Pioneering non-beating heart transplant success – thanks to animal research!

Yesterday a team led by Consultant Surgeon Stephen Large at Papworth Hospital near Cambridge in the UK announced the successful transplant of a non-beating donor heart to heart failure patient Huseyin Ulucan, the first time such an operation has been performed in Europe.

Current practice is for donor hearts are obtained when the donor has been declared brain dead, but their heart is still beating, and the heart is then cooled and transferred to the recipient.  The technique used in Mr Ulucan’s operation involves re-starting the heart in the donor five minutes after death and perfusing it and other vital organs with blood and nutrients at body temperature using the Transmedics Organ Care System (OCS). In this case the donor heart was kept nourished and beating for three hours before being transplanted into Mr Ulucan. The main importance of the technique it that it has the potential to substantially increase the  number of donor hearts available for transplant, though it also enables the surgical team to assess the health of the donor heart more thoroughly.

Transmedics_OCS

The Transmedics Organ Care System.

 

The technique they used was developed by Cardiothoracic Transplant Registrar Simon Messer, who developed it with Consultant Surgeon Ayyaz Ali, and commented:

Using techniques developed to recover the abdominal organs in non-heart beating donors, we wanted to apply similar techniques to hearts from these donors.

“Until this point we were only able to transplant organs from DBD (Donation After Brain-stem Death) donors. However, research conducted at Papworth allowed us to develop a new technique not used anywhere else in the world to ensure the best possible outcome for our patients using hearts from non-heart beating donors.”

This approach, known as normothermic donor heart perfusion, is an example of a technique that is showing great promise in surgery, in 2013 we discussed how the normothermic transplantation technique using the OrganOx system – developed through research in pigs – had been used successfully in a liver transplant operation, and large scale clinical trials are now underway.

In a review entitled “Normothermic donor heart perfusion: current clinical experience and the future” published in 2014 (1) Simon Messer and colleagues highlights the role of research in animals including dogs, pigs and monkeys in demonstrating that Donation After Cardiac Death (DCD) heart transplantation is possible, and that normothermic donor heart perfusion improves the success rate.

DCD heart transplantation has been shown to be possible in animal models [32-34] and in humans [35, 36] provided that the warm ischaemic time could be kept below 30 min. However, we suspect that the only safe way to adopt DCD heart transplantation into routine clinical practice is by ex vivo functional and metabolic assessment following appropriate reconditioning. Normothermic blood perfusion has been shown to be superior to cold storage in preserving DCD hearts in dogs [37]. In the pig, reconditioned DCD hearts were shown to have comparable function to BSD donor hearts [38]. In an asphyxiation pig model, DCD hearts exposed to 30 min of warm ischaemia were evaluated on the OCS using lactate assessment. Four of seven transplanted DCD hearts were subsequently weaned off cardiopulmonary bypass on low dose inotrope [39].”

In a key paper published in 2013 (2) – reference 38 above – an Australian team assessed whether the Transmedics OCS system could be used to successfully transplant non-beating hearts in pigs, concluding that:

The Transmedics OCS provides an excellent platform to assess DCD heart recovery following warm ischemia. Using a clinically applicable model, we have shown that DCD hearts with WIT ≤30 mins appear to be a viable source of additional organs in cardiac transplantation and warrant human studies.”

Pigs are a excellent species for many transplant research studies. Image courtesy of Understanding Animal Research.

Pigs are a excellent species for many transplant research studies. Image courtesy of Understanding Animal Research.

Results such as this led to Simon Messer and colleagues concluding in their 2014 review (1) that:

It is estimated that use of DCD hearts may increase the number of heart transplants by 11–15% [40]. We believe that functional assessment during ex situ normothermic donor heart perfusion must be made prior to transplantation in this setting. In Papworth Hospital, we are currently investigating whether DCD human hearts can be assessed on the OCS using pressure volume loop measurements.

In conclusion, cold ischaemic preservation for the donor heart has been universally adopted into clinical practice over the last 45 years. However, the diminishing pool of ideal donors coupled with the drive to further improve heart transplant outcomes mandate a rethink in this area. Normothermic donor heart perfusion is the logical next step and from the clinical experience to date, appears to hold promise.”

We congratulate Stephen Large, Simon Messer, Ayyaz Ali and colleagues at Papworth Hospital for taking this next important step successfully, and we wish Huseyin Ulucan a full recovery and long life.

Yesterday’s announcement was a reminder that more than 50 years after Norman Shumway’s pioneering heart transplants studies in dogs, animal research remains crucial to progress in this important field of medicine.

Paul Browne

1) Messer S1, Ardehali A, Tsui S.”Normothermic donor heart perfusion: current clinical experience and the future.” Transpl Int. 2014 May 23. doi: 10.1111/tri.12361. PubMed:24853906

2) Ali AA, White P, Xiang B, et al. “Hearts from DCD donors display acceptable biventricular function after heart transplantation in pigs.” Am J Transplant 2011; 11: 1621. Link

 

UK Charities Explaining Animal Research

Following from our previous post on US charities explaining their animal research, we will now take a look at UK charities using the same criteria. Of the UK top 200 charities (by income in 2012), only six conduct animal research.

The first thing to note is that all six organisations are members of the Association of Medical Research Charities (AMRC) – an umbrella organisation which demands that its members endorse a statement on the role of animals in research, a portion of which can be read below:

The public supports medical research charities to find new treatments and cures for debilitating and life threatening conditions. All AMRC charities have strategies for how they will fund high quality research to better understand disease and so improve health and wellbeing.
[…]
Whilst not all our members are currently funding research using animals as part of their strategy, they all support the principle of using animals in research when it is necessary to advance understanding of serious health conditions to develop better treatments and there is no alternative that can be used to find out the same information without using animals.

