1. Horror at 'three parent foetus' gene disorder
2. Cloning of human embryos to be strictly banned
3. U.S. Germ Warfare Review Faults Plan on Enforcement
4. GM Pigs - article + comment
1. Horror at 'three parent foetus' gene disorder
The Observer, UK [http://www.observer.co.uk/international/story/0,6903,49330-03,00.html]
Amelia Hill in New York Sunday May 20, 2001
The American doctor who trumpeted a fertility technique using three genetic parents failed to disclose that along with 15 healthy babies it produced two foetuses with a rare genetic disorder. Experts are horrified because the fault can be passed to future generations. Dr Jacques Cohen denounced as 'hysterical' growing criticism of his claims that the research posed no risks. Cohen, who worked in Britain for three years in the 1980s at one of the country's first IVF clinics, said: 'Many of the techniques I carry out in America are illegal in Britain but that does not mean they are immoral.'
Researchers at the Institute for Reproductive Medicine and Science of St Barnabus in New Jersey boasted of their success in an article in last month's issue of the respected British journal, Human Reproduction. The journal has since instituted tighter pre-publication procedures.
Twenty-seven infertile couples who could not conceive through IVF took part in the programme in which an infertile woman's egg is mixed with her husband's sperm and parts of a younger woman's egg. In 30 attempts, 15 babies were born. Their maternal genes came from their true mothers and all appeared completely healthy. 'These statistics stand alone as justification for the work we are doing,' Cohen maintained at the time. In their article the researchers concluded there was 'no reason' to believe the technique was harmful to foetuses or babies. But what Cohen's team failed to reveal was that although 15 babies were born, 17 foetuses were created. The first unborn foetus was aborted and the second miscarried after both developed a genetic anomaly called Turner's Syndrome, a rare chromosomal disorder in which an entire chromosome is missing. Two out of 17 far exceeds normal statistical expectation.
Turner's Syndrome, which affects females, is characterised by short stature and the lack of sexual development at puberty. It can also create heart defects and kidney abnormalities. Internal documents from Saint Barnabas quoted in the Washington Post acknowledge that the technique may be causing the problem, perhaps by enhancing the survival of flawed embryos that normally would not live beyond the first days or weeks of embryo development.
Cohen has been at the forefront of some of the most contentious areas of medical research - including IVF, male infertility and frozen embryos - for 25 years. He was defiant when he spoke to The Observer last week and denounced Britain's Human Fertilisation and Embryology Authority. Having worked at Bourn Hall Clinic, Cambridgeshire, he said he was well placed to make the comparison. He said: 'Much of the hysteria over my new technique can be put down to differences in cultures between Britain, the United States and other countries.'
He deplored the fact that there was so much political interference by the authority. It had become 'bogged down by the conflicting interests involved'. He added: 'Reproduction is a subject which everyone feels emotional about and, of course, everyone is entitled to feel that way. What seems unthinkable today will happen one day, I am sure of it.'
Guardian Unlimited (c) Guardian Newspapers Limited 2001 ---
2. Cloning of human embryos to be strictly banned
By Yang Sung-jin Staff reporter
THE KOREA HERALD May 19, 2001, Saturday
In a move that is likely to be contentious, the Korean government yesterday announced that it is drafting a law that will ban human cloning. It's understood the law will strictly ban artificial cloning of human embryos, as well as research on embryos in principle. In addition, all research projects will have to be registered with the authorities concerned and will be subject to regulations.
The Life Ethics Advisory Committee said it would hold a public hearing on the draft May 22 to determine the public reaction. The draft more or less prohibits life scientists and genetic engineers from meddling with human embryos.
