ISIS NEWS 11/12 October 2001 This is the plain text version for easy download. The full version with all pictures is available at www.i-sis.org/isisnews/i-sisnews11.shtml FROM THE EDITOR GM & bio-warfare **************** The US and UK governments and the World Health Organization have been sounding alarm over chemical and biological warfare in the immediate aftermath of the September 11 terrorist attacks. A month later, cases of anthrax emerged under suspicious circumstances in the US, and the first identified anthrax strain appeared to be genetically modified. Earlier reports have linked the UK foot and mouth disease outbreak to experimental GM vaccines and simulated bio-warfare emergency exercises. GM greatly increases the potential both for bio-weapons and for unintended accidents. GM may be worse than biological weapons, on account of the ease with which deadly pathogens can be created even in apparently innocent experiments, or humanitarian applic-ations, such as making vaccines against AIDS and other infectious diseases. Many AIDs vaccines undergoing clinical trials all over the world are hazardous, and could act as slow bio-warfare agents. We are calling for international control of both GM and bio-warfare. Scientists, please sign on by e-mailing us. The modern snake oil peddlers ***************************** "Cancer study may lead to obesity cure", so goes a recent headline. "Scientists have identified the molecule responsible for weight loss in cancer patients and believe it can be developed into a slimming pill." I couldn't help adding mentally, " and it's good for man or beast, taken internally or externally". Obesity, we are told, is the new disease epidemic. It's not a disease maybe, but it's associated with heart disease, high blood pressure and strokes. And, according to the 1998 Scottish Health Survey, 62% of men and 54% of women are overweight or obese. Even 10% of children in the UK are obese. Obesity-cure is obviously the big business, far bigger than cancer, when you lump all so-called obese in the same category, so they can be sold the same 'cure'. As an after-thought, the scientists say the discovery could also help treat cancer when weight-loss becomes life threatening. I am surprised they don't suggest cancer as a cure for obesity. Too many scientists are becoming modern peddlers of snake oil under the insidious influence of the corporate culture. More seriously, corporate scientists are endangering lives peddling fraudulent cures while profiting from stock market hype. British physicians have recently proposed a national panel to handle investigations of misconduct in biomedical research. Striking out for independence ***************************** Meanwhile, the genuine articles - independent science and scientists - are in danger of going extinct. Things are so desperate that the top biomedical journals have ganged up to insist on scientific independence, almost as a counsel of despair, because no other institutions will do so. Too many of our public institutions and universities have been commercialised and compromised. And rather than protect the endangered species, and foster open debate on matters ranging from declining academic standards to the safety of GM foods and medicines, they are actively persecuting independent scientists and hounding them out of existence. Along with the need to recapture public funding for independent science, we must refuse to let scientific knowledge fall into private ownership. Elsevier publisher is usurping the labours and creativity of generations of scientists by hoarding their papers on its commercial database. This should be resisted by a general boycott. Scientists should stop publishing with Elsevier or in any Elsevier journal. GM vs organics ************** There have been a spate of attacks on organic agriculture, not just from the proponents of GM, but from prominent scientists such as Sir John Krebs, Head of the UK Food Standards Agency, supposed to be impartial on such matters. There are even articles denigrating organic agriculture in the pages of the top science journals, based on little more than opinion. Meanwhile, the corporate bosses are engineering a takeover behind the scenes by trying to undermine organic standards. The good news is that Europe's new Directive on release of GMOs to the environment has finally shaped up sufficiently to sink all GMOs if properly implemented. A sure sign of trouble for the GM industry is when Sir John Krebs attacked the new rules as 'unworkable', parroting the US authorities and the biotech industry. Sir John should know that he is aligning with biotech giants such as Monsanto, a company showing all the signs of imposing corporate serfdom on farmers all over the world. And terminator technologies are definitely on the way. Bone marrow cells, not embryonic stem cells ******************************************* Also on the good news front is how the patient's own adult bone marrow cells can mend damaged hearts, in contrast to embryonic stem cells and 'therapeutic' human cloning both biting the dust due to genetic instability and other problems. Human cloning is the logical conclusion to the corporate takeover of reproduction and the medicalisation of childbirth, and one way for women the world over to regain control is to "hold onto midwife". Is reality quantum_ ******************* Finally, does quantum theory make a difference to science and ethics_ Can a quantum computer simulate reality, and more to the point, simulate human beings so perfectly that it is alive_ And how can we prevent an evil quantum computer from taking over the world_ Read on. REPORTS Heart Repair with Bone Marrow Cells *********************************** In a sensationally simple operation, doctors have patched up a patient's failing heart using stem cells taken from his bone marrow. No need for patented embryonic stem cells or immune suppressive drugs, which is why profit-driven corporate science can't afford to do it. Bone marrow stem cells removed from the 46-year-old man were injected into arteries near his heart. The cells migrated to areas damaged by a heart attack, and turned into healthy muscle cells. The operation was carried out four days after the man suffered a serious heart attack, and lost a quarter of his heart muscle as the organ was starved of oxygen. Prof Bodo Eckehard Strauer carried out the treatment at the Dusseldorf University Cardiac Clinic where he is director. He reported that in ten weeks, the size of the damage has reduced by nearly a third, and the capacity of the heart itself has clearly improved. "Stem cell therapy could be more successful than all other previous treatments put together." He said. "Even patients with the most seriously damaged hearts can be treated with their own stem cells instead of waiting and hoping on a transplant." Since March, Prof Strauer said he has treated six patients aged between 38 and 67 with their own stem cells, and they showed similar improvement. "Our results should show that it is possible to do this work without the ethically controversial embryonic stem cells," said Prof Strauer. See "Cloning and ES cells both biting the dust", "Mouse virus in human ES cells_", "Embryonic stem cells and cancer" and "Adult bone marrow cells mend heart without transplant", this issue. Source: "Stem cell therapy repairs a heart" by Hannah Cleaver and David Derbyshire, The Daily Telegraph, 25 August 2001. GM & Biological Weapons, Scientists Call for International Watchdog ******************************************************************* In the immediate aftermath of the September 11 terrorist attacks on the World Trade Centre and the Pentagon, US and UK government officials have warned of the possibility of further attacks with chemical and biological weapons [1]. Emerging evidence indicates that genetic engineering experiments could pose even greater risks to public health. There is an urgent need to bring both GM & biological weapons under international peaceful control. Back in July, the United States rejected a Protocol that would strengthen the Biological Weapons convention (BWC) [2]. The BWC came into force back in 1975 and now has 143 state parties including the US, but it lacks provision to monitor and verify compliance. That is particularly serious in the era of biotechnology, when new and dangerous pathogens can easily be created in small research laboratories. Monitoring is difficult because biotechnology is used for "legitimate" purposes such as vaccine production or research on how bacteria and viruses cause diseases. Earlier this year, the Pentagon drew up plans to engineer a potentially more potent variant of the deadly anthrax bacterium, in order to assess whether the vaccine now being given to millions of American soldiers is effective against the superbug [3]. Russian scientists have created such a superbug in 1995, by splicing a gene from Bacillus cereus, a food borne pathogen, into the anthrax bacterium. But even "legitimate" purposes have been raising serious safety concerns. There has been a series of breaches of safety regulations in university laboratories researching dangerous pathogens in Britain [4]. · In August, Imperial College of London University was prosecuted and ordered to pay £65 000 in fines and legal fees for exposing the public to a deadly new hybrid of the dengue fever virus and gene sequences associated with hepatitis C. · Earlier in the year, Imperial College was prosecuted for a 'seriously flawed' approach to health and safety involving research on AIDS virus, HIV. · Birmingham University was fined for putting staff and public at risk of contracting TB after ventilation filters in the medical school laboratories were found not to be working properly. · In May, the National Environment Research Council's laboratory in Oxford was criticized by government inspectors over its safety procedures involving genetic engineering research on a potentially lethal encephalitis virus. · In 1999, Edinburgh University was the first research institution to be prosecuted for work on HIV under new regulations governing research on dangerous genetically modified microorganisms in the lab. · There have been 12 other violations of the law designed to stop dangerous new GM viruses escaping into the environment. Serious concerns have been raised over the kinds of research that are being done in genetic engineering research laboratories around the world. · A lethal mousepox virus was created in Canberra Australia, in a genetic engineering experiment to design a contraceptive vaccine for mice [5]. · A mutant Ebola virus was engineered in Marburg Germany that was significantly more lethal to cells than the natural virus, in the course of investigating the virus' ability to cause disease [6]. · Researcher in Kyoto University Japan and in other laboratories have created 'SHIVs', hybrids between the human and monkey AIDS virus containing human interleukin genes that suppress immune response against viruses, in order to investigate the role of the interleukins in AIDs disease [7]. · At the same time, GM crops engineered with interleukin genes are being grown in open field trials [8]. · One SHIV used in monkeys and mutated into a pathogen so powerful that it kills rhesus macaques in weeks [9]. But this is now used as an AIDS vaccine challenge in all United States NIH-funded research. · Genetic engineers are creating new viruses in the process of cloning, or just to show it can be done [10]. The safety of genetic engineered vaccines is being called into question. · Evidence is accumulating that AIDS vaccines based on the HIV glycoprotein not only undermine the immune system of individuals but are also likely to create deadly viruses and bacteria that can spread through entire populations [11]. · A live GM vaccinia-rabies vaccine for wild-life has infected a woman resulting in serious illness [12]. The hazards of gene therapy research are beginning to unfold since the death of teenager Gelsinger from a clinical trial two years ago. The common gene therapy vector he received is now found to cause cancer in mice [13]. The events surrounding the foot and mouth disease outbreak in the UK, which started in February this year, suggest that it may be linked to tests of GM vaccines against the foot and mouth disease virus in 'simulated' bio-warfare emergencies [14]. Most recently, cases of anthrax have emerged in the United States under suspicious circumstances, and the first anthrax strain identified was reported to be genetically modified [15]. GM experiments are in some respects worse than biological weapons. For every biological warfare agent, it is possible to know its biological origin, its mode of action, where it is produced and where it is released, providing the BWC Protocol can be agreed. But in the case of accidental creation of deadly pathogens in GM experiments, or contamination with GM microorganisms, none of these parameters is known, and in most cases cannot even be predicted. In the event of disease outbreaks, diagnosis will be delayed, and more people will get ill and die. Genetic engineers are playing genetic Russian roulette with GM viruses and bacteria. The barrel of the gene gun is pointed at all of us: humans, domesticated plants and animals and wild life included. There is an urgent need for an international organization to monitor and control all GM experiments as a matter of urgency. This would be similar to the International Atomic Agency that controls all nuclear experiments and activities around the world. Please add your signature to this document, based on which we shall be drafting letters to international organizations. Warren Bell President, Canadian Association of Physicians for the Environment, Canada Joseph Cummins Department of Plant Sciences, University of Western Ontario, Canada Mae-Wan Ho Director, Institute of Science in Society, London, UK Herve Le Meur Department of Mathematics, University of Paris, France Jelena Prljic, Veljko Veljkovic, Nevena Veljkovic Laboratory for Multidisciplinary Research, Belgrade, Yugoslavia Huanming Yang Director, Beijing Genomics Institute, Beijing, China And others 1. "Attack on US raises specter of germ war, or worse" by Andrea Shalal-Esa, San Francisco Chronicle, September 15. 2. "US rejects stronger bioweapons treaty" Emma Dorey, Nature biotechnology 19, 793. 3. "U.S. Germ Warfare Research Pushes Treaty Limits" by Judith Miller, Stephen Engelberg and William J. Broad, New York Times, September 4, 2001. 4. "Threat from fatal bugs as labs breach safety rules" by Antony Barnett, The Observer, August 19, 2001. 5. "Disaster in the making" by R. Nowak, New Scientist 2001, 13, 4-5. 6. Volchkov VE, Volchkova VA, Muhlberger E, Kolesnikova LV, Weik M, Dolnik O, Klenk H-D. Recovery of infectious Ebola virus from complementary DNA: DNA editing of the GP gene and viral cytotoxicity. Science 2001, 291, 1965-9. 7. Kosyrev, Miura T, Haga T, Kuwata T and Hayami M. Construction of SIV/HIV-1 chimeric virus having the IL-5 gene and determination of their ability to replicate and produce IL-5. Arch Virol 2001, 146,1051-62. 8. See "GM AIDS virus more lethal" by Joe Cummins & Mae-Wan Ho ISIS Report, July 19, 2001 www.i-sis.org; also, this issue. 9. See "Skeptical about AIDS vaccine; testing method questioned" by Laurie Garrett, Newsday (New York), September 6, 2001. 10. See "Genetic engineering superviruses" by Mae-Wan Ho, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-10.shtml 11. Veljkovi V, Metlas R, Kohler H, Urnovitz HB, Prljic J, Veljkovic N, Johnson E and Muller S. AIDS epidemic at the beginning of the third millennium: time for a new AIDS vaccine strategy. Vaccine 2001, 19, 1855-62; see also See "GM AIDS Vaccines Dangerous" ISIS Report, 29 July 2001 http://www.i-sis.org/AIDS_virus.shtml 12. Rupprecht CE, Blass L, Smith K, Orciari LA, Niezgoda M, Whitfield SG, Gibbons RV, Guerra M and Hanlon CA. Human infection due to recombinant vaccinia-rabies glyco-protein virus. The New England journal of Medicine 2001, 345, 582. 13. "Common gene therapy vector causes cancer as well as toxic shock" by Mae-Wan Ho and Joe Cummins, ISIS Report September 20, 2001 www.i-sis.org; also this issue. 14. "Foot and mouth outbreak, GM vaccines & bio-war exercise" by Mae-Wan Ho, ISIS Report September 245, 2001 http://www.i-sis.org; also this issue. 15. "Investigators say anthrax strain was modified" by Sanjay Bhatt and Meghan Meyer, October 10, Cox News Service, via nlpwessex@bigfoot.com Europe's New Rules Could Sink All GMOs ************************************** New European legislation requires detailed molecular characterization of GMOs to document genetic stability. This is the single most important criterion in biosafety risk assessment in terms of concreteness and simplicity. Angela Ryan and Mae-Wan Ho ask why decades and billions of dollars of investments should have been wasted, when this criterion alone could have exposed the futility of the whole approach. The new European Directive 2001/18 /EC on deliberate release of GMOs is broadly welcomed by environmental groups and condemned by GM proponents, especially the US, claiming it smacks of trade restrictions and is unworkable. The most significant element in the new Directive, and one that, if strictly implemented, is likely to disqualify most if not all GMOs for environmental release, is the requirement for molecular data documenting that the GMO is genetically stable. The first line of defence against the risks of GMOs is the technical and scientific detail required to characterize the genetic modifi-cation(s), including "genetic and phenotypic stability" and "techniques for detecting transfer of GM material to other organisms". ISIS and other scientists have been warning for years that GMOs are unstable, and insisting that molecular data documenting genetic stability of transgenic lines must be provided before any environmental release is allowed. Unless the transgenic line is stable, one might as well forget about studying its long term environmental or health impacts. This should be good news for all concerned. It has the potential to simplify approval procedures for biotech companies and to restore transparency and public confidence, for the data can easily be checked by regulatory authorities. A Belgian research group recently showed how it could be done using Monsanto's Roundup Ready soya. Monsanto's technical dossier, submitted for approval, had claimed that Roundup Ready soya had a single insert with the intended order of genes. The analysis revealed, however, that both the GM construct and the host genome have been scrambled (rearranged), and hundreds of basepairs of unknown DNA has got in as well [1], which should have caused RR soya to be withdrawn there and then. The procedures are relatively simple and straightforward, and could be applied to any GMO, plant or animal. A potential loophole in the Directive exists under 'differentiated procedures' for non-commercial releases. The differentiated procedures of Article 7, in turn, enables competent authorities to make use of 'simplified procedures' of the old directive 90/220. Simplified procedures will apply if "sufficient experience has been obtained on releases of certain GMOs", allowing authorities to "establish the minimum amount of technical information necessary for evaluating any foreseeable risks from the release". The minimal criteria for 'differentiated procedures' in the current Directive include molecular characterization (Annex V, see box 3). It stipulates that, "information shall be available to demonstrate that any inserted genetic material is well characterized, including the cons-truction of any vector systems or sequences of genetic material used with the carrier DNA". But this could be excluded if the previous 'simplified procedures' were to apply. GMOs in farm scale trials come under differentiated procedures, and so there is the possibility for the simplified procedures to be applied. However, all GMOs will eventually have to satisfy the requirements of the new Directive before going onto the market. So, what is the point of wasting money investing in GMOs that will only be rejected later on because they fail in the most basic criterion of genetic stability_ There is no case for retaining the simplified procedures from the old Directive. Perhaps the proponents of GM can't face the awful truth that all GMOs may be genetically unstable [2]. This is confirmed by studies commissioned by the EC itself [3]. A three-year risk assessment at University Blasise Pascal in France and the Max-Planck-Institut für Zuchtingsforschung in Germany, explored mechanisms that contribute to genetic instability in GMOs. It concludes: "Biotechnology relies to a large extent on our ability to introduce foreign genes into cells. A major problem with present day technology is the non-predictability of the integration of such transgenes. DNA introduced into plant cells mostly integrates at random, i.e. at non-predetermined positions of the genome. The biological process ultimately responsible for random integration is known as illegitimate recombination. DNA integrated at random frequently contains multiply copies and often copies are scrambled. Multiple copies also often induce gene silencing and hence instability in the expression of the introduced genes. In addition, the DNA integrates at loci of unknown stability and capacity for expression of randomly integrated copies may induce unpredictable and undesirable mutations in the host genome…we still lack the knowledge for precision engineering of plants' genes." [4]. The commission also funded research to evaluate horizontal gene transfer from GMOs to the microflora, and in animal gut [5]. (This is another area ISIS has covered extensively, and follows directly from the structural instability of GMOs.) The study notes that the risks of "horizontal gene transfer cannot be excluded", stating, "Free DNA persists in some materials for weeks, and furthermore, some bacteria develop natural/chemical competence to take up DNA from the environment. In addition, in the gastrointestinal tract of man and husbandry animals, DNA may remain stable for some time, particularly in the colon." Genetic stability is perhaps the single most important criterion in biosafety risk assessment in terms of concreteness and methodological simplicity. It is astonishing that decades and billions of dollars of investments now should have been wasted, when this criterion alone could have exposed the futility of the whole approach. It is high time for all rational GM proponents to abandon ship and cut their losses, instead of continuing to imperil the rest of the world. 1. See "Scrambled genome of RR soya" by Mae-Wan Ho and Joe cummins, ISIS News 9/10, July 2001 ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-13.shtml 2. See "GM crops face potential genetic meltdown" by Joe Cummins, also "GM rice unstable" by Mae-Wan Ho, ISIS News 9/10, July 2001 ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-14.shtml , http://www.i-sis.org/isisnews/i-sisnews9-15.shtml plus many more on ISIS website. 3. We thank Mark Griffiths for this information. See www.btinternet.com/~nlpwessex 4. http://europa.eu.int/comm/research/quality-of-life/gmo/01-plants/01-14-project.html 5. http://europa.eu.int/comm/research/quality-of-life/gmo/04-food/04-07-project.html 6. The Traceability Report, www.traceabilityreport.com _______________________________________________________ BOX1 How the new Directive improves on the old The new Directive appears to cast off the permissive mantle of the old, which required minimal risk assessment, no labelling and no monitoring. Under the new rules, all GMOs have to carry the label, 'This product contains GMOs' and traceability from field to plate must be guaranteed (see Box 4). Importantly, post-release monitoring is also required. as well as molecular documentation of genetic stability (see main text). Directive 2001/18 acknowledges from the outset that the effects of GMOs may be irreversible and thus (precautionary) preventative measures should be taken, in line with the Cartegena Biosafety protocol to the Convention on Biological Diversity. Provisions for public consultation are in place (see Box 2) and on liability, the commission will bring forward legislative proposals before the end of 2001 to cover any damages incurred in all areas of the EU. Significantly, existing consents under the old Directive 90/220 are to be renewed under the revised criteria of the new Directive. But for GMOs released for any other purpose than placing on the market, there is a potential loophole in the new Directive under the 'differentiated procedures' of Article 7 (see main text). A comprehensive environmental risk assessment (ERA) is now in place under the new Directive and includes compulsory monitoring plans for cumulative long-term effects on human health and biodiversity (both agricultural and non-agricultural) after release. Member states are obliged to trace and identify any direct or indirect, immediate, delayed or unforeseen effects from GMOs and must ensure resources are secured for such research. Any adverse effects to human health and the environment that may occur through gene transfer from GMOs shall be accurately assessed on a case by case basis. Ethical considerations are also included in biosafety assessment. To improve the efficiency of this framework, the commission will set up a centralised authorisation procedure that includes the lodging of GMO samples for inspection purposes (Annex IV, see Box 3). Methodology is now being developed in Europe that could ensure specificity, sensitivity and reliability in tracing GM material (see main text). The notifier must provide detailed information on the nature of the vector, the structure of all parts introduced and any carrier or foreign DNA remaining in the GMO (Annex II & Annex III, see Box 3). The expression of the insert must also be well characterised, including information on the developmental expression of the insert during the lifecycle of the plant. Any toxic, allergenic and other harmful effects on human or animal health that arise from the modification must be determined. The genetic stability of the insert and the phenotypic stability of the GMO must be demonstrated, including any changes to the ability of the GMO to transfer genetic material to other organisms and its potential interactions with the abiotic environment. Altered susceptibility to pathogens facilitating the dissemination of infectious diseases and or creating new reservoirs or vectors must be addressed. The new directive stipulates phasing out antibiotic resistance marker genes by 31 December 2004 (Article 4). _______________________________________________________ BOX2 Consultation with the public Consultation with the public is covered by Article 9, and exchange of information between competent authority and the EC by Article 11. And all the information must be made available to the public for consultation purposes under article 9. Member states must consult the public and appropriate groups on the proposed release, and make arrangements for this consultation, including a reasonable time-period to express an opinion. The public shall have access to information on all part B releases in their territory, as well as all the information exchanged between the authorities and the commission. The commission will set up a system of exchange of information contained in notifications. Authorities must send, within 30 days, a summary of each notification to the commission AND to the public for consultation. The commission will then, within 30 days, forward these summaries to other member states. _______________________________________________________ BOX3 Annexes There are seven annexes in the new EU directive. Annex I defines the Directive's scope, which includes all types of GMOs, such as GM animals and GM microorganisms. Annex II sets out the principles of the environmental risk assessment. Annex III constitutes the environmental risk assessment proper and is split into to classes. Annex III A stipulates what is required in notifications for GMOs other than higher plants and Annex III B covers GM higher plants (GMHPs). Annex IV is additional information required, including details of the nucleotide sequences as well as the methodology necessary to identify the GMO(s). The commission will establish one or several registers to record information on genetic modification(s), that will help to assist monitoring and inspection. Annex V details the criteria for the application of differentiated procedures (article 7), which requires the inserted genetic material of the GMO to be well characterized. Annex VI contains the guidelines for the assessment reports. Annex VII details a compre-hensive, compulsory, case by case, monitoring regime. _______________________________________________________ BOX4 EC traceability legislation The European Commission's regulations on labelling and traceability of GMfood and ingredients, adopted July 25, require all food and feed derived from biotechnology to be labelled, including highly-processed corn and soybean oils that are now exempt because they cannot be tested for novel DNA or proteins. The proposals must also be approved by the European Parliament and Council of Ministers, whose approval is expected, but modification is possible. The traceability provisions would require records to be kept from the farm level on through the production process. The rule includes a 1% threshold for 'adventitious presence' of GM materials in non-GM com-modities. Producers must be able to show that the traces were "technically unavoidable", and the GM material must have been approved by the EU or an outside country for use in food [6]. Pro-GM Royal Society Fellow Named in Libel Case *********************************************** The High Court in London has been told that a letter from Prof. Anthony Trewavas, well-known champion of GM and critic of organic agriculture, contained a series of unfounded allegations about Greenpeace and Lord Melchett that should never have been published. Jonathan Matthews reports. The Scottish newspaper, the Herald, has just had to make a public apology for a series of allegations that had "no foundation" and "should not have been published". The High Court in London was told that the allegations were contained in a letter from Anthony Trewavas, Professor in Plant Biochemistry at the University of Edinburgh. In addition to the public apology for publishing the letter, the Herald has also had to pay undisclosed damages and all the legal costs arising from the libel case [1]. The libelous allegations concerned the campaigning over GM foods of Greenpeace and its former Director, Peter Melchett. The letter in question alleged that Greenpeace was profiteering through corporate "shakedowns" while its Director manipulated the market to line his own pocket. So how on earth did one of Scotland's leading dailies get into such a scrape_ The most obvious explanation for the paper's failure to apply its normal standards of editorial scrutiny is, of course, the confidence they may have placed in Prof. Trewavas. Trewavas is not only UK Government advisor on GM, but also a leading Fellow of the Royal Society, the very body that has sat in judgement on the issue of journalistic accuracy in relation to issues like the GM foods debate. Indeed, the Royal Society has issued guidelines for the press on science-related matters, and even provides the media with a directory of experts to ensure that journalists get their stories right [3]. Back in May 1999, following the Pusztai affair, a House of Commons Science and Technology Select Committee Report first called for the media's science-related coverage to be governed by a strict code of conduct for accuracy. The report began by quoting the Press Complaints Commission Code that, "newspapers and periodicals must take care not to publish inaccurate, misleading or distorted material", and warned, "Editors must be able to demonstrate that the necessary steps have been taken". To help the media to do this the Royal Society published its 'media directory' in order to provide a list of scientists that journalists should consult to give them access to "the best source" of "advice and comment". Had the Herald letters editor consulted the media guide, he'd have quickly found Prof. Trewavas listed among the "Royal Society experts" on genetic manipulation and plant molecular biology [3]. So will the Royal Society admonish Prof. Trewavas and remove him from its list of journalistic advisors_ It hardly seems likely given the Royal Society's own sorry history of media interference in this area: "We have contributed early and proactively to public debate about genetically modified plants..." [4]. Most notoriously, this pro-active contribution resulted in a front page story in the Guardian that suggested media manipulation of the GM debate has been critical to the RS's own agenda [5]. Prof. Trewavas, in an earlier letter to US scientists, advised them to work with far right politicians like Jesse Helms, and to make full use of letters to the press. He further stated that there was a group of about a dozen leading UK scientists who were working together at the core of pro-GM campaigning in this country. This letter was posted on a notorious pro-biotech e-mail list [6] that has been running smears against critics of GM - its most recent giving them a share in the blame for the September 11 terrorist attacks! It is from this list that Prof Trewavas now claims the material sent to the Herald originated. But it hasn't been just the Royal Society that has given Prof. Trewavas a place of honour. The UK Government has also sought to benefit from his expertise by appointing him one of its advisors on GM [7]. And, apart from sitting on the UK's Advisory Committee on Genetic Modification (ACGM), Trewavas is also on the Governing Council of the John Innes Centre, the UK's leading plant biotech research institute. The Governing Council has responsibility for developing , together with the JIC's Director, the long-term vision of the institute [8]. The JIC's Director, Prof. Chris Lamb, has publicly expressed his concern at the "polarisation of discussion about agriculture", and declared it is part of the JIC's vision to seek to foster "balanced scientific discussion". That vision cannot have been served by a member of JIC Governing Council reportedly accusing a non-profit public interest organisation of operating "various shakedown campaigns", receiving "big $$" from self-interested companies, and being susceptible to "well-placed pay-offs". But then, Prof Jonathan Jones of the JIC has shown his commitment to "balanced debate" by calling GM critics, "the green mujihadeen", and posting material on the JIC website describing them as "anti-scientific", "bigoted", "mystical", "myopic" and prone to erupt with "green bile" [9]. So the JIC is perhaps even less likely to take action over Trewavas and the implications of the libel case than the Government, or the Royal Society. And is it irrelevant to this world of double standards that both the JIC and many Fellows of the Royal Society have benefited hugely from investments from the leading biotech corporations_ The Royal Society, via its fundraising campaign, has also received millions from corporations, including Rhône Poulenc and Glaxo-Welcome [10]. And, of course, former food industry boss, GM enthusiast and biotech entrepreneur, Lord David Sainsbury, has given millions both to the John Innes Centre and to the governing Labour Party, who have given him a peerage and made him Science Minister [11]. 