Animal Experiments News

EU regulations - news

HLS/SHAC news

Table of Contents

11.07.2011 Sunday Times and Daily Mail exposed Harlan !!

Articles exposing Harlan have been published in Sunday Times on 10th and Daily Mail on 11th.

10.07.2011 FORTRESS drop HLS Major campaign victory !

info: shac-uk
http://www.shac.net/news/2011/july/10.html
Major campaign victory as Fortress pull out of their loan agreement with HLS

Fortress have been in talks with SHAC volunteers over their stopping of their
loan agreement to HLS, this has been a rather protracted affair lasting many
months, with Fortress' attorneys being slow to give us the proof we needed.
(Remember, Fortress had lied in the past to the campaign). So we not only
requested a statement, but we also wanted to see the legal documents showing
the end of the loan between Fortress and HLS.

01.01.2011 Cosmetics industry criticised as EU set to admit delay in animal testing ban

http://www.guardian.co.uk/world/2010/dec/31/animal-testing-cosmetics-industry-europe
A Europe-wide ban on the sale of cosmetics tested on animals anywhere in the world may now be delayed for up to four years.

The final phase of European law designed to eradicate testing on animals of chemicals used in the cosmetics industry is set to be delayed for as long as four years because it is thought that alternative ways of testing the safety of ingredients' will not be ready in time.

Cosmetics and testing experts predict the European commission will announce shortly that it is unable to introduce the third phase of the European cosmetics directive, as planned in 2013. This directive would have banned the sale in Europe of any cosmetics tested on animals anywhere in the world.

Neil Parish MP, chair of the associate parliamentary group for animal welfare, said "sufficient" replacement safety tests would not be available until 2017.

However, Parish accuses the cosmetics industry of deliberately delaying the development of alternative methods. "For too long the cosmetics industry has dragged its feet when it comes to developing alternatives to animal testing, and here they are again trying to stall legislation to improve the welfare of animals."

Parish is demanding an end to "needless animal testing purely for the commercial gain of industry".

Michael Balls, a professor and former head of the commission's European Centre for the Validation of Alternative Methods, also criticises the handling of the issue. "The whole thing is a way of looking for reasons for a delay. The EC is trying to make a delay look like a scientific issue."

Sabine Lecrenier, head of the cosmetics and medical devices unit of the commission's Directorate General for Health & Consumers, has already informed members of the European parliament's environment committee that it is "unlikely enough scientific progress" will have been made on alternatives by 2013. A commission assessment of alternative methods is due to report in early 2011, and a final decision will follow soon afterwards. A clause letting the commission delay the ban will then be invoked.

Europe's two biggest cosmetics bodies – the European Cosmetics Association (Colipa), and the European Federation for Cosmetic Ingredients – say the full ban will probably be delayed because, according to Colipa, "top scientists confirm that although phenomenal progress has been made, a full set of alternative tests to cover all areas of consumer safety will almost certainly not be available by 2013".

There are 10,000 cosmetic ingredients on the commission's permitted list, but new ingredients are still being tested on animals outside Europe and then used within the EU. It is also thought that some new ingredients are still being tested on animals in Europe for use in household products or food and then subsequently used in cosmetic products.

The delay to the European cosmetics directive comes just as another complex set of EU legislation, which mandates the re-testing of tens of thousands of chemicals, begins to be enforced.

The EU regulation Reach (registration, evaluation, authorisation and restriction of chemicals) was the commission's response to safety questions raised over many chemicals used regularly in household and industry products. The commission estimates that a minimum of 8m extra animals will be used in these tests, although some observers put that figure as high as 54m.

Experts now question how Reach can possibly be compatible with a Europe-wide ban on animal testing of cosmetic products and ingredients. Balls said: "I think the general public has the impression that the cosmetics directive banned the testing of all ingredients [the first phase came in 2004]. So most people believe that when you buy a cosmetic it won't have any chemicals in it that have been tested on animals. But I just don't think that's true, and I think it is incredibly misleading."

The professor said he hoped for a "chorus of objections" if chemicals tested under Reach were then used in cosmetics labelled, "This product does not contain chemicals which have been tested on animals".

Cosmetic industry representatives say Reach will not affect the bans already in place on ingredient and product testing.

However, the US mining company Rio Tinto confirmed to the Guardian that sodium borate, an ingredient used in products made by Boots, Avon and some cruelty-free firms including Burt's Bees, and Lush, had recently been subjected to animal tests in compliance with Reach.

Rio Tinto said: "We avoid animal testing whenever possible. But when we're required by regulation to do animal testing, we do it to ensure human and environmental safety."

Mark Constantine, managing director of Lush, said: "The confirmation that … sodium borate has been tested on animals by the borate SIEF [the Substance Information Exchange Forum, which collates data for registration of chemicals from European suppliers] confirms our worst fears about Reach. We're investigating the situation, and have removed it from one product and are working on the others."

Lush says it does not buy products from suppliers who carry out animal testing on their own products. Burt's Bees adheres to the "Leaping Bunny" accreditation scheme of the Coalition for Consumer Information on Cosmetics.

Christopher Flowers, director-general of the Cosmetics, Toiletries and Perfumery Association, argues, like other cosmetics bodies, that ingredients tested on animals under Reach will be eligible for use in cosmetics because Reach and the cosmetics directive are separate pieces of legislation.

But the courts could take a different view. In 2005, in a case brought against the cosmetics directive, the French attorney general ruled: "It seems clear that the ban on animal tests applies equally to tests performed for … complying with other legislation, in so far as substances that have been the subject of such tests may not be used as, or in, cosmetic products."

Flowers said: "When people expect, or try, to bridge the two [pieces of legislation] to produce a consistent course of action, the lack of joined-up thinking out there in the wide world starts to show up."

• This article was amended on 1 January 2011. One of the bullet points in the standfirst of the website version of the article referred to the pharmaceutical industry. This article is specifically about the cosmetics industry. This has been corrected.

08.12.2010 One million animals could be used for first REACH deadline

"Approximately one million animals could be killed for chemical tests in order to fulfill the testing proposals under the first REACH (the new European chemical testing regime) registration deadline of 1st December (for chemicals produced in quantities of more than 1,000 tonnes).

According to REACH, animal tests for these substances have to be proposed for consideration since they are part of the public consultation ‘testing proposal’ system.

The European Chemicals Agency (ECHA) announced on 1st December that 4,300 substances had been registered. These substances include chemicals used in industrial lubricants, coatings, fuels, paints and household products.

According to the BUAV estimates, 25% of these registrations contain a proposal to animal test. Based on experience of the system to date, the BUAV, therefore, estimates that this will result in over 1,000 proposals being published as ECHA evaluates the dossiers. Should all these proposals be agreed a total of nearly one million animals could be poisoned and killed. These tests include reproductive toxicity on rats and rabbits and long term safety studies on rats and fish. Each test can use between 50 and 2,000 animals.

This estimate does not include the testing on animals that might occur for other chemicals under other deadlines or the animal testing that can be done without a testing proposal.

Given that the number of chemicals registered under the first deadline is 60% more than the estimate given by the Commission in 2003 when REACH was being discussed, the BUAV now estimates that the total number of animals who could be used overall under REACH is now likely to be at least 13 million (possible range of 13-54 million). This is an appalling prospect."

http://buav.org/article/612/buav-estimates-a-shocking-one-million-animals-could-be-used-for-first-reach-deadline

30.11.2010 Wickham Laboratories guilty of causing unnecessary animal suffering

BUAV: "Home Office has released a report on Wickham Laboratories which finds breaches in animal testing licenses issued to the company.

The BUAV has welcomed some of the findings of the Home Office Inspectorate’s Review into Wickham Laboratories, including the fact that infringement proceedings are being considered against the institution. The Report substantiates many of the BUAV’s findings following an undercover investigation in 2009.

Key findings include:

1) Mice routinely died in cruel poisoning tests rather than being “humanely” killed by staff – a clear breach in the institution’s Government project license;

2) Staff incompetence in the way mice were killed led to their suffering – including the practice of neck breaking with a pen on the corridor floor;

3) Key staff did not carry out their legal responsibilities under the Animals Scientific Procedures Act, including the Named Veterinary Surgeon not ensuring rabbit welfare;

4) Staff training in the monitoring and killing of animals was poor;

5) There was a lack of enforcement of available non-animal alternatives;

In addition, the report highlights a potential conflict of interest with the Named Veterinary Surgeon, responsible for animal welfare, being a major company shareholder

Despite the above findings, the BUAV are disappointed that the Home Office have failed to properly investigate whether the drugs tested at Wickham Laboratories necessitated animal tests, in particular whether such tests were required by national and international regulators.

Following the BUAV’s investigation, it has emerged that one of the companies commissioning tests on rabbits at Wickham has since moved to non-animal alternatives and the UK Veterinary Medicines Directorate have launched a review into the use of rabbits for pyrogenicity testing. The Home Office investigation is a missed opportunity to review the need for animal tests across the institution and has seen the Government wash their hands of their responsibility to enforce non-animal methods.

BUAV Chief Executive, Michelle Thew said: “We are pleased that the Home Office has substantiated many of the BUAV’s findings, some of which echo our previous investigation of this establishment. We are very disappointed, however, that an opportunity to properly enforce non-animal methods has been missed. Yet again, despite the Government’s claim that we have the best animal-testing regulations in the world, our investigation has clearly shown unnecessary animal suffering and law-breaking in a UK establishment. In light of this report, we call upon the Government to remove the license from Wickham Laboratories and urgently ensure that the available non-animal alternatives are used.”

BUAV investigation inside Wickham Laboratories.

05.11.2010 UK trade in wild-caught monkeys for research

BUAV calls on UK Government to stop supporting the trade in wild-caught monkeys for research
http://www.buav.org/article/580/buav-calls-on-uk-government-to-stop-supporting-the-trade-in-wild-caught-monkeys-for-research
The BUAV is calling on the UK Government to disassociate itself from the cruel trade in wild-caught nonhuman primates for research. It believes the UK public is being mislead because despite a widely publicised ban on the use of wild-caught primates in research since 1997, there is no such ban on primates who are the offspring of wild-caught parents (known as F1 generation or captive-born) and those exported from farms which still trap wild primates for breeding purposes.

In answers to Parliamentary questions tabled by Henry Smith MP, Home Office Minister Lynn Featherstone has stated that in 2009, 1,257 and so far in 2010, 970 monkeys who were the offspring of wild-caught parents have been imported into the UK (1). Between 2008 and 2009 almost 5,000 nonhuman primates were imported for experimental use in the UK.

The source of primates used in research raises important ethical questions. Many of the primates used in UK laboratories are imported from countries outside the EU. Recent proposals by the European Commission to ban the import of wild-caught and captive born primates into the EU were vigorously lobbied against by the animal research industry. The proposals were subsequently dropped from the final revision of the EU Directive on animal experimentation.

The capture of nonhuman primates from the wild inflicts suffering and is inherently cruel. The substantial negative impact caused by the trapping and removal of wild primates from their natural social groups is universally recognised by a number of organisations and official bodies, including the UK government’s own advisory committee, the Animal Procedures Committee:

“Trapping wild primates can cause significant distress, suffering and physical injury.” (2).

The BUAV has undertaken numerous field investigations into the international trade in primates for research. Evidence obtained reveals the immense suffering inflicted on primates during their capture, caging, holding and transportation for the research industry. The most recent investigation carried out by the BUAV this year in Mauritius obtained shocking evidence of the cruelty and suffering involved in the trapping and breeding of wild monkeys (long-tailed macaques or Macaca fascicularis). Mauritius is the UK’s main supplier of primates, including the offspring of wild-caught parents – between 2008-2009, the UK imported 2,752 of these monkeys from Mauritius alone (3).

Read more and view footage from this investigation: http://www.buav.org/our-campaigns/primate-campaign/buav-primate-trade-investigations/trading-in-cruelty

BUAV’s Director of Special Projects, Sarah Kite, states: “The British public is misled into thinking our Government has taken a principled position against the involvement of wild-caught primates in research when the reality is very different. By allowing the importation of monkeys born to wild-caught parents, the UK is fuelling a cruel and unnecessary trade which is morally unacceptable. We call on the UK Government to ban the import of these primates and stop perpetuating this appalling cruelty.”

