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UK Early Day Motion - publish animal research results

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
This is an action for UK citizens only - to ask their MPs to vote in favour of this Early Day Motion (EDM). It is very important for animal research results to be published, as it is for clinical research, if we are to make decisions on whether animal research really benefits humans. My own paid and unpaid work and research indicate strongly that it doesn't, and there are many scientifically-knowledgeable people who have come to the same conclusion, as several of my blogposts show. People cite examples of when animal findings have corresponded with human findings, but there are many more examples of when they don't, resulting in scientists going down blind alleys, adverse effects in human patients, and trials and treatments having to be abandoned.

Early day motion 118

PUBLICATION OF ANIMAL EXPERIMENT RESULTS

Session: 2015-16
Date tabled: 10.06.2015
Primary sponsor: Dowd, Jim
Sponsors:
Hopkins, Kelvin Weir, Mike Day, Martyn Lucas, Caroline

That this House welcomes the requirement that all clinical trial results should be published; and calls on the Home Office to require and facilitate a similar arrangement for animal experiments, subject to the normal safeguards of commercial and academic confidentiality and safety, to enable researchers to avoid duplication and allow public discussion of the merits of the research.

http://www.parliament.uk/edm/2015-16/118

....................................................................................................

This is a very important and exciting initiative, and could really move the debate on whether animal research really advances our knowledge of human conditions and treatments for them, beyond the issue of ethics, dangers from animal rights extremists, etc.

MPs who do not want to sign may give excuses such as fear of extremism, cost, lack of precedent in other countries, etc. But these can be countered by pointing out that
  • any info that could identify researchers or institutions can be redacted.
  • if analysis of the data shows that animal research actually slows medical progress by producing misleading results, cessation of such research can in fact produce cost benefits.
  • lack of precedent should not override logic or science - the important thing is to do what advances knowledge and speeds progress towards safe, effective treatments.
Please ask your MP to sign the motion, and please forward widely.
 

msf

Senior Member
Messages
3,650
I think, unfortunately, animal research does benefit humans, just as, unfortunately, eating animals does benefit humans (if only in terms of B-12). In a lot of cases, an animal model is the only model available, since the tests are either too dangerous or too unethical to do on humans (I agree that this is subjective). A good example recently was Z-Mapp, which was tested on monkeys first, since no one would have approved a study in which Ebola was given to humans in order to see if they could be saved by Z-Mapp, and even if someone had approved it, it would have been very difficult to find volunteers for such a study. As a former vegan, I am not deaf to the concerns of animal rights campaigners, but I would rather 100 monkeys died (for instance) of Ebola than 100 humans. I think this makes me a speciesist. I would, however, support a ban on routine testing on great apes, as I think that a monkey model should suffice in most cases, and I feel more empathy for great apes than I do for monkeys (speciesist again!).

The motion mentions the need for safe, effective treatments - I do not see what could substitute for an animal model in cases like the one I mentioned (Z-mapp) if not a human model, and I don't think many people are willing to make that sacrifice.
 

eafw

Senior Member
Messages
936
Location
UK
In a lot of cases, an animal model is the only model available

I think the point of this motion is that we don't really have good stats for that, and what is being asked for is information such that better decisions can be made.

Perhaps related is the recent discovery that lab mice will get stressed around male (but not female) handlers/researchers in a way that is likely affecting outcomes. On top of this we have the question of just how well we can translate animal to human as well, so all worth looking into.

http://www.nature.com/news/male-researchers-stress-out-rodents-1.15106
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
I think, unfortunately, animal research does benefit humans, just as, unfortunately, eating animals does benefit humans (if only in terms of B-12). In a lot of cases, an animal model is the only model available, since the tests are either too dangerous or too unethical to do on humans (I agree that this is subjective). A good example recently was Z-Mapp, which was tested on monkeys first, since no one would have approved a study in which Ebola was given to humans in order to see if they could be saved by Z-Mapp, and even if someone had approved it, it would have been very difficult to find volunteers for such a study. As a former vegan, I am not deaf to the concerns of animal rights campaigners, but I would rather 100 monkeys died (for instance) of Ebola than 100 humans. I think this makes me a speciesist. I would, however, support a ban on routine testing on great apes, as I think that a monkey model should suffice in most cases, and I feel more empathy for great apes than I do for monkeys (speciesist again!).

The motion mentions the need for safe, effective treatments - I do not see what could substitute for an animal model in cases like the one I mentioned (Z-mapp) if not a human model, and I don't think many people are willing to make that sacrifice.

I think you are making the common mistake of confusing the ethical issues with the scientific issues. The EDM is not about ethics - it is about science. I am a scientist, and have specialised in the (ir)relevance of animal 'models', so have read a great deal on the subject. The more I have read, the more astonished and shocked I have become at the fact that the practice continues. The fact that an animal is currently the 'only model available' ignores the fact that the model may be seriously flawed and misleading, and one might as well toss a coin as rely on it.

