Animal Experimentation

David Amess Excerpts

Wednesday 7th December 2011 Commons Chamber

[Mr David Amess (Southend West) (Con)]

Throughout my time in Parliament I have consistently campaigned on animal welfare issues. I do not believe that I have been unreasonable, extreme or silly about those issues, but I have endeavoured to ensure that animals’ interests have been represented in this Chamber. By virtue of a ten-minute rule Bill, together with Lord Houghton of Sowerby and the then Minister, Douglas Hogg, I was fortunate to secure on the statue book the Protection against Cruel Tethering Act 1988. There are many other animal welfare measures regarding pet shops, exotic and endangered species, puppy farming and the like which I have tried to encourage through legislation. In 1986 I served on the Committee that considered the Animals (Scientific Procedures) Bill.

In 1876 Parliament passed the first legislation in any country in the world to control live experiments that might cause pain. The Cruelty to Animals Act 1876 was a response to some horrifying reports about the practice of surgical procedures on live animals without anaesthesia. That Act stood the test of time well, but the 1986 legislation brought it up to date. I well remember the then Minister, David Mellor, doing battle with the former Member of Parliament Harry Cohen. It was a very interesting exchange of views, but I am glad that the measure that ultimately reached the statute book was well appreciated.

The European Union has adopted a new directive on animal testing—Directive 2010/63. I point out to the Minister that the Home Office will be amending the Animals (Scientific Procedures) Act 1986 to comply with the directive. A number of colleagues have already contacted me to say that they are very concerned about this matter. It is true that there will be a public consultation, and I understand that the Home Office is currently analysing responses and putting together a draft proposal that will be sent to Parliament next year. However, my colleagues and I are very concerned about the European directive, simply because we in this country pride ourselves on the way in which we treat animals, and we need to be convinced that all countries in the European Union have the same high standards as we do.

Our country is allegedly a nation of animal lovers. Sadly, words and actions do not always match up. I consider the measure of a civilisation to be how animals are treated. I pay tribute to the many organisations and groups that battle to stop cruelty to animals, helping to generate support and awareness about various issues. As regards the particular matter that I wish to raise with the Minister, I am indebted to Kathy Archibald and Louise Owen, who, among others, have briefed me so well. Indeed, they are probably on the line now, hoping that I can make changes to the speech and get in yet another piece of lobbying.

Writing in Nature Reviews Drug Discovery, David Horrobin answered the question:

“Does the use of animal models of disease take us any closer to understanding human disease?”

His response echoes the concerns that I wish to raise in the House tonight:

“With rare exceptions, the answer to this is likely to be negative.”

The process before clinical drugs come to be tested on a human being should be well understood, but I am not sure that it is. Anyone who hopes to get a new drug on to the market must first put it through a series of tests on various animals. It is that reliance on animals as a final safety screen before products go to clinical trials that concerns me, for that “safety screen” is no such thing. Animal models are not a reliable indicator of how a human being will react to a drug.

My hon. Friend the Member for Stourbridge (Margot James), who has just taken her place, will be glad to hear that I have already raised the European directive that she is concerned about, and that the Minister nodded. I am therefore optimistic that Home Office officials will be working on the advice right now.

The safety of medicines is an issue of increasing concern. Every year, 1 million Britons are hospitalised by prescription medicines. That costs the NHS up to £2 billion a year. The Safety of Medicines Bill, which I introduced earlier this year, is intended to safeguard against this growing problem. I believe that the Bill has widespread support—but then I would say that. However, it has been misrepresented, although not intentionally I am sure, and it has certainly been misunderstood. Although my opposition to cruelty to animals is well documented, it is important to make it absolutely clear that the Bill does not call for animal tests to be replaced per se. It is about determining the best means to ensure the safety of medicines and to protect patients against adverse drug reactions.

It could be argued that the use of animals is ethically and morally wrong. Many people would argue that strongly. However, in this debate the criticism of the use of animals focuses not on the suffering of the animal, which can be quite shocking, but on the fact that animal models are not accurate indicators of human responses. That in turn creates risks for volunteers, patients and sufferers during and after human clinical trials. I believe that there is ample evidence to support the argument that animal models do not function properly in their role.

[Jim Shannon (Strangford) (DUP)]

I do not often disagree with the hon. Gentleman or question him. However, there are many examples of medicines that have been perfected by their use on animals and have saved lives. How will he ensure that that continues to happen, given what he has been setting out? My concern is that there is some goodness in this practice. Let us not lose that.

[Mr Amess]

The hon. Gentleman and I do not disagree on many things, and it would be a shame if we fell out on this issue. I hope to prove by the end of my contribution that there would certainly not be the adverse impact that he fears.