1. The Herald's apology contained the following statements, "On 3 November 2000 the Herald published a letter it had received from Anthony Trewavas, Professor in Plant Biochemistry at the University of Edinburgh. "The letter alleged that Greenpeace campaigns had deliberately spread unfounded fears about GM Foods, so as to further the financial interests of Lord Melchett and Greenpeace, that Greenpeace accepted donations from companies and had inappropriate links with commercial organisations. "The Herald acknowledges that there is no foundation in any of these allegations. "The Herald recognises that the letter should not have been published and offers its apologies to Greenpeace and Lord Melchett for its publication. Lord Melchett has agreed to donate his damages to charity; The Herald has also agreed to pay the Claimants' legal costs." http://www.thescotsman.co.uk/uk.cfm_id=113633 2. http://www.i-sis.org/sciencewar-pr.shtml 3. http://www.royalsociety.org/news/index.html 4. President's Address, The Royal Society Annual Review 1998-99. 5. http://members.tripod.com/~ngin/rs.htm 6. Tony Trewavas, "Advice to US scientists", Apr 18 2000, AgBioView.. 7. http://www.hse.gov.uk/foi/members.htm 8. http://www.jic.bbsrc.ac.uk/corporate/About_JIC/gov_council.html 9. http://members.tripod.com/~ngin/biospin.htm 10. The Royal Society Annual Review 1998-99, p.26. 11. http://members.tripod.com/~ngin/biospin.htm; http://members.tripod.com/~ngin/rsfunding.htm http://www.red-star-research.org.uk/subframe3.html Foot & Mouth Outbreak, GM Vaccine and Bio-warfare ************************************************* The recent foot & mouth disease outbreak in the UK has been blamed on intensive agriculture, eco-terrorists, and globalisation. Now, evidence has emerged that it may be linked to experimental GM vaccines tested in simulated bio-warfare emergency. Dr. Mae-Wan Ho reports on the unfolding story of a disaster that will be repeated unless bio-warfare and GM experiments are both brought under international peaceful control. The foot & mouth disease outbreak in the UK has gone on for the best part of a year. More than 3.8 million livestock have been culled since February. It has cost an estimated £27 billion and untold hardship for family farmers and small businesses. The UK Government has persistently refused to allow the animals to be vaccinated, instead of the massive culling that has sickened the public in more ways than one. The Government has also refused to conduct a proper public enquiry, amid rumours that biological warfare agents or vaccines were involved in the outbreak. The story is now unfolding from investigations of independent journalists. In August/September 2000, the company, United Biomedical Inc. (UBI) based in the USA had conducted tests on a vaccine for FMD Type O. That is the strain involved in the disease outbreak in the UK [1]. UBI announced on its website www.unitedbiomedical.com, "We have vaccinated pigs, challenged them with infectious FMDV [foot and mouth disease virus], and successfully protected almost all of them (45 of 46 animals) from viral infection and out-performed the commercial product. This has been done by four government laboratories on three continents." The three continents were Asia, America and Europe. The four governments were the US, the Chinese, the Mexican and the UK. Was the one pig the vaccine failed to protect in the UK government laboratory_ All the governments have admitted these trials took place except the UK. According to UBI, previous studies have been carried out in several biocontainment facilities, including the USDA Plum Island Animal Disease Centre, Greenport, NY, the Merial Animal Health Ltd Biological Laboratory, Pirbright, UK, and the Institute for Animal Science and Health, Lelystad, the Netherlands. But Merial UK denied it had any connection with UBI. Plum Island Animal Disease Centre had been researching foot and mouth disease since 1954. It is the repository for the North American Foot and Mouth Disease Vaccine Bank, established in 1982, which keeps vaccine for the US, Canada and Mexico [2]. Merial is a Merk and Aventis company that have foot-and-mouth vaccine production laboratories close to those of the government's Institute for Animal Health at Pirbright, Surrey. Scientists in the Institute for Animal Health have also been trying to genetic engineer a recombinant DNA vaccine against FMDV. FMDV is a member of the family Picornaviridae. Its genome is a single-stranded RNA of 8.5 kb with one large open reading frame coding for a polyprotein. FMDV is highly contagious and mutable, and it afflicts mainly cloven-hoofed animals, such as cattle, pigs, sheep and goats, as well as some wild animals such as deer, camels and giraffes. In the lab, rats and hedgehogs have also been infected with the virus, although whether that happens in the wild is unclear. The vaccine made by the Institute of Animal Health consisted of a plasmid containing FMDV type O sequences coding for viral coat and other proteins. It was found to protect only half of the vaccinated animals against the FMDV, and was not as effective as the conventional live viral vaccine. The paper also described the process of getting a particularly virulent strain of FMDV, "by serial passage of FMDV O1 Lausanne in pigs", a process designed to generate new recombinant viruses. This work was submitted to a journal last October and published earlier this year [3]. Work on genetically engineered foot and mouth vaccines have been going on for the past 20 years, for the ostensible reason that the conventional live vaccine had been unsatisfactory [4], "Production problems, the risk of live virus release, poor inactivation, antigen instability and the lack of cross-serotype protection of inactivated whole virus vaccines." The Sunday Express reported in April that a routine audit in the UK Government's bio-warfare research laboratory at Porton Down, Wiltshire, revealed that a container of foot-and-mouth virus was missing two months before the first official outbreak. The newspaper also claims it has seen documents confirming that some sheep carried the virus long before the outbreak was confirmed on February 20, 2001. A Welsh vet says the virus was in Wales as early as January [5]. Was the outbreak caused by the FMDV used to challenge vaccinated animals, either the strain from Porton Down or the virulent strain resulting from serial passage in pigs, which has escaped from one of the labs_ Could it have been due the virus from infected pigs escaping, or to an entirely new virus generated by recombination between the challenge virus and the vaccine_ These questions could easily be answered by molecular genetic analysis of the virus or viruses from infected livestock in the outbreak. But why are governments interested to test foot and mouth vaccines around the world when there has not been major outbreaks in any of the countries_ Britain had not had the disease for 34 years, and the USA and Canada had not been affected since 1929. Investigations by the Evening Chronicle [6] uncovered that the United States, Canada and Mexico began preparing for 'a simulated outbreak of foot and mouth disease' last October. According to papers leaked from the Canadian Food Inspection Agency, the exercise - which took place between November 6 and 9 - was 'for the purpose of emergency planning'. The papers reportedly state: "This exercise is the first of its kind and provides all three countries with a unique opportunity to apply their emergency response plans in the event of a real disease outbreak." At the same time, the UK Government was reported to be preparing its own 'contingency plans' for a foot and mouth outbreak - even though the last foot and mouth outbreak here was in 1967. The Evening Chronicle reported that MAFF officials began telephoning timber merchants as early as December asking if they could supply wood for pyres, should foot and mouth strike. Just days after the recent deadly terrorist attacks in the United States, lawmakers and experts are predicting assaults by biological weapons besides chemical and nuclear [7]. Representative Christopher Shays, the Connecticut Republican who heads the House Government Reform Subcommittee on National Security, said it's not a question of if there will be a biological or chemical weapons attack, but when, and of what magnitude. Shays, whose committee has held 17 hearings on terror threats, said the attacks on the World Trade Centre and the Pentagon underscored the need to step up efforts to combat terrorism. This was echoed across the Atlantic. British Foreign Secretary Jack Straw urged immediate attention to the "next threat to our collective security", noting that the people responsible for Tuesday's attacks would stop at nothing. "It should now be obvious to everyone that people who have the fanaticism and capability to fly an airliner laden with passengers and fuel into a skyscraper will not be deterred by human decency from deploying chemical and biological weapons, missiles or nuclear weapons or other forms of mass destruction, if these are available to them," Straw said. But if the foot and mouth disease outbreak in the UK was the result of a bio-warfare simulation or genetic engineering experiments gone wrong, we don't even have to wait for the terrorist attacks. The real lesson for our political leaders is that there can be no end to terrorist attacks with increasingly more deadly means, until and unless they make real effort to end all conflicts, and to bring these deadly weapons and experiments under international peaceful control. (Thanks to postings by Mark Griffiths nlpwessex@bigfoot.com) 1. "Lies And More Lies" by Ian Gurney, 4 September 2001, iangurney@ukwriters.net 2. "Lab returns to its roots, Plum Island mobilizes for its key role in warding off foot-and-mouth disease" by Ridgely Ochs, Newsday September 4, 2001. 3. Induction of a protective response in swine vaccinated with DNA encoding foot-and mouth disease virus empty capsid proteins and the 3D RNA polymerase. Journal of General Virology 2001, 82, 1713-24. 4. http://aleffgroup.com/avisfmd/A010-fmd/mod4/4500-control.html 5. http://www.lineone.net/newswire/cgi-bin/newswire.cgi/skynews/uk/story/2001/4/c-2001-4-8-1n29.html 6. "Animal Virus Ordeal Shock Report" by Nic Outterside, Evening Chronicle, June 29, 2001. http://icnewcastle.icnetwork.co.uk/0100news/0100local/page.cfm_objectid=1112427 1&method=full 7. "Attack on US raises specter of germ war, or worse" by Andrea Shalal-Esa, Washington (Reuters), September 15 www.aol.com Common Gene Therapy Vector Causes Cancer and Toxic Shock ******************************************************** The potential for gene therapy to cause cancer has been predicted for many years. This is now confirmed in a new study that highlights, yet again, the dangers of unregulated, profit-driven genetic engineering. Dr. Mae-Wan Ho and Prof. Joe Cummins report. Adenovirus is one of the earliest virus to be genetically engineered as gene therapy vectors, on grounds that it was 'safe and without side effects'. But from the beginning, these vectors were found to cause severe immune reactions in both human subjects and mice [1]. Undaunted, researchers continued to engineer new versions of the vectors and to experiment with them, claiming again, that they are "generally considered safe", until disaster struck two years ago. Teenager Jesse Gelsinger died three days after receiving gene therapy with adenoviral vector [2]. He had suffered liver injury and inappropriate blood coagulation within the first day. On the third day he had trouble breathing and his vital organs began to fail. He was taken off life support on the fourth day. The autopsy revealed further abnormalities. The researchers had directed the gene therapy vector to the liver, but significant amounts of the vector were found in the spleen, lymph nodes, bone marrow and other tissues. Now, yet another side effect long predicted by many scientists [1, 2] has surfaced in a new study in mice [3]. Ironically, adeno-associated virus vectors (rAAVs) were widely used initially because they were thought not to integrate into the genome. But it soon transpired that the wild-type, unmodified adenovirus integrates at high frequency into a specific site on human chromosome 19. However, this ability for site-specific integration is lost in rAVV vectors. Instead, they either persist as independently replicated 'episomes' outside the genome of the cell, or they integrate randomly into the human chromo-somes. For that reason, "the potential for rAAV to have adverse side-effects due to insertional mutagenesis may exist", the researchers concede. Newborn transgenic mice with the mucopolysaccharide storage disease MPSVII were treated with rAAVs carrying the enzyme that breaks down the mucopoly-saccharide. At 18 months of age, 3 of the 5 remaining treated, apparently healthy mice, selected at random, were killed in order to study enzyme activities in the internal organs. The enzyme activities were high, and identical to other treated mice that were killed at one year of age. But the signs of cancer were unmistakable. Following this unexpected discovery, the rest of the treated and control mice were examined, together with others that have been killed or have died earlier. In all, 6 treated animals with tumours were found, 5 with hepatocellular carcinoma (liver cancer in the cells lining the organ) and the sixth with angiosarcoma (a rare malignant tumour of the lining of the blood vessels). One of the five with hepatocellular carcinoma also had angiocarcinoma. None of the 8 age-matched controls had tumours. A further summary review of studies carried out by the same group revealed 33% hepatocellular carcinoma in one group of 12 treated animals at the age of 12 months, and 17% with angiocarcinoma at the age of 12-18 months. The cancers were found to be specific to rAAV, as they were absent in mice with bone marrow transplant and in transgenic mice carrying the same enzyme cassette but without the rAAV. Quantitative polymerase chain reaction (PCR) was carried out on the cancerous and non-cancerous tissues in affected and unaffected mice. This gave no evidence that cancerous tissues were associated with increased rAAV, as might be expected if insertion of rAAV had caused the cell to grow uncontrollably into the cancer tumour. As the authors state, "these data do not exclude rAAV as the causative agent for the tumours in the rAAV-treated mice." One possibility, not mentioned by the authors of the mice study, is that the initial insertion may have destabilised the genome, leading to large scale genome scrambling that is increasingly thought to underlie the cancerous state [4]. Under those circumstances, the cancerous cells may have lost most of the original rAAV insert. 1. The hazards of gene therapy vectors and other naked nucleic acids are reviewed in Ho MW, Ryan A, Cummins A and Traavik T. Slipping Through the Regulatory Net: Hazards of 'Naked' and 'Free' Nucleic Acids, Third World Network Biotechnology Series, Penang, 2001. 2. See "Gene therapy oversold by scientists who disregard risks" by Angela Ryan, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print), ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-27.shtml 3. Donsante A, Vogler C, Muzyczka N, Crawford JM, Barker J, Flotte T, Campbell-Thompson M, Daly T and Sands MS. Observed incidence of tumorigenesis in long-term rodent studies of rAAV vectors. Gene Therapy 2001, 8, 1343-6. 4. See "Rethinking cancer, from cure to prevention" by Brian Goodwin, ISIS News 7/8, February 2001, ISSN: 1474-1547 (print), ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-27.shtml Common Plant Vector Injects Genes into Human Cells ************************************************** The genetic engineering com-munity has assumed that Agrobacterium, a commonly used gene transfer vector for plants, does not infect animal cells, and certainly would not transfer genes into them. But this has been proved wrong. Prof. Joe Cummins warns of hazards to laboratory and farm workers. Agrobacterium tumefaciens is a bacterium that causes tumours to appear on the stems of infected plants. The bacterium causes the tumours by transferring genes to the cells of the infected plant cells from a tumour inducing plasmid (Ti). The Ti plasmid has virulence genes that determine attachment to cells and transfer of a segment of the plasmid, T-DNA, to the plant cell. The transferred DNA is integrated essentially randomly (no apparent sequence bias at the site of insertion) into the plant chromosomes and normally add bacterial genes that stimulate plant tumour cell growth. In crop genetic manipulation (GM), the growth-stimulating genes that give rise to tumours are replaced by GM constructs, which include genes for antibiotic resistance, plant viral promoters and genes for desired crop traits such as herbicide tolerance. Until quite recently, the genetic engineering community has assumed that Agrobacterium does not infect animal cells, and certainly would not transfer genes into them. But this has been proved wrong. A paper published earlier this year reports that T-DNA can be transferred to the chromosomes of human cancer cells [1]. In fact, Agrobacterium attaches to and genetically transforms several types of human cells. The researchers found that in stably transformed HeLa cells, the integration event occurred at the right border of the Ti plasmid's T-DNA, exactly as would happen when it is being transferred into a plant cell genome. This suggests that Agrobacterium transforms human cells by a mechanism similar to that which it uses for transformation of plants cells. The paper shows that human cancer cells along with neurons and kidney cells were transformed with the Agrobacterium T-DNA. Such observations should raise alarm for those who use Agrobacterium in the laboratory. The integrated T-DNA will almost certainly act as a mutagen as it integrates into human chromosomes. Cancer can be triggered by activation of oncogenes (ie, cancer genes) or inactivation of cancer-suppressing genes. Furthermore, the sequences carried within the T-DNA in the transforming bacterium can be expressed in the transformed cells (the viral promoter CaMV has been found to be active in HeLa cells [2]) and constructions currently being tested include pharmaceutically active human genes such as the interleukins [3]. It is clear that little has been done to prevent environmental escape of the transforming bacteria or to quantify such releases. In conclusion, a study of cancer incidence among those exposed to Agrobacterium tumefaciens in the laboratory and in the field is needed. It would be worthwhile to screen workers for T-DNA sequences. 1. Kunik T, Tzfira T, Kapulnik Y, Gafni Y, Dingwall C, and Citovsky V. Genetic transformation of HeLa cells by Agrobacterium. PNAS USA, 2001, 98, 1871-87. 2. Ho MW, Ryan A and Cummins J. CaMV 35S promoter fragmentation hotspot confirmed and it is active in animals. Microbial Ecology in Health and Disease, 2000, 12, 189. http://www.i-sis.org/mehd3.shtml 3. See "GM AIDS virus more lethal" by Joe Cummins & Mae-Wan Ho ISIS Report, July 19, 2001 www.i-sis.org, also this issue. Biomed Journals Strike Out for Scientific Independence ****************************************************** The world's top biomedical journals are striking out for scientific independence. In contrast, the universities and learned societies are deathly silent on the issue. Dr. Mae-Wan Ho reports "Governments, nationally and regionally, have consistently failed to put their people before profit. By contrast, academic institutions could intervene to support scientists when financial conflicts threaten to do harm. But these institutions have become businesses in their own right, seeking to commercialise for themselves research discoveries rather than preserve their independent scholarly status." The above passage came from an editorial in The Lancet earlier this year [1], which concluded, almost as a counsel of despair, that the science journals could be "one last means of protection" for scientists. In August, The Lancet and other top biomedical journals, including New England Journal of Medicine, Annals of Internal Medicine and Journal of the American Medical Association (JAMA), announced that they will reserve the right not to publish drug company-sponsored studies "unless the researchers involved are guaranteed scientific independence" [2]. A week later, Britain's top science journal, Nature, said that it will expect all its authors to declare "any competing financial interests" with the research papers they submit. It is unfortunate that Nature could not find itself supporting the much stronger position taken by the other biomedical journals. Many journals have required declaration of competing financial interests for years, but that has proven inadequate to counteract the undue influence that drug companies have over research results. It is hoped that the new, stronger guarantee of scientific independence will give researchers more leverage in their dealings with the pharmaceutical industry. Scientists who publish in biomedical journals are usually university professors and other experts in the field, but much of the research is paid for, and in large part carried out by companies. Company employees often collect and analyze the data, decide how it should be presented and write the reports. The journal editors decided to act after several recent high profile cases in which drug companies have been charged for withholding research results or present them in unjustifiably favourable light Last year, researchers at the Harvard University and the University of California at San Francisco defied a corporate sponsor by publishing a study concluding that its vaccine developed as an HIV therapy, Remune, did not benefit patients who were already receiving standard treatments. The company is seeking $10 million in compensatory damages. University of Toronto professor Nancy Olivieri lost her job after she spoke out and published an article in 1998 about a serious side effect of deferiprone, a drug for a blood disorder. Olivieri's contract with drug company Apotex contained a non-disclosure clause. Similar non-disclosure clauses are routine, and some even adopted by research institutions in Britain. In the early 1990s, University of California San Francisco pharma-cologist Betty J. Dong found that cheaper generic versions of thyroid hormone worked as well as Synthroid, the brand-name drug whose maker had funded the research. The company, Knoll Pharmaceuticals, successfully blocked publication of Dong's findings for seven years. In 1999, Knoll agreed to pay 37 states almost $42 million to settle a suit alleging that it had made false claims that Synthroid was superior to competing brands and had interfered with the publication of the study. Catherine D. DeAngelis, editor of JAMA, said her journal already has a policy of demanding that authors vouch for the integrity of their data. "The goal would be that all of the major journals would adopt similar . . . principles," she said. Surveys of the medical literature have shown that studies paid for by drug companies are more likely than those with other sponsors to show results favourable to the product tested. Many, though not all, medical schools in the United States include clauses in grant agreements with companies stating that researchers will be free to publish even if the results are negative. But these agreements do not necessarily protect researchers from pressures not to publish for fear of losing future funding. Bert A. Spilker, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, called the journal editors' concerns "patently absurd", and accused the journals of becoming more and more antithetical to the "industry perspective". The biomedical journals striking out for scientific independence is to be applauded. But unless there are other concrete measures to counter the corporate culture in science, there will continue to be self-censorship and failures of disclosure. Worse, there will be temptation for scientists with vested interests to endanger lives. Related items, "Independent scientists an endangered species", and "Corporate science kills", this issue. 1. "The tightening grip of big pharma", Editorial from THE LANCET, April 14, 2001. 2. "A stand for scientific independence" by Susan Okie, Washington Post, August 15, 2001. Independent Scientists An Endangered Species ******************************************** Independent scientists are a dying breed. All over the world, they are suffering persecution from an 'academic-industrial complex' bent on promoting corporate science and technologies that endanger lives and destroy the planet. We desperately need independent scientists if only to protect us from the failures, to anticipate the dangers and to repair the damages done. Dr. Mae-Wan Ho calls on civil society and government to take concrete measures to protect independent scientists, and to support independent science that benefit society as a whole rather than big corporations. Associate Professor Ted Steele is internationally renown for pioneering work in the genetics of the immune response, which earned him the label 'neo-Lamarckian'. He has fought many battles against the old guard, who feel so threatened by his work that they have blocked his papers from publication, reviled him in public, and called on a book he published in 1980 to be "burnt". Nevertheless, his idea that individual immune experience can directly alter the genome is supported by his own experiments and by the work of others [1], posing a deep challenge to the genetic determinist paradigm that has promoted genetic engineering biotechnology since the 1970s and still, today, dominates the mainstream. Most of Steele's work was done over the past 16 years while he was a tenured staff member of the University of Wollongong in Australia. But trouble brewed when the Australian government began to slash funding for research in 1996, in line with all other industrialised countries. This sent university managements into a cut-throat competition for corporate sponsorship. The University of Wollongong has been at the forefront of the drive to turn itself into a business enterprise. Support for Steele's basic research began to dry up. As in universities in other developed countries, staff were often hired not so much on their merit as scientist as entrepreneur, and poor students were taken in for commercial reasons. For Steele, the last straw came when borderline pass students were upgraded against his recom-mendation, so that they could qualify for post-graduate funding. He refused to let that happen, and was dismissed without notice by his University's vice chancellor, Prof. Gerald Sutton, in February [2]. In the weeks following, massive support for Steele came from within the University, which soon spread to the rest of Australia and the world at large. The University of Wollongong was served with a Federal Court action by the Australian National Tertiary Education Union (NTEU). Prominent Australians sent an open letter to condemn the University, and thousands of messages of support came from academics and faculty unions around the world, calling for Steele to be reinstated. In August, the Federal Court ruled against the University. It found Sutton's dismissal of Ted Steele had breached the conditions of the University's enterprise agreement with staff. There were calls for Sutton to resign. But the university council met behind closed doors, and afterwards, a short press release was issued stating that [3], "The council had reaffirmed its commitment to abide by enterprise agreements with its staff. It noted the decision of the Federal Court. And it required Prof Sutton to continue to regularly inform members of the council regarding progress of negotiations between the NTEU and the university." There was nothing to indicate that Ted Steele is to be reinstated. Steele, who has not been paid for six months, has had to cash in his superannuation fund and to hire his own lawyer. "I am still in negotiations," Steele says, "The university will reinstate me but I will be immediately retried on the old allegations and a range of new ones. Straight out of a Kafka nightmare." In fact, the University of Wollongong has appealed the Federal Court decision, which will mean another 6 months at least before there is any hope of a settlement. Steele's Union is finally calling for the University to reinstate Steele and to drop the appeal. But no reaction has been forthcoming from the University so far. Steele is not an isolated case. The latest victims of corporate persecution are scientists at the top academic institutions in the United States [4]. Dr. Steve Lagakos, Harvard University researcher, was running one of the largest trials of a new AIDS treatment. Three years into the trial, and he realised that the treatment was not working. He ordered a halt. When Lagakos broke the news to the sponsors, Immune Response Corp., the company executives seemed to have accepted it. But as the months passed, they first suggested, then insisted, that Lagakos and his collaborator, Dr. James O. Kahn of the University of California, San Francisco, report that its therapeutic vaccine had some effect. Lagakos and Kahn refused, and published their findings last November. In an unprecedented move, the company filed an arbitration claim seeking up to $10 million, alleging that the scientists have defamed its product. That product happens to be among an entire genre of AIDS vaccines that have been damned by other scientists for safety reasons (see "AIDS vaccines trials dangerous", this issue). The company's actions may have been unusual, but efforts by industry to manipulate, delay or suppress the findings of university-based research are not [5] (see "Biomedical journals strike out for scientific independence", this issue). Many academic researchers, unlike Kahn and Lagakos, keep quiet to avoid angering corporate