Safer Medicines - putting patient safety first

Putting patient safety first

Published Letters

New Scientist 20th July 2016

Brain models could replace primates

From Kathy Archibald (Safer Medicines Trust), Gerry Kenna and Barbara Pierscionek

You claim that the Weatherall Report helped to end debate about the validity of primate research (18 June, p 5). Yet the report states that “debate on the use of non-human primates in research would benefit from more systematic information on its overall impact on scientific and medical advances”.

Models using human tissues, reproducing key features of biochemistry and physiology, have enormous potential in brain research. A 2016 paper in Alternatives to Laboratory Animals concludes: “neuroscience would be more relevant and successful for humans if it were conducted with a direct human focus”. As scientists dedicated to ensuring the best outcomes for patients, we concur.

Kingsbridge, Devon, UK; Macclesfield, Cheshire, UK; and Kingston, Surrey, UK

The Times 4th July 2015

Sir, As biomedical scientists and physicians, we are disturbed that the Association of Medical Research Charities (AMRC) now requires its members to publicly declare support for animal research. Substantial evidence suggests that animal research does not reliably predict human response to medicines or accurately represent human diseases. The scientific community is becoming increasingly doubtful about the relevance of animal research to human medicine. An editorial in last year’s British Medical Journal, for example, suggested that “funds might be better directed towards clinical rather than basic (i.e. animal) research, where there is a clearer return on investment in terms of effects on patient care”. AMRC should allow its member charities the freedom to develop their own progressive policies. Enforcing an illusory united front on this divisive issue forces charities to choose between losing support from AMRC or from concerned donors. It also goes against the fundamental spirit of science, which promotes the open exchange of ideas.

Kathy Archibald, Director, Safer Medicines Trust
Professor Geoffrey Pilkington, Professor of Cellular and Molecular Neuro-Oncology, Portsmouth University
Professor Barbara Pierscionek, Associate Dean, Research and Enterprise, Kingston University London
Dr Lindsay Marshall, Senior Lecturer in Immunology, Aston University
Dr Kelly BéruBé, Reader in Cell Biology, Director Lung & Particle Research Group, School of Biosciences, Cardiff University
Dr Aysha Akhtar, Neurologist and Public Health Specialist
Dr Bob Coleman, UK Science Director, Safer Medicines Trust 
Dr Katya Tsaioun, US Science Director, Safer Medicines Trust 
Dr Andre Menache, Director, Antidote Europe 
Dr John Pippin, Cardiovascular Medicine Physician 


 

The Observer 31st August 2014: Using animals to test drugs is outdated and unreliable.


The Sunday Times 7th September 2014: Politicians impeding medical advances

Our unedited version: 

The micro-human systems in your article are an exciting technology and we hope they will become mainstream within three years, as predicted. Meanwhile, other human-based technologies are already available, which could be improving patient safety here and now.  The impediment is not science but political will. 

Public pressure to curb animal testing has been resisted for fear this would cost human lives.  But a landmark study has revealed that apparent safety in animal tests provides no assurance of human safety. Thus patients are exposed to greater risks than previously realised, both in clinical trials and as consumers of medicines. 

We urge the Government to act now to harness scientific advances that could reduce the toll of adverse drug reactions (ADRs), which kill more than 10,000 in the UK every year.* Across Europe, more people die of ADRs than of breast cancer or prostate cancer: equivalent to a jumbo jet every day.** We have the technology, we must implement it without further delay.

Kathy Archibald, Director, Safer Medicines Trust
Dr Kelly BéruBé, Director, Lung & Particle Research Group, Cardiff University
Dr Bob Coleman DSc, UK Science Director, Safer Medicines Trust
Professor Michael Coleman DSc, FHEA, School of Life and Health Sciences, Aston University
Professor Chris Foster DSc, FRCPath, Emeritus Professor of Pathology, Liverpool University and Medical Director, HCA Pathology Laboratories
Professor Barbara Pierscionek, Associate Dean of Research and Enterprise, Kingston University Faculty of Science, Engineering and Computing
Dr Katya Tsaioun, US Science Director, Safer Medicines Trust
Professor Sir Ian Wilmut FRS, MRC Centre for Regenerative Medicine, University of Edinburgh


*http://www.bmj.com/content/329/7456/15
**http://europa.eu/rapid/press-release_MEMO-08-782_en.htm?locale=en
http://wp.rxisk.org/too-many-drugs/

 

New Statesman, 4 January 2013


Reuters, 19 September 2012: Thalidomide’s big lie overshadows corporate apology

 

A powerful and moving article – as is the book, Suffer the Children. Many congratulations to Sir Harold Evans and the Sunday Times Insight Team for their brilliant expose of this terrible tragedy.

There is, however, a major and tragic irony in blaming insufficient animal testing for the disaster: more animal testing would not have prevented the release of thalidomide, since very few species suffer birth defects or other adverse effects in response to the drug. The Office of Health Economics concluded that: “It is unlikely that specific tests in pregnant animals would have given the necessary warning: the right species would probably never have been used.”

This in no way excuses Grünenthal for their catalogue of wrongdoing. But another dreadful legacy of thalidomide is the regulations it spawned: enshrining in law a system of animal testing that would not have averted the thalidomide tragedy and has not averted innumerable tragedies since. Adverse drug reactions are now one of our leading causes of death, and 9 out of 10 new drugs fail in human trials after appearing to be safe and effective in animal tests.