[Chris Williamson (Derby North) (Lab)]

I congratulate the hon. Gentleman on bringing this issue before the House, and I very much support him. I am sure that he is going to come on to this point, but my response to the hon. Member for Strangford (Jim Shannon) would be that in an infamous case, thalidomide was proven safe for use on animals, but we all saw the tragic consequences of that. There has been a lot of publicity about that, but there are many other examples that have not had the same level of publicity. As the hon. Member for Southend West (Mr Amess) pointed out—before the hon. Member for Strangford came into the Chamber, I think—1 million people a year are hospitalised as a result of taking prescription medication. We must consider that problem, and I hope that the Minister will listen to the contribution of the hon. Member for Southend West this evening.

[Mr Amess]

I welcome the support of the hon. Gentleman, whose maiden speech I was privileged to follow. I am going to mention two or three cases that enforce what he says.

There is ample evidence to support the fact that animal models do not function in their role. That is a very important matter for the Home Office to consider. In my time here many Ministers have held the relevant responsibility, and of course those advising Ministers are also very important. I do not expect the Minister to give me a firm yea or nay during the debate, but I hope she will write to me about the points that I make.

Experiments on animals cannot predict the mechanisms of the disease in question, risk factors or potential adverse reactions. According to the US Food and Drug Administration, the world’s largest drug regulator—I hate to keep using America as the example, but it seems to have the latest data—92% of potential new drugs fail in human trials. We cannot just dismiss that, because it is huge number, but no publicity is given to it. The drugs fail either because they do not work on, or are not safe for, humans. I will come later to one famous and disastrous incident. After appearing safe and effective in animal tests, those drugs fail completely.

Communities of senior scientists are very much aware of the dangers of using animals as human indicators. The Safer Medicines Trust, the patient safety charity of senior scientists, including Sir Ian Wilmut, the renowned “father” of Dolly the sheep, has expressed its concern. It is clearly not opposed to animal experimentation per se, but it is concerned for patients and for science in general. Indeed, it has sent open letters to the Prime Minister and the Secretary of State for Health stating that the current system for ensuring the safety of medicines before clinical trials is inadequate and results in harm to volunteers and patients.

These are difficult times, and I know that people are paid to volunteer for trials, but there have been a number of well-documented disastrous consequences. The danger to human beings from the use of animal testing is clear. Even in pre-clinical stages, lives have been lost because the results have misled scientists.

I wonder how many people realise that penicillin stayed on the shelf for more than a decade because the results in the rabbits on which Fleming tested it led him to believe that it would be ineffective in humans. That was quite the wrong outcome—and we can think of the number of lives that could have been saved all those years ago.

Lives are threatened in the human clinical stages of trials. In March 2006 six young men took part in a clinical trial at Northwick Park hospital and were nearly killed by a drug that had been tested on monkeys and shown to be safe, even at 500 times the dose that the men were given. That is not a trivial matter, and I can remember clearly when it happened. Again, I do not expect the Minister to respond now, but I hope that after she has taken advice she will be able to discuss what happened in that trial.

Clearly, the results from the monkeys created a false sense of security, yet the risk carries over even when drugs pass to market. Any number of hon. Members will have had constituents lobby them on the painkiller Vioxx, which was eventually withdrawn in 2004 after the biggest drug disaster in history—it killed more than 100,000 people worldwide in its five years on the market. Clinical trials of Vioxx revealed up to a fivefold increase in the risk of a serious reaction such as heart attack, heart failure or stroke, but tests on animals indicated that it was safe, and in some instances that it was protective to the heart, which supported the manufacturer’s decision to market the drug. I am currently dealing with two or three constituents whose loved ones were affected by the drug, and who are trying to get compensation, which, as hon. Members know, is quite a tough battle. One hundred thousand people were affected worldwide.

Why should animals be indicators of human response? Animals and humans are evolved complex systems and as such should be expected to demonstrate different responses to drugs and disease.

[Margot James (Stourbridge) (Con)]

A number of drugs registered for humans are effective in animals. Dogs in older age respond very well to Prozac if they are a bit down, and a hypertension drug for humans has proved effective in restoring the vitality of apes in zoos in Britain.

[Mr Amess]

I apologise to my hon. Friend in case I was going too far on one side; my argument needs to be balanced.

Mutations that cause genetic disease in humans are the norm in some animals. Johnson et al found in 2001 that out of 39 anti-cancer drugs tested on xenograft mice, only one mimicked the response in humans. I say to the hon. Member for Strangford (Jim Shannon) that that cannot be much to rely on.

[Jim Shannon]

We need balance in the debate because we are getting one side of the argument but not the other, which is that drugs have been successful in saving lives. I am not taking away for one second from those who have died as a result of inappropriate drugs but, with respect, we need that balance, but we are not getting it.

[Mr Amess]

Frankly, one life lost is too many, but we could have a big argument—

[Jim Shannon]

One life saved is worth it.

[Mr Amess]

Yes, I agree with the hon. Gentleman that it is a question of balance, but I hope to prove that animal experimentation is completely unnecessary and that we can achieve the same results through different methods.

