Category Archives: Animal experiments

Change, slow but steady

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How can we tell whether public opinions are changing? How can we tell whether views on particular issues have changed compared to some time ago? As animal advocates, our aim is to achieve change to policies, regulation and legislation that improves the lives of animals. Changing public opinion alone can make a difference to the lives of animals – when, for example, consumers stop buying the eggs of caged hens -, and it is essential to achieve regulatory and legal change.

Surveys and polls are a common way of gauging public views on political and social issues. They are important tools to monitor and evaluate animal advocacy, and provide direction for future strategies.

So what do we know about awareness of and views on animal experimentation, and whether they are changing?

Overseas surveys tell us that the public’s views on animal experimentation are changing:

  • a Pew Research Center survey from 2015 in the U.S. informed us that approximately equal numbers of people favour and oppose the use of animals in scientific research (47% vs 50% respectively), while the vast majority of scientists (89%) favour animal research, a difference of 42 percentage points.
  • a Gallup poll in 2015 found that a third of Americans want animals to have same rights as people (compared to 25% in 2008), while 62% said animals deserve some protection but can still be used for the benefit of humans.
  • A 2017 Gallup poll in the U.S. found a 51% acceptance of medical testing on animals, a decreased acceptance rate compared to polls in previous years.
  • In an Ipsos MORI 2016 poll in the UK, 65% (compared to 68% in 2014) of people said they could accept the use of animals in research as long as it is for medical purposes, and there is no alternative.
  • In Germany in 2017, a Forsa poll found 71% of respondents in favour of a ban on painful animal experiments, while 23% did not consider such a ban necessary.

In Australia, the results from a survey commissioned by Humane Research Australia (HRA) have just come in: Nexus Research surveyed 1,006 people in April 2018. The sample was quota controlled by age and gender, and selected in proportion to the population aged 16+ years in each State/Territory. A survey of this size is considered sufficient as a representative sample of the Australian population, with an error margin of around ±3%. More information about the survey can be found on the HRA website.

Taking small samples from large populations is a valid statistical technique for getting accurate information about the wider population, for a fraction of the time and cost.

HRA commissioned similar surveys in 2008 and 2013. Below are some of the findings, comparing how people’s awareness and views changed over the 10 years since the first survey.

Awareness

Awareness of animal research has changed over the years. While in 2013 only 57% of people were aware of animals being used in research, this increased to 71% in 2018. In the latest survey, people under the age of 30 and those with an income between $80,000-$120,000 had the highest awareness of animal research (both 79%).

awareness of AR.jpg

In 2013 and 2018, people were asked whether they were aware that monkeys and other non-human primates are used in medical research in Australia. The vast majority of respondents were not aware of this (91% in 2013, 82% in 2018). On the other hand, over the last five years the number of people who know that non-human primates are used in laboratories has doubled from 9% to 18%.

In the last survey, a new question was added: ‘Do you consider that our governments provide sufficient information to understand the extent of animal experimentation in Australia?’ About the same proportion as those who were not aware of primate research answered this question with ‘no’ (81%).

Positions against animal experimentation are typically based on two arguments: ethical considerations that deem inflicting suffering on sentient beings as morally wrong, and/or scepticism about the scientific validity of animal experimentation. Both were explored in the surveys.

Ethical concerns

Do humans have the moral right to experiment on animals? In all three surveys, more than half of the respondents did not believe this, and a significant proportion was unsure. More men than women (31% vs 15%) and more people aged 70+ than people under 30 years (34% vs 21%) believed that humans have the right to experiment on animals. People living in households with pets expressed a much stronger view against animal experiments than those who did not live with pets (64% vs 53%), while the latter expressed greater indecision (13% vs 22%).

moral right to exp

To gain more nuanced views, questions were asked about the purpose of research and the species of animals used. About three in four people opposed the use of animals for developing household products and cosmetics testing in all three surveys. Interestingly, this proportion decreased slightly over the 10-year period, while the proportion of those opposed to basic/scientific research, teaching/educational purposes and developing pharmaceuticals for people (medicines/tablets) rose slightly. A question about environmental research was only asked in 2018.

oppose use for of AR

People do not feel as strongly for rodents (mice and rats) and rabbits as they do for dogs and non-human primates. While concern for all four species increased slightly over the years, half as many people opposed research on rodents compared to dogs.

oppose by species

The level of discomfort and pain inflicted on animals also influenced people’s views: the more painful the procedures, the greater the opposition to animal research (2018: from 33% to 72%).

oppose by level of pain

Overall, more women than men expressed ethical concerns, as did younger people (<30) compared to older people (>70), and people who live in households with pets compared to those who do not.