New technologies that could improve drug safety are not being embraced today because governments still demand animal testing, despite its pitiful record.
Please read this excellent short article about thalidomide’s long shadow: http://www.thenational.ae/news/uae-news/ science/when-animals-fail-the-test


The Observer, 5 August 2012

The acrimonious animal testing debate should be over ("Inside the lab where animal testing staff live in fear", News). New scientific techniques give better information than animals. Questions previously tackled by animal tests can now be answered with real human tissues interconnected in "body on a chip" devices or by volunteers taking a small, safe microdose of a new medicine.

The debate is prolonged by spokespeople for animal testing, including Professor Roger Morris, making claims such as: "If we didn't test drugs on rats and mice, there would be a lot more dead people."

The tragedy is that we already have better tests, but they are not used routinely because the government does not require it. Instead, the government still mandates animal tests, despite the fact that nine out of 10 drugs that pass animal tests go on to fail in human trials. There is a global scientific consensus that animal toxicity tests are inadequate and must be replaced. How many more deaths will it take to make the government listen?

Kathy Archibald, Director, Safer Medicines Trust


Daily Mail, 26 July 2012

Michael Hanlon voices the fears of many in his belief that without animal experimentation, people would have to be used as guinea pigs (“Vivisection is right”, 24 July). Fortunately, such fears are groundless.

Science has advanced to the point where new medicines, for example, can be tested on real human tissues in ‘body-on-a-chip’ devices, rather than on real people or animals. If the drug passes these tests, it can be given to volunteers in a tiny, safe ‘microdose’, which will show how the body will handle the drug.

Of course, before the medicine is approved, it must be tested in patients and volunteers in clinical trials. This is where people have always been used as guinea pigs and always will be – otherwise medicine simply could not progress. But these heroic human guinea pigs should be protected from risk as far as is possible – and that means using the best and most relevant tests available. Evidence from scientific tests such as microdosing provide a more reliable guarantee of safety than any number of guinea pigs of the rodent variety.

 

Kathy Archibald, Director, Safer Medicines Trust


Safer Medicines Trust and colleagues respond to the pro-animal testing lobby's ill-informed attack on our letter in The Lancet thelancet.com/journals/lancet/article/PIIS0140-6736(11)61669-3


Open letter to David Cameron and Andrew Lansley published in The Lancet
Safer Medicines Trust joined forces with 21 senior scientists to call on the Prime Minister and Health Secretary to compare animal tests for drug safety with newer tests based on human biology. Our letter was published in the world's leading medical journal, The Lancet, here.


From Cambridge Evening News, 27th November 2010

It is profoundly disturbing to hear Cambridge University claim that "research with animals offers the greatest hope of effective treatments for conditions such as cancer, Parkinson's, multiple sclerosis, Alzheimer's, strokes and transplants" (117,000 tests on animals performed in just one year, Cambridge News, 20th November). They, of all people, should know that this is not true.

The exciting breakthroughs in research into each of these diseases are coming from studies of human biology, which provide insights that different species simply cannot.

As leading Cambridge University scientist Dr John Xuereb explains: "Alzheimer's, Parkinson's and other neurodegenerative diseases occur in humans and it is in human tissue that we will find the answers to these diseases."
Other researchers at Cambridge University have switched from studying animals in brain injury research to using human data because it is more relevant. I used human cell lines to study cancer, heart disease and psoriasis prior to my PhD at Cambridge University. Safer Medicines Trust believes that medicines would be safer and more effective if they were designed and tested for humans, rather than animals.

Dr Margaret Clotworthy, Science Director, Safer Medicines Trust


Vivisection value from New Scientist (www.newscientist.com), 30 June 2010

Simon Festing says that reducing publication bias in animal research would ensure a sound basis to move from animal studies into clinical trials (5 June, p 22). This would be true if the results of animal studies translate directly to humans. They do not, which is a far more important problem than publication bias.

Full publication of every animal study of the immunomodulatory drug TGN1412, for example, would still have suggested that it was safe to proceed to clinical trials, since the devastating response to the drug is unique to humans.

Systematic reviews of the applicability of animal results to human medicine - such as those by Pablo Perel and others (BMJ, vol 334, p 197) and by Daniel Hackam and Donald Redelmeier (The Journal of the American Medical Association, vol 296, p 1731) show consistently that animal studies predict human response incorrectly a majority of the time. In the case of stroke, is anyone seriously suggesting that more than 150 treatments successful in animals have failed in humans because of publication bias?

Of course, this bias should be addressed. There should unquestionably be a registration system for animal studies, as there is for human studies. As chief executive of Understanding Animal Research, surely Festing should be calling for this, rather than merely commenting that "it is not inconceivable that we might move towards a similar system".

Kathy Archibald, Safer Medicines Campaign


Animal testing futile (from The Herald ) http://www.theherald.co.uk
January 12 2009

Anne Johnstone (Medical benefits justify Scots primate research, January 8) has been misinformed.
I am very sorry that Ms Johnstone's father has Parkinson's disease and I hope that he may benefit from deep brain stimulation (DBS), the brain surgery to which she alludes.

However, DBS was actually pioneered in human patients, not monkeys, as lobbyists for animal testing dishonestly claim.

In fact, virtually everything we know about Parkinson's disease, in common with most diseases, has been learned by studying human patients and their tissues, not animals.

As Dr John Xuereb, director of the Cambridge Brain Bank, acknowledges: "Alzheimer's, Parkinson's and other neurodegenerative diseases occur in humans and it is in human tissue that we will find the answers to these diseases."

Kathy Archibald, Director, Safer Medicines Campaign, PO Box 62720, London.


