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Interim response to: Emerging Biotechnologies and the Animals (Scientific Procedures) Act 1986

Introduction

Uncaged Campaigns’ initial response focuses on the first two questions posed by the APC which cover the potential impact on animals of emerging biotechnologies. Because of time pressures, we are submitting an interim response while research and writing is conducted on the subsequent two questions. It is possible, however, to draw certain conclusions regarding questions (c) and (d). Furthermore, some brief observations will be offered on these questions in this interim response in lieu of a more detailed submission.

Question (a)

The number of experiments performed on genetically modified animals has been rising very quickly for at least a decade. The most recent statistics for animal use (for 1998) reveal an increase of over 25% on the previous year. (447,612 in 1998, compared to approximately 352,800 in 1997.) Bodies who support and conduct this kind of research, such as the Wellcome Trust, would like to see this expansion continue.

We envisage that these are the areas where biotechnological research could affect animals in the coming years:

  • Fundamental research involving experimental genetic manipulation of animals.
  • Attempts to develop "models" of human diseases by genetically modifying (GM) animals.
  • Mass destruction of animals that fail to incorporate microinjected transgenes.
  • Subsequent breeding of lines of transgenic animals.
  • Experiments performed on GM "model" animals to test new drug therapies.
  • Experiments to try to develop cloning techniques as a means of producing identical GM animals for both research and production of pharmaceuticals.
  • Subsequent cloning programmes.
  • Research on animals (GM or otherwise) to try to develop and test gene therapies intended for use in humans.
  • Research on animals to try to test safety of GM products such as GM foods.
  • Xenotransplantation research may, if unchecked, lead to the production of greater numbers of transgenic pigs and more experiments in primates to test transgenic organs.
  • The production of GM farm animals to improve their "productivity" as a source of agricultural goods.

Question (b)

Genetic modification procedures

Invasive surgical procedures are intrinsic to the genetic modification of animals. When genetic modification is attempted through the addition of a gene, this process includes the removal of fertilised eggs from pregnant animals (who are presumably put to death following this procedure) and the surgical implantation of the eggs after they have been injected with a transgene. When gene deletion is attempted, a gene is deleted or altered after embryonic stem cells have been isolated and cultured, and then the modified cells are placed into developing embryos.

In the case of the production of transgenic pigs intended as source animals for xenotransplantation, the sow that produces the eggs is killed, and the treated eggs are implanted into a surrogate mother. Such invasive procedures potentially cause suffering, and certainly cause profound harm to the female animals that are used to produce fertilised eggs.

Killing is harmful

The killing of these animals must be considered a profound harm: indeed, it is the ultimate, irrevocable harm. Setting aside the issue of any suffering involved, it is widely accepted in ethics and philosophy that not all harms consist of subjective or experiential suffering. Therefore, painless murder is still murder, and constitutes a harm to the victim. To have a conception of oneself as a being with future plans that would be frustrated by one's untimely death is not a necessary condition for an individual's life to be of value to them. All "protected" animals strive to sustain and protect their own lives. To deny that these lives are valuable to their "owners" would necessitate the acknowledgement that, infants, certain mentally disabled people, and the senile, would have valueless lives. This, of course, is untrue, and therefore we should accept that the lives of sentient animals are valuable - in fact they are, in a sense, of ultimate value because all other values are dependent upon them, and therefore killing them constitutes the gravest harm possible.

The acknowledgement of killing as a profoundly harmful action has implications right across biotechnology, as we shall discover in the course of this appraisal of biotechnology's impact on animals.

Unsuccessful transgenesis

A BBC News Online article quotes a New Scientist report that states only 1% to 10% of mice involved in the development of transgenic lines actually incorporate the injected transgene. The remainder are killed. (According to Home Office statistics [Table 2.2], mice account for the vast majority of genetically modified animals subjected to experiments [432,324 out of 447,612].) The annual Home Office statistics for animal experiments may, in fact, underestimate the number of animals used in genetic engineering experiments: "I think a lot of people may cull them [animals surplus to requirements] and not count them," Professor David Morton told New Scientist. In any case, it seems beyond dispute that as the development of new transgenic animals expands, the overall death toll of animals that will result from this activity will increase exponentially. Therefore, taking into account the above remarks concerning the harm of killing, it is certain that increased levels of genetic engineering activity will lead to massively increased costs to animals in terms of the destruction of animals (who do not incorporate the transgene) alone. Consequentially, it would be entirely inappropriate for the production and destruction of these animals to not require a project licence and thereby fail to appear in the annual statistics. It is right that the field of genetic engineering should be accountable for all the animals that are exploited and killed in experiments. To relax regulations in this area would be callous, dishonest and undemocratic.

