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You and Yours - Transcript 大象传媒 Radio 4 |
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TX: 02.07.07 - Risk Discussion PRESENTER: PETER WHITE |
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THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT. BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE 大象传媒 CANNOT VOUCH FOR ITS COMPLETE ACCURACY. WHITE A drug treating multiple sclerosis is expected to get the go ahead when NICE - the National Institute for Clinical Excellence - issues draft guidance tomorrow. It's acknowledged to be more effective, much more effective, than others that have gone before but with it it carries higher risks. So how do we, as patients, decide what is a risk worth taking? And how do the scientists working on new drugs decide what is a risk too far? Well in a moment we'll be discussing some of these issues that it raises, with a scientist, a representative of patients and of the drug manufacturing industry. But first this from our reporter Carolyn Atkinson: ATKINSON Well historically medicinal drugs have been what are called chemicals, they're chemical compounds, they're made up of small molecules either derived from plants or synthetically made, so things like morphine or paracetamol for example. They're injected or taken orally and the active bit passes round the body and it works its magic. Now though we have a new group of drugs known as the biologicals, which incidentally are a British invention. Now they're larger molecules, they're proteins, and they're all antibodies. So the molecule targets very precisely one type of structure in the body which has gone wrong in a disease say like cancer and it works like a lock and a key, so it's much more effective. Now cancer treatments are a very good example that we can use to illustrate the difference between chemicals and biologicals. Chemotherapy, for example, the chemical approach is a widespread attack, as well as targeting the tumour it also affects the rest of the body quite adversely in some cases. Now the new biological approach would be drugs like Herceptin and Avastin, which have been in the news very much recently. They target a tumour and not the whole body but with that comes a much higher risk, they're much cleverer but there's much more that can wrong. Well this week it's expected that NICE will pass one of these new biologicals for some people with multiple sclerosis. It's called Tysabri, it reduces relapses by 60% and other drugs on the market only reduce by about 30% at the moment and the key bit is that it's the first MS drug which is proven in trials to slow the progression of disability. It was developed in a lab run by Professor Larry Steinman at Stanford University in California, he's a neurologist with 30 years experience and he says Tysabri is a new type of drug for aggressive types of MS but it raises the stakes for patients. STEINMAN We've reached the stage in MS where we don't understand the disease that well but we have some drugs that have significant benefit. Those drugs are very strong hammers against the immune system. In the case of Tysabri you're blocking most of the migration of white blood cells into the brain which is beneficial for MS but problematic because we need to fight infections. So you have this great potential benefit and small but deadly risk. And it forces a very, very complicated decision. ATKINSON Now that risk he's referring to is a condition called PML. Basically it's a fatal brain inflammation. It's triggered by a virus that 86% of us carry round the whole time. Now based on the clinical trials that he was referring to one in a thousand people got this PML. Now that happened during the final bit of the trial, what's called phase 3, so it was stopped. But unusually the US Food and Drug Administration, the FDA, had already licensed it before the trials had finished. So the scientists all went back to the lab, they tried to work out what had happened, they decided who was affected and who was not, they decided it was affecting people who were also taking a second type of drug. So the FDA gave it the go ahead again, put it back on the market there, it got a licence in Europe and it automatically gets one here in the UK. So this week NICE is expected to give it the go ahead for a very strictly controlled group of people with MS, like 52-year-old former civil servant Mary Burke from Liverpool. She took part in the worldwide trials and she then decided to continue taking it afterwards because you're allowed to and she says despite knowing about the risks she decided to stick with it and she hasn't had a relapse for more than five years. BURKE Before that I would have at least one bad relapse every year where I couldn't get out and about, I couldn't drive, very often I was so dizzy I crawled around the room rather than stand up because I don't like falling over. So you know that's for me the positive side. I'm not thinking when is the next relapse going to come. For me the risk of getting this terrible illness has been outweighed by the benefits that the drug has given me. I've been able to carry on my life as practically having nothing wrong with me. So for me it's worked. ATKINSON But the facts are on the leaflet aren't they, when you read the potential risk it's a very, very serious risk. BURKE Oh they did, they wrote it down - there is a danger of death. And I thought well I could get run over walking