Alternatives To Primate Experimentation (from The Herald ) http://www.theherald.co.uk
Novermber 17 2008

Professors Millar and Savill believe there is a need to research infertility in monkeys. Professor Chris Barratt and Dr Ian Brewis at Birmingham Women's Hospital study human infertility using human testicular tissue, obtained from biopsies. They are demonstrating that human research is the way forward.

They observe: "In the field of reproductive medicine there is still an overwhelming obsession with performing research in animals We believe very strongly that this is totally unjustifiable and unwarranted as there is now good evidence that there are marked differences at the cellular, molecular, tissue and whole organism level between humans and animals We are pleased to report that researchers of international recognition are now discussing the limitations of animal work and the benefits of human research."

It is time Edinburgh University caught up.

Kathy Archibald, Director, Safer Medicines Campaign, PO Box 62720, London.


http://www.timeshighereducation.co.uk/story.asp?storycode=404304
Times Higher Education
Readers' comments

  1. Kathy Archibald, Director Safer Medicines Campaign 14 November, 2008

Sir Leszek Borysiewicz, head of the Medical Research Council (MRC), says "we don't know where new advances for acquisition of new treatments are going to come into play".

Does he not think they are most likely to come from human biology-based research, which has an unrivalled record already and is producing exponentially increased amounts of knowledge with the new biotechnological tools at its disposal?

That is surely more likely than any new-found success in translating findings from animals into human treatments, which has such a poor record to date.


Scotsman.com

Hypocrisy on animal tests
Published Date: 07 November 2008

Dr Simon Festing (Letters, 5 November) accuses David Martin, MEP, of regurgitating misleading propaganda, while doing precisely that himself.

Dr Festing claims that experiments on monkeys have led to treatments for conditions such as stroke and Parkinson's disease, but this is not true. In fact, scientists acknowledge that one of the main reasons for our lack of effective stroke treatments is that tests in animals, particularly monkeys, have been so misleading.

Everything we know about Parkinson's disease has been learned from human patients, not monkeys. It is by studying humans and their tissues that we will find the answers to these terrible diseases.

Mr Martin calls for modern, effective research, but Dr Festing, who is paid to defend animal research, hypocritically accuses him of blocking progress.

(DR) MARGARET CLOTWORTHY
Safer Medicines Trust
PO Box 62720, London


 

http://www.telegraph.co.uk/earth/main.jhtml?xml=/earth/2008/10/28/scitest128.xml

Professor Blakemore's piece has greatly exaggerated the benefits of animals
in medical research, particularly in view of the array of human
biology-based technologies we have today.

Northwick Park Hospital, March 2006, made headlines when 6 young men almost
died after taking a potential new drug. It TGN1412 had already been tested
at 500x the dose the men received in monkeys without causing any alarm. In
the wake of this debacle researchers developed a method of replicating what
had happened in the men's bodies- using human cells in the lab. Everything
is poisonous at some level, so there is little point in suggesting (as some
have) that 500x was simply not a sufficient margin of safety. Also, we now
have microdosing technology whereby tiny doses (less than 1/60 of the dose
those volunteers received) can be used to find out where a new drug goes &
how it is broken down. Given the disastrous effects of the drug on healthy
volunteers, it is not guaranteed that they would not have suffered side
effects, but they would likely have been better protected. Northwick Park
was not an isolated incident: in 2000, a director of clinical trials,
quoted under conditions of anonymity in prestigious journal Science insisted
that "If you were to look in [a big company's] files for testing
small-molecule drugs [the sort we think we understand better than
antibody-based drugs like TGN1412], you'd find hundreds of deaths."

The 20th anniversary of the discovery of the first treatment for HIV
infection was celebrated recently. AZT was discovered by testing failed
cancer treatments in human cell-based tests.

Penicillin languished for years unused after failing in rabbits

Regarding the invention of the polio vaccine: monkey research misled
researchers for years into thinking it was transmitted through the
respiratory rather than the digestive tract.

Mice & humans share more than 70% of their genetic sequences, but even
individual people can react very differently to a drug. The differences
between species are particularly great because the number of combinations of
ways in which genes can be regulated is vast. Genes are a bit like the keys
on a piano keyboard - you could have two pianos, side by side - the 'human'
piano and an 'animal' piano - both with (almost) identical keyboards. But by
pressing different notes (or expressing different genes) you can play an
infinite number of tunes - all very different!

Posted by Dr Margaret Clotworthy on October 30, 2008 4:00 PM


Daily Mail, May 29 2008

Monkey tests don't work

Tests on monkeys may be more likely to help find a cure for Huntington's disease than laboratory rats (Mail), but that likelihood is remote. Such experiments are more likely to raise false hopes for patients, which will be cruelly dashed when treatments that look promising in monkeys fail to translate into therapies for humans.

Such is the track record of research in monkeys, which mislead scientists with alarming regularity. Hundreds of treatments for stroke work well in monkeys but every one has failed in clinical trials. More than 80 HIV vaccines have shown promise in monkeys, only to fail in humans.

Six young men at Northwick Park Hospital were nearly killed by a drug that was safe at 500 times the dose in monkeys. Surely patients deserve therapies designed for humans, not monkeys.

Kathy Archibald, London SE27


From issue 2652 of New Scientist magazine, 19 April 2008, page 16-17
Testing animal tests

  • 19 April 2008
  • From New Scientist Print Edition. 
  • Margaret Clotworthy, London, UK

Europeans for Medical Progress

Your editorial suggests that it may be time to thank animal technicians in published papers for the indispensable role they play (29 March, p 5). Perhaps it is also time to assess the usefulness of animal research, to see whether causing so much grief to technicians, as well as to the majority of the public, is worth it.