U.S. Germ Warfare Review Faults Plan on Enforcement
By MICHAEL R. GORDON and JUDITH MILLER
The New York Times May 20, 2001, Sunday
A confidential Bush administration review has recommended that the United States not accept a draft agreement to enforce the treaty banning germ weapons, according to American officials. The recommendations appear certain to distress allies, who back the draft accord and are concerned that the new administration is concentrating too much on new military programs and not enough on treaties and nonproliferation. After six years of negotiations, diplomats in Geneva have produced the draft agreement, known as a protocol, which would establish measures to monitor the ban on biological weapons. A 1972 treaty, which 143 nations have ratified, prohibits the development, production and possession of biological weapons. But the treaty has always lacked a means of verifying compliance. United States support for the protocol is critical to the effort to give the treaty teeth. The Clinton administration cast the new protocol as an important tool to stem the spread of biological weapons.
And international negotiators in Geneva have been rushing to complete it by November. But the new Bush administration has taken a far more skeptical approach. In a unanimous review, its interagency team concluded that the current version of the protocol would be inefficient in stopping cheating, and that all its deficiencies could not be remedied by the negotiating deadline. "The review says that the protocol would not be of much value in catching potential proliferators," a senior American official said.
The White House has yet to formally endorse the review's conclusions, but since all the relevant agencies agreed to it, the White House is considered virtually certain to go along. The real issue is what steps to adopt in light of the recommendations, and how to proceed diplomatically.
Although the review strongly objects to the current version of the protocol, it does not rule out fresh attempts to address monitoring. And the review is also emerging as a sensitive diplomatic problem. President Bush heads to Europe next month, and his administration has already been under fire for steering too unilateralist a course on foreign policy, by backing away from the Kyoto accords on global warming and, to a lesser extent, the 1972 Antiballistic Missile Treaty. So the White House is eager to avoid a new split. Tibor Toth, the Hungarian diplomat who has overseen the effort to negotiate the protocol, will fly to Washington this week to try to change the Bush administration's mind, American officials said. "Different constituencies seem to see different flaws, which indicates it is a pretty good compromise," Mr. Toth said in a telephone interview. "If it still needs to be fixed, we have the time. Barriers have been raised to nuclear and chemical proliferation. If the world community fails to agree on a protocol to strengthen the ban on biological weapons after six years of talks, it will send a very unfortunate message."
The first step to ban germ weapons was taken when President Richard M. Nixon and other world leaders signed the treaty in 1972, at the dawn of arms control. But the agreement had no means of enforcing compliance. That became an enormous concern after President Boris N. Yeltsin conceded in 1992 that the Soviet Union had violated the accord by maintaining a long-standing biological-weapons program after the treaty went into force. Then evidence was acquired after the Persian Gulf war confirming that Iraq also had germ weapons, heightening fears over biological warfare. Most of the dozen or so countries that are believed to have biological weapons programs -- like Iran, Iraq, Libya and North Korea -- are members of the 1972 treaty. So a decade ago, during the administration of Mr. Bush's father, the United States and other nations began studying what could be done to monitor the treaty. Six years ago, they began talks on a new protocol. There have been many obstacles. China, which has little experience with formal arms-control treaties, is reluctant to allow on-site inspections. Pakistan is concerned that inspectors searching for germ weapons might investigate its nuclear weapons sites. And in the negotiations Iran has been trying to weaken controls on the export of biological equipment and materials, saying they hurt its civilian economies. The United States, for its part, has had conflicting motivations. On one hand, it has worked to limit the scope of visits by foreign inspectors in order to protect American pharmaceutical and biotechnology companies, which dominate the worldwide industry and are concerned with protecting their trade secrets. And at the behest of the Pentagon, the government tried to limit inspections of American biodefense installations, which develop vaccines and protective equipment and analyze the germ warfare threat. As a result, the United States has not been as tough on verification as most of its allies. And yet Washington also hoped that the protocol would discourage cheating. Under the 210-page protocol, parties agree to make known their vaccine production facilities, the largest biodefense installations and facilities that do genetic engineering or aerosol studies with germ agents that are most likely to be used in weapons. But it would not require a declaration of all types of facilities that could be used to make weapons, including food and beverage plants and some pharmaceutical plants. As for inspections, a