Guardian: Research on primates 'goes on despite ban'

http://www.guardian.co.uk/science/2010/nov/05/research-primates-ban
"Thousands of monkeys have been imported into the UK for use in laboratory research despite a legal ban, animal rights campaigners have claimed. The trade in primates continues because the ban, introduced in 1997, does not include the offspring of wild-caught parents, said the British Union for the Abolition of Vivisection (BUAV). Between 2008 and 2009 almost 5,000 primates were brought into the UK to be used in experiments. The figures were disclosed by the Home Office minister Lynne Featherstone in response to a parliamentary question."

29.06.2010 Experiments on dogs at the University of Liege

The University of Liege reacted after the manifestation outside the hospital Sart Tilman. The uni categorically denies that experiments carried at Liege Uni cause suffering: "There is no brutality towards animals (…) the research of this kind (experiments on dogs who inhale substances to cause bronchitis) have actually been conducted, but in respect of ethical standards : the drug or chemical quantities were so low that no animal showed any clinical symptoms : he had blood tests to detect effects of treatment. The experiments have been authorized , and also monitored."
http://www.rtbf.be/info/regions/liege/pas-de-brutalite-envers-les-animaux-a-luniversite-232342
Experimenting on animals actually is brutality!!!
Experiments on dogs at Liege Uni:

LUPA, Unravelling the molecular basis of common complex human disorders using the dog as a model system, Prof. Georges

http://www.eurolupa.org/
they of course experiment on other animals as well

16.06.2010 BUAV’s Cargo Cruelty campaign uncovers new primate shipments

from BUAV:
The BUAV’s long-standing campaign to end the transportation by airlines of non-human primates destined for the research industry has had many successes. The primate research industry is feeling the effects as an increasing number of airlines are helping to put a stop to animal cruelty and suffering by refusing to transport primates destined for the research industry. The BUAV’s list of airlines that do not transport primates include United Airlines, Virgin Atlantic, British Airways, Northwest Airlines, Qantas Airways, South African Airways, Delta Airlines, Eva Air and China Airlines.

Every year thousands of primates are transported around the world. Airlines play an important role in this chain of suffering. The individuals are packed into wooden crates, usually too small to allow them even to stand up, and travel as cargo, predominantly on passenger air flights. They often have to endure inadequate ventilation, noise and extreme temperature fluctuations, as well as delays as they are shipped on extremely long journeys to laboratories across the world.

A small number of airlines continue to facilitate this cruel trade. Recent information obtained by the BUAV shows that the following airlines transported primates for the research industry during 2009:

AIR CHINA — 109 rhesus macaques from China to the USA on 1st December
AIR FRANCE — 78 long-tailed macaques from Mauritius to USA on 18th February
AMERICAN AIRLINES — 20 night monkeys from Peru to the USA on 23rd June
AMERIJET — 42 African green monkeys from St Kitts to the USA on 26th October
CARIBBEAN AIRLINES — 36 African green monkeys from Barbados to the USA on 26th May
CHINA EASTERN AIRLNES — 60 rhesus macaques from China to the USA on 27th May
CHINA SOUTHERN AIRLINES — 120 long-tailed macaques from Indonesia to the USA on 13th November
EL AL AIRLINES — 120 long-tailed macaques from Israel to the USA on 1st October
PHILIPPINE AIRLINES — 100 long-tailed macaques from the Philippines to the USA on 1st November

Please support the BUAV’s Cargo Cruelty campaign to stop this suffering. Please send letters to these airlines: http://www.buav.org/campaigns/cargocruelty

03.06.2010 Cancer research on mice

BBC: Hopes for breast cancer vaccine - American scientists say they have developed a vaccine which has prevented breast cancer from developing in mice.
http://news.bbc.co.uk/1/hi/health/8714085.stm
The BUAV comment:
http://www.buav.org/a/2010/06/03/352
"The BUAV is disappointed to see yet more media hype and exaggeration surrounding cancer experiments involving mice. The BBC Website, in the article ‘Hopes for Breast Cancer Vaccine’ cited claims made by the immunologists responsible that the vaccine ‘could eliminate breast cancer’ in humans.

Although the report did include warnings that the mice results may not translate into benefits for human beings, it is of serious concern that mouse “models” of cancer continue to be widely used, and that so much positive spin is put on the outcome of those experiments.

Hundreds of billions of pounds have been devoted to cancer research to date, much of it using mice, yet little progress has been made in realizing effective treatments or cures. Scientists who continue to use mice are ignoring compelling data that reveal the failure of this approach. Some 95% of anti-cancer drugs that work in animals fail in humans (1, 2), and genes known to be involved in human cancers work very differently in mice (3, 4). Even in our nearest relatives, chimpanzees, at least 20 genes implicated in human cancer are significantly different, explaining why serious human cancers are almost unheard of in chimps (5).

Many scientists have asserted for years that a move away from using mice in research, notably for cancer, is imperative. For example:

“The history of cancer research has been a history of curing cancer in the mouse…We have cured mice of cancer for decades—and it simply didn't work in humans” (6)

“Preclinical models of human cancer, in large part, stink” (7)

“…the animal models on which clinical trials are predicated must at best be limited in power, and at worst wildly inaccurate." (8)

Just this month, a high-profile article pulled no punches in its criticism of mouse models in immunological research:

“Mice make a lousy model for the human immune system”

“Studies on mice… aren't reflecting the needs of the [human] population”

“It's not a sustainable strategy to stay focused on mice.”

“…inconsistencies between human and mouse immunity often leave patients in the lurch…Hundreds of clinical trials have been based on curing mice, but almost none led to clinical treatments.” (9)

It is fortunate that many scientists are taking a human-focused approach to cancer research – using human tissues and cells, for example - which is leading to tangible progress and saving lives (e.g. 10, 11). Such superior methods, combined with more effective prevention programmes that could prevent around 50% of cancers, are the way forward. Scientists persisting with cruel and ineffective mouse “models” are hindering progress, not aiding it.

References
1. Roberts, T.G.J., Goulart, B.H., Squitieri, L., et al. (2004). Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 292, 2130-2140.
2. Kola, I., Landis, J. (2004). Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3, 711-715.
3. Tang, W., Dodge, M., Gundapaneni, D., et al. (2008). A genome-wide RNAi screen for Wnt/beta-catenin pathway components identifies unexpected roles for TCF transcription factors in cancer. Proc Natl Acad Sci U S A 105, 9697-9702.
4. Hamad, N.M., Elconin, J.H., Karnoub, A.E., et al. (2002). Distinct requirements for Ras oncogenesis in human versus mouse cells. Genes Dev 16, 2045-2057.
5. Puente, X.S., Velasco, G., Gutierrez-Fernandez, A., et al. (2006). Comparative analysis of cancer genes in the human and chimpanzee genomes. BMC Genomics 7, 15.
6. Klausner, R. LA Times 1998, May 6.
7. Leaf, C. Why we're losing the war on cancer [and how to win it]. Fortune Magazine 2004, March 22. Vol. 149(6). Quoting Prof. R. Weinberg, Massachusetts Institute of Technology.
8. Kamb, A. (2005). What's wrong with our cancer models? Nat Rev Drug Discov 4, 161-165.
9. Leslie, M. (2010). Biomedical research. Immunology uncaged. Science 327, 1573.
10. Parsons, D.W., Jones, S., Zhang, X., et al. (2008). An integrated genomic analysis of human glioblastoma multiforme. Science 321, 1807-1812.
11. Jones, S., Zhang, X., Parsons, D.W., et al. (2008). Core signaling pathways in human pancreatic cancers revealed by global genomic analyses. Science 321, 1801-1806."

20.05.2010 Cell test could replace animal experiments - More funds go to alternatives

Lun University: http://www.lu.se/o.o.i.s?id=23042&news_item=5125
"Tens of thousands of animals are already used to test new substances in household products, cosmetics, paints, etc. The EU chemical legislation REACH will mean many times more animals will be used in experiments if alternatives to animal experiments cannot be developed. A research group at the Biomedical Centre in Lund is well on the way to doing this.
“Look at this!” says Reader in Immunotechnology Malin Lindstedt, indicating an image on her computer screen.

The image shows a number of green dots gathered in the bottom left corner, while a number of red dots are scattered across the rest of the screen. The red dots are allergenic chemicals, while the green probably do not affect the skin at all or only cause temporary irritation. The red and green are neatly separated, which means that the test clearly distinguishes between substances that present a risk and those that are harmless.

Malin Lindstedt is taking part in a major EU project on alternatives to animal testing. Her test comprises human cells of a specific type, which are stimulated with both sensitisers (substances that are expected to produce an allergic reaction) and control chemicals that are harmless. The cells’ genetic reactions are used to predict whether the substance could cause oversensitivity in the skin. If everything goes as planned, the test could in the future replace current animal experiments on mice and guinea pigs.

It may seem strange that good alternatives to animal testing have not been developed long ago. Mice are not people and the all-clear from animal experiments does not necessarily mean that a certain substance is harmless to humans.

“It was believed that these tests must at least be performed on living beings and not just on cells. The major research funding bodies did not believe in the idea, and so not many research grants were awarded and it was not possible to develop any alternative methods”, says Malin Lindstedt.

However, the situation has now changed. The technology required has become cheaper, the demands for alternatives have increased and the grants have started to come in. Malin Lindstedt’s group has now not only received EU grants, but also money from the Swedish Board of Agriculture, the Swedish Fund for Research without Animal Experiments and the Swedish Research Council.

When the EU decided that cosmetics testing on animals would be banned from 2013, the industry also got a move on. Cosmetics giant L’Oreal has invested millions of euros in alternative methods and is now, along with Unilever and others, part of the EU project ‘Sens-it-iv’, within which the Lund group works.

Another driving force behind the push to develop alternatives to animal testing is the new EU chemicals legislation, REACH*. Under these rules, around 30 000 chemicals are to be tested for their health impact on humans. The European Chemicals Agency calculates that around 9 million animals will be used in the tests, which sounds like a huge number. However, the former head of ECVAM (the European Centre for the Validation of Alternative Methods), Professor Thomas Hartung, thinks the figure will be even higher, between 50 and 140 million animals.

Reducing this huge consumption of animal lives is an important aim for Malin Lindstedt.

“Of course I am committed to my research for purely scientific reasons. But the fact that it is also for a good cause helps me to keep working even when progress has been slow”, says Malin Lindstedt.

The method she has developed is based on human skin cells grown in test tubes. In a complicated process with multiple stages, a cell sample is exposed to a certain chemical, then the cells’ RNA (a type of genetic material) is isolated and transferred to a microchip. The chip can then be read by a computer, which shows which genes have reacted in different ways to the chemical. As few as 10 genes appear to be enough to differentiate between harmless and allergenic chemicals.

Using cell cultures and microchips is both quicker and simpler than the allergy tests on animals that are standard today. In an animal experiment, the chemical in question is applied to a mouse’s ear and then the researcher examines whether any immunological reactions have occurred in the mouse’s lymph nodes. The process is time-consuming and requires special animal enclosures, as well as staff who can handle the animals and eventually kill and dissect them.

“You don’t even have to employ the ethics argument. Speed is enough of an argument, if our method continues to produce the same promising results”, says Malin Lindstedt.

In addition, she believes the alternative method could become both safer and more accurate. Safer because it requires much smaller quantities of the potentially dangerous chemicals, and more accurate because as many as 15 per cent of animal experiments produce misleading results. This is something that is only discovered later, once a chemical has become more widely used and has caused major allergic reactions.

Malin Lindstedt has so far only managed to test her method on chemicals that cause oversensitivity in the skin. In order to also cover allergies in the airways, e.g. to pollen and mite proteins, she needs to develop the test further for other types of cell. At the same time, research groups in other countries are working on ways to test chemical substances’ toxic effects and effects on reproduction without using animals. The ultimate goal is to have a whole range of cell- and microchip-based tests available in a few years’ time.

Malin Lindstedt and her colleagues are planning to patent the method they have developed. They have also become much more cautious about what substances they surround themselves with.