As Robert Matthews recently noted (16 February, p 20), there have been few systematic studies of the value of animal experiments, and there is no published evidence that animal studies are more informative than tossing a coin.

Europeans for Medical Progress would like to see a comparison between animal tests for drug safety with a panel of state-of-the-art techniques based on human biology. In the UK, 250 members of parliament and 83 per cent of general practitioners support this idea.


2007 European Molecular Biology Organization EMBO reports VOL 8 | NO 9 | 2007 795 correspondence science & society
Comment on ‘The ethics of animal research’ by Festing & Wilkinson

Simon Festing and Robin Wilkinson’s scientific defence of animal research rests on their claim that the development of new medicines and treatments is “all made possible by animal research” (Festing & Wilkinson, 2007). Yet the Advertising Standards Authority (ASA; London, UK) has ruled that such claims are misleading (ASA, 2005).Europeans for Medical Progress (EMP; London, UK) is an independent organization dedicated to the safety of patients. Our concern is that patients are endangered by an unwarranted reliance on results from animal models that have not been validated and are frequently misleading. We seek unprecedented scientific scrutiny of animal tests to predict drug safety—the track record of which is abysmal. Our aim is to ensure that biomedical research practices are rigorously evidence-based. However, the results of evidence-based medicine often conflict with the agenda of special interest groups (Dickersin et al, 2007).

We wonder why the Research Defence Society (RDS; London, UK) opposes an independent comparison of animal tests with the latest human-based tests for drug safety, and why they have even lobbied members of the British Parliament (MPs) not to support EMP’s initiative. Surely, all sides should agree that an evaluation of the scientific strengths of animal-based testing of drugs is a positive exercise? However, no independent comparison of the relative efficacy of animalcompared with human-based methods has ever been attempted. All four enquiries mentioned by Festing & Wilkinson in their Talking Point (Festing & Wilkinson, 2007) concluded that reviews of the reliability and relevance of animal research are necessary. The House of Lords Select Committee report concluded this was “a matter of urgency” (UK, 2002).

The report further acknowledged that, “all sides of the debate on animal procedures say that animals are highly imperfect models. It will be for the benefit of science, and ultimately of human health, if better methods of research and testing could be developed.” Festing & Wilkinson also did not acknowledge the failings of animal research, such as the fact that 92% of new drugs fail in clinical trials, even following success in animal tests (FDA, 2004), as dramatically illustrated by the recent TG N1412 trial. Approximately 150 stroke treatments that were successful in animals have failed in clinical trials (www.camarades.info), sometimes injuring or killing patients, for example Aptiganel (Birmingham, 2002).

Vioxx® (Merck, Whitehouse Station, NJ, USA) caused hundreds of thousands of heart attacks and strokes despite animal testing indicating that it was cardioprotective (Topol, 2004). How much more evidence of failure is needed before we consider directly assessing the worth of animal tests relative to the latest tests that are now available? In January 2007, a systematic study in the British Medical Journal based on six reviews found that animal tests accurately predict human response less than 50% of the time (Perel et al, 2007). A study of the translation of animal research into human treatments cautioned those who conduct clinical research to expect “poor replication of even high-quality animal studies” (Hackam & Redelmeier, 2006).

Festing & Wilkinson highlighted the difficulty of mimicking a whole living system; however, the answer is unlikely to be found in studying the wrong system: “[A] relative lack of severe toxicity in animal models should never be construed as a guarantee of safety in man, as the story of thalidomide taught us” (Goodyear, 2006). This is where technologies such as microfluidics and, in particular, microdosing, come into their own. Festing & Wilkinson’s criticisms of microdosing are unsupportable. By 2010, 90% of pharmaceutical companies plan to use microdosing (Wilkinson, 2007), and the European Medicines Agency (EMEA; London, UK) and the US Food and Drug Administration (FDA; Rockville, MD, USA) support its use to reduce the time, cost and risks associated with developing new drugs (EMEA, 2004; FDA, 2006).

In the light of so much evidence of the hazards posed by misleading animal data, unsubstantiated claims that Festing & Wilkinson make in their Talking Point, such as, “[t]he benefits of animal research have been enormous”, are an inadequate form of justification. In addition, stating that, “it would have severe consequences for public health and medical research if it were abandoned” does not withstand scrutiny in the face of promising advances such as microdosing, microfluidics, virtual organs and virtual clinical trials. UK Biobank (Stockport, Cheshire, UK) promises to build substantially on an exciting breakthrough just announced by The Wellcome Trust (London, UK). The identification of many new genes implicated in serious, common diseases was only made possible by the analysis of DNA from thousands of patients and volunteers (Todd et al, 2007).

Medical progress depends on a continued focus on humans and their varying susceptibility to diseases and drugs. Now that we have the technology to design and test drugs specifically for humans, what is the value of animal tests? Cancer Research UK (London, UK) acknowledges that “We do trials in people because animal models do not predict what will happen in humans” (Burtles, 2006).

