News
July 2008
Pleural plaques
A consultation produced by the Ministry of Justice is available on the Ministry of Justice website: www.justice.gov.uk
Mesothelioma UK Update July 2008 (extracts)
Chemotherapy in Mesothelioma Project (ChiMP)
It is very encouraging to see the way recruitment to the ChiMP audit has taken off. We are all hopeful that this will provide some really useful data to support the development of services for mesothelioma patients.
Data from the National Lung Cancer Audit in 2006 was patchy on mesothelioma, but only 10% of patients were recorded as having received chemotherapy. ChiMP has recruited 155 patients in less than 5 months which should mean we will reach about 400 within the year, suggesting we have captured a significant proportion of those receiving treatment. Many thanks to all of you who have entered patients! To those who haven’t yet, we hope you appreciate the potential value of this project and will start to put patients in.
Out of the 155 patients registered we have 53 patients with complete data. If you require any help or need further advice either with registration or the data set, please do not hesitate to contact me either by email or telephone through the mesothelioma website.
Don’t forget for every complete set of patient data sent to us £15.00 will be paid into a study/research fund or in book tokens at the end of the audit year. Please ask for details. Jill Lemon – ChiMP Audit Manager Email: jill.lemon@uhl-tr.nhs.uk
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TRIALS UPDATE
Changing routine clinical practice requires reliable evidence from randomised trials, and, for numerous reasons, few such large trials have been conducted in Mesothelioma. Radical surgery is only possible for a tiny minority of patients, radical radiotherapy is inappropriate in this disease, and few chemotherapy drugs have been shown to be active. The MRC MS01 trial which was recently reported in the Lancet (Muers et al, Lancet 2008, 371, 1685-94) was the 2nd largest randomised trial so far reported in this disease, but did not give a clear green light for the use of chemotherapy. It could be argued, of course, that the chemotherapy regimens used had been superseded, but that is the dilemma of large trials, which can take up to 10 years from design to publication. Embarking on such projects therefore requires some belief that the treatments being investigated will be of relevance a decade hence. However, we are now in the era of new agents and molecular markers, and future treatments will almost inevitably be based around attempting to select the best treatment for each individual patient. In Mesothelioma we know that only a small proportion of patients respond to chemotherapy, but if we can identify those patients upfront we can potentially improve the lives of both the patients who then receive that chemotherapy, and those who don’t, who will be spared the burden of pointless chemotherapy. The challenges therefore, perhaps before we embark on another large randomised trial, are to identify some strong predictive biomarkers and subsequently build trials around them. Richard Stephens MRC Clinical Trials Unit –
Email: rs@ctu.mrc.ac.uk
MARS
97 patients have now been recruited to the registration phase of MARS. A big thank you to all of you who have been working hard to recruit these patients. However, we still have some way to go if we are to achieve our goal of randomising 50 patients by September 2008 (when funding for the recruitment phase from Cancer Research UK (CRUK ceases). By the end of May 2008 41 patients have been randomised. There is therefore a need to register as many patients as possible by the end of June, so that their chemotherapy and other investigations are complete prior to eligibility review and randomisation. Email: mars-icrctsu@icr.ac.uk
MALCS/TIPS
A new centre for TIPS (The Inhaled Particles Study) patients (BirminghamHeartlandsHospital) is now active. We are contacting patients. who have had a spontaneous pneumothorax on behalf of the team at BHH.
MALCS (Mesothelioma and Lung Cancer Study) continues to recruit steadily. We have had 157 notifications of cases of Mesothelioma, since March 2007.
The report from the first part of the study is still awaiting publication and peer scrutiny. It is hoped that this will soon be published.
We would like to express our continuing gratitude to all patients who are involved with our research. It is only with the help of patients, that we may be able to understand more about the disease and its epidemiology. We would also like to thank all those involved in recruitment to the study, and to encourage you to continue, your help is invaluable to us.
If you are not recruiting and would like to please contact us at MALCS@icr.ac.uk or phone 0208 722 4298 and ask for the MALCS team in Epidemiology.
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Proposal for a randomised controlled trial investigating the role of prophylactic radiotherapy to intervention sites in malignant mesothelioma
Patients with malignant pleural mesothelioma (MPM), who undergo chest instrumentation, may develop seeding at the site of intervention, leading to subcutaneous tumour.
This is believed to be reduced by the common practice of prophylactic irradiation to intervention tracts (PIT). However, evidence to support PIT is currently inadequate and contentious. Recent studies have thrown this practice into question but have not provided definitive answers due to underpowering. The British Thoracic Society and the French Speaking Society for Chest Medicine advocate the use of PIT, but other organisations recommend against it.
We recently carried out a national survey of PIT in MPM (54 centres). Out of the 45 centres that replied, 76% practiced PIT, yet 70% of respondents wanted a trial to determine PIT efficacy (31 centres). We propose a randomised controlled trial of PIT versus no PIT (21Gy in 3 fractions) for newly diagnosed mesothelioma patients, pre commencement of any planned systemic treatment, to see if this practice reduces the occurrence of chest wall nodules post instrumentation. To show a reduction in occurrence of nodules from 20% to 5% with a power of 80%, we would need 81 patients in each arm. We plan to stratify for chemotherapy, type of intervention and centres. An outline proposal has been submitted to the NCRI Lung Clinical Studies Group. If the PIT trial is supported we are planning to submit it to CTAAC in the autumn for funding. Email: Corinne.Finn@christie.nhs.uk
Dr Corinne Faivre-Finn
MD, PhD, FRCR
Department of Clinical Oncology, ChristieHospital NHS Trust, Wilmslow Road, Manchester, M20 4BX. UK.
