FDA director, 14 months to choose an NIH director, and seven months to choose a White House science adviser for the Office of Science and Technology Policy. Once Bush had appointed a head of OSTP, he demoted the rank of the position, moved the office out of the White House, and cut the number of associate directors from four to two. An OSTP spokeswoman argues that the administration's decision to move OSTP was inconsequential and that reducing the number of associate directors was just a way of "reducing the stovepipes." But geography and staff equal clout in Washington, and unarguably signal how much the people in power care about what you do. Moreover, Bush appointed to one of the two associate director positions Richard Russell, a Hill aide credentialed with only a bachelor's degree in biology, and let him interview candidates for the job of director. "It bothers me deeply [that he was given that spot], because I don't think that he is entirely qualified," says Allen Bromley, George H. W. Bush's science adviser, who worked for some of his tenure out of prime real estate in the West Wing of the White House. "To my astonishment, he ended up interviewing some of the very senior candidates, and he did not do well. The people he interviewed were not impressed." Cynical Trials When required to seek input from scientists, the administration tends to actively recruit those few who will bolster the positions it already knows it wants to support, even if that means defying scientific consensus. As with Bush's inquiry into stem-cell research, when preparing important policy decisions, the White House wants scientists to give them validation, not grief. The administration has stacked hitherto apolitical scientific advisory committees, and even an ergonomics study section, which is just a research group and has no policy making role. Ergonomics became a politicized issue early in Bush's term when he overturned a Clinton-era rule requiring companies to do more to protect workers from carpal tunnel syndrome and other similar injuries. Late last year, the Department of Health and Human Services rejected, without explanation, three nominees for the Safety and Occupational Health Study Section who had already been approved by Dana Loomis, the group's chair, but who also weren't clearly aligned with the administration's position on ergonomics. Loomis then wrote a letter saying that "The Secretary's office declined to give reasons for its decision, but they seem ominously clear in at least one case: one of the rejected nominees is an expert in ergonomics who has publicly supported a workplace ergonomics standard." Another nominee, who was accepted, said that she had been called by an HHS official who wanted to know her views on ergonomics before allowing her on the panel. The administration has further used these committees as places for religious conservatives whose political credentials are stronger than their research ones. For example, on Christmas Eve 2002, Bush appointed David Hager--a highly controversial doctor who has written that women should use prayer to reduce the symptoms of PMS--to the FDA's Reproductive Health Drugs Advisory Commission. Bush has also taken to unprecedented levels the political vetting of nominees for advisory committees. When William Miller, a professor of psychology at the University of New Mexico, was considered as a candidate for a panel on the National Institute of Drug Abuse, he was asked his views on abortion, the death penalty, and whether he had voted for Bush. He said no to the last question and never received a call back. "Not only does the Bush administration scorn science; it is subjecting appointments to scientific advisory committees and even study sections to political tests," says Donald Kennedy, editor in chief of Science, the community's flagship publication. Control Group Politics Any administration will be tempted to trumpet the conclusions of science when they justify actions that are advantageous politically, and to ignore them when they don't. Democrats, for instance, are more than happy to tout the scientific consensus that human activity contributes to climate change, but play down evidence that drilling in the Arctic National Wildlife Refuge (which they oppose) probably will have little impact on the caribou there. But Democrats will only go so far down the path of ignoring scientific evidence because they don't want to alienate their scientific supporters. Increasingly, the Republicans feel little such restraint. Hence the Bush administration's propensity to tout scientific evidence only when it suits them politically. For instance, though numerous studies have shown the educational benefits of after-school programs, the Bush administration cited just one recent report casting doubt on those benefits to justify cutting federal after-school funding. Meanwhile, the White House has greatly increased the federal budget for abstinence-only sex