Harmful unforeseen consequences of genetic modification

One of the most famous examples of unforeseen animal suffering caused by genetic engineering is the experiment conducted at a US Department of Agriculture research station - Beltsville - where a human growth hormone gene was injected into pigs. Although the animals did grow faster, they were also severely arthritic to the point where they could not stand, suffered lethargy, ulcers and heart problems, were partially blind, and the male pigs were impotent. Genetically modified sheep have proved to be diabetic and suffer high mortality.

In gene deletion experiments, frequent multiple pathologies have been observed, including deformed genitals, missing limbs, extra limbs, involuntary movements, and gross deformities of the head and brain.

In actual fact, unexpected biological disturbances after genetic modification are, paradoxically, to be expected. Genetic modification is an imprecise exercise. It is impossible to achieve meaningful control over where or how many transgenes insert themselves. Furthermore, as the Banner Committee has pointed out: "There are some 50,000 to 100,000 expressed genes in mammals and the effect of an inserted gene will depend on its position and on its interaction with other genes." Therefore: " [A]ny modification risks producing an animal whose welfare is in some way harmed."

The unpredictability of the consequences of genetic modification is even more unfathomable than the quote from the Banner Committee suggests. This is because genes not only function in a complex network made up of tens of thousands of other genes, but genes are subject to wider physiological and environmental influence and feedback, which has the knock-on effect of creating instability in modified genes, genomes and organisms over time.

All animals have evolved over millions of years to be able to cope with their natural surroundings as efficiently as possible: they have evolved an optimum fitness. Deliberate disruption of the animal's evolved genome carries the intrinsic risk of creating systemic disturbances within the organism which, when they occur, will inevitably lead to psychological and/or physical suffering. To genetically manipulate an animal is to knowingly endanger its health, viability and welfare: it is unfairly manipulative, reckless and cruel.

Attempts to create GM animal "models" of human diseases

The express intention of this area of research is to create animals that are predestined to become ill and suffer with diseases such as cancer, cystic fibrosis, AIDS, leukaemia and a condition similar to Alzheimer's that, it is supposed, model "analogous" human diseases. Some animals have even been genetically altered in such a way that they are more prone to anxiety and fear.

One kind of GM animal predisposed to disease is the oncomouse. The oncomouse was developed at Harvard University in research largely sponsored by the chemical company Du Pont. A U.S. patent was granted for the oncomouse in April 1988, the first ever patent issued for a plant or animal. The oncomouse was produced through the addition of a gene linked to cancer in some mammals (including humans): it is unusually susceptible to cancer. As Reiss and Straughan explain: "Common sense, the scientific literature and the courts have all concluded that these animals suffer. Oncomice develop tumours in a variety of places including mammary tissue, blood, skeletal muscle, the lungs, the neck and the groin. Tumours can lead to severe weight loss (40% body weight or more) while large tumours may ulcerate. In some instances. oncomice have suffered limb deformities as a side effect of the genetic manipulation." Half of the female oncomice develop breast cancer before they are a year old.

An undeniably worrying prospect for animal welfare is demonstrated by the development of a transgenic monkey in the United States. The researchers expressly admit that their hope is to produce primate "models" of human diseases where monkeys develop Alzheimer's, cystic fibrosis, diabetes, muscular dystrophy and mental disorders. The breeding of GM primates may also be accelerated through the splitting of embryos to supposedly create genetically identical models. The prospect held out by this development is an increase in the numbers and suffering of non-human primates in experiments.

GM animals intended as models of diseases undoubtedly suffer, in many cases intensely so. Uncaged Campaigns believes that to deliberately induce chronic, painful, debilitating and lethal disease in sentient creatures is, to any fair-minded and civilised person, maliciously wicked: it is an extreme form of torture. If the current fashion in biotechnology for creating GM animal "models" persists, then the implications for animal welfare are very dark indeed.