It seems that the public remains to be convinced about the merits of animal testing. In a 2006 Sky News poll—which dwarfed the surveys quoted by Festing & Wilkinson—52% of almost one million people said they were not in favour of testing on animals (news.sky.com/skynews/ polls/displayresults/1,,91153-1003444- 2,00.html). Our own survey of GP s revealed that only 21% would have more confidence in animal tests for new drugs than in a battery of human-based safety tests, and that 83% would support an independent scientific evaluation of the clinical relevance of animal experimentation; figures which the polling company has never disputed (www. safermedicines.org). Furthermore, a majority of MPs also support an independent scientific evaluation of the use of animals as surrogate humans in drug safety testing and medical research (Hancock, 2006). It seems that provivisectionists are alone in opposing scientific scrutiny of the controversial practice they defend.

REFERENCES

ASA (2005) Non-Broadcast Adjudications: Association of Medical Research Charities. London, UK: Advertising Standards Authority

Birmingham K (2002) Future of neuroprotective drugs in doubt. Nature Med 8: 5

Burtles S (2006) Report of the Expert Scientific Group on Phase One Clinical Trials. London, UK: Cancer Research UK

Dickersin K, Straus SE, Bero LA (2007) Evidence based medicine: increasing, not dictating, choice. British Medical Journal 6: s10

EMEA (2004) Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose. London, UK: European Medicines Agency

FDA (2004) Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products. Rockville, MD, USA: Food and Drug Administration

FDA (2006) Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies. Rockville, MD, USA: Food and Drug Administration

Festing S, Wilkinson R (2007) The ethics of animal research. EMBO Rep 8: 526–530

Goodyear M (2006) Learning from the TGN1412 trial. British Medical Journal 25: 677–678

Hackam DG, Redelmeier DA (2006) Translation of research evidence from animals to humans.JAMA 296: 1731–1732

Hancock M (2006) Early Day Motion: Animal Testing of Drugs. London, UK: Parliamentary Information Management Services

Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P, Macleod M, Mignini LE, Jayaram P, Khan KS (2007) Comparison of treatment effects between animal experiments and clinical trials: systematic review. British Medical Journal 27: 197–200

Todd JA et al (2007) Robust associations of four new chromosome regions from genome-wide analyses of type 1 diabetes. Nature Gen 39: 857–864

Topol EJ (2004) Failing the public health— Rofecoxib, Merck, and the FDA. N Engl J Med 351: 1707–1709 UK (2002) House of Lords Select Committee on Animals in Scientific Procedures, Volume I— Report. London, UK: The Stationery Office

Wilkinson M (2007) Xceleron to accelerate growth further. Online article published on http://www.drugresearcher.com, 3 May. Montpellier, France: Decision News Media

Kathy Archibald is Director of Europeans for Medical Progress; Margaret Clotworthy is Science Consultant for Europeans for Medical Progress Trust.
doi:10.1038/sj.embor.7401057


BMI 29 January 2007 Moving away from animal research for clinical benefit

Congratulations, British Medical Journal, on three excellent articles on the thorny issue of the clinical value of animal testing. Pablo Perel et al conclude that "discordance between animal and human studies may be due to bias or to the failure of animal models to mimic clinical disease adequately" (1), while Daniel Hackam concludes that "it seems prudent to be critical and cautious about the applicability of animal data to the clinical domain" (2). Geoff Watts' article (3) on the other hand comes from an animal welfare perspective, though he highlights the view of drug companies and contract research organisations that “the value of the animal data they collected was limited”, or even “of no practical use.”

It is becoming increasingly clear that addressing the failings of animal models in the clinical domain entails shifting the emphasis away from animal studies, to more promising methods such as microdosing. Simon Festing of the Research Defence Society effectively says as much, with his comment that such methods have been developed for scientific reasons (3). But there is no evidence to support the contention that "You could phase out the use of animals if you were prepared to put more risk on to humans". The evidence suggests that employing a battery of human-based tests, including microdosing, for assessing the safety of new drugs would decrease the risk to humans currently posed by our reliance on 'proof of safety in animals.' Think of TGN1412, or this example from the Perel study (1): corticosteroids were administered to head injury victims for decades, based on evidence of benefit from animal tests. This misguided practice is estimated to have killed 10,000 patients.[4]

1) Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P et al. Comparison of treatment effects between animal experiments and clinical trials: systematic review. British Medical Journal 2007;334:197-200.

2) Hackam DG. Translating animal research into clinical benefit. British Medical Journal 2007;334:163.

3) Watts G. Alternatives to animal experimentation. British Medical Journal 2007;334:182 -184

4) Daily Telegraph. 8 October 2004. Head injury drugs 'may have killed 10,000'. By David Derbyshire, Science Correspondent

Competing interests: Competing interests: Director of Europeans for Medical Progress: an independent organisation devoted to rigorous scientific analysis of animal experimentation to assess the balance of help or harm to human health: www.safermedicines.org

Kathy Archibald, Europeans for Medical Progress, London


BMI 23 January 2007 Medical Progress: thanks to clinical research, not animal research

Marco Mamone-Capria's observations are clear and irrefutable - though proponents of animal experimentation will undoubtedly refute them!

The waters of this debate have become muddied by the sheer volume of publications making the implicit assumption that the animal experiments involved in any particular field of research were predictive and were therefore responsible for guiding the direction of that research. But it is probably more often the case that clinical observation drives the direction of research, for which 'validatory' animal experimentation is often then awarded the credit.

A good illustration of this is provided by British Medical Journal's Medical Milestones supplement, celebrating key advances since 1840s. All 15 stories were an enthralling read, with many important take-home messages. One lasting impression left on me was how they were driven by the ability of the human mind to harness both serendipitous and diligently-sought discoveries to the purpose of solving human health problems, as perceived through careful observation of patterns of disease and individual responses to disease.