Secondly, all six organisations have signed the Concordat on Openness on Animals in Research in the UK which, among other things, demands signatories will:

Commitment 1: We will be clear about when, how and why we use animals in research

Commitment 2: We will enhance our communications with the media and the public about our research using animals

Ratings Criteria:

The ratings criteria are the same as that used to look at the US charities. To me, the most important thing is that information exists if people need it. Preferably people need to be able to find this information online rather than have to call up for it. Each of the following five criteria will give a charity one star.

  • There is a statement available
  • It provides a good overall explanation of why they fund animal research
  • It is available on their website
  • It provides an explanation on how they determine when to fund animal research
  • Does the website make any mention of the use of animals, for example, in the summaries of research they fund

Cancer Research UK

Five out of Five stars 5/5The main policy page on “The use of animals in cancer research” is disappointing, with only a short statement:

A great deal of cancer research is carried out without using animals. In certain areas, however, animal research remains essential if we are to understand, prevent and cure cancer. Cancer Research UK only uses animals when there is no alternative.

Cancer patients and their families are at the heart of everything we do. We believe that all our research is vital if we are to save the lives of more patients in the future.

However, CRUK also have an easily googleable blog post on the issue which they often provide to those wanting more information. This blog post is fantastic, it begins:

More people are surviving cancer than ever before.

Thanks to decades of research, survival from cancer has doubled in the last 40 years, giving thousands of people more time with their loved ones. In fact, more than half of all patients will now survive for at least ten years.

But this progress simply wouldn’t have been possible without animal research.

At Cancer Research UK, research using animals is part of our efforts to beat cancer. This includes discovering the faulty genes and molecules that cause cancer, investigating how the disease grows and spreads, developing and testing new treatment and tests, and exploring how our immune system can help fight tumours.

The 2,500+ word post, written by the Director of Science Funding, explains why animal research is important, its past contributions, and the reasons and conditions under which animal research projects may be funded. The main pity is that this blog post isn’t linked to from the policy statement, or better yet the information from the blog post put onto the policy statement page.

CRUK also mention animals (usually mice) in research news stories, such as a recent piece that found the activity levels of particular genes in breast tumours could identify more aggressive forms of the disease. This story was mainly about clinical studies, but mentioned early findings in mice that led them there.

Cancer Research UK – 5/5 stars

The Wellcome Trust

Five out of Five stars 5/5
The Wellcome Trust provides an easy-to-find, lengthy statement regarding why they both conduct and fund animal research. Here is a portion.

The use of animals in research has enabled major advances in the understanding of biology and led to the development of nearly every type of drug, treatment or surgical procedure in contemporary medical and veterinary practice. Some of the best-known examples include:

  • antibiotics such as penicillin and streptomycin
  • vaccines for polio, meningitis, distemper, foot and mouth
  • treatments for conditions such as cystic fibrosis and asthma
  • drugs to treat mental diseases like depression
  • organ transplants and blood transfusions
  • the use of insulin for diabetes
  • and contraception for use by people and in controlling animal breeding.

The Wellcome Trust is therefore convinced that the use of animals in research remains valid where the potential benefits to be gained by humans and other animals from such research outweighs the use of animals in that research.

The subheadings in the statement show the breadth of the statement:

  • Why animals are used in medical research
  • How many animals are used?
  • Research involving animals is licenced by the Home Office
  • Research must be approved as ethical
  • Wellcome Trust-funded research involving animals
  • The 3Rs – replacement, reduction and refinement
  • Alternatives to animals in medical research

Wellcome news articles and other communications regularly mention the use of animals. For example their recent letter to the UK House of Lords regarding mitochondrial donation mentions the role of mice and monkeys in the development and testing of this new method.

The Wellcome Trust – 5/5 stars

British Heart Foundation

Five out of Five stars 5/5BHF finish the list of British charities in equal form. They provide an extensive statement about their use of animals providing links to other organisations and to their fantastic leaflet on the issue. Here is a portion of the statement:

BHF's leaflet on animal research

BHF’s leaflet on animal research

By studying new medicines and techniques in human cells in the lab first, and carefully trialling the best ones in animals, we’ve done all we can to make sure they’re going to be effective and safe for treating patients.

Researchers are studying how the heart develops in mice and fish to better understand what can go wrong to cause babies to be born with heart defect

Potential new heart medicines that work on human cells in the dish must be assessed in a living system before trials in patients can be carried out

Animal studies can reveal potential problems with new treatments allowing dangerous side effects to be spotted before clinical trials

The research community is constantly developing new techniques to help reduce the number of animals needed or non-animal models. Scientists we fund carry out as much of their research as possible on human volunteers, cells, or computer models for example.

However, completely replacing all animals in research is not yet possible. There is no alternative method that can reproduce the complicated working of our hearts and circulatory systems.

Similarly their news article and other pages on the website will frequently mention the use of animals like rats, mice and zebrafish. British Heart Foundation should also be congratulated for going front and centre with their animal research when they put out a TV advert mentioning their research on zebrafish.

British Heart Foundation – 5/5 stars

Arthritis Research UK

Four out of five stars 4/5Arthritis Research UK are signed up to the AMRC statement, and link to it, but also provide their own perspective. Here is an extract:

Medical research using animals has made a vital contribution to advances in medicine and surgery which have brought major improvements to the health of people. Research using animals will continue to be essential to tackle many of the unsolved problems in understanding and treating musculoskeletal conditions.

The UK has one of the most rigorous systems in the world for regulating animal research. The UK requires permissions from both central Government and local ethical reviews to conduct research involving animals. As part of this approval process, each medical research project using animals must be examined and ways to improve adoption of the 3Rs are considered

The whole statement covers regulation and the 3Rs, to explain when animal research can happen, but I’m not convinced they made the strongest case for why animal research is necessary. An example treatment made possible by animal studies would have really strengthened the statement.

Arthritis Research UK regularly mention animal research in their news posts, such as a recent cell-based approach to regenerate bone and cartilage developed in mice.

