Tag Archives: animal testing

The Freedom of Speech Paradox

Posted on January 16, 2012 by | 8 Comments

The world is a complex mix of competing views. Politicians and pressure groups have fought long and hard to find a balance between the desire for free speech, and the need to limit the voices of extremism and irresponsibility within our communities. Few would condemn the arrest of someone who shouts “fire” in a crowded, confined space; however most respect our right to peaceful protest.

Incitement to violence, harassment or intimidation against those of different creeds, lifestyles or  beliefs should not be regarded as acceptable in a modern liberal democracy. The challenge comes in deciding what should be regarded as incitement, and what should not. I believe that a tiny minority of animal rights extremists have crossed the lines of acceptability and to this end I provide two examples – one recent, and one from some years back.

Case 1: Incitement to murder

Jerry Vlasak is an influential player within the extreme end of the animal liberation movement. As press officer of the North American Animal Liberation Press Office he has become one of the mouthpieces of the Animal Liberation Front and the Animal Rights Militia. His position as a role model has not appeared to bring upon any sense of responsibility for his words.

I think there is a use for violence in our movement. And I think it can be an effective strategy. Not only is it morally acceptable, I think that there are places where it could be used quite effectively from a pragmatic standpoint.

For instance, if vivisectors were routinely being killed, I think it would give other vivisectors pause in what they were doing in their work — and if these vivisectors were being targeted for assassination … — and I wouldn’t pick some guy way down the totem pole, but if there were prominent vivisectors being assassinated, I think that there would be a trickle-down effect [...]

And I don’t think you’d have to kill — assassinate — too many vivisectors before you would see a marked decrease in the amount of vivisection going on. (Source)

Now I have little doubt that Vlasak does not intend to murder anyone himself. However it would take only one young, idealistic activist trying to build his reputation and strike a blow for animal liberation to follow Vlasak’s twisted logic into the unthinkable.

Vlasak is not the only person to call for violence against animal researchers (and their families). If the unthinkable was to happen, there would be many animal rights extremists whose words will have played a part in its creation. Nonetheless, surely, there is a moral line in the sand which few if any would be willing to cross, after all the animal rights movement is fundamentally in the business of saving lives (albeit not human ones)? Surely….?

May 31st, 2009, a doctor is shot dead at a church service. It is not the first time he has been shot for his beliefs and line of work, individuals have already called for the death of doctor’s in the same line of work.

The above is not the actions of animal rights activists, but that of anti-abortion extremists. In 2009 Scott Roeder crossed the lines of acceptability and morality and murdered Doctor George Tiller. Such actions were roundly deplored, but little time is spent considering the impact of those that had called for Tiller’s death, and the death of other abortionists. Sadly, many similarities can be found between the tactics of the animal rights extremist movement, and those of the anti-abortion extremists.

Where do we draw the line between Freedom of Speech and Incitement to Violence? This fire at the house of a Pharmaceutical Executive was started by animal rights extremists

Case 2: Naming the targets

The second situation further strains the relationship between freedom of speech and freedom from harassment. What if a known extremist movement does not directly call for the death of its enemies, but instead provides the information necessary to target them. They may not have put the gun in anybody’s hand, but they are certainly showing them where to point it.

Negotiation is Over, a fringe animal rights extremist group has provided such information on a number of occasions. Providing names and contact information for a variety of researchers. NIO’s words are reminiscent of our earlier discussion.

Every time a vivisector’s car or home — and, eventually, the abuser him/herself — blows up, flames of liberation light up the sky [...]

The only effective approaches to veteran abusers appear to be through incendiaries, intimidation, and violence.

Bear such words in mind when you consider that on January 8th 2012 NIO decided to publish floor plans for research facilities at the University of Florida. No threats were published alongside it, but then with a website full of calls to harass and intimidate researchers, they hardly needed to put them in the same post.

Is free speech a sufficient barrier to hide behind when distributing such potentially risky materials. When does one person’s freedom of speech justify infringing on another’s right to live free from harassment?

Before I decided to write this post I received an email from a colleague of a researcher who was under threat. One paragraph particularly stuck with me:

I actually cannot believe a court of law would allow documents of this nature containing names of people who work at an institution to be given to a group of people sworn to kill, torture and terrify them. Their site is already filled with people licking their lips about harassing families and even people discussing murder. I have counted a fair number of people who made implications of going to schools where their kids studies. These clearly are a lot of idle threats but it takes just one person to turn an idle threat into a tragedy.

Just one person.

The comments made by Vlasak and others, the documents and finger pointing of groups like Negotiation is Over, are permitted under the guise of free speech. The effect is a generation of researchers who do not dare to speak up for what they do lest they become the next target. Even though many researchers are not aware of characters like Vlasak, or the particulars of the threats made to fellow colleagues in science, these extremists contribute to a general awareness of a dangerous animal rights movement whom many scientists would prefer not to cross. Furthermore, fear may cause some aspiring scientists to choose different career paths at a time when science plays such a crucial role in the economic prosperity and health of a nation.

