Category Archives: Animal Rights News

Research with dogs develops an artificial pancreas to treat diabetes

White Coat Waste is a conservative animal rights organization devoted to the elimination of animal research. Its first target is biomedical research conducted using dogs at the US Department of Veterans Affairs (VA). Unfortunately, this campaign is gaining traction. While White Coat Waste is supported mainly by Republicans, some Democrat representatives like Dina Titus (Nevada) and Ted Lieu (California) have expressed their support. In view of that, it is important to highlight the remarkable achievements of dog research at the VA and the tremendous loss that its cancellation would be for Veterans and the general public. 

Diabetes is a nasty disease that affects millions of people worldwide and continues to increase. It is a metabolic disorder in which the body becomes incapable of controlling the blood levels of glucose, either because the pancreas fails to produce enough insulin (type 1) or because cells in the body fail to respond to insulin (type 2). Untreated, diabetes can lead to cardiovascular disease, stroke, kidney disease, neuropathic pain, gangrene of the extremities, amputations, blindness, and death. In 2014, 422 million people had diabetes worldwide (8.5% of the population). These numbers have more than tripled since 1980 (108 million; 4.7% of the population) and continue to increase due to poor dietary habits and lack of exercise. The annual number of deaths worldwide was estimated at 4.9 million in 2014. The incidence of diabetes is particularly high in the USA and other developed countries, but it is increasing fast in Asia and Africa. In the USA, diabetes has a high impact in Veterans: one in four patients receiving care at the US Department of Veterans Affairs (VA) has diabetes. This makes it a high priority for medical research at the VA.

People with serious cases of diabetes need multiple daily injections of insulin. Failure to administer the insulin appropriately can lead to kidney failure, amputations, blindness, coma, and even death. However, the dose of insulin has to be tuned to the needs of the body. To do this, patients measure the glucose level in their blood by drawing blood from their fingers using needle sticks. This has to be done several times a day in order to calculate and inject insulin according to the blood glucose levels. An artificial pancreas has been developed at the VA to help improve the outcomes for diabetic patients. This device measures glucose in the blood in real time and automatically administers the right dose of insulin. This technology will dramatically improve the patient’s quality of life and reduce life-threatening complications. It would also tremendously reduce diabetes-related healthcare costs.

The artificial pancreas uses a reconfigured smart phone as part of its system. Image by UVA

This research project was initiated decades ago by Dr. Seymour Levin, a VA endocrinologist who specialized in diabetes and was horrified by the large number of VA patients who needed amputations because of problems with properly administering insulin to treat their diabetes. He obtained funds from the Mann Foundation. In the early 1980s, the Mann Foundation created a company called MiniMed Technologies to design an insulin pump that patients could wear throughout the day. MiniMed Technologies used dogs at the VA diabetes laboratory to test prototypes of this pump. In the early 2000s the company was acquired by Medtronic, which has been fully supporting this research project ever since. No taxpayer money has been used for it, a detail that seems to be important for White Coat Waste.

Taking advantage of new computer technology, the device being developed incorporates not only an insulin pump but also a glucose sensor and software to calculate the amount of insulin to be injected into the blood according to the glucose level. This makes it a true artificial pancreas. Working with dogs allows researchers to do the pre-clinical testing of the artificial pancreas required for approval by the USA Food and Drug Administration (FDA) at the same time that the hardware and the software are refined and improved.

Why use dogs for this research project? Animals like mice, rats or guinea pigs are too small for the devices being tested and their blood volume is not large enough to allow for frequent blood sampling without causing them harm. On the other hand, dogs have been an important model for metabolic studies and can replicate human diabetes quite well (much early research into diabetes and insulin relied on research in dogs). They can also be used for long-term studies lasting years, which are not possible in rodents. The sensors and catheters implanted in the dogs are the same ones to be used in humans, and the dogs adapt very well to wearing them. Dogs also like interacting with humans and can be trained to go along with these painless procedures without needing to be anesthetized or restrained. Other large animals like pigs and sheep were tried and were found to be far less suitable than dogs for this work.

The standard procedure consists of having the dog rest on a soft bed, unrestrained. Glucose sensors are inserted under the skin and an insulin pump is attached via a subcutaneous catheter (similar to a human patient using these devices). The procedures are painless and the dog soon becomes habituated to them. The dog is given a small amount of glucose solution to raise its blood-glucose level in order to see how the experimental sensor, software, and pump respond. Blood samples are then tested on a large and expensive glucose analyzer to see how well the sensor is working.

The dogs in the VA diabetes research project are very well cared for, and the diabetic ones are maintained on insulin pumps. Pet dogs sometimes develop diabetes as they age. Just like humans, they develop cataracts, kidney problems and all the other complications of diabetes. Even when they are given insulin injections under a veterinarian’s care, they all die within 1-2 years. In contrast, the diabetic dogs in this research program are maintained free of symptoms by the insulin pumps and live at least a decade with no cataracts or other diabetes complications. Non-diabetic dogs are adopted out at the end of the study period whenever feasible.

dog, animal testing, animal experiment

Beagle in research

On September 28, 2016, the FDA approved the first artificial pancreas, the Medtronic’s MiniMed 670G System, intended to automatically monitor blood-glucose levels and adjust basal insulin doses in people with type 1 diabetes. The pre-clinical testing of this device was all done on dogs at the VA diabetes research laboratory. However, the research project is ongoing and much work remains to be done. If it is canceled due to political pressure from White Coat Waste, it would be a huge loss for Veterans and the millions of people worldwide who need more reliable ways to treat their diabetes.

Juan Carlos Marvizon, Ph.D.