I list many of the views of other scientists and relevant experts on the subject here. Whilst there are also many who insist that the practice is relevant, I find their arguments stale, tired, predictable and unconvincing, and they never seem to come up with evidence, whereas there have been a few reviews that show animal findings to be extremely unreliable, and it is becoming increasingly common for animal researchers to include caveats in their papers about the questionable relevance of their findings to humans.

If results could be published more widely, they could be properly analysed by a wider range of people. Then the debate could move on. It just seems to go in circles at the moment, which is very frustrating.

There are research charities that fund the development of humane alternatives, and I have written a report (unpublished) critiquing animal models which gives details of numerous types of alternative.
 

msf

Senior Member
Messages
3,650
I noticed that neither of you came up with a alternative to the monkey model for Z Mapp. My sister is a scientist too, one who did a lot of her work on mice, and I doubt she would have done it if it wasn't necessary in her opinion, as she didn't really enjoy killing them.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
I noticed that neither of you came up with a alternative to the monkey model for Z Mapp. My sister is a scientist too, one who did a lot of her work on mice, and I doubt she would have done it if it wasn't necessary in her opinion, as she didn't really enjoy killing them.

I don't think it's reasonable to ask an individual - especially a chronically-ill one - to come up with a specific alternative to a specific test! It takes time to study the info already available, and it would require looking at numerous scientific papers, revising specific facts about physiology, finding out about the drug (much of which might be confidential, thus unavailable), etc. One would never get anything else done! I don't even have the time or brainpower to read all the stuff about ME that I want to read - one reason it takes me so long to find out what I need to do for myself.

Why not read some of the info in my blog?

This thread is about asking the government to make info available so that it can be analysed, to move the argument forward.
 

msf

Senior Member
Messages
3,650
Ok, good luck with that, I doubt it will change my mind completely on this issue, but perhaps it will show that a significant proportion of animal research is unnecessary.
 
Messages
15,786
I think it really depends on the similarity of the biological mechanisms being studied. If it's something where the enzymes (and genes) are pretty much identical in both species, it might work. But a lot of animal research doesn't seem as relevant: such as making rats swim until exhausted as a supposed comparison to CFS :confused:
 

msf

Senior Member
Messages
3,650
Also, how about research that is not directly aimed at providing a treatment for humans? A good example of this was a recent paper I read on Yersinia - they found that in chronic infection Yersinia undergoes changes in gene expression. They did this by infecting rats with it and then sacrificing them. I think this was an important step in understanding how Yersinia can persist in the body.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Ok, good luck with that, I doubt it will change my mind completely on this issue, but perhaps it will show that a significant proportion of animal research is unnecessary.

I wonder whether your sister could help with an initial, somewhat-anecdotal bit of info? Does she have a rough idea of what proportion of candidate drugs that she, her team or her lab found promising results for in animals (any species) have gone on to become safe, effective treatments for humans?

You see, the problem with people citing cases of drugs that have been licensed - and stayed licensed - as evidence of animal testing being beneficial - is that it omits the fact that the ones that did not get licensed - or had their licences withdrawn due to inefficacy or adverse effects (including death) - also tested safe and effective in animals.

The successful drugs are outnumbered by the unsuccessful ones. So the animal tests have really told us nothing about how the drugs will work in humans.

Here is one of the many expert quotes in my blogpost referred to above:

from The Lancet, Vol 377, Issue 9781, page 1915, June 4, 2011:

We are writing to you as a group of clinicians and scientists to express our concern about the escalating problems of drug failures and adverse drug reactions. The UK pharmaceutical industry is in crisis, as the departure of Pfizer from the Sandwich site makes plain. Likewise, health care is in a web of crises, many of which are intimately linked to the pharmaceutical industry's major problems.

Adverse drug reactions have reached epidemic proportions and are increasing at twice the rate of prescriptions.1 The European Commission estimated in 2008 that adverse reactions kill 197 000 EU citizens annually, at a cost of €79 billion.2 The cost of new medicines is rising unsustainably, creating an ever-increasing burden on the National Health Service (NHS). Meanwhile, many increasingly prevalent diseases, such as Alzheimer's disease, diabetes, many cancers, and stroke, remain without adequate treatments.

The major reason for the rising cost of new drugs is the fact that more than 90% of them fail in clinical trials.3 Companies need to recoup the cost of development not only for the drug that succeeds, but for the nine others that fall by the wayside.