The Freedom of Speech Paradox is thus – when people misuse this right, as provided by the First Amendment, in order to intimidate others away from being able to use their same right to defend and justify their work.

Tom Holder

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A Proposal for the Labeling of Medicines

Posted on January 12, 2012 by | 4 Comments

In a recent poll conducted by Zogby, 2,100 adults in the U.S. were asked the following question.

Do you agree or disagree with medical and scientific research that requires lab animals?

The results showed  a similar outcome to that of other recent polls.

About 52% of the population approve of animal research in various degrees, about 27% disapprove in various degrees, 15% are neutral and 6% are unsure about their position.

Despite the many polls done on the subject it remains unclear on what grounds do some people object to the use of animals in science.

Is it perhaps that they find the work morally wrong?  Is it that they believe all living beings have the basic rights to liberty and freedom?

Some insight into these questions can be gained by asking the same group of people what would the do in the following scenario.

Suppose you suffer from a leaky heart valve, and that doctors say you have two years left.   You could have a valve replacement surgery that might save your life.  But, in order to obtain the replacement tissue necessary for a surgery, a pig must be killed.

Which of the following statements best reflects what you would do if faces with a similar situation?

Statement A: I would have the surgery.  I think it is ethical.
Statement B: I would have the surgery, but I think it is unethical.
Statement C: I would not have the surgery, but I think it is ethical.
Statement D: I would not have the surgery because I think it is unethical.

Here are the results from the same poll:

Now, if one believes animals have rights they surely ought to be respected.  If you believe a pig has the same basic rights to life and freedom as your neighbor, then you ought to refuse the surgery for the same reason that you would not kill your neighbor to save your own life.

However, only a mere 3% of those asked appear ready to act in a way consistent with such a position.  It is interesting to note that also about 3% of the US population are vegetarian, although most of them do it for health reasons and not ethical objections to the use of animals as food.

Thus, those that oppose research do not appear to do so because of belief that all living beings have the same basic rights to life as that of fellow humans.

Another small minority, 2%, would not have the surgery despite the fact they think such surgical intervention is ethical.  It would appear this group simply is uncomfortable with the notion that pig tissue would be implanted in their human hearts.

About 12% of the group would opt to save their lives despite having ethical objections.  It appears this group feels there is something inherently wrong in killing an animal to allow them to survive and yet, if faced with the situation they would nonetheless go ahead with the surgery.  Arguably, this group realizes that the pig is a living being that we owe moral concern, but that when human and animal lives are at stake, opting to save the human is morally permissible.  Alternatively, they may genuinely opt for behaving in an immoral fashion when it comes to saving their own lives.

Finally, the vast majority, 73% of them, will opt for the surgery without having any moral concerns whatsoever.   None at all.   That is roughly 3 out of 4 people in the US population.

A natural question is then why wouldn’t the same group, at the very least, be in favor of animal research that advances medical knowledge and human health?

One likely possibility is that they fail to see the direct link between research and the therapies and medicines that it produces.  They fail to see that the medicine that will save their lives next time they visit the emergency room will be, in all likelihood, the result of animal research.  They may wrongly perceive basic and translational research as two being completely different things.  The contribution of basic knowledge to human health may be lost in translation.

So, what can be done?

Aside from scientists and physicians reaching out to educate the public on this matters, we could begin by labeling each and every single medication that resulted from basic research in animals with such basic information.  Note that I am not talking about safety testing in animals — which is required by the law.  Instead, I am referring to medicines developed through the identification of molecular targets or the discovery of specific mechanisms with the use of animals in basic research.  In other words, I propose to label medicine as derived from animal research if it actually produced the knowledge that actually allowed scientists to understand how a particular therapy could be developed.

Shouldn’t the public be entitled to know where their medicines come from? Shouldn’t the public be entitled to understand the range of benefits produced by their tax dollars?

What do you think?

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Ignorance or Deception?

Posted on January 9, 2012 by | 3 Comments

Animal rights activists may want to start cooling down their engines.

Apparently, by 2050 we can expect the complete elimination of animal use in science.

At least, this is the prediction made by Dr. Andrew Rowan, Chief Scientific Officer of the Humane Society of the United States (HSUS) in a recent article that appeared in The Scientist.

The title of the piece was “Avoiding Animal Testing.  Advances in cell-culture technologies are paving the way to the complete elimination of animals from laboratories”.

The first half of the article focuses on the development and adoption of alternatives to the use of animals in toxicology.  Our public health officials and the FDA have long made the sensible decision to require any company that introduces new chemicals or drugs into the market to provide an initial experimental assessment of their potential toxicity to humans.

This use of animals for such safety screening is typically called animal testing.