References:

  1. Grosman B, Voskanyan G, Loutseiko M, Roy A, Mehta A, Kurtz N, Parikh N, Kaufman FR, Mastrototaro JJ, Keenan B. Model-based sensor-augmented pump therapy. J Diabetes Sci Technol. 2013 Mar 1;7(2):465-77.
  2. Loutseiko M, Voskanyan G, Keenan DB, Steil GM. Closed-loop insulin delivery utilizing pole placement to compensate for delays in subcutaneous insulin delivery. J Diabetes Sci Technol. 2011 Nov 1;5(6):1342-51.
  3. Panteleon AE, Loutseiko M, Steil GM, Rebrin K. Evaluation of the effect of gain on the meal response of an automated closed-loop insulin delivery system. Diabetes. 2006 Jul;55(7):1995-2000.

Animal Testing and Human Trials: Alternatives or Complements?

The Animal Justice Project, a British-based animal rights group, is no stranger to misinformation. Previously we have debunked their factual errors regarding malaria studies in Sweden and eye injury studies. There was also the time they produced a press release which suggested 52oC (125oF) was the same as boiling water (which admittedly might be true if you tried to make a cup of tea in the lower stratosphere).

Recently on their website, a blog by Judith Snaith has been put up. The blog is a mash up of animal rights myths and misinformation, but one line was of particular interest.

More than 100,000 humans are killed yearly by prescription drugs that passed animal testing. Animal research is not the final phase, 90 per cent of drugs that pass the animal tests fail in human trials. So if we have to test on humans to be accurate, can we not skip out the middle monkey?

Let’s break this down bit by bit. The figure of 100,000 is an American one (Lazarou et al, 1998) with the figures for the UK approximated at around 10,000 (Pirmohamed et al, 2000) using a similar methodology. We have mentioned the flaws in these figures in our “Animal Rights Pseudoscience” page:

The statistic of 100,000 deaths in a year is taken from a 1998 meta-analysis by Lazarou and colleagues that examined rates of adverse drug reactions (ADRs) observed in 39 studies undertaken between 1966 and 1996 (Lazarou et al, 1998). The methods used in this meta-analysis were subsequently criticised for failing to adequately take into account differences between the 39 studies examined, a failing which may have lead to an over estimation of the number of deaths due to ADRs (Kvasz et al, 2000).

Between 2001 and 2002 Pirmohamed and colleagues analysed admissions to two hospitals in Merseyside, in order to determine if the cause of admission was an adverse drug reaction (Pirmohamed et al, 2000). Their results indicated that ADRs accounted for 6.5% of hospital admissions, and that ADRs may be responsible for up to 10,000 deaths a year in the United Kingdom. The study also found that:

  • 95% of ADRs were predictable from the known pharmacology of the drugs (i.e. from animal testing and human clinical data).

  • A large majority of ADRs were caused by older drugs.

  • About 70% of ADRs were either possibly or definitely avoidable.

So a large amount of these deaths come down to human error as the adverse drug reactions were both predictable and avoidable.

Judith mentions that these 100,000 deaths came from drugs which had passed animal tests. What she chooses not to mention is that these 100,000 deaths came from drugs which had also passed clinical trials in humans. There is no logical reason to put these deaths at the feet of animal tests – particularly as the animal tests do not check for the common causes of drug deaths – accidental overdose, negative drug-drug interactions from secondary medications, incorrectly prescribed medication etc.

Judith then goes on to mention that 90% of drugs that pass animal tests go on to fail in humans:

Animal research is not the final phase, 90 per cent of drugs that pass the animal tests fail in human trials

We’ve definitely seen and debunked this statistic before. The inference is that animal tests are not effective as many drugs fail later on. Prof Lovell-Badge explains some of the many flaws in this argument. Firstly, there is a similarly high failure rate in the human trials:

Consider that of all the drugs which pass Phase 1 clinical trials in humans, 86% will fail in later stage human trials. Yet, we do not hear activists suggesting that humans are an entirely inappropriate model for drug development (though we should note that one human is not a perfect model for another).

Furthermore, this whole argument is premised on a misunderstanding of the different role of animal and human trials:

The role of preclinical animal tests is to check if the drug offers any potential therapeutic value and, importantly, if it is safe enough to move to Phase 1 trials in humans. This does not even mean free of all side effects, but to learn whether a drug can safely be given to humans and at what approximate dosage.

Put another way, every stage of drug testing acts as a safety barrier for dangerous drugs being sold. Pre-clinical in vitro tests, pre-clinical animal tests, Phase I clinical trials, and Phase II-III clinical trials all work successively to remove potentially dangerous compounds from reaching the market. These are not their only functions, animal tests may help assess appropriate therapeutic doses, which can be later refined during clinical trials. These tests (animals and humans) may also help discover potential side effects (this does not mean the drug will be rejected – it depends on the seriousness of the condition it is intended to treat).

Judith Snaith goes on to combine her two assertions to claim that we don’t need to do the animal tests – we can just move straight to humans.

So if we have to test on humans to be accurate, can we not skip out the middle monkey?

This ignores the huge number of dangerous compounds which are removed from the drug development process because they show toxic effects in animals. To skip this step would be to allow these compounds to be trialled in humans. Furthermore, when one safety check doesn’t guarantee safety, that doesn’t mean removing the check makes anyone safer.

Animal testing is not an alternative to human trials, it complements it. Medieval castles had high walls and soldiers in them – both protect the defenceless people in the keep. Sometimes high walls and soldiers were not sufficient, and the castle was sacked, but no one would conclude that high walls were pointless and that everyone would be safer if there were just the soldiers. In reality, doing away with the castle would mean more soldiers would die, just as doing away with animal tests would likely lead to more deaths in Phase I and II clinical trials; the consequence of this would be that fewer people would volunteer for clinical trials (just as fewer soldiers would wish to defend a low-walled castle).

We use a variety of methods in biomedical science – computer simulations, tissue studies, animal models, clinical trials, epidemiology etc. Different methods can teach us different things and the results are often used in combination to build our knowledge and understanding of physiology and disease. The same is true in safety testing – all methods of screening drugs have advantages and drawbacks, but if we use them effectively, in combination, we can see that safe and effective drugs make it to market.