sponsors, according to Drummond Rennie, a medical journal editor who has studied the issue. This is confirmed by surveys carried out in Britain and Australia. And in far too many cases, it is the academic institution that victimizes those scientists who dare to stand up for independence. Lagakos and Kahn may be among the fortunate few to enjoy institutional support. In Britain, the Pusztai affair has been widely reported [6,7] and misreported to this day, so perhaps it bears repeating. Dr. Arpad Pusztai, senior scientist of the publicly-funded Rowett Institute, and his collaborators were awarded a 1.6 million pound government grant to carry out systematic safety testing of GM food, which hitherto had never been done. They found that the GM potato lines tested were toxic to young rats, and Pusztai informed the public in a brief interview, which formed part of a TV documentary broadcast in 1998. A few days later, he was sacked from his job, denied access to his data, and forbidden to speak on the subject until an international group of twenty-four scientists spoke up for him six months later. This opened the floodgates of attack and vilification against him and his supporters from within the scientific establishment, of which he has been part. Among the most vociferous critics were government scientists who have been responsible for approving GM foods for the market and also the hitherto most respected and prestigious association of top scientists, the Royal Society. Fellows of the Royal Society accused Pusztai of endangering 'sound science' in making public findings which have not been peer-reviewed and published in a scientific journal. An official review was set up by the Royal Society to discredit Pusztai's work in public. Puztai and his collaborator, Dr. Stanley Ewen of Aberdeen University, published part of their findings a year later amid a fresh storm of attack, and even reported threats to the editor of The Lancet from a fellow of the Royal Society. There are still no plans to repeat the work, nor serious efforts to support independent scientific research that would throw light on the hazards of GM. On the contrary, the scientific establishment, the government and corporate business have been working seamlessly together to suppress scientific debate and to promote biotechnology [7]. There have been other casualties since. Dr. Susan Bardocz, senior biochemist, was forced to take early retirement because she is Pusztai's wife and coworker, according to Pusztai; so has Stanley Ewen. Further afield, those scientists within public institutions whose work provided key evidence of horizontal gene transfer, and who have warned of its risks in GM crops, have also lost their grants or their posts. I, too, was retired early last June. My department has banned ISIS from campus after a traumatic episode [8], even though I have a written contract from the University for a Visiting Readership after the retirement. The contract states that one of my main task is to run ISIS. My name has been removed from the University website, and the department is in the process of hounding me out altogether, by reducing my office space, and especially, laboratory space until it becomes unworkable. Why are so few scientists speaking out_ Is it that the vast majority of them do believe in biotechnology_ A survey on attitudes toward biotechnology among Cornell University agricultural and nutrition-science faculty and extension staff (who advise farmers) found that nearly half have reservations about the health, safety, and environmental impacts of GM crops and doubt they are the answer to global hunger [9]. Only 37% were strong biotech supporters, while 8% thought agricultural biotech might have useful applications and help alleviate global hunger, but were concerned about food safety and inadequate testing. Though in the minority, the biotech promoters said they felt very comfortable voicing their views in public, in contrast to the concerned majority that did not. Too few academics are willing to openly criticize biotechnology for fear of retribution from the biotech boosters, says John Ikerd, a retired agricultural economist and biotech skeptic from the University of Missouri. In his view, the enormous public resources devoted to biotechnology programs are corporate give-aways that come at the expense of other kinds of research, which is exactly what is happening in Europe [10]. Ikerd's own work is on sustainable agriculture systems serving family farms rather than the big agribusiness models that land-grant universities have been promoting for more than 50 years. His research is seen as a threat to corporate agriculture, he says, because it reduces farmers' reliance on agrochemical inputs that the companies sell. Ikerd's candid remarks don't go down well at his university. "You are not on committees you used to be on, you're not involved in the leadership of the department, and you don't get write-ups in the university publications..." How true! Over the past year, there have been persistent rumours of staff departing from the John Innes Center, Britain's top GM crop research institute. Those staff members that have been doing sustainable agricultural research or any kind of non-GM research have disappeared. Meanwhile, corporate scientists are outdoing themselves attacking organic agriculture and promoting GM in direct opposition to the wishes of the overwhelming majority of the people. Corporate scientists are rapidly becoming public enemy number one. When will our academic unions, universities and learned societies follow the lead of the top biomedical journals and take a firm stand against the persecution of independent scientists (see previous report), to support open discussion and debate_ When will our government legislate to support and protect scientific independence, and to fund the kind of science that genuinely benefit society as a whole_ 1. Steele EJ, Lindley RA and Blanden RV. Lamarck's Signature: How Retrogenes are Chainging Darwin's Natural Selection Paradigm, Allen and Unwin, Sydney, 1998. 2. "Senior scientist sacked defending academic standards", by Mae-Wan Ho, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-3.shtml 3. "Talks over Steele sacking" by Paul McInerney, Illawarra Mercury, Saturday , August 18, 2001. 4. "Standing up to industry" by Douglas M. Birch and Gary Cohn, Baltimore Sun, June 26, 2001. 5. See "Big business = bad science_" By Peter Saunders and Mae-Wan Ho, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-7.shtml 6. See "Pusztai publishes amidst fresh storm of attack" by Mae-Wan Ho, ISIS New 3, december 1999, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews3.htm#pusztai 7. See "The new thought police. Suppressing dissent in science" by Mae-Wan Ho and Jonathan Mathew, ISIS News 7/8. Feb. 2001, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews3.htm#pusztai 8. See "The corporate takeover of science", by Mae-Wan Ho, ISIS News 7/8, February 2001, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews7-35.shtml 9. "How industry's public-relations campaigns stifle debate over biotechnology" by Karen Charman, Sierra, The Sierra Club. 10. "Slaving science and society with public subsidy" by Mae-Wan Ho, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print); ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-1.shtml Cloning and ES Cells Both Biting the Dust ***************************************** Failure of cloning from embryonic stem cells may spell the end of embryonic stem cell research and 'therapeutic' human cloning, Dr. Mae-Wan Ho reports. "Cloning by nuclear transfer (NT) is an inefficient process in which most clones die before birth and survivors often display growth abnormalities" [1] This is now admitted by an international team of animal cloners who have examined mice cloned using donor nuclei from embryonic stem cells. They found the epigenetic state - the state of gene imprinting and expression - of the ES cells "extremely unstable". Similar variations were found in the mice cloned from them. Many of the cloned animals survived to adulthood "despite widespread gene dysregulation" compared with controls. The researchers warn, "Our results indicate that even apparently healthy cloned animals can have gene expression abnormalities that are not severe enough to impede development to birth but that may cause subtle physiological abnormalities which could be difficult to detect."(p.97) The research findings have implications not just for cloning but for ES cell research. The extreme instability of ES cells is not surprising, as such 'somaclonal' variations in cell culture is well known for both plant and animal cells, and we have drawn attention to this for ES cells [2]. Cell biologist Harry Rubin spent 20 years documenting the endless variation of mammallian cells arising in successive passages in culture, despite their supposed genetic uniformity [3]. The present authors state, "Because ES cells are a potential in vitro source of many cell types for transplantation medicine, it will be important to assess whether the epigenetic state of human ES cells is as unstable as that of murine ES cells" ( ref. 1, p.97) If human ES cells are just as unstable, it would be foolhardy to expect them not to cause problems in the transplant recipient. It transpires that in the original draft of their paper, the authors had called for research to see if genetic instability in stem cells might "limit their use in clinical applications". But Jaenisch was allowed by the editor of Science to eliminate the sentence days before publication [4]. Now, the researchers are claiming that the variability may even be put to good use. For, if seemingly identical cell lines are subtly different from each other, then some may have particular promise for making "new brain cells for Parkinson's patients", and others may become cardiac tissue for heart attack patients. And "You may have to establish hundreds of lines to get the few you'd want to have," said John Gearhart, a pioneer stem cell researcher at Johns Hopkins University. Gearhart said he agreed with Jaenisch that the newly discovered genetic instability in embryonic stem cells probably will not interfere with the project of turning the cells into therapies. This claim is fallacious, because somaclonal variation is uncontrollable and unpredictable. In other words, if human ES cells turn out to be just as unstable, there is no way to get useful stable lines out of them at all. Another observation is that there is no significant correlation between abnormal fetal development and the abnormal expression of any single imprinted gene. "It is possible that the disturbance of placental and fetal growth is due to the cumulative action of many abnormally expressed genes which may have opposing influences on fetal growth.." (ref. 1, p.97) They should have checked the ES cells for chromosomal abnormalities, which are also frequently found in cultured cells. In fact, largescale genomic instability may be present in addition to epigenetic instability. That should well and truly consign embryonic stem cells to the dustbin. 1. Humpherys D, Eggan K, Akutsu H, Hochedlinger K, Rideout WM, Biniszkiewica D, Yanagimachi R and Jaenisch R. Epigenetic Instability in ES Cells and Cloned Mice. Science 2001, 293, 95-7. 2. Ho MW and Cummins J. The unnecessary evil of 'therapeutic' human cloning. ISIS News 7/8, Feb. 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews7-15.shtml 3. See Rubin H. Cancer development: the rise of epigenetics. European Journal of Cancer 1992, 28, 1-2. 4. "Clone Study casts doubt on Stem cells" By Rick Weiss, Washington Post, July 5, 2001, http://www.washingtonpost.com/ac3/ContentServer_pagename=article&articleid=A24840-2001Jul5&node=nation Mouse Virus in Human ES Cells_ ****************************** Most, if not all, human embryonic stem cell lines available to publicly funded researchers in the US have been mixed with mouse cells and may not be suitable for clinical trials. This came as a blow as George Bush announced on 9 August that federally funded researchers will only be able to work on existing stem cell lines. Human embryonic stem cells are obtained by extracting a tiny mass of cells from an embryo about five days old. The vast majority of the cell lines all over the world were grown on a 'feeder' layer of embryonic mouse cells, which release growth factors that help sustain the human embryonic stem cells. The problem is that the mouse cells may harbour endogenous viruses dangerous to humans, and transplanting the existing human embryonic stem cells into humans would constitute xeno-transplantation (the transplantation of tissue from an animal into a human), and be regarded as such by the US and Drug Administration. Using existing human embryonic stem cells in transplants would not be impossible, but it would be difficult, say some US scientists. "If the research looks great and we're ready to go to human trials, we will need more stem cells," Jeffrey Rothstein of Harvard University told the Washington Post. California-based Geron Corp claims it has succeeded in growing human embryonic stem cells without using mouse cells, but it is not clear whether they have been created before Bush's announcement. Source: "Stem cells face xenotransplantation glitch" by Emma Young, 24-8-01 GM AIDS Virus More Deadly ************************* Researchers have been creating one deadly virus after another in the laboratory, and the latest is 'SHIV', a hybrid between the human and monkey AIDS virus containing human interleukin genes that suppress immune response against viruses. At the same time, GM crops engineered with interleukin genes are being grown in open field trials. Prof. Joe Cummins and Dr. Mae-Wan Ho ask whether the relevant biosafety Committees have taking these dangerous scenarios on board when they separately approve the laboratory experiments and the field trials. In January this year, researchers in Canberra Australia created a GM mouse-pox virus that killed all its victims simply by inserting into it a gene coding for interleukin 4, a protein belonging to the cytokine family that regulates thymus (T ) helper-cells in the immune response. This deadly virus also killed half of the mice that have been immunized against the mouse-pox virus [1]. Unbeknownst to most of the world, researchers in Kyoto University, Japan, have created far worse. In order to investigate the role of cytokines in the progression of AIDS disease, they made 'SHIV' - a chimeric virus containing several genes from the human virus, HIV, in a basic frame of the monkey virus, SIV - which is capable of infecting both human and monkey cells. Into this SHIV, they insert various human cytokine genes in order to investigate how the virus replicate in cell cultures and in experimental macaque monkeys infected with the GM virus. In the first experiment reported last year [2], the human gene for interleukin 6, IL-6, was inserted into a SHIV with a deletion in one of the genes from the HIV sequence in the chimeric virus. The deletion slowed the replication of the SHIV, but does not abolish it. IL-6 is known to be elevated in AIDS disease and to contribute to immunological abnormalities in HIV-infected patients. The resultant GM virus successfully replicated in a human thymus cell line as well as in monkey and human peripheral blood mononuclear cells, with high levels of expression of IL-6. Surprisingly, the inserted gene was stable for at least four passages in the human thymus cell line, and it was suggested that the IL-6 gene in the GM virus might make the virus grow faster. In a second report just published [3], the researchers inserted the human gene for interleukin 5, IL-5, into two SHIVs with deletions in different HIV genes. Again, the GM virus replicated stably in human thymus-derived cell lines as well as monkey peripheral blood mononuclear cells, with very high expression of IL-5, especially in one of the GM viruses. The researchers stated, "The replication of both SHIVs having IL-5 appeared to be faster than that of the parental viruses without the IL-5 gene. These results show that co-expression of IL-5 stimulates SHIV replication in vitro. Thus, it is expected that expression of IL-5 will also have an effect on viral replication and pathogenicity in vivo." (p.1051, italics ours) The researchers themselves admit that chimeric viruses such as the SHIV constructions with interleukins are potentially threatening to both humans and primates. Unintended release of these viruses through infection of human beings or escape of experimental monkeys injected with the virus should be matters of grave concern. These GM viruses can readily recombine with all kinds of viruses to give them at least one gene - the interleukin gene - that would make them more virulent. Do the risks of producing SHIV chimeras with interleukins outweigh the potential benefits that may result from learning about the role of interleukin in facilitating virus multiplication_ We do not think so. Such laboratory experiments should never have been approved on grounds of both safety and animal welfare. In a parallel development, inter-leukins are being produced in GM crop plants. Field trials of a crop engineered with an interleukin gene had been carried out in the county where one of us reside. The approval has been given without considering the risks associated with pollution of surface and ground water by the protein following plant-wounding or breakage of rootlets. Birds and mammals readily consume sucking insects feeding on the test crop. Interleukin genes may spread by pollen to crop plants and weeds consumed by human beings, livestock as well as wild mammals. The interleukins consumed may lead to suppression of immune response and immune memory, thereby promoting the spread of viral diseases. In addition, all kinds of viruses may pick up the interleukin gene from the GM crops, to become more lethal than nature's worst. As field trials and production sites for GM crops producing pharma-ceuticals are not made public, the first recognition of their presence near a community may be devastating viral diseases spreading through human, domestic and wild animal populations. 1. Jackson R, Ramsay A, Christensen C, Beaton S, Hall D and Ramshaw I. Expression of mouse interleukin 4 by a recombinant ectromelia virus suppresses cytotoxic lymphocyte responses and overcomes genetic resistance to mousepox. J Virology 2001, 75,1205-10. See also "Genetic engineering superviruses" ISIS News 9/10, July 2001, http://www.i-sis.org/isisnews/i-sisnews9-10.shtml. 2. Haga T, Kuwata T, Kozyrev J, Kowfie T, Hayami M and Miura T. Construction of a SIV/HIV type 1 chimeric virus with the human interleukin 6 gene and its production of interleukin 6 in monkey and human cells. AIDS Research and Human retroviruses 2000, 16,577-82. 3. Kosyrev, Miura T, Haga T, Kuwata T and Hayami M. Construction of SIV/HIV-1 chimeric virus having the IL-5 gene and determination of their ability to replicate and produce IL-5. Arch Virol 2001, 146,1051-62. Beware Corporate Takeover of Organics ************************************* While science thugs and Oxford dons are busy attacking organics in the public arena, the corporate paymasters may be engineering a takeover. Dr. Mae-Wan Ho reports on her visit to Inverness, Scotland, in August, where eleven have subsequently been arrested, and six charged, for placing themselves in the path of the tractor planting GM seeds. The fields have been planted, but a 24h vigil continues to this day. One of the arrested is Donnie Macleod, who manages a 600 organic box scheme for local inhabitants from his 130 acre farm, less than a hundred yards from the beach, where he also runs bed and breakfast, organic café and shop. Donnie is also chairman of the Highlands & Islands Organic Association representing fifty-six organic farmers and processors in the region, covering 4000 acres. Many are already contributing to the box scheme, and more are set to join in. Like a large number of farmers in Britain, Donnie converted to organic quite recently, in his case three years ago, when his father became ill and he came home to the farm, and has since taken on his new life with great conviction and determination. "We work on a food hierarchy system", he explained as we drove through some of the most beautiful countryside on the way to the rally, the sun was shining after weeks of rain, and the air was sparkling fresh. "We supply local produce as far as possible, but if the customer wants something that we don't have locally, we get it from the nearest supplier within the country, then in Europe; and if necessary, then the rest of the world." That's a compromise, he admitted, because he takes minimising 'food miles' very seriously. The vast distances food is currently shipped from field to the plate contribute a lot to carbon dioxide emission and global warming. But it was important to accept that in order to win the customers he must respect their choice and meet their demand. Otherwise, they would be forced back into the hands of the supermarkets when local produce simply is not there. Donnie is a wiry man of medium height, in his forties, perhaps, sporting red shirt and blue jeans. He has become a local celebrity, if somewhat reluctantly, in the campaign against the local field trials of GM oilseed rape in Roskil Farm at Munlochy, Black Isle. He pointed to a hill on an island across the pristine Munlochy Bay surrounded by greenery. What a desecration! I thought of the new bird species I had already spotted since I arrived, and the glufosinate herbicide runoffs into the bay… A further two fields will be planted in Aberdeenshire farms at Daviot and Rothienorman. Both the Munlochy and Aberdeenshire sites belong to a single family, a rather wealthy gentleman farmer, who has refused to listen or to give up the trials. People are overwhelmingly against the field trials, and they are very angry. There has been little or no public consultation. "The fields were planted last year as we were having the first public meeting," Donnie recalled. And it is not because the local government does not respect the people. "The Scottish Highlands Council has voted against the field trials at least three times. All the Members of Parliament and Members of European Parliament have also declared themselves against the field trials." Has devolution of Scotland meant nothing_ "No, we were told GM trials are not a devolved issue!" The fields on the Black Isle are up wind of a burgeoning organic area. "They've done it on purpose, to destroy organic farming," said Donnie. The mass rally attracted more than 500 of all ages. The march that preceded the rally was a sight to behold. The marchers, or rather, strollers, five or more abreast, extending easily a mile, snaked along like a festive dragon adorned with yellow balloons and bristling with placards and banners. Bagpipe and drums were playing, and children with painted faces, holding balloons, shaking rattles, skipping and dancing without a care in the world. Was it a conspiracy that all the GM field trials in the UK seem to be near organic farms_ Or is it just that organic farms are popping up everywhere_ It is generally believed that the corporate agenda is to contaminate the organic produce so widely that people will have no choice but to accept GM. The European Commission's long-awaited regulations on labeling and traceability of GM food and ingredients adopted in July, sets a 1% threshold for 'unavoidable' contamination in products labeled 'non-GMO'. But the major organic certification bodies, such as the Soil Association and the Scottish Organic Producers Association (SOPA), are insisting on 'zero tolerance' for GM contamination. Under pressure from the United States, there are already moves to raise the EU threshold even further to 5% contamination for GMOs that have been approved, and 1% for unapproved GMOs. That is not all. Behind the scenes, there appears to be concerted machinations by corporate business and the UK government to undermine the existing organic certification controlled by farmers and primary producers, and to place it under the control of industry. The fear is that organic standards will become diluted, and further down the line, even GM may be accepted as organic. An opening was created when SOPA's certification officer, Carolyn Beatty, resigned after many years of service at the end of 2000. The Board of SOPA was undecided as to whether to replace her and continue the certification scheme, or to sub-contract out certification to another organisation such as the Soil Association. SOPA has been negotiating with the Soil Association for a joint initiative, Organic Scotland. And the membership of SOPA gave a clear mandate to that at its last annual general meeting. However, a wild card emerged from within the Board of SOPA, to subcontract the certification to Scottish Food Quality Certification Ltd (SFQC), a wholly owned subsidiary of Checkmate International (CMI). Neither SFQC nor CMI has had any special experience or qualification in organic certification. Their clients are the Supermarkets, and not the end users or farmers. CMI's corporate stature is increasingly evident when it recently applied to UKROFS (the Government body that oversees organic certification) to become an organic certifier. It has already been granted this status. In January this year, certain Board members of SOPA took it upon themselves to send a letter persuading the membership to vote for subcontracting to SFQC, before the full Board including the Chairman, had the chance to meet and discuss the options. In April, SOPA announced it has subcontracted organic certification to SFQC, to the dismay of the Scottish organic farming community and the Soil Association. It is not just the dilution of organic standards that's at stake. It is compromising a whole philosophy, a way of life committed to working with natural biological cycles, in soils, crops and livestock, to enhance the environment and avoid pollution; and to build up consumer trust. It is not primarily or only a business. This could well be the most important science war of this century, and it will be fought in local communities all over the world, with people braving arrests and harassment. Meanwhile, the mangetous peas and pale round zuchinis I bought from Donnie's shop were absolutely delicious. And I just bit into the orange beetroot, which is inspiration itself. I am told it is originally indigenous to Inverness. Wonder what else will grow in the Scottish Highlands, or here in my garden in London… Corporate Science Kills *********************** As academic institutions are getting into an orgy of incestuous relationships with industry, scientists find themselves testing drugs they have invented, sitting on committees approving the drugs and holding financial stakes in companies that stand to profit from them. Dr. Mae-Wan Ho reviews reports on how scientists in the growing 'academic-industrial complex' are endangering lives. "All over the planet, especially in the majority world to which I belong, crimes are being carried out in the name of scientific and technological progress. Yet every few months conferences like this come together and do little more than discuss their fashionably abstract theories.." [1]. That sums up the rot in our academic institutions. For decades, the scientific establishment has been blithely hiding behind the façade of 'scientific objectivity' to declare "there is no evidence of harm", to allow corporations to poison people and our planet with impunity. It is now saying the same about genetically engineered crops and medicines. This time round, big money is eating away the soul of science itself. Two years ago, teenager Jesse Gelsinger died in a gene therapy trial at the University of Pennsylvania. Government regulators cited the researchers for numerous safety violations. The scientist overseeing that trial and the medical centre had financial stake in the therapy tested. The public enquiry which followed concluded that gene therapy has been oversold by the scientists themselves [2]. But that was just the tip of the iceberg. Here's a litany of misconducts that recently came to light [3]. Doctors at the Fred Hutchinson Cancer Research Centre allowed a cancer experiment to go on for years, even though patients were dying at a higher rate than with standard therapy. At least 20 patients died from causes directly attributable to the treatment. The Centre and some of its physicians had financial stake in the treatment. A University of Pittsburgh scientist funded by several drug companies was accused in a lawsuit of manipulating a study of children's ear infections and contributing to the dangerous overuse of antibiotics. The FDA reprimanded a Tufts University researcher for improperly treating a cancer patient with a gene therapy that may have caused his tumour to double in size. Both the scientist and a Boston medical centre held large stake in the company developing the treatment. Society has long relied on publicly funded institutions and universities to research and develop drugs and therapies. But these traditionally independent institutions are teaming up with pharmaceutical and biotech companies and metamorphosing into a monstrous 'academic-industrial complex'. Academic-industry partnership is not new. In the United States, it goes back to the 1862 federal legislation that created the land-grant universities [4]. But the partnership developed at a greatly accelerated pace with the passage of the Bayh-Dole Act in 1980, which for the first time, allowed universities to patent the results of federally funded research [5]. The Business-Higher Education Forum, a coalition of corporate and academic leaders, and similar groups lobbied to get universities joined up with the marketplace. Since then, the US Congress has passed numerous other laws to cement university-industry ties, including generous tax breaks for corporations investing in academic research. From 1980 to 1998, industry funding for academic research expanded at an annual rate of 8.1% , reaching $1.9billion in 1997, nearly 8 times the level 20 years ago. Before Bayh-Dole, universities produced roughly 250 patents a year, many never commercialised. But in 1999, more than 120 US research universities filed a total of 7,612 patent applications. Licenses to industry generated $641 million for the universities - and about $40 billion in economic activity overall. Another factor driving academic institutions into the maws of big business is the cut in public research budgets, which enables corporations to buy up departments and whole institutions for new ideas and prestigious labour at bargain prices. Postdoctoral fellows earn as little as $15,000 a year working, at times, round the clock. Projects in a university lab typically costs about half what it would at a drug company. And the public has greater faith in research at universities than in private labs. The Swiss drug giant Novartis is paying $24 million over six years to the University of Maryland's Psychiatric Research Center for access to its brain tissue bank and one of its labs. Novartis came at the invitation of Dr. William T. Carpenter Jr., Director of the Psychiatric Research Center. Carpenter was faced with budget constraints standing in the way of understanding schizophrenia, and approached the company's researchers at a scientific meeting several years ago. The University of California at Berkeley, similarly, had suffered decades of financial cutbacks when Novartis agreed in 1998 to pay $25 million to be allowed to sift through the research of the department of plant and microbial biology, and license up to about one-third of the research results. Along with that, the company gains the right to sit on a committee deciding on the research of the department. The company also pays $20 million a year for some research at the Scripps Research Institute in California and over the past decade has paid up to $100 million for research at the Harvard-affiliated Dana Farber Cancer Institute. Scientists at other institutions are uneasy of such close links to industry. Dr. E. Fuller Torrey, Director of the Stanley Foundation Research Programs in Rockville, says his group shares its collection of about 400 brains with researchers around the world. There's only one requirement: that all research be freely published. He is worried that deals like the one at the Psychiatric Center in Maryland is constricting research. Many researchers collect consulting fees. The chief of psychiatry at Brown University medical school received more than $500,000 in fees from drug companies in 1998, much of it from the makers of antidepressants he praised in journals [3]. So many prominent academic researchers serve as paid industry consultants that the Food and