Transferability

All three surveys asked respondents about their views on the transferability of results from animals to humans. However, the wording of the question changed in the 2018 survey:

‘Do you believe or not believe that it is always safe to transfer results from animal research (e.g. from rabbits, mice, rats and dogs) to apply to humans?’ (2008 and 2013)

‘Do you believe that it is safe to transfer results from animal research (e.g. from rabbits, mice, rats and dogs) to apply to humans?’ (2018)

The change in wording might explain the significant increase in the number of people who believed that results from animals apply to humans (2008: 14%, 2013: 13%, 2018: 35%). About a third of respondents were unsure. In 2018, significantly more men than women (42% vs 29%) and older people aged 70+ compared to those aged under 30 years (50% vs 31%) believed that it is safe to transfer results from animal research to apply to humans.

transferability

Alternatives

In 2018, people were asked whether they were ‘aware of any current alternatives instead of using animals in research for human medicines. Only 20% responded that they were aware of such alternatives.

It is no surprise then, that the vast majority of respondents favoured ‘allocating a proportion of medical research grants to finding scientific alternatives to animal experiments’, although this support decreased over the years from 79% to 67%. I have no explanation for this trend.

Change, more change

To my knowledge, this Nexus survey is the only of its kind in Australia. How sure can we be that it describes accurately Australians’ opinions about animal experimentation? Nexus Research recruited survey participants from a panel. While there have been concerns expressed about this type of recruitment, ‘the quality of the answers obtained from online panels does not seem to be worse than that from more traditional methods of data collection and, in some cases, may be better.’ So, for the time being, this is the best we have.

As the president of Humane Research Australia I’d like to think that our work has contributed to greater awareness of animal research and increasing compassion with the animals used in laboratories. It is clear that the public wants accurate and comprehensive information about animal research. It is also clear that the public needs to be better informed about alternatives to animal research. Without such knowledge, how can people develop informed views and considered moral judgment about animal research?

 

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World Week for Animals in Labs

This week is World Week for Animals in Laboratories when we commemorate the suffering of millions of animals in laboratories around the world and raise awareness of better, human-relevant research methods that do not involve inflicting pain on animals.

Animal research is still a mostly secret industry. Although research institutions are required to collect data about animal research, this information is not made publicly available in full. Here in Australia, Humane Research Australia (HRA) collects available data and makes them available on its website. The latest available statistics  indicate that during 2015 approximately 9.9 million animals were used in Australia (although this includes studies that involve observation only). HRA also publishes case studies of horrific procedures that are being carried out on animals in this country.

Over the last decades, increasingly evidence has come to light showing the pitfalls of animal research. For example, scientist have been able to cure different types of cancer in mice, but a cure in humans is still elusive.

The development of penicillin was delayed because the researcher Dr. Alexander Fleming thought it was ineffective in a rabbit model of systemic infection. In fact, Fleming later stated “How fortunate we didn’t have these animal tests in the 1940s, for penicillin would probably never have been granted a license, and possibly the whole field of antibiotics might never have been realised. (Kramer & Greek 2018)

While animals have been used in experiments for decades, animal models have not been validated; they have not been tested to see whether they are fit for purpose. And yet, most regulatory testing still requires that new drugs and treatments be tested on animals before they are evaluated for safety and efficacy in clinical trials with humans. On the other hand, any new testing method that does not involve animals has to go through a rigorous validation process.

The vast resources dedicated to animal experimentation have an opportunity cost for humans: new drugs that fail in animals but would benefit humans do not become available. We know that one in ten new drugs that are safe and effective in animals fail in humans. We do not know how many new drugs that would be safe and effective in humans never made it to drug trials in humans. And we do not know how many patients have suffered or died prematurely due to this opportunity cost.

 Even for two individuals within the same species, small differences in DNA can mean the difference between life and death. A tiny difference of one amino acid within the human chromosome is all that separates a patient with life‐threatening sickle cell anemia from those of us who do not suffer from that condition. Dramatic differences can exist across species even without changes in amino acid sequences. Genes are regulated—turned on and off—by other genes. For example, mice and humans share the gene that allows mice to grow a tail. The reasons humans do not normally grow a tail during development is that the gene is never turned on (i.e., expressed). Differences in gene regulation and expression vary within and between species and account for differences in response to drugs and disease. (Kramer & Greek 2018)

Even supporters of the practice point to numerous flaws in animal research. The National Health and Medical Research Council (NHMRC) is the major funder of biomedical research in Australia. In 2017, it published a report  with the title Best practice methodology in the use of animals for scientific purposes. This report includes a long list of flaws in animal research: flaws in the quality of experimental design, flaws in the quality of experimental statistics, flaws in the quality of techniques and procedures, and flaws in reporting (pp. 10-13).