new executive council would be established and a majority vote of the body would be required before an investigation of a suspicious plant could be carried out. That procedure, insisted on by American industry, is less strict than a similar provision in the treaty banning chemical weapons, which stipulates that such investigations are to be done unless there is a vote by three-fourths of a similar body to block them. Inspectors under the biological protocol would have to be granted access 108 hours after an inspection was approved. Defenders say the goal of the protocol was never to provide air-tight verification but rather to increase the chances that cheaters would be caught and thereby deter violations. Some monitoring and openness, they say, is better than none. But critics of the protocol say the accord would not really provide much security. A nation that was determined to cheat could find a way to do so and might use the limited inspections to throw other nations off the trail, they say. In this view, the United States would open itself up to inspections and get little in return. When the Bush administration took office, the issue came to the fore. Donald A. Mahley, the American negotiator at the talks, proposed a review. The interagency group he led included working-level officials from the State Department, the Pentagon, the Commerce Department, the Energy Department and intelligence agencies. The review found 38 problems with the protocol, a handful of them serious. But its basic assessment was very critical. It concluded that the verification measures in the treaty were unlikely to detect cheating. At the same time, the review concluded that these same provisions might be used by foreign governments to try to steal American secrets. The review recommended that the United States not support the draft protocol that Ambassador Toth had overseen. And it concluded that there was not enough time to fix all the problems before the negotiating deadline. Secretary of State Colin L. Powell has approved the review, which has been circulating in the administration. Officially, however, the White House insists that the review has not been completed, in part because it has yet to figure out a new policy. But as word of the review has begun to seep out, it is already prompting debate. Barbara H. Rosenberg, a specialist at the Federation of American Scientists, said the Bush administration should have worked to improve the accord during the last negotiating round if it did not like it. Instead, the United States was passive, with the new administration claiming that it could not act while the policy review was supposedly under way. "The U.S. sat quietly throughout the sessions and said nothing," Dr. Rosenberg said. "It made no effort to improve the text." But Michael L. Moodie, a senior arms control official in the first Bush administration, said the protocol was severely flawed and needed to be replaced by a new approach. "The protocol was not going to get the job done," Mr. Moodie said. "It is it not going to deter proliferation."
And if it was put into effect, he said, "we still would not be confident that there were not major violations going on." If the White House, as expected, affirms the review, it has several alternatives. One is to try to improve the accord before the November deadline but to accept the fact that the United States is unlikely to obtain all the changes it would like. But there is little or no support for that approach in the administration. Another is to ask that the deadline be extended so that negotiators would work on a substantially different protocol. Or the United States could take a significantly different approach. Supporters of that idea, which is being actively discussed in the administration, say Washington should propose a stripped-down version of the protocol that would provide for investigations when violations of the convention are suspected. Such inspections, for example, might be carried out if there was a suspicious outbreak of disease, as happened in Sverdlovsk, Russia, in 1979 when anthrax spores escaped from a biological weapons plant. There is a recognition within the administration that breaking off talks on biological-weapons monitoring altogether is not feasible because of diplomatic costs. That is especially the case because the administration is already involved in sensitive talks with its allies on the missile defense issue and has been eager to show that it is not ideologically opposed to arms control. Still, the turnabout in American policy is likely to provoke concern from American allies, particularly the British, who have been very active on the treaty. When Prime Minister Tony Blair visited Washington in February, he insisted that the United States promise to pursue nonproliferation measures and not just missile defense, and the Bush administration agreed to mention nonproliferation in the statement that both leaders issued. http://www.nytimes.com GRAPHIC: Chart: "CLOSER LOOK -- A Biological Warfare Sampler" Biological weapons like those listed below are banned under the germ weapons treaty. Anthrax, a bacteria, causes fever, fatigue, cough and other discomforts followed by severe respiratory distress. Shock and death can occur within 24 to 36 hours. Tularemia, a bacteria, can result in fever, headache, weight loss, pneumonia and other symptoms, occasionally leading to death. Smallpox, a virus, causes fever, vomiting, headaches, and in some cases delirium. Patients should be quarantined.