Would the French soldiers have taunted King Arthur if they didn’t have high walls? (Monty Python’s Holy Grail)

Speaking of Research

Context matters: How a veterinary image became “cruel animal testing”

Recently, a photo depicting a rabbit with pretty serious hair loss was tweeted by an image sharing Twitter account, and then retweeted over 4,300 times. The photo appears quite shocking, and the post by the Twitter account reflected that.

Uber_Pix has written, in all caps: “NEVER WANTED A PIC TO SPREAD MORE IN MY LIFE”. The image is a screenshot of a post with comments from Tumblr, where the user “the_vegan_mothership” writes:

“This is a bunny at L’oreal lab. L’oreal does a lot of cruel needless animal testing. Please don’t buy products made by L’oreal. The more products they sell, the more animals are tortured.”

Twitter users saw this image and were shocked. Many upset responses resulted:

The problem with the shared image is that the origin is just not true. The image is definitely that of a rabbit suffering from hair loss, but the image comes from a Florida veterinary clinic’s website. The image was posted to the clinic website to illustrate some of the cases they have dealt with in rabbits and other less common mammalian pets that the clinic sees.

Click image to go to page

The rabbit is suffering from an ear mite infection, caused by the parasite Psoroptes cuniculi. The rabbit in the photo actually appears to be on the (long) road to recovery, as the commonly seen thick scales usually present in an infection that has spread this badly have cleared up. When an ear mite infection goes untreated, it can easily spread to the neck, abdomen, and limbs, as seen with this rabbit.

Ear mites in rabbits are commonly treated with a potent but effective drug called Ivermectin, which kills the mites as they take blood meals from the treated host. Ivermectin itself is a fascinating drug, discovered by an international team of scientists, working with isolates from Japanese soil microorganisms. While Ivermectin is a very commonly used antiparasitic medication in veterinary medicine, it is also considered a “wonder drug” in human medicine, improving the lives of millions of people in the developing world who suffer from neglected tropical diseases.

When shocking images such as this one appear, it is very easy to get caught up in the emotion of the moment and want to react and share with your social media circles. However, it is important that we try our best to check sources, look for the origins of a photo, or get a second opinion. This rabbit image has been making its rounds on the internet since 2013, with the claims that the rabbit is a “victim” of animal testing. L’Oreal even responded to the claim, stating that they no longer test their products, or ingredients on animals, and that they do not contract the testing out to other facilities, either. The exception being for parts of the world where such testing is mandated by law (e.g. China). However, they are also actively working with nations where testing is required by law, in order to find suitable alternatives.

Keep in mind as well, what the real purpose is of Twitter accounts such as @Uber_Pix. These image “scrapers” actively take images and videos off of social media, strip the credit from them, and re-upload them in order to gain as much traffic, subscribers, and click-through as possible. Why do they do this? To spam subscribers with ads, to sell stuff. Don’t give them the time of day.

This is not the first time we have seen images repurposed to tell a story fitting the animal rights agenda. In 2014, we noticed a picture of cats tied to boards was being described as animal testing when in fact it was cats being prepared for spay and neuter in order to be adopted out.

This picture was used to misrepresent animal research

In both cases, thousands of internet users have been tricked by someone who is willing to lie to create a false case against animal research. Next time you see an image criticizing “cruel animal testing”, try to find the original image source, and make sure you’ve got the full context of the picture before you click to retweet!

Christine

Disappointing lack of context by Cruelty Free International, as worst press release on animal testing numbers is revealed

Cruelty Free International (CFI), a British-based animal rights group (formerly known as the British Union for the Abolition of Vivisection), has produced its annual press release about animal research numbers at British Universities. The release, entitled: “Disappointing lack of progress at UK universities as worst offenders for animal testing are revealed”, is full of hyperbole, half-truths and even a few outright factual mistakes. The release is likely to leave those readers who have little prior knowledge of animal research, with a less accurate impression of what it entails than if they’d consulted the universities themselves. The full CFI release can be found at the bottom of this article.

The press release begins with

Cruelty Free International has today revealed the five worst offending universities for animal testing in the UK, which are each responsible for carrying out experiments on over 175,000 animals per year. The universities of Oxford, Edinburgh, Cambridge, University College and King’s College London, forced 997,839 animals to suffer in experiments in 2015. This represents a collective increase of 7% compared to 2014.

This might be more “revealing” if it wasn’t for the fact that these universities (and five more) came together six months earlier to proactively press release their 2015 animal research numbers. This release included nine case studies of research being done at the institutions in order to provide additional context to the numbers. The article was picked up by the Huffington Post (and a few other outlets).

From Huffington Post UK

The article included the number of procedures on animals carried out by each institution:

Perhaps CFI didn’t see it, you may ask? Well no, CFI’s Katy Taylor is quoted in the Huffington Post article, responding to the information provided by the Universities.  Interestingly, CFI ends the first paragraph of its press release by noting that this represents a 7% rise by the top five universities over their 2014 statistics. This rise is exactly in line with the 7% rise in animal experiments that happened across all institutions in the UK (on average).

Cruelty Free International goes on to provide a table of the numbers (which they erroneously describe as “number of animals” when they mean “number of procedures” – a rookie mistake for an organisation which claims to be an authority on the issue). It notes the rise in the number of procedures at four out of the five universities, but describes the (very small) decline in numbers at the University of Oxford as “virtually no change”. That probably sounded better for their release. CFI also gets the number of procedures at the University of Cambridge wrong – it is 181,080, a number which is freely available on the university website.

The five universities mentioned also appear together in another list – they account for five of the top six British Universities on the QS World University ranking. Perhaps what CFI describe as the “worst universities for animal experiments” are in fact some of the best universities in the world for biomedical research (all five are also in the top 50 world institutions for “biological sciences”) and for advancing human health.

These are the six top ranked British Universities on the world university leagues tables. The numbers on the left represent their position in the world, including institution outside the UK.