Animal experimentation is cruel, ineffective and a waste of our taxes. It supports an industry that is outdated and needs to change. This change has started, but it is very slow. I have written about this in previous posts, for example here. Unfortunately, Australia is not at the forefront of innovation.

So what can we do to get a move on the end of animal experimentation and replace the use of animals with advanced science? Some ideas: Share your views on outdated animal research with friends and family, politicians and on social media. Make a donation to a charity that works towards ending animal experimentation. Organise a fund-raising event. Don’t buy cosmetics and household products that have been tested on animals.

Thoughts and prayers on World Day for Laboratory Animals on 24 April and during the week are not enough.

UK biotech companies call for more human-relevant research methods to meet patient needs and increase profits

 

Industry leaders say that the key issue is the low predictive power of existing pre-clinical models, with academic research supporting this hypothesis. We will address this by bringing more patient-derived approaches into the mainstream. These include advances in patient derived targets and biomarkers, and more complex models, such as organoids, for discovery and pre-clinical research. These technologies need to be woven throughout the discovery process to place the patient at the heart of the research process.

A new report from the UK has pointed to a productivity crisis in pharmaceutical research: new drugs have a high failure rate, the number of drugs launched per $1bn of research and development spending has fallen nearly thirty-fold over the last 40 years, leaving the pharmaceutical industry return on capital now at only 3.2%.

Let me briefly recap the phases of development that a new drug undergoes. Preclinical research is the stage of research that occurs before the drug is tested on humans. It usually involves in vitro and in vivo tests. In vitro (Latin: in glass) tests are sometimes called test-tube experiments, for example microorganisms in Petri dishes. More recently developed in vitro methods involve omics, such as genomics, proteomics or metabolomics.  In vivo (Latin: within the living) tests are conducted on living organisms or cells. In biomedical research, in vivo methods generally involve animal experiments.

Preclinical research is followed by three stages of clinical trials on humans. Phase I is usually conducted for safety testing. If the drug is found to be safe, it is tested in Phase II to see whether it works as intended. Phases I and II involve small numbers of humans. If the drug is found to be safe and effective, it proceeds to Phase III, where it is tested on a larger number of people and compared to placebo or other treatments for the condition under study. Sometimes there is a fourth phase: after the drug has been marketed, further information is collected on effectiveness of the drug and side effects, or to investigate the effectiveness of the drug for a different condition or in combination with other drugs.

Three pharmaceutical industry groups collected data on clinical development success rates from 2006-2015 and found the following average rates:

probability of success

NDA – New Drug Application to the FDA (US Food and Drug Administration)
BLA – Biologic License Application to the FDA

After in vitro and/or in vivo testing, on average only 9.6% of new drugs achieved approval from the FDA. Cancer drugs had the lowest approval rate (5.1%), haematology drugs the highest (26.1%). A dismal – and very expensive – failure rate.

Back to the UK report. Based on over 100 in-depth interviews with senior executives of UK drug discovery companies and electronic surveys of 250 experts, the authors summarised the problems as follows:

  • Global R&D productivity is under unprecedented pressure
  • The model of medicines R&D must be radically reshaped to meet patient needs
  • A key problem is reliance on using inadequate models for human diseases
  • Commercialising emerging technology will require new models of collaboration
  • Data science is now indispensable to medicines R&D: research data is now generated in such high volumes that the ability to harness it has become a critical factor in developing new medicines
  • It is imperative for the UK to provide industry with straightforward, well-governed access to consented patient data and human tissue samples – this is an acute problem for SMEs*
*SMEs – small and medium-sized enterprises

The authors of the report observed that too much of the preclinical research is patient-free and relies on animal models of disease and toxicology that are a poor approximation of humans. They wrote that drug discovery must be ‘humanised’:

Our interviews and surveys identified many emerging technologies that can ‘humanise’ the drug discovery process. These technologies make the early stages of research more predictive of how a drug will work in real life. They can generate a wealth of humanised in-vitro data, resulting in better drug candidates entering human trials. The benefit is lower attrition and therefore improved research productivity for industry.

… and pointed to new and emerging technologies that don’t involve animal research:

There are many emerging technologies that can make pre-clinical drug development more humanised. Most are derived from human stem cells and the resultant technologies that allow us to create and sustain human tissue in the laboratory. Just 20 years ago, keeping such tissue alive in the lab was a challenge. Now, thanks to pluripotent stem cells, advanced culture methods, microfluidics and precision gene editing we can manipulate the way such tissue grows and differentiates, even down to the substructures of cells and the stratum of the disease which the model reflects. When linked to large human cohorts, we can develop libraries of disease models that reflect the molecular spectrum of human disease, just as the Sanger Centre has done with their library of cancer cell lines. These complex predictive models, when used appropriately, have the potential to be much more discriminating in their ability to weed out the false positives in drug discovery i.e. those compounds that are too toxic, or insufficiently disease modifying.