There is a variation of response within humans—African Americans are more susceptible to lung cancer than Caucasians—so how can we expect animals to be reliable models?

Using animals as human indicators is also expensive, for it can keep cures off the market, hence the large cost of modern drugs to consumers and the health service generally. In the words of Robert Weinberg, from the Massachusetts Institute of Technology, the use of pre-clinical tests results in

“hundreds of millions of dollars…being wasted every year by drug companies using these [animal] models”,

according to Leaf 2004.

Other areas of valuable research that might help in understanding the impact of drugs in human beings suffer as a result of animal testing. Despite animal models forming a very minor part of research, they receive a large proportion of funding. Society does not need new research methods; it simply needs to fund the ones that we already have. The important point is that it is possible to test these clinical drugs on humans, so that we can have a better indication of how they will react pre and post-clinical trials.

Society needs to make a fundamental change from animal-based research to human-based research. If it is humans whom we are trying to help, then scientists must study disease and drug reactions in humans. New technologies, outlined by the Safer Medicines Trust, are based on monitoring human responses to new drugs in a variety of ways. Those range from combinations of tissues in “body-on-a-chip” devices to safe volunteer studies such as micro-dosing, where tiny amounts of a new drug are administered to human volunteers. Scientists, in turn, evaluate what the drug does to the body and what the body does to the drug. Micro-dosing in particular has shown to be highly predictive of results in the clinic. Astoundingly, these tests are already commercially available from a number of UK companies, and offer a much safer and less risky alternative to using animals in clinical trials.

More than 150 colleagues have signed a motion calling on the Government—it is Christmas and this is not too much to ask—to initiate a small, cheap comparative study to demonstrate whether these new technologies are indeed superior. Sadly, the Government are resisting such a study and insist that human biology-based tests are not better able to predict adverse drug reactions than animal tests, despite scientific evidence to the contrary.

[Roger Williams (Brecon and Radnorshire) (LD)]

The hon. Gentleman makes a compelling argument. Indeed, no one doubts his sincerity. However, if these human-based tests were more effective and cheaper than the animal tests, why are the commercially sensitive companies not taking that route? Why do they persist with animal testing?

[Mr Amess]

I am not going to fall out with a tough farmer, because the hon. Gentleman and I have perhaps slightly different views about animals generally. I understand his point, but he will be pleasantly surprised to find that there are many companies that now want to go for this different option. I have taken a lot of advice on it and we just need a little more encouragement from the Home Office and its advisers.

The attitude at the moment—I do not wish to be unkind to the Home Office—typifies the herd mentality that we are facing; a mentality that aims to promote quantity of opinion and that goes against the pioneering mentality of many breakthrough scientists. The comparison with human biology-based methods has attracted high-level support among scientists. Some 83% of GPs who were surveyed were in favour. Many colleagues have supported the early-day motion and I have received strong support for the Safety of Medicines Bill. All the scientists at the conferences of the Safer Medicines Trust in the House of Lords and the Royal Society were also in favour of my Bill.

The British Union for the Abolition of Vivisection is concerned that Britain is not one of the countries, such as Austria and Belgium, that has urged the European Commission to stand firm on an animal ban for cosmetics without exceptions, as was provisionally agreed by the European Union for 2013. That is not acceptable. Although I welcome the Government’s commitment to trying to encourage a reduction in animal experiments, there has so far been a lack of new initiatives to reverse what the evidence shows is a rising trend. I know that the Minister has received more than 20 proposals from the BUAV for policy changes. I very much hope that she will respond to those 20 points in correspondence.

Let me conclude with these thoughts. I am talking about negligible expenditure on a comparative study. The amount is quite small relatively, and—I say this to the hon. Member for Brecon and Radnorshire (Roger Williams)—pharmaceutical companies will willingly fund such a study, which would therefore not impose a cost on the public purse. Such a study could save the billions of pounds that are currently wasted on animal testing by reducing ADRs and boosting pharmaceutical company efficiency. Critically, the sheer scale of ADRs and the fact that they are increasing at twice the rate of prescriptions means that we have an ethical imperative to take action to address what is a serious public health problem, with reported deaths up by 155%, according to The Independent. The key question is this, and I hope that the Minister can answer it—if she cannot, I would appreciate it if she wrote to me: on what basis do the Government refute the evidence that a number of human biology-based tests have predicted ADRs that animal tests failed to predict?

As we move towards Christmas celebrations, we are drawn to the image of the nativity, with the infant baby Jesus and his parents surrounded by animals. The image and the link could not be clearer. I trust that the Government will reflect on what I have said today and ensure that the proposals in the Safety of Medicines Bill, which I introduced earlier this year through the ten-minute rule procedure, can be enshrined in legislation, as the final gift, after gold, frankincense and myrrh, to both kingdoms represented by the nativity.