“The sensitising substances we work with can be found in many products in our surroundings, including skin creams, shampoo and hair dye. Therefore there is a need for really good allergy tests for all the chemicals around us”, she says. "

16.04.2010 Meta-Analysis Review Proves Animal Models In Stroke Research Are Flawed

http://www.drhadwentrust.org/news/meta-analysis-review
"Meta-analysis reviews, or systematic reviews, refer to the analysis of a large collection of previous results obtained from individual studies for the purpose of integrating and comparing these findings. The use of such reviews has become an important tool in medical research since by pooling together these results, one can assess for the validity of experimental approaches. For the purpose of assessing the validity of a model, such as the use of an animal for the understanding of a human disease, such reviews are proven very useful since any inconsistency would suggest the inadequacy of this model.

A Meta-analysis review on the use of animal models for the treatment of stroke in humans was published last week (Publication Bias in Reports of Animal Stroke Studies Leads to Major Overstatement of Efficacy) in the journals PLoS (Public Library of Science) Biology together with a commentary article (Can Animal Models of Disease Reliably Inform Human Studies?) in PLoS Medicine. Both publications describe various statistical techniques to estimate how many studies in this particular field have gone unreported due to ending with negative or non-significant results.

Using a database encompassing 16 different attempted therapies, which together account for 1,359 experiments and 19,956 animals experimented on, the report finds that only a very small fraction of the publications (2%) report no significant effects of treatment.

As mentioned by the authors, these numbers suggest that in the case of animal-use in stroke studies, a significant proportion of animal experimentation is not being reported in the literature. The authors’ estimate that up to 214 other experiments, which would correspond to 3600 animals would have shown a negative or non-significant effect were never reported. (…)"

10.02.2010 Computer model helps understanding of Parkinson’s disease

http://www.scienceroom.org/computer-model-helps-understanding-of-parkinsons-disease
"Since each available animal model only targets some specific features of PD but not the disease as a whole, the weakness of these models will always remain for such a multifactorial disease."
"model provides a mechanistic account for several phenomena, including not only the positive effects observed with medicated patients compared to non-medicated patients, but also some of the negative effects of the treatment. By studying the combined effects of dopamine treatment on different parts of the human brain, this computational approach is a major improvement compared to the inadequate and limited animal models

14.01.2010 Alternative to LLNA: Hurel Allergy Test on a Chip

"The new device, named “Allergy Test on a Chip™,” is intended to comprise a technological substitute for the animal test known as the local lymph
node assay (“LLNA”). LLNA is presently accepted by regulatory agencies worldwide as a standard means for evaluating potential allergenic responses to new ingredients of consumer and industrial products."
"HUREL® Corporation is a bioanalytic tools company based in New Jersey, USA, that provides microfluidic devices and advanced cell cultures with human-relevant predictive sensitivity for testing new chemical products. The HUREL® biochip consists of a glass chip with human cells and chemicals that simulate the body’s immune system. When the product to be tested comes into contact with the chip, the cells and chemicals interact to mimic the human body’s natural allergic response. In addition to cosmetics, the technology could be applied to test household cleaners and pesticides.
The new technique could be used as an alternative to classic animal tests on guinea pigs, and the widely-used local lymph node assay (LLNA) that involves applying chemicals to the ears of mice. The LLNA is accepted by regulatory agencies worldwide as a standard means for evaluating potential skin sensitization responses to new compounds. "
L'oreal - one of the biggest brands tested on animals funded Hurel research - is it enough to excuse animals? No! The company needs to switch to alternatives if it wants exists on european market anyway….

info: http://www.scienceroom.org/a-good-start-to-2010-for-replacement-research
Hurel press release: http://www.hurelcorp.com/docs/LOreal-Hurel%20joint%20press%20release100114.pdf

20.01.2010 Streamlined chemical tests rebuffed

http://www.lsblog.org/blog/?p=9752
Story Summary: Toxicologists who advocate the switch, however, say that their scientific case is overwhelming. Its the only way to make the legislation feasible, says toxicologist Thomas Hartung, former head of the European Centre for the Validation of Alternative Methods in Ispra, Italy, and now at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. He estimates that using the extended one-generation study would reduce animal use in REACH by 40-60%. Costs would be reduced in a similar range, he says. All chemicals sold in the EU in quantities of more than one tonne per year must be registered, along with toxicity data, by 2018. The ECHA estimates that about 30,000 substances will be logged, requiring 9 million animals to be used in tests costing EU1. But a study by Hartung suggests that this is a gross underestimate, and that at least 68,000 chemicals will have to be registered, requiring the use of 54 million animals (T. Hartung and C. Rovida 460, 1080-1081; 2009). The Organisation for Economic Co-operation and Development (OECD) is drawing up guidelines for its member states for a one-generation study. These would include a more extensive battery of tests that are not routinely performed in the existing two-generation studies, including histopathology and neurobehavioural tests. Another study (G. Janer 24, 97-102; 2007) found that in 176 multi-generation studies on 148 substances, there were only three instances in which reproductive toxicity was not identified until the second-generation test. But it is up to the ECHA to recommend that the new tests be used in REACH, and the agency, which attended the October meeting, is not convinced by such studies. In a statement to Nature, the ECHA said: The two-generation study is the only study that covers effects on reproduction after exposure during all life stages. Hartung points out that the OECD, which is expected to approve a final version of the guidelines for one-generation tests in March, could use its political clout to lobby for European regulators to approve the tests. Please keep to our Community Guidelines…
The full story:
http://www.nature.com/news/2010/100113/full/463142b.html?s=news_rss

16.12.2009 Study finds animal research is “sloppy”

http://www.examiner.com/x-6180-Birmingham-Science-News-Examiner~y2009m12d1-Research-finds-sloppy-science-reporting-is-pervasive

A paper submitted for review on November 30, 2009 details the lack of proper methodology in scientific reporting in animal experimentation. The danger of this activity is potentially horrendous.

The majority of scientific papers that deal with animal experimentation do not properly report the number of animals used, do not provide sufficient documentation to make the experiment reproducible, and fail to provide sufficient statistical data to evaluate the results. This failure is not reserved to papers involved in animal experimentation but is pervasive in published peer reviewed journals. This is simply bad sloppy science.

The eventual results of animal experimentation is a drug or product for human consumption. If the science used in the animal research is sloppy and the Phase I, Phase II and Phase III clinical trial reporting is also as sloppy, then there is considerable justification to believe the results in use by humans are dangerous if not deadly.

In the United States many blame trial lawyers for the high cost of medical treatment. The reality may be that the sloppiness of the science feeds the trial lawyers with more than sufficient fodder for a successful lawsuit that does raise the cost of medical treatment. The judgment is paid by insurance or funds held in reserve for lawsuits. These funds could be used more judiciously if the science was done well. The FDA approves drugs based on this sloppy science so the "watch dog" is complicit in the crime and always has been.

The desires of ambition, promotion, income, and being the first are a constant temptation to researchers as is the drive by their employers to produce a money making product as quickly as possible. But hell things have gotten past the bounds of reality if this report itself is unbiased.

These quotes are from the paper cited below that evaluates the scientific and statistical accuracy of papers reporting experiments using animal subjects.

"Many of the studies surveyed omitted details about the strain, sex, age and weight of the animals used."

"In some of the included publications, the number of animals used was not reported anywhere in the methods or the results sections. Reporting animal numbers is essential so that the biological and statistical significance of the experimental results can be assessed or the data reanalyzed, and is also necessary if the experimental methods are to be repeated. Crucially, none of the studies assessed in more detail discussed how the sample size was chosen."

"Many of the studies that did report the number of animals used reported the numbers inconsistently between the methods and results sections. The reason for this is unclear, but this does pose a significant problem when analysing, interpreting and repeating the results."

"The assessment of experimental design found that random allocation of animals to treatment groups was reported in only a very small proportion of all the studies surveyed. Randomisation reduces selection bias, increases the validity of the findings and, in principle, is always an appropriate and desirable aspect of good experimental design when two or more treatments are compared."

"We cannot rule out that some of the studies surveyed may have used randomisation where appropriate, but did not report using it. If this was the case, then this kind of reporting omission can easily be rectified. But if not, incomplete reporting masks potentially flawed experimental methods."

"Reviews of animal research in the field of emergency medicine found that studies which did not use randomisation and blinding to reduce bias when comparing two or more experimental groups, were significantly more likely to find a difference between the treatment groups."

"Our findings indicate that there are problems both with the transparency of reporting and the robustness of the statistical analysis of almost 60% of the publications surveyed. In many papers, due to the lack of information detailing the statistical methods it was difficult to judge whether or not the statistical analysis were appropriate, or if data had been efficiently extracted and analysed."

Carol Kilkenny 1, Nick Parsons 2, Ed Kadyszewski 3, Michael F. W. Festing 4, Innes C. Cuthill 5, Derek Fry 6, Jane Hutton 7, Douglas G. Altman 8
1 The National Centre for the Replacement, Refinement and Reduction of Animals in Research, London, United Kingdom, 2 Warwick Medical School, University of Warwick, Coventry, United Kingdom, 3 Pfizer Global Research and Development, Groton, Connecticut, United States of America, 4 Animal Procedures Committee, London, United Kingdom, 5 School of Biological Sciences, University of Bristol, Bristol, United Kingdom, 6 Animals Scientific Procedures Inspectorate, Home Office, Shrewsbury, United Kingdom, 7 Department of Statistics, University of Warwick, Coventry, United Kingdom, 8 Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

Citation: Kilkenny C, Parsons N, Kadyszewski E, Festing MFW, Cuthill IC, et al. (2009) Survey of the Quality of Experimental Design, Statistical Analysis and Reporting of Research Using Animals. PLoS ONE 4(11): e7824. doi:10.1371/journal.pone.0007824

Editor: Malcolm McLeod, University of Edinburgh, United Kingdom

Received: August 25, 2009; Accepted: October 15, 2009; Published: November 30, 2009

One must note the following which could be a source of bias. "This survey was co-funded by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and the National Institutes for Health/Office of Laboratory Animal Welfare (NIH/OLAW)(http://grants.nih.gov/grants/olaw/olaw.h?tm ). NIH/OLAW had no role in study design, data collection and analysis, or preparation of the manuscript. Members of the NC3Rs Experimental Design Working Group (EDWG; independent, unpaid experts in experimental design and statistics) designed the survey. The NC3Rs paid independent Information Specialists to search published databases, and two independent statisticians Nick Parsons and Ed Kadyszewski to collect and analyse the data. The data were also analysed, and the manuscript prepared and submitted, by the NC3Rs (Carol Kilkenny) in consultation with members of the EDWG."

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0007824

Equally disturbing is a paper published on December 1, 2009 that evaluates the bias exhibitd by the editorial boards of three very prominent scientific journals.

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008092

The paper concludes "Our findings suggest that PNAS "Contributed" papers, in which NASmember authors select their own reviewers, balance an overall lower impact with an increased probability of publishing exceptional papers"

David G. Rand 1,2, Thomas Pfeiffer1
1 Program for Evolutionary Dynamics, Harvard University, Cambridge, Massachusetts, United States of America, 2 Berkman Center for Internet and Society, Harvard University, Cambridge, Massachusetts, United States of America

Citation: Rand DG, Pfeiffer T (2009) Systematic Differences in Impact across Publication Tracks at PNAS. PLoS ONE 4(12): e8092. doi:10.1371/journal.pone.0008092

Editor: Tom Tregenza, University of Exeter, United Kingdom

Received: September 17, 2009; Accepted: November 3, 2009; Published: December 1, 2009

05.12.2009 Epilepsy breakthrough NOT using animals

In contrast to the reports of harmful research using animals coming out of Newcastle University last week, THIS WEEK other researchers also based at Newcastle have reported that they have made a breakthrough in epilepsy research without resorting to the use of animals.

Researchers of the Epilepsy Surgery Group have been able to record spontaneous epileptic activity in brain tissue that had been removed from patients that had undergone surgery on their brains for epilepsy. They were able to ‘fool’ the brain tissue in the test tube that it was still part of the brain and observe the electrical signals preceding an epileptic attack. By comparing the activity of the brain cells between the epileptic patients and normal patients they found that that there is a particular type of electrical brain wave pattern that triggers an attack, rather than a chemical based reaction. This has big implications for the treatment of epilepsy which are often chemical based and may explain why they sometimes do not work.