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July 2008
Asbestos Victims Support Groups Forum UK Update
Mesothelioma Provisions in the Child Maintenance and other Payments Bill
It is expected that the provisions in the Bill relating to mesothelioma lump sum payments will be enacted in October 2008. The Department for Works and Pensions will be holding seminars in September in major cities on the new provisions and the new scheme application forms.
The Bill, once enacted, will provide for a new scheme to make lump sum payments to mesothelioma sufferers who do not qualify for a payment under the Pneumoconiosis etc. (Workers Compensation) Act 1979 (1979 Act) and for those who are ineligible for Industrial Injuries Disablement Benefit, so that ALL mesothelioma sufferers will receive a lump sum payment. Payments under the new scheme will be commensurate with amounts recovered under the 1979 Act, and will be less than 1979 Act payments for about three years by which time payments should be equalised.
Most importantly, we understand that the 12-month time limit for an application for a ayment under the new scheme will NOT apply for the first year.
Employers Liability Compulsory Insurance
The government intends to revoke the 1999 regulation requiring employers to retain insurance policies for 40 years. Each year, hundreds of claimants fail to receive compensation because insurance policies cannot be traced for employers who are no longer trading.
If the government refuses to listen to the many representations from MPs, the TUC, PIL and asbestos victims support groups, and revokes the regulation without putting in place other safeguards, such as a statutory requirement for employers to record insurance policies on a central database, the government will be justifiably condemned for undermining its stated intention of speeding up mesothelioma claims and helping mesothelioma sufferers.
To see Commons early day motions in employers’ compulsory liability insurance 1829 and 1839 go to: http://edmi.parliament.uk/EDMi/EDMList.aspx
Pleural Plaques
The Damages (Asbestos-related Conditions) (Scotland) Bill was published on the 24 June 2008. The Bill allows an application for damages for pleural plaques, symptomless asbestos-related pleural thickening and asbestosis, so that the House of Lords decision on pleural plaques would cease to apply in Scotland.
The Bill and ancillary documents are available on the Scottish Parliament web site: http://www.scottish.parliament.uk/s3/bills/12-Asbestos/index.htm
The Government, which is opposed to overturning the House of Lord’s decision, will issue a consultation document on pleural plaques in July 2008. A scheme has been mooted which would pay a fixed payment to all plaques sufferers and allow a claim for damages should another asbestos-related disease develop. The Industrial Injuries Advisory Council (IIAC) which advises the Secretary of State for Works and Pensions about Industrial Injuries benefit has been asked to conduct a review of pleural plaques. Information about the review, and how to give evidence to the review, can be obtained from the IIAC website:
http://www.iiac.org.uk/pdf/reports/asbestos_pleural_plaques_200608.pdf
Anthony Whitston – Email: asbestos.gmavsg@virgin.net
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April 2008
MESOTHELIOMA UK UPDATE
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TRIALS UPDATE
MARS
MARS (Mesothelioma and Radical Surgery) is a multi-centre randomised controlled trial comparing extra-pleural pneumonectomy (EPP) (within the context of tri-modality therapy) versus no EPP. The trial is sponsored by Guy’s and St.Thomas’ NHS Foundation Trust and is currently in the feasibility phase aiming to randomise 50 patients. This will allow reasonable inferences to be drawn regarding recruitment, compliance and feasibility of surgery.
At diagnosis, and following consent, potential MARS patients are registered into the pilot study from one of 14 local participating centres. Patients are then prescribed 3 courses of a platinum based chemotherapy and undergo mediastinoscopy. Following re-staging patients are then reviewed by a virtual multi-disciplinary team (vMDT) comprising members of the Trial Management Group and includes the Chief Investigator (Tom Treasure), at least one surgeon, radiologists, oncologists and members of coordinating trial team within the Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU). The patient’s clinician from the local centre is also invited to join in the discussion.
Following evaluation of suitability for surgery and radical radiotherapy, eligible patients are asked to consent to randomisation. If the patient is allocated EPP this will be performed at one of three specialist surgical centres (currently Guy’s, Leicester or Leeds) and will be dependent upon geographical location (where possible) but also on surgeon availability. Further surgical centres are at present proceeding with approvals which will provide patients with wider availability across the UK.
It is expected that patients who have had EPP surgery will also undergo radical radiotherapy, provided at a separate radiotherapy centre if the local centre is unable to provide this service.
The pilot phase has taken considerably longer than expected to set up, given the need to establish complex logistical and clinical arrangements. Recruitment is now steadily increasing and Cancer Research UK have extended the funding to the Autumn of 2008 by which time recruitment must be complete.
By mid April 2008 ninety-seven patients had been recruited to the registration phase and forty randomised. Centres are therefore urged to screen all mesothelioma patients for entry into MARS to help achieve the target accrual by September 2008. The next phase of conducting a mesothelioma surgical trial will then be considered at a general meeting to which all those involved will be invited.
We are very grateful to all clinicians and research nurses for their hard work in helping with this very important trial and our sincere thanks go to the patients who have kindly agreed to take part.
If you would like any further information please contact The MARS Trial Office via email mars-icrctsu@icr.ac.uk or one of the team on 020 8722 4057/4039.