education programs despite a notable lack of evidence that they work to reduce teen pregnancy. The administration vigorously applies cost-benefit analysis--some of it rigorous and reasonable--to reduce federal regulations on industry. But when the National Academy of Sciences concluded that humans are contributing to a planetary warming and that we face substantial future risks, the White House initially misled the public about the report and then dramatically downplayed it. Even now, curious reporters asking the White House about climate change are sent to a small, and quickly diminishing, group of scientists who still doubt the causes of global warming. Many scientists were shocked that the administration had even ordered the report, a follow-up to a major report from the 2,500-scientist Intergovernmental Panel on Climate Change, the world's leading climate research committee. Doing that was like asking a district court to review a Supreme Court decision. Experts in Exile This White House's disinclination to engage the scientific community in important policy decisions may have serious consequences for the country. One crucial issue that Congress and the Bush administration will likely have to confront before Bush leaves office is human cloning. Researchers distinguish between "reproductive cloning," which most scientists abhor, and "therapeutic cloning," which may someday allow researchers to use stem cells from a patient's cloned embryo to grow replacement bone marrow, liver cells, or other organs, and which most scientists favor. When the President's Council on Bioethics voted on recommendations for the president, every single practicing scientist voted for moving therapeutic cloning forward. Bush, however, decided differently, supporting instead a bill sponsored by Sen. Sam Brownback (R-Kan.) to ban all forms of embryonic cloning. John Marburger, the president's current scientific adviser--a longtime Democrat who says that he has good relations with Bush and is proud of the administration's science record--wrote in an email statement which barely conceals his own opinion: "As for my views on cloning, let me put it this way. The president's position--which is to ban all cloning--was made for a number of ethical reasons, and I do know that he had the best, most up-to-date science before him when he made that decision." Jack Gibbons, a former head of the Congressional Office of Technology Assessment, calls Bush's proposed ban "an attempt to throttle science, not to govern technology." Harold Varmus, the former NIH director, believes that "this is the first time that the [federal] government has ever tried to criminalize science." Another potentially costly decision is the Bush administration's post-September 11 restrictions on the ability of foreign scientists to immigrate to the United States--restrictions which many scientists argue go far beyond reasonable precautions to keep out terrorists. In December 2002, the National Academy of Science, the National Academy of Engineering, and the Institute of Medicine issued a statement complaining that "recent efforts by our government to constrain the flow of international visitors in the name of national security are having serious unintended consequences for American science, engineering and medicine." Indeed, MIT recently abandoned a major artificial-intelligence research project because the school couldn't find enough graduate students who weren't foreigners and who could thus clear new security regulations. Unscientific Method Like Gingrich, Bush favors investments in scientific research for the military, health care, and other areas that garner strong public and industry support. Indeed, the White House quickly points to such funding increases whenever its attitude toward science is questioned. But for an administration that has boosted spending in a great number of areas, more money for science is less telling than how the Bush administration acts when specific items on its agenda collide with scientific evidence or research needs. In almost all of those cases, the scientists get tuned out. Ignoring expert opinion on matters of science may never cause the administration the kind of political grief it is now suffering over its WMD Iraq policy. But neither is it some benign bit of anti-elitist bias. American government has a history of investing in the capabilities and trusting the judgments of its scientific community--a legacy that has brought us sustained economic progress and unquestioned scientific leadership within the global intellectual community. For the short-term political profits that come with looking like an elite-dismissing friend of the everyman, the Bush administration has put that proud, dynamic history at real risk. Nicholas Thompson is a Washington Monthly contributing editor. ********************************************************************* 3. Focus Part One: The science - Babymakers from The Independent 