Dr. Rowan correctly points out that advances in the development toxicology methods may allow us eventually to relax the regulations that require the use of animals in testing.  But he rapidly moves to insinuate such advances imply that by 2050 we could see the end of animal use in laboratories:

This overall decline in animal use can be attributed to the advent of novel technologies such as improved cell-culture systems and micro-analytic techniques; more sophisticated model systems; improved understanding of signaling and metabolic pathways; and a host of other new methods that allow scientists to answer important questions about the functioning of healthy and diseased tissues without subjecting whole animals to harmful procedures. With a 50 percent decline in animal research since 1975, we are roughly at the halfway point towards the complete elimination of animal research. Thus, we argue that, by 2050, we might finally see the last of animal use in the laboratory, particularly if all stakeholders put their minds to it.

First, the assertion that the total use of animals is systematically declining is not supported by the data.  The slide below, for example, was taken from a recent talk Dr. Rowan gave at the University of Wisconsin.  It shows the total number of animals used has been stable since the mid 80s, with the number of non-genetically modified (Non-GM, faint dashed line) animals decreasing and stabilizing in the 90s (see also data here), while the number of  genetically modified (GM) animals, which are largely mice, has been systematically increasing.

Second, even if correctly asserting that we can expect a diminished need for animals in toxicology testing, Dr. Rowan’s generalization of such trend from a such narrow field to all of biomedical research is groundless and misleading.

Let us be clear, our universities do not engage in animal testing, but in animal research.

What’s the difference?

Scientists are largely concerned with elucidating the basic mechanisms of biological processes in health and disease.  We want to study how cells in our bodies work, how they communicate, how they develop, how they age and how they die.   We want to understand how the brain, our immune system, and internal organs work and how they fail.  And so on…

Why is it critical we develop such an understanding?

Because without this knowledge there will be no hope to combat disease. Indeed, the mission of the National Institutes of Health (NIH) recognizes this fundamental fact in its opening statement,

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce the burdens of illness and disability.

Implicit in such declaration is the acknowledgment that it is basic knowledge that drives advancements in human health and well-being.  Basic knowledge of nature is what drives progress.  This point is critical –   translational or applied research would not exist without basic knowledge as the raw material.  Without knowledge there would be nothing to translate nor apply.

Those that declare an imminent end to the use of animals in science are effectively implying that they envisage all basic knowledge needed will be acquired by a certain date, or that we will have methods that would allow us to proceed with studies non-invasively in human volunteers. Dr. Rowan’s statement that “Advances in cell-culture technologies are paving the way to the complete elimination of animals from laboratories” is nothing short of utter scientific nonsense.

Is it possible for Dr. Rowan to be ignorant of the role of animals in scientific research?  Could he legitimately be confused about the difference between safety testing on one hand and the development of therapies and basic research on the other?

This seems highly unlikely giving his academic credentials and the fact that he has served on IACUCs before.  In fact, another slide from his talk, shows him delineating these different uses of animals, and illustrating that animal testing for human safety accounts for merely ~25% of total animal use.

No, Dr. Rowan is not confused at all.  He knows what he is talking about.  This is unfortunate as one can only conclude his article is simply a misguided attempt to deceive the public about the fields in which we might realistically expect science to successfully replace animals in the near future.

And I emphasized science above for a good reason.

As difficult as it is for animal advocates to understand, scientists also believe we will see a day when we can eliminate the use of animals in all animal research.  And the day will arrive because of the hard work, progress and achievements of dedicated scientists, such as this one, and not because of deception of those that want to oppose animal research at all cost.

For HSUS to suggest that all animal research could be eliminated by 2050 is  flatly wrong from a scientific point of view, and utterly irresponsible from a public health perspective.

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A Closer Look at the Great Ape Protection Act (GAPA)

Posted on November 21, 2011 by | 2 Comments

The status and future of chimpanzee research in the US are at the heart of much discussion lately in both scientific and public spheres.  A committee convened by the Institute of Medicine (IOM) to consider the issue held a number of meetings and is expected to report its findings to the NIH by the end of this year. Legislation to end great ape research, also introduced in 2007 and 2009 (H.R. 1513: Great Ape Protection and Cost Savings Act of 2011;  S. 810: Great Ape  Protection and Cost Savings Act of 2011; GAPA), was again introduced last Spring.

Discussion of human relationships with the great apes, their role in research—past, present, and future—and our responsibility for their continued care deserve thoughtful, well-informed consideration by both the scientific community and the public.  One of the primary goals of Speaking of Research is to contribute to dialogue about animal research and to provide factual information that is sometimes missing from the public conversation.

In the case of chimpanzee research, their housing and care, and the GAPA legislation, it seems clear that there is uneven understanding of the current situation in the U.S., as well as lack of attention to the details and consequences of the proposed legislation were it to be enacted.  There has been significant and widespread discussion of whether chimpanzee research should continue.  What has received far less attention is what should happen to the chimpanzees should invasive research not continue. We take a closer look at GAPA here and also welcome others’ thoughts on the future of chimpanzee research, care, and housing in the U.S..