One of the researchers, Dr Cunningham, is quoted as telling ‘Live Journal’: “Until now we have only been able to mimic epilepsy using experimental animal models, but this can never give you a true picture of what is actually going on inside the human brain in epilepsy. Our findings help us to understand what is going wrong and are an important step towards finding new epilepsy treatments in the future.”

These great results show how important it is to maximize the use of human information when trying to understand and cure diseases. Perhaps it is no surprise that this research came out of a clinical (human based) department.

Read Live Journal's news report
http://www.journallive.co.uk/north-east-news/todays-news/2009/12/01/newcastle-university-epilepsy-researchers-make-breakthrough-61634-25291001/

02.12.2009 Anthrax study rejected by OSU

Some can say that is because money and anyway if not OSU there are lots of labs which would be happy with this job - but aren't animal experiments done for money??
http://www.newsok.com/anthrax-study-rejected-by-osu/article/3421451?custom_click=headlines_widget
Euthanasia of primates may be to blame for decision to cancel veterinary school project
STILLWATER — A project to test anthrax vaccines and treatment on baboons was quashed by Oklahoma State University administrators because the primates would be euthanized.

This micrograph reveals submucosal hemorrhage in the small intestine in a case of fatal human anthrax. Photo provided

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Veterinary medicine researchers were told by e-mail last month that OSU President Burns Hargis wouldn’t allow the National Institutes of Health-funded project, even though an internal faculty committee had spent more than a year setting out protocol for the care and use of the primates.

Veterinary scientists say the decision was sudden and arbitrary, and now they fear the president may call for ending other projects involving animal research.

OSU administrators declined to comment for this story, but released a statement through OSU spokesman Gary Shutt stating "this research was not in the best interest of the university. The testing of lethal pathogens on primates would be a new area for OSU that is controversial and is outside our current research programs.”

The Oklahoman attempted to contact Hargis, Vice President of Research Stephen McKeever and Veterinary College Dean Michael Lorenz.

The statement also said: "OSU is focused on enhancing and expanding its existing research strengths including our ongoing programs in bioterrorism research. The proposed work would have distracted from those efforts.”

Veterinary doctor Michael Davis said the research is justified because the implications of finding a cure or vaccine for anthrax could be important for humankind.

"This isn’t a hypothetical thing,” said Davis, a member of the Institutional Animal Care and Use Committee that approved the project. "There has in fact been anthrax terrorism in the United States. All those people are dead.”

He said primates are the best animals to test treatments because they are similar biologically to humans. But the primates must be destroyed after anthrax exposure to ensure they don’t infect others.

"We don’t want to, but by the same token we don’t want people to be killed by anthrax,” Davis said. "Right now, this is the only way and the best way we have of preventing someone from getting killed by anthrax.”

Anthrax-laced letters killed five people and rattled the nation shortly after the terror attacks of Sept. 11, 2001.

The project was to be conducted in a multimillion dollar lab at OSU designed for research on bioterrorism agents. Davis said administrators have known for years that primates would be used in research in the new lab.

Veterinary scientist Richard Eberle said the faculty believes Hargis’ ruling was influenced by an animal rights advocate or other organization.

He fears the decision will jeopardize future projects as well.

"OSU is now seen by researchers at other institutions as an unreliable research partner and afraid of animal rights demonstrators,” Eberle said. "It is sad that such a golden opportunity for OSU and the state of Oklahoma to attain national recognition has been missed as the result of a single individual’s decision.”

Davis also fears the change in policy might lead to more bans on research into other animals. Davis’s research into the metabolism of sled-dogs in Alaska has long been touted by OSU leaders. He does not euthanize the dogs he works with.

"I don’t know if I’m going to be out of business tomorrow,” he said. "This can shut down careers.”

Veterinary doctor and OSU professor Kenneth Bartels said Hargis failed to consult faculty before changing policy.

"The president certainly has the prerogative to make this decision arbitrarily,” Bartels said. "But we have a standing committee that is approved by U.S. Department of Agriculture and works under auspices of Animal Welfare Act. That expertise shouldn’t really be ignored.”

Background
In April, OSU announced that animals will no longer be euthanized in teaching labs at the veterinary school.

Controversy about euthanizing animals after students performed surgeries on them arose after Madeleine Pickens, the wife of billionaire benefactor and OSU alumnus T. Boone Pickens, threatened to redirect a $5 million donation to the vet school because she did not agree with such practices.

02.12.2009 'Toxichip' system may replace animal testing

http://www.irishtimes.com/newspaper/health/2009/1201/1224259787253.html
DICK AHLSTROM, Science Editor

AN INTERNATIONAL research team including scientists from the Tyndall National Institute have developed a highly sensitive toxicity testing system. They believe it could provide a replacement for animal testing in toxicity screening.

The Minister for Education and Science, Batt O’Keeffe, launched the Toxichip yesterday in Cork to mark the beginning of Nanoweek, a week-long celebration of nanotechnology research to help raise public awareness of the importance of this technology to Ireland’s economy.

The Toxichip is a sensing system developed at Tyndall in collaboration with European academic and industrial partners funded under the EU’s Framework Programme 6.

It is sensitive enough to measure the effects of toxic substances on human or animal cells in culture. It provides this information in real time which means the system can be used to gauge the direct effect of chemical pollutants, experimental drugs and toxic substances in food and beverages.

Tyndall researchers led by Dr Eric Moore developed the biosensors for the system, which he believes has the potential to replace animal testing.

EU directives have placed new strictures on the use of animals for toxicity testing, both under the Reach chemical directive and the Cosmetics Directive. They force companies to reduce the use of animals for toxicity testing.

The Toxichip demonstrated how research under way at Tyndall and at other centres around the State could contribute to the “smart economy”.

The creation of “a strong research, innovation and commercialisation ecosystem” was central to an economy based on knowledge, the Minister said.

* Nanoweek runs from November 30th to December 4th. Full details of public events during the week are available at www.nano week.ie

30.11.2009 UK: making animal experiments Top Secret

foi-displayimage.jpg

"The Freedom of Information Act 2000 (FOIA) sets out the ways the public can get access to information held by the Government. This includes information held by the Home Office, Universities and other bodies about animal experimentation.
There are a number of exemptions for the FOIA including one that says if another law bans information from being given out, then the FOIA doesn’t apply to that.
Unfortunately, this applies to animal experiments. Because Section 24 of the Animal (Scientific Procedures) Act 1986 stops the Home Office giving out information about experiment licences which researchers want to keep secret, we can’t use the FOIA to get this information.
The BUAV doesn’t think this is fair. We don’t want to know researchers names or addresses or anything that is genuinely confidential. However, we do think the public has a right to know what is being done to animals in experiments and why."
"An article written by David Thomas, BUAV's legal advisor, has been published in the leading Freedom of Information Act (FOIA) journal, 'Freedom of Information.' In the article, David Thomas looks at the issues surrounding access to information about animal experiments.
The BUAV believes that informed public debate is essential but it cannot happen without meaningful information being available. In addition, effective scrutiny – parliamentary, public and, ultimately, judicial – of the way the Home Office regulates the experiments is impossible under a secretive system."

Read the article here

EDM 277: Take action !

29.11.2009 "Living Cadavers" Replace Living Animals in Surgery Training

http://www.awionline.org/ht/display/ContentDetails/i/16211/pid/16201

The replacement of live animal models with alternatives is an encouraging recent trend in medical education. Where the use of live animals was once standard practice in medical school curricula, today 152 of America’s 159 medical schools (which include allopathic and osteopathic schools) have eliminated these methods in favor of more modern and effective alternatives.

One of the challenges specific to surgical training is the simulation of dynamic, living tissue. Available training models such as mannequins, computer models, virtual reality (VR), and ethically-sourced cadavers all offer valuable training opportunities, but (with the exception of some VR simulators) do not bleed, ooze or pulsate. A solution to that challenge has been developed by Dr. Emad Aboud, a neurosurgeon at the University of Arkansas for Medical Sciences.

Elegant in its sheer simplicity, Aboud’s system involves connecting a human or an animal cadaver to a mechanical pump. Plastic tubing is spliced onto the major arteries and veins, and artificial blood is then pumped into the vessels to fill the specimen’s vascular tree. The other end of each vessel is coupled to a reservoir of "blood" (water mixed with food coloring works fine). The pump can be adjusted for both pulsation speed and pressure. Clear liquids can mimic cerebrospinal fluid when working with head and spine specimens.

Though not yet commercially available, the system has potential for widespread use owing to its flexibility and low cost. It has training application to all kinds of surgical procedures in all surgical fields, including endoscopic (e.g., bronchoscopy and colonoscopy) and endovascular (e.g., angiography, aneurysm repair) procedures; making and suturing incisions in skin or organs; dissecting soft, oozing tissues; ligation of severed vessels; vascular anastomosis (connecting two ends of a severed vessel); intestinal anastomosis; and transplantations. "Living Cadavers" can also be used to practice non-surgical techniques such as withdrawing blood and inserting central and arterial lines (used for obtaining cardiovascular measurements and long-term administration of medications).

Naturally, the method is equally applicable to animal cadavers. In fact, Aboud first tried the technique with a dead fox he removed from a roadside and later using a dog cadaver for laparoscopic and open surgical procedures. According to the Humane Society Veterinary Medical Association, nearly half of the nation’s 28 veterinary schools still conduct terminal surgeries on animals, and Aboud is now seeking to expand his model’s use in veterinary training. Ethical sources of animal cadavers include willed-body programs, animals who have died naturally or in accidents, and animals euthanized for medical reasons. Crucially, acquiring animal cadavers need never involve purpose-breeding or killing animals; thus, Class B dealers—who acquire animals from a variety of sources and then sell them to research institutions or veterinary schools—can and should be kept out of the loop.

Aboud’s model is in regular use at the University of Arkansas and has been featured at training workshops and courses in neurosurgery across the U.S., as well as Germany, Finland, Syria and the Netherlands. His team is ready and willing to help with setting up the system at other surgical training facilities. "It’s a win-win-win solution," says Aboud, "providing advanced training at low cost with the promise of further replacing animals in medical and veterinary training."

Contact information

Dr. Emad Aboud

Neurosurgery Department

University of Arkansas for Medical Sciences

4301 W. Markham St., Slot #507

Little Rock, AR 72205
moc.liamg|dameduoba#moc.liamg|dameduoba

19.11.2009 Shock findings from UK undercover investigation shows inadequacies of proposals for EU animal experiment directive

The BUAV, the UK’s leading animal group campaigning to end animal experiments, is handing over a crucial dossier of evidence this week to the European Commission and key MEPs, Members of the Agricultural Committee. The shocking findings obtained during a major undercover investigation carried out in a UK animal laboratory highlight the inadequacies of the current proposals concerning the revision of European animal experiments rules, Directive 86/609/EEC. The BUAV is calling for these findings to be taken into account when the proposals are being considered by the Council of Ministers and the Parliament, under the Swedish Presidency.

The findings of the investigation are of direct relevance to the revision of Directive 86/609. In particular to the issues of transparency, severity of suffering, the ethical evaluation for licensing experiments, regulatory testing, the re-use of animals and the implementation of alternatives. (See notes below for further details.)

Between January and October 2009, the BUAV conducted an 8-month investigation at Wickham Laboratories in Hampshire, England. Wickham is a contract-testing laboratory. The investigation revealed graphic disturbing evidence of the cruelty and suffering inflicted on thousands of animals every year, largely relating to quality control of drugs and other products, including, the appalling suffering typically inflicted on mice in laboratories around the world for the craze of using botox products for vanity purposes. Animal tests carried out included the archaic poisoning test LD50 (lethal dose 50 - this is the dose at which 50% of the mice would be expected to die when injected with the toxin), and pyrogen tests where rabbits can be starved for up to 30 hours, restrained in stocks for up to 8 hours and are re-used repeatedly in further pyrogen tests, adding to their distress.

The BUAV has accused the Home Office, which regulates animal experiments in the UK, of breaking the law in several ways including not enforcing the use of non animal alternatives and failing to minimise the suffering inflicted on animals. In addition, some animals suffered in tests that are no longer required by national and international regulations. This destroys the often made claim that companies have to do animals tests because regulators require them.