6 July 2003 http://news.independent.co.uk/world/science_medical/story.jsp?story=422088 The first test-tube baby was born 25 years ago this month. Since then thousands have become parents due to the miracle of assisted reproduction. But as scientists turn their dreams into our reality, we are becoming more and more uneasy about a future of designer babies and pregnant men. In the first of three special reports on the possibilities, pitfalls and dilemmas of the mother and father of all scientific debates, Steve Connor examines the future of babykind Making babies was once such a simple affair. A candle-lit dinner, the scent of someone you love, and the rest could be left to nature. The problem for an increasing number of couples, however, is that nature can no longer be trusted to complete the cycle of life. More people than ever are turning to science to cure their childlessness. The trend for career women to start their families later in life and the problems of falling sperm counts in men have exacerbated the incidence of sub-fertility in Western societies. For many couples, fertility treatment has become the last hope of realising their cherished dream of starting a family. Since the first test-tube baby was born 25 years ago, thousands of couples have become parents thanks to the technology of assisted reproduction - yet the science behind in vitro fertilisation (IVF) has generated disturbing questions about ethics and morality. Last week we became aware of just how bizarre this world of reproductive medicine can appear from outside the fertility clinics and research institutes. "Horror as docs take eggs from dead tots" ran one tabloid headline about a study to mature the eggs of 25-week-old aborted foetuses. "Now they want the eggs from aborted babies" was how another newspaper interpreted the research released at the European Society of Human Reproduction and Embryology in Madrid. If ever there was a field of scientific endeavour so fraught with Promethean possibilities it is human reproduction and embryology. This is where the stuff of life itself is conceived, where the first sparks of human development are nurtured and the point where our precious genetic inheritance is passed from parents to children. The proto-scientist Victor Frankenstein was trying to breathe the same life force into his cadaverous creation. Walking around the conference centre outside Madrid, there were no obvious Frankensteins among the delegates. Young researchers in T-shirts mingled with portly middle-aged men in Armani suits - the denizens of the private fertility clinics where the wealthy and the desperate are charged up to #10,000 for a single cycle of IVF treatment. This was the annual rendezvous for veiled female researchers from the Muslim world, for scientists and doctors from China and Africa, and the reproductive specialists from the wealthiest universities and research centres in Europe and the US. One such scientist was an Israeli from the Meir Hospital-Sapir Medical Centre in Kfar Saba. Before a packed auditorium, Tal Biron-Shental, a trained gynaecologist, gave a bland presentation about her attempts at maturing ovarian follicles - the fluid-filled sacs where eggs develop - taken from seven aborted foetuses aged between 22 and 33 weeks. As she explained in her matter-of-fact manner: "The shortage of donated oocytes [eggs] has prompted suggestions of the putative use of oocytes from aborted foetuses." The study involved bathing foetal ovarian tissue in hormones to mature the unripe follicles to a stage never previously reached in earlier experiments. The ultimate goal, Dr Biron-Shental said, was to mimic the natural maturity of eggs in the ovaries of an adult woman so that foetal eggs could be "farmed" in a test tube and supplied to infertile women lacking functional ovaries of their own. "The local ethical committee of our medical centre approved the study and informed consent was obtained from the mothers," Dr Biron-Shental said. However, on closer questioning she had to admit that "there are a lot of ethical questions [and] we don't have all the answers for those ethical questions". Supplying fully developed eggs from foetal ovaries raises the prospect of creating children whose biological mothers were never born. But, however strange the concept of "unborn mothers" is to the wider public, there are scientific reasons to pursue the idea, at least theoretically. A principal cause of infertility is the inability of women to produce their own eggs. Every girl is born with her full complement of eggs and there is no natural way of regenerating those that are lost during her lifetime, unlike the sperm-making factories within testicles. This is why much research has centred on ways of preserving ovarian tissue outside the body in the hope that follicles could be stimulated in the test tube to produce viable eggs for IVF. Some doctors, such as Roger Gosden of the Jones Institute in