The report also called for better collaboration between all stakeholders, the sharing of data and better access to consented patient data and human tissue samples.

Data from failed trials and failed pre-clinical projects could be transformative in reducing rework.

Further, a lack of validation efforts was noted. The experts that were interviewed said that ‘many potentially powerful human in vitro models remain in academia. There they have no obvious commercialisation path in the UK, given they often lack IP and so are hard to spin-out.’ Several people pointed out that validation is not a good fit for grant funding.

Many reasons tied up with their careers hold researchers in academic institutions back from leaving animal experiments behind:

It is important to recognise that researchers can be reluctant to invest time and money in implementing a new technique, or to replace an animal model that has served as the basis of their research for many years. … There may be concerns about a lack of historic data comparability, or invalidating past results. Setting up a new model can require additional technical expertise or development of new infrastructure. Referees are familiar with data from the ‘gold standard’ animal models, and may request additional in vivo data to be generated to support in vitro findings. These factors can delay publication in a highly competitive research environment and result in a lack of motivation to change models. (Jackson and Thomas 2017)

Researchers in the pharmaceutical industry are free of some of these constraints. The animal model research paradigm is truly outdated and better, human-relevant methods and technologies are available and are being further developed. This report by Medicines Discovery Catapult and the UK BioIndustry Association is a welcome guide to a future of biomedical research that serves patients, leaves behind cruel and unnecessary animal experiments, and promises a better return on investment for biomedical companies.

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Many thanks to Andrew Tilsley for his permission to use an image of his artwork ‘Cures for Diseases’.

When evidence and vested interests collide

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Source: Flickr/ Etienne

The scientific method is the best approach we have to study and learn about the physical and natural world. When new knowledge is gained and comes to be the best available evidence at the time (until new, more accurate or in some other way better evidence becomes available), one would hope that the new knowledge finds its way quickly into the relevant disciplines, that practitioners take note and incorporate it into their practice, procedures and policies. In the health area, this time lag has been assumed to be 17 years – but we don’t really know, and “further research is needed”, as they often write in research articles.

There are many reasons for the length of the health research translation process. One of these is conflict of interest. A recent article in MJA InSight demonstrates this nicely. The article is titled “Prostate cancer: urologists fight back”.

We have known for some time that – from a population perspective – screening for prostate cancer and the resultant surgical procedures have overall little benefit for men. Two recent studies have now shown that for men with early prostate cancer, prostatectomy (i. e. surgery to remove all or part of the prostate gland) did not result in reduced mortality, but left many with nasty side effects.

Two recent clinical trials, Prostate Testing for Cancer and Treatment (ProtecT) and Prostate Cancer Intervention versus Observation Trial (PIVOT), completely undermine the stratospheric spin associated with prostate cancer being a death sentence. They are unambiguous in their implications.

The bottom line? Men with early stage abnormalities of the prostate who do not undergo surgery or radiation treatment, but whose condition is monitored for any progression of the cancer, live just as long as men who opted for complete removal of the prostate and who now live with its immediate consequences, including incontinence, intimacy issues, bowel problems and intervention regret.

This should be good news for older men. But they may never be told.

The MJA InSight article quotes prominent urologists who appear to have difficulty accepting the new evidence. Instead, they dismiss the two studies as being flawed.

Besides, a radiation oncologist claims that the surgeons are gatekeepers who often don’t refer higher risk patients to radiotherapy, which – she claims – is as effective as surgery:

There’s a massive financial conflict of interest there, because they don’t have a vested interest in referring men on to a radiation oncologist. They lose income if someone chooses a non-invasive intervention. People are reluctant to say it, but that’s the elephant in the room.

But might radiation oncologists have conflicts of interest as well?

Meanwhile, it may be worth pondering the results of a US study, which compared the recommendations of urologists and radiation oncologists for the treatment of localised prostate cancer. Surprise, surprise: for the same cases, the specialists overwhelmingly recommended the treatment that they themselves delivered.

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Source: Flickr/ Patrick Marioné

I argue there are parallels to animal experimentation. Animal researchers have built their careers on experimenting on animals. That’s their area of expertise, that’s the subject of their publications and conference talks, that’s how they make their living. In universities, the pressure to publish or perish is such that researchers rarely have the luxury to take time out for learning new non-animal, human-relevant methods. Operating on mice and using advanced computer-modelling techniques, for example, are quite different skills.

