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| Listen to this programmeFactsheet of this programmeTranscript of this programme Print this page FactsheetIn TouchRadio 4 TX Day and Date Tuesday 02/10/2007 TX Time 20:40 – 21:00 Line Identity 0800 044 044 MACULAR DEGENERATION Guests: Manchester ophthalmologist Michael Lavin; Tom Bremridge, of the Macular Disease Society; and Steve Winyard, Head of policy for the Royal National institute of Blind people The programme reports on the trialling of the drug Avastin as a treatment for wet macular degeneration and a possible alternative to the more expensive Lucentis. The trial is currently under way and is not seeking any further volunteers. ABOUT AMD The macula is located at the back of the eye at the centre of the retina. It enables us to see what's directly in front of us and allows us to see fine detail. It plays a vital role in helping people to read, write and drive, and perform other detailed tasks. It also enables us to recognise faces and see colour. Different types of AMD There are two types of AMD, 'dry' and 'wet': Dry AMD is the commonest form of the condition. Cells in the retina fail to function properly as a person gets older. The cells don't take in enough vital nutrients and fail to clear by-products of cell functioning. This causes tiny abnormal deposits, called drusen, to be left under the retina, making it uneven. In time, retinal cells degenerate and die causing sight loss. This occurs very gradually over many years. Currently, there's no treatment for this type of AMD, although there are vision aids available that can help people to maximise the use of their residual sight. Wet AMD accounts for 10 to 15 per cent of cases. It often develops quickly and is also known as 'neovascular AMD' because it involves the growth of new blood vessels behind the retina. These new blood vessels are very fragile and so may leak fluid or blood. This results in scarring that causes rapid visual loss. Fortunately, new treatments mean it's possible to treat the majority of cases. CAUSES It is unclear what causes AMD. It becomes more likely as a person ages because, over time, the cells in the macula become damaged and worn out. Both eyes are usually affected, although one eye may be affected before the other. The good eye usually compensates for the affected eye and for many years this can disguise the fact that there’s a problem. There's no pain or redness of the eyes. Because it's central vision that's affected, patients retain some residual vision, but this is at the periphery of their field of vision where images aren't in focus. Any activity that requires detailed, clear vision is compromised, and in the late stages of the disease sight loss is so severe that patients are offered registration as partially sighted or blind. TREATMENT Currently, there is no medical treatment for dry AMD. However, not smoking and eating a healthy diet may help to slow the rate of deterioration. Additional lighting and magnifiers can help those with dry AMD to make better use of their residual sight. Medical breakthroughs in the treatment of wet AMD mean that, in most cases, treatments can prevent further visual loss, and in some cases restore partial sight. There are three types of treatment for wet AMD: - Photocoagulation uses a hot laser to seal leaking blood vessels, but can only be used in a minority of cases where the leakage is not directly in the centre of the macula. - Photodynamic therapy (also known as PDT) uses a cold laser to seal leaking blood vessels. This involves injecting a drug that reaches and coats the abnormal blood vessels via the blood stream. The drug is then activated by shining a light at the coated blood vessels and it destroys them. - Anti-vascular endothelial growth factor (anti-VEGF) treatments target a protein involved in the formation of new blood vessels. High levels of VEGF can cause proliferation of blood vessels and fluid leakage. The drugs are injected under the macula. The number of injections varies. In trials the injections were given either every four or every six weeks, but in practice clinicians have to decide on the most appropriate treatment regime based on their assessment of the patient's response to the drugs. Anti-VEGF treatments have been shown to halt sight loss and in some cases restore it. One type of anti-VEGF treatment is currently licensed in the UK and most treatment is private. Patient groups are campaigning for treatment to be made available on the NHS. To find out if an anti-VEGF treatment would help your condition, talk to your eye specialist. CONTACTS THE MACULAR DISEASE SOCIETY PO Box 1870 Andover SP10 9AD Tel: 0845 241 2041 http://www.maculardisease.org/ The Macular Disease Society is a self-help society