BUAV’s Chief Executive, Michelle Thew states: “The BUAV investigation has come at a critical time during the revision of EC Directive 86/609. Our findings show the total inadequacy of the proposals that are currently on the table. We call on the Council to throw out these proposals and instead fulfill their obligations and give animals in laboratories the protection they need.”

ENDS
For further information, images and video footage, please contact Carla Owen on +44 (0)207 700 4888 or gro.vaub|newo.alraC#gro.vaub|newo.alraC or BUAV (out of hours) +44 (0)7850 510 955 or visit our website http://www.buav.org/
NOTES:
The BUAV’s findings are of direct relevance to the revision of EC Directive 86/609 and highlight just how inadequate the current proposals are. In particular:

1. Transparency: only undercover investigations can reveal the truth about animal experiments. The BUAV investigation has revealed an appalling catalogue of animal suffering and failure to use available alternatives.

2. Implications for the directive: the current proposals for transparency are wholly inadequate. The proposal is that only ‘non-technical summaries’ need to be provided. In practice, these are likely to be very short and would not enable the public – or courts - to understand what is really happening.

3. Severity: Wickham carries out the notorious and discredited Lethal Dose 50 poisoning test on tens of thousands of mice for a type of botox (Dysport) every year. The LD50 is designed to determine the dose of a particular substance which will kill half the animals. The mice in the higher dose groups suffered grievously – paralysis, suffocation, weight loss, dehydration. The project licence acknowledges that the symptoms are ‘very severe’. Euthanasia prior to death (the so-called ‘humane endpoint’) resulted in only a small proportion of the animals being killed, the majority died from the effects of the poisoning.

4. Implications for the directive: the latest Council draft would allow experiments of this nature where death is an ‘endpoint’. Indeed, it would in practice allow suffering which is both severe and long-lasting – even, under a very wide derogation, where suffering cannot be ameliorated.

5. Ethical evaluation: Dysport is licensed in the UK for some relatively rare medical indications and the UK Government claims that it only allows animal testing on botox products for those indications. However, both Dysport and other botox products are used on a massive scale for cosmetic treatment and the Government cannot control it what use animal-tested botox is put.

6. Implications for the directive: this highlights the need to limit the purposes for which animal experiments are permitted. Article 5 is drawn very widely and would allow animals to be used for just about any purpose, despite the high suffering which may be involved.

7. Re-use: at Wickham, rabbits are used in pyrogenicity tests, to determine whether injected substances are contaminated. A single test involves: starving the rabbits for up to 30 hours; placing them in stocks by the neck for 6-8 hours with a temperature probe inserted into their rectum; depriving them of water for this period and injecting the foreign substance into their ears. Damage to ear veins and back injuries can occur and, not surprisingly the rabbits are very distressed. The UK Government classifies the experiments as ‘moderate’.

Rabbits are repeatedly re-used. During the first 6 months of 2009, there were 944 pyrogen tests; the colony at any given time is around 100.

8. Implications for the directive: the latest Council text proposes that individual animals could be used endlessly in ‘moderate’ experiments, with weak safeguards. This investigation demonstrates the appalling implications. A single use in ‘moderate’ experiments can involve multiple surgical procedures and multiple other adverse effects.

9. Alternatives: a UK government laboratory developed alternatives to the LD50 over 10 years ago, specifically for Dysport. Botox companies are refusing to co-operate to validate the alternatives which are already provisionally accepted by the European Pharmacopeia.

In addition, both the European Pharmacopeia and the US version specify and prefer a non-animal method for most of the drugs for which the rabbit pyrogen test is carried out at Wickham.

10. Implications for the directive: this once again highlights the fact that there is a chasm between the rhetoric about alternatives and the reality of their use.

11. Regulatory testing: so-called humane endpoints (early intervention to prevent unnecessary suffering) were set and applied improperly, suffering was not kept to a minimum in other ways and alternatives were not used when clearly available.

12. Implications for the directive: the latest Council draft would allow ‘multiple generic projects carried out by the same user when those projects are to satisfy regulatory requirements or product or diagnostic purposes with proven methods’ and would allow ‘tacit approval’ for such experiments where the competent authority delays giving express approval. This would mean that competent authorities would be very unlikely to prevent the type of legal breaches revealed by the BUAV investigation, and would be unable to conduct an ethical evaluation as to whether animal tests should be allowed for particular substances or products.

BUAV Press Realase: http://www.eceae.org/press.php?p=547&more=1

02.11.2009 Undercover investigation exposes shocking animal cruelty and major failings by the UK government

The BUAV, one of the world’s leading organisations campaigning to end animal experiments, has today revealed graphic disturbing evidence of the cruelty and suffering inflicted on thousands of animals every year in UK research; including for the first time, the appalling suffering inflicted on mice for the worldwide craze of using botox products to temporarily reduce facial lines and wrinkles.

The BUAV has also accused the Home Office, which regulates animal experiments in the UK, of breaking the law in several ways including not enforcing the use of non animal alternatives and failing to minimise the suffering inflicted on animals.

The BUAV placed an undercover worker in Wickham Laboratories in Hampshire for 8 months to the end of October 2009. She secretly filmed the appalling suffering inflicted on thousands of animals inside the facility. The laboratory carries out poisoning tests on thousands of mice every month for a product called Dysport ® (manufactured by Ipsen), which contains the deadly botulinum toxin. Botulinum toxin is licensed in the UK for some relatively rare medical conditions – and the Home Office claims it only allows the animal tests for these purposes - but is increasingly being used “off-label” in cosmetic clinics for purely cosmetic purposes where it is commonly referred to as ‘botox.’

In practice it is impossible for the Home Office to ensure that the Dysport ® tested at Wickham on an industrial scale does not end up in cosmetic clinics. The Government has banned animal testing for cosmetics since 1997.

The test used is the archaic poisoning test LD50 (lethal dose 50 - this is the dose at which 50% of the mice would be expected to die when injected with the toxin), one of the cruellest and most controversial tests carried out on animals. Even the Home Office classifies it as ‘substantial severity.’

Wickham also uses rabbits in pyrogenicity (fever) tests where a test substance is injected into an ear vein to detect contaminants. The rabbits are restrained by their necks in stocks with a temperature probe deep in their rectum for many hours at a time, with no access to water. According to the laboratory, damage to the ear and rectum can occur as well as damage to the rabbits’ backs from struggling in the stocks. Rabbits can be starved for up to 30 hours and are re-used repeatedly in further pyrogen tests, adding to their distress.

Key findings:

* The UK government is failing in its legal obligation to enforce the use of the 3R’s (Replacement, Reduction and Refinement) principle for non-animal alternatives where they exist and to ensure that, if animals are used, then it should be the minimum number and with the minimum amount of suffering.

* The appalling suffering inflicted on thousands of animals in cruel, crude and archaic tests. Animals kept in small, virtually barren cages that failed to meet their behavioural and social needs.

* The total inadequacy of measures to intervene before death with the LD50 poisoning tests - far more animals died an agonizing death than were euthanased.

* Mice crudely killed by having their necks broken on a corridor floor with a ball point pen. Some staff breaking the backs of mice rather than their necks resulting in excruciating additional suffering.

* Some animals suffered in tests that are no longer required by national and international regulations. This destroys the often made claim that companies have to do animals tests because regulators require them.

* A glaring conflict of interest by the statutory ‘Named Veterinary Surgeon,’ responsible for advising on the animals’ welfare. He is a director of Wickham and with his wife owns virtually all the shares. Recorded weekly visits by him often lasted just for a few minutes.

Tests such as the LD50 test for botulinum toxin and the pyrogenicity test have valid in vitro alternatives and it is outrageous that they are not being implemented. The Limulus amoebocyte lysate assay (LAL) is an ‘in vitro’ method that can often be used for detecting bacterial pyrogens and is recognized by regulatory authorities in both Europe and the USA as an alternative to the rabbit pyrogenicity test. Indeed, European guidelines stress the alternative is often more reliable..

The SNAP-25 assay, a method that does not use live animals but instead measures the activity of the toxin in a test tube, can be used to replace the botox mouse LD50 tests. The BUAV believes that under UK law this test should be used. Furthermore, this test has been validated by an official UK government laboratory, the National Institute for Biological Standards and Control (NIBSC), and has been used by them since 1999, specifically for Dysport ®. Inexplicably, the UK Home Office is not insisting on this test even after all these years.

BUAV’s Director of Special Projects, Sarah Kite states: “Time and time again the government and animal research community claim that animals are only used as a last resort for vital medical research and that animal suffering is kept to a minimum. This BUAV investigation has blown those claims wide open. Our shocking findings show that crude, archaic and extremely cruel animal tests are still allowed in the UK even when an alternative test exists and animal testing is not required by official bodies.”

article + video in Timesonline
Staff maim lab mice with ballpoints

20.10.2009 Parkinson’s disease tests on monkeys – the BUAV responds

The BUAV has expressed its profound concerns and reservations regarding the highly invasive experiments involving monkeys that were announced today using Oxford Biomedica’s Parkinson’s disease drug ProSavin. These concerns include:

• The monkey “model” for Parkinson’s disease has significant differences to human Parkinson’s disease, which seriously affect its clinical relevance.2 Artificially producing Parkinson’s-like signs in monkeys by injecting their brains with a toxin does not faithfully model human Parkinson’s disease.

• The ProSavin intervention only addresses one aspect of the many facets of Parkinson’s disease – dopamine loss. Elucidation of Parkinson’s pathology and the progress of the disease has been and will continue to be via the use of superior human-specific scientific methods, such as brain-imaging techniques, use of post-mortem brain tissue from patients, human genetic studies and population studies.3 People knowledgeable in the field recognise this:

“Alzheimer's, Parkinson's and other neurodegenerative diseases occur in humans and it is in human tissue that we will find the answers to these diseases” - Dr. John Xuereb, Director of the Cambridge Brain Bank and Wolfson Brain Imaging Centre. BBC Radio Cambridge, 7th February 2002.

• The monkey can neither be considered to usefully augment the existing human data, nor to increase the probability that ProSavin will be successful in larger and more comprehensive human trials and/or in the clinic. This is due to significant and intractable species differences between humans and monkeys. Such differences mean that – while occasional correlations do occur - results from animal models are not predictive of human response. Only clinical trials can provide reliable and relevant information regarding the drug’s safety and efficacy in humans4 – and these are already being conducted. Notably, there are many superior scientific approaches to testing drugs prior to human trials that do not use animals. When used in concert, these tests – such as microdosing, toxicogenomics, computer modelling and batteries of human cell and tissue assays – predict more efficiently the likelihood of success or failure in patients.5

• The clinical results are preliminary: many drugs appear promising in early clinical trials yet go on to fail in later-stage investigations (such as Cephalon’s CEP-1347).6

The BUAV agrees that it is important to find a cure for human Parkinson’s disease and to alleviate the suffering it causes. However, the monkey experiments reported in the ProSavin article were cruel, unnecessary, irrelevant and not predictive for humans. Despite decades of research, much of it using monkey “models” of Parkinson’s disease, there is still neither a cure nor any treatment that halts the progress of the disease or is effective against its symptoms in the long term. Until more researchers join the ranks of forward-thinking scientists who utilise human tissue and perform ethical human studies, Parkinson’s research will continue to stall and throw up disappointments in the form of new drugs and interventions that “worked” in animals but do not in people.

