Chris Williamson
Main Page: Chris Williamson (Independent - Derby North)Department Debates - View all Chris Williamson's debates with the Home Office
(13 years ago)
Commons ChamberI 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.
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.
I can assure all Members in all parts of the House that the Government want the development of those medicines to continue, as long as a responsible and careful attitude is adopted to the animals that are used in the quest for better medicines. Those who conduct such experiments must adhere to the stringent standards to which I have referred, and search further and harder for alternative technologies. When I visited University College hospital recently, I saw some of the machinery that it is using instead of animals. The advances that have been made, have almost been made or will be made in the near future are amazing, and I am sure that any institution, whether a university, a scientific research establishment or a commercial venture, will want to provide the best conditions for their animals in order to get the best results.
On that basis, will the Minister assure us that we can look forward in the next few years to a significant reduction in the use of animals in experimentation, given that alternative methods are now available and more are coming on stream?
My intention and job is to push as hard and as far as I possibly can. In that, I have to be advised by the scientific community, my advisers, the Animal Procedures Committee and other groups, and I often meet animal rights and welfare groups to ensure that I get the balance right. I cannot give a definitive number, but the intention is to secure a reduction, as promised in the coalition agreement, in the use of animals. The NC3Rs is doing some amazing work and incentivising scientists to be innovative and to come up with good things that people will want to use. I have not brought the brochure with me but it was incredibly impressive on some of the changes that it is delivering. However, we can only go at a pace that can be gone at because, as the hon. Member for Strangford (Jim Shannon) said, I would not wish to inhibit genuine advances in what we can do to preserve human life.
Although there are differences between animals and humans, there are also many similarities, and it is these similarities that scientists seek out when choosing and developing animal models. In most cases, because body systems in other mammals tend to work in similar ways to those in humans, animal tests can predict how the human body will react to a new drug. Otherwise, they would not be used. It would be useless.
On the safety of medicines, which goes to the heart of this debate, animal studies are considered to be an indispensable component in the assessment of the safety and efficacy of a new medicinal product. Without animal testing, it is highly likely that a large number of potentially dangerous medicinal products would have to be tested in healthy volunteers and patients in clinical trials. That would be quite unacceptable. I shall mention micro-dosing in a moment.
For a medicinal product to be granted a licence, European and international legislation requires that the toxicity profile of a new drug be defined. In part, that entails the use of animal studies. Nevertheless, I accept the point made by my hon. Friend the Member for Southend West that the earlier a potential new drug can be safely tested in humans the better. Companies are pursuing this through methods such as micro-dosing, but that approach does not replace animal tests entirely.
On the use of new technologies and non-animal tests, I can assure my hon. Friend that, contrary to his fears, the testing of medicines has evolved and that new scientific methods, including those using human tissues, are being used and do have a place in safer medicine testing.
Today’s approach to drug development has evolved on a rational and scientific basis over more than 30 years and involves an integrated programme of computer-based work, in vitro studies, animal testing and clinical trials. I can report from my own observations on a recent visit to one of our leading universities that modern researchers use a variety of in vitro and computer-based methods alongside animal methods.
My hon. Friend mentioned adverse drug reactions. This is a far more complex matter than it at first appears. Like other Members, I have personal experience of this, as I am allergic to some common drugs that most people can take without difficulty. I attribute that not to an inherent fault in the drugs, which seem to work perfectly well for millions of other people, but rather to a quirk in the way my body reacts to them. I am allergic to certain antibiotics.
More generally, I think it is going too far to suggest that the occurrence of adverse drug reactions can be attributed to flaws in safety testing using animals. It has been estimated that 76% of adverse drug reactions are what are known as type A reactions, in which the medication has a predictable, but exaggerated, effect. Of the remaining, unexpected type B reactions, most are the result of allergies, such as mine, or individual susceptibilities that are difficult to predict in any trial.
On the attrition rate in the development of new drugs, new drugs are first tested in batteries of computer-based and in vitro tests. Refinements of these tests, including by using human tissues, are making them increasingly predictive. Many compounds are rejected as a result of findings from these tests before they are even tested in animals. It is true that at the next stage, as a result of adverse findings from animal studies a large number of drug candidates never progress to being tested in humans. However, as I have already mentioned, companies hope that this attrition rate will be reduced by using human material.
Finally, on the value of animal research, it is at present the case that without the judicious use of animal studies we would have no modern drugs, and we should acknowledge that the national health service would be unable to function effectively were it not for the availability of medicines and treatments that have been developed, or validated, through research using animals.
As I have explained, the Government are committed to minimising animal testing and to encouraging the development of other non-animal methods in place of animal testing where possible. The National Centre for the Replacement, Refinement and Reduction of Animals in Research brings together stakeholders in academia, industry, Government and animal welfare organisations to facilitate the exchange of information and ideas and the translation of research findings into practice that will benefit both animals and science. We will continue to give the work of the national centre our wholehearted support.
My hon. Friend the Member for Southend West asked the key question at the end of his speech: on what basis do the Government refute the evidence that a number of human biology tests predicted adverse drug reactions that animal tests failed to predict? The Government do not doubt the value of human biology tests in the testing of the safety of medicines, but it is important to recognise that all medicines have the potential for unwanted effects. There is not one in vitro test, or one series of in vitro tests, specifically for adverse drug reactions. It must be recognised that even extensive clinical trials in humans do not always predict the adverse drug reactions seen later when drugs are in widespread use.
If I have omitted to answer any of my hon. Friend’s questions, I will write to him. I thank him and all Members who have participated. This has been a valuable and thought-provoking debate, and I am grateful to my hon. Friend for securing it.
Question put and agreed to.