First up is the question of what exactly would be banned under GAPA.  The legislation is pitched as a measure to end invasive research with chimpanzees.  Much of the media coverage and discussion of chimpanzees in research also makes specific reference to invasive studies.

But what exactly does that mean?  The general definition given by the legislation is:

“The term ‘invasive research’ means any research that may cause death, injury,         pain, distress, fear, or trauma to a great ape, including—

– the testing of any drug or intentional exposure to a substance that may be detrimental to the health or psychological well-being of a great ape;

– research that involves penetrating or cutting the body or removing body parts, restraining, tranquilizing, or anesthetizing a great ape; or

– isolation, social deprivation, or other experimental manipulations that may be detrimental to the health or psychological well-being of a great ape.

Exclusions include:

– close observation of natural or voluntary behavior of a great ape, if the research does not require an anesthetic or sedation event to collect data or record observations;

– the temporary separation of a great ape from the social group of the great ape, leaving and returning by the own volition of the great ape;

– post-mortem examination of a great ape that was not killed for the purpose of examination or research; and the administration of a physical exam by a licensed veterinarian or physician conducted for the well-being of the individual great ape.

Physical Exam is defined as:

A physical exam conducted for the well-being of an individual great ape, as described in clause14 (i)(IV), may include the collection of biological samples to further the well-being of the individual great ape, the social group of the great ape, or the great ape species.”

It seems likely that when most people think of invasive research with chimpanzees they would probably consider studies that involve surgery or infectious disease.  Looking at the text above, it appears obvious that these would be precluded under GAPA.

What is less clear is whether noninvasive studies would also be disallowed under GAPA. Why?

First, because it precludes “research that involves … anesthetizing a great ape” something that is typically necessary to ensure both human and animal safety for studies that use noninvasive techniques such as neuroimaging (ex. magnetic resonance imaging, MRI; positron emission tomography, PET). Studies using MRI and PET with nonhuman primates are aimed at a wide spectrum of research addressing questions that range from evolutionary consideration of brain-behavior relationships to uncovering the effects of aging and factors that contribute to individual differences in health. Are these the types of studies—using equipment and techniques that are commonly used with humans– that typically come to mind as invasive studies? Probably not.

Whether anesthetizing a chimpanzee is an invasive procedure or one that is stressful is not clear-cut and is a question likely to generate a wide range of views among those with first-hand chimpanzee experience.  In part, it depends upon whether animals are trained to voluntarily, calmly, and cooperatively receive injections—something that is a best practice successfully implemented at many chimpanzee research facilities.  This video, shared with us by Dr. Steven Schapiro and the Michael E. Keeling Center for Comparative Medicine and Research  serves as an excellent illustration of the practice.

The video shows a chimpanzee voluntarily, and without coercion, working with his human caregivers to give a sample of blood in exactly the manner of a human blood donor. The chimpanzees shown here are part of a training program led by a long-time leading expert in behavior and primatology, Dr. Schapiro. The video shows a chimpanzee who voluntarily places and holds his arm in a tube to provide a technician with access to draw blood. The chimpanzee is not restrained and is not coerced. The technician cues the chimpanzee with a “clicker” which provides an audible cue to signal the animal. The chimpanzee remains calm throughout the process and receives treats. The curious and calm approach and observation by another chimpanzee also tells us that the entire process is one that is not stressful to the animals.

Much of the language surrounding GAPA appears to be designed to convey a very different impression of the care of chimpanzees housed in research settings. We believe that a more honest discussion of chimpanzees in research should include consideration of the full range of housing and behavioral management, including acknowledgement of best practices such as those illustrated in this video and practiced in a wide range of settings.

The second question about what GAPA would preclude surrounds behavioral and cognitive research.  Many of these studies depend upon testing animals individually by temporarily separating them from their groups. GAPA asserts that such studies would be allowed only under very stringent—and possibly impractical—conditions. The chimpanzee could be temporarily separated from his/her group, but only if it were able to leave and return by its own volition.

For example, consider a recent study of prosocial behavior in chimpanzees by Frans de Waal and colleagues that was published in the Proceedings of the National Academy of Sciences USA.  This study was positively featured on a Scientific American blog that also endorses GAPA. The study was conducted by bringing pairs of animals into a testing room containing tokens that they could exchange with the experimenter for a food reward. Their choices could result in both animals receiving food, or in a “selfish” outcome. The methods section doesn’t specify whether the animals were free to leave and enter the test room at their own volition, but it appears that they were not. If not, would we consider it invasive research?

A third question is whether GAPA would preclude studies that depend upon collection of biological samples that are acquired while animals are anesthetized for physical exams.  The language surrounding this is somewhat ambiguous, as it allows the sample collection if it is to “further the well-being of the individual great ape, the social group of the great ape, or the great ape species.”  What is not ambiguous is that, as written, GAPA would preclude even a simple blood draw—something humans routinely receive as part of medical care or even research—outside of an annual physical exam.