Norfolk, Virginia, have experimented with the idea of removing ovarian tissue and replacing it after, say, a woman has undergone cancer treatment that would have otherwise have left her sterile. It is a noble and justifiable idea and one that circumvents the ethical issues centred on using foetal material. Yet banking ovarian tissue for transplant later in life raises its own intriguing possibilities. Few would argue about the ethics of ovarian transplants for cancer patients, but what about young women who want to bank their ovaries until after they have established their careers? Some women might merely want to carry out the procedure to delay the menopause and prolong youthfulness, and why not? Yet another idea is to create mature human eggs from other cells, such as skin tissue. This is called "haploidisation" and involves tinkering with the way a normal or "somatic" cell divides so that instead of retaining the full complement of 46 chromosomes (the diploid number), precisely half (the haploid number) are lost in the same way that they are ejected when "gametes", the eggs and sperm, are created within the ovaries and testes. If scientists can create viable human eggs from skin cells then it would enable women lacking functional ovaries to have genetic babies. But it raises the prospect of generating eggs from the skin of men, allowing, for instance, a homosexual couple to be father and mother to their own genetic child. Even male pregnancies are not such a far-fetched idea in the world of fertility research. Professor Mats Brannstrom, of Sahlgrenska University in Gothenburg, Sweden, has shown in experiments on mice that womb transplants are feasible. Mice who have been given wombs from other mice have given birth to healthy offspring, and Professor Brannstrom sees no reason why it should not be possible to carry out a similar procedure on women with no womb of their own. He envisages womb transplants between relatives and friends, such as an older sister who has completed her family to a younger sister who cannot even start. It might even be possible to transplant a womb from a mother to a daughter so that the younger woman could bear a child in the same uterus in which she herself had developed. "We know that a uterus from a 60-year-old woman can be as good as a womb from a younger woman," said Professor Brannstrom, who said there is nothing in theory to prevent a womb being transplanted into the abdominal cavity of a man. "Although I wouldn't do it," he added. Fertility problems in men tend to be concentrated on abnormal sperm that cannot swim properly, or low sperm counts. The development of ICSI - intracytoplasmic sperm injection - has overcome many of the difficulties by taking individual sperm cells and inserting them directly into the human egg to by-pass the first stages of fertilisation. Normally, sperm and eggs fuse in a more controlled manner and the events that follow the point when a sperm powers its way through the thick, gelatinous coating of an unfertilised human egg is one of the most wondrous acts in biology. Having penetrated the egg's outer shield, the head of the sperm fires out protein strands that act like harpoons, some of which anchor themselves to the egg's nucleus, dragging it towards the waiting head of the sperm, which is packed with the man's genetic information. A courtship of the chromosomes takes place during fertilisation, with the 23 pairs - one set from each parent - aligning in formation to produce the required 46 chromosomes of the fully fertilised egg. Shortly after this point is reached, the fertilised egg begins its cycle of cell division. It divides into two cells, then four, then eight and so on until a ball containing hundreds of cells appears less than a week after conception. Precisely how a single, fertilised egg can become the trillions of specialised cells of a new-born baby is largely a mystery. What is known, however, is that up to a certain stage of embryological development, perhaps two, three or four days following fertilisation, each cell of the dividing embryo retains this ability to make a complete human being. Taking one cell from a three-day-old embryo does not seem to affect its develop- ment - which is why scientists can test individual cells for genetic disorders as part of a pre-natal genetic diagnosis. It allows them to select embryos that do not carry harmful genetic traits. For others, however, the technique is just another step towards the creation of "designer babies". Once again, a development in assisted reproduction can bring important advances in medicine. But like so many other developments in IVF, they can be used in more than one situation and what might be an acceptable use for some people, can be quite unacceptable for others. Making babies has never been so difficult. Severino Antinori Five years ago, the Italian fertility specialist announced plans to use cloning technology to help infertile couples. In 2001, the