MALCS
MALCS (UK National Mesothelioma and Lung Cancer Study) was set up over 6 years ago to estimate the Mesothelioma and lung cancer risks caused by specific occupations and work practices across the UK, particularly those involving asbestos exposure. A report based on the first 624 Mesothelioma patients and 1420 controls has been submitted for publication. The well known asbestos exposure hazards in dockyards, on ships, in asbestos factories, in power generation and in insulation still account for 25% of all Mesothelioma cases; but the majority of cases are in construction or other industries.
Part 1 Results
The lifetime Mesothelioma risk for British men born between 1940 and 1960 who did more than 10 years of relevant work before age 30 will be about 6% for carpenters and 2% for plumbers, electricians and painters, with lower but still substantial risks to general construction and other workers exposed to asbestos. The lifetime risk in unexposed men and women (about 0.1%) is doubled in those who lived with an exposed worker before age 30. There was no overall risk in men and women who reported living within a mile of an asbestos factory, shipyard or power plant. The excess of lung cancer in “asbestos exposed workers” appears to be similar to the Mesothelioma risk.
Are you Recruiting?
MALCS is open until 2015. The patient completes a postal questionnaire (not a telephone interview as in part 1). Britain already has the highest Mesothelioma rate worldwide and the rate is still increasing 25 years after asbestos use virtually ceased. Funded by Cancer Research UK and HSE recruitment to MALCS continues. We need to document the origins and evolution of this extraordinary public health disaster. In addition, recruiting lung cancer patients enables further assessment of the relationship between asbestos and lung cancer.
Please notify the MALCS study team of the following patients:
- Male Mesothelioma patients born since 1940
- Male primary lung cancer patients born since 1940 who have had a lung resection
- Female Mesothelioma patients born since 1925
For more information contact the study team by email: MALCS@icr.ac.uk or tel: 0208 722 4298.
Chemotherapy in Mesothelioma Project (ChiMP)
On 24th January 2008 the ChiMP project went to Dublin where it was presented by Liz Darlison to the BTOG members. The Project was received in a positive and enthusiastic manner and delegates were very keen to know more about the project. We had a stand in the main hall which generated a lot of interest and we gave over 30 registration starter packs and leaflets away. ChiMP registered over 20 sites that day which was fantastic for the project.
On the 1st February 2008 the ChiMP project was officially launched and the response was exceptional. In the first two months over 30 sites registered.
In the first week we had our first 3 patients registered from The Queens Hospital Burton, “Congratulations and well done to Burton”. The last 2 months have seen a steady increase in the number of patient registrations and enquiries and we now have sites with several patient registrations due to how user friendly the system is. I hope this will be encouraging for the sites yet to register their patients with us.
We are still looking for more Oncology centres to register, please ensure the Oncology centre you refer to is involved in the audit.
Where We Are Now?
We are now 3 months on since ChiMP was launched and are well on our way to achieving our aim to have all 158 Lung MDT sites throughout England registered with us. We haven’t quite achieved this target yet so if you haven’t registered to date please do so today.
Thank you for your support, we continually need your help to make this project a success.
Jill Lemon
Mesothelioma Audit Manager
27 February 2008
Action Mesothelioma Day, Manchester
Photograph, Geoff Tweedale
23 January 2008.
NICE finally approves Alimta for treatment of mesothelioma
Asbestos Victims Support Groups Forum – UK
Today, NICE announces that it has rejected an appeal against its decision to approve the use of Alimta for the treatment of mesothelioma, a fatal tumour of the lung pleura caused by exposure to asbestos.
This decision brings to an end an approval process which has taken nearly three years, and which led to one of the worst examples of post code lottery funding. While mesothelioma patients in Scotland, the North West and North East of England received treatment, hundreds of patients were refused treatment in other parts of the UK.
This agonisingly long appraisal process has caused untold distress for hundreds of mesothelioma patients who might have benefited from treatment with Alimta, which, although not a cure for mesothelioma, can extend life and alleviate symptoms for many patients. Average life expectancy from diagnosis for mesothelioma sufferers is 12 months: for many patients this decision has come far too late.
Final guidance will now be issued by NICE so that PCTs will at last be obliged to uniformly provide treatment, although they have the option of a 90-day lead in period following an official announcement by NICE.
Tony Whitston, Chair of the Asbestos Victims Support Groups Forum, commented:
PCTs should respond immediately to NICE’s announcement today and follow Department of Health Guidance which encourages early implementation of NICE guidance. In light of today’s clear and unequivocal decision by NICE it would be perverse for any PCT to refuse a request for treatment after so many years delay and anguish for patients and their families.
Currently, mesothelioma patients are waiting for PCTs to respond to requests for treatment. For comments by patients who will be hoping for a positive response to today’s announcement please contact Forum member:
Joanne Carlin, Derbyshire Asbestos Support Team, Tel: 0124 623 1441
For information about this press release please contact Tony Whitston Tel: 0161 636 7555; mobile: 07748189837
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NOTES FOR EDITORS
Deaths from mesothelioma have increased from 153 in 1968 to 2037 in 2005. Latest projections suggest that they will peak somewhere between current levels and 2450 deaths some time between 2011 and 2015.
(HSE http://www.hse.gov.uk/statistics/overall/hssh0607.pdf)
Alimta plus Cisplatin received a license for safe use in the UK in 2004. After a lengthy appraisal process, in 2007 NICE changed its decision not to approve treatment with Alimta but this decision was appealed which led to further delay. The appraisal process has taken over two and a half years.