Drug Administration, in need of expertise, has to allow them to sit on drug approval advisory committees. Sometimes, half the members of a panel will have a financial stake in the outcome, through ties to the drug manufacturer or a competitor. Universities in the US still receive most of their money for research from the National Institutes of Health. But drug companies spend about $30 billion a year on drug research and development, and some of that goes to academic labs. Large drug companies spend up to one-fifth of their research dollars at universities; and small biotech companies may do half of their research on campus. At many universities, corporate grants are growing faster than federal support. Johns Hopkins University has clung onto its independent status for the longest time. It passed up the chance to patent a DNA-testing method that was subsequently turned into a $100 million product by a Bethesda company, but not any more. Today, it is fast becoming one of the nation's most entrepreneurial universities. Scientists at Johns Hopkins serve as paid consultants and scientific advisers to corporations. The university filed more patent applications in 1999 than all but two other major research centres. It helped launch 18 companies in recent years, and corporate-sponsored research at the medical school has nearly quadrupled in the past decade. Johns Hopkins is taking a permissive attitude towards its scientists researching products on which they have financial stakes. For example, a senior scientist was allowed to test an experimental vaccine developed by a company he co-founded. Tiny Magnetic Resonance Imaging devices were tested on humans by scientists who invented the devices, developed by a company that the scientists and Johns Hopkins partly own. Dr. Bart Chernow, then vice dean of research at the medical school, proposed a business partnership to Craig Venter of Celera, the private company that sequenced the human genome, back in 1998. He boasted that Johns Hopkins was "one of the biggest biotech companies in the world", and suggested that the school could supply Venter with blood and tissue samples from some of the 100,000 patients that Johns Hopkins scientists see each year. "There is this supposed immorality in trying to patent genes and develop new medicines," Chernow said, shaking his head. But Johns Hopkins, he said, had finally recognised that industry was not its adversary but its greatest ally. On 19 July 2001, the US government ordered a suspension of all clinical trials in Johns Hopkins following the death of a previously healthy 24 year old volunteer in an asthma experiment, for which the University accepted full responsibility. The shutdown lasted 3 days, but 2 200 research protocols will have to be reviewed by ethics board before they can recommence [6]. The unholy alliance of academia and industry is turning out some high profile science crimes and severely rattling public trust. The situation is so serious that British physicians are proposing the formation of a national panel to handle investigations of misconduct in biomedical research [7]. Researchers at the University of Alabama at Birmingham carried out tests on cancer patients with a drug they knew to be useless. But they had financial stakes in a company making the drug. The drug, BCX-34, was the first product developed by BioCryst, a biotech company co-founded in 1986 by Dr. Charles E. Bugg, a biochemist at the Birmingham school. Company officials traded 5 percent of BioCryst stock to the University Research Foundation in return for rights to university patents. Within a decade, the company was paying the university more than $500,000 a year for research. Faculty members moved freely between the university and industry. BioCryst saw BCX-34 as a potential cure for a common skin disease, psoriasis, as well as a rare skin cancer. A dermatologist, Dr. W. Mitchell Sams Jr., a friend of Bugg was paid $2000 a month as consultant in two company-funded studies - one on 22 cancer patients at the Birmingham school, the other on 40 psoriasis sufferers. As with many drug studies sponsored by the manufacturer, the company retained significant control. Sams provided the patients and oversaw the tests. But the company designed the study and analysed the results. A lot hinged on BCX-34. BioCryst's losses had risen from $1.3 million in 1991 to almost $7 million in 1994. The drug was the closest thing the company had to a product. Because cutaneous T-cell lymphoma is rare, the FDA could waive expensive large-scale clinical trials if early studies produced striking positive results. Dr. Harry W. Snyder Jr., a scientist who taught at Cornell University medical school before working in the biotech industry, joined BioCryst in 1993 and was given responsibility for the trial. His wife, Renee Peugeot, a nurse, was hired to assist Sams. Both husband and wife held shares in BioCryst and stood to gain from favourable trial results, but Bugg was unconcerned. Over the next two years, Snyder and Peugeot falsified the records and made exaggerated claims about the efficacy of the drug. More than a month before the BCX-34 studies ended in January 1995, Snyder wrote to colleagues, claiming that the drug was working, even though it was supposed to be a blind study and he had no legitimate way of knowing the results. In early January, Peugeot and Snyder bought BioCryst stock, adding to their shares and options. At one point, they owned BioCryst stock and options worth $600,000. When Snyder's data were analysed at the end of the trial, BCX-34 seemed to have performed impressively. The company issued a news release in early February 1995, announcing that the drug had proven highly effective in treating psoriasis and, more important, the skin cancer. About a week later, BioCryst told the FDA that the drug had reduced or eliminated the cancer in 59 percent of the patients. The company, it appeared, had found a cure for an incurable disease. The company's stock shot up - from less than $6 a share at the beginning of February 1995 to nearly $13 some months later. One investor bought $5.5 million worth of newly issued BioCryst stock. In June, Dr. William J. Cook, hired from the university as BioCryst's medical director and Snyder's boss, decided to write up the scientific paper. He asked Snyder for the key to the blind trials and got a computer printout. Cook calculated the results, and was dismayed to find they did not match those announced in February. He went to the trial co-ordinator for the original key, which was locked up safely, and repeated the calculations. The results were different again. In both the cancer and psoriasis trials, Snyder had made the results appear more favourable for the drug. The company notified the FDA of the new results, but fell short of charging Snyder. It took five more years and investigations by two federal agencies to bring Snyder and his wife to book. They were convicted last year of defrauding the U.S. Food and Drug Administration. Sams, one of the nation's top dermatologist, was banned from testing drugs for the FDA. Investors lost an estimated $34 million in the company. The National Institutes of Health accused the UAB of poor oversight and suspended enrolment of patients in 550 studies. Across the Atlantic, things are no better, and possibly worse. Many fledgling companies in US test their new drugs in Germany to exploit loopholes to save time and cost [8]. Early in August, the German pharmaceutical giant Bayer was forced to withdraw its anti-cholesterol drug Baycol, with the admission that it might have killed 52 worldwide, with another 1 100 potentially crippled. Germany's health minister, Ulla Schmidt, accused Bayer of sitting on research documenting Baycol's lethal side-effects for nearly two months before the Berlin Government was informed. Bayer claimed it complied with EU rules when it reported the problems to the authorities in Britain where the drug was originally registered Later in the same month, another case came to light in Germany over human experiments with a fraudulent "cancer vaccine". This vaccine came from a scientist in a prestigious university, who claimed to have discovered it, and was tested on more than 200 terminally ill patients at Gottingen University. It was an outright fake, and many of the first batch of human guinea pigs are already dead. German scientist Alexander Kugler published a paper two years ago purporting to show that his fused cells had defeated kidney cancer. The crucial evidence was a photograph illustrating the miracle of vanishing cancer cells. There was no other proof, and no one else had duplicated his findings. Dr. Kugler received the prestigious Ernst-Wiethoff medical prize, and his group signed a deal with the German company Fresenius to manufacture and test the vaccine. But Prof. Ulrich Zimmermann of Wurzburg, a leading authority in this field, had grave doubts from the start. He alerted his colleagues at Gottingen University of "accumulated errors" and "misinterpretations" in Kluger's paper. An investigation followed. It turns out that the photographic 'evidence' came from the website of a US company, Molecular Probes. Nowhere in the world would this trial have taken place, Fresenius admits. But there is a loophole for "compassionate use". What was conducted was not a clinical trial but a 'healing experiment', claims Oliver Heick, a Fresenius spokesman. These experiments only have to be approved by local ethics committees. Sams, the dermatologist in the UAB case, left the University and wrote an article for the Journal of the American Academy of Dermatology afterwards, in which he warned that "the very soul of medicine is corroding and eroding at an unprecedented pace." He lamented the medical profession's "convenient and sometimes excessively cozy relationship to ... industry." "We let it happen. It happened slowly, by a sort of progressive creep," he wrote. "We succumbed to the siren songs of scientific advances, political power and, worst of all, financial success." 1. Remark of Professor Shiv Visvanathan from the Centre for the Study of Developing Societies, New Delhi, cited in "A Truth and Reconciliation Commission for Science_" by Tom Wakeford, Education Guardian May 14, 2001, http://education.guardian.co.uk/higher/columnist/story/0,9826,490820,00.html 2. "Gene therapy oversold by scientists who disregard risks" by Angela Ryan ISIS News 9/10, July 2001, ISSN: 1474-1547 (print), ISSN: 1474-1814 (on line) http://www.i-sis.org/gene_therapy.shtml. 3. "Of Patients and Profits: How a cancer trial ended in betrayal" by Douglas M. Birch and Gary Cohn, Baltimore Sun, June 24, 2001; "Of Patients and Profits, The changing creed of Hopkins science" by Douglas M. Birch and Gary Cohn, Baltimore Sun, June 25, 2001; "Standing up to industry" by Douglas M. Birch and Gary Cohn, Baltimore Sun, June 26, 2001. 4. "Corporate cast & campus labs" by Mark Clayton, claytonm@csps.com. The Christian Science Monitor, June 19, 2001. 5. Press, E. and Washburn, J. (2000). The Kept University. The Atlantic Monthly March 2000 6. "Johns Hopkins researchers fume over government crackdown" by Meredith Wadman, Nature 2001, 412, 363. 7. "Doctors propose panel on research misconduct" by Erica Klarreich, Nature 2001, 413, 442. 8. "Medical scandal: Death of patients given fake vaccine is just the latest failure of laws designed to protect human guinea pigs, Phoney cancer drug exposes EU shambles" by Imre Karacs in Berlin. The Independent on Sunday 26 August 2001. ARTICLES GM & Corporate Serfdom Official ******************************* We are witnessing the most outrageous acts of corporate theft and domination in history. At its heart is the manipulation of life-forms and the use of this technology to gain control over the food chain. Nick Papadimitriou charts the recent antics of Monsanto. Giant agbiotech companies such as Monsanto are aggressively imposing a new form of serfdom on North American farming practices. By patenting both naturally occurring gene sequences and genetically modified forms of life, Monsanto can use aggressive lawsuits to ward off any potential rival. At the same time, insidious forms of surveillance and barely concealed threats are whittling away any options farmers have for getting seeds from other suppliers. In April, Monsanto secured a "torpedo" patent designed to sink all rivals on antibiotic resistant marker genes used in practically all GMO crops [1]. This immediately resulted in court battles and a requirement for everyone who has made use of the technology to pay Monsanto royalty fees. Monsanto has now launched another torpedo. A patent is pending on the complete genome of Agrobacterium tumefaciens. The bacterium is used in a vector system to insert new genetic material into crop plants and is a staple of the agricultural biotechnology sector. The patent has been pending for 18 years, as challenges were made by rival companies claiming to have invented the same. But the original technology was actually developed by non-industry academics on government funds [2]. Monsanto stipulated in its "New Monsanto Pledge", announced last November, that it was committed to sharing knowledge and technology in order to benefit people and the environment [3]. Working with a research team from the University of Richmond, the company purports to have placed the genome of Agrobacterium tumerfaciens onto a 'public' database. However a perusal of the terms and conditions reveals that access is strictly limited to non-profit groups willing to enter into a licensing contract with Monsanto. A similar arrangement holds with the Monsanto genome database for rice. The database registration agreement, available for download at Monsanto's devoted site, places severe restrictions on would-be researchers. Any patent resulting from information in the database has to be filed with Monsanto, and this applies anywhere in the world. Monsanto reserves the right to claim royalties for such work. Even more disturbingly, information on the database that is duplicated in any public source, and gained from that source, is also subject to those conditions. Unrestricted publication of research gained from using Monsanto's database is limited to 250 kilobases [4]. That is only half the story so far. Monsanto has become renowned for throwing its weight about in the farming community. Several hundred lawsuits are pending following the successful prosecution of Canadian farmer Percy Schmeiser for alleged illegal possession of Monsanto's Round Up Ready canola. Schmeiser has now launched an appeal citing seventeen instances of the judge having erred or judged contrary to law. Amongst these are the determination that a farmer who inadvertently grows Roundup Canola has no right to grow or sell any such seeds or plants regardless of how they came to be there. Another crucial ground for appeal is that Justice McKay placed the onus on Schmeiser to prove how the seeds came to be in his field whether by contamination or otherwise [5]. Monsanto subsequently set up a "snitch" line, advertised on radio stations in western Canada, to encourage reports on other alleged 'malpractices'. Following protests, this has been dropped [6]. Now Monsanto is suing another Saskatchewan farmer for allegedly growing Round Up canola without a license. Kelly Ryczek is accused of obtaining Round Up seeds from a source other than Monsanto. Ryczek allegedly planted some of these seeds and sold others on. Monsanto is insisting Ryczek surrenders the seeds, and is demanding a penalty for breach of their patent rights [7]. The Schmeiser case, because it took place in Canada, has prompted concerns that it will serve as a legal precedent in other commonwealth nations. Professor Brad Sherman of the Centre for Intellectual Property in Agriculture, Australia National University, has pointed out that Schmeiser was prosecuted for infringement of exclusive rights awarded to Monsanto. Monsanto won the case based solely on the fact its GM canola was found growing on Schmeiser's land, regardless of the fact Schmeiser was a victim of contamination. Sherman thinks farmers are being pressured into buying Monsanto seeds, because, if not, they run the risk of being prosecuted like Schmeiser. Sherman concludes that the patent holder "has no incentive to take responsibility for controlling its technology". On the contrary the farmers are being made responsible for controlling the patented genes [8]. It gets worse. The selling point behind Roundup Ready is that it is a glyphosphate-resistant strain. Spray on the herbicide and you're left with nothing but Monsanto crops. However, after two years application, glyphosphate-resistant volunteer corn plants begin to flourish. This has led to the most bizarre Monsanto patent yet awarded. US patent # 6,239,072 covers the practice of mixing glyphosphate with other herbicides, and any premixture thereof. This patent has been awarded despite the fact that mixing herbicides is what any sensible, thinking farmer would naturally do, and has been doing, in the event of resistant plants emerging. The patent also serves as a "de facto" admission of the GM "superweed" problem and that Roundup technology lacks efficacy and predictability. It doesn't end there. The scope of Monsanto's 'invention' extends to using the mixtures on any straggler volunteer crops that may develop glyphosphate resistance by accident or design, at any time in the future. Using such broad patents, Monsanto assures that nothing escapes its clutches. By forcing farmers to use faulty technology and then patenting further methods to rectify those faults Monsanto is placing the farming community in a quicksand of ongoing legal obligations [9]. Fortunately, Monsanto doesn't always get its way. Monsanto was subject to a US department of Justice Antitrust Division enquiry back in 1998 regarding their acquisition of DeKalb Genetics Corporation. Similarly, when Monsanto attempted to acquire Delta & Pine Land Co in 1999 to gain control of that company's terminator seed technology, the Antitrust Division indicated that it was prepared to sue to prevent the transaction. In a recent speech made before the Organization for Competitive Markets in Nashville, Douglas Ross, Special Counsel for Agriculture at the Antitrust division outlined the basis on which prosecution for antitrust regulations can be brought. Amongst others, he cited conspiracies to deny market access or otherwise suppress competition, the use of predatory and/or exclusionary conduct to hold on to a monopoly in the market and mergers that are likely to lessen competition in the market. Monsanto is guilty on all three counts [10]. 1. "Monsanto's "Submarine Patent" Torpedoes Ag Biotech", RAFI News Release, April 26,2001 www.rafi.org 2. "Owning the future: The green-back revolution" by Seth Shulman, Techreview.com, Sept 2001 http://techreview.com/magazine/sep01/shulman.html 3. "Monsanto makes empty promises to change their practice" by Charles Abbott, Nov 27, 2001 www.purefood.org/monsanto/promises.cfm 4. Monsanto database registration agreement, Sept, 2001, rice -research.org 5. "Common farmers forced to buy GM seeds_" Norfolk Genetic Information Network, Aug 27,2001 www.ngin.org.uk 6. ""Monsanto Representatives" Intimidate Farmers with the use of Private Investigators", Monsanto vs Schmeiser website, Sept 15, 2001 7. "Monsanto ready to wage war: Schmeiser case opens door for Monsanto to pursue other patent breaches" by Murray Lyons, The StarPheonix, Canada, July 19, 2001 8. As [5] above 9. "Monsanto sees opportunity in glyphosphate resistant volunteer weeds" by David Dechant, Aug 3, 2001 www.cropchoice.com 10. Speech made by Douglas Ross, Department of Justice Antitrust Division, July 20, 2001 www.usdoj.gov/atr/public/speeches/8681.html Hold onto Midwife, Here Comes the Doctor **************************************** The corporate takeover of reproduction started with the medicalisation of childbearing and childbirth. This is now reaching its logical conclusion with the spectre of human cloning and germ line genetic manipulation. Sam Burcher and Mae-Wan Ho describe how women everywhere can regain control of the reproductive process and more, by holding on to their midwife. Midwife vs doctor The 'mid' in 'midwife' originates from the German word, 'mit', meaning 'with'. A midwife is literally the woman who is with the wife for the birthing of her child. When a woman lets go of her midwife, she is letting go of womanhood, and turning her back on a tradition that respects and values her womanhood and the infant she brings into the world. She is relinquishing responsibility and control of her own life-process that is also part of the cycle of renewal and regeneration of the community to which she belongs. Most of all, she loses an essential support system that helps to bring gestation to fruition, that nurtures mother and child both before, during and long after birthing. Conversely, as the woman places herself in the hands of the medical doctor, she becomes a passive instrument of reproduction, to be invaded and probed by an increasing armory of other instruments, to be mutilated in the name of efficiency and progress. Her 'labour' turns painful and unproductive until it becomes an illness that has to be treated. She is rendered unconscious while the child is wrenched from her birth canal with forceps, or straight from her cut-open womb. Mother and 'newborn' are registered in the official statistics, and, except for further medical tests and interventions, abandoned to their own devices. That is the powerful message in Naomi Wolf's new book [1], written from her personal experience of motherhood in the United States. The trend towards making childbearing and childbirth a medical condition in industrialised countries has been spreading to the Third World with devastating consequences. Third World healthcare and globalisation Malaysia is one of the wealthier countries in the Third World, and her health system has long been regarded as one of the successes. Until recently, she had a network of health centres, "one within a five-mile radius of every inhabitant", according to Dr. Lye Munn Sann, Director of the Medical Research Institute, Ministry of Health. Health services were, if not free, within the means of most people. But primary health systems all over the Third World have come under severe threat over the past decade as the result of the intensification of economic globalization. Economic globalization has been promoted under the banner of 'free-trade' and laissez faire neo-liberal economic ideology in international financial institutions such as the World Trade Organization (WTO), the World Bank and the International Monetary Fund. It aims to remove all national barriers to trade, investment and, as a final straw in the latest millennium round of the WTO, the procurement of services, so that everyone can supposedly benefit from the most competitive global market. In practice, economic globalization has perpetrated and deepened the gross inequities of colonial times, enabling corporate business to exploit people and natural resources with impunity. It has resulted in widespread increase in poverty and indebtedness, especially in the poorest Third World countries, with concomitant erosion of public health and education. Although the major impact on healthcare is economic, much of the damage is due to misguided government policies inspired by excessive faith in reductionist models of modern western medicine that also comes with globalisation. The plight of Malaysia's midwives Malaysia's traditional midwives are facing marginalisation and prosecution for the valuable services they have given to women and children in local communities for centuries. The rich women in that country are about to experience the dehumanising, humiliating and crippling treatment that Wolf describes, while the poor will be left with no support at all. The Association of Traditional Midwives was formed in Penang in 1992 under the registered name Persutuan Bidan Wilayah Utara [3]. Bidan is the popular name for the traditional midwives who have safely delivered babies for several centuries before the advent of modern medicine, and have enjoyed high prestige within local communities. Bidan received widespread support in their call for inclusion of traditional healers into primary health care, and for the government to recognize their services to the community. Since the Malaysian government passed the Midwives Amendment and Extension Act in 1990, however, bidan have been forbidden from delivering babies unless they have registered with the Health Ministry. Under this law, non-registered midwives can be fined up to RM2000 (about £400) or jailed for a year, or both, if found guilty of delivering a baby. Not only are the bidan punished, but the child's parents will have trouble getting a birth certificate [4]. In addition, the re-registration criteria disqualifies any woman over the age of 60 years, thereby excluding some of the most experienced bidan who have trained under royal midwives and delivered the countries' political leaders. In turn, these women have trained countless other women. The Malaysian bidan provide more than just child delivery, they act as counselors, nutritionists and masseuses for mothers before, during and after childbirth. These skills are vital to the health of both mother and child, which could never be provided so consistently in a hospital setting. These services can extend for up to 40 days after the birth, ensuring optimum health of those in their care. Since the bidan were outlawed, many women in rural communities are being subjected to the traumas caused by inexperienced government nurses. A bidan is often called to salvage the situation, only to risk punishment [5]. Nowadays in Malaysia as in some countries in Europe and the United States, a woman who has elected to have a home-birth can find herself being rushed off to hospital where she risks painful, unwanted practices such as episiotomy (cutting the birth canal) and forceps delivery. A highly trained bidan is easily able to cope with breech birth and would never shave or cut a mother's birth canal to facilitate the natural birth processes. And, when an expectant mother displays serious com-plications, she is always referred to the hospital by the bidan. Why then the interference with rural womens' rights to their traditional bidan_ The Malaysian Ministry of Health has linked high maternal deaths with rural Malays who practice home births. This prejudiced view fails to take account of the fact that rural Malays have the highest poverty and the highest numbers of births. Indeed, 40% of the deaths are in women who have had five or more children. There is no evidence that an uncomplicated birth is any safer in hospital. And this is a crucial area where the bidan and government nurses could work together to provide information and assistance to vulnerable women in the community [6]. Under the Rural Health Programme, health services have been allocated RM708.30 million of the total Plan's health expenditure of RM5.5 billion. None of this money is finding its way to the bidan whose knowledge is irreplaceable. In Penang in 1999, the ratio of doctors to patient was 1 to1,465. With government nurses not yet up to scratch on natural birthing methods, it would seem that there are the resources available as well as public demand for the services of bidan. A synergy between traditional and modern medicinal methods can be developed without excluding the valuable services of bidan. This would prevent the loss of a priceless cultural practice and promote the "wellness paradigm" cited in the Eighth Malaysian Plan Period where "primary health remains a focus of National Health development to improve equity and quality" [7]. Naomi Wolf in her book also emphasizes the need for equal partnership between traditional midwives and obstetricians in providing care for expectant mothers. The Dutch experience The one country in Europe where the autonomous profession of the midwife has survived is the Netherlands, where one third of babies are home-births. Midwives are part of the primary healthcare system, having the authority to decide which women can have a home birth, which women can deliver in short stay hospitals known as a "polyclinics" attended by midwives and which women must be referred to a specialist. Such is the power of the midwife that the specialist who coerces a woman into having a hospital birth against her wishes will no longer receive referrals. The obstetrician who is not "woman-friendly" is ostracised by the midwives, and is only re-connected to their system when he asks what can he do to ensure that he receives referrals. If a midwife is in town, then, by law, she is given precedence over the GP as the birth attendee. This level of authority has come about through the 1865 Act of the Practice of Medicine in which the profession of midwifery was defined and protected. Other factors are the social/cultural environment that regards pregnancy and childbirth as normal physiological processes, a well organized maternity home care system that facilitates continuity of home births, and careful screening systems for high-risk pregnancy. Dutch midwives are being encouraged to be more scientific with a post graduate year being added to their three-year training course. Current statistics show that of an annual birth of 74,500, 46% are attended by midwives, 46% by obstetricians and 8% by GP [8]. A study in 1986 found a perinatal mortality rate (PRM) of 20.2% in 41,861 women having first babies in hospital, compared with a PMR of only 1.5% in 15,031 women having first-time babies at home. Similar results have been found in a British study in 1970 [9]. The hospital PMR was 27.8 per 1000 births versus 5.4 per 1000 for homebirths. This was not because hospitals handled more high-risk births. When PMRs were standardized on age, parity, hypertension/toxemia, prenatal risk prediction score, method of delivery and birthweight, the adjusted hospital PMRs for each category ranged from 22.7 per 1000 to 27.8 per 1000 while homebirth rates ranged from 5.4 per 1000 to 10.5 per 1000. British data collected in 1985 confirmed the earlier study. At a lower level of risk, PMR was seven times higher in hospital. At a higher level of risk, the perinatal death rate was four and a half times higher in hospital [10]. The British author examined 1986 birth data from the Netherlands, where one-third of births are at home. The country as a whole has excellent maternity care and outcomes. However, PMR for hospital births was six times higher than for homebirths. For pregnancies of normal length, PMR was ten times higher for obstetricians than for midwives. In the United States, a study comparing 2,092 home births and 2.092 hospital births revealed that the hospital group having a six times higher fetal distress rate [11]. Maternal hemorrhage was three times higher. Limp, unresponsive newborns arrived three times more often. Thirty permanent birth injuries were caused by doctors along with lacerations to the mothers, neonatal infections, forceps deliveries cesarean sections and nine times more episiotomies. There was no difference in PMR between hospital births and home births. Research also reveals that unnecessary interventions have been linked with birth trauma and interferes with mother and child bonding [12]. Natural childbirth versus medical childbirth Natural childbirth is something that many women all over the world want, which is to experience birthing as free of fear and pain as possible. Ina May Gaskin is a "naturalist and a realist" as Naomi Wolf discovered when she visited her natural birth "Farm" in Tennessee. Gaskin is the author of a classic childbirth manual "Spiritual Midwifery". She trained herself as a lay midwife from 19th Century birthing guides and has been delivering babies for more than 30 years. Now over 60 years old and regarded as an icon in her field she lays claim to a success rate 20-30 times higher than the national average. The hands and knees position so frowned on by obstetricians is known as the "Gaskin manoevre". In a study conducted on the 1 319 births on the Farm between 1970 and 1994, only 35 or 1.8% were cesarean. There were 60 breech births, none of which had to be referred to hospital and all were successfully, naturally delivered. Sixteen women that had previously delivered by caesarian all completed a vaginal delivery. The midwives on the Farm have a good working relationship with local medical authorities in difficult birthing cases. In contrast, surgical instruments dominate the delivery room. Anesthesia, early forceps delivery, foetal heartbeat monitoring, caesarians, episiotomies and epidurals are all part of the time pressured modern birth, with traumatic consequences for both mother and child. Starting with the epidural, further interventions are inevitable. Once the woman is "numbed out" physically and emotionally she becomes "a magnet for medical equipment". Fetal monitors, intravenous lines and catheters are minor problems compared to other risks. Maternal fever is a complication under epidural - in one study 11.8%-28% women developed fever against 0.2% of women without medication. A by-product of maternal fever can mean the baby being taken from the parents immediately after birth for treatment. Twice as many women under epidural receive severe perineal lacerations, increased chances of forceps or vacuum assisted delivery and higher rates of cesarean sections. Babies born to women under epidurals are 400 times more likely to need antibiotic treatment. Epidurals kill the pain of labour, but they also kill the experience. In the United States, between 50% and 80% of women giving birth for the first time are given episiotomy, said to be a "minor surgical procedure" that widens the birth canal. In reality, it is a deep tissue cut that weakens the entire perineum, an area rich with nerves and blood vessels. Surgery in this area can cause pain during sex and loss of sexual sensation for up to seven years. But it gets the baby out quicker and is easier to suture than any natural irregular tear that the mother-to-be might suffer. Caesarians are increasingly common. UK rates of cesareans have trebled since 1970. The latest Department of Health figures quote an average national rate of 18-20%. With cesarean rates at 40% for some maternity clinics, exceeding WHO recommendations of 10-15%. There are 870,000 caesarians per year in the United States. A study by the Public Citizen Research Group involving 906,000 cases estimated that half of these were unnecessary, resulting in 142 avoidable maternal deaths. When midwives rather than obstetricians attend births, cesarean rates drop to less than half the national average. Indeed, in one New York hospital, midwives were faulted for their cesarean rate of 12.9%, well below the city's average of 23.1%[12]. If the 50% of unnecessary cesareans were avoided American hospitals would lose $1.1billion in revenue a year. The middle way To get the best of both traditional midwife support and hospital backup, freestanding birth centres are emerging in the US and the UK (available on the NHS and privately). Wolf visited one of these in New York and was moved to tears. It was devoted to the needs of mother and child down to furniture designed to encompass the pregnant form comfortably. The birthing rooms are safe and private, warm with dimmer-switch lighting, almost womb-like. There are floor mats and cushions to kneel or squat on, birthing rockers support your weight, but enable you to move around to find that all-important comfortable position. Hydrotherapy suites are provided where two people can sit in a jacuzzi or just have a soothing shower or massage. Water, during the birth process is recognised as an efficacious analgesic. A dining room is adjacent where the mother can eat and drink normally. There are no restrictions on the amount of visitors and birthing feasts are positively encouraged. Why shouldn't birth be a joyous celebration with the mother and baby as the fulcrum of love and attention_ At the centre, there are home visits for the mother and child the day after delivery, providing all kinds of help and advice with postpartum problems such as breastfeeding. The centre has a 9% cesarean rate and a 3.7% episiotomy rate. The key to their success lies in their faith that a healthy woman, having no contra-indications to a normal birth can expect to experience a safe, careful, intimate delivery with support before, during and after. Here we are approaching the standard of care and attention given by the Malaysian bidan. So, women everywhere, hold onto your bidan! 