Arthritis Research UK – 4/5 stars

Parkinson’s UK

Five out of Five stars 5/5Parkinson’s UK provides a long statement online which includes a strong explanation of why animal research is necessary, past medical breakthroughs made possible thanks to animal studies, quote from a patient, examples of grants, an explanation of the Concordat on Openness on Animal Research and more. Here is an extract:

We believe there is an urgent need for ongoing research to advance our understanding of Parkinson’s, improve treatments and ultimately find a cure. We believe theuse of animals, such as fruit flies and fish, is currently an essential tool in this research, but we are committed to the minimum possible use of animals and to ensuring that highest regulatory standards are maintained.
[…]
Since the 1970s, the lives of millions of people with Parkinson’s around the world has been transformed by the drug levodopa, This acts to partially replace the dopamine that is no longer produced in the brain due the eh death of nerve cells. Research involving animals has formed an essential step in the understanding of the effect of this vital drug.

Parkinson’s UK provide a quarterly publication, which is littered with examples and mentions of animal studies. The most recent issue’s first news story mentions rats, as well as having a letter about the use of animals in research. Parkinson’s are also willing to engage in the news, we have in the past mentioned Parkinson’s UK’s strong letter to a local newspaper responding to activist claims

Parkinson’s UK – 5/5 stars

Leukaemia & Lymphoma Research

Five out of Five stars 5/5Leukaemia & Lymphoma Research have a strong statement and an FAQ on the issue of animal research. Both are easily googleable, and includes details of what animal species are used and what proportion of research projects involve animals (29%).

Some of the biggest achievements in treating blood cancer that are now in routine clinical practice, such as stem cell transplantation, have only been made possible through the use of animals in research.

The achievements of understanding blood cancer progression, understanding the basis for chemotherapy, and identifying the principles of bone marrow transplantation are just some of the revolutionary and lifesaving developments in blood cancer treatment that would not have been possible without using animals.

Whilst there is a considerable amount of research that we support that does not require the use of animals, we believe that animal research is still necessary.  Understanding how disease affects systems within the body, as well as possible treatments, requires investigation in whole body systems. Our animal research mostly uses mice, but we also use other animals like fruit flies and zebra fish.

While the LLR website doesn’t put a lot of news in its research section, when it does it includes mention of the animals. A story about studying genes of patients with blood disorders mentions that cells from mice are also used to study how misfiring enzymes can lead to histone changes.

Leukaemia & Lymphoma Research – 5/5 stars

Summary of Results:

UK Charities doing Animal Research and Animal Testing

Fantastic results from the six biggest UK medical research charities, though they are far from being the only British charities who talk about their funding of animals. You can see some of these and other charities’ statements below:

When comparing the UK and US charities we see some stark differences. All the UK charities we looked at have a statement available on their website (and googleable). All make an effort to explain how and why animals are used in research. In contrast, most of the US charities do not have a statement available online, though many do mention the use of animals in news articles on the website.

So what can the US charities learn from the British cousins? Well many US charities have prepared statements on the use of animals in research; they just need to get them online. If every charity which had a statement put them online they would raise the average score of American charities from 2.4 out of 5, to 3 out of 5. Many of the American charities could also work to improve their statements – there is good practice both sides of the Atlantic, and they could either take examples from other US charities like the American Cancer Society (see previous post) and Alzheimer’s Association, or they could look to their British equivalents.

But why is it important that charities be open about their animal research? As we discussed in more detail in the previous post there are three main reasons:

They are taking public donations, and the public have a right to know how this money is spent. If charities think funding animal research is important they should be able to explain why frankly and openly.

Charities cannot hide their animal research – animal rights groups can find out even if it is not on their website. However, by putting information openly on their website the charity defends itself against activist attempts to “out” them. The public cannot be “shocked” by the “dirty little secret” that a charity funds animal studies if they have that fact stated openly and clearly on their website (with an explanation as to why). It is better for a charity to state it does animal research and explain the reasons why, than it is to let an activist or journalist put their own spin on it.

Finally, we must foster an environment where both the public, and policy makers, understand the importance of animal research. The former demands the laws and regulations, and the latter put them in place. If the scientific community want to make sure their research environment is secure then they must encourage openness on the issue.

For those charities wanting to improve the way they discuss animal research with the public, there is a fantastic booklet jointly produced by the Association of Medical Research Charities and Understanding Animal Research which provides guidance and support. It covers how a charity can be prepared for questions about its animal research, how to answer those questions (be them by phone, social media, or in person), and finally looks into ways in which charities can find opportunities to be more proactive in their explanation of why they fund or conduct animal studies. The introduction states:

This guide is designed to help medical research charities answer questions from the public about the use of animals in research. Charities have contact with their supporters and the public in many different ways. They need to be able to explain how they are investing donations effectively and be equipped to answer any questions

Hopefully next time we conduct this analysis we will see even higher scores for charities across the world.

Speaking of Research

US Charities Explaining Animal Research

In June 2012 we reviewed five large American health charities which conducted animal research to see how well they communicated this use. The results were not encouraging: three charities got 0/4 stars for their animal research statements, and two charities for 1/4. So has anything changed?

In this post I will look at those charities conducting or funding animal experiments in the US who are on Forbes’ list of top 50 charities (2014). There were nine charities I found that fit the bill:

Ratings Criteria:

I believe the most important thing is that information exists if people need it. It is one reason why we created a searchable list of organisations with a statement on why they conduct or fund animal research. Preferably people need to be able to find this information online rather than have to call up for it. Each of the following five criteria will give a charity one star.