CFI’s press release then goes on to make unverified claims about things going on at the five universities. Because CFI provides no evidence or paper references for the claims that, for example, monkeys were “deprived of food or water”, or were “restrained for hours”, it is impossible to speak to the veracity of these claims. However, similar claims by other animal rights groups have often been found to be either false or misleading.

Dr Katy Taylor, CFI’s Director of Science, who is quoted in the press release, suggests these universities should be leading in “replacing and reducing animal testing”. Setting aside the fact that these institutions do animal research, and very little animal testing (which is a term for safety tests, usually done by pharmaceutical companies and CROs, and require by law before potential new medicines can move into human trials), the truth is that these institutions are leading the way in both animal and non-animal methods. For instance, researchers at the University of Cambridge have won NC3Rs Prizes, for the Replacement, Refinement and Reduction of animals in research, in 2008, 2009, 2011 and 2013; Oliver Britton at the University of Oxford won the prize in 2014 for a computer model of cardiac electrophysiology; and Dr Anna Williams at the University of Edinburgh was highly commended in 2011 for her work on cell cultures which can reduce the number of mice needed to test MS treatments. King’s College London, meanwhile, has developed a number of animal alternatives, such as this artificial gill system which reduces the need to use fish, and University College London is the home of the Replacement of Animals in Research Conference  alternatives conference. Just because an institution is doing great work Replacing and Reducing animal research, doesn’t mean overall numbers will come down – as this is influenced by many factors.

Finally we come to one of trickier claims. Katy Taylor goes on to say:

63% of the 65 universities that reported testing on animals in 2015 still do not publish their animal testing statistics online, despite claiming that they agree there should be more transparency.

It is worth noting that the Universities that do the most animal research DO publish their statistics online. A quick search found 22 institutions that definitely published their statistics – they accounted for 1,612,166 procedures, of the 1,977,928 procedures conducted by all universities and medical schools in 2015 (Table 11). So rather than saying 63% of universities do not publish their figures (remembering that some of these institutions may only do a few dozen procedures), it might be more meaningful to say that 81.5% of procedures are accounted for in the data published by universities. It is unclear where CFI’s figure of 1,920,171 animals comes from as it does not appear in the 2015 statistical report.

Taylor then goes on to attack the University of Bristol over its statistics:

Bristol University now stands alone as the only university experimenting on animals that still refuses to provide its figures on the grounds that it does not hold the information centrally, despite promising to update its record keeping.

The Freedom of Information Act sets limits on the time that institutions can be expected to spend answering any single FOI question. The Information Commissioner’s Office has agreed with the University of Bristol and has upheld their claim that the University would be unable to provide the information asked of it due to the excessive lengths of time it would take to collate. The institution is in the process of changing how this information is collated and has expressed its intention to proactively publish this in the future.

It is an open question as to why, six months after a press release from UK universities went the extra mile to inform the general public about how many animals were used for what purposes at these institutions, anyone would strip it of its context and case studies, add the word “revealed” and republish it alongside their own anti-animal research diatribe.

Given that Cruelty Free International regularly calls for greater transparency in animal research, surely they should be welcoming the work that top universities are doing to provide more information about the research they conduct – rather than using this information as the basis of a press release criticising such research. We must hope that journalists choose to report the accurate numbers and representative case studies of medical progress released by the universities, rather than the account of an organisation whose sole purpose is to end the use of animals in experiments.

James

————————————————

Press Release sent by Cruelty Free International
Disappointing lack of progress at UK universities as worst offenders for animal testing are revealed
Nearly 1 million animals tested at five worst universities for animal experiments
Cruelty Free International has today revealed the five worst offending universities for animal testing in the UK, which are each responsible for carrying out experiments on over 175,000 animals per year. The universities of Oxford, Edinburgh, Cambridge, University College and King’s College London, forced 997,839 animals to suffer in experiments in 2015 (the year for which the most recent figures are available). This represents a collective increase of 7% compared to 2014.
In 2015 the following numbers of animals were used by each of the top five universities:
  • Oxford University (226,214) – virtually no change on the previous year
  • Edinburgh University (212,695) – 6% increase
  • University College London (202,554) – 15% increase
  • Cambridge University (181,090) – 13% increase
  • King’s College London (175,296) – 6% increase
According to the Home Office, testing in universities continues to make up almost 50% of all animal experiments in Great Britain. Despite claims that animals are only used in tests where there is no viable alternative, the figures collected for 2015 by Cruelty Free International under Freedom of Information (FOI) requests or accessed from university websites show a collective increase of 7.5% in animal testing at universities from the previous year. In 2015, over 1,920,171 animals were used in tests.
Four of the worst five universities reported subjecting macaque and/or marmoset monkeys to experiments (all except for Edinburgh). Recently published experiments from these institutions included monkeys being deprived of food or water, being restrained for hours in ‘primate chairs’ to perform repetitive computer tasks, having electrodes surgically implanted into their skulls, coils implanted in their eyes, having portions of their brain damaged, being trapped inside plastic boxes or injected with antidepressant drugs.
Experiments by university staff were also carried out on rabbits, sheep, guinea pigs, ferrets, fish, birds, frogs, rats and mice. Recent examples include blocking or cutting the arteries of pigs and rabbits to induce heart attacks, and purposefully stressing rats by restraining them inside plastic tubes, restricting their food and keeping them in isolated, barren cages.
Dr Katy Taylor, Director of Science at Cruelty Free International, said: “Our top universities should be leading the way in replacing and reducing animal testing, yet they remain some of the biggest users of animals in Britain. The public wants to see meaningful and lasting changes towards ending the use of animals in laboratories; our universities should be setting the example not adding to the problem.”
63% of the 65 universities that reported testing on animals in 2015 still do not publish their animal testing statistics online, despite claiming that they agree there should be more transparency. Bristol University now stands alone as the only university experimenting on animals that still refuses to provide its figures on the grounds that it does not hold the information centrally, despite promising to update its record keeping. A Cruelty Free International complaint to the Information Tribunal about this failure is ongoing [1].
ENDS