PCTs are allowed 90 days to implement a decision by NICE. Department of Health Guidance encourages PCTs to implement a decision as soon as possible, and says in the Funding Direction.
The Funding Direction
The Directions provide PCTs with a period of three months within which to make a health care intervention available to NHS patients in recognition of the fact that it can take some time to put the necessary funding arrangements in place.
Each PCT should use its best endeavours to ensure that any new treatments recommended by NICE are available as soon as possible after NICE issues Technology Appraisal Guidance. If it is possible for a PCT to make the necessary arrangements without utilising the full three month period stipulated in the Directions, it should do so.
(Good Practice Guidance on Managing the Introduction of New Healthcare Interventions and Links to NICE Technology Appraisal GuidanceLS2, 14th December 2006)
Action Mesothelioma Day
27th February 2008, Manchester
MESOTHELIOMA
is a lung cancer caused by asbestos
~ Asbestos is still a hazard at work ~
~ 5 people die every day from mesothelioma ~
Mesothelioma Awareness Day
Wednesday 27th February 2008
at 12.30pm Release of Sponsored Balloons
in aid of Mesothelioma Research
in Albert Square, Manchester Town Hall
then
at 1.00pm Public Meeting & Tea & Coffee
The Friends Meeting House, Mount
Street (near Albert Square) calling for:
? Government Funded Mesothelioma Research!
? Employer Action on Protection from Asbestos!
Speakers:-
Michael Lees - asbestos in schools
Nigel Bryson - asbestos and maintenance work
Greater Manchester Asbestos Victims Support Group:
0161 636 7555
MESOTHELIOMA UK
Bulletin January 2008
Direct Line 0116 256 3739
Fax 0116 250 2810
National Macmillan Mesothelioma Resource Centre
Email: mesothelioma.uk@uhl-tr.nhs.uk
Helpline 0800 1692409
Website www.mesothelioma.uk.com
MESOTHELIOMA UK UPDATE
The helpline continues to be open Monday – Friday 09.00 -16.30 hours. To date it has taken 2030 calls, averaging 73 a month or 17 calls per week. We have also received 435 email enquiries. The website is continually being reviewed and currently receives over 1000 hits each month.
In October 2007 Mesothelioma UK held the second patient and carer day in London. An overwhelming 150 delegates attended and evaluation following the event was outstanding. A Mesothelioma UK Newsletter for patients and carers that will be distributed quarterly was launched shortly after, which included a comprehensive write up by Debbie Brewer on the Patient and Carer day presentations. For more information please check the Mesothelioma UK website.
The third Mesothelioma UK Symposium at the National Lung Cancer Forum for Nurses annual conference was also held in November 2007 and again this received excellent evaluation.
Working with the Asbestos Diseases Forum a booklet advising mesothelioma patients how to gain access to Pemetrexed has recently been completed. It explains the NICE process for approving drugs, how to apply for funding and appeal against local negative PCT decisions. Copies can be obtained from any of the Asbestos Diseases Support Groups or Mesothelioma UK.
Mesothelioma Nurse Action Team M-NAT
In response to the National Mesothelioma Framework 30+ members of the National Lung Cancer Forum for Nurses, representing every cancer network, have joined forces to form an action team, M-NAT, the aim being to identify priorities for nurses within mesothelioma care and develop a national action plan to enable nurses to work together to achieve improved standards. The team’s progress will be reported in the Mesothelioma UK bulletin.
ACTION MESOTHELIOMA DAY – 27th FEBRUARY 2008
The third annual Action Mesothelioma Day (AMD) is being held on February 27th 2008. The main aim of AMD will be to build on previous years with regard to raising awareness of mesothelioma and campaigning on the points in the Mesothelioma Charter. A variety of activities are taking place around the UK, many organised by Asbestos Support Groups, patients and carers. The British Lung Foundation has surveyed cancer networks to evaluate progress made toward the National Mesothelioma Framework. They are also continuing to explore the variation in coroners’ practice and will be holding a parliamentary reception.
Mesothelioma UK communicates events for the day to everyone and anyone interested. If you are organising an AMD event in your area please forward details so that we can let everyone know.
Action Mesothelioma Day Case Studies
The BLF are hoping to get The Sun to support this year's Action Mesothelioma campaign and the health editor seems quite keen as trades people are among their key readers, but would ideally like three case studies, so for example, a builder, carpenter and gas fitter.
If you have a patient who would consider having their story 'in print' please seek their permission and forward their details to Mesothelioma UK or to Kerry Kalcher, Press Officer, The British Lung Foundation, Tel: 0207 688 5564.
Mesothelioma Provisions in the Child Maintenance and Other Payments Bill (CMOP)
Little has changed since we last reported on this bill in July 2007 and until it is enacted regulations remain unchanged. If you would like to keep up with what is happening yourself follow the link Bills and Legislation under the Business Heading http://www.parliament.uk/
Meso Uk was contacted recently by one department within the DWP. Forms are currently being developed for the new act which is currently referred to as the 2008 Diffuse Mesothelioma Act. It is thought that the act will be in place by this summer.
Health Technology Appraisal
Pemetrexed disodium for the treatment of mesothelioma
Nice have now confirmed that full guidance along with the final appraisal decision will be published and made available on their website (www.nice.org.uk) on Wednesday 23 January 2008.
British Mesothelioma Interest Group
The BMIG held its first meeting in Leicester in 2001, when 183 delegates met to discuss research findings and clinical aspects of mesothelioma.