  • There is a statement available
  • It provides a good overall explanation of why they fund animal research
  • It is available on their website
  • It provides an explanation on how they determine when to fund animal research
  • Does the website make any mention of the use of animals, for example, in the summaries of research they fund

American Cancer Society

Four out of five stars 4/5There is no information available on the website but by using their webchat I was given the following statement:

The American Cancer Society advocates the use of non-animal systems in research whenever possible; however, there are times when scientific research using animals remains essential for developing treatments and cures for people with cancer.  When that is the case, the American Cancer Society insists that such research complies with the highest ethical standards to protect the health and welfare of animal subjects.

After talking a little longer I was also provided with the following:

The American Cancer Society supports animal research when:

  • The use of animals is appropriate, and no non-animal alternatives exist.
  • Animals are only used when the answers to scientific questions cannot be obtained in any other way.
  • Computer models do not adequately present how individual molecules, cells, or tissues of the body work when healthy or when disease strikes.
  • The researchers guarantee the highest ethical and compassionate standards to protect the health and welfare of animal subjects and comply with federal and institutional guidelines.

Animal research is important to the American Cancer Society because:

  • New cancer drugs must be tested on living systems.
  • Proper doses and possible side effects in human bodies must be identified and evaluated.
  • Research with animals has led to significant advances in medicine, including the discovery of insulin injections for treating diabetes.
  • Research with animal models has produced successful cancer treatments for childhood leukemia.
  • Animal research is crucial for understanding many causes of cancer.

For future research, the American Cancer Society believes:

  • Test tube experiments are often effective in early phases of research.
  • The continued use of stem cell and organ tissue cultures offer hope for non-animal research.
  • The continued use of computer models offers hope for future studies.
  • It shall serve both humans and animals in diseases and prevention.
  • The Society will show continued support of stringent guidelines and regulations for the well-being of all animal subjects.

In all truth this is a fairly good response – it explains when and why they conduct animal experiments. If only they put this up on their website *sigh*.  The research news section of the website does mention the animal models used, for example a recent ACS-funded researcher used mice to assess the best timing for taking anti-cancer drugs – which it turns out is immediately after traditional chemotherapy.

American Cancer Society – 4/5 stars

St. Jude Children’s Research Hospital

Three out of five stars 3/5St Jude does not have any position or policy statement on their website. When I phoned them up the operator wasn’t sure if they conducted research on animals. They passed me to someone else who also didn’t know, and then passed to someone who wasn’t there. After emailing them I did receive a reply:

As a research institution, St. Jude has a unique mission to generate the knowledge that will save the lives of children stricken with cancer and other catastrophic diseases. In the course of our research to find cures for these deadly diseases, we do use laboratory animal models, mostly rats and mice bred specifically for that purpose.

There is no substitute for animal testing when evaluating the effects of diseases and proposed treatments to fight those diseases. Most biological systems do not behave in a predictable manner and cannot be replicated by computer simulations. St. Jude is usually legally required, and always ethically obligated, to test treatments on laboratory models to ensure safety and efficacy before those treatments are studied in children. Without this research, St. Jude would not be able to provide hope for cures to our patients and their families.

Please be assured that St. Jude does not conduct useless laboratory research. We are very careful to abide by the laws, statutes, and ethical guidelines for animal research. Our procedures comply with the government’s Animal Welfare Act, and we are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International to ensure the best care for the animals used in our research. Our labs are inspected regularly by the Department of Agriculture.

So there is a statement that attempts to explain when animals are used. Get it up on the website and relate it to many neonatal and pediatric treatments than exist thanks to animal studies. There are already many mentions of animals used by St. Jude researchers in the medicine and science news section of the website, such as using specially bred mice to identify a potential target for drugs to combat leishmaniasis.

St. Jude Children’s Research Hospital – 3/5 stars

American Heart Association

Two out of five stars 2/5Despite searching their website I was unable to find a position statement (through the menus or the search bar) on their animal research, however after phoning them up I was guided to a page with position statements on animal research, cloning, gene therapy and stem cell research. The statement is good, but could certainly be expanded to provide more information on animal research.

The American Heart Association supports using animals in biomedical research — because it helps us improve heart health and save lives. In fact, the decline in U.S. death rates from heart disease and stroke since the 1960s is due in part to discoveries from research using animals.

So, when animals are needed for experiments we fund, researchers must handle them responsibly and humanely.

  • Before receiving our funding, we require researchers to show that:
  • They have considered alternative methods to using animals.
  • Their research can’t be successfully done without using animals.
  • Their experiments are designed to produce needed results and information.

So there is a statement, thought its explanation for animal research is a little week. It is online, though not that easy to find.

While a search for “mice” does come up with some search results, most link to the names of scientific papers or presentations rather than explaining the use of animal models in research.

American Heart Association – 2/5 stars

Memorial Sloan Kettering Cancer Center

One out of five stars 1/5There was no information available on their website – something which was confirmed over the phone. The operator seemed very nervous about giving me information, asking repeatedly what I wanted the information for.

A second phone call to the public affairs department didn’t get me any closer. Despite repeatedly being put on hold no one seemed to have any idea about their position on animal research. No statement at all!

This is made more frustrating when you know that there are many mentions of animal research in their Recent Discoveries & Advances section, such as developing a rat model to “study the neurological side effects of radiation to the brain”.

Memorial Sloan Ketering Cancer Center – 1/5 stars

Mayo Clinic

One out of five stars 1/5Nothing on the website. After a phone call I received the following by email:

Mayo Clinic believes in the vital role that animals have in advancing medical knowledge and developing new treatment options. Researchers would not have discovered new ways to treat heart disease, found cures for childhood cancers or advanced knowledge in many neurodegenerative diseases such as Parkinson’s without animals as part of the research process. Animals used to help advance science are treated with the utmost respect and care and in accordance with Mayo’s Institutional Animal Care and Use Committee. Mayo Clinic adheres to or exceeds all federal and state laws and regulations regarding animal use in research and makes every effort to ensure the safety and well being of animals. Mayo uses animals in research only when necessary and always with the goal of providing improved treatment or therapies for patients.