The genetic modification of animals to experience fear and anxiety in an attempt to model apparently analogous human experiences brings into sharp focus the true suffering of not only GM animals but other animals used in research. This particular GM research and the Government's licensing of behavioural and psychological experiments on animals, including rodents, means that the animal researchers in question and the Government believe that there is some degree of similarity between the experiences of humans and other animals. (Though we stress that the complex biological processes that underlie these experiences vary in subtle yet profound ways which totally undermine the notion that non-humans are analogous models for humans.) Given the acknowledgement of this experiential similarity, it would be an act of stunning moral blindness to dispute the severe psychological harm inflicted on animals genetically modified to suffer anxiety and stress. When trying to weigh the costs to animals of proposed animal research, researchers and regulators should ask themselves: How would I feel in those circumstances? Obviously, different animals are suited to different environments, but the experience of pain and deprivation caused by incarceration in laboratory conditions is possible to empathise with in a meaningful way. Uncaged Campaigns strongly defends such a call to empathise with nonhuman animals against charges of unjustified anthropomorphism. To deny the continuities between human and nonhuman experience would not only undermine, according to the researchers themselves, one of the necessary (but insufficient) conditions for psychological and behavioural research to be applicable to humans, but it would fly in the face of common sense, evolutionary theory and empirical observation. Furthermore, to deny the essential similarity of human and nonhuman experience would require the unfounded introduction of a Cartesian-like hiatus between humans and the rest of the animal kingdom. Such a notion would be based more on superstition than fact. Given the weight of argument (and, indeed, the existence of this presumption in psychological research on animals) in favour of inferring that nonhuman and human suffering would be essentially similar in many situations (especially the experience of physical pain and psychological suffering), the lack of serious attention given by researchers and regulators to the profound ethical implications of this concept is a deeply reprehensible example of cognitive dissonance.

Cloning

Like genetic engineering, cloning is a largely unsuccessful process: Dolly was the only successful birth out of 277 embryos created by nuclear transfer, of which only 29 were deemed to have developed sufficiently normally to be implanted into surrogate mothers. Wastage and death loom large in cloning experiments and production.

Cloning from adult cells, the process that produced Dolly the sheep, may result in animals with shorter life spans and increased susceptibility to cancers according to a report in Nature. A similarly cloned calf developed heart problems, and then suffered a dramatic fall in its red blood cells resulting in death at only seven weeks of age. It had also lost many lymphocytes, and a post-mortem revealed that the lymphoid tissues had developed abnormally. The researchers suggest that the type of cloning that produced Dolly the sheep may result in long-term damage to health. Cloned sheep, cows and mice have been known to die before or shortly after birth.

In fact, the main goal of research at the Roslin Institute is exemplified by Polly, not Dolly. Polly was born in 1997 having been cloned from a cell of a 26 day old sheep foetus into which had been inserted a human gene for factor IX, the protein used to treat a type of haemophilia. Roslin turned to cloning as a more "efficient" way of establishing herds of genetically engineered living factories mass-producing valuable pharmaceuticals in their milk. Subsequently, cells from Polly were cloned in the hope of creating an 'elite herd' that, like her, would produce the same factor IX in their milk. However, the cloned lambs were abnormal and eight times as likely to die at birth as ordinary lambs. In general, "large-offspring syndrome", associated with cloned animals, leads to high rates of miscarriage as well as harming and endangering the pregnant animal.

Apart from the suffering and death caused by cloning techniques themselves, the production process itself is cruel. According to Dr Mae-Wan Ho: "The animal is made to lactate early with hormone treatment and thereafter is kept lactating permanently in order to keep up production. The protein the animal has to produce is in addition to all the normal proteins in her milk, which in transgenic sheep like Tracy [a genetically-modified forerunner of Dolly developed by Roslin] is more than twice as much protein as in ordinary sheep milk. So she is under permanent metabolic stress." This kind of overproduction is known to cause mastitis, lameness, general malaise and exhaustion in dairy cows.

In summary, both the cloning process itself and the aim of the cloning - the rapid breeding of GM animals producing biological products - threatens to increase both the volume and the intensity of suffering and death inflicted on animals.

Xenotransplantation

Xenotransplantation imposes welfare costs to animals in several areas: the production of transgenic pigs, experiments in cloning pigs (at the Roslin Institute, according to reports), the requirement to keep the pigs in qualified pathogen free (QPF) environments, the killing of pigs in order to remove their vital organs, and experiments on primates in order to test transgenic pig organs.

Pigs "are just as intelligent as dogs on any animal-IQ scale." According to a recent Parliamentary answer, 10,000 pigs have been bred in the last four years by companies trying to develop xenotransplantation in the UK. Given the unpredictable nature of transgenesis, it is possible that some transgenic pigs have suffered adverse health effects. Indeed, researchers at Imutran/Novartis trying to develop homozygous lines of transgenic pigs have dropped a heavy hint that suggests that such pigs may have suffered quite severely: "In addition, breeding to homozygosity might cause undesirable effects to the stability and health of pigs."