Citations:

1. http://www.reuters.com/article/scienceNews/idUSTRE59D4DL20091014
2. Hantraye P. Modeling dopamine system dysfunction in experimental animals. Nucl Med Biol. 1998 Nov;25(8):721-8. Bailey J. Non-Human Primates in Medical Research and Drug Development: a Critical Review. Biogenic Amines 2005;19(4-6):235-255. Schober A. Classic toxin-induced animal models of Parkinson's disease: 6-OHDA and MPTP. Cell Tissue Res. 2004 Oct;318(1):215-24. Epub 2004 Jul 28.
3. Bruck A et al (2001) Positron emission tomography shows that impaired frontal lobe functioning in Parkinson's disease is related to dopaminergic hypofunction in the caudate nucleus. Neurosci Lett. 311:81-84. Sanai N et al (2004) Unique astrocyte ribbon in adult human brain contains neural stem cells but lacks chain migration. Nature 427: 740-4. Dawson TM and Dawson VL (2003) Molecular pathways of neurodegeneration in Parkinson's Disease. Science 302:819-822. Ascherio A et al. (2006) Pesticide exposure and risk for Parkinson's disease. Annals of Neurology 60: 197-203. Marvanova M et al. (2003). Microarray analysis of nonhuman primates: validation of experimental models in neurological disorders. FASEB J 17, 929-931.
4. Harding, A. (2004). More compounds failing phase I. FDA chief warns that high drug attrition rate is pushing up the cost of drug development. The Scientist (6 August).
5. Bailey J, Taylor K. The SCHER report on non-human primate research - biased and deeply flawed. Altern Lab Anim. 2009 Sep;37(4):427-35.
6. http://www.pdpipeline.org/advocacy/cephalon_halts_cep1347.htm

13.10.2009 An Examination of Chimpanzee Use in Human Cancer Research

Study Challenges Importance of Animals in Research

Tuesday - October 13, 2009 (posted in Project R&R News)

Boston – A recently released paper by Project R&R published in the journal Alternatives to Laboratory Animals (ATLA 37, 399–416), presents a serious challenge to long-standing claims that animals are an important part of human cancer research. “An Examination of Chimpanzee Use in Human Cancer Research” found that chimpanzees, our closest genetic relatives, have contributed little to combating cancers and cost society not only time but wasted research dollars. The paper comes on the heels of a national ad campaign (ResearchSaves, Sept.16, 2009) launched by The Foundation for Biomedical Research advocating animal use.

(ATLA 37, 399–416: http://www.releasechimps.org/pdfs/chimpanzees-and-human-cancer-research.pdf)

Geneticist Jarrod Bailey, Ph.D., Science Director for Project R&R: Release and Restitution for Chimpanzees in U.S. Laboratories, conducted a comprehensive analysis of the use of chimpanzees in cancer research over the past four decades as well as proposed future uses.

According to Bailey, “There are significant biological differences between humans and chimpanzees. Despite an overall – although superficial – genetic similarity to humans, and despite claims by the research industry, chimpanzees have proven to be a poor model for human cancer research.”

The study found that chimpanzee tumors are extremely rare and biologically different from human cancers. Literature describing potential new cancer therapies tested in chimpanzees included significant caveats concerning species differences, and described interventions that had not been pursued in humans, presumably due to adverse reactions. Further, available evidence indicates that chimpanzees are not essential in the development of monoclonal antibody therapies for cancer treatment.

The U.S. is the only remaining large-scale user of chimpanzees in biomedical research in the world. Arguments regarding the inefficacy of chimpanzee use in biomedical research for humans have been mounting. H.R. 1326, the Great Ape Protection Act, was recently introduced to the House of Representatives. The bill seeks to end invasive biomedical research and testing on an estimated 1,000 chimpanzees remaining in U.S. laboratories.

The study concludes: “It would be unscientific to claim that chimpanzees are vital to cancer research and reasonable to conclude that cancer research would not suffer if the use of chimpanzees were prohibited in the U.S.” The cancer paper follows other studies investigating chimpanzee use to study human health and disease, including HIV/AIDS vaccine development. That study found chimpanzee use has not benefited but rather has hindered our search for an effective human vaccine against HIV/AIDS.

13.10.2009 EU controversy over primate research continues

For Immediate Release: 13/10/09 – By: BUAV
EU controversy over primate research continues with the publication of a new paper accusing the European Commission of producing a “deeply flawed and biased”

A paper released today in the journal Alternatives to Laboratory Animals (ATLA) accuses the European Commission of producing a scientifically flawed report on the use of nonhuman primates in research. The report is based on a recent inquiry conducted by the Scientific Committee on Health and Scientific Risks (SCHER), into the validity of primate research and the alternative methods that could replace it. This inquiry was in part a response to a written declaration signed by no fewer than 433 MEPs in 2007 calling on the Commission to bring forward proposals to replace primate use.

The paper, titled ‘The SCHER Report on Non-Human Primate Research – Biased and Deeply Flawed’ exposes serious shortcomings in the SCHER inquiry and subsequent report which strongly backed primate use and played down the role and potential of alternatives. Drs Jarrod Bailey and Katy Taylor, scientists at the BUAV, analysed this report in detail. The ATLA paper demonstrates:

• Neither SCHER nor its working group had the necessary expertise in primate research or in alternative techniques. Most of the working group members were animal researchers (but not primate researchers), and just one member had (limited) expertise in alternatives to primate use.

• SCHER presumed the validity of primate research, while ignoring substantial peer-reviewed evidence submitted by the BUAV/European Coalition to End Animal Experiments (ECEAE )and numerous other organisations casting serious doubt on the efficacy of primate research. This covered such important areas as AIDS, stroke, malaria and Parkinson’s Disease. For example: not one of the 85 or more candidate AIDS vaccines tested successfully on primates has worked in patients; over 1,000 potential stroke treatments have been tested in animal models but none of the 150 that have progressed to human trials has proved successful.

• Similarly, SCHER dismissed or ignored significant evidence concerning the existing and potential application of alternatives to primate experimentation, including human clinical studies, in vitro (test-tube) techniques, neuroimaging and computer modeling.
The ATLA paper argues that the implications of such a flawed analysis are extremely serious, both for animal welfare and for human health and safety. In particular, because in revising the EU Directive on animal experiments, which is currently being considered by the European Parliament, the EU is basing its position to non-human primate research directly on the findings of the SCHER inquiry.

BUAV’s Scientific Coordinator, Dr Katy Taylor, said: “The conduct of the SCHER inquiry, and its published Opinion, should be of major and widespread concern and should not be given any political, scientific or legislative credibility.”

Scientific Consultant to the BUAV, Dr Jarrod Bailey, said: “The SCHER investigation was conducted by scientists poorly and inappropriately qualified to do so, and the subsequent report in support of non-human primate research was based on flimsy evidence and ignorance of the evidence against.”

04.10.2009 Ireland: Number of animals tested doubles in year

http://www.tribune.ie/news/home-news/article/2009/aug/16/number-of-animals-tested-doubles-in-year/

http://againess-en.wikidot.com/animal-experiments-news

Tribune. 16 August 2009

Number of animals tested doubles in year

John Downes, News Investigations Correspondent

Concerns have been expressed that Ireland is becoming an international centre for animal testing. Latest government figures reveal that the total number of animals used in experiments almost doubled to over 112,800 last year. The unpublished Department of Health figures show there were increases in the number of dogs, rabbits, pigs, and fish used in experiments during 2008. The number of cattle used in experiments almost doubled to 4,019, while the number of mice used almost tripled to 71,224 when compared to the previous year.

Overall, 557 dogs, 456 sheep, 224 pigs, 91 guinea pigs, 68 hamsters, 204 rabbits, and 23,198 fish were subjected to scientific procedures, all of which represented an increase on the previous year, the figures reveal. Among the few categories to buck the trend were cats (down to 295 from 421 during the previous year), birds (582 compared to 1,016 in 2007) and horses, donkeys and crossbreeds (144 versus 153).

Animal welfare campaigners say these figures are still too high, and point out that the total of 112,835 animals used in research last year represents by far the highest number recorded over the 18-year period since 1990. But supporters of scientific testing on animals argue it is necessary to develop treatment for many human illnesses such as cancer, Alzheimer's disease and arthritis.

According to a more detailed breakdown of the statistics, all of the cats and the vast majority of the dogs (547) came from registered Irish breeders or supplying establishments. This has prompted the Irish Antivivisection Society (IAVS) to reiterate its concerns that these animals are effectively being "bred to die".

Most of the dogs (543) and all of the cats were also used in experiments which did not involve anaesthesia, the figures show. IAVS spokeswoman Yvonne Smalley, who obtained the figures, said she was "horrified" to learn that the number of animals used in experiments here has almost doubled in the space of a year. She questioned whether companies have been "wooed to Ireland" on the basis that they can conduct "any amount" of animal experiments on limitless numbers of animals.

"Six new commercial companies have been licensed to experiment on animals in the last couple of years, bringing the total to nine," she said. "Poisoning animals for commercial advantage is unethical and should have no place in this country's stated policy to encourage the latest scientific research and testing technologies to flourish in Ireland."

One of Ireland's most celebrated authors John Banville has in the past strongly criticised the use of animals for experiments in universities such as Trinity College Dublin, which he said was "morally indefensible". This followed the publication of figures in this newspaper showing that TCD had spent more than €600,000 over a period of three years procuring 41 live beagle dogs, 69 pigs and over 16,000 mice for medical or scientific research. The new figures show that none of the cats and just 14 of the dogs used in scientific experiments last year were licensed to universities and colleges. By comparison, all 295 cats and 455 dogs were approved for use in commercial establishments.

Almost 18,500 mice, 7,900 rats, 120 rabbits, 357 cattle and 34 horses, donkeys and crossbreeds were licensed for use in universities and colleges last year, while a further 50,759 mice, 3,108 rats, 84 rabbits, 99 horses, donkeys or crossbreeds and 91 cattle were licensed to commercial establishments.

Under current regulations, private companies or colleges that wish to conduct research using animals must apply to the department for a licence. The figures reflect the number of occasions on which they made such applications in 2008.

To download a copy of the 2008 statistical report click here:

http://www.irishantivivisection.org/statistics_2008.pdf

24.09.2009 Wickham Labs loses bid for new rural site

http://www.portsmouth.co.uk/newshome/Animal-test-lab-loses-bid.5676118.jp
Controversial plans to build a new animal testing laboratory in a rural village have been unanimously rejected.
Wickham Labs, currently based in Wickham, failed in its latest bid to win permission for a purpose-built facility at Torbay Farm in Lower Upham.

More than 20 animal rights protesters turned up to stage a demonstration outside the civic offices of
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Winchester City Council, where the planning committee was holding its meeting yesterday.

Several police officers watched the demonstration, and sat in on the meeting – which all the protesters initially came in to – but there was no trouble.

However, the committee was warned they would not be able to refuse the application on potential security problems.

Planning officer Neil Mackintosh told members: 'The actions of third parties cannot be controlled by the planning committee and are a matter for the police.'

After two-and-a-half hours the 10-member committee voted unanimously against the officer's recommendation to accept the proposals on the grounds that the building would be too large and its design unsympathetic for the rural setting.

The main proposed building was about 50m by 30m and nine-and-a-half metres high.

Echoing many of his colleagues, Councillor Ian Tait said: 'In an industrial estate or a business park this building would be fine – but we aren't, we are in Upham.'

Cllr Therese Evans, who represents Wickham and is also on the committee, acknowledged that security wasn't their concern, but added that Upham, in the Meon Valley, would not be a suitable place because of the attention the labs would attract.

She added: 'There was a demonstration a couple of weeks ago in Wickham where all the roads were closed and there were 130 police.'
Afterwards, veteran animal rights campaigner Helen Nelson said: 'We are absolutely delighted. We have been working so hard towards getting this result, it's such a relief.

'I'm sure they will try again – they're not going to give up. They think they can trample over everyone and get their own way, but this proves they can't.'

Moving the operation to Torbay Farm has been a longheld ambition for owner William Cartmell.

Ray Botterell, representing the labs at the meeting, refused to comment afterwards.

24.09.2009 China will soon be the most important exporter of lab monkeys in the world

We always have no much time to celebrate any success. Until they all are free….

Made to suffer: Exporting primates for reasearch
The mainland is quickly and quietly becoming the world's leading breeder of primates destined for laboratory research. The country has many factory farms devoted to the business
MONKEY FARM
Richard Jones
Sep 13, 2009

Thousands of tiny hands grip the cage bars. Their resemblance to those of children is discomforting - but a similarity to humankind is the reason their possessors are here.

Cage after cage in row after row stretch along the subtropical valley floor. Inside sit long-tailed macaques: the favoured monkey of the vivisectionist because they are small and easily handled. The creatures look like they know what their future holds; wide-eyed they cower at the back of their cages, already terrified of human contact. Mothers clutch babies in their sterile prisons, their fate etched in code on metal discs that hang around their necks.

The monkeys' short lives will come to an end in laboratories in Europe, the United States and Japan; their torture the dark side of advances in science and medicine.