A short statement that didn’t quite say enough to gain stars for why and when its research is done. Better than nothing though.

While searches for “mice”, “rat” and “dog” on the Mayo Clinic website did bring up search results, few of them appeared to give pages meant for public consumption.

Mayo Clinic – 1/5 stars

Leukemia and Lymphoma Society

Three out of five stars 3/5Unfortunately the Leukemia and Lymphoma society does not have a statement on their website. After chatting with someone in their communications department I was sent the following statement:

Our work depends on broad and open-ended scientific inquiry. In this context, LLS supports the appropriate use of animals in conducting research to find potential cures for blood cancer patients.

Much of what we know about the diagnosis and treatment of diseases that afflict humans, including cancers and specifically the blood cancers, is the result of scientific studies conducted in animals. Moreover, lymphoma and leukemia are major killers of domestic and companion animals, and so there are potential benefits not only for humans but also for animals when research yields successful new cancer therapies and vaccines.

LLS requires that research using animals must adhere to federal and state laws, and follow the guidelines put forth by the NIH Office of Laboratory Animal Welfare. Research supported at foreign institutions must also abide by NIH’s policy on animal use. All researchers receiving LLS funding work with their institutional animal care and use committee to review and approve any protocol related to animal use. The purpose of these committees is to ensure that research strictly adheres to all federal and state guidelines regarding the care and use of animals.

We recognize the importance of the development and use of non-animal alternatives such as cell lines and cell cultures, computer simulations and mathematical modeling, and encourage their use when scientifically sound; i.e. accurately representing cancers in patients. However, in many instances the humane and appropriate use of living animals is both critical and ethically valid.

The absence of a suitable non-animal alternative and the explicit justification to use a given species and number of animals are required to qualify an applicant for any research support from LLS, as is the explicit documentation of steps taken to eliminate or minimize any potentially painful procedure. These humane considerations must be developed with the assistance and under the supervision of a qualified veterinarian and fully approved by an applicant’s research institution.

This is a strong statement and it is a pity, like many other charities, that they do not choose to put this up on their website for the public or media to find. It explains why they use animals and the conditions under which animal research is done. It also discusses why alternatives cannot replace all animal studies. Good statement, but they need to get it on their website.

There appeared to be no mentions of animal models in the news releases (or anywhere else) on the website.

Leukemia and Lymphoma Society – 3/5 stars

Dana-Farber Cancer Institute

One out of five stars 1/5The DFCI did not have any information on their website. When I phoned up they confirmed that they conducted such research but had no statement available on their website. When I asked where I could get more information they replied that they “try to stay away from making any public statements on the matter”. Concerning.

This “no comment” approach seemed to contradict a more open attitude to mentioning the use of animal models in their research news. When I checked, one of the top stories in their “Featured Research” was an article entitled “Mouse Models Play Pivotal Role in Testing Combination Therapies” – excellent!

Dana-Farb Cancer institute – 1/5 stars

Alzheimer’s Association

Four out of five stars 4/5The Alzheimer’s Association do have a two page document on their website on the “Use of Animals in Research”. It starts by clearly explaining why they feel animal research is necessary:

Currently, the complexity and intricacy of the human brain is beyond the capacity of even the most sophisticated science to simulate in man-made models (for example, with computers) or through the use of cells grown in the laboratory or lower organisms.

The Alzheimer’s Association believes that the use of animals in research is essential to the success of research into the causes, treatment, prevention and cure of Alzheimer’s disease and related disorders.

It is too long to reproduce in full, but it then goes on to explain the conditions under which they will fund animal research and provides information about knowledge gained through animal research.

A quick search of “mice” on the website brought up just shy of 600 results, though most were abstracts from research grants rather than information oriented for public consumption. The most recent blog entry mentioning mice was in 2013, suggesting that mentioning animal research was not common.

Nonetheless, well done to Alzheimer’s Association – this is probably the best statement. I found it without too much issue and it was fairly comprehensive for a policy statement (certainly compared to other charities). Four stars.

Alzheimer’s Association – 4/5 stars

National Multiple Sclerosis Society

Three out of five stars 3/5Having asked the question by email, I received a link to an obscure policy document. A policy statement on “Research involving human subjects or animals” could be found on Page 6.

For research involving animals, written approval from the grantee’s Institutional Animal Use and Care Committee (IACUC) must be received by the Society prior to the release of any funds. This approval must be signed by the Chairperson of the Committee, and a copy of the letter must be received by the Society on an annual basis during the funding term of the research award.

All biomedical research which involves the use of animals must adhere to the following principles:

  1. Animals shall be used in biomedical research only when no other means of obtaining scientifically sound, valid and useful results are available.
  2. The minimum number of appropriate animals required to obtain and validate results shall be used.
  3. The acquisition, care and use of animals must be in accordance with all applicable federal, state and local laws and regulations.
  4. Certifications must be received from research facilities prior to being approved for a research grant that the facility(ies), its researchers and employees adhere to the Animal Welfare Act, National Research Council Guide for the Care and Use of Laboratory Animals, and any appropriate U.S. Department of Agriculture or National Institutes of Health regulations and standards.
  5. In cases requiring the death of an animal, only the most appropriate and humane form of euthanasia shall be used consistent with the purpose of the research

The statement is sound, but doesn’t seem to be written with the public in mind. It would benefit from a simple and open explanation of when and why animal models can play a key role in developing an understanding of MS.

Despite the relatively weak statement, the NMSS was much stronger in mentioning and explaining the use of animal models in their research news. For example, stories like, “Researchers Funded by National MS Society Report Early Success Testing a Novel Strategy for Protecting the Nervous System in Mice with MS-like Disease“.

National Multiple Sclerosis Society – 3/5 stars

Summary of the Scores:
US Charities doing Animal Research and Animal Testing

Well done to the American Cancer Society and the Alzheimer’s Association for coming top of the list of organisations being open and honest about their animal research. The Alzheimer’s Association is particularly strong in its animal research statement.