1. Wolf N. Misconceptions: Truth, Lies and The Unexpected On The Journey To Motherhood. 2001. Chatto & Windus. ISBN 0 7011 6727 0. 2. See many chapters in The Case Against the Global Economy & For a Turn towards Localization, Ed. By Edward Goldsmith and Jerry Mander, Earthscan, London 2001. 3. Idris. SM. Press Release. Association of Traditional Midwifes. Consumer Association of Penang. 15 October 1992. 4. Jessy. S. The Traditonal Bidan Fight Back. New Straits Times. 1.7.93. 5. Report. Workshop with traditional midwives of traditional health and midwifery practices. Consumer Association of Penang. October 1992. 6. Ramly. B. Village Midwives : Driven out of practice and bidan - an essential service. Utusan Konsumer, June 1989. 7. Raman. M. National Conference on Privatisation & Health Care: Financing in Malaysia. Emerging Issues & Concerns. "Ensuring universal access to reliable and affordable health care". 1997 MMA USM CAP. 8. Smulders B. Future birth- A place to be born. Presented at A Place To Be Born Conference, Australia for Birth International. February 1999. 9. Henci Goer, Obstetric Myths Versus Research Realities, A Guide to the Medical Literature, Bergin & Garvey, 1995. 10. Tew M. Place of birth and perinatal mortality. Midwifery Today JR coll gen pract 1985 35 (277): 390-394. Enews@midwiferytoday.com 11. Smit L. www.Storknet'sHomebirth Cubby! -Is Homebirth Safe.htm 12. Schlenka PF. "Safety of Alternative Approaches To childbirth. August 15 1999. 13. Baquet D. Fritsch J. New York hospitals fail and babies are the victims. New York Times 1995 vol 144 March 5, 6, 7. Who Owns Scientific Knowledge_ ****************************** Prof. Peter Saunders calls on all scientists to resist the privatisation of scientific knowledge by refusing to publish in journals belonging to publishers profiteering from closing off free access to scientific archives. Patents and copyrights exist so that people can be rewarded for what they have invented or created. Recently, however, some corporations have been using them to gain ownership of things they didn't invent. No one invented the so-called breast cancer gene BRCA1 and the company that holds the patent didn't even do most of the work of discovering it; they only put the last piece into the jigsaw. No corporation invented the neem tree or Basmati rice. But that hasn't stopped them from filing patents. Now some publishers, notably Elsevier, are trying to do the same with scientific knowledge. They are setting up electronic archives that will effectively make them the owners of large amounts of scientific knowledge. As with patents on genes, the problem arises largely because the law has failed to keep up with new technology. The scientific literature is vast, and it can be very hard to find the information you need. Most scientists know all too well that you can discover only by chance and often too late something it would have been very useful to know when you began your work. Someone may even have published essentially the same result a few years ago in a journal that your library doesn't take, and in an article whose title wouldn't have caught your eye even if you had seen it. Scientific results are generally picked up quickly, or not at all. If no one has cited a paper within two or three years of publication, the work it contains is very likely to be lost. The development of highly efficient search engines will change this by making it possible to trawl through thousands of articles in an electronic archive and pick out the few that might be relevant to your work. This will greatly extend the amount of research that any scientist will be able to draw on and so makes the ownership of electronic archives crucial. Some publishers are now working hard to ensure that this knowledge belongs not to the scientific community, not to the general public, but to them. This is knowledge that they haven't even paid for. It's important to remember that academic journals are not like other publications. The most obvious difference, and one that surprises outsiders, is that the authors are not paid. Neither are the reviewers, even though it is peer review that gives the journals much of their authority. The editorial board and the editors, too, generally receive no payment for their work. The publisher gets all that for free, and most insist that the author signs over the copyright as well. The reason this arrangement has survived is that the journals have been the chief means of letting other scientists know about your work and of establishing your scientific reputation. The editors and reviewers, almost all in paid employment, have regarded their work for the journal as a part of their contribution to science. As long as the publishers made only reasonable profits, this was acceptable as payment for a useful service to the scientific community, though in recent years some commercial publishers have been raising their prices at rates far in excess of inflation or special costs like the price of paper. As for the copyright, that didn't seem to matter too much. It doesn't cover the ideas in the paper, only things like the typesetting, the diagrams and so on. The chief effect of copyright was that anyone who wanted to reproduce the material in another publication (as distinct from merely using the results of the research) had to obtain permission and possibly pay a suitable fee. In recent years, it has become more important because it limited photocopying. That largely affected only teaching; there was relatively little effect on research. Things are now changing. If material can be put on an electronic archive, and if almost every scientist will want to refer to the archive while carrying out research, then the copyright becomes very valuable. The copyrights that authors signed over without giving the matter much thought may now mean that the very results of their research are effectively the property of whoever owns the archive. Anyone will still be able to use the results for free, but only those with access to the archive will know they exist. There's not much we can do about those papers for which the publishers already hold the copyright. They may not have paid for them, but the law says they own them. Scientists have just realised that their copyright is valuable, not because we expect to make money out of it ourselves, but because to assign it to a publisher may now mean that our fellow scientists will have to pay to use it. The most vocal opponents to this privatisation of knowledge are a group who call themselves the Public Library for Science. They are demanding that all published papers should be placed on a free archive six months after they have appeared. They argue that this should not affect the sales of journals because people will still pay to see research as it appears, and they are asking scientists to sign a declaration that they will not publish in any journal that does not agree to this. So far almost 27000 scientists from 170 countries have signed. There is also a list of journals that have already agreed to make the papers they publish available after six months, and this includes the highly prestigious Proceedings of the National Academy of Sciences of the USA. Setting up and maintaining an electronic archive is a considerable undertaking, and it is not clear what is the best way forward. Six months before access is free may be a long enough delay in some fields but not in others. It is not even obvious that there should be a single archive at all, whoever controls it. But at the very least, the Public Library of Science has drawn attention to the problem and well and truly thrown down the gauntlet: if what they are arguing is not practicable, then we have to find something better. Over the past ten or twenty years there have been massive increases in the prices of many journals. Most university libraries have been forced to reduce the number of journals they take, which makes it harder for scientists to keep up with new work in their field. The publishers have thus increased their profits by providing not a better service to the scientific community but a worse one. We allowed that to happen by continuing to publish in overpriced journals. We must not repeat the mistake by allowing our work to disappear into overpriced archives. We must stop publishing in those journals. (The Public Library of Science's policy statement and open letter can be found on www.publiclibraryofscience.org. For contributions from all sides of the debate, see for example www.nature.com/debates/e-access/index.html ) Organics Enter the Science Wars ******************************* Prominent scientists have been denigrating organic agriculture recently on both sides of the Atlantic. This debate has even reached the pages of the top science journals. Angela Ryan reviews and rebuts the arguments put forward. Sir John Krebs, Head of the UK Food Standards Agency (FSA) said, "in my opinion and in the opinion of the FSA, consumers who buy organic produce are not getting value for money if they think they're buying food with extra nutritional quality or extra safety"[1]. Soon afterwards, as if on cue, an article appeared in Nature entitled, Urban Myths of Organic Agriculture, by Anthony Trewavas, Prof. of Plant Biochemistry, Edinburgh University. It sets out to refute a common argument "that organic farming is 'holistic' and superior to reductionist 'chemical' agriculture". This dichotomy is false, and "neither is superior". He claims "there is very little science to organic farming" [2]. Organic agriculture bans the use of synthetic pesticides, herbicides, fertilizers, fungicides, veterinary drugs (antibiotics, growth hormones), synthetic preservatives and additives, and irradiation, many of which are associated with harmful effects on health and biodiversity. Not only that, a United Nations Food and Agricultural Organisation (FAO) 1998 report on organic farming suggests con-siderations like ethical values and sustainable production principles are gaining weight in the food sector as "integral product values" for consumers [3]. The former UK Ministry of Agriculture Fisheries and Food (MAFF) 1998 Review examined comparative studies on biodiversity, and concluded, "organic regimes have the greatest benefit for biodiversity at the farm level". But according to Trewavas, organic farming practices do not "necessarily conserve the environment". He claims that "current synthetic pesticides are very unstable; only transient declines of most field insects are reported even at full pesticide dosage". And conjectures, "lower levels of aphids observed on organic farms could well reflect lower nitrogen and protein content of organic crops". A new study comparing arthropod communities and pest damage levels to fresh market tomato, Lycopersicon esculentum, was carried out on 18 commercial farms in California, representing a range of management practices, half operating as organic and half as conventional [4]. The study found that insect pest damage varied across the spectrum of farm management practices and organic and conventional farms did not differ significantly for any type of damage to tomato foliage or fruit. However, there was a significant difference between the actual community structures of arthropods. There was higher abundance of natural enemies, and greater species richness of herbivores, predators, parasitoids and others in organic farms where arthropod biodiversity was one-third greater. Trewavas claims "developments in the past 25 years have shown how conventional agriculture can be much more sustainable and environmentally friendly than organic farming". He cites the Institute of Arable Crops Research (IACR) website as reference. The scientific literature contradicts his claim. A new study in Nature compared the sustainability of organic, conventional and integrated apple production systems in Washington State from 1994 to 1999 and found the organic systems ranked first for environmental and economic sustainability, with the integrated second, and the conventional last [5]. The researchers measured soil quality, horticultural performance, orchard profitability, environmental quality and energy efficiency, which are all specific indicators of sustainability. They found that all three systems gave similar apple yields. The organic and integrated systems showed higher soil quality and lower negative environmental impact. But the organic systems produced sweeter and less tart apples, higher profitability and were more energy efficient. Tree growth was similar for all three systems but analysis of fruit firmness at harvest and after storage showed that the organic fruit was firmer. Environmental impacts were assessed using the rating index employed by scientists and growers. The total environmental impact rating of the conventional system was 6.2 times higher than that of the organic system, and the integrated system was 4.7 times higher. Energy accounting was divided into inputs (labour, fuel, fertilisers and so on), output (yield) and output/input ratios (energy efficiency). Energy efficiency for the organic system was 7% greater than the conventional system and 5% greater than the integrated system. Enterprise budgets were generated each year to calculate net returns from total costs and gross receipts. There was no price premium for integrated fruit but the price premium of organic apples averaged 50% higher than conventional prices. Hence, the organic system was more profitable. The use of manure on organic farms results in higher, beneficial levels of biodiversity, especially earthworms, but Trewavas claims there are "numerous problems", including "possible effects on human health". Manure is also widely used on conventional farms. Faecal matter is known to contain a range of human pathogens but properly treated manure is effective and safe. Furthermore, unlike conventional regimes, mandatory organic certification bodies inspect farms to ensure standards are being met. Trewavas states, "ploughing in of legume crops on organic farms to improve soil fertility and continued manure breakdown leads to nitrate leaching into aquifers and waterways at identical rates to conventional farms". The occurrence of nitrates is a major public health hazard as they can be converted to nitrosamines, which are carcinogens and nitrates impair the ability of blood to carry oxygen. But FAO reports that nitrate content on organic farms is "significantly lower" due to absence of soluble fertilizers and the governments of Germany and France encourage conversion to organic farming in a bid to improve water quality in certain areas. Furthermore, the use of 'biosolids' from wastewater treatment facilities (sludge) on conventional farms raises concern over heavy metals, toxic organic compounds, such as dioxin, PCBs and persistent microbial pathogen contamination. The Codex and EU organic standards prohibit the use of sewage sludge and the US National Organic Programme also bans it. Organic regulations recommend hay for animal feeding, but Trewavas claims "hay-fed animals infected with Escherichia coli 0157 incubate this dangerous organism longer than conventional animals fed with grain". FAO report that the US Centres for Disease Control (CDC) identifies the main source of E. coli infection as meat contaminated during slaughter. Virulent strains of E. coli such as 0157, develop in the digestive tract of cattle that are fed mainly with starchy grain [6]. Cows fed with hay generate less than 1% of E. coli found in faeces of grain-fed animals. FAO concludes, "ruminants like cattle and sheep fed in the organic system reduce the risk of E. coli infection". Trewavas writes, "food mycotoxins from contaminating fungi definitely contribute to European cancer rates, and fumonisin and patulin are both reported to be higher in organic products". He claims "failure to use effective fungicides on organic farms has led to these farms acting as repositories of disease" and "organic farms may be protected from the full effects of disease outbreak because they are surrounded by conventional farms using proper fungicides." Mycotoxins are toxic by-products of certain moulds that can grow on food. Since fungicides are not allowed in organic systems, many studies have investigated their presence in both organic and conventional foods [7]. From these, FAO conclude, "it cannot be concluded organic farming leads to an increased risk of mycotoxin contamination". FAO report two studies that found aflatoxin levels in organic milk were lower than conventional, suggesting additional risks involved with feeding mainly grain to conventionally raised livestock. Aflatoxins are most toxic and can induce liver cancer at low doses if ingested over time. The report states, "as organically raised livestock are fed higher proportions of hay, grass and silage there is a reduced opportunity for mycotoxin contamination." Several other hazards are associated with conventional food production. In Central and Eastern Europe, there are areas of high contamination due to industrial activities, from mining, smelting, the energy sector, agricultural practices and disposal of hazardous and municipal wastes. FAO reports, "A more widespread use of organic agriculture would contribute to a reduction of environmental degradation, ultimately resulting in reduced levels of contaminants in food". Furthermore, "EU member states increasingly see organic agriculture as a tool for improving rural economies and stability, while simultaneously increasing biodiversity and environmental sustainability". It is clear that holistic approaches that link ecology and economics benefit both the ecosystem and human health, and are competitive in commercial markets. 1. Urban Myths of Organic Farming, by Anthony Trewavas, Nature, Vol 410, 22 March 2001 pp 409-410 2. 'Nutritionists question study of organic food', Nature, Vol 412, 16th August 2001 3. Twenty Second FAO Regional Conference for Europe, Porto, Portugal, 24-28 July 2000, Agenda Item 10.1, Food Safety and Quality as Affected by Organic Farming, Available for download at http://www.fao.org/organicag/frame2-e.htm 4. D.K. Letourneau & B Goldstein (2001) Pest damage and arthropod community structure in organic vs. conventional tomato production in California, Journal of Applied Ecology, vol 38, pp 557-570 5. John P Reganold, Jerry D Glover, Preston K Andrews and Herbert R Hinman (2001), Sustainability of three apple production systems, Nature, Vol 410, 19th April, pp 926- 930 6. Couzin, J et al (1998) Cattle Diet Linked to Bacterial Growth, Science Vol 281, pp1578-1579 7. Marx H, Gedek,B & Kallarczil, B (995) Comparative investigation of mycotoxicological status of alternative and conventional grown crops, Z Lebensm Unters Forsch, 20, 83-6 AIDS Vaccines Trials Dangerous ****************************** The embattled OECD Conference in Genoa announced a $1.2 billion package to help combat AIDS in the Third World. Vaccine developers and United Nation agencies are pushing for large-scale clinical trials of AIDS vaccines in vulnerable Third World populations ravaged by the AIDS pandemic. AIDS virologists point to evidence that the vaccines are not only ineffective but also dangerous. They call for a UN body to monitor and control GM experiments. Dr. Mae-Wan Ho reports. The culprit viral gene ********************** The intended vaccines all contain gp120, a glycoprotein (protein decorated with side-chains of carbohydrates) belonging to the envelope of the human AIDS virus, HIV-1. The candidates include recombinant HIV proteins and peptides (subunit vaccines), HIV-1 or SIV (the monkey AIDS virus), killed or 'attenuated', ie, rendered harmless by successive passage in cultured cells, and a wide range of recombinant viral, bacterial and plasmid vectors expressing HIV proteins. (Plasmids are pieces of parasitic genetic material existing outside the cell's genome, and are replicated by the cell independently of the cell's genome.) HIV researchers Dr. Veljko Veljkovic and his colleagues in Belgrade Yugoslavia, have shown that the gp120, is similar to the part of human immunoglobulin (antibody) proteins (Ig) involved in binding foreign antigens, a crucial step in the immune response. Thus, any AIDS vaccine containing the gp120 glycoprotein or the gene coding for it could strongly interfere with the immune system and make the host more vulnerable to the virus. And in the longer term, it could accelerate disease progression in HIV patients that do not yet have symptoms. But the gp120 gene has other properties that pose an even greater threat to the vaccinated population. It contains 'recombination hotspots' similar to those in bacteria and viruses such as Haemophilus influenzae, Mycobacterium tuberculosis, hepatitis B virus and herpes simplex virus, that often co-infect with the HIV, and also similar to recombination elements found in immunoglobulin genes and oncogenes (genes associated with cancer) in the human host. Recombination hotspots are breakpoints at which genetic exchange or recombination occurs much more frequently than usual. Recombination of HIV with bacteria and viruses would generate new pathogens. Within the human host, recombination with human genes would promote chromosomal rearrangements and formation of abnormal immuno-globulins, thus undermining immune responses. HIV-1 sequences integrated into the genome can act as retrotransposons (jumping genes) that can mutate genes by jumping into them, and some of the mutations may trigger cancer [1]. Dr. Veljkovic's team, in collaboration with researchers in UK, Italy and US, have already found evidence of recombination between gp120 and a gene from Haemophilus influenzae [2]. Recombination between an HIV gene and Mycoplasm fermentans has been implicated in 'Gulf war syndrome' [3] affecting a high proportion of soldiers from the United States and the United Kingdom who served in the Gulf war. A new subtype of HIV-1 may also have resulted from recombination between HIV-1 and SIV [4]. The proponents of the AIDS vaccination trials argue that the desperate situation precipitated by the AIDS epidemic justifies acceptance of the 'small risks' involved. But Veljkovic and his colleagues have written a monograph documenting the lack of efficacy of the vaccines and the enormous risks involved [5]. Not effective and dangerous In 1994, the AIDS Research Advisory Committee of the US National Institutes of Health (NIH) recommended that phase III clinical trials of gp120 vaccines should not be conducted "at this time and in this country". The reasons, according to Dr. A. Fauci, director of National Institute of Allergy and Infectious Diseases (NIAID), were that the vaccines were ineffective; and there was a remote chance that the vaccines would compromise the immune system and make the recipient more vulnerable to infection [6]. The possibility that a vaccinated individual runs a greater risk of developing an established infection, or of progressing to disease more rapidly once infected, was confirmed subsequently [7]. The recombinant gp120 subunit vaccine tested in HIV-negative individuals was ineffective in protecting them against infection. Those who became infected during or after vaccination actually had in their blood sera significant levels of antibodies against the vaccine before they became infected, but those antibodies failed to protect them from infection. On the contrary, the vaccine appeared to have acted as a decoy to fool the immune system into mounting an attack on it, while allowing the HIV itself to slip through the host defence to get established. This subunit vaccine is due to go on Phase III clinical trial in Thailand. Live recombinant viral and bacterial vaccines The safety concerns for the individual are bad enough. But it is the effect on vulnerable populations that really worries Veljkovic and his colleagues, especially from the live recombinant viral and bacterial vector vaccines (see box). Many viral and bacterial pathogens are being used as vectors, and a number are currently considered promising AIDS vaccines. But they are also promising candidates for generating new infectious agents. The Salmonella vaccine in Uganda The AIDS vaccine based on live Salmonella vector was developed by the International AIDS Vaccine initiative (IAVI) in partnership with the US-based Institute of Human Virology (IHV) of the University of Maryland and the Uganda Ministry of Health. The development of the 'disarmed' Salmonella vector expressing HIV-1 gp120 and gp120-derived peptides was started in the early 1990s. The Salmonella vector expressing HIV envelope proteins has been tested in 37 people in a phase I trial by NIAID. Uganda will be the first country in Africa to host a clinical trial of this vaccine. The only safety concern, it seems, was to ensure that the vaccine did not induce Salmonella disease (ie, diarrhea) in participants [8]. Whereas, Veljkovic stressed, the right safety question should be: "Is the probability for transfer of HIV's genetic material from recombinant Salmonella vector to other pathogens equal to zero_" To which the answer is an emphatic no. Salmonella has the same kinds of recombination hotspots (called 'Chi') that are present in gp120, and is known to exchange blocks of genes with E. coli and other bacteria. The potential is rife for generating new pathogens by recombination between the Salmonella vaccine and diverse endemic infectious bacteria in Africa. The Venzuelan equine encephalitis vaccine in South Africa An AIDS vaccine based on the live Venezuelan equine encephalitis (VEE) virus vector, developed jointly by South Africa and the United States, was due for phase I clinical trials early this year, moving on to large trials lasting several more years. The country hoped to make a vaccine against AIDS generally available by 2005. According to a spokesperson for the Medical Research Council of South Africa, a successful vaccine has the potential to save 20 million lives during its first decade of use. The VEE vaccine was developed by the University of North Carolina at Chapel Hill with five-year federal funding from NIAID totalling more than $12 million. The stated advantages of the VEE vaccine, according to the developers, are that it targets cells in the lymph nodes, and that "unlike vaccinia virus, poliovirus, adenovirus, herpesviruses and influenza virus-based vaccine vectors, most of the human population have never been exposed to VEE. Therefore immunisation to HIV with a VEE-based vector would not be restricted by preexisting immunity to the vector itself"[9]. Unfortunately, that is not the case. VEE virus is carried by arthropods, and it is endemic in northern South America, Trinidad, Central America, Mexico and Florida; and eight different VEE strains have been associated with human disease. These agents also cause disease in horses, mules, burros and donkeys. Natural infections are acquired by bites from a wide variety of mosquitoes. The same virus was also developed as a biological weapon by the US in the 1950s and 1960s. A herpes simplex viral vaccine that shows promise in non-human primates A modified herpes simplex virus (HSV) that invades host cells and expresses protein from the SIV has been developed by researchers at Harvard University into a live attenuated AIDS vaccine, which show promise in non-human primates. They claim that "HSV vectors show great promise for being able to elicit persistent immune responses and to provide durable protection against AIDS" [10]. The same research team has also developed an HSV-2 vector based on another herpes virus responsible for genital herpes, with the expectation that this vector could serve a double role as vaccine for HIV as well as genital herpes. Unfortunately, the HSV genome contains the greatest number of Chi recombination hotspots of all the microorganisms listed. It also contains Ig class-switch sequences (also recombination hotspots) and other sequences involved in the genetic rearrangements that take place in producing human immunoglobulin genes in blood cells. High levels of recombination have already been identified in the HSV genome associated with these hotspots. A vaccinia virus vaccine led to disease and death Among the first AIDS vaccines with live viral vectors to be tested in humans was a recombinant, highly attenuated vaccinia virus expressing HIV-1 proteins. The vaccinia-gp160 vaccine was developed by Bristol-Myers-Squibb who performed the preclinical study in the period 1985-1988. The phaseI/II research began in 1988 and was dropped in 1993, then continued for an additional year. These studies combined the vaccinia-p160 vaccine with gp160 or gp120 vaccine developed by MicroGeneSys, Chiron, Genetech, and Immuno AG. Unfortunately, a recombinant HIV-vaccine virus arose from the attenuated live vaccine, which was harmful for the immune compromised individuals, producing symptoms of progressive vaccinia and death [11]. There was also the danger that the recombinant virus could spread and harm other persons with AIDS. A canary pox vaccine in Uganda, Haiti, Trinidad and Brazil Another poxvirus was used, the canarypox virus. When the canarypox virus carrying HIV genes infect human cells, the cells make proteins from the genes and package them into HIV-like particles called pseudovirions that are non-infectious. These trigger the host immune response against HIV. The first such canarypox viral vaccine carrying the HIV-1 gp160 gene was developed by Pasteur-Merieux-Connought and, in combination with Chiron's gp120 construct. It entered phase II trial in the US in 1997. The first phase I trial of a canarypox vaccine in Africa was launched early in 1999. It was tested for safety and immunogenicity in Ugandan volunteers, and to reveal the extent to which immunized Ugandans have cytotoxic lymphocytes that are active against the subtypes A and D of HIV, which are prevalent in Uganda. The vaccine was planned to enter phase I/II trials in Haiti, Trinidad, and Brazil during 2000. Is canarypox virus safer than vaccinia virus_ Most probably not. Both are orthopox viruses and are rich in recombination hotspots. This family of viruses is widely distributed, and recombination between different poxviruses can readily take place. Recombinants have arisen that are more virulent than either parent, and it is impossible to predict the fate of released canarypox vaccine with HIV genes. The use of these vaccines in Africa where monkeypox is endemic is likely to generate recombinants with unpredictable pathogenicities. Monkey pox is transmitted from human to human, but the natural virus is relatively harmless. Could a recombinant virus arise that may be as virulent as the smallpox virus_ AIDS vaccines in plants could generate recombinant viruses that switch hosts from plant to animal Finally, AIDS vaccines based on HIV antigens produced in plants are also being developed. The tobacco mosaic virus, TMV, has been used as a vector to express recombinant coat protein of alfafa mosaic virus (AIMV) containing antigenic peptides from the rabies virus and HIV-gp120 [12]. There have already been many examples of recombination between viral coat proteins in transgenic plants and infecting viruses [13]. In addition, there is also evidence that a plant virus has switched host to infect vertebrates and recombined with a vertebrate virus [14]. Vaccine trials in breach of UNAIDS ethical, scientific and safety standards According to the WHO report 2000, more than 90% of all AIDS cases are in developing countries. UNAIDS and NIH are the two most important organizations involved in developing AIDS vaccines. UNAIDS Executive Director Peter Piot has declared, "It is our collective responsibility to ensure that all vaccine trials are conducted under the strictest possible ethical and scientific standards." But Dr. Veljkovic has shown that current vaccines based on HIV-1 gp120 can harm the immune system of individuals and, on account of its recombinogenic tendencies, has the potential to generate deadly viruses and bacteria that can spread through the vaccinated populations and to wild life. The intended vaccine trials are in serious breach of ethical, scientific and safety standards. AIDS, more so than other diseases, cannot be addressed simply by vaccinations, even if efficacious and safe vaccines could be found. More than drugs and vaccines, we need to end poverty, malnutrition and environmental destruction, to reinstate social equity and free access to primary healthcare and education. 