Grants are won on the basis of prior experience, and the peer review system “punishes researchers with innovative projects that may be risky, but could be highly successful”. Doing things differently and taking risks doesn’t pay:

Well established investigators with mature projects produce large amounts of preliminary data for applications. However, younger researchers (who completed their PhD less than 15 years previously) with new research programs or groundbreaking research, struggle to generate similar volumes of data; their teams are smaller and have less funding; they take more risk and this leads to lower success rates in obtaining funding.

Also, it takes a special person to be able to acknowledge after a career in a particular area that much of their work was of limited use. Dr Elias Zerhouni, ex-director of the US National Institutes of Health (NIH) had this to say:

We have moved away from studying human disease in humans,” he lamented. “We all drank the Kool-Aid on that one, me included.” With the ability to knock in or knock out any gene in a mouse—which “can’t sue us,” Zerhouni quipped—researchers have over-relied on animal data. “The problem is that it hasn’t worked, and it’s time we stopped dancing around the problem…We need to refocus and adapt new methodologies for use in humans to understand disease biology in humans.

The pressure to publish for the sake of publishing can lead to dreadful research. Dreadful because of its cruelty in the treatment of animals, and dreadful because it is a great waste of limited resources. This page on the Retraction Watch website critiques one such study.

The evidence for the limited value of animal experimentation is accumulating. Some point the finger at inferior study design in animal research, or more broadly a lack of scientific rigour, compared to studies that involve humans, while others identify species differences as responsible for the poor predictive value of animal models. For further links to studies that highlight why animals are not good models for human medicine, go to this website and search for the keyword “bias” (without the quotation marks).

Why do we let vested interests, financial or otherwise, have such a detrimental influence on the allocation of resources for biomedical research? That might be a topic for another blog post.

 

 

Will you support us?

Are you already a member of Humane Research Australia (HRA)? If so, I invite you to renew your membership. It’s only $30 pa. If you are not a member, would you consider becoming one?

I started this blog 3 ½ years ago. I’m the president of HRA, and while I’ve mentioned HRA in some of my blog posts, I haven’t dedicated a whole post to HRA. So this is what we do and what we want to achieve:

Here in Australia, the use of animals in research is very high for such a small country. Only the USA, Japan and China use more animals. We want to see animal experimentation phased out and replaced by humane and human-relevant methods.

Why do we want this? We can’t be sure that insights gained from experiments with animals will be applicable in humans. Animals are not reliable models for human disease. For example, cancer was cured in mice decades ago, but the results didn’t translate to humans. Sadly, scientists know more about mice than humans. Animal research involves many procedures that would be regarded as animal abuse if carried out on our pets. Even when no painful procedures are carried out, the animals are usually kept captive in artificial environments that do not allow for species-specific behaviours. It is a sad situation, both for the lab animals who suffer stress and pain, and for people who miss out on treatments and cures because the research is not relevant to humans.

Many people still think animal experimentation is a necessary evil. But research articles pointing to the many shortcomings of animal research are accumulating*.

So what does HRA do? Below are some of the activities and achievements over the last 12 months.

Campaigns

The Ban Primate Experiments campaign has highlighted the use of non-human primates in invasive, cruel experiments. The macaques, marmosets and baboons involved in these experiments are bred in three government-funded facilities in Australia. While these sentient animals are genetically and cognitively similar to us, they are sufficiently different for primate experiments to result in research findings of little value to humans.

I and another member of HRA’s committee of management (Dr Eleonora Gullone) were signatories to an open letter asking to stop neuroscience research involving non-human primates. It was signed by 22 scientists, primatologists and animal welfare experts, among them Sir David Attenborough and Dr Jane Goodall.

Following a campaign by People for the Ethical Treatment of Animals (PETA) and HRA, the Royal Australasian College of Surgeons (RACS) announced earlier this year that it will phase out the use of live animals for its Early Management of Severe Trauma (EMST) program by 2018. EMST trains physicians and Australian Defence Force (ADF) medical officers on treating traumatic injuries. To date, the training involves cutting holes into the throats, chests, and limbs of live animals including dogs and pigs. This will be replaced by human-simulation technology.

Earlier this month the Australian Government introduced a bill to ban animal testing of cosmetic products. This is a result of campaigning by animal welfare groups around the country, and including HRA and Humane Society International’s Be Cruelty Free Campaign.

Case studies

It is difficult for the public to find out exactly what experiments are conducted on animals. Universities and other research institutions are reluctant to provide detail. Not all animal research is published in professional journals. When it is published, the articles are often behind a pay wall and written in a way that does not make much sense to the lay person. HRA has summarised some of these studies in plain English.