In sum, the issue of defining invasive research and the parameters of what should be allowed is clearly a complex issue. That complexity should be acknowledged in discussions of the future of chimpanzee research.  Virtually all of the procedures used in biomedical research involving chimpanzees that are regarded as invasive procedures are used in human beings in providing medical care.  The GAPA regards these procedures as acceptable if performed for the benefit of the individual great ape to provide care to that animal, but it is unacceptable if it is performed to gain knowledge that will improve the care of human beings or other great apes.

Similarly challenging are a range of other issues presented by consideration of the future of chimpanzees in the U.S., including decisions about their housing and care, as well as the source of long-term funding.

One premise of GAPA is that “research laboratory environments involving invasive research cannot meet the complex physical, social, and psychological needs of great apes.”  Sanctuaries are offered as the alternative for housing, yet little of the public discussion has focused on rigorous comparison of sanctuaries and research facilities in terms of either care offered or cost.

Finally, in this year’s iteration, the legislation has added language about “cost-savings” that appears to be based in analysis provided by the Humane Society of the United States (HSUS).  Whether the cost-savings claim is accurate or not remains open for debate.  Each of these issues will be covered in more detail in subsequent posts.

Whether the current legislation about great ape research passes or not, at this time it is perhaps more apparent than ever before that public interest in discussing the welfare of these animals is high. We hope that this interest carries over to serious discussion about the full range of issues and not only those that lend themselves to short-interest and emotive campaigns.

Allyson J. Bennett

*Disclosure – some of my collaborative research has involved behavioral and neuroimaging studies in laboratory chimpanzees.

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YES to Animal Welfare and NO to a Ban on Animal Research

Posted on November 2, 2011 by | Leave a comment

The following is a guest piece by Prof. Michael Hengartner of the Basel Declaration. An organization founded in Germany to promote well-regulated humane research using animals.

The Goals of the Basel Declaration and the Basel Declaration Society

Animal welfare and scientific and medical progress are not contradictory. More than 800 international researchers have already shown their commitment to accepting greater responsibility in animal experiments by signing the Basel Declaration and supporting the corresponding organization. The Basel Declaration Society aims for a more impartial approach to scientific issues by the general public, and more trusting and reliable cooperation with national and international decision makers.

In November 2010, life science researchers from Switzerland, Germany, Sweden, France and the UK addressed the challenges of animal research and adopted the “Basel Declaration”. This document marks an unprecedented effort by the scientific community to achieve more trust, transparency and communication around animal research. The event was echoed in international media, among them the Scientific American, the Medical Tribune and nature.

“The high quality of medical care today would not have been achieved without research in animal experiments. It is important to inform society about the major significance of research using animal experiments for the health of humans and animals,”

- Prof. Dr. Burkhard Ludewig, Director of the Medical Research Center, Institute of Immunobiology, Kantonsspital St. Gallen, Switzerland.

Signatories to the Basel Declaration commit to accepting greater responsibility in animal experiments. They also sign up to intensive, unprejudiced dialogue with the general public. This dialogue is factual, and focuses on achieving concrete goals. The signatories additionally demand that animal experiments needed to obtain research results remain permitted, now and in the future.

“The Basel Declaration came about not in response to any specific occasion, but as a spontaneous voluntary commit­ment by the scientific community to the best-possible approach to indispensable animal experiments. We present a picture of our modern animal experiment-based science, the deliberation process, the basic conditions and our approach to the issue of animal experiments and show openly what we do and why,”

- Prof. Dr. Stefan Treue, Director, German Primate Center, Göttingen, Germany.

The goal is to make the Basel Declaration the worldwide ethical guideline on animal research, comparable to the Helsinki Declaration which defines ethical guidance on research into humans.

“Basically we have long regarded the principles behind the Basel Declaration as a matter of course, because no researcher performs animal experiments unnecessarily. The Basel Declaration establishes a platform for us on which we can network internationally in order to demonstrate this to the public more clearly still. The message is evidently getting across: For the first time we are now engaged in sustained dialogue with representatives of critical organizations in a spirit of genuine partnership that bring all sides together more than any extremist slogans do,”

- Prof. Dr. Rolf Zeller, Department of Biomedicine at the University of Basel, Switzerland and first President of the Basel Declaration Society, which was founded in September 2011.

The Basel Declaration Society celebrates its first birthday

Sign the Basel Declaration!

“The aim is for as many researchers as possible to learn of our initiative and affiliate themselves with it. We invite all colleagues and the general public to accept this offer of a genuine dialogue and to really live this Basel Declaration,”

- Prof. Dr. Michael Hengartner, Dean of the Faculty of Mathematics and Natural Sciences, Institute of Molecular Biology, University of Zurich, Switzerland.