across the road. I know it's a very horrible death, I mean - and I'm not meaning to trivialise it all. Two people actually died and I know there's one been left very badly disabled. But I think if you get given any drug and you read all the leaflets you just wouldn't take them because there are so many side effects and so many things happening you think oh, and if you're the type of person who thinks oh no that's going to happen to me then you just wouldn't take anything. But I felt that it was worth it for me. WHITE Mary Burke. Well to discuss the issue of risk and how we deal with it I'm joined by Professor Colin Blakemore, who's head of the Medical Research Council; Neil Betteridge, chief executive of the charity Arthritis Care and Dr Phillip Wright, who's director of science and technology at the Association of British Pharmaceutical Industries, which is a trade body. Colin Blakemore, first of all, what's driving this, is this improved science or is this raised expectations by patients? BLAKEMORE Well it should be both things, in an ideal world they'd work together, that the needs of patients would be answered by the progress of science. And it's notable that this particular drug was first approved by the FDA by a fast track mechanism, ahead of the normal process of running all through the stages of clinical trials before the effectiveness and the safety of the drug were demonstrated to everyone's satisfaction. And it was approved by a fast track method because of the demands of the patient community. MS is a terrible disease, we don't know how to get treatments for it yet, so it's understandable that patients should want treatments more quickly. WHITE And quite briefly, how does that work, how is the - people's demand, because everybody wants to get better, how does that actually work running through as a line from patients wanting it to it ending up as a possible treatment? BLAKEMORE Well I think that Neil, sitting next to me here, can tell us more about that but patient groups and their representatives can be influential and effective. But also the fast tracking is based on the more rational quantitative analysis of what's called the burden of disease and particular needs and the benefits both economic and in health terms that would come from the more rapid introduction of particular new treatments. WHITE Neil Betteridge, in the specific case of arthritis, which you have, as well - you know you're chair of a users group, what are the kinds of choices patients can now expect to be able to make or perhaps to have to take? BETTERIDGE Well in arthritis, as in many conditions like MS, we've come a long way in a very short time, relatively speaking. And that's an important factor I think because a lot of the treatments we're talking about, like the biologics, are very young and we don't know yet what the long term consequences may be. So for example I developed juvenile arthritis in the mid sixties when I was three years old and my choice was aspirin or not to take the aspirin. So really we should be in an era celebrating some fantastic advances but actually we're in an era of some confusion. The lady from the Liverpool mentioned the patient information leaflet which listed death as a possible side effect, well the most commonly prescribed drug for people with rheumatoid arthritis is Methotrexate, which has exactly that. How do you process that information as a patient? And I think the only way to begin to answer that question is by the quality of the discussion that goes on between the patient and the clinician and as we've said the patient and sometimes the patient organisations who can provide advice. I just think we need to move away from that bold axis of a drug being either a killer or a wonder drug because most of the time they're neither. WHITE Well we'll come back to how you process that information but Dr Phillip Wright, first of all, this presents you with a problem because you're developing these drugs for us but how do you decide what is an acceptable risk? WRIGHT Well it is an interesting conundrum but there are three factors that companies take on board when they're actually looking to develop a new medicine. Firstly, obviously, the safety of the medicine, secondly is efficacy - I mean does it actually deliver the improvement in patient outcome that we want in the target patients - and of course medical need, where you have unmet medical need where there is a life threatening illness, some of the cancers which we still haven't actually targeted very effectively, where there's no effective medicine for those you may accept a higher risk in terms of patient possible adverse events than you would for a cancer where there is a number of existing treatments which are highly effective. So you have to balance these three factors if you're going to get something through. But I think I wanted to pick up the point that Neil made, I think the factors at the moment, the increase in complexity, the number of medicines that are available, the dialogue with the GP is critically important because it's not just about understanding the safety of a single medicine, it's understanding its safety in actual usage by the patient in their own home. WHITE And surely the problem is - it sounds to me as if you don't know, and doctors can't be quite sure, who is going to suffer. Mary Burke took the risk, she was told there was a risk, she's been okay. But you can't - can you really quantify? WRIGHT