In addition to the surgical interventions, killings of sows, and early weaning techniques used in the course of attempts to breed transgenic pigs, the QPF conditions themselves are likely to cause psychological and physical suffering to animals because of the confinement, lack of foraging substrate and other environmental deprivations. (See section 6.2 of attached "Comments on Draft Report of the UKXIRA's Biosecurity Steering Group" for discussion of welfare costs to pigs.) In order to accelerate their research, Imutran/Novartis have exported scores of transgenic pigs to countries with weaker regulations on animal research such as the Netherlands, Japan, USA, Canada, Spain and Italy. Some pigs taken to the Netherlands have been used in experiments at a primate research centre criticised by the RSPCA and Advocates for Animals for its poor welfare conditions.

Xenotransplantation experiments have been performed on some 270 primates in the UK in the last four years. Rhesus macaques and wild-caught baboons have been used as "model" recipients of transgenic and non-transgenic pig organs. Every single primate has died as a result of these experiments or has had to be put down because of the suffering they have endured. Indeed, Home Office Inspectors have had to order researchers at Imutran/Novartis to euthanase primates, thereby frustrating researchers' desire to gain maximum information regarding transgenic pig organ rejection and function.

These are some of the published studies of pig-to-primate xenotransplantation experiments conducted by Imutran/Novartis:

  • An ineffective and toxic immunosuppressive protocol was administered to cynomolgus monkeys and baboons who had been implanted with transgenic hearts heterotopically and orthotopically respectively. The cynomolgus monkeys survived 40 days (median) and the baboons 2.5 days (median).
  • Seven transgenic kidneys and six normal (control) kidneys were transplanted orthotopically into cynomolgus monkeys. The monkeys were then immunosuppressed (very heavily, one can surmise) with cyclosporine, steroids and cyclophosphamide. Median survival time was 13 days for the transgenic group and 6.5 for the control group.
  • Ten baboons were orthotopically implanted with transgenic pig hearts, and were immunosuppressed with a combination of cyclophosphamide, cyclosporine, and steroids. "Five of the grafts failed within 18 hours… Pulmonary artery thrombosis induced by a size mismatch was observed in two of these baboons. The other three died because of failure to produce even a low cardiac output and/or dysrhythmia. The remaining five animals survived between four and nine days. One animal died of bronchopneumonia on day 4. Three xenografts stopped beating on day 5 due to acute vascular rejection. The longest survivor was killed on day 9 with a beating, histologically normal xenograft because of pancytopenia ["a simultaneous decrease in the numbers of red cells, white cells, and platelets in the blood," according to the Oxford Concise Medical Dictionary]."

It is clear that experimental pig-to-primate xenotransplantation procedures are lethal and likely to cause severe suffering in primate recipients.

GM farm animals

The prospect of creating GM animals intended to be more efficient meat and milk producers is one of the most gratuitous forms of animal exploitation to be considered. The notorious "Beltsville" pigs incident is a startling example of the potential for unforeseen, painful side effects to arise from attempts to stimulate faster growth rates. Furthermore, we believe that animals are already being pushed beyond reasonable biological limits in the quest for greater profitability. There can be no benefit that can legally justify such research, and the very least we would expect from the APC would be a recommendation to ban the genetic engineering of animals for agricultural purposes.

Testing of GM products

This area falls into two categories: the development and testing of gene therapies, and the testing of other GM products such as GM food.

1. Gene therapy

Reports of the death of a gene therapy patient in the U.S. last autumn have revealed both the suffering to animals, including primates, caused by experiments, and their lack of value as predictors of human responses.

On September 17, 18 year old Jesse Gelsinger died of multiple organ failure following gene therapy treatment at the University of Pennsylvania. He suffered from ornithine transcarbamylase deficiency, a metabolic disorder, but it was controlled through diet and drugs. The experiment in which he participated was designed to test a treatment for babies with a fatal form of the disorder.

In the experiment, Gelsinger received "an infusion of corrective genes" encased in a weakened cold virus - an adenovirus. The virus was used as a "vector" to carry the new genes into his liver. Post mortem studies have demonstrated that the adenovirus triggered "an unusual and deadly immune system response that led to multiple organ failure" and death.

Previous animal testing had not predicted the lethal chain reaction suffered by Gelsinger: jaundice, a blood-clotting disorder, kidney failure, lung failure and ultimately brain death. Scientists who reviewed extensive animal studies performed before the experiment said that they "revealed no information that would have predicted the events that led to Gelsinger’s death."

In those studies, three monkeys died after suffering the same blood-clotting disorder that afflicted Gelsinger after the gene infusion. But those animals received a different vector to Gelsinger; that vector used was a stronger cold virus, and was administered at a dose 20 times higher than the one Gelsinger received. In addition, none of the animals showed evidence of the lung failure that ultimately led to Gelsinger’s demise.