Of White Papers And Commentators: The Use Of Nonhuman Primates In Research

Two weeks ago, nine scientific societies, including the American Physiological Society, the Society for Neuroscience, and the American Academy for Neurology, published a white paper entitled “The critical role of nonhuman primates in medical research“. The paper, which notes how nonhuman primates are critical to all stages of research, provides a huge number of examples of medical breakthroughs made possible thanks to studies in nonhuman primates. Among the paper’s appendices is a list of over fifty medical advances from the last fifty years alone; these include: treatments for leprosy, HIV and Parkinson’s; vaccines for measles, mumps, rubella and hepatitis B; and surgeries such as heart and lung transplants. This is no small feat considering the group of species accounts for around only 0.1% of animal research in most countries (that provide data).

critical-role-of-non-human-primates-in-medical-research

On September 2nd, 2016, John P. Gluck wrote an op-ed for The New York Times called “Second Thoughts of an Animal Researcher“. Gluck is a Professor Emeritus in the Department of Psychology at the University of New Mexico. However, this Op-Ed has not come out of the blue. Gluck has long worked alongside PETA and other animal rights groups to condemn nonhuman primate studies. This op-ed is timed for just before today’s NIH workshop on “Ensuring continued responsible research with non-human primates” – a workshop that PETA is petitioning congress about. The article explains why Gluck stopped conducting animal research, his ethical stance against it, and concludes by saying:

“The federal government should establish a national commission to develop the principles to guide decisions about the ethics of animal research. We already accept that ethical limits on experiments involving humans are important enough that we are willing to forgo possible breakthroughs. There is no ethical argument that justifies not doing the same for animals.”

This is disingenuous of Gluck. The strict regulatory system that exists in the US, and most other developed nations, is the very embodiment of principles aimed to guide decisions on when and how we should conduct studies on nonhuman primates (as well as other species). Some countries have specific regulations surrounding primate research (e.g. the UK considers them a specially protected species and researchers must explain why no other species can be used instead). In the US, all primate research is governed by the Animal Welfare Act (enforced by the USDA), and any research receiving federal funds will also be subject to the Public Health Service Policy on Humane Care and Use of Animals (PHS policy; enforced by OLAW). The PHS Policy also endorses the US Government Principles for the Utilization and Care of Vertebrate Animals Use in Testing, Research and Training, which forms the foundation for ethical and humane care and use of laboratory animals in the US. Every research protocol must be approved by an Institutional Animal Care and Use Committee – a group made up of including scientists, veterinarians and lay-persons – who review and evaluate the study, recommending ways in which it could be improved (both scientifically and from an animal welfare perspective).

Other commentators have noticed this as well. As Wesley J Smith writes in the National Review:

Gluck would have readers believe there are no strict ethical regulations that govern primate research. Nothing could be further from the truth. The Animal Welfare Act already has many stringent requirements governing research on monkeys-as the law should-including cost-benefit analyses, the requirement that any pain experiments cause be palliated, and the requirement that oversight boards approve the purpose and approach of proposed experiments.

Ultimately, Gluck’s article reads as an ethical objection to animal research with some scientific gloss. The heart of his objections is Singer-esque in nature (he mentions Peter Singer earlier in the article). He almost directly condemns our different treatment of humans and nonhuman primates as speciesist:

The ethical principle that many of us used to justify primate experiments seemed so obvious: If you are ethically prevented from conducting a particular experiment with humans because of the pain and risks involved, the use of animals is warranted. Yet research spanning the spectrum from cognitive ethology to neuroscience has made it clear that we have consistently underestimated animals’ mental complexity and pain sensitivity, and therefore the potential for harm. The obvious question is why the harms experienced by these animals, which will be at least similar to humans, fail to matter? How did being a different member of the primate grouping that includes humans automatically alter the moral universe?

No doubt our understanding of the cognitive abilities of animals has improved, and with it has come a greater appreciation for their capacity to suffer. We are a long way from the 17th century philosophers, like Malebranche, who thought animals could not suffer. Our greater understanding of the capacity of animals to suffer pain or distress informs the way we treat animals in laboratories. For example, it was not until the early 1990s that the USDA adopted regulations requiring group housing of nonhuman primates (DiVincenti and Wyatt, 2011), this was thanks to many years of studies showing that nonhuman primate welfare was best met by keeping primates in social groups. As such, it is wrong for Gluck to claim that harm to animals “fail to matter”. While we may give animals a different consideration compared to humans (it is legal to eat animals and keep them as pets), it would be wrong to say they exist outside our moral sphere. The UK’s House of Lords set up a select committee in 2002 to look at animal studies; when assessing the ethics they concluded (s 2.5):

The unanimous view of the Select Committee is that it is morally acceptable for human beings to use other animals, but that it is morally wrong to cause them unnecessary or avoidable suffering.

This is the heart of sensible moral consideration – that we should minimise the suffering of animals wherever possible while realising that we also have a moral imperative to conduct animal studies to reduce greater suffering among humans and animals.

Image from Californian National Primate Research Center

Photo by Kathy West.

Primates at the Californian National Primate Research Center. Reproduced with permission.

And there is no doubt we have a moral imperative. To return to the recent white paper:

Research with monkeys is critical to increasing our knowledge of how the human brain works and its role in cognitive, motor and mental illnesses such as Alzheimer’s, Parkinson’s and depression. This research is also fundamental to understanding how to prevent and treat emerging infectious diseases like Zika and Ebola. NHP research is uncovering critical information about the most common and costly metabolic disorder in the U.S. – type 2 diabetes – as well as the obesity that leads to most cases.