1. See "Superviruses and Superbugs from AIDS vaccines, ISIS News 9/10 ISSN1474-1547(print), ISSN1474-1814 (online). 2. Prljic J, Veljkovic N, Doliana T, Colombatti A, Johnson E, Metlas R. and Veljkovic V. Identificaion of an active Chi recombinational hot spot within the HIV-1 envelope gene: consequences for develop-ment of AIDS vaccine. Vaccine 1999: 17: 1462-7. 3. Nicolson GL, Nicolosn NL and Nasralla Mycoplasmal infections and fibromyalgia/ chronic fatigue illness (Gulf War Illness) associated with deployment to operation Desert Storm. Int. J. Med. 1998: 1: 80-92. 4. Simo F, Mauclere P, Roques P, Muler-Trutwin MC, Saragosti S, Georges-Courbot MC, Barre-sinoussi F and Brun-Verzinet F. Identification of a new human immunodeficiency virus type I distinct from group M and group O. Nature Med. 1998: 4: 1032-7. 5. Veljkovic V et al Chapter 7. Safety and ethical considerations of AIDS vaccines (courtesy of Dr. Veljkovic). 6. "The HIV vaccine paradox". Science 1994, 15, 475. 7. Locher CP, Grant RM, Wrin T. et al. Antibody and cellular immune responses in breakthrough infection subject after HIV type 1 glycoprotein 120 vaccination. AIDS Res Human Retovir 1999, 71, 1685. 8. Gold D. IAVI launches project to develop oral HIV vaccine. IAVI Report, April-June 2000. 9. Caley IJ, Betts MR, Irlbeck DM. Et al. Humoral, mucosal, and cellular immunity in response to a human immunodeficiency virus type 1 immunogen expressed by a Venezuelan equine encepphalitis virus vaccine vector. J. Virol. 1997, 71, 3031. 10. Murphy CG, Lucas WT, Means RE. Et al. Vaccine protection against simian immunodeficiency virus by recombinant strains of herpes simplex virus. J. Virol. 2000, 74, 7745. 11. Picard O, Lebas J, Imbert JC. et al. complications of intramuscular/subcutaneous immune therapy in severely immune-compromised individuals. J. Acquir. Immun. Defic. Syndr. 1991, 4, 641. 12. Yusibov V, Modelska A, Steplwski K. et al. Antigens produced in plants by infection with chimeric plant viruses immunize against rabies virus and HIV-1. Proc. Natl. Acad. Sci. USA, 1997, 94, 5784. 13. Reviewed in Ho MW, Ryan A, Cummins J. Hazards of transgenic plants with the CaMV 35S promoter. Microbial Ecology in Health and Disease 2000, 12, 6-11. 14. Gibbs MJ, Weiller GF. Evidence that a plant virus switched host to infect a vertebrate and then recombined with a vertebrate-infected virus. Proc. Nat. Acad. Sci. USA 1999, 96, 8022. Terminator Patents Decoded ************************** Terminator technology is a collection of genetic engineering tricks to make seeds sterile, so farmers cannot save and replant the seeds. The sole purpose of this technology, now owned by the big seed corporations in collusion with the US government, is to control seed production at source. It violates the basic human right of people to grow their food from saved seeds, and also introduce some of the most dangerous genes and constructs into crop-plants. This highly immoral and hazardous development must be stopped. All terminator crops that have been released commercially or undergoing field trials must be recalled and destroyed. ISIS exposed the duplicity of biotech corporations that have been testing and growing terminator crops since 1990, while pretending that none has yet been produced. Dr. Mae-Wan Ho and Prof. Joe Cummins have written a primer explaining the technology in general terms (see "Terminator crops are here, ISIS exclusive" and "Killing fields near You", ISIS News 7/8). This sequel article unravels several different versions of the technology that have been patented. The patents cover not only terminator techniques that engineer seed/pollen sterility, but also the control of expression of specific traits such as insect tolerance, drought tolerance or modification of secondary metabolism. The overall aim is certainly to control either seed production or agronomically important traits at source. The genes used, as well as the constructs will have catastrophic consequences on biodiversity and health. USDA and Delta and Pineland Company patent US5925808: Control of Plant Gene Expression, filed July 20, 1999/ Dec. 19, 1997 This is substantially the same as US 5723765, granted in 1998. It is a broad patent that includes not only constructs for controlling plant gene expression, but also the methods whereby the transgenic plants are generated by transformation, the vectors for transformation, and the various crosses between plants. Cotton plants are mentioned specifically in this patent. The main constructs are as follows, 1. A lethal, terminator gene, call it gene a, linked to a transiently active promoter, call it p(t), the gene and promoter being separated by a blocking sequence, call it block flanked on either side by specific excision sequences, call them ex. p(t)-ex-block-ex-gene a 2. A second gene, call it recom, encoding a recombinase, specific for the excision sequence ex of the first construct, linked to a repressible promoter, call it p(r), that is active during seed germination. p(r)-recom 3. A third gene, call it repress, encoding the repressor that binds to the repressible promoter p(r) to turn the second gene off. Although not mentioned in this patent, the repressor is one that can respond to an external chemical, such as tetracycline, which through a tetracycline responsive promoter p(tet) linked to the repressor, can turn the repressor on (or off, in another version). p(tet)-repress In one version of how this is intended to work, the seeds are germinated, by the company, in the presence of tetracycline, which turns on the repress gene, the repressor protein binds to p(r) and stops recom from being expressed, so gene a is blocked, and nothing happens. In the absence of tetracycline, say, when the farmer sows the seeds, the repressor protein is not expressed, so during seed germination, recom is turned on to make recombinase. The recombinase snips out the blocking sequence, block, and gene a is expressed. If gene a is a lethal gene that kills the male part of the flower, and p(t) is a promoter that acts only in the male part of the flower, the plant will be male sterile. If gene a and its promoter are specific for the female part of the flower, the plant will be female sterile. If gene a and its promoter are specific for germination, then seeds will set, but they can't germinate. Each of the genes, promoters and repressors itself can be any one selected from an entire group of possibilities. Thus, gene a may be one of the following: lethal genes that kill the cell (terminator gene proper), insecticidal gene, fungistatic gene, fungicidal gene, bacteriocidal gene, drought resistance gene, protein gene product or a gene that alters secondary metabolism. Similarly, the transiently active promoter p(t) may be a promoter that is active in late embryogenesis, in seed development, in flower development, leaf development, root development vascular tissue development, pollen development (male sterility), after wounding, during hot and cold stress, water stress, or during or after exposure to heavy metal. The specific excision sequences and recombinase are selected from a group that comprise not only site-specific recombinase but transposase, flippase, resolvase, and integrase, Male sterility includes any lethal gene linked to an anther-specific promoter or pollen-specific promoter. Lethal genes include ribosomal inhibitor protein. A lethal gene linked to a promoter that is active during late embryogenesis, for example, will give rise to seeds that are sterile, one that is linked to a promoter active during germination will result in seeds that fail to germinate. The blocking sequence can be a sequence that confers male sterility. Syngenta (Zeneca) patent US 5808034: Plant gene construct comprising male flower specific promote[r], filed 15 September 1998). This is an update on a patent first filed in 1990. It involves a cascade of gene regulation, the end result is the expression of a protein that disrupts pollen development. The disrupter protein is restricted to the male parts of the plant by an upstream promoter specific to male flowers. The male specific promoter being placed under the control of a regulatory sequence called the operator, that is turned off by a repressor protein binding specifically to it, and the expression of the repressor protein can be induced by a specific chemical externally applied. The constructs are as follows: 1. A promoter p(I) responsive to the presence or absence of an exogenous chemical inducer, linked to the gene repress for the repressor protein. p(I)-repress 2. An operator op responsive to the repressor protein linked to the male specific promoter p(m), which is linked in turn to disrupt, the gene for the disrupter protein that kills the pollen. op-p(m)-disrupt When the chemical inducer is applied, the cascade goes as follows: external chemical inducer Ý repressor Ý operator Ý no expression of disrupter protein. The net result is the line can be maintained. In the absence of the external chemical inducer, the repressor is not expressed, so the disrupter protein is expressed and the result is male sterility. This is rather similar to the USDA-Delta Pine patent above, but the constructs are a bit simpler, and do not involve a recombinase. Clearly the company can sell the proprietary chemical inducer to restore fertility to the line or to maintain it. As said, the whole point of the patent is to control the production of fertile seeds. As in the USDA-Delta Pine patent above, each element in the patent can be realised with any one from a whole group of possibilities. The chemical switch, p(I), is exemplified by the promoter of the maize glutathione-S-transferase (GST II) gene, which is responsive to a host of chemicals, called 'safeners'. Safeners, also known as antidotes are used to protect crops from herbicide injury, as they induce a family of enzymes, glutathione-S-transferases which catalyse the detoxification of a large range of hydrophobic (water-insoluble, fat-soluble) electrophilic (eletron-loving) compounds, ie herbicides, by joining up with them via the sulphydryl group, and causing their removal from the body of insects and mammals. The patent lists many potential chemical inducers of the GST II gene . Safeners are used in combination with herbicides to reduce crop damage from the herbicide. The herbicide families requiring safeners are thiocarbamate and chloroacetanilide herbicides used to control weeds in corn, rice, sorgum and other grasses. The chemicals listed in the patents include the safteners with common names like flurazole, napthinic anhydride, dicyclonon, oxabentrinil, fenclorim, cyometril, fluxofenim, furilazole and dietholate. There do not seem to be many publications reporting on the safety of the safeners. United States Patent 5,750,867(Plant Genetic Systems, now Aventis): Maintenance of male-sterile plants, filed May 12, 1998 This patent, first filed in 1992, covers "transgenic plants that have, stably integrated into their nuclear genome, a maintainer gene comprising a fertility-restorer gene and a pollen-lethality gene" (italics ours, because we don't believe any evidence exists that the integrated foreign DNA is indeed stable). The plants can be used to maintain a homogeneous population of male-sterile plants. This specific patent covers maize plants, but the method has already been tried out in oilseed rape. A complicated process for maintaining a male-sterile line is required, in which a male-sterile line is crossed with a 'maintainer line'. The male-sterile line is homozygous for a male-sterile gene, barnase, coding for a ribonuclease (barnase) from the bacterium Bacillus amyloliguefaciens, placed under an anther-specific promoter p(a), which acts early in the development of the male flower. In other words, it has two copies of the construct, one on each of a pair of chromosomes. This can be represented as follows. p(a)-barnase p(a)-barnase The 'maintainer line' is male fertile. It has the same genotype as the male-sterile line (ie, it is homozygous for the male sterile gene and stamen-specific promoter), and in addition, and not linked with the male-sterility gene, is heterozygous for a 'restorer gene' directed by a 'restorer promoter', p(r), which is at least also expressed in the stamen cells, linked with a 'pollen-lethality' gene under the control of a pollen-specific promoter p(m), ie, one which is expressed late in the development of the male flower, in pollen-cells after meiosis, the cell division leading to halving the chromosome complement. (The male-sterility gene is expressed before meiosis.) The restorer gene, barstar producing the protein barstar, also from Bacillus amyloliguefaciens, is a specific inhibitor of the male sterility gene product, barnase, while the 'pollen-lethality' gene, lethal, prevents pollen from being formed. The genotype of the maintainer line can be represented as follows (the big rectangle on the outside represents a cell). Before meiosis p(a)-barnase p(r)-barstar-p(m)-lethal p(a)-barnase - After meiosis p(a)-barnase p(r)-barstar-p(m)-lethal p(a)-barnase - As can be seen, after meiosis, the only viable pollen is the one with barnase, which confers male sterility. This pollen will spread the male-sterility trait around. Each piece of the genetic jigsaw can be any one of several genes. Thus, p(a) can be the promoter of the zm 13 gene from maize or the TA29 gene from tobacco, or any promoter that directs expression in the tapetum cells of the stamen. The male-sterility gene barnase, can be any ribonuclease instead of barnase, while the restorer gene could be any ribonuclease-inhibitor instead of barstar, which is specific for barnase. The restorer promoter p(r) could be identical to p(a) so long as it leads to the expression of the restorer protein at the same time and in the same cells as the terminator protein. As the restorer gene and the sterility gene are not linked, half of the ovule (female part) of the restorer plants, on average, will be male-sterile with barnase only. The other half will have both barnase and the barstar linked to the pollen-lethal gene. The pollen-lethal gene linked to the restorer gene prevents the male gametes containing the restorer gene from developing, so the only pollen available is one without the restorer gene, but carrying the male-sterility gene all the same (see diagram above). When the maintainer line is selfed, the progeny will consist of 50% heterozygotes, ie, same as the maintainner line, and 50% male-sterile. So, it is necessary to incorporate a selectable marker, such as herbicide tolerance, next to the male-sterile gene or the restorer gene, or a different selectable marker can be put next to each. Say, a gene coding for phosphinothricin acetyl transferase (PAT) linked to the barnase gene in the male-sterile line, and that will enable only male-sterile seeds to be selected. United States Patent 5,633,441 (Plant Genetic Systems, now Aventis): Plants with genetic female sterility filed May 27, 1997, This patent, first filed in 1990, is similar to the male-sterile patent, except that a female-specific promoter is used to control expression of a lethal terminator gene in the female part of the flower without affecting the male part. The female-sterility gene is linked to a selectable marker gene with its own promoter, so that the female-sterile plants can be selected. In addition, a 'transit-peptide' is included in both the female-sterility gene and the marker gene to direct the gene product into chloroplasts or mitochondria, presumably so it does not affect pollen development, although many plants do have chloroplasts in pollen. Terminator genes include, besides barnase, papain active protein, or the A-fragment of diphtheria toxin. Marker genes used include herbicide resistance gene, or a gene conferring a disease or pest resistance, a GUS gene for glucuronidase, or a gene encoding a Bacillus thuringiensis (Bt) endotoxin. The second promoter, linked to the marker gene, may be a constitutive promoter (expression at all times in all cells), a wound-inducible promoter, a promoter which directs gene expression selectively in plant tissue having photosynthetic activity, or a promoter which directs gene expression selectively in leaf cells, petal cells or seed cells. The patent claims include methods and vectors for making the transgenic plants, the various bits of DNA, the genes as well as the style-, stigma-, ovary-, seed- and embryo-specific promoters. Also claimed are the cell cultures, the hybrid seeds produced by crossing the female-sterile plant with a female-fertile plant; and a process for producing such hybrid seeds, as well as seedless fruit. The plants for which the patent is claimed include corn, potato, tomato, oilseed rape or other Brassica species, alfalfa, sunflower, cotton, celery, soybean, tobacco, and sugarbeet. Hazards galore We have pointed out the hazards of terminator technology in earlier papers ("Terminator in new guises", ISIS News 3, December, 1999; "Killing fields near you", ISIS News7/8 Feb. 2001), and will only briefly recapitulate them here. There are many different constructs, all of which have to be precisely engineered, and integrated into plants as intended, which is beyond the capability of current technology. A lot of gene scrambling occurs in artificial GM constructs as they are integrated, and genetic engineers cannot control where they are integrated either, thus multiplying the uncertainties and unpredictability of the GM crops produced. The recombinase and similar enzymes in the USDA-Delta Pine patent is perhaps the most dangerous, as it is known to cause recombination at non-specific sites, thereby causing largescale genome scrambling (see "Terminator recombinase does scramble genomes", ISIS News 7/8). The terminator lethal genes and gene products are known to be harmful to cells, including mammalian cells. Some of the most hazardous genes are designed to spread through pollen, including 'male-sterile' gene-constructs, and indeed, female-sterile constructs. Genes and GM constructs can spread, not just through cross-pollination, but by horizontal gene transfer to unrelated species, and this process cannot be controlled. The instability of GM constructs in general and the complicated ones in terminator constructs in particular, increase the propensity for horizontal gene transfer and recombination. Horizontal gene transfer and recombination is one of the main routes for generating new viruses and bacteria that cause diseases, and for spreading drug and antibiotic resistance to make the diseases untreatable. This highly hazardous and immoral development must be stopped, and all terminator crops that have been released commercially or undergoing field trials must be recalled and destroyed. SPECIAL ESSAY Science & Ethics in a New Key ***************************** Dr. Mae-Wan Ho presented this essay in parts during the Science and Society Conference held in Emory College, Atlanta, Georgia, USA, October 4-7, 2001 In his recent book, Michael Fox asks whether genetic engineering will mean the end of the natural world as we know it, and take us beyond evolution [1]. But the remark that strikes me most of all is, "We have become blind to the perfection of larks". It sums up the mechanistic science that makes gross violations of the natural world a matter of routine. Western science began in sixteenth century Europe under the legacy of the Judaeo-Christian tradition which inspired the search for eternal laws, such as could make the universe move in predictable, mechanical ways. Through Copernicus, Galileo and Descartes, this strand of thought eventually culminated in Newton's laws of mechanics. So successful was the mechanistic framework that every event in nature came to be seen in this perspective. Another strand in the legacy of the Judaeo-Christian tradition is that human beings are considered to be created in the image of God and to have immortal souls, while animals and the rest of nature are there to be used by human beings. Descartes established the dualistic separation of human beings from nature, of mind from body and matter from spirit. He maintained that only human beings can reason, that animals are unfeeling machines; and condoned cruel experiments on dogs and cats. Francis Bacon, similarly, urged that we "vex Nature of her secrets" that it was our right to extend our power and dominion over the universe. In The Island of Dr. Moreau, he described, prophetically, animal parks used for public viewing and for "dissection and trials, that thereby we may take light what may be wrought upon the body of man…" Genetic engineering is a step up in the exploitation of nature. The first transgenic mice were created for use in research in the 1980s. Michael Fox and Jeremy Rifkin challenged the National Institutes of Health (NIH) to suspend government-funded trans-genic animal research until the ethics and consequences had been fully explored and publicly aired. They questioned the right of our species to interfere so profoundly with the telos, or inherent nature, of animals, but met with united opposition from the scientific establishment. Dr. Maxine Singer, world-famous molecular biologist, declared, "Species can have, and many in the past have had a telos (an end), namely, extinction. That is the only telos known to exist." Dr. David Baltimore, Nobel laureate molecular geneticist, stated that he opposed prohibitions and regulatory statements about "morally and ethically unacceptable" practices because "those are subjective and therefore provides no basis for discussion". Fox caused a ruckus at the NIH and other animal laboratory facilities when he sent letters to several vets in charge of animals asking what analgesics they used. Many were using none to alleviate pain following various experimental procedures. One animal scientist, when challenged as to whether pigs have feelings in a debate on factory farming, replied "We need to do more research before we can be really sure." On transporting calves in veal crates over long distances, the same scientist defended the practice on grounds that "There is no scientific evidence that veal calves need to turn around." In a recent survey of academics from various disciplines, 17 to 25% of those in animal science and zoology believed animals do not have minds. Since the 1980s, genetic engineering of both plants and animals has expanded. Millions of transgenic mice are now used in research laboratories as models of human diseases. However, too many models do not give the same disease symptoms as in human beings, a point noted by the UK Royal Society, which defends their use, nevertheless [2]. Livestock and fish are genetically engineered to grow bigger faster, or to produce leaner meat, and further down the line, to be resistant to diseases. Farm animals are engineered as 'bio-reactors', to supply pharmaceuticals and industrial material in their milk, blood, urine and semen. Pigs are engineered to supply organs for transplant into human beings. Closely linked to transgenesis is cloning, so herds of identical transgenic animals could be created for the various uses. Mechanistic biology has reached its logical conclusion when even human beings are to be genetically engineered and cloned for the use of other human beings. In so-called 'therapeutic' human cloning, the nucleus containing the genome of an adult human being is transferred into an egg from which the egg's nucleus has been removed. This is then stimulated to grow into an embryo from which embryonic stem cells are harvested, to be further cultured for use in cell and tissue replacement, the embryo being killed in the process [3]. The first 'human' clones were created by injecting the genetic material of human beings into the eggs of cows and pigs, all too reminiscent of Mary Shelley's parable of Frankenstein. Transgenesis and animal cloning are both characterised by high failure rates and large numbers of monstrous abnormalities even among the 'successes' [reviewed in 4, 5]. Many clones die before birth, others succumb suddenly weeks or months after birth. In some cases, the surrogate mothers carrying the cloned foetuses are also affected. Three cows died while pregnant with clones, from fatty livers and other abnormalities. "Cloning by nuclear transfer (NT) is an inefficient process in which most clones die before birth and survivors often display growth abnormalities" [6] so admits an international team of researchers recently, who have examined mice cloned using nuclei from embryonic stem cells. In short, transgenesis and cloning are notable for colossal failures. Unlike Dr. Frankenstein, his modern counterparts are unrepentant, and would carry on business as usual. The much-touted embryonic stem cells carry cancer risks and are prone to uncontrollable variations in culture [3,6]. Foetal cells, presumed to contain stem cells and transplanted into the brain of 5 Parkinson's patients, turned into an irredeemable nightmare because the cells grew uncontrollably [7]. Meanwhile, it is increasingly clear that bone marrow and other stem cells from adults show much greater promise in cell and tissue replacement. A doctor has succeeded recently in using a patient's own bone marrow cells to mend his failing heart [8]. The procedure is so simple that it does not require any patented medicines to suppress immune rejection, nor any patented cell lines for transplant, which is why profit-driven corporate science cannot afford to do it. Transgenesis carries the potential hazard of creating new viruses that cross species barriers. The danger of new viruses and the excessive suffering inflicted on the animals are both clearly evident in xenotransplantation [9,10]. Primates have been cruelly abused as experimental transplant recipients, and endogenous pig viruses are found to infect animals receiving pig cell or organ transplants, precisely as predicted by virologists who have been warning of the danger from the beginning. To counter this unfolding horror of mechanistic science out of control, we desperately need to recover our sense of the perfection of larks and our kinship with all of creation in another kind of science. Most people accept that there is a two-way connection between science and society. Science is both shaped by the politics and the mores of society and it can reinforce them. But what is often overlooked is that science, by its very nature, transcends the status quo and can bring social change, if we consciously will to do so. Mechanistic science has shaped and coloured every htmlect of our lives from its inception to the present day. Thomas Hobbes, contemporary of Descartes, surpassed both Descartes and Newton. He maintained that nothing exists except body, matter and motion, that not only the universe, but man himself can be explained mechanically [11]. Hobbes' influence passed down to us via Charles Darwin in an age that saw the birth of capitalism and the expansion of Adam Smith's 'free' market under the military might of the British Empire. Nature became finally reduced to isolated atoms jostling and competing in the struggle for survival of the fittest [12]. In its present-day form, neo-Darwinian sociobiology has changed little from social Darwinism. It is based on denying and explaining away every good there is - such as love, moral feelings and altruism - as different forms of disguised selfishness. The neo-liberal economic theory underpinning the current economic globalisation is a more pernicious form of Adam Smith's laissez-faire theory. While both glorify competition, only the latter is tempered by moral restraint. And so, through the self-fulfilling prophecy, mechanistic science has created a dysfunctional, dog-eat-dog society and a global market regime that has hastened the destruction of our planet to maximise corporate profit, while failing spectacularly to serve the physical and spiritual needs of the vast majority of humanity. That was why fifty thousand took to the streets in Seattle in December, 1999, marking the start of a global protest movement that will grow until and unless people's over-riding htmliration for a safe, equitable and just world are met. The mechanistic paradigm has clearly failed the reality test in life. Equally importantly, it has also failed within science, having been thoroughly discredited by scientific findings. But the discredited paradigm is perpetrated by mainstream academic institutions, where it serves to promote the engineering of life. The ideology of genetic determinism - genes determine what we are - has ruled biology and the popular culture before genetic engineering really got underway. It offers a simplistic view of the living world that is a complete travesty of the interdependence and complexity of organic reality. Scientific findings over the past 25 years speak loud and clear that genes do not work in isolation, but in complex, entangled networks. Genes are above all, sensitive, dynamic and responsive, to other genes, to the cell or organism in which they find themselves and to the external environment. Genes are active, or not, depending on the environment. They mutate, multiply, rearrange and jump around. Genes may even jump out of one organism to infect another. The genetic material is so flexible and dynamic that geneticists have coined the phrase, "the fluid genome" way back in the early1980s. The new genetics is