It is increasingly clear that an important factor contributing to these problems is the over-reliance of the pharmaceutical industry on the use of animals to predict drug behaviour in man. The stark differences, not only in the diseases of different animal species, but also the ways that they respond to drugs, are now well known. Many studies have shown that animal tests frequently fail to translate to the clinic, with estimates of their ability to predict effects on people as low as 37—50%, or no better than the toss of a coin.4

Our reliance on animals to establish safety results in the exposure of clinical volunteers and patients to many treatments that are at best ineffective and at worst dangerous. Take for example the notorious Northwick Park clinical trial drug, TGN1412, that left six young men in intensive care in 2006. This drug was demonstrably safe in monkeys at doses 500 times higher than those that nearly proved fatal to the volunteers.5 Soon after the disastrous trial, an assay that used human cells was developed to predict such an immune system over-reaction.5 Had this assay been in use before human beings were exposed, the trial would never have taken place. Surely the time has come for there to be a rigorous assessment of the ability of such human-based tests to improve on the deeply flawed, animal-based approaches in current use?

We call on the UK Government to initiate a comparison of a set of human-biology-based tests with those currently used, as proposed in the Safety of Medicines Bill 2010—11,6 to see which are more effective for predicting the safety of medicines for patients. Several new technologies promise increased clinical predictability as well as substantial improvements in efficiency and cost. The Bill does not propose any replacement of animal tests, merely their assessment of fitness for purpose. 148 Members of Parliament have already signed a motion7 in support of this proposal.

Some of us recently made representations to the UK Department of Health, and were told that the Government believes that human-biology-based systems have not been established as being more predictive than are animal studies for developing safer medicines. We agree, but that is because no rigorous examination of such systems has been undertaken. The very purpose of the proposed comparison is to initiate such an examination, which is urgently necessary for the sake of the NHS, the pharmaceutical industry, and, most importantly, patients.
We urge you to act now to ensure that the best technologies currently available are used to establish the safety of medicines for patients.

Kathy Archibald, Robert Coleman, Christopher Foster, on behalf of 19 other signatories who are:

1. Dr Kelly BéruBé (PhD), Director, Lung & Particle Research Group, Cardiff
University
2. Dr David Bunton (PhD), Chief Executive Officer, Biopta, Ltd, Glasgow
3. Dr Margaret Clotworthy (PhD), Director, Human Focused Testing, Cambridge
4. Dr Ann Cooreman (PhD), Chief Operating Officer, Tissue Solutions Ltd, Clydebank
5. Professor Anne Dickinson, Director, Alcyomics Ltd, Newcastle upon Tyne
6. Professor Barry Fuller, Department of Surgery, UCL Medical School, London
7. Dr B J Nathan Griffiths (PhD), Commercial Director, Abcellute & Abcellute Tissue Bank, Cardiff
8. Dr Morag McFarlane (PhD), Chief Scientific Officer, Tissue Solutions Ltd,
Clydebank
9. Professor Chris Hillier (PhD), Professor of Physiology, Glasgow Caledonian University
10. Anup Patel, Consultant Urological Surgeon, St. Mary’s Hospital, Imperial College Healthcare NHS Trust and Chairman of Clinical Studies Committee, European Association of Urology Research Foundation
11. Professor Barbara Pierscionek, Head of Vision Science Research, University of Ulster
12. Dr Cathy Prescott (PhD), Director, Biolatris Ltd, Cambridge and Chair of the UK National Stem Cell Network Advisory Committee
13. James Root, Senior Scientist, Pfizer, Sandwich
14. Professor Gerry Thomas, Chair in Molecular Pathology, Imperial College, London and Director of Scientific Services, Wales Cancer Bank
15. Dr Katya Tsaioun (PhD), Chief Scientific Officer, Cyprotex, Macclesfield
16. Dr J Malcolm Wilkinson (PhD), Chief Executive Officer, Kirkstall Ltd, Sheffield
17. Professor Sir Ian Wilmut FRS FRSE, MRC Centre for Regenerative Medicine, University of Edinburgh
18. Dr Amanda Woodrooffe (PhD), General Manager, Asterand UK Ltd, Royston
19. Dr Karen L Wright (PhD), Peel Trust Lecturer in Biomedicine, Lancaster University
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Also, how about research that is not directly aimed at providing a treatment for humans? A good example of this was a recent paper I read on Yersinia - they found that in chronic infection Yersinia undergoes changes in gene expression. They did this by infecting rats with it and then sacrificing them. I think this was an important step in understanding how Yersinia can persist in the body.

We could go on citing individual examples for the rest of our lives. BTW, we really need to know whether each case proved relevant in humans if it is to progress the arguments. I have no idea whether the rat/Yersinia info has been found to be the same in humans.

But I really don't want to spend time on this - I have a mountain of things to do and have gone through these discussions too many times.