Italian medical authorities warned that he risked losing his right to practise in Italy because of his plans to clone humans. Professor Ian Craft Head of the London Fertility Clinic. In 1976, he became professor of obstetrics and gynaecology at the Royal Free Hospital School of Medicine. His team pioneered work resulting in the birth of Europe's first IVF twins on 29 April 1982. Robert Winston Professor of fertility studies at Imperial College School of Medicine. Lord Winston was part of the team that produced the first test-tube baby in 1978 and he founded the first NHS IVF programme. His techniques have been adopted worldwide. Muhammed Taranissi Director of the Assisted Reproduction and Gynaecology Centre in London, which has a licence to store women's eggs. He argues that the process could help women undergoing cancer treatment and career women to have children in later life. ********************************************************************* 4. Focus Part Two: The couple - Kylie wanted a baby. The clinic wanted eggs. They made a deal. If only life were so simple... 6 July 2003 http://news.independent.co.uk/world/science_medical/story.jsp?story=422087 By Marina Cantacuzino Kylie and Aaron Sidney vow never to go down the baby- technology road again. Not only have they failed to have a child but Kylie has also endured two miscarriages, over-stimulated ovaries, a suspected pulmonary embolism and a severe allergic reaction to the drugs. "I walked into the fertility clinic a fit, fertile woman, full of hope; three years later, aged 25, I've come out an infertile woman with nothing but regret and bad memories," she says. Aaron and Kylie couldn't have children because he had had a vasectomy in his first marriage. They met in 1997; she already had two children and he had three, but they were desperate to have a baby together. Despite the severe emotional pressure of fertility treatment, theirs is a strong marriage. From the age of 17 she wanted nothing more than to have children; he, 11 years her senior, is a protective man who has embraced her two children as if they were his. Because they couldn't afford Aaron's vasectomy reversal, Kylie came up with the controversial solution of trading her eggs in part-exchange for the operation. But having contacted a number of clinics, she was turned down on medical grounds, on account of having had two miscarriages. Only one clinic responded positively - the London Fertility Centre, run by the pioneering infertility expert Professor Ian Craft, who invited the Sidneys to his Harley Street office. Professor Craft uses a similar system as egg-sharing, called egg-giving. But rather than two women sharing one harvest of eggs, the woman providing eggs gives one month's harvest away and then uses a second harvest for her treatment. In this way, there are more eggs and more chances of getting pregnant. Professor Craft says that there is a small risk involved, but one that is no different from the risks of fertility treatment. "A scan showed I had mild PCO [polycystic ovarian syndrome]," says Kylie, "but they said it wouldn't affect the treatment." The treatment made her feel odd even before the egg collection. "My whole body was bloated. My face was a big, fat moon. I even had to go to the jeweller's to have my wedding ring cut off," she says. Then came the operation to collect eggs. "Coming to, it felt like a huge piece of concrete had been dropped on my chest. I was vomiting and screaming. They said that I was hyperstimulating." At home in King's Lynn, Kylie was unable to get out of bed and Aaron called an ambulance. In hospital, she was given oxygen and put on a drip. Her condition had been exacerbated, it transpired, by Voltrol - a painkiller which had caused an allergic reaction. Despite her poor health, Kylie was determined to go ahead with the second egg harvest three months later. "My mother was dead against it," she says, "but I wanted a child and I was going to get one." This time, when she woke from the egg-collection operation, the pain was crushing, she could barely breathe and she had to be dressed by two nurses and helped to a taxiby Aaron (himself recovering from the operation to collect sperm). Before she went she was given a paracetomol-based drug, despite claiming to have warned the clinic she was allergic to it. "At King's Cross the guards wouldn't let me on the train at first - they thought I was drunk because I was vomiting, crying and could barely walk." The next day Kylie collapsed on the sitting-room floor. "She went blue and her eyes were bulging. I tried to resuscitate her but was sure she was a goner," says Aaron. The cause of her problems again seemed to be hyperstimulation. In tonight's Panorama on BBC1, Professor Craft stresses that hyperstimulation is a routine part of all fertility treatment, and that patients sign a consent form that tells them this. Kylie and Aaron decided yet again to try for a baby and went ahead