Without NHP research, we lose our ability to learn better ways to prevent negative pregnancy outcomes, including miscarriage, stillbirth and premature birth. This research is also helping scientists to uncover information that makes human organ transplants easier and more accessible, literally giving new life to those whose kidneys, hearts and lungs are failing.

The eradication of these diseases is not worth giving up on. For some animals such research could be the difference between survival and eradication. Ebola has a 95% mortality rate for gorillas. An outbreak in 1995 reportedly killed more than 90% of the gorillas at a national park in Gabon. Overall it is estimated that one third of all the world’s gorillas have been wiped out by Ebola in the last 20 years. If nonhuman primate research (primarily in monkeys rather than great apes), can come up with a vaccine then it will be both animals and humans who can benefit. Humans are unique in that they are the only species with the cognitive capability of making a decision of this magnitude. In the words of Wesley J Smith:

This is the difficult fact that can’t be avoided: We need primate research if we are going to advance science, relieve human suffering, and bring new treatments into medicine’s armamentarium. At some point, we have to decide whether to help humans or not experiment on monkeys.

Looking forward to today’s NIH workshop (which will be streamed live online), it would seem they have struck the right tone. Reviewing the evidence, reviewing the policies, and looking to see what can be improved – that is the essence of science – while still appreciating that the duty of the NIH is to improve the health of a nation.

[T]he Office of Science Policy is taking the lead in planning a workshop on September 7th, 2016 that will convene experts in science, policy, ethics, and animal welfare. Workshop participants will discuss the oversight framework governing the use of non-human primates in NIH-funded biomedical and behavioral research endeavors. At this workshop, participants will also explore the state of the science involving non-human primates as research models and discuss the ethical principles underlying existing animal welfare regulations and policies. NIH is committed to ensuring that research with non-human primates can continue responsibly as we move forward in advancing our mission to seek fundamental knowledge and enhance health outcomes.

Tom Holder

Why we haven’t cured the common cold – a response to PETA’s science advisor, Dr. Julia Baines

For a previous post that also debunks comments made by PETA, read our article, “Biology, History and Maths: A lesson in debunking PETA’s nonsense”.

The United Kingdom recently released their annual statistics of scientific procedures on living animals and, as expected, interested parties weighed in and provided their views and interpretations of these numbers (e.g., here, here and here). While it is acknowledged that providing a context for these numbers is key, it is often quite difficult to do so without sufficient passage of time. Indeed, the timeframe required for the translation of research from bench to bedside takes years, if not decades. Moreover, as science is self-generating and self-correcting, there is no explicit requirement that an applied benefit results from all scientific research, including research performed on animals.

With this in mind, which facts can we infer from these annual statistics? We can, for example, quantify the number of animals used by species (mice, rats, primates, etc.), by establishment (e.g., government, university), and by study type (e.g., basic research, breeding, applied research) to name a few. We can also do a retrospective account of the amount of pain experienced (severity) by animals used in experimental procedures. What we should not do based on these statistics, is make false claims about the procedures involved in animal research and what animal research should have achieved. In what can only be viewed as an attempt to evoke the maximum emotional response, Dr. Julia Baines, a science advisor for PETA, was quoted as saying:

“Given that the latest Home Office statistics reveal that a staggering 4.14 million scientific procedures were carried out on animals in British laboratories in 2015, we should have a cure for everything, including the common cold, by now if this was a useful method of gaining scientific information.” [Our emphasis]

As Dr. Baines correctly points out, 4.14 million scientific procedures were carried out in British laboratories. And, it is true that 4.14 million is a large number of procedures. What Dr. Baines fails to do is to provide a fact-based context for those numbers, as for example was done here and here. Such a context would reflect, for example, that the number of animals used between 2013 and 2015 increased by only 0.5%. Next, Dr. Baines goes on to imply a causal relationship between animal use and a cure for all diseases, including the common cold. While this statement is at best an example of illogical abstraction and at worst logically flawed thinking below what one would expect from a “science advisor”, I found it useful to reflect on the question, “Why don’t we have a cure for the common cold?”

The first thing worth pointing out is that the common cold is not a single virus strain. Rhinoviruses are the most common form of the cold virus but even then there are over a hundred known types of rhinoviruses.

Furthermore, curing the common cold would mean eradicating a long list of viruses which cause similar symptoms, such as adenoviruses and coronaviruses. To further complicate matters, in a given geographical area, only 20 to 30 different types of the “cold virus” circulate each season, only 10% of those will show up next year for that season, and due to viral mutation, new strains will emerge across time.  Thus, we immediately see that for something seemingly as “simple” as the common cold, producing a “cure” is exceedingly difficult.

Rhinovirus caption: Surface of the human rhinovirus 16, one of the viruses which cause the common cold. Source:Wikipedia Commons

Rhinovirus caption: Surface of the human rhinovirus 16, one of the viruses which cause the common cold. Source:Wikipedia Commons

Moreover, the statement by Julia that we should have a “cure for everything” is something that cutting edge science is working on. The basic premise is that because there are many viruses and many diseases caused by viruses, as well as many viral mutations, it may be virtually impossible to eradicate all viruses by utilizing single vaccinations. For example, Todd Rider is working on a broad spectrum antiviral approach, dubbed DRACO, which causes infected cells to die while leaving uninfected cells intact.

DRACOs have worked against H1N1 influenza in cells and mice. NIAID/Flickr (CC BY 2.0) Source: Secondary citation from here: http://www.techinsider.io/todd-rider-draco-crowdfunding-broad-spectrum-antiviral-2015-12

DRACOs have worked against H1N1 influenza in cells and mice. NIAID/Flickr (CC BY 2.0)
Source: Secondary citation from here: http://www.techinsider.io/todd-rider-draco-crowdfunding-broad-spectrum-antiviral-2015-12

Consistent with the 3Rs, this method was first developed in vitro, and given that the method showed evidence of proof of principle, in vivo trials were begun, recognizing that currently, alternative methods such as in vitro studies complement rather than replace animal research.