These scenarios are not only highly unethical; they are unscientific. Data cannot be extrapolated from one species to another with certainty of success.

We need to challenge the researchers and the funding bodies and encourage them to embrace new technologies – non-animal methodologies that are both more humane and scientifically-valid as they relate specifically to human conditions. This is the critical role of HRA. It’s imperative that the community and HRA supporters particularly, are aware of what is happening and what they can do to help stop it.

Over the last year, the Australian media have reported on cruel experiments. Some of these reports have been re-published in other countries. For example, the Sydney Morning Herald reported about cruel greyhound experiments at Monash University and the Alfred Hospital in Melbourne, where the dogs were suffocated and had their hearts removed. Those hearts were then transplanted into other greyhounds who were killed after the procedure.

Animal use statistics

Unlike many other countries, Australia does not have a national collection of animal use data. HRA attempts to make up for this absence of data. The states and territories collect these data, but not all states make them available. HRA collects the available data, publishes them on its website, and provides an estimate of the total number of animals used for research and teaching in Australia. For 2015 this number was close to 10 million animals (this also includes environmental studies where animals were observed rather than experimented on).

Submissions

HRA writes submissions to government bodies, encourages its members and the public to write submissions, and provides background information to assist with submission writing. At present, the proposed Code of Practice for the Keeping of Racing Greyhounds (in Victoria) is open for public comment until 14 August 2017.

This is not all we do. For example, we also lobby the federal government and funding agencies to redirect funding away from animal experimentation and instead provide financial incentives to researchers to develop alternatives to animals. This lobbying takes considerable time and resources. We need your financial support to continue this work, and your assistance to help us to do this is greatly appreciated.

Follow us on Facebook or Twitter , or subscribe to our e-news to learn more about our work.

Here is a video of me (and my best mate Sheba) asking you to support us in the important work we do to end cruel and unnecessary animal experiments. If you have a look at the video, you’ll see that we don’t waste money on media production. It was done in-house, in the HRA office, with our multi-talented CEO Helen Marston directing, filming and editing.

Unlike many other charities, HRA does not have DGR (Deductible Gift Recipient) status – because our work is not classified as public benevolent, and does not involve “hands on” care of animals. This means that we do not qualify for many philanthropic grants that are available and which many charities depend on for their continued work. It also means that we are unable to take advantage of various other schemes such as workplace giving as these also require DGR status.

Furthermore, we do not receive ANY government funding. We are therefore solely reliant on memberships and donations to fund the important work that we undertake towards ending cruel and unnecessary animal experiments.

Thank you for reading this, and I’m more than happy to respond to any questions and/or suggestions.

* On the HRA website, we have dedicated a page to links to academic papers, conference proceedings and government reports that show animals as bad models for human medicines and treatments. Search for “bias” (without the quotation marks) on this web page.

 

Australia’s new cosmetics testing bill – a welcome move

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Source: Flickr/ Lynette Olanos

During the 2016 election campaign, the Australian Government committed to introduce a ban on animal testing of cosmetic products. The Industrial Chemicals Bill 2017 has been introduced in the House of Representatives on 1 June 2017 to implement this commitment. The following sections of the bill refer to animal testing:

103 Ban on animal test data for determining category for cosmetics

(1) Without limiting paragraph 102(1)(b), if an industrial chemical is to be introduced     for an end use solely in cosmetics, rules made for the purposes of that paragraph may include the requirement mentioned in subsection (2).

(2) The requirement is that, when determining the category of introduction for such an industrial chemical, a person must not use animal test data obtained from tests conducted on or after 1 July 2018 in circumstances prescribed by the rules.

168   Ban on animal test data for applications for cosmetics

(1) Without limiting subsection 167(1), if an industrial chemical is to be introduced for an end use solely in cosmetics, an application under this Act relating to the introduction must meet the requirement in subsection (2).

(2) The requirement is that the application must not include animal test data obtained from tests conducted on or after 1 July 2018 in circumstances prescribed by the rules for the purposes of this subsection.

Government legislation to support the end of cosmetic animal testing and trade in Australia is very welcome. However, the draft legislation offers a loophole which would allow newly animal tested cosmetic ingredients to be introduced to the Australian market after the bill becomes law. This would fail to meet the Coalition’s election promise and the expectations of the Australian public to fully end cosmetics testing in Australia.

The loophole rests on the word solely. Only new animal test data used in introductions which are solely for cosmetics use would be prohibited. If the new chemical ingredient would also be used for other purposes, for example in cleaning products, animal testing would still be allowed.