Let's get the info PUBLISHED.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
I think it really depends on the similarity of the biological mechanisms being studied. If it's something where the enzymes (and genes) are pretty much identical in both species, it might work. But a lot of animal research doesn't seem as relevant: such as making rats swim until exhausted as a supposed comparison to CFS :confused:

There is no such species (physiologically similar), @Valentijn. I don't have time to post links to all the files I have on the differences, but they include a wide range of biochemical entities such as genes, enzymes, gut microbes and cytokines, and anatomical differences such as gut anatomy and brain anatomy. It includes our closest relatives - chimps.

I think that there are expert comments on this in the blogpost I keep referring to.

EDIT - one example:

It has been known for some time that humans and chimpanzees share about 98.5% of their DNA sequence in common (Pääbo, 1999). This sounds impressively similar, but put another way, this is 18-30-fold greater than the variation amongst humans and implies that humans and chimps differ at some 45 million individual nucleotides. Initial surveys indicate that the sequence encoded by corresponding (orthologous) genes differs between chimp and human in at least 60% of proteins (Eyre-Walker and Keightley, 1999). Andrew O.M. Wilkie, Weatherall Institute of Molecular Medicine, Oxford University

Now I am running late on lunch!
 

msf

Senior Member
Messages
3,650
Sorry, she was involved in stem cell studies, and I'm pretty sure none of the things she was working on have been licensed yet.

The quotation above that states that animal studies are only predictive 37-50% of the time shows a misunderstanding of the relevance of this statistic. It does not mean that animal studies are only as effective as flipping a coin, as the 'expert' suggests, because this assumes that there are only two outcomes, good and bad, and that they have an equal incidence. A simple analogy would be a weather forecast that is only accurate 37-50% of the time - if you were planning your wedding and you had two possible dates in mind, would you use the weather forecast to choose the day or would you flip a coin?
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Sorry, she was involved in stem cell studies, and I'm pretty sure none of the things she was working on have been licensed yet.

The quotation above that states that animal studies are only predictive 37-50% of the time shows a misunderstanding of the relevance of this statistic. It does not mean that animal studies are only as effective as flipping a coin, as the 'expert' suggests, because this assumes that there are only two outcomes, good and bad, and that they have an equal incidence. A simple analogy would be a weather forecast that is only accurate 37-50% of the time - if you were planning your wedding and you had two possible dates in mind, would you use the weather forecast to choose the day or would you flip a coin?

The quote is in fact signed by 22 people, most with the title 'Professor' or 'Dr'. They are clinicians and scientists.

I don't think it shows a misunderstanding at all.
 

msf

Senior Member
Messages
3,650
I'm surprised that someone who has ME still has such respect for the titles Dr. and Prof. If it is not a misunderstanding, it is disingeneous. The only way they could make that statistic relevant is if they mentioned the predictive rate of other methods of discerning the potential effect of drugs, such as cell studies.
 

msf

Senior Member
Messages
3,650
Plus, isn't the quote contradictory in this context? You used it to support a call for more information being made available on the efficacy of animal studies, but your supporting quote mentions that several studies have shown that they are predictive only 37-50% of the time. Either we do not need more information, or that quote is based on insufficient evidence.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Plus, isn't the quote contradictory in this context? You used it to support a call for more information being made available on the efficacy of animal studies, but your supporting quote mentions that several studies have shown that they are predictive only 37-50% of the time. Either we do not need more information, or that quote is based on insufficient evidence.

I am simply replying to your points - you said 'expert' and I was pointing out that there were quite a few backing the statement.

We do need more information. There have been a few comparison studies, including the one referred to by the scientists and clinicians in the 37-50% context, which is here.

But we need a lot more info than that, and analyses by a lot more people. The authors of the few existing comparison studies may be accused of bias, deliberate or otherwise. Others may argue that the findings do not apply to their particular line of research. The field of animal experimentation is huge and varied. Just the range of species and genetic lines involved is huge.

But you have already said "I doubt it will change my mind completely on this issue", which I find puzzling.

Please, let UK folk just contact their MPs and ask them to support this EDM or not. I just don't have time for this discussion, which I have had much too much of over the years. The point of the EDM is to establish the facts to everyone's satisfaction, or as far as is possible.

I am currently working so have to dash again.
 

msf

Senior Member
Messages
3,650
Ok, I doubt either of us is going to change each other's mind on this, so I will let it lie. I said I doubt I will change my mind completely because I feel that the logic of animal studies is pretty sound, but you obviously don't agree, so let's leave it at that.

I am not stopping anyone doing what you suggested in your opening post, and like Valentjin I saw you posting it here as an invitation to debate the issue. I assumed you were looking to persuade more people to come round to your way of thinking. If that was not your intention then I apologise for wasting your time.