The key observations and discoveries were necessarily clinical in nature. Yet we are constantly told that 'virtually every medical breakthrough has relied upon animal experimentation, without which medical progress would cease.' In light of these 15 stories, that claim rings very hollow.

Of course, animal experimentation has been involved in much medical progress - but has it been the driver of that progress and would future progress be impossible without it? Of course not.

250 MPs and 83% of GPs in a nationwide survey (see www.safermedicines.org) want to see an independent scientific evaluation of the clinical relevance of animal experimentation. Yet the Government prefers the advice of those campaigning to prevent an evaluation which would be in all our interests. As the champions of evidence based medicine as a Medical Milestone point out: the results of evidence based medicine often clash with the agenda of special interest groups.

Competing interests: Director of Europeans for Medical Progress: an independent organisation devoted to rigorous scientific analysis of animal experimentation to assess the balance of help or harm to human health: www.safermedicines.org

Kathy Archibald, Europeans for Medical Progress, London


Mail on Sunday, 17th December 2006: Monkey trials are doomed to fail

I was hardly surprised when a panel of scientists said last week that experiments on monkeys are vital to human health. But many of their claims are nonsense.

Eighty AIDS vaccines have failed in human trials following success in primates, while virtually everything we know about Alzheimer's and Parkinson's Disease has come from studying patients rather than animals. Research in primates has failed to produce treatments for any of our leading killers, including heart disease and cancer. 

On top of that, tests on monkeys created a false sense of security at Northwick Park Hospital, almost killing six young men, and the arthritis drug Vioxx has been linked to the deaths of thousands of people, despite 'proof of safety' in monkeys.

Kathy Archibald, Europeans for Medical Progress, London


Guardian online 13th December 2006 http://www.guardian.co.uk/commentisfree/story/0,,1970782,00.html

A report by Sir David Weatherall, a professor at Oxford University - mired in controversy over the building of its new animal laboratory - could hardly have concluded that primate research is not necessary!

But many of its claims are nonsense. Primates have contributed little to Alzheimer's or Parkinson's treatment:virtually everything we know about these diseases has been learned by studying patients. Deep brain stimulation was pioneered in patients, not monkeys. 80 AIDS vaccines have failed in human trials following success in primates. Research on primates has failed to produce treatments for any of our leading killers, including heart disease and cancer. Monkey tests created a false sense of security at Northwick Park, almost killing six young men. Vioxx, the world's biggest drug disaster, killed tens of thousands, despite 'proof of safety' in monkeys.

A scientific review by patient safety organisation Europeans for Medical Progress (www.safermedicines.org/reports) shows primate research is irrelevant and often hazardous to human health. Dr John Xuereb, Director of the Cambridge Brain Bank Laboratory explains; "Alzheimer's and Parkinson's occur in humans and it is in human tissue that we will find the answers to these diseases."

Kathy Archibald, Director, Europeans for Medical Progress, London


Evening Standard and Daily Mail online 26th November 2006:

Adam Wishart's claim that he, of all people, understands the benefits of animal experimentation reveals only that he has succumbed to the emotional blackmail so effectively employed by the pro-vivisection lobby: "Your father would have had no treatment... this young boy would never walk again if not for animal experimentation." Wishart, who is not a scientist, believes these claims because they are made by qualified scientists whose opinions he trusts. The tragedy is that these claims are nonsense. Deep brain stimulation for Parkinson's and dystonia is, in fact, a triumph of human clinical observation; not primate experimentation. Cancer research has been hindered more than helped by animal experimentation. This issue must be judged on facts, not rhetoric. Proponents of animal testing should provide scientifically supportable evidence for their claim that animal tests are vital: something they have never done.

Kathy Archibald, Director, Europeans For Medical Progress, London, UK


Guardian online 24th November 2006

http://commentisfree.guardian.co.uk/ed_owen/2006/11/ed_owen_on_testing_on_animals.html

I wonder if Ed Owen could explain why he opposes scientific scrutiny of animal testing and what is 'extreme' about the idea? A majority of back-bench MPs support it, as do 83% of GPs - hardly an extremist or ignorant minority.

Europeans for Medical Progress is indeed an independent organisation of scientists and medical professionals dedicated to improving patient safety, as anyone can see from our website. Our position is rigorously evidence-based. Notice that Mr Owen did not provide any scientific evidence in support of his belief that animal experimentation is beneficial to humans - nor do proponents of animal testing ever provide any real evidence in support of their claims. Considering they are seeking to defend such a controversial practice, this is somewhat surprising, to say the least.

Overwhelming evidence shows that animals are not reliable predictors of human reactions, as the Northwick Park clinical trial fiasco demonstrated so spectacularly. The track record of animal research is abysmal: 80 AIDS vaccines have failed in human trials after success in primates and other animals; likewise 150 stroke treatments. Research on animals, even including great apes, has failed to produce treatments for any of our leading killers, including heart disease, cancer and malaria. More than 9 out of 10 drugs that pass animal tests fail in human trials; injuring and sometimes killing the volunteers. Side effects of prescription medicines - all tested for safety on animals before they can be administered to humans - are now the fourth biggest killer in the western world. Animal tests are failing to protect us and the government is failing to learn from disaster after disaster.

Scientific consensus changes as new evidence emerges. In light of recent catastrophes such as Vioxx – the biggest drug disaster in history, which killed thousands despite ‘proof of safety’ in monkeys, many scientists are questioning our continued reliance on animal tests, now that superior, human-based methods are available. The devastating effects of both Vioxx and TGN1412 (the Northwick Park drug) could easily have been predicted in human tissue. More and more eminent scientists lament the failings of animal research. Cancer Research UK acknowledges; "We do trials in people because animal models do not predict what will happen in humans."