On the other end of the scale, the Memorial Sloan Kettering Cancer Center, the Mayo Clinic and the Dana-Farber Cancer Institute need to look at ways of being more open on this issue. Most of the cancer treatments we have today have come about thanks to a huge number of studies on animals. Herceptin, a recent drug for breast cancer, is a humanised mouse antibody which could not have been created except for the use of mice in its development and testing.

So why should charities bother to be open about their animal research? I believe there are three reasons.

Firstly, they are taking public donations, and the public have a right to know how this money is spent. If they believe animal research is an important part of what they fund, then they should be prepared to explain this frankly and openly.

Secondly, regardless of whether they put a statement up on their website, animal rights groups will find out. It took me a few days to ascertain which US charities did, or did not, conduct or fund animal research – others could follow the same process. Putting information openly on the website helps create resilience on the issue – members of the public can no longer be “shocked to discover” that a charity they support funds animal experiments, and animal rights groups cannot go to the paper announcing a charity’s “dirty secret they try desperately to hide”. Any member of the public of journalist can be told straight away by the charity that “Yes, we conduct and fund animal research. We say so openly on our website, and you can find out more information on the reasons why there – we have nothing to hide”.

Lastly, it is important that we foster an environment where both the public, and policy makers, understand the importance of animal research. The former demands the laws and regulations, and the latter put them in place. If the scientific community want to make sure their research environment is secure then they must encourage openness on the issue.

In a second post, we will have a look at British charities which conduct animal research

Speaking of Research

The BUAV – More Spies, Lies and Inspection Reports

The British Union for the Abolition of Vivisection (BUAV) is a UK anti-vivisection group with a history of infiltrations to labs and unsubstantiated allegations against labs. A newly published report from a government investigation reveals just how far the BUAV bent the truth when they made false allegations against the University of Cambridge last year.

Fool Me Twice

In October, 2014, we wrote about how two separate investigations by the Animals in Science Regulation Unit (ASRU; the Government’s inspection unit) found allegations by the BUAV to be almost entirely groundless. In both cases the allegations had followed an infiltration by a BUAV activist.

The first report investigated the BUAV’s allegations against Imperial College London:

Over 180 individual allegations, made by the animal rights organisation, of non-compliance were investigated. Of these, all were found to be unsubstantiated apart from five formal non-compliance cases which have been completed – one category A and four Category B [none of which involved significant, avoidable or unnecessary pain, suffering, distress or lasting harm to the animals].

A second ASRU report into BUAV allegations against a pharmaceutical company conducting tests on veterinary medicines found:

No non-compliance with authorised programmes of work was detected apart from two minor issues with no welfare implications.
[…]
Our detailed investigations and review of available records and other evidence, does not support the allegations in the investigation report.

So twice last year the BUAV has been found misleading the public with their unsubstantiated claims.

Third Time Lucky?

In the post “The BUAV – Spies, Lies and Videotapes” we discussed an infiltration by the BUAV at Cambridge University. The infiltration and subsequent “expose” regarded research on sheep into Huntington’s and Batten’s disease. The allegations made were that there was “…distressing animal suffering, unlawful regulation by the Home Office, in adequate care of animals and inadequate enforcement by the inspectorate”. The 32-page report by the BUAV was supplemented by a four-and-a-half minute edited video (put together from hours and hours of footage by the infiltrator) but when ASRU officials wrote to them requesting further video footage they might have, the BUAV replied that “there was nothing further they wished to share with ASRU”. One guesses hours of footage of Cambridge University researchers abiding by the laws and regulations was not in BUAV’s interest to share. It also proves that the BUAV’s aim is not to address animal welfare issues at Cambridge, but to score points in their stated effort to “end all animal testing”. This month ASRU released their report into the allegations.

A sheep with Batten’s involved in the study at the University of Cambridge (Image credit: University of Cambridge)

Cambridge had previously provided a strong rebuttal of each the claims made by the BUAV. These claims appear to be a mix of exaggerated information and flatly false information. For instance Cambridge noted:

It is alleged that a lamb had to be euthanized at a UK airport after becoming sick during transit from New Zealand. One of the lambs did appear disorientated on arrival in London, but was cleared by the Veterinary surgeon as being fit to continue his travels. No adverse effects were seen in any of the animals on arrival in Cambridge a few hours later.

ASRU’s report is equally clear about this claim [p.13]:

In summary, we conclude that this allegation is simply untrue in relation to the sheep imported for the Project Licence holder’s research. No animals required euthanasia or were found dead on arrival a Heathrow Airport.

And some of their allegations appear to be of the BUAV’s own making. Cambridge noted:

We are careful to avoid causing stress to the Batten’s disease sheep. As their disease develops, they become confused and can become agitated, particularly when approached by unfamiliar people or surroundings. Thus the animal care team is careful not to isolate any sheep from its flock-mates, allow interaction with strangers, or make sudden or unnecessary changes to their routines. It appears that the BUAV infiltrator not only disrupted their routines in the making of the undercover videos, but also isolated the animals. This will have made the sheep appear more agitated than they are when under routine care.

ASRU have added that [p.13]:

The Establishment has mechanisms in place for whistle-blowing, and it is of note that no animal welfare concerns had been raised by any staff at the Establishment, including the animal rights organisation’s infiltrator…

A similar comment was made in the ASRU report into the Imperial allegations. The conclusion to the ASRU report makes damning reading for anyone who believed in the integrity of the BUAV.

Our detailed investigations, and review of available records and other evidence to do not support any of the allegations made by the animal rights organisation
[…]
None of these allegations has been substantiated nor has any allegation given us further cause for concern with regard to compliance with the requirements of the legislation at this Establishment.