This meeting was highly successful and attracted the regional press and television. All went quiet for a while, whilst BMIG was incorporated into the ever-growing British Thoracic Oncology Group, which has held annual meetings since 2003. A BMIG Investigators Meeting was held in July 2007 in London, at which point it was decided to use the organisation to:
- disseminate information about basic science research
- encourage collaboration between research groups
- act as lobby group for matters pertaining to mesothelioma research, in particular to dedicated research funding
- act as a “think tank” for future clinical trials, reporting to the National Cancer Research Network Mesothelioma Subgroup
Co-ordinated by Mr John Edwards, Consultant Thoracic Surgeon in Sheffield, the BMIG intends to meet twice yearly with these aims in mind. There will be two sessions dedicated to Mesothelioma at the BTOG meeting at the end of January, at which basic science research and current and future trials of chemotherapy and surgery will be discussed.
Mr Edwards can be contacted at john.edwards@sth.nhs.uk
Royal Oldham Hospital Cordotomy Service
The Department of Health early this year produced their Mesothelioma Framework document. In this it stated that palliative care plays a key role in these patients care. To quote: “Specialist palliative care including specific interventions such as radiotherapy to the site of chest drainage/biopsy, nerve blocks & cordotomy, are of particular importance in providing relief for some patients”.
Cordotomy is a specialised pain intervention technique, which can be done under local anaesthetic. It is best done early if indicated, rather than late in the disease when patients are unable to lie flat for the procedure. Doing large numbers in a specialist centre is more likely to consistently achieve high success rates with low complication rates. Currently the only centre doing large numbers of patients each year in the UK is at Portsmouth.
In order to provide cordotomy services across the country a large expansion will be required, to allow sufficient numbers to meet demand and to allow for convenient patient access to these specialist services.
A new service outside Manchester has been established in the RoyalOldhamHospital by myself and is open for referrals from December 2007.
I am attempting to contact known cordotomy practitioners across the UK to try to encourage the establishment of a service within each Strategic Health Authorities (SHAs). To date Dr Hugh Antrobus (see previous newsletter) has agreed to coordinate a cluster of clinicians around Birmingham area.
Each new ‘centre’ will need a small core of doctors who are prepared to do large numbers of cases (at least 40-80 per annum) with the resource implications implied on time and funding. This will ensure service continuity. They will need Trust and regional backing. In addition, training new additional practitioners will be a priority. For more information contact: Dr Paul Cook, Consultant in Anaesthesia & Palliative Care on: 0161 627 8829 or email: paul.cook@pat.nhs.uk.
TRIALS UPDATE
MALCS and TIPS
MALCS was set up over 6 years ago, to recruit mesotheliomaand primary resected lung cancer patients from across the UK, and we have obtained MREC approval to continue recruiting patients until 2015.
We aim to identify the occupations and work practices currently conferring the highest risk of mesothelioma through telephone interviews with patients.
We would like to say a big THANK YOU to all those individuals and centres who have been recruiting patients for us over the years and encourage you to continue. We would also be delighted to hear from new centres able to recruit patients for us. We are actively seeking to recruit all female mesothelioma patients (of any age) and male mesothelioma patients aged under 60. In addition, we are seeking to recruit male resected lung cancer patients born after 1940. Data from the first 624 mesothelioma patients and 425 resected lung cancer patients interviewed and are just about to be published and anyone on our mailing list will receive an outline of these results.
The Inhaled Particles Study (TIPS) is closed to recruitment of new centres as we have enough centres currently participating.
TIPS was set up to evaluate the risk of mesothelioma to much younger (construction and other) workers. This study will also determine any possible risks from current environmental or DIY asbestos exposures.
If you would like to help us with MALCS and you see mesothelioma patients or resected lung cancer patients, we would be delighted to hear from you.
Please contact the MALCS study team on MALCS@icr.ac.uk or email Elaine.Mills@icr.ac.uk.
MESOVATS Trial
The MesoVATS study has seen a marked increase in activity at Papworth towards the end of last year and we predict that this trend is likely to continue for a while as we have several patients in screening at the moment. Recruitment at Guys and Leicester is ongoing although numbers are small. It is hoped that Basildon (Andy Ritchie), Brompton (Eric Lim) and Sheffield (John Edwards) will all soon be in a position to start recruiting - all systems are in place to facilitate this. We are optimistic that with six surgical centres and their local hospitals, we will experience a corresponding rise in MesoVATS activity. For further information, please contact either Helen Munday - helen.munday@papworth.nhs.uk or Robert Rintoul - robert.rintoul@papworth.nhs.uk.
Chemotherapy in Mesothelioma Project (ChiMP)
ChIMP (Chemotherapy In Mesothelioma Project) is a 1 year national project that aims to clarify what, where and how much chemotherapy treatment is being prescribed to Mesothelioma patients in England. Once completed the audit will help the funders of health care assess the likely cost impact, provide evidence of the characteristics of the patient group being treated, their fitness for treatment and any toxicity they experience. It should demonstrate where such patients are being treated and give insight into the frequency of suitable patients not being treated and why this occurs.
A clinical advisory group is monitoring progress of the audit and every effort has been made to ensure the audit is patient focused, uncomplicated and remains as user friendly as possible. Any help and support required by clinical teams to enter patients into the audit will be provided where possible.
Our intention is to start the audit on the 1st February 2008 and get as many centres involved as possible. We will be attending BTOG where you will be able to enrol your hospital or centre on the day or pick up an information leaflet.
