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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
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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 Observer

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.  

Equally important is the draft's denial of any patent rights stemming from research programs and byproducts related to human cloning research on embryos. The main thrust of the draft, however, is its strict restrictions  concerning research into embryos, while other countries,  notably Britain and Japan, allow such research and even  cloning under limited circumstances. The only alternative  the draft allows for is limited research on extra embryos  produced as a result of infertility treatment, though the  parents of such embryos much give explicit permission for  the research to take place. The draft, if enacted into law,  would also guarantee that the government will set up a state-run embryo center. Eugenics-oriented genetic treatments are also banned with the exception of research  into somatic cells to cure cancers and AIDS, the draft says. Genetic experiments using animals will be permitted for  research purposes. It is expected that the draft will be  discussed in several forums and hearings before it is  floated in the National Assembly's regular session this  fall. (This email address is being protected from spambots. You need JavaScript enabled to view it.) LOAD-DATE: May 18, 2001
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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]
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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.
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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.

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
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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
The Observer

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.'