Sound familiar? Once again the inspection reports have found the BUAV telling lies, with their spies and their videotapes.

The BUAV

Of the £1.3 million that BUAV spent in 2014 (not including money spent by their three associate companies, Animal Properties, BUAV Charitable Trust and Cruelty Free International), around £200,000 was spent on “Investigations”. Any curious journalist should be asking the BUAV whether they were paying these infiltrators, how much these payments were, and what they expected (video wise) from their employees.

BUAV investigations expenditure 2011-14

To remind people of what we have said before. These are not casual whistle blowers, but people who are working at animal research facilities with the express intention of creating horrifying videotapes. Be it a school, a hospital, a factory or a restaurant, there are few businesses for which you could not create a cleverly edited 5 minute shock video having secretly filmed for hundreds of hours.

One has to wonder how many BUAV infiltrators are in labs around the UK. Moreover, one wonders, how many BUAV infiltration videos were never publicised due to the lack of shocking footage (even after clever editing)?

Speaking of Research

Veterinarians Bringing Research to the Public

Scientist, technicians, animal care attendants and veterinarians all have different roles to play in explaining how and why animals are ethically used to advance scientific discoveries and improve therapeutic treatments of illness. Speaking of Research committee member Michael Brunt was asked to speak to laboratory animal veterinarians and LA veterinary residents from Canada and northeastern USA about the role of their profession in public outreach. The Mini-Laboratory Animal Symposium was hosted by the Ontario Veterinary College at the University of Guelph.

Michael Brunt talks Science

Michael Brunt talks Science

While scientists are the most appropriate group to explain the importance and relevance of their research, veterinarians are likewise the most appropriate group to explain to the public the aspects of medical care, husbandry and welfare of these animals. Pictures accessed through Freedom of Information requests or “under cover” videos are frequently taken out of context and presented in a way that misrepresents the accuracy of image to the public (here, here, here). Veterinarians have a vital role to explain the medical procedures depicted in many of these images. Many of these procedures, like TB testing, are part of a routine clinical care and diagnostic testing that ensures the health and welfare of the animals in their care.

It is imperative that misinformation be corrected to ensure that the public has an accurate understanding of what is occurring with animals used in science. All professionals working in this field have a role to play to bring research to the public.

Speaking of Research

Educating Ourselves and the Public – The Toll of Caring

This article, by SR member Michael Brunt, was first published in the March 2015 issue of AALAS’ Laboratory Animal Science Professional.

In 2013 the Canadian Association for Laboratory Animal Science (CALAS) launched the InReach for OutReach program. One goal of InReach for OutReach is to assist our members to actively articulate the positive contributions they make to our society. The hope is to foster a culture where laboratory animal science professionals will feel accepted, valued, and recognized for their hard work and dedication to improving the lives of animals and people. Canada is an open-minded county when it comes to science. Roughly 60% of Canadians believe the potential suffering of an animal to be acceptable or somewhat acceptable for safety testing of medicine, conducting medical research or teaching and training of professionals such as veterinarians.1 Ninety-three percent of Canadians are moderately or very interested in scientific discoveries or technological developments and also have the lowest reservations towards science in the 17 countries considered. 2 This is great news for laboratory animal science professionals because we are an essential part of making many of those discoveries happen. With such a receptive population, the InReach for OutReach program can play an important role to empower laboratory animal science professionals in Canada.

Animal Technician with a CatAnother goal is forging international partnerships to create synergies, utilize existing resources and coordinate outreach efforts. During the AALAS Foundation’s “WE CARE” campaign to educate the general public about the professionals that care for research animals, many groups and associations assisted in its international promotion across social media. “Caring for Animals – It’s Not Just My Job…It’s My Passion” is a message that reached millions of people, educating and fostering a culture where the contributions, dedication to our animals and personal sacrifices of laboratory animal science professionals can be openly acknowledged and valued.

Animal Tech with RabbitMost laboratory animal science professionals choose this career because they love animals. We talk to our animals. We hold them close, hug or stroke them. We get to know their personalities. Most importantly we bond with them. We know that the emotional bond that is formed enhances the psychological wellbeing of the animals and helps to give them the absolute highest quality of life while they are with us. Sadly, projects end and our companions are euthanized to retrieve the vital scientific data that is required to make discoveries that will improve the health and relieve the suffering of millions of humans and animals. Rationally we know that it’s true but it doesn’t make it hurt any less. So what do laboratory animal science professionals do?  We cry and grieve, and bond with the next group of animals that arrive because they deserve the absolute highest quality of life while they are with us as well. The repeated traumatic emotional loss for laboratory animal science professionals can cause significant health effects, confusing feelings of guilt, burnout and even cause some individuals to leave the profession. Everyone copes with loss in differing ways but I feel it is most important to support each other at every opportunity.

It is imperative for each of us to explore these emotional questions because we must educate ourselves with our own answers before we can share our truth to educate the public.  In 2001, a U.S. nonprofit association for euthanasia technicians, the Mazer Guild, published 12 supportive concepts for its members. They have been adapted for laboratory animal science professionals by Alison Hopkins (www.monkeypuzzletraining.co.uk) in an article that was published in Animal Lab News.3 The supportive concepts acknowledge the challenges that laboratory animal science professionals face on a daily basis.  Through that acknowledgement one is able to explore and navigate the emotions associated with the repeated traumatic loss of our animals.  The concepts also reiterate our obligations as laboratory animal science professionals to promote public understanding, encourage discussion and support others that choose this career path.

We choose this path because it is our passion!  We are passionate about animals that we have the privilege to care for with compassion and respect.  We are passionate about the science that continually makes strides towards new therapeutic advancements.  We are passionate about alleviating the suffering of our fellow animals and people who agonize with debilitating and painful diseases.  “Caring for Animals – It’s Not Just My Job…It’s My Passion”

Michael Brunt, MSc, RMLAT, CMAR is a Project Manager for the Campus Animal Facilities at the University of Guelph, Canada.