Everybody involved in animal research or animal care around the world is asked to sign the Basel Declaration, and to become a member of the Basel Declaration Society. Doing so marks a commitment to strengthen public awareness of the importance of animal models in experimental biomedical research, to foster communication between researchers and the public, and to enhance acceptance of the Basel Declaration.

Animal research is under ever-increasing public and governmental scrutiny, even though its importance for biomedical innovation and the necessity of animal experiments to further knowledge in basic research are beyond controversy.

Scientists and technical staff conducting animal experiments face increasing public distrust, and often even aggressive rejection. Media covering the topic frequently lack objectiveness.

This is why already more than 800 international leading scientists have signed the Basel Declaration, to show their conviction that responsible animal research and the sustainable advancement of science and medical progress are compatible.

We hope you will join them with your signature.

Better education

“Animal experiments will remain necessary in biomedical research for the foreseeable future, but we are constantly working to refine the methods with animal welfare in mind,”

- Prof. Dr. Michael Hengartner, Dean of the Faculty of Mathematics and Natural Sciences, Institute of Molecular Biology, University of Zurich, Switzerland.

Advancing the knowledge, implementation and use of 3R principles to reduce, replace and refine animal experiments plays an important role in embedding the Basel Declaration in daily practice. All stakeholders, i.e. everyone engaged in experimental research, the general public and authorities/decision takers, must be made more aware of 3R principles and their current implementation. Moreover, 3R-related issues must be an integral part of scientific publications, and peer reviewers must be better informed about the use, dissemination and quality control of 3R methods. More research is required that captures results in a comprehensive and validated database related to 3R technology and methods.

The 3R principle (replace, reduce, refine) has its origins with William M. S. Russell & Rex L. Burch, who published their “Principles of Humane Experimental Technique” in 1959. These principles are regarded internationally as the guideline for avoiding or reducing animal experiments and the suffering of laboratory animals:

  • Replacement: replacement of animal experiments by methods that do not involve animals
  • Reduction: reduction in the number of animals in unavoidable animal experiments
  • Refinement: improvement in experimental procedures, so that unavoidable animal experiments

More than a piece of paper

On October 16-18, 2011, more than 80 international life sciences researchers and signatories to the Basel Declaration met in Berlin. Their aim was to continue making a constructive and active contribution to the debate taking place in society. They request that the incorporation of the new EU Directive on the protection of animals used for scientific purposes into national law by January 2013 happens consistently in all European countries, and to the highest standards – like those in Switzerland.

Animal Welfare is a high priority for scientists

The Swiss severity classification system helps to identify the impact of scientific procedures on the health and well-being of experimental animals. A thorough severity degree classification is essential for improvement in line with the 3R principles. It helps to define humane endpoints in advance, and to assess progress in refinement, project by project. Participants in the Berlin conference recommend the implementation of severity classification systems, and voluntary use of such systems by the scientific community in countries where these are not yet mandatory.

Obligation to the public

Berlin conference delegates unanimously agreed that science must not only take a clear stand on the responsible handling of laboratory animals, but also has to show greater transparency towards the general public. To make their motivation and methods more comprehensible to the public and decision makers, the researchers committed to cooperate more closely with politicians, the media and schools, and to give greater importance to the communication of science. As a first step they presented position papers, developed in working groups, to representatives of the European Parliament, the EU Commission and the Federal Swiss Veterinary Office FVO.

The Basel Declaration signatories acknowledge the need for greater discussion of animal experiment issues and also of the risks of research approaches and possible misuse of new technological developments. In addition, they declare their intention to communicate not only results und scientific controversies, but also processes and approval procedures, in order to foster a deeper understanding of research.

“We realize that society funds our research and has a lot of justified questions on the subject of animal experiments and on research in the life sciences. Our aim is to engage in an in-depth, sustained and transparent dialogue. This reduces anxieties and promotes acceptance of views – on both sides,”

- Prof. Dr. Michael Hengartner, Dean of the Faculty of Mathematics and Natural Sciences, Institute of Molecular Biology, University of Zurich, Switzerland.

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Good Lord! They’re Defending Animal Research

Posted on October 27, 2011 by | 7 Comments

Individual European governments are currently working out how to translate a new EU Directive on Animal Research into their own national laws. It would seem a good time for governments to be talking about the benefits of well-funded, humane research using animals. Wait a minute …. the British Parliament are.

To ask Her Majesty’s Government what plans they have to change the regulations governing experiments on animals.

On the 24th October 2011 the British House of Lords (Upper House of Parliament) debated the issue of animal research regulation (click for full text of debate). In response to Lord Wills’ initial questions on the impact of the directive on UK law there was a flood of support for the medical breakthroughs made possible by animal research.

The House of Lords

Lord Winston

Lord (Professor) Winston, an eminent British scientist who works in both reproductive biology and the field of organ transplantation, spoke of the role of animals in experiments in his own field.