with another embryo transfer. Following the operation, she was assured by the clinic that it had been an easy transfer. A home pregnancy kit test was positive but after days of uncertainty she was informed she was having a miscarriage. She sank into a depression, unable to look after the children or carry on working as an agency nurse. "Aaron tried to be sympathetic but I didn't want his sympathy. I wanted his congratulations." In February 2002, there was another embryo transfer. The Sidneys' hopes were once again raised only to be dashed - two weeks later Kylie miscarried. Following a small service with the chaplain of the King's Lynn hospital for all her failed embryos, she returned home and collapsed, determined never again to go through the ordeal of fertility treatment. The couple were offered another free-of-charge embryo transfer, but it had to be stopped early because the combination pill Kylie was given resulted in deep vein thrombosis. Despite all this, the Sidneys haven't given up. While never stopping grieving for their "tiny unfinished babies" they still hope to have a baby some day. Three weeks ago Aaron's company loaned him the money for a vasectomy reversal and Kylie is hoping that one day through surrogacy, using Aaron's sperm, she will get the baby she longs for. Now, snuggling up to her husband, Kylie says, "Financially I have sort of wrecked the family because it meant that I couldn't hold down a job." Even though at times her obsession with having a third child nearly wrecked their marriage, Aaron has stood by her, accompanying her to every appointment and claiming to want a baby as much as she does. "But it was a nightmare," he admits. "Kylie was totally preoccupied." ********************************************************************* 5. Focus Part Three: The debate - 'The lack of regulation really shocked me' Shelley Jofre says existing rules deny patients the protection they deserve 6 July 2003 http://news.independent.co.uk/world/science_medical/story.jsp?story=422086 Dipping into the world of fertility treatment for Panorama over the past few months has been something of an eye-opener. I had always assumed it was a world that was very tightly regulated. But our investigation found that the Human Fertilisation and Embryology Authority (HFEA) is struggling to keep up with what is happening inside Britain's fertility clinics. In Hampshire, embryologist Paul Fielding was jailed earlier this year for deceiving dozens of his patients. He had told them he was freezing their embryos, when he was not. Some even had what they thought were thawed embryos placed back inside them. In fact, it was salt water. But when the case hit the headlines, the public did not hear about the gross failure of the HFEA to stop Fielding's deception at a much earlier stage. We have discovered that the regulator knew he had no success with frozen embryo transfers for three years, yet did nothing. And, incredibly, on one HFEA inspection, the team did not even bother to visit one of the clinics where Fielding worked before signing it off. We have also discovered that some senior fertility experts believe the HFEA is not doing enough to protect patients. There are 24,000 women a year going through fertility treatment, most in the private sector. One in four attempts fails, so it's hardly surprising that some women will take desperate measures to try to get pregnant. Many women, who need treatment but can't afford the #2,000-#3,000 that each attempt costs, are attracted to egg-sharing schemes that are being run in clinics around the country. If they have healthy eggs they can share some with another woman who needs eggs for her treatment. That woman then pays for some of the donor's treatment. It sounds like a win-win situation. But donating eggs is a risky and often painful procedure. And what happens if the recipient gets pregnant and the donor does not? Or vice-versa? The HFEA has outlawed the sale of donor eggs, so why does it allow them to be traded for treatment? One Harley Street doctor has taken egg-sharing a step further. A donor on Professor Ian Craft's egg-giving scheme gives a whole harvest to the woman paying for her treatment, then has a second harvest collected to use for her own treatment. Professor Craft says it gives both women a higher chance of getting pregnant, which must sound attractive to both sides. But when it does not work according to plan it can leave the donor feeling like little more than a battery hen. Women who agree to donate their eggs purely as an act of charity have been left feeling equally cheated. One altruistic donor we spoke to agreed to give her eggs to a childless couple, only to discover straight after the operation that they had pulled out. She had not produced enough eggs and they did not want to waste their money using them in a course of IVF if there was little chance of success. Another woman became ill after taking drugs to stimulate her