A joint statement by #BeCrueltyFree Australia and Humane Research Australia observes:

This is very welcome progress; however, as not all substances are used exclusively as cosmetic ingredients, some cosmetic ingredients will still be able to be newly animal tested and introduced into Australia under the current proposed language. This is an important departure from existing bans in the European Union, Norway, Switzerland, Israel, and India, which have all banned the use of newly animal-tested ingredients when introducing or marketing cosmetics.

How many of the new chemicals might be used for multiple purposes? A 2013 report by the European Commission stated that:

… large cosmetics manufacturers estimated that, on average, around 10% or less of the new ingredients used by large cosmetics manufacturers were new to market (i.e. have not previously been used in other product sectors).

Dropping the word solely from the bill might fix this loophole. It would ensure that the ban applies to all cosmetics ingredients, and the use of chemicals for non-cosmetic purposes would not be impacted by the ban.

What would happen if a chemical not previously used in cosmetics has been tested in animals and a human health risk has been assumed? Obviously, such a chemical would not be introduced for use in cosmetics, irrespective of the ban (this case would represent disqualifying a chemical for use in cosmetics, rather than introducing one).

On the whole, while this bill does not change much for companies that manufacture cosmetics, it sends a message that Australia does not support cruel and unnecessary testing on animals – if for cosmetics only.

The bill will not have much impact on the number of animals used in animal experiments in Australia, as – to my knowledge – no cosmetics testing on animals has taken place here for some time. But is it a first step towards phasing out animal experimentation for other purposes, too?

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Source: Flickr/ Melody

 

Other countries have made much more progress in this regard. For example, the Parliament of the Netherlands in 2016 passed a motion to phase out all research on non-human primates, and by 2025 the Netherlands aims to become a world leader in animal-free science. The Netherlands National Committee for the Protection of Animals Used for Scientific Purposes (NCad) has provided a schedule for phasing out animal procedures.

In the EU, the Directive 2010/63/EU on the protection of animals used for scientific purposes requires national governments to assist in the advancement of alternative methods to animal testing and to promote the use of non-animal methods.

Unlike Australia, the European Union keeps track of progress made in developing and using alternatives to animal testing. The European Chemicals Agency has just published its third report on “The use of alternatives to testing on animals for the REACH Regulation”. It looks promising:

Registrants use existing information and alternatives to animal testing. Altogether, 6290 substances were analysed for the report. Out of these, 89 % have at least one data endpoint where an alternative was used instead of a study on animals.

The most common alternative method was using information on similar substances (read-across), used in 63 % of the analysed substances, followed by combining information from different sources (weight of evidence, 43 %) and computer modelling (QSAR prediction, 34 %).

In the US, the Federal Accountability in Chemical Testing (FACT) Act was introduced in Congress earlier this year:

The FACT Act would improve reporting by EPA, FDA, NIH, USDA and other government agencies about their efforts to replace inefficient, multi-million-dollar animal tests with faster, less costly and more effective alternative methods for assessing the safety of chemicals, drugs, foods, cosmetics and other substances.

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Source: Flickr/ pumpkincat210

 

However, it’s anyone’s guess if or when this bill might become law, given that the U.S. Department of Agriculture has removed public access to tens of thousands of reports relevant to animal welfare.

Banning cosmetics testing on animals in Australia has been long overdue and is a welcome contribution towards the global move away from animal experimentation more broadly.

 

 

PS – On 6/06/2017 the Humane Cosmetics Act was introduced in the U.S. House of Representatives. See this press release.

The Animal Model Market

Animals are used as “models” for studying human biology and diseases, to test drugs and vaccines. Most of these animals are specifically bred for research purposes, although they are also obtained from other sources. For example, in Australia “surplus” dogs from the greyhound racing industry have ended up in research labs.

Although animals have proven poor models for human disease research, and only around 5% of drugs that are safe and effective in animals are suitable for humans, the animal model market is a big industry. Mice and rats (murine models) are the most commonly used animals in research labs. Other animals bred for research purposes include, for example, monkeys, pigs, dogs, cats, and rabbits. The main applications include physiology, toxicology, cancer research, neurological research, biomedical research, genetic research, and xenotransplantation.

The Animal Model Market does not only include the breeding and sale of animals; the animals also need cages, feed, bedding, and other care products.

The end users in this market are pharmaceutical companies, research institutes, contract research organisations, and educational institutes.

Different types of mice and rats are for sale. For example:

  • inbred mice, genetically engineered mice, conditioned/surgically modified mice, hybrid/congenic mice, outbred mice, spontaneous mutant mice
  • knockout, outbred, inbred, hybrid, immunodeficient, conditioned rats.