Well this is a big area for research at the moment, there's an awful lot of monies going into research looking at safety and the reasons why people have certain adverse events or don't react or don't respond positively to a medicine. We call it pharmicogenetics, it's quite a long word, but basically what we're doing is, is looking at the genetics of people and what that means in terms of how they absorb a drug, how they metabolise it, how they respond to it. And what we know is, for example, for asthma there's not one cause for asthma, there's a number of causes for asthma, which is caused by their underlying genetics. WHITE So Colin Blakemore, how are we going to do this, I mean especially when we live in a very litigious age I mean isn't there a real danger that people will listen to the information, rather like we listen to financial experts, and then our eyes begin to glaze over and we hear a lot of long words like the one we heard from Phillip just then and we actually think I don't think I can quite follow this and - but we might say that we do and we still might try to sue when it goes wrong? BLAKEMORE Well I think as has been said an awful lot depends on the relationship between the physician and the patient, the nature of the advice that's given and the role of the patient even in giving their explicit consent. I think it's very interesting to contrast the situation for drugs where people expect to be given a prescription to go and fill it at the chemist, to throw away the leaflet that comes with it and expect that it will be completely safe and that's the routine that we're into. As opposed to surgery for a life threatening condition, let's say a brain tumour or an aneurysm inside your brain, where you can sit down with a surgeon, he'll say to you look we're pretty good in this hospital, we have an 80% success rate, people get better, 10% of people don't and I'm afraid there's a certain chance you might actually die from the procedure, will you sign here to allow this to go ahead. There will be a discussion and people sign on the dotted line. Now imagine that a drug was released with a 10% chance of death, it would be inconceivable. We've got to find a border range between those two extremes in which patients are properly involved in understanding the nature of the risks and decide with their physician whether they're willing to take the risk. WHITE Neil Betteridge, disabled people lately have been calling for a choice, information, not to be patronised, isn't part of the deal that you accept the kind of deal that Colin Blakemore, Professor Blakemore's described, and you do sign on the dotted line, isn't that the only way to take that kind of risk? BETTERIDGE Yes that is one of the ways to take that risk certainly. Don't forget though that people have over the last 59 years now been conditioned I think by the health service to be fairly passive in what happens to them, to be done and to, and I think we are entering an age where actually government fully expect patients to be active participants in managing their own care and so on, which is great except to do that people do need access to the best available information. Then they're in a position to take on the responsibilities you've just described. People with long term conditions like arthritis take those difficult decisions day in day out, about whether to give up work, whether to try for a pregnancy and so on, things which could go terribly wrong for them given their condition. And medicines should take their part in that portfolio of decisions they have to make. It's a bit like Hollywood, you know at the end of a Hollywood film any disabled character either dies or gets killed, there's no in between, but life ain't Hollywood. WHITE No indeed. And Phillip Wright, how come it's not just about of course the patient, how do the drug companies feel about this new world where you've had cases in the past like the Northwick Park case, for example, where things did go wrong, are you equipped ready to operate in this kind of world where people know that they're taking and admit they're taking risks? WRIGHT Two things, I think Northwick Park was a particular and very different context of what was happening. That was in a phase one study in healthy volunteers. And just to put it in context, that was one study out of about - over a thousand going on around the world at any one time. So there are particular issues around that which would take too long to go into. But in terms of the companies, companies don't want to take a medicine which is going to - when it gets through into the patient population is going to suddenly appear to have unexpected safety issues. We want to understand as early as possible what the safety profile of a new medicine is. And interestingly myself and a number of companies are working with people like the Medical Research Council, we're discussing with clinical colleagues actually how can we identify some of these, what we call, clinical biomarkers, the clinical adverse event markers, and take that back earlier into drug development. And that's a critically important thing. WHITE I'm going to have to, as I feared, we've only just started this discussion but clearly it has to go on. Professor Colin Blakemore, Neil Betteridge, Dr Phillip Wright thank you all very much indeed. Back to the You and Yours homepage The 大象传媒 is not responsible for external websites |
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