Mesothelioma UK is leading this project and with your help and support it will be a success. For further information contact Jill Lemon via Mesothelioma UK Mon - Fri 9.00am – 5.00pm on 0800 169 2409 or e-mail mesothelioma.uk@uhl-tr.nhs.uk
2 November 2007
Mesothelioma pre action protocol
These comments apply to the latest draft pre-action protocol for mesothelioma claims. If you want a copy of the draft, I will e mail it to you.
This draft protocol has been produced following negotiations between a small number of people representing specific insurers and/or the Association of British Insurers (ABI), and the Association of Personal Injury Lawyers (APIL), overseen by the relevant government departments.
APIL has not at the date of writing consulted its membership about the desirability of having a new protocol, or the text of the protocol.
At the time of writing, the final version has not been published. The final version will be published and will go out to consultation in about 2 weeks.
It may be a limited consultation over a short time.
The draft pre action protocol is designed to compensate mesothelioma victims without court proceedings being necessary, and to delay court proceedings until substantial steps have been taken and information exchanged.
If a victim’s solicitor starts court proceedings too soon, the solicitor or the victim will be subject to sanctions – “Sanctions” means costs orders against the solicitor or the victim, or no payment for the solicitor for the work done and money paid out on behalf of the victim.
My experience is that mesothelioma cases just do not settle, and do not settle on the best terms for the victims, until court proceedings are not only issued, but close to completion, and that the best thing for the client is to start court action as quickly as possible.
There is already a pre action protocol for disease and illness claims. It deals with mesothelioma.
It states: “In a terminal disease claim with short life expectancy, for instance for a claimant who has a disease such as mesothelioma, the time scale of the protocol is likely to be too long. In such a claim, the claimant may not be able to follow the protocol, and the defendant would be expected to treat the claim with urgency.” In other words, mesothelioma victims can issue their cases and get on with them, and there is no suggestion that there will be sanctions against solicitors and victims who do progress their cases rapidly. There is nothing wrong with the existing disease and illness protocol.
Contrast the proposed new protocol: “1.4…If proceedings are issued, it will be for the Court to decide whether non-compliance with a protocol should merit adverse consequences. Guidance on the Court’s likely approach will be given from time to time in practice directions. 1.5 If the Court has to consider the question of compliance after proceedings have begun, it will not be concerned with minor infringements e.g. failure by a short period to provide relevant information. One minor breach will not exempt the “innocent” party from following the protocol. The Court will look at the effect of non-compliance on the other party when deciding whether to impose sanctions.”
In other words, complete uncertainty. The victim or his solicitor may be punished for getting on with the case, or might avoid sanctions, if “lucky”.
The notion of financial sanctions being imposed on mesothelioma victims or their solicitors, simply for pushing ahead with their cases, beggars belief.
This is a regressive and destructive document that, if implemented, will damage the interests of one of the most vulnerable and deserving groups of people. It should be opposed.
September 2007, Alimta
Two appeals have been filed against a decision by the National Institute of Clinical Excellence (NICE) to make the chemotherapy drug Alimta available on the NHS. Guidance for the use of Alimta was issued in July that would have allowed it to be given to patients under the NHS in many cases. Now, that decision has been put on hold, as NICE waits to hear two appeals against its original decision. NICE cannot yet make public who has appealed, or the basis of the appeals.
Mesothelioma incidence growing
"For men, the most rapidly increasing cancer incidence rates were for malignant melanoma (56%), prostate cancer (39%), mesothelioma (31%) and liver cancer (30%).
For women the most rapidly increasing rates were for mesothelioma (38%), liver cancer (38%), malignant melanoma (35%) and uterus cancer (33%)."
Source: Cancer Research UK Website
Alimta (Pemetrexed) to be available under NHS for malignant pleural mesothelioma in many cases, June 2007.
National Institute for Health and Clinical Excellence
Final appraisal determination – Pemetrexed for the treatment of malignant pleural mesothelioma, June 2007
"The Committee discussed the subgroup of patients with both advanced disease and good performance status, in view of the relatively favourable ICERs of pemetrexed plus cisplatin versus cisplatin alone (£37,000 per QALY gained, or £34,500 per QALY gained assuming a 100-mg pemetrexed vial becomes available) that were calculated for this subgroup.
The Committee was aware that most people with unresectable disease would be considered to have advanced disease and that this subgroup of patients comprised the majority of people with Malignant Pleural Mesothelioma (MPM) seen in UK clinical practice. The Committee accepted that it was plausible that people with good performance status were likely to show a better response to treatment than those with poor performance status.
The Committee noted that not all patients respond to treatment with pemetrexed plus cisplatin and saw that, in the EMPHACIS trial, 87% of those who responded had done so within four cycles.
Furthermore, the Committee noted from the consultation that it would be unusual for a UK oncologist to continue treatment beyond four cycles if there was disease progression or no response to treatment. The Committee therefore accepted that the mean number of cycles in clinical practice was likely to be less than the mean of six cycles reported in the EMPHACIS trial, and this would result in lower estimates of pemetrexed drug costs.
The Committee discussed the possibility that differences in symptom relief (including pain and dyspnoea [breathlessness]) and quality of life between pemetrexed plus cisplatin and cisplatin alone may not have been captured fully by the economic model because the utilities for both treatment and comparator had been estimated based on data from people with NSCLC.