When complete, at the end of the year, this monkey farm, north of Guangzhou, will be the biggest in the world, able to house 50,000 primates. The facility is being built in some secrecy in Conghua county by Blooming Spring Biological Technology Development.

The location was well chosen; it is obscured by a hill, invisible from a nearby highway and within 30 minutes of an international airport. The cages are hidden in a pink-tiled compound more than a kilometre in length that is surrounded by a three-metre-high wall. Inside, scientists scurry about in white coats.

The mainland has been quickly and quietly building monkey farms since about 2000, when breeding stock was imported from Cambodia. The mainland now has 39 farms, most of which are licensed to breed for the lucrative export trade. Although numbers are difficult to ascertain, official figures - along with those from US sources and this investigation - suggest there are more than 200,000 captive primates on the mainland. Official figures last year put the number of monkeys in farms licensed for export at 170,000.

Guarded and gated, the farm compounds have been built in dead-end valleys, jungle clearings and even on an island. Visitors are not welcome and journalists are despised only slightly less than animal-rights activists.

"How did you find this place?" demands a security guard at the anonymous entrance to the Blooming Spring farm, which has the appearance of a nondescript factory. By searching country lanes and questioning locals for two days is the answer, but we do not give it.

"No one comes here," says the guard, calling through to a superior. "No visitors are allowed here."

The guard's boss, who introduces himself as "Supervisor Deng" and seems ever alert for potential buyers, is more welcoming. He drives us through the facility in a black jeep.

"We have bought that hillside," he says, nodding to his right. "Soon it will also be covered in cages. We have our own water supply and feeding facilities here for up to 50,000 monkeys."

The DNA of long-Tailed macaques and other primates is about 96 per cent identical to that of humans, making their bodies an accurate testing ground for scientific procedures and drugs prior to them being declared safe for humans. Research that even a generation ago would have seemed whimsical - into gene therapy, cures for cancer, Parkinson's and Alzheimer's, stem cells and antibody-based treatments - requires a lot of testing; on monkeys.

Figures published in July show British scientists carried out 4,598 experiments on primates last year, a 16 per cent rise on 2007. The US is the world's largest consumer of lab monkeys; 2007 figures (the most recent available) total 69,990 primates - an all-time high. The British Union for the Abolition of Vivisection (BUAV) claims about 90,000 monkeys are used annually worldwide.

Increasingly these animals are coming from the mainland. Eighteen thousand long-tailed macaques were exported from the country to the US last year. Many of these monkeys, the BUAV claims, are "torn from the wild", a practice forbidden by European law. A film taken this year and screened on the BUAV's website shows Cambodian traders capturing and bagging macaques for sale to farms that trade with the mainland.

The organisation's director of special projects, Sarah Kite, says, "The BUAV investigation exposed the shocking cruelty inflicted on wild monkeys during their capture, handling and subsequent confinement in small plastic bags and storage under the planks of a boat.

"BUAV investigators filmed trappers as they illegally hunted primates in the swamps and jungles of Cambodia, including inside a specially protected wetland nature reserve."

Shirley McGreal, director of the International Primate Protection League (IPPL), says, "The animal farms are sucking up monkeys from Cambodia and Vietnam and there is no question that they are getting them illegally. The US Fisheries and Wildlife Service has ongoing investigations into the sources of monkeys coming from China.

"The trade is an ugly one and we foresee a future where monkeys are wiped from the face of the earth. In 30 years or so there will be no primates available [in the wild]."

Conservation International, a non-governmental organisation that promotes biodiversity and world conservation, reported last year that 11 of the world's 25 most endangered primates are native to Asia.

The mainland's farmed monkey population needs to be continually replenished to ensure a strong genetic base and prevent inbreeding. Dr Yue Feng, general manager of a Nanning bioengineering firm and spokesman for the Primates Biotechnology Research and Development Centre, says, "It is necessary to go to the origin of the crab-eating monkeys [long-tailed macaques] to find some better quality monkeys" to introduce into the farmed populations, an admission offered up repeatedly by monkey farmers.

A long-awaited vote on the use of laboratory animals in the European Union in May proved a major disappointment for animal-rights groups. Big pharmaceutical companies and scientific establishments spent fortunes lobbying politicians to ensure there were no big changes to the law. European scientists argue that restrictions on using primates would give researchers in the US an advantage.

Scientists are adamant that the use of primates is essential. Oxford University neuroscientist Tipu Aziz told a preliminary meeting of European parliamentarians that a ban would force him to abandon research that could lead to new treatments for Alzheimer's, motor neurone disease, strokes and many other illnesses. Aziz's research on monkeys taught him how to insert electrodes into the brains of Parkinson's sufferers, delivering instant relief.

Despite their victory in the European Parliament, it appears some pharmaceutical companies are planning ahead, hedging their bets in case a future vote goes against them.

McGreal says she was told by a spokesman for a large pharmaceutical company that his company was setting up a lab on the mainland, in which 7,500 monkeys would be housed.

"He told us that the feeble oversight of animal facilities in China and the cheap workforce meant it was easy and cheap for them to operate in China," she says.

A report released by the Chinese delegation at a Convention on International Trade in Endangered Species meeting in Mexico last year stated: "Because of the high cost of maintaining laboratory animals and the animal welfare issue, many companies in developed countries want to move their animal experiments overseas, especially to the developing countries."

The mainland could make a lot of money experimenting on monkeys on behalf of other countries. Overseas researchers would be able to work in a country that has no animal-welfare laws and in which animal-rights groups would find it almost impossible and unlawful to operate.

But, for now, mainland businessmen are concentrating on breeding monkeys for export.

An enterprising Fujian province zookeeper, Yu Zhengyang, 38, became a monkey trader when he decided there was no money to be made in public zoos. He now breeds rhesus macaques, the second-most sought after primate for testing, which he sells on to labs.

"Domestic scientific research units demand more than 10,000 rhesus monkeys annually," he says. "There is no doubt that the market potential is great. I bought my first 70 monkeys at 5,000 yuan [HK$5,680] each and can sell ‘cultured’ animals for 10,000 yuan each. I have around 200 monkeys and in two or three years I hope to have 700 and be the biggest farm in Fujian province."

The price paid for "cultured" (healthy and pathogen-free) monkeys when exported runs at between US$2,000 and US$3,000 each - equating to a market that runs into hundreds of millions of US dollars.

The monkey farms are mostly located in remote areas of Guangxi, Yunnan and Guangdong provinces. The hot, humid, bamboo-covered hills of Conghua county are home to at least four such operations.

One of the country's oldest farms is located on a jungle-covered island in the middle of the Mekong River, in Xishuangbanna prefecture, on the border with Vietnam. The farm breeds 14 species of monkey and a research worker at the facility claims it exports the primates to Britain and is also carrying out a "big research project" for an American concern.

Blooming Spring chairman Deng Zhuobiao is keen to show off his headquarters, about 20 kilometres from the new farm complex. He's proud of the fact his monkeys are sold "overseas only".

"Business has been growing steadily for the past four years. I have a lot of confidence in the future of this business," he says as he gives us a brief tour.

The quarantine room houses 368 stainless-steel cages. "We have three rooms like this," says Deng. "The facility could push out 1,104 monkeys every 60 days."

Next come the labs in which the monkeys are tested to ensure they are disease-free, followed by cage upon cage of petrified animals, many carrying babies. Before we leave the facility Deng shows us his export licence and breeding certificate.

"We already do business with some very big US companies," he says, "and we export to Europe."

Deng also stresses that Blooming Spring is applying for recognition by the Association for Assessment and Accreditation of Laboratory Animal Care, which would permit it to carry out experiments for international organisations.

"With the government behind us it makes things very easy," says Deng, the supervisor. "Things have loosened up with the current economy. The government wants us to succeed."

At the Conghua Yueyuan Laboratory Animal Breeding Farm, about 30 kilometres from the Blooming Spring farm, the chief veterinary surgeon, a Mr Li, explains that only about two yuan is spent per day on the upkeep of monkeys that fetch at least US$2,000 when they are exported.

"Our biggest overseas customer is an American company involved in both cosmetic and pharmaceutical businesses," says Li. "They buy at least 500 monkeys every year. That's US$1 million right there. We also have customers in South Korea and Germany."

A Blooming Spring worker says monkeys are transported 180 at a time in specially made metre-long plastic crates. "We have to give them space or the animal-welfare people overseas complain."

According to Michael Budkie of the NGO Stop Animal Exploitation Now, the "hellish conditions" monkeys are subjected to in mainland farms is "nothing compared with what they will experience once they arrive in the US".

Budkie, who has been investigating conditions in US animal laboratories for more than 20 years, says macaques from the mainland are used in a variety of experiments, including brain-mapping and research into drug abuse, and will be infected with "any number" of diseases.

"The monkeys are trained [to carry out repetitive tasks] using water deprivation for up to 22 hours at a time," says Budkie, explaining the brain-mapping tests. "They are put in restraint chairs, a hole is cut into their skull and electrodes are hard-wired into their brain. The research goes on for several years - if they can keep the animals alive that long.

"Drug research involves force-feeding them heroin, cocaine and PCP and then examining withdrawal. The monkeys are placed alone in stainless-steel cages that are just nine square feet," he says. "There are no stimuli for the macaques, which are normally social animals - they literally go insane. Drug addiction therapy can continue for 10 years, the longest was 14 years."

However, most export monkeys, having been selected for quarantine when they are between one and three years old, won't have to suffer for that long. "Most are dead within a year of arriving in the US," says McGreal.

It is an open secret that the US Defence Department is one of the monkey farms' biggest clients. "The monkeys are used in bio-warfare weapons research," says McGreal. "They are poisoned with rycin, sarin, anthrax, even Ebola. We attended a conference for an institute of lab science and a lady from the defence department was quite candid about the suffering the monkeys go through. They only put them out of their misery right at the end, she told us."

Back at the Conghua Yueyuan farm, Li tries to interest us in a business proposition. "If you wanted to set-up as a monkey exporting agent for the UK you can make yourself some good money," he says. "We will do all of the hard work and you can just communicate with the UK labs and make yourself easy money.
"I have no doubt in my mind that China will soon be the most important exporter of lab monkeys in the world."

http://www.scmp.com/portal/site/SCMP/menuitem.2af62ecb329d3d7733492d9253a0a0a0/?vgnextoid=6484449c6be93210VgnVCM100000360a0a0aRCRD&ss=China&s=News#Top

14.09.2009 "Animal testing redundant in 20 years"

BUAV: "The 7th World Congress on Alternatives to Animal Experiments in Rome ended with the issuing of a statement from the organisers stating that due to scientific advancements in alternatives, animal testing of chemicals, cosmetics, pesticides and drugs will be “totally redundant within 20 years”.
They explain that the developments discussed at the conference, ranging from genomics (gene profiling), computational technologies and cell based tests, are sufficiently well advanced, that they could replace animals sooner than anticipated.
Prof. Herman Koëter, one of the organisers of the congress said: “These technologies, bringing together so much more knowledge of possible adverse effects of substances on biological systems than we were able to detect and understand ever before, will make us consider the use of experimental animals for such purposes as extremely old-fashioned in the foreseeable future”.

The Congress Press Release
"Milestone animal welfare achievements at the World Congress on the Use of Animals and Alternatives in the Life Sciences, Rome, Italy"
http://www.aimgroup.eu/2009/WC7/files/PressreleaseSeptember3.pdf

Meanwhile, UK animal welfare group, the British Union for the Abolition of Vivisection (BUAV), calls for "common sense" to animal tests under REACH. BUAV scientific coordinator Katy Taylor spoke at the conference that more than 8 million animals could be saved without duplicative reproductive toxicity tests.

11.09.2009 International acceptance of alternatives to cruel rabbit Draize eye test finally achieved

info: http://www.buav.org/a/2009/09/11/199
The BUAV today welcomed the publication of the OECD’s (The Organisation for Economic Cooperative Development) final guidance on how to conduct eye irritation tests without using live rabbits. If properly implemented, this move will prevent the untold suffering of thousands of rabbits throughout the world who would otherwise be forcibly restrained while potentially irritating chemicals and cosmetics were dripped into their eyes.