Adelaide University’s Laboratory Animal Services provide a price list “for inbred, outbred and hybrid rodents for internal clients and external clients”. Prices range from $3.24 for outbred new born mice under 6 days to $80.80 for a time mated Hybrid F1 mouse.

The following is a collection of quotes (grammatical errors included) from websites that provide/sell information about the Animal Model Market.

Animal model market: Market wise overview

Animal models are emerging globally and there is a growing trend in the usage of animal models in drug discovery. Rapid advancement in the novel technology made the animal models constructive and easy. The market witness high competitiveness and high capital investment with animal models. Even though high cost of animal model research it never hampers the growth. The high incidence rate of diseases and adverse effects of the drugs drives the market towards animal models to ensure the safety of the humans. Other factors the contributing the growth of the animal model includes government involvement in research and research institutes for development of standard protocols for animal models.

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Obese diabetic mouse. Source: Flickr/Mycroyance

Mice

Mice Model Market is poised to reach USD 1.59 Billion by 2021 with 7.5% CAGR during the forecast period of 2016-2021.

In 2016, North America is expected to account for the largest share of the market, followed by Europe, Asia-Pacific, and the Rest of the World (RoW). North America’s large share is attributed to the rising demands for monoclonal antibody production, continued and responsible use of animals ensured by animal care organizations, rising preclinical activities by CROs and pharmaceutical companies, growing stem cell research in Canada, and government support for the development of protein drugs in Canada.

CAGR = compound annual growth rate

The mice model market is projected to reach USD 1.59 Billion by 2021 from USD 1.11 Billion in 2016, at a CAGR of 7.5% in the next five years (2016 to 2021). The growth of the market can be attributed to ongoing innovations in mice models, continuous support in the form of investments and grants, and growing demand for humanized mice models. In the coming years, the mice models market is expected to witness the highest growth rate in the Asia-Pacific region. The high growth in the region can be attributed to less stringent regulations on the use of animal models for research in the region, international alliances for R&D activities in China, growth in regenerative medicine, biomedical, and medical research in Japan, growing presence of global players, development of bioclusters to boost the biotechnology industry in India, ongoing biomedical research activities in Australia, and rising pharmaceutical & biotechnology R&D activities.

Mice Model Market Drivers:

  • Ongoing innovations in mice models
  • Mice models for immune diseases
  • Mice models for cancer
  • Mice models for rare diseases
  • Growing consumption of personalized medicine driving the demand for humanized mice models
  • Continuous support in the form of grants and investments
  • Growing number of pharmaceutical R&D activities
  • Increasing focus of associations on the development of embryonic stem cells as well as knockout and mutant mice
  • International Mouse Phenotyping Consortium (IMPC)
  • International Knockout Mouse Consortium (IKMC)

Mice Model Market Restraints:

  • Growing use of rat models
  • Increased benefits from cryopreservation
  • Regulations and laws for ethical use of animals in research
  • The Animal Welfare Act
  • Public Health Service Policy on Humane Care and Use of Laboratory Animals

Mice Model Market Challenge:

  • Development of alternative methods to animal testing
  • Advancements in zebrafish model development
  • Growing need for improved mice models

Stakeholders of the Mice Model Market 

  • Mice models and services companies
  • Mice model and services distributors
  • Animal care products manufacturers and suppliers
  • Out–licensing life sciences companies (Pharmaceutical/Biopharmaceutical/Biotechnology)
  • In–licensing life sciences companies (Pharmaceutical/Biopharmaceutical/Biotechnology)
  • Clinical research organizations (CROs)
  • Academic institutes
  • Government and private research institutes
  • Medical research centers
  • Public and private animal health agencies
  • Animal care associations
  • Business consultancies
  • Venture capitalists

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Rats

The global rat model market size was valued at USD 412.3 million in 2016 and is expected to grow at a CAGR of 8.3% over the forecast period. Growing development of new medical devices and biotechnological products is anticipated to support growth of the market.

The rising incidence of chronic conditions, introduction of new infectious strains, and growing healthcare economic burden over matured regions such as North America are expected to boost the research activities within the area.

On the contrary, possibility of research at reduced cost in countries such as Japan, India, Thailand, and Singapore is anticipated to promote growth of the rat model industry within the Asia Pacific region. The region is expected to hold over 10.0% of the share by 2025.

 

The Animal Model Market is an industry of substantial size with many stakeholders. Continuation and market expansion is in their interest. Can we expect stakeholders in this market to acknowledge the limitations of animal research, phase out animal experiments and use more human-relevant models?

It is difficult to get a man to understand something, when his salary depends upon his not understanding it!