The Committee noted that there was some evidence from the EMPHACIS trial showing that pemetrexed plus cisplatin was associated with statistically significant symptomatic improvements (especially with pain relief) compared with cisplatin alone. The Committee agreed that the economic analyses may have underestimated the overall quality of life benefits of pemetrexed in people with Malignant Pleural Mesothelioma.
Having considered the likelihood of lower numbers of treatment cycles in clinical practice, the potential availability of a 100-mg pemetrexed vial and the likelihood of greater quality of life benefits than assumed by the cost-effectiveness analyses, the Committee agreed that the incremental cost-effectiveness ratio for pemetrexed plus cisplatin in the fully supplemented subgroup with advanced disease and good performance status was likely to fall within acceptable levels.
The Committee also noted that pleural mesothelioma is a rare and aggressive malignancy caused by occupational exposure to asbestos, and was mindful that this disease has a very poor prognosis.
The Committee concluded that pemetrexed in combination with cisplatin should be recommended as an option for the treatment of Malignant Pleural Mesothelioma only in people who are considered to have advanced disease and who have a performance status of 0 or 1, in whom surgical intervention is not considered appropriate."
International Workers Memorial Day
28 April 2007
Manchester Joint Union Workers Memorial Day Rally
Saturday 28 April
11am in Peace Gardens, behind Manchester Town Hall
Speakers: Tony Lloyd MP, Regional Trade Unionists and
Families of those killed by work
Names of those killed will be read out
Minute's silence at 12 noon
Music from Claire Mooney
Followed by Refreshments at Mechanics Institute
Sponsored by Thompsons Solicitors
Later in Manchester 4pm to 6pm at Friends Meeting House, Mount Street:
Families Against Corporate Killers (FACK) sponsored FREE event
featuring a play: 0.079 p/h by Escape Theatre, followed by a discussion.
Plus video - 'The Human face of mesothelioma '
from the Asbestos GroupsForum
More details, contact
GMHC at mail@gmhazards.org.uk
Tel 0161
636 7557.
29 March 2007. Withdrawal of NHS funding for Alimta chemotherapy for mesothelioma
The press statement below by Eli Lilly, manufacturers of Alimta, comments on this decision, and the background to it.
NICE SAYS NO TO TREATMENT FOR PATIENTS DYING OF LUNG CANCER CAUSED BY ASBESTOS EXPOSURE
The National Institute for Health and Clinical Excellence (NICE) is turning its back on men and women dying from asbestos-induced lung cancer in the UK. In the latest communication concerning the use of the licensed chemotherapy, Alimta® (pemetrexed disodium), NICE makes the recommendation that “pemetrexed disodium is not recommended for the treatment of (malignant pleural) mesothelioma. ”
Consequently, hundreds of patients are to be denied access to treatment which could give them up to an extra year of life. The recommendation also calls into question the use of cisplatin, a widely used chemotherapy agent that is given in combination with Alimta.
Professor Nick Thatcher, specialist lung consultant at the Christie Hospital NHS Trust and South Manchester University Trust Hospital comments: “Yet again NICE have applied their particular costing approach of one size fits all and as a result NHS patients will die prematurely from pleural mesothelioma. NICE’s way of assessing clinical evidence fails for drugs which treat rare and difficult conditions. This is devastating news for those people living with mesothelioma and their families who deserve better from the NHS, and will prevent further clinical research into rare and deadly conditions”.
Mesothelioma is primarily caused by exposure to asbestos – in the UK that means it affects people who have historically worked in manufacturing industries such as shipbuilding, construction work and railway engineering and is therefore concentrated in areas such as Glasgow, the North East, the North West, Belfast, Plymouth and Hampshire. Asbestos affects not only those who are directly exposed to it but other family members who have come into contact with the deadly fibres on clothing worn at the place of work.
Safety concerns with asbestos were first voiced in the UK in late 1970s meaning that most cases today are linked to exposure that occurred over 30 to 40 years ago. In the UK over 1,600 people died from mesothelioma in 2004 with the number of new cases of the disease expected to peak at 2,500 in 2015 .
Following a review of clinical trial data, Alimta received a licence in the UK in December 2004 and has been prescribed to patients for over 2 years . As recently as February this year, an independent review of Alimta data by The Cochrane Collaboration – a highly respected and influential review body - concluded that Alimta is an effective agent in the treatment of malignant mesothelioma providing a significant gain in survival when used with cisplatin.
According to Bob Stephenson, North East Asbestos Support and Awareness Group: “This latest decision by NICE is an injustice to those men and women who were unwittingly exposed to asbestos in their working lives. Alimta can extend life and yet is being denied to patients because it is not considered cost-effective. The cost to the NHS is minimal as pleural mesothelioma affects a minority of the population and will decline after the peak anticipated in 2015. On behalf of our members, we will continue to fight for access to Alimta and to raise awareness of this unjust decision.”
Dr Joanna Nakielny, Medical Director of Lilly UK, makers of the medicine, comments; “We are dismayed by this latest recommendation from NICE which makes it almost impossible for clinicians across the UK to prescribe Alimta, the only licensed treatment for malignant pleural mesothelioma, to their patients. We are committed to challenging this decision, and hope that those healthcare professionals and MPs that come into contact with this devastating condition continue to challenge their Primary Care Trusts to ensure local access to this treatment.”