Todd is not the only scientist working on this problem. Brian Lichty is adopting a somewhat different approach, looking at the mechanism via which immune cells detect viruses in the body and how they trigger an immune response. Both approaches recognize the complexity of curing viral diseases, both at the level of the host and the agent, and the valuable role which animal research plays in the development of cures.

What emerges from a review of scientific history and method is this: be patient.

Dr. Baines is not alone in wishing that cures and medical progress were faster and error-free – many of us have this wish. Unfortunately, that isn’t the way science or reality works. With the help of animal research, we have great potential for curing many diseases, including diseases which affect non-human animals. It just may take some time. More importantly, I encourage all readers of information on the internet to carefully scrutinize what is presented, including this post. We are often faced with common-sense notions in our everyday life, and we often do not question such information, particularly if it is something that is consistent with what we believe to be true. We saw this behaviour most recently with the release of the animal use statistics in the UK for 2015, with facts being flagrantly misrepresented and, frighteningly, widely publicized.

Jeremy D. Bailoo

The opinions expressed here are my own and do not necessarily reflect the interests of the University of Bern or the Division of Animal Welfare at the University of Bern.

Biology, History and Maths: A lesson in debunking PETA’s nonsense

On 21st July the UK government released its stats on how many animals were used in UK research and the race was on. Many British universities raced to tweet the numbers of animals they’d used in 2015 and draw attention to their webpages on the subject. Science organisations raced to explain to the media what they were looking at in terms of real-world research. Animal rights groups raced to get their fantasy narrative into as many newspapers as possible.

Upon hearing of a 0.5% increase from 2013, Michelle Thew of Cruelty Free International said “This lack of progress is completely unacceptable”. This is perhaps unsurprising: in 2012, Thew noted of a 2% rise that “the lack of progress is completely unacceptable”; In 2013 (8% rise), Thew noted “This lack of progress is completely unacceptable”; and in 2015, after stats showed a 6% FALL in the animal statistics, she still noted “This lack of progress is completely unacceptable”. Perhaps it’s time for a new speechwriter?

Cruelty Free International also press released that “A shocking 30% of experiments were assessed by animal researchers and the Home Office as being moderate or severe”. This was a bit of statistical trickery. Having just mentioned that there were “4.14 million experiments* completed during 2015”, the 30% only referred to “experimental procedures” and not “procedures for creation and breeding of genetically altered animals” (see table below). The truth is that of the 4.14 million procedures, only 18.2% were moderate or severe (13.7% vs 4.5%), down from 19.2% in 2014 (14.4% moderate vs 4.8% severe)**.

*CFI’s press release uses ‘experiments’ and ‘procedures’ almost interchangeable. The UK tends to prefer ‘procedures’, which is any intervention, or set of interventions, which have the potential to cause suffering or harm equal or greater than a simple injection.

Severity of animal research in the UK in 2015

Severity of animal research procedures in the UK in 2015

Hyperbole came thick and fast from PETA, whose own press release noted “126,000 animals didn’t regain consciousness after experiments classified as ‘non-recovery’” before going on to mention severe experiments. Non-recovery studies mean animals are put under with anaesthetic and intentionally given an overdose of anaesthesia to ensure they never wake up**. These animals do not suffer from the procedure – they are completely anaesthetised from the beginning of surgery until death.

**For more information about severity categories in the UK, please read “Advisory notes on recording and reporting the actual severity of regulated procedures“. 

A special distinction, though, goes to Julia Baines from PETA, who wrote an article for International Business Times that gleefully twists reality to the point that Mark Twain would probably have considered it a credible piece of satire.

“Four million animals were used in British experiments in 2015 – why aren’t we using alternative methods?”

The title is fairly quickly answered by the fact that in the UK, it is illegal to use an animal if there’s an alternative. The author knows this, but still decides to spend another 651 words not mentioning it.

“Britain is officially one of the worst offenders in Europe for scientific animal testing. According to the annual government statistics released today, cats, dogs, monkeys and other animals were used in a staggering 4.14 million experiments in 2015, a figure comparable only to France and Germany throughout the continent.”

Well on a purely empirical level this is false. British, French and German figures are all considerably lower than those in Norway, which used 4.82 million animals in 2014 (mostly fish). Then there is the rather tricky description of animals used. Rather than mention the mice, rats and fish that account for over 93% of research, they pick three species which  together account for 0.2% of animal studies in the UK.

PETA misinforms public over statistics

“Currently, despite evidence that experiments on animals systematically fail to benefit humans, scientists in Britain …”

This huge statement is taken as fact. No “evidence” is provided. Perhaps she does not wish to bore us with details.

“continue to withhold food and water from animals in order to make them cooperate with experimenters; poison them with ever-increasing doses of toxic chemicals until they die; and attach bolts to their skulls so that they can be “fixed” to a chair.”

There is NOTHING in the article linked to, which suggests food was withheld, or even restricted. The study did restrict water intake for 6 days per week (It was not withheld; animals were always given adequate hydration). We spoke to the study author, who told us:
All animals get as much food and liquid as they want and need, and the animals are not food or water deprived. We maintain controlled access to food or liquid and give specific amounts for behavioural reactions, and we supplement food or water if they don’t get enough during experimental sessions.

The second claim is even more egregious, as of the list of 19 studies linked to, NOT ONE involves repeatedly increasing the dosages of a compound until an animal dies. Rather, studies are full of phrases like “Animal welfare costs are minimised by the careful selection of dose levels to reduce the likelihood of unexpected toxicity” and other such animal welfare considerations.

The final claim is misleading due to the information left out. The description seems to evoke images of Frankenstein’s monster. The original paper says “The monkeys were trained to sit in restraining chair in front of a computer with the head fixed”. Surgical screws are required to fix their head. The surgery is done under anaesthesia in a sterile environment.