479 Draize eye tests took place in the UK during 2008 and around 4,000 rabbits are used in the EU annually.

The BCOP (bovine corneal opacity and permeability) test and the ICE (isolated chicken eye) use eyes from animals killed for food via slaughter houses. The BCOP test was developed in the 1940s, pioneered by alternatives experts in the 1970s and finally validated by the European Centre for Alternative Methods in 2007. It is shocking that it has taken this long for international acceptance.

The OECD is an economic alliance of 30 of the world's industrialised countries. Based in Paris, the OECD co-ordinates the development of standardised chemical testing guidelines which are then adopted by the member countries.

30.08.2009 Victory! Nepalese Monkeys Saved From Vivisection

http://www.gatewaytohell.net/news/2009/june/01_09_NP.htm

After a campaign that lasted for six years (2003-2009) the Nepal government has decided to definitely halt the breeding of monkeys for biomedical research in the USA. It shows that it pays to have patience and that the good forces sometimes do win in the end!
It has been a long ride for many of us, with countless ups and downs. In the meantime four of five Ministers came and went, high level bureaucrats changed postitions, and the population of captive monkeys increased significantly.
As Manoj Gautam points out: 'It shows what can be achieved when one person takes his responsibility serious.' Kudos to Minister Dipak Bohara, and to everyone who has been involved in the Stop Monkey Business Campaign.

*

This victory will be the end of the Gateway To Hell campaign.
The Gateway To Hell campaign was all about the Nepal monkeys, and now that we won this campaign the people who were doing this work will shift their focuss on other targets.
It doesn't mean that we turn our back on the animals, not at all, it means we take other campaigns 200% seriously and the Gateway To Hell campaign is being put aside because of this.

We want to thank everybody who has been active for this campaign, many people from many countries have showed their best side by being so active for the animals.
We hope you will all stay active for the animals in other campaigns!

the Gateway To Hell team.

**
30-08-2009 eKantipur, Nepal

Around three hundred monkeys that were to be exported to the United States of America from this week will be able to find their food in
freedom, in their own country. A letter from the Ministry of Forestry for the immediate their immediate release will be send to Pravesh Man Shrestha, who has been breeding monkeys for the past five years.

Forestry Minister Deepak Bohra said, "We have decided not to allow the monkeys to be exported. He further added, "We will ask Pravesh Man to release the monkeys within a week."

After consulting the Department Heads of the Ministry Minster Bohara came to conclusion that it was illegal to export the monkeys. As a
first step toward exporting monkeys Shrestha had planned to export 25 of the 300 monkeys to the Southwest Foundation for Biomedical Research Center.

Shrestha was breeding the monkeys under the auspices of Nepal Biomedical Research Center. American citizens had also financially
supported this venture. They have now landed in Kathmandu looking for compensation. Shrestha had paid twenty five thousand rupees per
monkey as tax to the Department of National Park and Wildlife Protection to procure 200 monkeys per the Forest animal breeding and
research program Working Guidelines, 2060.

"The law does not permit the export of any wild animals, thus, giving approval to export the monkeys would contravene the law," said an
Under Secretary of the Ministry. "The Ministry has come to the conclusion that the monkeys should be released to their natural environment."

Red monkey [Rhesus monkeys] are listed in the Appendix 2 of the CITES Convention. CITES has banned the export of wildlife in this list.

Dr. Shirley McGreal, OBE, Chairwoman
International Primate Protection League
PO Box 766
Summerville, SC 29484, USA
Phone - 843-871-2280, Fax- 843-871-7988

E-mail - gro.lppi|laergcms#gro.lppi|laergcms, Web: www.ippl.org
Working to Protect All Primates Since 1973

27.08.2009 BUAV: Response to: “Chemical-safety costs uncertain”, Nature Magazine (26 August 2009)

The BUAV has reacted with shock and outrage to reports that toxicity testing required by the European Union under its REACH legislation (Registration, Evaluation and Authorisation of Chemicals) could result in up to 54 million animals being poisoned and killed.

The study, reported in Nature Magazine (26 August 2009), by Thomas Hartung, of Johns Hopkins Bloomberg School of Public Health will be presented at the World Congress on Alternatives and Animal Use in the Life Sciences in Rome that begins on 30 August.

BUAV Chief Executive Michelle Thew, said: “The BUAV is appalled to hear the estimated 54 million animals may end up suffering and dying in these cruel toxicity tests. The BUAV welcomes the call for an increase in funding of new toxicology testing methods that are alternatives to animal experiments. Not only is there an underinvestment of non-animal alternatives, the lengthy process of getting official international validation of such methods can take years. Part of the problem is the massive obstacles that are put in the path of non-animal alternatives, obstacles that animal tests never had to face.”

17.08.2009 Animal rights groups call for urgent ECHA action

14-Aug-2009 http://chemicalwatch.com/2586

Four European and two US animal rights and ethics groups today wrote to Geert Dancet, executive director of the European Chemicals Agency (ECHA), to demand urgent action to prevent companies from undertaking unnecessary animal testing. The organisations are the Humane Society International - Europe, Eurogroup for Animals, European Coalition to End Animal Experiments, People for the Ethical Treatment of Animals Europe, People for the Ethical Treatment of Animals US and the Physicians Committee for Responsible Medicine.

In their open letter, which was also sent to members of the European Commission, the president of the European Parliament and industry associations, among others, the groups warn of three pressing issues that could force firms to undertake testing in the near future:

  • Pre-emptive testing to meet the 2010 deadline - the worry is that companies are rushing ahead and commissioning tests before they check on the availability of data through substances information exchange fora (SIEFs) as required by the REACH Regulation. The slow formation of many SIEFs is exacerbating this problem and the groups call on ECHA to issue a warning to firms.
  • Redundant tests within Annex VIII - the groups point to inconsistencies and a lack of clarity in the testing requirements set out in Annexes VIII, IX and X, which may lead to firms carrying out unnecessary testing. They call on ECHA to advise firms that for substances manufactured or imported in sufficient tonnage to qualify for Annex IX and X testing, they must not undertake the Annex VIII repeated dose and reproductive/developmental toxicity tests.
  • Improving the utility of Agency third party scrutiny procedure for test proposals - noting ECHA's publication of the first testing proposal for consultation this month, the groups say this provided insufficient information to allow others to meaningfully understand what tests are proposed and whether these are necessary. They also call for the opportunity to contribute information other than quantitative test data, such as suggestions for read-across or other intelligent testing strategy techniques.

The groups request a meeting with Mr Dancet to discuss the issues with the aim of ensuring animal testing is only done as a last resort.
Joint NGO letter: http://www.hsus.org/web-files/PDF/hsi/ari-joint-echa-letter-duplicative-testing.pdf

15.08.2009 German authority rejects permit for experiments on primates again

http://www.eceae.org/news.php?p=526&more=1

The Health Authority in Bremen has confirmed that the primate experiments of brain researcher Dr Andreas Kreiter may not be continued. The University wants to appeal against the decision and is prepared to take it to Germany's highest court, the Federal Constitution Court.

In October 2008 the authority, which is responsible for granting licenses for conducting animal experiments in Bremen, denied a further extension of the permit. Until then Dr Kreiter's permit had been extended every three years, the last extension expiring on November 30th 2008.

The neuroscientist filed a formal objection against Bremen health authority's decision and simultaneously applied for an interim court order allowing him to continue the experiments until the legal dispute is settled. This can take years.

In December 2008, Bremen's Administrative Court ruled that the experiments may be continued for a maximum of two months subsequent to service of the health authority's pending decision on the objection.

The Health Authority's decision that the experiments on primates cannot be continued means that Dr Kreiter can now only conduct the experiments for another two months.

However, Dr Kreiter is expected to apply for another interim order allowing him to continue his experiments beyond this two months period.

Further information: http://www.aerzte-gegen-tierversuche.de/en/resources/primates/238-the-situat

07.08.2009 Guardian "The dead end of animal research"

Kathy Archibald
Despite persistent lobbying for animal testing, the evidence shows it is of little use in developing medicines for humans

In his Guardian article Of mice and medicine, Alok Jha poses the question: "If a treatment works on rodents, will it cure us?" Although he acknowledges that mice have some limitations, his response to the question is basically "yes".

This is the image that Understanding Animal ResearchUnderstanding Animal Research – cited as a source for the article – is keen to promote: that while laboratory animals are not perfect model humans, they are invaluable nonetheless. It should be noted that this organisation is not a charity, as stated, and is funded by the pharmaceutical industry to lobby exclusively for animal research.

My answer to the question "If a treatment works on rodents, will it cure us?" is "probably not, based on the weight of evidence to date". Cancer is a good example: former director of the US National Cancer Institute, Dr Richard Klausner lamented: "We have cured mice of cancer for decades, and it simply didn't work in humans." Aids is another: while at least 80 vaccines work in animals, all 80 have failed in human trials. Similarly, every one of more than 150 stroke treatments successful in animals has failed in human testing. A study in the British Medical Journal (pdf) found that animal tests accurately predict human response less than 50% of the time.

What other area of science with such a poor track record would be promoted as indispensable? The truth is that animal research is a costly distraction from the real business of medical progress. Most medical breakthroughs are made in human studies, although animal research usually takes the credit. For example, deep brain stimulation for Parkinson's disease was pioneered in humans, not monkeys, as frequently claimed.

The key to curing human disease is to study human, rather than animal biology – as highlighted for me by my experience as a patient with a pancreatic tumour. During my treatment, researchers announced that the pancreas differs so dramatically between rodents and humans that research in animals is futile: future studies must be human-based.

Leading scientists agree that the best model for human drug development is human beings. At a recent international conference, they showcased a breathtaking array of technologies to develop medicines in a human context. These state-of-the-art techniques promise to reduce the tragic toll of adverse drug reactions, which hospitalise 1 million Britons and kill more than 10,000 every year.

Safety tests on animals are still required by the government, although they have never been compared with the latest human biology-based methods. Many MPs agree that it is time they were. A cross-party group of MPs has launched the Safety of Medicines (Evaluation) Bill 2009, calling on the government to conduct that comparison. Anyone who would like to see animal tests put to the test should ask their MP to sign Early Day Motion 569: Safety of Medicines. We must move safety testing into the 21st century, for all our sakes.

10.06.2009 Dr Hadwen Trust research heralds asthma breakthrough

http://www.scienceroom.org/asthma-breakthrough
Research with samples of human airway tissue from asthmatics, funded by the Dr Hadwen Trust, is enabling breakthroughs in the understanding of severe asthma.

The Dr Hadwen Trust supported work at King’s College London to improve access to airway tissue from volunteers with asthma using fibreoptic biopsy to supersede the use of animals and resected human lung tissue.

Professor Tak Lee, Head of the Division of Asthma and Allergy Research at King’s, who led the research commented:

“Research is this area has historically been limited by the relative lack of clinical materials, which have to come from asthmatic patients undergoing thoracic surgery for unrelated conditions (such as cancer) or post mortem. Animal models have therefore been used but models are not entirely representative of the human disease.”

“A few years ago we successfully developed techniques to obtain bronchial smooth muscle from asthmatic subjects using fibreoptic bronchoscopy. This is safe and can be done relatively easily. The smooth muscle cells can then be isolated from the biopsies and studied in detail.”

Newly published research in the Proceedings of the National Academy of Sciences [1] explains changes in muscle cells lining the airways in asthmatics that lead to breathing difficulties.

Smooth muscle cells from people with moderate asthma contain abnormal levels of calcium and reduced levels of SERCA2, one of the pumps controlling cellular calcium levels. Depleting SERCA2 in normal airway cells makes them behave like cells from asthma patients. This research suggests that lack of SERCA2 plays a role in the development of asthma and that replacing SERCA2 may be the key to new treatments.

Using human-relevant approaches, in place of animal models, has provided vital clues that could lead to new methods of treating asthma or preventing long-term changes to the airways of asthmatics.

Reference

1. Mahn K, Hirst SJ, Ying S et al (2009) Diminished sarco/endoplasmic reticulum Ca2+ ATPase (SERCA) expression contributes to airway remodelling in bronchial asthma. PNAS 106: 10775-10780 http://www.pnas.org/content/early/2009/06/18/0902295106.abstract

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