for those diagnosed with any of the eye conditions encompassed by the overall name of Macular Disease. The Society is dedicated to providing information and practical support so that those with the condition may make the most of their remaining vision. RNIB Royal National Institute of Blind People 105 Judd Street London WC1H 9NE Talk & Support Services telephone number: 0845 3303723 Helpline: 0845 766 9999 (UK callers only - Monday to Friday 9am to 5pm) Tel: 0207 388 1266 (switchboard/overseas callers) Web: www.rnib.org.uk The RNIB provides information, support and advice for anyone with a serious sight problem. They not only provide Braille, Talking Books and computer training, but imaginative and practical solutions to everyday challenges. The RNIB campaigns to change society's attitudes, actions and assumptions, so that people with sight problems can enjoy the same rights, freedoms and responsibilities as fully sighted people. They also fund pioneering research into preventing and treating eye disease and promote eye health by running public health awareness campaigns. NATIONAL INSTITUTE OF CLINICAL EXCELLENCE (NICE) http://www.nice.org.uk/ GENERAL CONTACTS RNIB Royal National Institute of the Blind 105 Judd Street London WC1H 9NE Talk & Support Services telephone number: 0845 3303723 Helpline: 0845 766 9999 (UK callers only - Monday to Friday 9am to 5pm) Tel: 0207 388 1266 (switchboard/overseas callers) Web: www.rnib.org.uk The RNIB provides information, support and advice for anyone with a serious sight problem. They not only provide Braille, Talking Books and computer training, but imaginative and practical solutions to everyday challenges. The RNIB campaigns to change society's attitudes, actions and assumptions, so that people with sight problems can enjoy the same rights, freedoms and responsibilities as fully sighted people. They also fund pioneering research into preventing and treating eye disease and promote eye health by running public health awareness campaigns. HENSHAWS SOCIETY FOR BLIND PEOPLE (HSBP) John Derby House 88-92 Talbot Road Old Trafford Manchester M16 0GS Tel: 0161 872 1234 Email: [email protected] Web: www.henshaws.org.uk Henshaws provides a wide range of services for people who have sight difficulties. They aim to enable visually impaired people of all ages to maximise their independence and enjoy a high quality of life. They have centres in: Harrogate, Knaresborough, Liverpool, Llandudno, Manchester, Newcastle upon Tyne, Salford, Southport and Trafford. THE GUIDE DOGS FOR THE BLIND ASSOCIATION (GDBA) Burghfield Common Reading RG7 3YG Tel: 0118 983 5555 Email: [email protected] Web: www.guidedogs.org.uk The GDBA’s mission is to provide guide dogs, mobility and other rehabilitation services that meet the needs of blind and partially sighted people. ACTION FOR BLIND PEOPLE 14-16 Verney Road London SE16 3DZ Tel: 0800 915 4666 (info & advice) Tel: 020 7635 4800 (central office) Web: www.afbp.org Registered charity with national cover that provides practical support in the areas of housing, holidays, information, employment and training, cash grants and welfare rights for blind and partially-sighted people. Leaflets and booklets are available. NATIONAL LEAGUE OF THE BLIND AND DISABLED Central Office Swinton House 324 Grays Inn Road London WC1X 8DD Tel: 020 7837 6103 Textphone: 020 7837 6103 National League of the Blind and Disabled is a registered trade union and is involved in all issues regarding the employment of blind and disabled people in the UK. NATIONAL LIBRARY FOR THE BLIND (NLB) Far Cromwell Road Bredbury Stockport SK6 2SG Tel: 0161 355 2000 Textphone: 0161 355 2043 Email: [email protected] Web: www.nlb-online.org The NLB is a registered charity which helps visually impaired people throughout the country continue to enjoy the same access to the world of reading as people who are fully sighted. DISABILITY RIGHTS COMMISSION (DRC) Freepost MID 02164 Stratford-upon-Avon CV37 9BR Tel: 08457 622 633 Textphone: 08457 622 644 Web: www.drc-gb.org The DRC aims to act as a central source of advice on the rights of disabled people, while helping disabled people secure their rights and eliminate discrimination. It can advise on the operation of the Disability Discrimination Act (DDA). DISABLED LIVING FOUNDATION 380-384 Harrow Road London W9 2HU Tel: 0845 130 9177 Web: www.dlf.org.uk The Disabled Living Foundation provide information and advice on disability equipment. THE MACULAR DISEASE SOCIETY PO Box 1870 Andover SP10 9AD Tel: 0845 241 2041 http://www.maculardisease.org/ The Macular Disease Society is a self-help society for those diagnosed with any of the eye conditions encompassed by the overall name of Macular Disease. The Society is dedicated to providing information and