“Worse even than the fact that these tests are ineffective is that for decades, some doctors believe experiments on animals have actually derailed medical progress. For example, according to Steven R. Kaufman and Neal D. Barnard, president of the Physicians Committee for Responsible Medicine and co-chairman of the Medical Research Modernization Committee, we delayed our understanding of polio transmission, heart disease, and diabetes because we studied them in other species.”

Physicians Committee for Responsible Medicine have previously been criticised for their activism and claims by the American Medical Association, who passed a resolution in 1990 that condemned PCRM for “implying that physicians who support the use of animals in biomedical research are irresponsible, for misrepresenting the critical role animals play in research and teaching, and for obscuring the overwhelming support for such research which exists among practicing physicians in the United States” [Page 123]. Their claims about the delayed understanding of polio transmission, heart disease and diabetes have been thoroughly debunked by us before:

All of this also seems to ignore that monkeys were key to our understanding of polio and development of an oral vaccine; a number of animal models were essential for the development of treatments for cardiac arrest and ventricular fibrillation; and dogs were indispensable for the discovery and isolation of insulin to treat diabetics.

Indeed the president of the Royal College of Surgeons said in 1993, “I think there is no doubt whatsoever that all forms of cardiac surgery which depend upon the heart-lung machine were developed through experiments on animals. There is no way that the heart-lung machine could have been devised and developed other than through studies on living creatures”.

“And Richard Klausner, the former head of the US National Cancer Institute, has also admitted, “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.””

Now we come to the misrepresentation of someone who does have credibility, Dr Richard Klausner, former director of the National Cancer Institute. Speaking of Research has mythbusted before the claim that “We have cured mice of cancer for decades – and it simply didn’t work in humans.”, but it was a throwaway quote lifted from this Los Angeles Times feature. Back in its proper context, it’s a reaction to the pleas made by desperate cancer patients for new cures to be tried, i.e. it means ‘we’re trying!’ Of course, other treatments for cancer based on animal studies did/do work. Why does Dr Baines think we don’t have cancer treatments? Breast cancer drug Herceptin is based on a humanised mouse antibody. How would Dr Baines have acquired this without a mouse?

Dr Baines’ next few paragraphs discuss alternative technologies such as ‘organs on a chip’ and 3D human skin cultures. No doubt these are exciting and important methods which, in their rightful place, can help to improve our understanding of medicine and disease. However, they are just one of a number of tools – including animals – which are used together to build up a picture of biomedical research. To this end I must return to my earlier point that under UK law you must use non-animal methods instead of an animal wherever they can be used. However, sometimes we need a full, living organism – for example neither skin cultures nor organ on a chip  get pregnant – they are of limited use in such research. The Home Office website clearly states “Implementing the 3Rs requires that, in every research proposal, animals are replaced with non-animal alternatives wherever possible”. Alternatively check the original legislation – Section 5 (5).

Implementation of the 3Rs in UK law

“Seventy-nine per cent of the British public wish to see more exploration of these kinds of non-animal methods. The problem is that at the moment, the scientific community and the government lack the political will to end animal tests. It is unconscionable that of the £300 million in UK government funding for biosciences, only about 1 per cent is directed towards replacing animals in experiments.”

It is unclear where Dr Baines got her £300million figure from since just one of the UK’s bioscience funders – The Medical Research Council (MRC) – allocates some £678 million [p.20] each year to research. Other government funders of animal research include the Biotechnology and Biological Sciences Research Council  (BBSRC; £334m) and the Engineering and Physical Sciences Research Council (EPSRC). Not all of this funding is for animal studies, for instance the MRC estimates one third of its research programmes involve animal studies. This is likely to be much lower for the EPSRC.

Calculating funding into replacements is similarly hard. The National Centre for the 3Rs, which looks at developing alternatives to animals, had an annual budget of around £10 million (the actual amount changes year to year). The BBSRC estimates they spend £1.5m on 3Rs research. Many other Government-funded projects will involve furthering the 3Rs, but will not be noted as this if it is not the prime objective of the research.

Another problem is in comparing funding for the developing of non-animal methods, with funding for using animal methods. Dr Baines has not attempted to look at the millions of pounds spent using non-animal methods – computers, tissue studies, human studies. Nor has she compared funding into developing replacements with funding for developing new, better, animal models – which will account for only a small proportion of overall animal studies. Apples and pears indeed.

There’s a just a bit of time to fit in some scaremongering before she leaves us.

“But if this nation continues down the same road it always has regarding animal testing, then uncoupling from EU legislation could lead to lowering animal welfare standards and permitting tests on animals that are currently deemed illegal under EU law – betraying both humans and animals.”

This is of course about the UK leaving the EU. What Dr Baines fails to mention is the fact that EU regulations around animal research have never been policed at the European level – they’re transposed into a UK law via Parliament so leaving the EU should not affect them. Furthermore, it should be pointed out that EU law was heavily based on the UK system, which has been in place since 1986.

Chimpanzee in IB articleFinally is the question of pictures. It is unclear if those responsible for the choice of images are Dr Baines or IB Times. The first image is that of a chimp. Now, chimps aren’t used in UK research. No Great Ape has been used for over 30 years in regulated research in the UK, and reading the caption the picture was taken in Germany in 1995. How illustrative of UK research! For good measure we also have some rats but they’re not from the UK either, they’re from China in 2008, a country with less strict animal research laws than exist in the UK. We can see how the images contrast with those taken by The Sun newspaper a few days earlier, showing what a UK lab actually looks like.

Overall, what’s striking about the article is how divorced its narrative has become from reality and I can only wonder at what mental gymnastics are required by the author to convince themselves they’re not purposely trying to misinform.

While we have taken apart PETA’s claims one statement at a time, not everyone has the scientific knowledge to do so. Many are left innocently believing, and even repeating, the claims made by PETA. Dr Baines, on the other hand, should know better. It is disappointing to see any scientist abusing the trust her position affords her by writing articles like this.

Chris and Tom

Speaking of Research