Following Gelsinger’s death, federal officials issued a plea for gene researchers across the U.S. to report any undisclosed deaths or illnesses. As a result, it has emerged that scientists and drug companies have failed to notify another U.S. federal regulator, the National Institutes of Health (NIH), about six deaths in the last year and a half.

Gene therapy appears to be a growing field of research that could lead to the suffering of animals subjected to experimental gene therapy procedures. 

2. GM food

If research continues into the development of GM crops, pressure will arise to test these crops on animals, research exemplified by Pusztai’s experiments on rats at Aberdeen. In addition to the harms intrinsic to the breeding and incarceration of animals in laboratories, Pusztai reported physiological changes in the rats that will probably have lead to suffering. Obviously, this potential arises in any experiment designed to test safety. Once again, GM crop research appears to be an expanding area, potentially leading to a corresponding increase in animal experimentation.

These animal experiments cannot reliably inform us about either the short term or long term potential health effects on humans, never mind the effects on ecosystems caused by interactions between GM crops and the environment. Furthermore, the APC must also ask itself whether the production of genetically modified crops provides, on balance, benefits that could not be achieved by alternative methods.

For instance, the claim made by promoters of GM crops that such research could feed the world is surely bogus. This is largely because the causes of hunger are social rather than agricultural, insofar as they relate to the distribution of food rather than the volume of food produced. The potential environmental dangers of GM crops also bring into question whether they are beneficial. Testing GM crops on animals is, together with the genetic modification of animals to increase meat and dairy productivity, one of the clearest examples of gratuitous animal experimentation designed to permit the sale of non-essential products for commercial reasons. It would certainly be more ethical to do without GM crops than experiment on animals. If the regulatory framework for animal testing is to have any credibility at all then such testing should be outlawed.

Questions (c) and (d)

Emerging biotechnologies threaten to extend and intensify the suffering of animals in British laboratories. In our opinion, this will make a terrible situation even worse. The moral significance of increased levels of harmful animal experiments has at least some validity. For example, such a prospect, we argue, should be perceived to be a backward step for a civilised society. However, this perspective is beyond the narrow case-by-case approach to animal experimentation currently adopted by the Home Office. We suggest that this is a serious limitation of current legislation and its enforcement.

The genetic modification of animals also represents a new and extreme form of exploitation insofar as disrupting the genome of an animal comprises a profound assault on the animal’s integrity and telos. Therefore, it represents a hitherto unseen interference with living beings. We believe that widespread public suspicion of GM could well be based on a sense of a qualitative increase in the intensity of exploitation of animals that GM represents.

The additional actual and potential harms inherent to the practice of the genetic modification of animals are, we believe reason enough to justify a ban on this practice. However, this very uncertainty also has implications for an assessment of any benefits that may accrue to humans from GM technology. Attempts to mimic human disease in nonhuman animals by genetic modification or otherwise are doomed to failure because the introduction of human genes into an animal will not make that animal human-like. The human genes will produce an effect through interaction with the rest of the animal’s genome and the genome’s environment. It cannot, therefore, accurately model the human condition. To hold that it can is, we believe, absurdly reductionist and demonstrates a willful ignorance of biological and environmental phenomena.

Not only are human benefits speculative to say the least, but the effects of GM technology are potentially catastrophic. For example:

  • The creation of exotic organisms through genetic modification threatens to disrupt ecosystems because of the qualitative difference in evolutionary processes effected by such modification.
  • Xenotransplantation and other biological products obtained from animals create unparalleled opportunities for the introduction of new pathogens into the human population which cannot be effectively controlled.
  • The instability and unpredictability of genetic modification means that gene therapies will always carry risks for patients and, perhaps, the wider population (especially in the case of germ-line therapy).
  • GM technology also raises disturbing questions about how the technology may end up being applied to human beings. Eugenics and GM biological warfare are the most obvious possibilities.
  • The fundamentally misguided and commercially motivated concentration on GM technologies means that more effective means of safeguarding and improving human wellbeing which are consistent with a realistic view of biological phenomena will be neglected.

To conclude, we shall quote Dr Mae-Wan Ho:

"The cloning and 'pharming' of livestock, the creation of transgenic animals for xenotransplantation and to serve as animal models of human diseases, are all scientifically flawed and morally unjustifiable."

Dan Lyons, Uncaged Campaigns

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Uncaged 1993-2012: This is the archived website of Uncaged. All information correct at the time of archiving - November 2012.