practical support so that those with the condition may make the most of their remaining vision. OPTIMA LOW VISION SERVICES Web: http://www.optimalowvision.co.uk/ The BBC is not responsible for external websites General contacts Back to top TranscriptIN TOUCHTX: 02.10.07 2040-2100 PRESENTER: PETER WHITE PRODUCER: CHERYL GABRIEL White Tonight we return to the debate about the most effective and the most cost effective treatment for the eye condition AMD and ask are they the same thing. Twenty six thousand people in Britain each year are diagnosed with Age Related Macular Degeneration - AMD is the commonest form of sight loss in Britain amongst older people. In one form of the condition, known as wet AMD, new blood vessels form at the back of the eye but are fragile and therefore weak and cause scarring which in turn leads to rapid sight loss. It's this form of the disease which is most aggressive but it's also this type which can be halted and even reversed by new drugs. In particular two closely related drugs - Lucentis and Avastin - have both achieved very effective results. But at the moment of the two only Lucentis is licensed for use in this country. The problem with Lucentis is that it's very expensive, a year's treatment of six to eight doses can cost around £10,000. The unlicensed Avastin costs only a fraction of that amount but is it really as effective and is it safe? Well the Department of Health recently announced a trial to make a direct comparison between the two but the results of that could be at least four years in coming. Meanwhile, ophthalmologists in around 15 primary care trusts have taken the bull by the horns, declared Avastin is safe enough for them and prescribed it to patients desperate for treatment. But the Royal National Institute of Blind People has said that they can't recommend it before it's been properly trialled and licensed and that blind people should not be used as guinea pigs. So who's right? First, let's hear from two ophthalmologists with opposing views. First the case for prescribing Avastin now and whenever possible, licence or no, from Manchester ophthalmologist Michael Lavin. Lavin Doctors worldwide written specialists of great experience cannot distinguish between the two drugs in terms of their effects, their improvement in vision achieved or their side effects. What we do know is that Avastin appears to last longer and may require fewer doses. Most importantly we know a great deal about Avastin from its use in cancer so we can be very comfortable from the evidence obtained of very high doses in cancer patients that it is quite safe for the doses used in the eye. White But of course that is the issue - it's been licensed for cancer in this country, it's not been licensed for eye use should we not take proper cognisance of the licensing programme, after all what's licensing for if it's not to tell us that something is safe? Lavin A good question. Licensing isn't to tell us that something is safe, licensing is a way of controlling the behaviour of the drug owner in the commercial marketplace when it wishes to sell a drug and in terms of the claims it makes. So once a drug is licensed it can be used for any number of other reasons, off label reasons, when a doctor and a patient are satisfied that it will do the job. It's used in almost 100% of Dutch and New Zealand patients receiving injections into the eye for wet macular disease. It's used in about 85% of German patients receiving these treatments. In 50-60% of American patients. And at present the NHS doesn't offer routine access to either - Avastin or Lucentis - leaving our patients to suffer needless blindness. White So why, do you think, Novartis doesn't want Avastin to be licensed in this country? Lavin There are commercial links between Roche, Novartis and Genotech. These companies are quite legitimately pursuing their commercial interests, they have a duty of care to their shareholders and the commercial concerns of the company need not coincide with those direct concerns of a patient and a doctor. I'm a doctor and I'm concerned to get the best treatments for my patients. Current NHS policy does not allow us to deliver these treatments to our patients and the RNIB policy, in focusing on licensing, is focusing on a commercial issue, not on patient requirements. For many patients who cannot obtain treatment via the NHS cost is a very major issue and an NHS that seeks value for money can use the money saved from any other treatments. White Ophthalmologists have been told by PCTs if you prescribe this you do it at your own risk, are you quite confident in doing that? Lavin I'm confident that the data that I've read is reliable and prepared by doctors who are careful and have studied the matter in great