Botulinum, a toxin, results in general weakness, dizziness, blurred vision, and leads to paralysis and respiratory failure. (Source: U.S. Army Medical Research Institute of Infectious Diseases)(pg. 12) LOAD-DATE: May 20, 2001 [Entered May 20, 2001]
Really Big Fish
The Washington Post May 19, 2001, Final Edition EDITORIAL
THE ECOSYSTEM may or may not be ready for the first genetically engineered salmon, but the regulatory system emphatically is not. It is stuck in the legacy of decisions about biotech regulation made in the mid-1980s, when food was food, drugs were drugs and a lot of people thought most biotech products were going to be microbes. The creatures and products that have come along instead -- corn that makes its own pesticide, animals that make drugs, goats that carry a spider gene and make silk -- are straining that simple model. The case of the salmon shows how badly the framework needs updating. A coalition of 60 consumer and environmental groups recently asked the Food and Drug Administration (FDA) to block importation and marketing of the souped-up salmon, which reaches full size faster because of genetically stepped-up production of growth hormone. The fish have been under development under controlled conditions in Canada, but they have not been commercially marketed. No significant health issues have been raised about humans eating the fish. But environmentalists fear that if the altered fish escape from the ocean pens in which commercial fish are typically grown, they could mate with wild salmon and wreck ecological balances. That issue is unlikely to get the best possible airing at the FDA, which has classified the genetic enhancement as a drug for animals. That technically means the main task of its review will not be to look at the effects of the fish on the environment or the fish on the consumer, but to study the effect of the growth hormone on the fish. Environmental issues will be covered, the FDA promises. But the environmental and marine specialists who could best address them are housed at other agencies, and no law requires their routine involvement in decisions about the handling of genetically modified organisms that might get released into the environment. Even the Environmental Protection Agency gets involved only under narrow circumstances. It was able to regulate Starlink, the bioengineered corn that found its way into the food supply after being denied a permit for human consumption, only because the corn was classified as containing a pesticide.
Such piecemeal authority won't foster consumer confidence in the growing number of genetically modified organisms, especially given the irrational fears that have swept Europe. Consumers can benefit hugely from these products, but only if whatever needs checking is being checked. Those producing these organisms likewise need to have a reliable notion of what sort of hurdles they face. The opposite situation now obtains: Most checking is voluntary, especially for foods, but the coalition that petitioned the FDA on the salmon has also filed the request with the Departments of Agriculture, Commerce, Interior (which houses the Fish and Wildlife Service) and Defense (the Army Corps of Engineers). Any of these could theoretically claim jurisdiction under statutes ranging from the Endangered Species Act to laws governing the control of exotic foreign species. A better way is mapped out in legislation being drafted by Rep. Peter DeFazio (D-Ore.). It would require approval of new genetically modified organisms through a single "address," probably an assistant EPA administrator for biotech, who would then be required to consult with experts in other agencies depending on each organism's properties. The exact address is less important than the idea of a process flexible enough to keep up with bioengineers' limitless ingenuity.
4. GM Pigs - article + comment from Roger Mainwood
Anyone who buys the Observer will have seen an article yesterday called "GM pigs smell sweeter - and cut down pollution" by their science editor Robin McKie. I've pasted it in at the bottom of all this for reference.
It was about how a team of scientists at Guelph University in Ontario are working on developing genetically modified pigs that could reduce the amount of phosphate in a pig's manure, and so have environmental benefits. Phosphates are given to pigs in their food in order to boost their growth, and as I understand it would not occur otherwise.
I have been in contact with Ann E Clark, who also works at Guelph University, in the department of Plant Agriculture. She was not connected with the team that have been doing these experiments, and has written a number of papers about the impact of GM on agricultural systems.
Here is her reply..............
Roger: Regarding the pig story from Guelph, first understand that what they have done so far is actually with mice - not pigs. They are intending (claiming) that the application will be in pigs, but the only thing they've actually done so far is with mice. The magnitude of the benefit was 11% - hardly earthshattering.