Scientific beliefs MUST be based on evidence. Tradition, academic authority, even the weight of opinion of the entire scientific establishment cannot alter the truth of the evidence before us: the facts speak for themselves. It is time to re-examine the entrenched belief in the value of animal testing. This emotive issue must be judged on facts, not opinions, through an independent and transparent scientific evaluation, which all sides should welcome if they have the courage of their convictions.

Kathy Archibald Director, Europeans for Medical Progress, London


The Independent 18th November 2006: Animal testing helps us discover cures for mice, not men

Letters: Animal testing http://comment.independent.co.uk/letters/article1993607.ece

Sir: Christopher Clayton (Letters, 15 November) points out the alarming fact that all medicines withdrawn for killing patients, such as Vioxx, which killed tens of thousands, have been "proved safe" in animal tests. Conversely, we have undoubtedly lost cures for cancer and other diseases because they were ineffective in animals. Dr Irwin Bross, former director of the world's largest cancer-research institute (New York's Sloan-Kettering), stated: "While conflicting animal results have often delayed and hampered advances in the war on cancer, they have never produced a single substantial advance either in the prevention or treatment of human cancer."

Until we acknowledge that human-based research holds the key, we will keep curing mice of cancer, instead of people.

KATHY ARCHIBALD,  DIRECTOR, EUROPEANS FOR MEDICAL PROGRESS, LONDON W13


New Internationalist, October 2006

Lee Jones' claim that more animal tests would have averted the thalidomide tragedy (letters, September) is simply untrue. Thalidomide would be pronounced safe by animal tests even today. Dr JL Schardein, an authority on birth defects, states; "In approximately 10 strains of rats, 15 strains of mice, 11 breeds of rabbits, 2 breeds of dogs, 3 strains of hamsters, 8 species of primates and in other such varied species as cats, armadillos, guinea pigs, swine and ferrets in which thalidomide has been tested, teratogenic effects have been induced only occasionally.''

To claim that animal tests ensure drug safety is preposterous when prescription drugs hospitalise 250,000 Britons every year. Superior tests involving human tissues, microdosing and DNA chips would make our drugs much safer. Incredibly, animal tests have never been compared with these modern methods to establish the best way to protect public health and safety. 234 MPs and 83% of GPs are calling for that comparison (see www.safermedicines.org) but Pro-Test is fighting hard against it.

This issue must be judged on facts. The only way to settle the matter is through an independent scientific evaluation, which all sides should welcome - unless they fear the outcome. 

Dr Margaret Clotworthy, Europeans For Medical Progress Trust, London


Worcester News, 28th October 2006

Simon Festing falsely claims to have commissioned the first proper national survey for 13 years of family doctors' views on animal testing. In fact, patient safety organisation Europeans for Medical Progress commissioned a larger national survey of 500 GPs only two years ago.

We found that 83% of doctors want to see the medical value of animal testing evaluated scientifically. In light of the Northwick Park disaster - where six young men were nearly killed by a drug 'proven safe' in monkeys - the figure today is doubtless higher. Tests on human tissue could have predicted the disaster, where monkeys failed so tragically.

Most back-bench MPs also want to review the practice of assessing drug safety in animals, now that superior methods are available to protect clinical trial volunteers and, ultimately, the public from side effects of prescription drugs: currently our fourth leading killer.

It is astonishing that lobbyists such as Dr Festing oppose an evaluation which would improve drug safety. Could it be because they are funded by the pharmaceutical industry - the world's most profitable industry, for whom animal testing provides liability protection in court?

Kathy Archibald, Director, Europeans For Medical Progress, London


Daily Mail online, 14th September 2006

One reason for drugs' appalling safety record is that their safety is assessed in animal tests, which predict only 5-25% of side effects. This is why nine out of ten drugs fail in human tests despite success in animals, as the Northwick Park clinical trial fiasco showed. Six unfortunate men were reassured that the drug was safe because it was safe in monkeys. Vioxx was shown to be good for the heart in animals. Superior human-based tests would have predicted the effects of both the Northwick Park drug and Vioxx, where animal tests failed so tragically. 83% of GPs and most back-bench MPs believe the performance of animal tests should be assessed as a priority. Patient safety group Europeans for Medical Progress campaigns for this vital assessment but is vilified by pharma-funded lobbyists desperate to discredit us and block an evaluation which would improve drug safety. Kathy Archibald, Director, Europeans For Medical Progress, London


British Medical Journal Rapid Response online, 22nd August 2006

http://bmj.bmjjournals.com/cgi/eletters/332/7543/677
Michael Goodyear says that whether we need to consider a parallel drug testing process, using human tissues, needs careful consideration. Surely the case for doing so is overwhelming, particularly in view of the fact that human tissue company Asterand have a standard assay which could have predicted the TGN1412 reaction - see http://www.asterand.com/Asterand...2006.aspx. The Government is making no investment into the increased application of ethically-donated human tissue testing, so it is left to small, struggling companies like Asterand to develop tests which would benefit all of humanity, let alone the pharmaceutical industry, entirely unaided.

Let us not forget that 92% of drugs fail in clinical trials, having successfully passed through animal studies. Although they do not often fail in such spectacular fashion as TGN1412, trial volunteers can nevertheless be harmed or even killed by experimental drugs. Surely they deserve better protection than 'proof of safety' in animals, which - as thalidomide, eraldin, opren, clioquinol, isoprenaline, rezulin, Vioxx, etc, etc. should have taught us - means very little for humans.