detail. I'm quite prepared to take these risks for my patients, jointly with them, after they have fully understood the issues. White The RNIB says it's taking its advice from the Royal College of Ophthalmologists and that they are taking this cautious line, you're presumably a member of that, why do you think that is? Lavin I think the Royal College of Ophthalmologists has been extremely slow to adapt to the evidence base. Its advice does not reflect changes in practice worldwide. Retinal specialists worldwide adopted these sight saving treatments at a very early stage when it was patently obvious to all concerned that these treatments made a very dramatic and real difference to our patients facing blindness. The College of Ophthalmologists only changed their advice in May 2007, whereas most retinal specialists changed their practice at the end of 2005. You'd have to ask the college for their own comments. White Well I intend to do precisely that. Professor Jonathan Gibson is an ophthalmologist at Hartlands Hospital in Birmingham and he speaks today on behalf of the Royal College of Ophthalmologists. Professor Gibson, so why are you so sure that Avastin is at this stage something which can't be approved? Gibson The issue with Avastin is it is, as you know, an off label drug which means that as yet we still don't have any long term safety and efficacy information about it. I know it's being used worldwide in thousands of patients now but it's still the case that it is being used in an unlicensed format and the trouble is the GMC guidelines tell us that as a doctor to use a drug we have to be satisfied that it would better serve the patient's need than an appropriately licensed alternative. And because we have a licensed alternative in the form of Lucentis we would have to - the GMC is - beholds upon us to be absolutely sure that we have a better drug. Now at the moment we don't know if Avastin is better or as good as Lucentis. White Can I just quote something from the chair of your own scientific committee on Avastin and he says the assertion that more than 10,000 intravitreal injections have been given worldwide without any complications is it extremely worrying as this is statistically impossible. The implication is that complications aren't looked for or remain unreported. Now that's in Eye News. It does sound a bit like hunting with the hounds and running with the hares - it's a bit like saying if there are complications then we will draw attention to them, if there aren't we'll say that that's worrying too. Gibson Yeah I mean the issue is that complications with Avastin, because there hasn't been any long term clinical trials so far, they're very much self-reported by the ophthalmologists using it. As far as we can tell there aren't any major complications. At the moment we're relying on sort of self-reporting of ophthalmologists and perhaps you know that's not as good as a clinical trial. White Michael Lavin has suggested that licensing is a bit of a red herring, he suggests that that's about commercial viability and commercial respectability, it's not about the safety of the drug. Gibson Yes, I mean I take that point, I mean it's being used in thousands of patients worldwide and in probably many patients in the UK but we don't have any sort of clinical trial data and that's the gold standard that we base our safety decisions on. I mean for instance there hasn't really been any trials, as far as I'm aware of, to work out the correct dose of Avastin, it's just been arrived at one that seems to work. And that's very unusual for drugs coming into the Western world now, we normally have phase 1 trials to work out exact dosing and to make sure that they're safe and don't have side effects. Avastin fortunately seems to work with the dose that was tried. I mean obviously as time goes by we're getting more and more information about its use because it's being used off label in many patients. I mean eventually the volume of evidence may be overwhelming for it and if the Department of Health changes its view on the PCTs being able to take responsibility for the use of unlicensed drugs then the college will probably change its view as well. White Well listening to those two assessments have been Tom Bremridge of the Macular Disease Society, he's the chief executive and Steve Winyard, head of policy at the Royal National Institute of Blind People and he's in our Blackpool studio at the Conservative Party Conference. Steve Winyard, one of the RNIB's charter objectives is the prevention of blindness and in your literature you say we therefore seek to ensure that new sight saving treatments are quickly available on the National Health Service. Is this the most effective way to go about that in this example of