References

  1. Canadian Council on Animal Care. [Internet]. 2013. 2013 National Survey. [Cited 7 January 2015]. Available at: http://www.ccac.ca/Documents/2013_National_Survey.pdf
  2. Council of Canadian Academies. [Internet]. 2014. Science Culture: Where Canada Stands. [Cited 7 January 2015]. Available at: http://www.scienceadvice.ca/en/assessments/completed/science-culture.aspx
  3. Alison Hopkins. [Internet]. 2014. Towards Fostering Emotional Resiliency in the Workplace. [Cited 7 January 2015]. Available at: http://www.alnmag.com/articles/2014/04/toward-fostering-emotional-resilience-workplace

The Stop Vivisection Initiative – Trying to Ban European Animal Research

This guest post by Aamna Mohdin has been simulposted with EARA.

There is a new effort to ban animal research in Europe. The Stop Vivisection European Citizens’ Initiative, and its 1.2 million signatures, has been submitted to the European Commission and the organisers have now been invited to discuss their petition. The initiative calls for “the European Commission to abrogate directive 2010/63/EU on the protection of animals used for scientific purposes and to present a new proposal that does away with animal experimentation”. The organisers will have the opportunity to present their ideas at a public hearing held by the European Parliament. The Commission now has three months (from March 3rd) to decide how to respond and explain their reasoning.

Stop Vivisection is the third initiative to be successful under the citizens’ initiative programme, where EU citizens are able to propose and amend legislation to the European Commission. First introduced by the Lisbon Treaty, the citizens’ initiative programme attempts to make EU-law making more accessible and democratic. Each initiative must gain one million signatures across from at least seven member states, these signatures are then checked and validated by the Commission.

Stop Vivisection collected 1,173,130 signatures across 26 of the EU’s 28 member states. The majority of these signatures come from Italy – where anti-animal research sentiment has been running high -, and five out of the seven members of ‘citizens’ committee’ are Italian. This comes as no surprise as the anti-science movement continues to grow in Italy, with the government recently restricting the use of animals in research; forcing scientists to change the focus of their research or pursue their research elsewhere.

Antivivisection European Intitiative

These seven countries account for 90% of all the signatures.

Among the misleading claims made by Stop Vivisection, the initiative argues that the Directive facilitates greater reliance on animal research. When, in fact, the Directive specifically requires that animal models are only used in research if no alternative is available. Regulation 12 of the Directive notes:

“The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable”

At the heart of the directive is the 3Rs—researchers must replace animals with alternative techniques when available, reduce the number of animals required in research, and refine procedures to minimise suffering.

In response to the initiative, over 120 organisations—including notable learned societies, patient groups and leading universities— have signed a joint statement supporting European Directive 2010/63/EU. The statement calls on the European Parliament to oppose the ‘Stop Vivisection’ initiative as repealing the Directive will damage Europe’s leading role in advancing medical progress, which human and animals hugely benefit from.

The statement is as follows:

Statement supporting European Directive 2010/63/EU (“Directive”) on the protection of animals used for scientific purposes

The European Parliament and Commission must oppose the ‘Stop Vivisection’ Citizens’ Initiative that is seeking to repeal the Directive and ban animal research. The Directive is vital to ensure that necessary research involving animals can continue whilst requiring enhanced animal welfare standards.

Summary: The use of animals in research has facilitated major breakthroughs in medicine which have transformed human and animal health. We support research using animals where alternative methods are not available, where the potential benefits to health are compelling, and where acceptable ethical and welfare standards can be met. The Directive has enhanced animal welfare standards and introduced the concepts of refinement, replacement and reduction (‘3Rs’) across the EU, while ensuring Europe remains a world leader in biomedical research. The ‘Stop Vivisection’ Citizens’ Initiative must be opposed by the European Parliament and the Commission – repealing the Directive would represent a major step backwards both for animal welfare in the EU and for Europe’s leading role in advancing human and animal health.

Research using animals has enabled major advances in the understanding of biology and has contributed to the development of nearly every type of treatment used in medical and veterinary practice today. Research on animals continues to be necessary to understand human and animal health and disease, and to develop and improve treatments for patient benefit across the world.

Animals may be used in research under the Directive where the potential medical, veterinary and scientific benefits are compelling and there is no viable alternative method. The use of animals for testing cosmetic products was banned across the EU in 2009 and the importation and sale of cosmetics that have been tested on animals from outside the EU was completely banned in 2013.

For research using animals to be both ethical and scientifically rigorous, it must meet high welfare standards and the implementation of the Directive is key in achieving these standards consistently across the EU. Shaped by consultation with animal welfare groups, scientists and animal technologists, the Directive importantly embeds into EU legislation the requirement to consider the 3Rs when using animals in research. The 3Rs are:

  • Replacement – methods which avoid or replace the use of animals;
  • Reduction - methods which minimise the number of animals used per experiment;
  • Refinement – methods which minimise any suffering and improve animal welfare.

Developments for alternative methods to the use of animals in research, such as use of human cell models and computer modelling, continue to progress and the biosciences sector must continue to drive these forward. However, alternative methods are not able to fully replace the use of animals at this time. For many diseases, including complex conditions such as cancer, heart disease and diabetes, which affect multiple organs, we must understand how the whole organism interacts, which means that research using whole animals continues to be essential.

We call on the European Parliament and Commission to reaffirm their commitment to the Directive. Any roll back from this would both undermine animal welfare and compromise high-quality research using animals. Such research is critical to advancing human and animal health in the EU and globally -and to maintaining Europe’s leading role in that endeavour.

It’s important to remember that although the petition passed the one million threshold, it still only represents less than a quarter of one percent of the EU’s population. It’s therefore vital the scientific community remains open about animal research and opposes initiatives such as these to protect both human and animal welfare.

Aamna