My field has largely been that of in vitro fertilisation and reproductive biology. It is interesting to consider that more than 1 million babies could not have existed without the research that has been carried out on rodents. That is true of my work in the screening of embryos for genetic disorders. This has been a revolution in reproductive medicine. It means that women can embark on a pregnancy knowing for certain that they will be free from having a baby which will die in the first few years of life. That was made possible purely through extensive animal research. Animal research has contributed hugely to physiological medical research in virtually every field, whether it be the liver, heart, brain or kidneys, or neuroscience or any major discipline.

Lord Winston also spoke of the need for the Government, and scientific community to engage the public on this issue.

It is quite shocking that every university in this country does not admit that we have an animal house where we do animal experiments. If we do not say this very clearly to the public, if we do not make that message clear, then of course people will start to think there is something clandestine or something to be ashamed of in our research programmes. I really do not think that is true

Baroness Warwick of Undercliffe

Baroness Warwick of Undercliffe, spoke clearly about the benefit of animal research and the high standards of care that exist in the UK.

From my previous experience in the university world, where a substantial proportion of medical research is conducted, I know that the highest standards of ethical behaviour are required and adhered to. That is as true in research involving animals as in other areas. Research using animals has been the fundamental basis for many of the medical advances that we now rely on. I do not think that I can do better than quote the Wellcome Trust, one of the most important funding charities in this field. It said:

“The use of animals in research has enabled major advances in the understanding of biology and led to the development of nearly every type of drug, treatment or surgical procedure in contemporary medical and veterinary practice”.

There is a long list of diseases and treatments where these advances have had an impact-tuberculosis, Parkinson’s disease, high blood pressure, stroke, asthma, Alzheimer’s, and anaesthetics. In the area of organ transplants, in which I have an interest as chair of the Human Tissue Authority, heart and kidney transplant techniques, together with vital anti-rejection medication, were developed using animals-as my noble friend Lord Winston described so vividly. In the financial year 2009-10, 3,706 people received major organ transplants through the NHS.

Using sentient animals in research places a huge responsibility on researchers and Governments. Regulation is therefore essential. Indeed, the UK was the first country in the world to protect research animals by law, in 1876. The UK is now widely regarded as having the tightest legislative control on medical research in the world, together with a reputation for high animal welfare standards. Perhaps even more telling, in order to obtain a license to experiment on animals, researchers must demonstrate to the Home Office that their research cannot be done using alternative non-animal methods.

Lord Taverne, founder of Sense about Science, spoke about the importance of
public support.

Public support is of course important-as many previous speakers have pointed out. The progress made in the three Rs also plays a part in this, and there is no doubt that there has been better education, but it could still be improved. I would add to the suggestion of the noble Lord, Lord Winston, that it would be beneficial if every general practice surgery displayed a notice stating, “All the drugs used or recommended in this surgery have been tested on animals”.

[...]

It is for the sake not only of the health of human beings but of the welfare of animals that we continue to be vigilant to ensure that animal research proceeds effectively and with due care for the animals affected.

Lord Willis of Knaresborough

Lord Willis of Knaresborough, who formerly chaired the House of Commons Science and Technology Committee (as an MP in 2010), gave the Government’s position.

Our priorities are: to promote high-quality science and patient benefits; to ensure high standards of animal welfare; to apply the principles of the three Rs; to harmonise EU regulatory requirements so that we do not have different levels in different countries; and to promote public confidence in humane animal research, which can be done only through openness and transparency. … You cannot achieve world-class research unless you treat your animal models with respect and care.

The British Government continue to affirm their commitment to well regulated biomedical research involving animals. Thank the Lords!

Cheers

Tom Holder

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UK Trends in Animal Rights Activism – The Rest of the Story

Posted on October 24, 2011 by | 7 Comments

Recently, I posted an analysis of animal rights extremism in the UK, USA, Italy, Germany, Mexico and Sweden. By looking at the number of Animal rights activities annually over a 3 month period I described in a drop in the number of illegal incidents in the UK.

Incidents of animal rights activism or animal rights extremism

Number of Animal Rights related incidents during the July-Sept period

In the previous post I said:

The UK had the highest levels of activism (average of 24 incidents/quarter) although a massive crackdown on extremism by UK authorities is probably a major part of the decline which has seen only 8 incidents in the July-Sept period for 2010 and 2011 combined. This is certainly promising news for biomedical research in the United Kingdom. See more about activism in Britain in the UK Experience page.

However, an interesting article in The Economist suggested the truth is not quite as positive:


A similar (but not identical) drop in the number of illegal attacks over the time period is shown as in our earlier analysis. However, this is linked by a solid rise in the number of legal protests over the same period. The Economist suggested:

The number of peaceful protests against institutions that perform research on animals has increased markedly of late (see chart), as memories of the violent attacks on the homes and cars of researchers have faded, according to information supplied by members of the Association of the British Pharmaceutical Industry, a lobby group that keeps tabs on such matters. It reckons that many moderate protesters were so appalled at the increasingly abhorrent tactics used by extremists—which culminated in a grave-robbing in 2004—that they abandoned the cause. Only after such attacks had all but halted in 2009 did they return to the barricades.