Lucentis and Avastin? Winyard Just let me stress, we in all of this are very much following the line of the Royal College of Ophthalmologists and the Royal College has observed, very recently, as Professor Gibson has noted that there's insufficient data on the long term efficacy and safety of Avastin. He also mentioned the gold standard of randomised control trials, that's what RNIB, going back many, many, many years, new treatments are brought forward, people seek RNIB support for new treatments and we'll always say well what's the evidence and what's the evidence from randomised control trials? And in the case of Avastin it doesn't exist. White But time is of the essence here isn't it because real people are losing - I don't want to use overly emotive language but that is the truth of the matter and it's people like that that you're there to represent. Winyard And the truth of the matter is that the great majority of primary care trusts and an increasing number of primary care trusts are providing a Lucentis service and we're working with the Macular Disease Society to persuade more of them to do that. And most are. It's just a number who seem to be willing or the consultant ophthalmologists seem to be willing to take the risk or indeed they're being pressured by their primary care trust - go for the cheap option. White Right, but cost is a factor, you must understand that, cost - mathematics say that it stands to reason that if one form of treatment is vastly more expensive than another, which many people say is just as good, that you can treat many more people more quickly by using the cheaper one. Winyard Well that's right and that's why we want the safety data for Avastin. And when we have that and if it's shown to be safe and is effective then clearly there's going to be a very, very powerful case for Avastin being used but we're not in that position at the moment. White Let me bring in Tom Bremridge of the MD Society. Where does the Macular Disease Society, which is a self-help group, so you're very close to your members, where do you stand on this issue? Bremridge Well our focus is entirely on patients. We're not promoting either treatment and we depend on the judgement of ophthalmologists, individual ophthalmologists, and it is at the moment, as you know, it's down to a 152 PCT areas to make decisions on these things. And we want to get as many patients treated as possible. If a local ophthalmologist decides that Avastin is what he's going to use and having looked at the evidence he decides that with the primary care trust he'll allow it to be used we have absolutely no objection at all. But I would like to say we're not promoting either treatment. White So what's your view of the RNIB's stance? Bremridge I respect their position. They are in a semi-regulatory position in that they are giving advice and they are to some extent, I think, as you heard Professor Gibson saying, led by the General Medical Council. But I think the whole question of off label, we can be driven down a siding by this. Don't forget that Lucentis is being used off label quite happily to treat myopics and to treat some of the dystrophies and diabetic retinopathy and nobody's blinked an eyelid about that. White So you think Avastin - you differ from the RNIB in thinking that Avastin could be used off label, it's okay for it to be used off label? Bremridge Absolutely, we've got no problem about it at all. White Steve - Steve Winyard, the RNIB has a close relationship with Novartis which markets Lucentis in Europe and you list donations from Novartis in your public annual report of 2005/2006 to the tune of almost £100,000. That's money which is used I think to assist something called the AMD Alliance UK. Doesn't such a close relationship with the company which effectively sells this drug, doesn't that cast doubt on how objective you can be when advising or campaigning about them? Winyard Well let's put this in context. A hundred thousand is point one percent of RNIB's annual income, it's a tiny amount and our position is, as I've said repeatedly Peter, is completely based upon the position of the Royal College of Ophthalmologists ... White Yeah it's such a tiny amount is it worth compromising your neutrality by actually accepting money from them? Winyard It's not compromising our neutrality at all we in fact take money, I think, from six pharmaceutical companies, we take money from Barclays Bank, we take money from a very, very wide range of corporate - corporates and in no way is our policy influenced by those. You know I mean the BBC takes virtually all of its money from government and I'm sure you would be the first to jump in and say no we're not influenced by government. You know it's a very simplistic view. You get