Kathy Archibald Director, Europeans for Medical Progress, London


New Scientist magazine, 01 July 2006, page 26: No need for monkeys

The Medical Research Council and Wellcome Trust's claim that "many medical advances would have been impossible without experiments on monkeys" is simply not true (10 June, p 6). Their new report states that benefits that have arisen from primate research include the polio vaccine and treatments for stroke and Parkinson's disease, although not a single reference is provided to support those claims.

In contrast, a review of primate research by Europeans for Medical Progress, which opposes animal testing, cites almost 100 references and asserts that monkey experiments delayed the polio vaccine and failed to produce a single successful treatment for stroke (www.safermedicines.org/reports//page/faqs_index). Deep-brain stimulation for Parkinson's disease is, in fact, a triumph of human clinical observation, not primate experimentation, as was described in your own pages two years ago (New Scientist, 24 July 2004, p 40).

There are serious scientific objections to primate experimentation, the track record of which is in our view abysmal. Eighty HIV vaccines - 50 preventive and 30 therapeutic, according to the US National Institutes of Health - have failed in human trials following success in primates.

The monoclonal antibody TGN1412 failed spectacularly this year in humans, causing major organ failure in six people at Northwick Park Hospital in London, despite "proof of safety" in monkeys. Tests carried out in human tissue could have averted this fiasco.

Scientific justification for such a controversial practice must be demonstrated, instead of being merely asserted without substantiation.

Kathy Archibald, Europeans for Medical Progress, London, UK


Cambridge Evening News, Western Daily Press, Gloucester Citizen and Lichfield Mercury, 22nd June 2006

Jo Tanner is wrong to claim that medicines result from animal experimentation. In fact, all of our current drugs and treatments were discovered through astute observation of patients, pioneering self-experimentation, ingenuity and advances in technology. Aspirin, the world's most common medicine, owes nothing to animals: nor do antibiotics, anaesthetics, AIDS drugs, anti-depressants - the list goes on.

As a geneticist who has worked in pharmaceutical development, and who owes my life to much medical intervention, I share the conviction that medical research is vital. It is important to point out, however, that medical research and animal research are not one and the same thing, and that it is logical to support one and oppose the other.

This issue must be judged on facts, not rhetoric. Patient safety group Europeans for Medical Progress - supported by 245 MPs and 83% of GPs - suggests a scientific evaluation to settle the matter once and for all.

Kathy Archibald, Director, Europeans for Medical Progress, London


Daily Mail online 31st May 2006

Sewing up kittens' eyelids has not saved the sight of any children with squint: knowledge of squint has come from human observation, not experiments on kittens or monkeys. According to Harvard University pediatric opthalmologist, Dr Nedim Buyukmihci, "This work has no applicability to the human situation.” Despite decades of animal experiments, there has been "no change in concepts or in treatment methods over the last 100 years or more."
 
Pro-vivisectionists deceive the public with their mantra that "Some of the major advances in the last century would have been impossible without animal research." Yet the ASA recently ruled that this misleading claim should not be repeated.

240 MPs and 83% of GPs want a scientific evaluation of animal testing to settle this matter once and for all. If pro-vivisectionists had the courage of their convictions, they would welcome an evaluation to prove their point - but they are fighting it tooth and nail. What are they afraid of?

Kathy Archibald, Director, Europeans for Medical Progress


The Independent on Sunday, 2nd April 2006

Milton Wainwright says it is inconceivable that scientists should have tested penicillin on humans, (Letters, 26 March). But we all benefit from antibiotics today because they did.

Even today, animal tests mislead. In the light of near-tragedies such as the blunder that has led to six young men being put on life-support, it is time to question whether animal tests are the best method to protect human health. Europeans for Medical Progress, along with 209 MPs, want a scientific evaluation.

Dr Jarrod Bailey, Europeans for Medical Progress, London W13


British Medical Journal Rapid Response online, 31st March 2006

Safety testing in animals deserves scrutiny

Michael Goodyear comments that the tragic TGN1412 trial will probably change the face of drug testing and that an independent inquiry is needed. Patient safety group Europeans for Medical Progress agrees. We believe a vital part of any inquiry should be a comparison of animal tests with microdosing, human tissue tests and other state-of-the-art methods of predicting human metabolism.

83% of GPs and over 200 MPs support such a scientific evaluation of the best means to protect public health and safety: see www.safermedicines.org

Michael Goodyear is right that relative lack of severe toxicity in animal models should never be construed as a guarantee of safety in man, as the story of thalidomide should have taught us. TeGenero insists monkeys and rabbits showed TGN1412 was safe. Monkeys and mice even showed that Vioxx was cardioprotective. When will we learn?

Kathy Archibald, Director, Europeans for Medical Progress


New Scientist magazine, 4th February 2006, page 24: Trial by species

You highlight the fact that nine out of 10 drugs fail in humans despite success in animal models (21 January, p 6). This suggests that animal tests may not be the best way to ensure the safety of new medicines.

Clearly, if people can be used without risk - as with microdosing, for example - they would make far more appropriate models. Why not compare animal tests against a battery of human-based tests, including microdosing, to determine how best to protect the public from another Vioxx? Europeans for Medical Progress is calling for precisely such an evaluation: see www.safermedicines.org for details.

Kathy Archibald, Europeans for Medical Progress, London,

Share
Follow Us