Organizations such as NETCU – the National Extremism Tactical Coordination Unit – have been effective at curbing animal rights extremism, but were not designed to win the hearts and minds of people to prevent the spread of animal rights ethics. It is crucial that researchers continue to reinforce the link between animal testing and the medical benefits derived from it.

A good example was the recent article in The Independent (UK national newspaper) which explained the crucial need for animal experiments despite the array of other methods that complement such research:

Professor Morris is unapologetic. “There is a lot you can do without animals. Most scientists who use animals do so as part of a whole portfolio of techniques, which will include work with isolated molecules and genes, building up to whole cells growing on plastic dishes in tissue culture to study the more complex integration of cells to work together as a single tissue,” he says. Some 90 per cent of his staff’s work is done with individual molecules and cells in culture.

“At all these stages, extensive use is made of computational modelling, and analyses of databases, to bring together all the information available on how the particular aspect we work on functions in a living body,” he continues. “And there are now non-invasive brain imaging techniques that tell us a lot. But real diseases are diseases of the whole body, and can only be studied in the whole body.”

Dopamine deficiency is a key component of Parkinson’s but the underlying cause is a complex set of interactions triggered by inflammation in the autoimmune system. “So we need to understand the interaction between two complex bodily systems – the brain, and the immune system – to understand this multi-tissue, multi-step disease. The body’s controls on how those two systems interact are lost the moment both are cultured in a plastic dish. We need to look at living brain.”

Cheers

Tom Holder

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All in a day’s work: Scientists promote alternatives

Posted on October 12, 2011 by | 4 Comments

Once upon a time, the medication BoTox (made by a company called Allergan) was tested for its potency, on a batch by batch basis, in living animals. This medication, which is really a protein derived from bacteria, has many important therapeutic purposes. For example, it has been shown to be very effective in the treatment of chronic migraine headaches – a condition that can have disabling effects on those who suffer from it. It is used to treat disorders in which people sweat profusely (hyperhidrosis) or have overactive bladders, both of which affect people’s qualities of life by impairing normal social functioning. It has also been used in the treatment of motor disorders like spasticity and dystonia, preventing the irregular and disruptive involuntary movements that are found in these disorders, thereby reducing the physical pain that is so often a consequence of them. Of course, it has also been used for aesthetic reasons, an arguably less compelling medical use.

BoTox is used to treat patients with spastic cerebral palsy, lesseing the pain they suffer as a result of their uncontrolled movements

Because the potency of individual batches of BoTox produced vary, the Food and Drug Administration (FDA) in the United States required Allergan to test each batch on live animals. For each batch, studies were conducted in which the amount of BoTox that was required to produce a specific toxic effect was evaluated in live animals, and the dose was adjusted to ensure that the potency of the drug across batches could be accounted for (roughly, if the batch was half as potent, this can be accounted for by giving twice the dose, ensuring that clinical effects were stable over time). This testing involved a lot of animals, mostly mice.

However, earlier this summer, the FDA changed its mind. It was approached by an organization that had – at considerable expense – developed a test that could determine BoTox potency just as well as the animal tests – but without involving live animals. The test is conducted on cells in a dish.

The organization spent millions of dollars to develop the test and to petition the FDA to consider this replacement for live animal use based upon its empirical results. They were successful.

Who was this organization? Was it the Humane Society of the United States? Perhaps it was People for the Ethical Treatment of Animals, or the Physicians Committee for Responsible Medicine?

It was none of these. Indeed, since none of these organizations spend their operating budgets on the laboratory research that is required to develop alternatives to live animal studies, it couldn’t have been any of them.

So, who accomplished this? It was Allergan itself. Biomedical researchers at the company who used animals in their tests became determined to find a model system that could replace living animals, and they didn’t stop until they found one. They did this though it came at a huge expense to the company. They were committed to producing medicines that people need and to use the fewest animals in the process, and they accomplished that. As the Allergen press release notes, there have been several attempts, using a variety of methods, over the past two decades to develop a replacement for the LD50 test, but until now all these have fallen short.  A report from a 2008 scientific workshop convened by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)  and the National Toxicology Program Interagency Program for the Evaluation of Alternative Toxicological Methods (NICEATM) provides a good overview of many of the challenges involved in delevoling a replacement for the LD50 test, and the different approaches used to address them.

As always, the alternatives that exist for animal use in biomedical science came from the very scientists who are otherwise roundly criticized by the anti-animal research movement. Maybe the irony is lost on organizations like PCRM, HSUS and PeTA, but not on us. At UCLA, our administration has instituted a funding program that provides seed funding to scientists to promote work on refinement, reduction and replacement. What have the leading anti-research groups done? Nothing, but complain. Perhaps instead of criticizing scientists, these organizations should join with us in attempting to discover alternatives and reduce animal use.

Regards,

David Jentsch

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