As I have stated in the press already, while laudable in a general sense - as a means of reducing adverse environmental impact - the wider picture is less encouraging. Virtually all commercialized GM to date, as well as this experimental initiative, serve to facilitate and prolong production practices which are ecologically unsound. They 'patch up' or 'cover up' problems, but don't address them directly.
A more insightful approach would be to step back and ask why are we feeding pigs in high density confinement facilities, on a very high grain ration - which is the reason for the problem - in the first place? I suggested that the example of Greg Gunthorp of LaGrange, Indiana - a fourth generation pasture pig producer - to illustrate the commercial feasibility of producing pigs (farrow-to-finish) outdoors, yeararound, even in a northern climate. He does not have a P-in-manure problem because a good-sized fraction (100% in the case of the sows) of the ration is not grain but herbage. His is a good example of problem avoidance - just not generating the high P waste to start with - while the Guelph work is a good example of problem solving after the fact.
It also remains to be seen if the effect seen in mice can, in fact, be effectively introduced into pigs without incurring other adverse side effects analogous to what Benbrook has recently reported for Roundup Ready soybeans (see www.biotech-info.net/troubledtimes.html).
Hope this helps - Ann
The original story from the Observer:
GM pigs smell sweeter - and cut down pollution
Pig manure is a bio-hazard, but now gene scientists have created a super breed which will keep planet clean
Robin McKie, science editor
Sunday May 20, 2001
Scientists have succeeded in developing a bizarre new weapon in the fight against pollution: pigs that have been genetically engineered to make perfect manure. The super porkers produce excrement that is low in phosphate and so does not cause the contamination of water supplies and the destruction of wildlife.
From now on, the pigs' reputation should be green and sweet smelling, say the super-pork creators - although this new status is likely to get a mixed reception from ecologists who view gene modification as anathema.
'People think transgenic animals are evil, but our work shows that what really matters is how you use this kind of technology,' said one of the pigs' creators, Dr Serguei Golovan, of Guelph University in Ontario.
Scientists have worried for years about the problem of phosphate pollution. The chemical is present in many fertilisers and is washed from fields and crops by rain. It contaminates streams and eventually produces harmful algal blooms in lakes.
A major source of phosphate pollution is pig manure, a popular form of 'natural' fertiliser. Phosphates are given to pigs in their food in order to boost their growth. However, most of it simply passes through their digestive system and into the soil.
In many parts of the world, the result is serious pollution. Indeed, so bad is the environmental hazard in some countries that pig farming is banned.
But now Dr Golovan and his colleagues believe they have come up with the solution: a breed of pigs that excretes phosphate-low manure. In the current issue of Nature Biotechnology, the group reveals details of their successes.
They started by isolating from a bacterium a gene that makes phy tase - a naturally occurring enzyme involved in breaking down phosphates.
The group then inserted this gene into mice - who began to produce saliva rich in phytase. Boosted by this success, the researchers, led by microbiologist Professor Cecil Forsberg, repeated the trick with pigs.
The end result was a trio of piglets which also had saliva rich in phytase. 'That was very encouraging,' Dr Golovan said. 'However, getting a transgenic animal to produce a new enzyme or chemical is relatively simple. Proving that this chemical is actually working inside their bodies as you wish it to do is a different matter. Quite often an added gene makes an enzyme or protein in an inactive state. That would have been useless for our work.'
In its paper, the team reports that its first creations, genetically engineered mice, did make excrement that was low in phosphates. More importantly, the group has also carried out a two-year study of their pigs - who all passed with flying colours and with lots of excrement that had low levels of phosphate.
'We have still to publish this work, but we have now shown that we can make pigs that make manure low in phosphates and which should be a great help in cleaning up the environment. We still have some more trials to do, but in a few years, we should be able to start marketing these animals.'
Dr Golovan added that the group is also working on adding other genes to pigs, including ones that would boost their ability to process cellulose in vegetables, and stop them from producing excrement rich in nitrogen - another major source of pollution.
He said: 'Nitrogen and phosphorus are major pollutants, and if we can stop pigs producing these elements then we will help the environment - and save the pig's reputation.'