radically ecological, organic and holistic, and is diametrically opposed to the mechanical conception of nature that has dominated the west for hundreds, if not thousands of years. The new genetics is all of a piece with the recovery of the organic, participatory perspective in contemporary western science, especially in quantum physics. Quantum theory tells us that separateness is an illusion, that all nature is mutually entangled in organic space-time, as is the 'observer' with the 'observed'; and that each act of 'observation' transforms both. What it does is to reinstate the holistic, ecological knowledge systems of indigenous cultures across the world, which have enabled people to live sustainably for millennia. As we face the threats of genetic engineering in the midst of the climate change catastrophe, poet Wendell Berry reminds us, "Thine life is a miracle, think again" [13]. Think again, for it is imperative to replace the destructive, mechanistic and instrumental view of life with the truly organic and miraculous. The organic whole is a concept totally alien to the mechanistic perspective. Just think of the "I" in each of us, the soul of our being, that is resolutely singular, despite the astonishing fact that we are made of 100 trillion cells and astronomical numbers of molecules of diverse kinds. Like all organisms, we are possessed of the irrepressible tendency towards being whole, towards being part of a larger whole. That miracle of organisms deserves volumes, and I have written just one of them [14]. To appreciate the organic whole, you have to experience live organisms, especially as you may never have experienced them, with an imaging technique invented in my laboratory, when they take on all the colours of the rainbow. The technique is a slight modification of the polarised light microscopy routinely used to look at rock crystals and more recently, liquid crystals. But crystals have static molecular order, so how can living, moving organisms appear crystalline, when all the molecules in the body would be moving around transforming and transferring energy_ The answer is that the molecules must be moving coherently together. Because the coherent motions are much slower than the vibrations of light, the molecules appear static as the light passes through. It is like capturing a sharp still photograph of a moving object with a very fast film. These images demonstrate that highly coherent molecular motions must be taking place in the organisms' body. Scientists have discovered coherent electrical activities in the brain not so long ago, to their great surprise. The coherence here is on a much larger scale than anyone has ever imagined, extending throughout the entire body. The organism is thick with coherent activities, from the molecular to the macroscopic. There is no preferred level within the organism. All the parts at every level are actively participating in the whole. These images also demonstrate that how we observe determines what we observe. As someone said, if your only tool is a hammer, then everything looks like a nail. Mechanistic biology is like a hammer, so everything looks dead as nails, or like nuts and bolts. If we observe with the sensitivity of organisms, however, we see them resplendent as organisms. This imaging technique is non-destructive. You can put the organisms back into the aquarium, or the pond, afterwards. Let me draw out some of the main lessons the organism teaches us about the organic whole as opposed to the mechanistic whole. The organic whole is an ideal democracy of distributed control. It does not work in hierarchies of controller versus the controlled, but by intercommunication and participation. Ultimately, each is as much in control as it is sensitive and responsive. In the ideal coherent system, local freedom (or autonomy) and global cohesion are both maximum. That is impossible within a mechanical system where public and private, local and global, are inevitably in conflict. Another important lesson is that the organic whole is quintessentially diverse and pluralistic. It is the antithesis of uniformity and homogeneity. We have some 30 000 genes and 300 000 proteins, astronomical numbers of metabolites, cofactors, inorganic ions, in numerous types of cells, constituted into tissues and organs that make up our body; all of which are necessary for sustaining the whole. In the same way, populations are naturally diverse, and thriving ecosystems are rich in species. And I must stress in the strongest terms that we need the diversity of cultures in the human species to sustain the human miracle, to express the full creative human potential. Now think of an organism as a domain of coherent activities. Its boundaries are dynamic and fluid, expanding and contracting with the extent of coherence. An organism could be an individual, a society, or indeed the whole earth and beyond. More importantly, each organism, in becoming itself, enfolds the environment consisting of other organisms into a unity residing in a 'self', while htmlects of the self are communicated and enfolded by other organisms. The realisation of 'self' and 'other' are completely intertwined. The organic society is thus a community of mutually implicated organisms. We are literally constituted of all our fellow human beings, just as every fellow human being holds hostage to a part of us. The organic universe of mutually entangled nested wholes is the rational basis of a naturalistic ethic reflecting the highest moral ideals shared by all cultures, that can reshape society and transform the very texture and meaning of our lives. We begin to appreciate that the will and purpose of each organism and species is entangled with that of every other. Our humanity emerges from this entangled whole. We cannot do arbitrary violence to one another, nor to the nature of other species without violating our own. The ethic of science is no different from that of being human. It is in this context that we must heed the message of Martin Luther King Jr. (Strength to Love, 1963), particularly in the painful aftermath of the September 11 attacks on the United States [15], "Darkness cannot drive out darkness; only light can do that. Hate cannot drive out hate; only love can do that. Hate multiplies hate, violence multiplies violence, and toughness multiplies toughness in a descending spiral of destruction....The chain reaction of evil - hate begetting hate, wars producing more wars - must be broken, or we shall be plunged into the dark abyss of annihilation." 1. Fox, M. Beyond Evolution, The Lyons Press, New York, 1999, ISBN 1-55821-901-3. 2. See "UK Royal Society soft-selling GM animals" by Mae-Wan Ho, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/gene_therapy.shtml. 3. Ho MW and Cummins J. The unnecessary evil of 'therapeutic' human cloning. ISIS News 7/8, Feb. 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews7-15.shtml. 4. Ho MW. Genetic Engineering Dream or Nightmare_ Turning the Tide on the Brave New World of Bad Science and Big Business, Gateway, Gill & Macmillan, Dublin, 1998, 1999; Continuum Books, New York, 1999. http://www.i-sis.org/genet.shtml 5. Ho MW. Why Biotech Patents Are Patently Absurd. Third World Network Biodiversity, Knowledge & Rights Series 2, Penang, 2001. http://www.i-sis.org/trips2.shtml. 6. Humpherys D, Eggan K, Akutsu H, Hochedlinger K, Rideout WM, Biniszkiewica D, Yanagimachi R and Jaenisch R. Epigenetic Instability in ES Cells and Cloned Mice. Science 2001, 293, 95-7. 7. "Cell implants in Parkinson's study cause catastrophe" by Gina Kolata, International Herald Tribune, 9 March 2001. 8. "Heart repair with bone marrow cells" ISIS Report, October 2001 www.i-sis.org 9. Ho, M.W. and Cummins, J. Xenotransplantation - How Bad Science and Big Business Put the World at Risk from Viral Pandemics, ISIS Sustainable Science Report #2, August 2000 ; Third world Resurgence 127/128, 2001, 46-55. http://www.i-sis.org/xeno.shtml. 10. "Xenotranplantation must end" by Angela Ryan, ISIS News 7/8, Feb. 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/i-sisnews7-11.shtml. 11. See The Post-Corporate World by David Korten, Kumarian Press, 1998. 12. See Genetic Engineering Dream or Nightmare_ Turning the Tide on the Brave New World of Bad Science and Big Business, Gateway, Gill & Macmillan, Dublin, 1998, 1999; Continuum Books, New York, 1999. 13. Life is a Miracle by Wendell Berry, 2000. 14. The Rainbow and The Worm, The Physics of Organisms by Mae-Wan Ho, World Scientific, Singapore, 1993, 2nd ed., 1998. http://www.i-sis.org/rnbw+wrm.shtml 15. Scientists for Global Responsibility Forum, Special Issue on the Terror Attacks in the USA, Issue No. 36/2001 (Dateline: September 13, 2001) Biopatents & Biopiracy ********************** Nick Papadimitriou rounds up worldwide Bush Whacked by Embryonic Cell Patent President Bush's clearance for government scientists to work with pre-exiting lines of embryonic stem cells lays bare the absurdity of the US patent laws. Wisconsin University's Alumni Research Foundation (WARF) owns the US patent on all human and primate embryonic stem cells (ES cells), including methods for isolation. As government officials negotiated access to the cell lines, WARF insisted their patent would not impede research. However, the patent is so broad that US government scientists do not have the option of turning elsewhere for ES cell-lines.Not only does this scupper Bush's intention to allow scientists access to the ES cells worldwide, it also lines up WARF as the sole financial beneficiary of any medical applications that may ensue. WARF is already suing Geron Corporation, with whom it previously held a contract granting exclusive rights to Geron to develop six cell types from ES cells. The relationship has soured following Geron's attempts to extend its rights to another 12 derivative cell types. Furthermore, two non-US companies, Bresagen (Australia) and ES Cell International (Singapore) are prepared to give away cells to publicly funded scientists. In return they are asking for first rights to license therapeutics and medical procedures arising from the research. Bresagen claims its cells differ sufficiently from WARF's and justify a separate patent. But the Bresagen cells only differ in that they are a few days older. Source: "Patent Laws May Determine Shape of Stem Cell Research" by Sheryl Gay Stolberg, The New York Times, Aug 17, 2001 GM Human Insulin Makers Fight Over Royalties A lawsuit worth $500m is being fought over royalties arising from patent rights to genetically modified human insulin. GM human insulin, one of the first GM medicines, was developed in the late seventies by City of Hope biologists, funded by Genentech, who were a small start-up company at the time. The development brought huge wealth to both parties and fuelled Genentech's subsequent growth. Now City of Hope accuses Genentech of cheating on them and stealing millions in royalties through violating the 1976 contract. The contract gave Genentech the patents on the insulin, which had sales of $1.7bn last year. City of Hope stood to gain 2% from all sales resulting from the patents. However, precisely which product the patent covers, is open to dispute. Genentech claims the agreement is limited to the proteins that the City of Hope biologists helped develop. City of Hope however, claims the contract is more far reaching and entitles them to royalties on 27 licensing agreements struck by Genentech with third parties. Genentech have subsequently licensed to GlaxoSmithKline, among others. The settlement demanded by City of Hope could put Genentech in the red for one year. Source: "Cancer Center, Drug Firm Fight Over Biotech Riches" by Denise Gellene, Los Angeles Times, Aug 28, 2001 http://www.latimes.com/business/la-082801patentstory TRIPS-Plus - Imperialism Strikes Again! Industrialized countries are using bilateral treaties to gain a stronger monopoly over rights to biodiversity in the developing world. Third world governments are being forced beyond their commitments to WTO by bilateral trade and aggressive investment deals. These so-called "TRIPS-plus" treaties enable western countries to bypass current WTO limits on patents on indigenous biodiversity. The TRIPS (Trade Related Intellectual Property Rights) agreement does not go far enough for greedy countries, who are negotiating closed deals of their own, effectively tying the hands of developing nations into extreme commitments. Moreover, they are being kept secret and hence difficult to challenge. So far, 23 TRIPS-plus agreements have been identified in a report issued by GRAIN, but this is just the tip of the iceberg. Some 150 nations in the developing world are affected. The proponents of these deals include the US, EU, Switzerland and Canada. Henk Hobbelink, Coordinator at GRAIN, said "in country after country TRIPS-plus agreements undermine national decision making processes and hijack policy options for the South, having serious consequences for farmers, research and the public interest". They are "manipulative" and "undemocratic" and render the debate on patenting of life irrelevant and obsolete. Source: ""TRIPS-plus" treaties leave WTO in the Dust", GRAIN July 27, 2001. Report available in English at www.grain.org/publications/trips-plus-en.cfm UN Protection against TRIPS TRIPS came under UN scrutiny again over the Protection of Human Rights. The UN Sub-committee on the promotion and protection of human rights resolved to call for action against biopiracy, more serious attention to human rights and a special review of how TRIPS affect indigenous people. It urges all governments to put human rights before economic policies and calls them to integrate national and local policies that honor international human rights obligations. Highlighting the international covenant requiring signatories to co-operate and protect economic, social and cultural rights, the UN resolves to gain "observer status" for UN High Commissioner for Human Rights at the World Trade Organisation. This will enable the ongoing review of the TRIPS agreement as well as analyse impacts on the rights of indigenous people. Source: "Intellectual Property Rights and Human Rights." United Nations Sub-Commission on the Promotion and Protection of Human Rights, resolution 2001/21. Sent by GRAIN Spain http://www.unhchr.ch/Huridocda/huridoca.nsf/(symbol)/ Canadian Farmers Union Balk at Patents The Canadian National Farmers Union (NFU) has initiated an unprecedented campaign to prevent intellectual copyrights being applied to the seed industry of the developing world. The NFU wants to prevent biotech companies from using patents to tighten their grip on the world's genetic resources. NFU executive member, Terry Boehm said "It's highly unlikely [patenting] can be stopped in the North American context". But "TRIPS and plant breeders rights are privatizing the fundamental building blocks of nature and nature itself." NFU members agree the last thing farmers in the developing world need is more monocultures pushed on them by multinational corporations. Source: "NFU fights seed patenting trend" by Adrian Ewins, Western Producer, Canada, July 5, 2001 http://www.producer.com/articles/20010705/news/20010705news14.html Public Subsidy of Pharma Corporations A new report issued by the US watchdog Public Citizen challenges the US pharmaceutical industry's claim that drugs cost an average of $500m each to develop. This figure is used by industry to justify tight patent controls and high prices. Public Citizen points out that pharmaceutical companies "cherry-pick" choice research from publically funded labs. As a consequence R&D costs per drug are closer to $100m. According to an internal NIH document obtained by Public Citizen 50% of the research resulting in the top five drugs of 1995 was carried out in the public sector. That's how our public money is subsidising the corporations. Source. www.publiccitizen.org, Aug 2001 BMA Calls for Debate on Life Patents As Britain edges closer to establishing its own national DNA databank, the opportunities for claiming broad patents rises and the British pharmaceutical industry is no strangers to claiming patents on the human genome. The British Medical Association [BMA] has called for international debate on gene patenting. The European Patents Office implemented the current EC directive on patents on life [98/44/EC] in June 1999. The directive states that a gene cannot be patented if it forms part of the body. But it can, if it is isolated from the body. Several EU member states are challenging the directive on the grounds of ambiguity. Professor Vivienne Nathanson, Head of Health Policy at the BMA insisted there is a desire for clear information. "The issues are very complex" she said. The BMA are particularly concerned that patents match the amount of innovative work done. As the situation stands biotech companies can take out patents on work done at the public expense. Public labs solicit investor interest to spin-off research with little returns, given the rewards that follow. Such "spin-out" companies from public labs are routinely floated on the stock market. Meanwhile, the UK government has set up a new commission to examine how gene patenting rules can be improved to take account of the worlds poor. The Commission on Intellectual Property Rights [CIPR] is to report in March 2002 and will investigate the exploitation of traditional knowledge, the impact of TRIPS, benefit sharing, human gene patenting and issues of consent. Sources: "BMA calls for debate on gene patenting", BMA Press Release, Aug 6, 2001 Web page of UK Commission on Intellectual Property Rights, Aug 2001 http://www.iprcommission.org "Frankenfish" In a scenario of true Frankenstein proportions, the European Patent Office (EPO) has granted a patent on genetically modified fish. The patent (EP 578 653) issued under the controversial 1998 EC directive was awarded to Canadian company Seabright. It covers Atlantic Salmon and any other fish carrying a gene for faster growth. The Seabright patent application describes experiments that resulted in monstrous fish, eight times the normal size. Greenpeace has denounced the patent, stating the giant fish will become invasive species and cause havoc in the marine ecosystem. This mirrors concerns expressed repeatedly elsewhere in the scientific literature. They have called on the EU to immediately ban the release of these fish. Seabright, which has since become 'Genesis' ,claims to have 15 million genetically modified fish eggs for sale to fish farms around the world. An application for the commer-cialization of the fish has been filed with the US Food and Drug Administration Source: "Greenpeace Denounces The First Ever European Patent Granted For Genetically Modified Fish", Greenpeace International, Sept. 10, 2001. www.greenpeace.org/~gengeng/highlights/gmo/Gefish_new2.htm Former IRRI Boss Attacks Biopiracy Former director of the International Rice Research Institute (IRRI) and Nobel laureate M.S. Swaminathan criticized the logic and conduct of biotechnology companies. Evoking the spirit of Gandhi, Swaminathan said biotechnology should be used to improve lives, not exclude those in most need. The industry should consider themselves as 'trustees' rather than 'owners'. Swaminathan thinks biotech will come to depend on biodiversity and safeguarding biodiversity should be ensured so that future molecular breeding programs can succeed. He stated "What we need are bio-partnerships, not bio-piracy", adding " the present situation is not conducive to conservation". Source: Innovation interview- M.S Swaminathan: "Partnerships not Piracy", Far Eastern Economic Review, Aug 23, 2001 Victory for Indian Farmers Following protests by several international groups, the Indian Government looks set to pass a new bill granting farmers the right to sell their seeds and keep control over food production. The Plant Variety and Farmers Rights Bill has already been passed in India's lower house and will now be placed before her upper house for approval. The bill, which allows farmers to sell seeds - a right formally reserved for seed companies and multinational seed giants - effectively prevents the monopolization of India's food supply. Source: "Farmers Right to Sell Seeds Protected in New Legislation", The Hindu, India, Aug 22, 2001 Basmati Biopiracy Upheld by US The US Patent and Trademark Office (USPTO) has upheld three patents for hybrid strains of basmati rice awarded to US company RiceTec, despite attempts by the Indian government to have all the patents originally granted in 1997 quashed. USPTO ruled to disallow RiceTec from calling the rice "basmati", but allows them to label it "a superior basmati rice", adding insult to injury! The Indian Government was furious. Devinder Sharma, a New Dehli-based food expert is scathing of the government's failure to demand USPTO reject the patents. The Indian Government delayed in recognizing India's claim to have basmati protected under geographical indication provisions at the WTO. India is claiming a victory in that RiceTec have been denied the use of the word "basmati" as a trade name. Source: India Still Sifting Grain From "Basmati" Chaff, by Ranjit Devraj. Aug 22, 2001 Posted on Norfolk Genetic Information Network (ngin), http://www.ngin.org.uk Amla Tree - More Theft in India USPTO has granted five patents on amla (phyllanthus emblica), a tree that is widely grown and used in India. Amla is one of the three ingredients of triphala, a traditional ayurvedic formulation used for thousands of years. One of the patents, filed by Unilever Corporation, claims an invention using extracts of amla in a hair coloring preparation. Four further patents involving amla have been filed in the Japanese Patent Office. Source. "Amla turns patenters' darling!" by M. Somasekhar, July 9, 2001 http://www.hinduonline.com/ Brazil Sold Sugar Cane Genome Brazil's Sugar Cane EST Genome Project (SUCEST) has just handed over exclusive rights of access to CropDesign, a Belgian agbiotech company, in exchange for an undisclosed sum. CropDesign intend to combine their bioinformatics expertise to select genes for entry into their TraitMillTM, a high throughput evaluation system, designed to put together sequences for 'superior crops'. Furthermore, CropDesign intend to commercialize their results outside Brazil. Brazil grows 25% of the world's sugarcane and exports large quantities of rice, corn and wheat. Sugarcane is a close genetic relative of these other crops and any useful similarities identified from SUCEST could become the intellectual property of CropDesign. Source "CropDesign and SUCEST in Functional Genomics Alliance, Atlas Venture News, Sept 4, 2001 http://www.atlasventure.com/news_content.html_ne_id=420 Breast Cancer Gene Patent Challenged Paris-based Curie Institute is challenging Myriad Genetics in the courts over the US company's Euro patent covering the BRCA1 gene. Myriad Genetics was awarded the patent (EP 699 754) for BRCA 1 in January. This means that European users are obliged to pay $2,400 for Myriad's screening test for genetic disposition to breast cancer. Myriad exercise its exclusive rights to carry out diagnostic tests on both BRCA 1&2 by insisting that all samples for testing be sent to the company labs in the US. The patent covers all tests based on comparing sample sequences with the sequence it describes for BRCA1. The Curie Institute intends to challenge the patent on grounds of lack of novelty and inadequate description. They also point out that the patent is based on "prior art" drawn from public genome databases and that the original patent application contained errors limiting its usefulness. The French Government is officially supporting the challenge and intends to introduce legislation extending compulsory licensing to cover genetic tests. Source: "French researchers take a stand against cancer gene patent", Butler & Goodman, Nature, Sept 17, 2001 p95 Research Deal Divides University A huge potential conflict-of-interest issue is simmering on the West Coast of the United States. US venture-capital firm Burrill has set up a scheme with University of California, San Francisco (UCSF) in a move calculated to cash in on university-based research. The aim is to fund high-risk projects of the type usually by-passed for funding by public agencies. Burrill intend to hand out grants of up to $500,000 per project and would also help to establish start up companies alongside UCSF and other partners to exploit any commercial potential. Needless to say, a disproportionate part of revenues generated from patents will end up in Burrill's hands. It is not all plain-sailing for Burrill however; UCSF faculty have accused Burrill and their own university administrators of reaching the agreement without their formal consent and have voiced concerns about implications for academic freedom. One faculty member is quoted as saying "this deal raises huge conflict -of-interest issues." Source: "Venture Capital concerns Academics", Rex Dalton, Nature, Sept 17,2001, p95. Biopirates Eying Borneo's Anti-HIV Bintangor Tree Widespread, untoward attention to Sarawak's native bintangor tree by US pharmaceutical companies intent on developing a new anti-HIV/AIDS drug has prompted NGOs to sound the alarm. Mark Bujang of the Borneo Resources Institute says the East Malaysian state's natives are in danger of having their traditional knowledge of medicinal plants stolen by biopirates. He points out that the concept of property rights is unfamiliar to them. The locals freely share in benefits from traditional knowledge passed down through generations. His institute wants to make sure a share of any profit arising from native wisdom goes to the people of Sarawak. Meanwhile, the state-led Sarawak Biodiversity Centre (SBC) has initiated a project to record, in writing, the orally transmitted knowledge of the locals. This is because recognition skills are fast disappearing. Today's youngsters can often name 10-20 medicinal plants and animals whereas the previous generation knew hundreds of different species. Local populations would be free to keep any written records to themselves, thus assuring a share in any financial benefits arising from that knowledge. The records will also help Malaysia's efforts to implement the International Convention of Biological Diversity, requiring countries to ensure benefits derived from research of native genetic resources are shared with indigenous peoples. Source: "Bio-pirates stalk Borneo tribe's treasure trove", Patrick Chalmers, Sept 4, 2001. http://sg.news.yahoo.com/010904/3/1e3cb.html Venter & US Terrorist Attack_ In an interview published in the London Evening Standard, Sir John Sulston of the Human Genome Project launched a vitriolic attack on rival Craig Venter, president of Celera Genomics, and the privatization of the genome sequence. As well as chastising Venter for blurring the distinction between science and business, Sir John insists that the idea of exploiting the genome was "a morally wrong decision. Yes, I'll stick to that." In a further comment that the interviewer could only describe as "something that seems initially wild," Sulston, while in no way condoning terrorism, says the following about the attack in the US: Sulston: "…I cannot help, in my heart of hearts, relating this to the way both American and European military industrial complexes are treating the rest of the world…It is very clear to me that western policies are driving the world further and further apart in terms of rich and poor, and causing large groups of people in the world to have justifiable resentments." Interviewer: "And the Venters of the world will make the world unfairer_ The West's rich might get cancer cures, the Middle East's poor might not…and that breeds further resentment_" Sulston: "Exactly so, which is why I relate the two things.. Source: The Andrew Billen Interview, Evening Standard, Sept 19, 2001 p27. SCIENCE BYTES ************* Embryonic Stem Cells and Cancer Prof. Stewart Newman of New York Medical College contributed this important item. In light of recent public proclamations about the "enormous promise" of therapies based on human embryo stem cells, people might be surprised to learn that mouse embryo stem cells have been worked on for 20 years. There are many mouse models for human diseases, but there do not appear to be any scientific papers reporting cures, and fewer than a half dozen describing any amelioration, of any of these mouse conditions with mouse embryo stem (ES) cells. It should also be of interest that one of the major distinguishing characteristics of mouse ES cells when they were first identified was that they caused cancer when injected into mice. This fact, which is also likely to apply to human ES cells implanted in humans, has not figured in the public discussions of potential therapeutic uses of such cells.* Indeed, until human embryonic stem cells were identified and patented during the last three years there seems to have been no significant discussion in the scientific literature (as indexed in Medline) of using ES cells as therapeutic agents. The abstract of the first report of mouse ES cells [1] is printed below. "This report describes the establishment directly from normal preimplantation mouse embryos of a cell line that forms teratocarcinomas when injected into mice. The pluripotency of these embryonic stem cells was demonstrated conclusively by the observation that subclonal cultures, derived from isolated single cells, can differentiate into a wide variety of cell types. Such embryonic stem cells were isolated from inner cell masses of late blastocysts cultured in medium conditioned by an established teratocarcinoma stem cell line. This suggests that such conditioned medium might contain a growth factor that stimulates the proliferation or inhibits the differentiation of normal pluripotent embryonic cells, or both. This method of obtaining embryonic stem cells makes feasible the isolation of pluripotent cells lines from various types of noninbred embryo, including those carrying mutant genes. The availability of such cell lines should made possible new approaches to the study of early mammalian development." 1. Martin GR. Isolation of a pluripotent cell line from early mouse embryos cultured in medium conditioned by teratocarcinoma stem cells. Proc Natl Acad Sci U S A 1981, 78(12):7634-8 *Editor's note: The danger of teratoma formation was mentioned in "The unnecessary evil of 'therapeutic human cloning', by Mae-Wan Ho and Joe Cummins, ISIS News 7/8, Feb. 2001 www.i-sis.org. It is very good to have the original paper cited, which we did not do. Adult Bone Marrow Cells Mend Heart without Transplant Hearts damaged by lack of blood supply can be mended by the body's own bone marrow cells, researchers have now demonstrated. This gives the lie to the claim that embryonic stem cells research is necessary. Sudden blockages of a major artery to the heart cuts off blood supply and lead to rapid death of the muscle cells and blood vessels in the heart. This condition, myocardial infarction, is a common form of heart disease. Despite the demonstration that some of the heart muscle cells can multiply and new vessels formed, regeneration is restricted to the living part of the heart wall. The 'infarcted' or dead area is irreversible, and in time, scar tissue is formed. Attempts to replace the dead tissue by transplanting heart muscle cells or skeletal muscle cells have failed to mend the damaged part properly. In previous experiments on mice, researchers in New York Medical College and the National Institute of Health injected bone marrow cells along the border of the damaged area of the heart, and found that the cells did differentiate into muscle and blood vessels. But this surgical intervention killed a high number of the mice and the grafting success was only 40%. This prompted them to consider a 'non-invasive' method, which involved stimulating the mice to overproduce bone marrow cells before and after myocardial infarction was induced [1]. For the purpose, the mice were given daily injections of two cytokines (small molecules that influence the activities of cells), stem cell factor (SCF) and granulocyte-colony-stimulating factor (G-CSF), which increased the number of circulating stem cells two to three hundred fold. Mice given cytokines had a survival rate of 73% after the operation, compared with 20% in controls not given cytokines. There were clear signs of repair in the damaged area of the heart in the cytokine-injected group, both new heart muscle and blood vessels were formed, whereas only scar-tissue was found in controls. The hearts of the cytokine-injected group also performed significantly better than the controls. The experimental results looked impressive enough even though the protocol of inducing myocardial infarction in such large numbers of animals is debatable. In addition, there is an unaccountably small number of experimental animals, only 15 compared to 52 in the group of controls. This may be because the researchers excluded mice that died within 48h of the operation, "to minimize the influence of the surgical trauma". But could it be that the mice died from stress of overproduction of bone marrow cells caused by the cytokines injected_ There are certainly more ways to be invasive; and much more effort should be devoted to reducing unnecessary and stressful interventions, both physical and chemical. It is most important to clarify the effects of the cytokines before these are recommended for clinical trials. 1. Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A and Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. PNAS Early Edition www.pnas.org/cgi/doi/10.1073/pnas.181177898 MWH Vaccine Turns Harmless Virus into Lethal Pathogen The debate over the efficacy and safety of mass vaccination has gone on for decades. One circumstantial evidence against mass vaccination is that previously relatively harmless viral diseases have become lethal conditions. Researchers have now provided molecular genetic evidence to show how a vaccine has turned a harmless virus into a lethal pathogen by recombining with the virus [1]. Bovine viral diarrhea virus (BVDV) is one of the most important pathogens of cattle, it can cause abortion, diarrhea, and hemorrage. Most frequently, however, the infected animal does not show any symptoms. Such nonpathological BDDV can be passed on to the offspring through the placenta. The offspring become immunologically tolerant to the original BVDV strain, but may come down with mucosal disease, which is fatal. In addition to the persistent, non-pathogenic BVDV, a pathogenic strain can always be isolated with mucosal disease. Previous research by the same group has suggested that the pathogenic BVDV has evolved from the non-pathogenic strain by non-homologous RNA recombination, ie, recombination that does not depend on similarity of base sequences. Pathogenic strains are altered in their genomes, and frequently have gene sequences from the cells of cattle inserted, together with large duplications of viral sequences and genomic rearrangements and deletions. One important difference between pathgenic and nonpathogenic strains is the expression of a certain gene for a non-structural protein, NS3, which presumably plays a role in regulating the expression of other genes. In the new publication, independent fragments of the pathogenic BVDV were isolated from cattle that died of mucosal disease, in addition to the nonpathogenic strain which represents the persistent infection. All the fragments of the pathogenic BVDV isolated have the same structure, indicating that they came from a single strain. They all carry the same sequence acquired from the cell, which encode part of a ribosomal protein S27a fused to a truncated gene for ubiquitin lacking the first 3 codons. Moreover, this insertion, as well as the viral sequence flanking either side of the insertion, are more than 99% identical to that previously identified in a BVDV vaccine. Detailed analysis indicate that both nonhomologous and homologous recombination have occurred between the vaccine and the nonpathogenic virus to generate the pathogenic virus causing fatal mucosal disease. 1. Belcher P, Orlich M and Thiel H-J. RNA recombination between persisting pestivirus and a vaccine strain: generation of cytopathogenic virus and induction of lethal disease. Journal of Virology 2001, 75, 6256-64. MWH BOOK BRIEFS *********** Quantum Computer_ Is It Alive_ The Feynman Processor, Quantum Entanglement and The Computing Revolution, by Gerard J. Milburn, Perseus Books, Cambridge, Mass, 1998, ISBN 0-7382-0173-1. Dr. Mae-Wan Ho reviews. My father has become an internet user at age 81. He sends me messages containing the latest digital family photographs, so I can see how he is putting on weight and regaining his health after a recent illness, and I can reply to tell him so immediately. He likes e-mail because it is so much faster than airmail and he can reach me when he doesn't know where I am. He would be astonished to hear that scientists are still trying to make computers go even faster as well as smaller. And that we might be able to communicate faster than light using a quantum computer. At the end of 1996, Intel Corporation, in collaboration with the United States Department of Energy (DoE) announced the first 'ultra-computer' to reach one trillion (10 to the power 12) operations per second, or one 'teraflop'. It cost $55 million. The full system consists of 76 large cabinets with 9072 Pentium Pro processors and nearly 6 billion bytes of memory. The ultra-computer is the product of DoE's Accelerated Strategy Computing Initiative (ASCI), and would ultimately reach a peak performance of 1.8 teraflops. ASCI is a ten-year program to move nuclear weapons' design and maintenance from being test-based to simulation-based. Were it not for the ultra-computer, Clinton would not have been able to sign the Comprehensive Test Ban Treaty on 25 September 1996. But could a computer simulate reality perfectly_ Is it possible that the DoE's confidence in the ultra-computer is misplaced_ The quest for yet faster computers did not stop there. IBM's computer, Deep Blue, defeated world chess champion Gary Khtmlarov in 1998, by sheer force of speed in checking the possible moves ahead. It can calculate 50 to 100 billion positions in three minutes, the time allowed for moves in major tournaments. It was a landmark victory, but it is clear that Deep Blue won not because it is cleverer than Khtmlarov. A computer just isn't ever clever, at least, not clever enough. There are lots it can't do. It doesn't know to laugh at jokes, or feel sad. It can't even walk into a MacDonald's on the high street to order a hamburger. And it will be 2005 before a computer will attempt to simulate a protein molecule folding into shape. A new supercomputer, Blue Gene, costing $100 million, will be equipped with SMASH (simple, many and self-healing), which will dramatically simplify the use of instructions carried out by each processor. Instead of a single microprocessor on a chip, Blue Gene's chips will hold 32 processors and about a million microprocessors, so it will perform one quadrillion (10 to power 15) operations per second, or a 'petaflop'. Even then, it will take a year to simulate an average protein folding, a process that's complete in split seconds in the body. So, speed doesn't make up for the fact that reality may be quite different, and works on different principles. It was Alan Turing, inventor of the universal Turing machine, the direct precursor of the modern computer, who first cast doubt on the computer's ability to simulate reality. Turing proved, devastatingly, that the Turing machine can't tell whether it can produce an answer to a problem in principle. Given a problem, the machine could run for a while and come to a stop, when it will have produced an answer, or else it could run forever. Turing proved a theorem that says there is no general algorithm (a logical step by step procedure) which will determine if a Turing machine working on an arbitrary input is going to finish or run forever. The Turing machine is a classical clockwork machine. What if there is another kind of machine_ Enters the quantum computer. David Deutsch, theoretical physicist at Oxford University, thinks reality can in principle be simulated provided the universal machine is a quantum computer. And so does Gerald Milburn, Professor of Theoretical Physics, University of Queensland Australia, a key scientist in the effort to make a quantum computer, who has written an excellent book to tell us why. A quantum computer can do things a classical computer cannot do. To simulate a system of N particles moving randomly, it would take a time that scales as NN, ie, exponential in the size of the system. For 10 particles, the ultra-computer working at 1 teraflop will take about three years just to compute the first time step. A quantum computer, on the other hand, will produce an arbitrarily accurate simulation of a quantum physical system. Similarly, the fastest computer will need billions of years to find the prime numbers, that multiplied together, result in a number containing 400 digits; whereas a quantum computer could finish the job in a year. To see how quantum computing differs from classical computing, we need to understand the fundamental difference between the randomness of an ordinary coin-toss and that of a quantum coin-toss. And here is where Milburn's exposition is admirable. This book really rewards the diligent reader with critical understanding, unlike too many popular science books that obfuscate with over-simplification. The classical probability of coming up head (H) or tail (T) in a single coin-toss is 0.5. If you toss the coin twice, there are four possible outcomes: HH, TT, HT and TH, the probability of each result being 0.5 x 0.5, or 0.25. The quantum equivalent of a coin-toss is a light beam striking a half-silvered mirror, or beam splitter, where half of it is transmitted and half reflected. When the intensity of light is reduce sufficiently, single photons (irreducible quanta of light) strike the beam splitter, one at a time. Photon detectors placed in the path of the transmitted and the reflected photons will show that approximately half of the photons are transmitted (T) and half of them reflected (R). If instead of the photon detector, a fully reflecting mirror is placed in the path of the reflected and transmitted light respectively, the beam can be sent through a second beam splitter. This is equivalent to a second coin-toss. So, in analogy to the classical coin-toss, there are four possible paths for a photon, TT, RR, TR and RT. In the arrangement shown in the Figure, paths TT and RR will end up in the upper (U) detector, whereas TR and RT will end up in the lower (L) detector. So, just as in the classical coin- toss, the U and L detectors will each detect half of the photons. However, if we have certain knowledge that the photon is reflected or transmitted after the first beam splitter, ie, if we observe, then the number of photons registered by the U or L detectors will no longer be half. That is the first sign of quantum strangeness. So far, we have been treating the light beam as if it were a stream of particles, which it is not. Light is simultaneously both wave and particle. This becomes evident as the relative light paths in the upper and lower half of the figure is altered, so that the light waves can interfere destructively with each other. It can be arranged that no light reaches the U detector, or the paths can be adjusted so that U receives say 20% of the light and L 80% of the light. But when the intensity of the light beam is reduced so that only single photons strike the beam-splitter at a time, all the photons will be registered by the U detector, or the U detector and L detector will register 20% and 80% of the photons respectively. It is as if the individual photon can still interfere with itself, as though it were a wave. This strange behaviour of light can be perfectly described by considering probability amplitudes instead of probabilities, and probability amplitudes change when unobserved, indistinguishable alternatives become distinguishable. And this can lead to paradoxical situations such as quantum 'seeing in the dark', or getting information about something without light ever reaching it. Probability amplitudes give probabilities when squared, and the rule for combining them was discovered by quantum physicist Richard Feynman. Feyman's rule says that if an event can happen in two or more indistinguishable ways, the probability amplitude for that event is the 'sum' of the probability amplitudes for each way considered separately. The final probability of an event is then obtained by the sum of the squares of the two numbers describing the resultant probability amplitude. Feynman's rule is Pythagora's theorem: a2 + b2 = c2, which tells us how to obtain the length of the hypotenuse of a right-angled triangle from the lengths of the two sides. We learned that in elementary Euclidean geometry in school. It seems that Euclidean geometry enters fundamentally into quantum reality. But why should that be_ "Nobody knows how it can be like that," said Feynman. An ordinary coin-toss provides one bit of information, yes or no. Its quantum counterpart, however, provides anything from one bit to infinity, depending on how many indistinguishable possibilities are generated by beam splitters placed in the path of the photon. To capture this difference, Bill Schumaker coined a new word, qubit. "A qubit is infinity in a coin toss." Now, add quantum entanglement, the correlation between subsystems in a state of quantum superposition, to Feynman's rule and one comes up with still stranger stuff, the e-bit, or information transfer through the entangled state, the possibilities of quantum crytography, teleportation (beam me up Scotty), and quantum computing. The popular parable of the entangled state is Schrödinger's cat, which is in superposition of being both dead and alive at the same time. In fact, Feynman's rule already describes the superposition of indistinguishable alternatives, ie, the entangled state. Quantum computing depends above all, on the coherent entangled state, or pure state that contains the superposition of multiple, even mutually exclusive alternatives. The more alternatives are entangled, the faster the quantum computing. It is the ability to ask many questions all at once, rather than one question at a time. The theory of quantum computing is well advanced, but no quantum computer has yet been built. The Department of Defence is supporting a lot of work in this area, perhaps as part of star-wars weaponry. Different bits of hardware are used to create entangled states. These include single ions trapped in a strong electric field, atoms trapped in tiny optical cavities, and nuclear magnetic resonance to create superposition of spins of atomic nuclei in organic molecules such as chloroform. One major problem is decoherence, or loss of coherent superposition, which would make the computer stop working. Are quantum physicists looking in all the right places_ I have proposed, some time ago, that quantum coherence is the basis of living organisation (see "Science and Ethics in a New Key", this issue). The coherence of organisms is actively maintained, and extends, in the ideal, over all space-time scales. Could the organism be the model of the quantum computer that quantum physicists are trying to build_ Could it be that proteins in the body fold to perfection in split seconds because the process involves quantum computing via infinitely many entangled states that encompass the entire body_ Can a quantum computer simulate reality perfectly_ Milburn asserts that "the physical world is a quantum world", which makes "a quantum computer not only possible, but inevitable." I agree only in the sense that the organism may already be a kind of quantum computer. Milburn goes further, he says it may take decades or perhaps a century, but "a commercially viable quantum computer is a certainty." I am not so sure of that. Certainly, a quantum computer could solve what a classical computer cannot solve. But Milburn and others believe that not only will the quantum computer be able to simulate reality, it will be part of the fabric of reality. That should send chills up and down our spine. Will a quantum hyper-computer take over the world_ Will it simulate a human being so exactly that it is a hyper-intelligent human being_ Well, if it starts to laugh at jokes I'd be worried. And if it can really simulate a human being perfectly, we better start setting a good example. Otherwise it has every chance of turning out to be a power-hungry despot intent on enslaving the whole world. Genetic Risk Assessment without Genes Methods for Genetic Risk Assessment, Edited by David J Brusick, Lewis Publishers CRS Press, 1994, ISBN 1-56670-039-6. Angela Ryan reviews This book results from a joint program between the United Nations Environmental Program (UNEP) and the International Commission for Protection against Environmental Mutagens and Carcinogens (ICPEMC) some years ago. But in view of the lack of publication in this area since, we must assume that the volume is still taken seriously by regulators. US Environmental Protection Agency (EPA) scientists dominate the list of contributors. The rest are from Europe, and one, from The Radiation Effects Research Foundation in Hiroshima City, Japan. This highly technical book about genetic risk assessment risks disqualifying itself as such by not mentioning the mutagenic potential and other harmful effects of transgenic nucleic acid (rDNA and rRNA) even once. (Readers who want to know more about this vital topic should consult Slipping Through the Regulatory Net: 'Naked' and 'Free' Nucleic Acids, by Mae-Wan Ho, Angela Ryan, Joe Cummins & Terje Traavik, Third World Network Biotechnology Series, Penang, 2001.) This is a major omission, particularly as the book states from the outset, "Chemical substances and their by-products are being released into the environment, on a worldwide basis, at increasing levels. It is estimated that up to 90% of these agents have not been adequately evaluated for their mutagenic activity toward somatic or germ lines of mammalian species. Because the pool of genes that will form all future generations of species is held by the existing individuals, it is essential that their exposure to mutagens be minimized." The environment of the industrialised world now contains innumerable industrial substances that have never been evaluated for genotoxic (ie, mutagenic) effects. Moreover, the contributors suggest, industry and government would have us remain ignorant of the damage these agents cause. And above all, who will pay for the research_ Very few investigations have been carried out, and this trend is set to continue. The book appeals to developing nations not to repeat the same mistakes that now beset the Northern Hemisphere. It recom-mends that third world countries expand pre-market testing programs and employ regulatory action in order to reduce exposures to mutagens. UNEP expresses a firm commitment to providing information already available on chemicals, as well as providing guidance for the implementation of programs for testing and regulation. Unfortunately, too many toxic industries have already migrated to poor countries in the Third World as regulation tightens up in the north. It would have helped for the scientists involved to call for tougher international regulatory regimes to prevent that from happening. Risk assessment is explained as a complex function of "perception" and "cultural factors", "economic" and "risk-risk trade offs", and the "knowledge and education of the people conducting the risk assessment". Furthermore, important stress is made to consider these factors early in the risk-assessment process and not after release when it is too late. All that said, the book is a valuable asset to any regulatory personnel. It is highly technical yet fully accessible, providing clear explanations at every stage. The scientists are meticulous in covering the ground. The references in some of the chapters extend beyond 20 pages. It is divided into five main sections; hazard identification, assessment of exposures, methods of assessment, risk characterisation and monitoring. Identification of the full range of hazards is an enormous task and this book suggests the most immediate and simple strategy is to prevent the introduction of new hazardous chemicals. Screening new substances plays the most important role in limiting exposure to genotoxic agents, motivating industry to withdraw from using them. Chemicals already released from established industries require a greater burden of proof in order to be recalled requiring huge investments. Moreover, there are "high political costs" associated with "remedial action" and the book repeatedly expresses hopelessness in this respect. It suggests other strategies. Existing hazards in the environment should be identified so as to prevent further releases in other parts of the world, and epidemiological data will also help to prevent the ongoing spread of hazardous agents. But these strategies will not be effective unless the scientists and the institutions concerned also make a firm stand to change the existing burden of proof and for remedial action. Genotoxicity tests are readily available that effectively and efficiently identify the vast majority of mutagens, including single chemicals and complex mixtures. The universality of DNA is the basis on which any agent detected as a mutagen in one organism can be considered a mutagen to all other organisms, including humans. Nevertheless, there are differences between mice and men in terms of size/dose relationship and level of DNA repair activity and different organs differ in levels of susceptibility. Methods for assessing risk reveal the complexities of mutagenesis in vivo. Chemical mutagens act in a stage-specific way over time and this has important implications for risk assessment. There are many methods including pharmacokinetic modelling, identification of molecular damage and somatic cell mutagenesis assays. Short-term assays provide rapid yes-no answers and testing systems range from free DNA through prokaryotes to eukaryotes and from isolated cells in vitro to intact animals. The most conclusive data obtained are considered to be those involving in vivo mammalian mutagenicity assays, but these are slow and very expensive and cannot keep pace with the rapidly expanding group of chemicals with potential mutagenic properties. Therefore it suggests short-term microbial mutagenicity assays are a "forced" compromise. However, the book also promotes the use of in vivo mutagenicity assays based on transgenic mice, particularly when a strong burden of proof is needed. The value of animal experiments is highly questionable in terms of animal welfare as much as scientific validity (see "Royal Society soft selling GM animals" and "Animal experiments worse than useless", ISIS News 9/10, February 2001). Again, there is no substitute for setting the burden of proof in line with the precautionary principle (see "Use and abuse of the precautionary principle", ISIS News 6, September 2000). The probability of "hazard" is a function of the sources of the genotoxic substance, its occurrence, concentration and bioavailability in contact media. The pertinent issues being the presence and formation of genotoxicants in environmental media, and the contacts of humans and biota with these media. The most alarming htmlect of "contact media" is the multifactorial nature of exposure. Industrial chemicals are released on a daily basis into indoor and outdoor air, water, soils, foods, medicines and consumer products and the role of transport and transformation processes between all of these amounts to a chemical concoction of nightmarish proportions. Exposure pathways for humans are ingestion, inhalation and dermal uptake. I was horrified to learn that my bathroom is probably the most dangerous place in my home. The pores of the skin are wide open in a steaming bathroom where multitudes of potential genotoxic agents in bathroom products are rapidly absorbed through the skin. This is especially sinister considering genetic damage to epithelial and endothelial cells are responsible for the most common cause of cancer in humans. The authors emphasise that the chemical and physical properties of genotoxic agents, in terms of their ability to react with DNA, also give these agents an ability to react with RNA, proteins and other molecules present in the cell. Therefore these agents induce other toxic effects in addition to genetic damage. There is evidence to suggest genetic damage contribute to ageing and cardiovascular disease. It also affects fertility. In fact, the range of effects is vast as all organ systems and biological processes are subject to somatic genetic disorders at any time from conception to old age. Moreover, many diseases such as diabetes, psychosis and cardiovascular disease are thought to result from interactions between multiple genes and environmental factors in ways that are not yet fully understood. The book recommends hazard identification should include prioritizing agents according to their prevalence in the environment. Monitoring is a vital part of hazard identification, as complex mixtures of thousands of different chemicals can be found in the environment. These can be separated out using chemical fractionation for testing. Various methods for quantifying risk are described along with recommendations for comparing and ranking risks. Emissions from urban, rural, industrial or energy-related activities should be ranked in terms of risk to human populations. The ranking of geographical areas and regions should also be done for the purpose of intervention and control of high levels of genotoxicants. Monitoring strategies for identifying and tracking these agents demands a tremendous amount of work. For example, approximately 2800 compounds have been identified in ambient air, but information on genotoxic activity is available for less that 11% of these. The reader is reminded that the human species is dependent on the domesticated plants and animals of agriculture and on certain wild animals such as fish. All organisms are mutually interdependent through complex food chains and biogeochemical cycles of the local and global ecosystems in which they live. Any alteration in ecosystem structure, function and stability from genotoxic agents will have adverse effects. Interestingly, the examples of ecological adverse effects used by this book are "the emergence of pesticide, herbicide or antibiotic resistance and changes in virulence and host range of pathogens". It states, "The genes controlling these phenotypes may be propagated "horizontally" from organism to organism and across "species boundaries". The author here alludes to a 1987 America Association for the Advancement of Science (AAAS) report from a selected symposium on biotechnology titled, The Infectious Spread of Engineered Genes, to evidence the point that genes do spread horizontally in the environment. One major shortcoming of this book is that it leaves the non-chemist reader blind as to the exact identity of the 10% of chemicals, which have been evaluated. Three broad classes of chemicals are discussed in detail, each representing hundreds of different molecules. Nevertheless, the chemicals to avoid are vinyl chloride and vinyl bromide, which are used mainly for polymer production, 2-Nitropropane a volatile industrial solvent, and ethylene and ethylene oxide, both of which are important industrial chemicals. Finally, I re-iterate my main criticism of this otherwise important book in the permissive stance it adopts towards industry. Instead of insisting on the precautionary principle and requiring industry to prove products and processes safe before they are approved, the scientists chose to emphasise monitoring after the event, almost in the hope of finding body counts large enough just to force remedial action. This is all the more serious considering the risks of rDNA molecules entering an environment rich in genotoxicants that will induce further rounds of mutation in the rDNA molecules as they transfer horizontally and recombine out of control. Economic & Cultural Exclusion in a Fragile Earth Won't Go The Little Earth Book by James Bruge, Alistair Sawday Publishing, 2000, ISBN 1-90197023-X. Nick Papadimitriou reviews. Recent events in New York will alert us once again to the incredible fragility of this world of ours. We are living within a closed system that renders economic and cultural exclusion a potentially lethal combination. A book that challenges the politics of division and dominance is reviewed here. The pocket sized Little Earth Book is a compressed encyclopaedia of our world, its degradation by the forces mentioned, and what we can do to prevent this. Concision is the key, and Bruge certainly manages that. In less than 150 pages he takes us on a world tour of the complex issues that need to be taken up and challenged if we want this home of ours, and us on it, to survive. The author aims to put the forces of change in the hands of creative individuals rather than leaving global problem solving to experts. I can imagine a few copies of this book found their way into the united rucksacks of Genoa. The book is divided up into small, two or three page sections, each devoted to an htmlect of the interwoven systems that shape our existence. As well as resource issues to do with water, food and the corporate take-over of same, and the human world of economics and trade, Little Earth Book encourages us to reappraise the world-view that runs at the heart of the shambles we are making of this planet. Thus, the assumed primacy of economic growth is challenged in a superb section based on the arguments of Frederick Soddy, Nobel-winning atomic scientist who applied the second law of thermodynamics to economics. Soddy concluded that science in the service of economics would inexorably result in environmental degradation and political conflict. Other sections of the book look at alternative frameworks for thinking about wealth, having, in passing, challenged the notion of GDP as a measure of "wealth." The alternatives include Citizens' Incomes, and the issuing of local scrip notes. Occasionally, Bruge comes across as a little naïve: The CO2 tax imposed on the developed world to counter the enormity of its "ecological footprint" and carbon trading could be seen as placing less developed countries more firmly in an economically dependant relationship with the former. Other sections serve as a primer for understanding the function of the World Trade Organisation (WTO), Third World Debt, Free trade (tellingly subtitled "winners and losers"), and the role of banks. The topical issue of genetic engineering appears - somewhat falteringly drawn from our own Dr Ho - as well as organic farming, pollution, ecology and armaments are all included. Bruge is well clued-up on the way biotechnology is increasingly posing as the new "environmental" approach. Gathering up patents to ancient herbal treatments; the emergent language of bioremediation and the chilling quote from Monsanto's CEO that they are dealing with "primary needs: food, shelter and clothing" show how biotech giants are projecting an image the precise opposite of what they are. Overall, Little Earth Book is worth reading because it dwells on solutions as well as problems. It is a democratic little manual, treating the reader as an intelligent and responsible world citizen, fully equipped to reach her or his own conclusions. Each section of the book contains facts highlighted in green if they are deemed sufficiently crucial, surprising or shocking (frequently all three). At the tail-end of each section, the reader is directed to further books - and not always ones that accord entirely with Bruge's take on things. Incidentally, we picked up our copy of Little Earth Book at the local charity shop. In fact, we found about eight of them there. It is curiously appropriate and yet sadly indicative that this challenging book should've found its way to one of the few places in the UK where recycling values are visibly active. NEW POSTINGS TO THE I-SIS WEBSITE Open Letter to New Zealand Royal Commission on Genetic Engineering Reply to Open Letter from Commissioner Peter Hodgson Letter to Indonesia against GM cotton http://www.i-sis.org/Indonesia.shtml Letter to Sri Lanka against lifting ban on GMOs http://www.i-sis.org/Sri_Lanka.shtml Rejected Letter to Nature re UK field trials by Mae-Wan Ho and others http://www.i-sis.org/Letter_to_Nature.shtml Letter to The Lancet calling for a moratorium on AIDs vaccines by Dr. Veljko Veljkovic and others Three CaMV 35S promoter scientific publications, by Mae-Wan Ho, Angela Ryan and Joe Cummins Gene technology and gene ecology of infectious diseases (Scientific publication) by Mae-Wan Ho and others Comments to EPA on the human health impact of Bacillus thuringiensis toxin gene product in genetically modified crops by Prof. Joe Cummins http://www.i-sis.org/Bt-toxin.shtml Response to terrorist attacks on the US (from Scientists for Global Responsibility) http://www.i-sis.org/terrorist.shtml If you like to receive ISIS news on a regular basis, please sign on to our mailing list at www.i-sis.org for an electronic copy emailed directly to you. 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