ENDS
For further information please contact:
Jennie Talman, Just:: Health PR 020 8877 8404 07970 282209
Nick Francis, Lilly UK 01256 775201 07786 277 980
Note to Editors:
The NICE Process for Alimta
In June 2006, NICE issued draft guidance recommending a ban on mesothelioma patients receiving Alimta. Following appeal, NICE have now circulated the latest Appraisal Consultation Document (ACD) for a consultation period ending on 8th May 2007. If it becomes final later in the year, the only course of action is Judicial Review.
Anyone wishing to submit comments regarding this decision may write to NICE at the following address:
National Institute of Clinical Excellence
Technology Appraisal Manager/Alimta (pemetrexed disodium) in Malignant Pleural Mesothelioma
MidCity Place
71 High Holborn
London
WC1V 6NA
Prepared March 2007, AT 221.
National Institute for Health and Clinical Excellence. Appraisal Consultation Document. Pemetrexed disodium for the treatment of malignant pleural mesothelioma. March 2007.
Data on File. Eli Lilly and Company Limited. 2007.
CancerResearchUK. http://info.cancerresearchuk.org/images/excel/cs_mort_t6.1.xls.
Health & Safety Executive. Mesothelioma mortality in Great Britain: estimating the future burden. National Statistics 2003. http://www.hse.gov.uk/statistics/causdis/meso.htm
Alimta® (pemetrexed) is a registered trademark of Eli Lilly and Company. Launched in December 2004 pemetrexed was the first licensed treatment for malignant pleural mesothelioma (MPM), in combination with cisplatin. SPC, December 2004.
Green J, Dundar Y, Dodd S, Dickson R, Walley T. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. The Cochrane Collaboration. February 2007.
13 March 2007, Reform of mesothelioma compensation
Extracts from Information sheet provided by The Government at the Mesothelioma Summit on 13 March 2007.
MESOTHELIOMA SUMMIT – WORKING IN PARTNERSHIP
IMPROVING CLAIMS HANDLING FOR MESOTHELIOMA CASES.
ANNEX A
STAGE ONE - PRESCRIBED CLAIMS HANDLING PROCESS
Civil compensation:
· Mesothelioma claims process streamlined through new pre-action protocol and, where appropriate, civil procedure rules/practice direction
· Improved process will speed up the system and aim to resolve disputes
without litigation, by providing, for example:
o Better and earlier exchange of information
o Earlier admissions of liability
o Less legal work before some admissions of liability
o Fixed time periods in which to carry out certain steps preproceedings
o Standardisation of relevant information
o Agreed expert lists
o Significant reduction in the time taken to pay final compensation
through agreed timescales
o Interim payments at the earliest opportunity once liability and
causation have been established.
· Where a claim cannot be resolved, the process will have identified the
issues still in dispute; claims can then be resolved by the current
effective court-based mesothelioma fast track system.
State benefits:
· Standardised claims forms for IIDB and the 1979 Act ensuring
consistency of completion and usage across GB · Better links between claims for the various state benefits available
· Streamlined approach to evidence provision
· Improved provision of information on leaflets and claim forms
· Look at speeding up benefit recovery process (recovery from incomerelated benefits when IIDB award backdated).
Progress so far
9. On 20 July 2006 SoS announced a number of interim measures to ensure
faster compensation for those with mesothelioma. These interim
measures already go someway towards meeting the objectives of this
approach:
· Mesothelioma Pre-Action Protocol: Work on the pre-action protocol is
making good progress and DCA will shortly seek the views of
stakeholders more widely.
· Claimant leaflet explaining the help available: APIL, TUC and the
British Lung Foundation have drafted a leaflet which will be available at
the Summit.
· Financial Services Compensation Scheme to be able to pay money
direct to defendant employers/ insurers. Regulations were made on 6
December and FSA rules changed with effect from 22 December 2006.
· HM Revenue and Customs trace employer records in 10 working days
(compared with the previous 25-30 days) introduced in July 2006.
· Code of Practice for tracing Employers’ Liability Compulsory Insurance
policies. ABI agreed to pilot a new system involving: a draft leaflet on
using the Code; an updated request form for easier identification of
mesothelioma claims; designated postbox for fast tracked cases; and
to recruit a designated contact point to manage a dedicated telephone
helpline, filter duplicate/multiple claims, train insurers on using the
Code, and share best practice. Many of these are already in place and
the Code Review Body members will review progress later this year.
· Removing the need to resurrect insolvent companies to access ELCI
policies: DCA is awaiting a legislative slot to do this as part of a
package with other Law Commission proposals on third party rights
against insurers.
What still needs to be considered?
10. Work to fully achieve this approach would include consideration of:
· Consolidating claim forms eg finding either an administrative or
legislative solution for combining a claim for IIDB and a claim under the
Pneumoconiosis (Workers’ Compensation) Act 1979
· Removing overlaps in the information required for both claims
· Streamlining claims for other benefits such as DLA and AA where mesothelioma is involved
· Speeding up the benefit recovery process (from income-related
benefits when IIDB awarded)
· Ensuring consistency of completion and usage of forms across GB.
We consider that these are achievable and we will involve stakeholders in
developing them further.
STAGE TWO - IMMEDIATE FINANCIAL SUPPORT
1. This approach is more complex and will need legislation, so it cannot be
introduced as quickly as the Stage One actions. It provides up-front
financial support as in the Pneumoconiosis (Workers’ Compensation) Act
1979 (“the 1979 Act”). We suggest we do this by breaking the
occupational link so everyone with mesothelioma can claim. In practice
this will mean that all those with mesothe