it from the government and that's who decides how much you get. So clearly we're not influenced by these very small sums. What we are influenced by, as you quite rightly said, is our Royal Charter objective which is the prevention of blindness and that's why we're pressing hard for a positive decision from NICE. NICE hasn't been mentioned at the moment but that's the body that is going to be taking a decision about cost effectiveness of Lucentis and Macugen. White Well I will mention NICE. You've pressed NICE to recommend the prescription of Lucentis in a far greater number of cases than they have. Sir Michael Rawlings, NICE's chair, has questioned the relationship that a number of charities have with drug companies in an article in The Times, he's quoted as saying: The Times article In the long term it will do the patient organisations an immense amount of damage and the confidence in their neutrality will dissipate. It certainly is distasteful. And he went on to say: I hope the members of my appraisal committee keep their minds clear but there is always a worry that they will be tainted and that he who shouts the loudest gets it. Hasn't he got a point there because I've not heard you ask on this programme why is Lucentis so expensive? Winyard The reason it's expensive is because these new treatments have in fact gone through phase 1, phase 2 and phase 3 trials and those are very expensive to run, as I understand it, whereas of course Avastin hasn't. And if you put Avastin through the full phase 3 - 3 phase trial process it would be a lot more expensive. Trials do cost a lot of money. White Of course they do cost a lot of money but essentially that's not your problem, is it, we understand of course that drug companies have to make their research and development money back, they have - they're selling a product but that's not your problem, your problem is to get the best possible treatment for as many blind people as possible as quickly as possible. Winyard That's right and that's why we're very supportive of the Ivan trial and the trial in the United States, we want these trials to go ahead as quickly as possible. White Tom Bremridge, the AAT, that's Action for AMD Treatment, which are currently operating, people can ring them and get advice, that too is funded by Novartis, doesn't that too put a question on the independence of the advice that can be given? Bremridge No I don't think it does. We have had no core funding from Novartis at all and they have given us £6,000, along with four other companies to help produce our standard guide to Age Related Macular Degeneration. So we feel not obliged to anybody as far as our advice or decision making is concerned. But as far as AAT is concerned, this is a project which is funded by Novartis and we're very glad that it has been. I don't think it taints us or puts pressure on us in any way because the AAT service is not striving for Lucentis treatment, it's striving for a treatment for people and they remain completely neutral and must go on remaining completely neutral about what drug is given. It's down to the individual primary care trust and ophthalmologist to make that decision. And Action for AMD Treatments, uncomfortable as it may be for Novartis, have obtained treatment for people and in many cases it's turned out to be Avastin. White Ruby Harris has AMD, she lives in the Manchester area and so was one of those people who was offered Avastin, having been told that there was no chance there that she would get Lucentis, having weighed up the evidence herself she made a conscious decision that she'd go for it. Harris I have to tell you that with all the reading I've had, all the literature I've had, from the MD and the TNAUK newspaper article, I came to the conclusion that if I didn't do something about it and take the risk I would end up going blind. And even the consultants didn't promise anything, they said sometimes some people have - you see it's all so new that I don't think the consultants are hundred percent sure about what the results will be. So you do take a risk and I've taken the risk. I'm in me 82nd year and halting it is imperative. White Steve Winyard, aren't those the kind of risks that people want with the right advice to take and are the RNIB perhaps being over cautious here in their approach? Winyard As Tom has rightly said in the end there's going to be a relationship, a conversation, between a consultant and patient and what must happen in that conversation is full informed consent. White Steve Winyard, Tom Bremridge thank you both very much indeed. You can call us on 0800 044 044. From me Peter White, my producer Cheryl Gabriel and the rest of the team goodbye. Back to top |
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