ovaries, but the clinic went ahead with the operation to remove her eggs anyway. Afterwards she had to spend five days in hospital, and the consultant said she could have died. The regulator has a tough job. Commercial pressures for private clinics to get results have never been greater and policing them must be tricky. But it is clear from our investigation some patients feel badly let down by the HFEA. UK law is envy of the world says Suzi Leather The reality of the European fertility industry's annual gathering, this year in Madrid, is far less bizarre than recent media reports would suggest. It tackles benign subjects such as lessening the risks associated with reproductive technology by replacing only one or two embryos or eggs to bring down the numbers of twins and triplets. This reflects exactly the proposed code of practice of the Human Fertilisation and Embryology Authority (HFEA). In Madrid, there was also discussion of how to advance stem cell research while outlawing reproductive cloning. Again, in Britain, Parliament has already legislated to allow the research and ban the cloning. The UK is regarded as a world leader in this kind of regulation. The Human Fertilisation and Embryology Act 1990, which set up the Human Fertilisation and Embryology Authority, is widely admired. But in such a fast-moving field as this we cannot afford to stand still. Nor has our regulation proved perfect. Now we have instituted wide-ranging reforms. Gone is the system of authority members themselves chairing inspections; we have recruited and trained new inspectors and expect existing inspectors to undergo updated training. There is double witnessing for all stages of gamete and embryo transfer. We require clinics to carry out an annual 100 per cent audit of embryos in store. We have random unannounced inspections and have started to involve patients in inspections to ensure that their voices are heard. This year, we have also introduced an alert system whereby when clinics report adverse incidents the HFEA alerts all other clinics in the country with the details so they can ensure they learn from actual and potential mistakes. This is truly ground-breaking: no such system operates either in Europe or the United States. Our job is certainly not made easier by the increasing gap between what the science could do in 1990 and what is possible now. And there are methods of assisted reproduction that cannot be regulated by the HFEA; gamete intrafallopian transfer (Gift), for instance, was not deemed in need of regulation by Parliament in 1990 because it did not involve the creation of embryos outside the body. Yet Gift contributes to the multiple birth problem and it is difficult to see why patients having this kind of assisted reproduction treatment should not have the same protection as others having IVF. Some reform would be helpful. None the less, many other countries look with envy to the system of regulation and control of IVF and embryo research we have achieved. And, above all, the advances in treatment have benefited the people who have become parents. Suzi Leather is chairwoman of the Human Fertilisation and Embryology Authority Lifelines: 25 years of pushing back the embryology frontiers 25 July 1978 Louise Joy Brown, the world's first successful test-tube baby, born in Britain. Technology is heralded triumph for medical science, but causes many to raise ethical doubts over misuse. 1980 Two Australian teams succeed in IVF deliveries after drug-induced superovulation in the mother, a step forward making IVF programmes viable. 1983 Freezing of human embryos by Linda Mohr and Alan Trounson, left, Infertility Medical Centre (IMC) in Australia, results in world's first frozen embryo baby. 1984 IMC team achieves the world's first birth in a woman without ovaries, using donor eggs, an artificial menstrual cycle, and a special hormone schedule. 1988-89 Gamete intrafallopian transfer (Gift) used as alternative to IVF. First successful pregnancies. 1990 Human Fertility and Embryology Act and Human Fertility and Embryology Authority created. 1992 Rosanna della Corte, above, gives birth at 62 after IVF treatment by Severino Antinori. 2000 The culture of embryonic stem cells opens way for made-to-order tissue for transplant surgery. 2001 US and Italian teams working on first human clone. 2002 Antinori claims three human-cloned pregnancies taking place, two in Russia, one in an Islamic country. ********************************************************************* To Subscribe / Unsubscribe to HGA's News clipping service, contact us via e-mail on with 'Subscribe plus' in the subject field for daily updates 'Weekly plus' for weekly updates. 'Unsubscribe' to be taken off our mailing list. Human Genetics Alert 22-24 Highbury Grove 112 Aberdeen House London , N5 2EA TEL: +44 20 77046100 FAX: +44 20 73598423 -------------------------------------------------------------------------------- home back side |