A clinical trial for patients with malignant mesothelioma is currently recruiting participants. The trial is sponsored by Papworth Hospital in the UK, although it is open to any mesothelioma patient that meets the criteria. This study will evaluate video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
According to information on ClinicalTrials.gov, a service of the U.S. National Institutes of Health, this is a randomized phase III trial. Video-assisted surgery removes part of the tissue layer covering the inside of the chest cavity, which researchers think may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not known at this time which thereapy is more effective.
The primary objective of this study, as stated in the project outline, is to compare the effectiveness of these two modes of treatment in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.
Secondary goals of the study include comparing the control of pleural effusion, comparing procedure-related complications, comparing symptoms and quality of life of these patients at 3, 6 and 12 months after treatment, comparing the length of hospital stay, the exercise tolerance level of these patients at 3, 6 and 12 months after treatment, and to determine the cost to the health service, in terms of resources used for procedures, hospital bed usage and cost of primary and secondary care over 12 months.
Recruiting locations in the UK are Basildon University Hospital, Gelnfield Hospital (Leicester), Guy’s Hospital (London), Papworth Hospital (Cambridge) and Royal Hallamshire Hospital (Sheffield). Principal investigator for the study is Robert Winter, MD, Papworth Hospital.
This study is identified in the U.S. at clinicaltrials.gov by ID number NCT00821860.
For contact and recruiting information, visit the Clinical Trials information page at http://clinicaltrials.gov/ct2/show/study/NCT00821860.
Monday 24 August 2009
James Hardie Executives Fined In Asbestos Fund Case
James Hardie Executives Handed Penalties In Asbestos Compensation Fund Case
The Australian Securities and Investment Commission (ASIC) reported this week that the New South Wales Supreme Court on Thursday ruled that it will impose penalties against seven former directors and three executives of James Hardie Industries Limited. James Hardie is a manufacturer of Fiber Cement Siding and Backerboard. The court said the former Australian listed entity (JHIL) breached the Corporations Act in 2001 when making statements about the adequacy of asbestos compensation funding. The court also ruled James Hardie Industries NV (JHINV, based in the Netherlands) breached its continuous disclosure obligation in 2003.
James Hardie was one of Australia’s largest manufacturers of asbestos building products, and was alleged to have known the dangers of asbestos for decades.
The current proceedings came about as a result of ASIC’s investigation of matters identified by the Special Commission of Inquiry into the Medical Research and Compensation Foundation. James Hardie established the foundation, which was intended to compensate families who lost loved ones to asbestos disease, in 2001. The inquiry into the MRCF was established in 2004, and the commission found that James Hardie industries deliberately underfunded the victims’ compensation fund
According to a report by Nonee Walsh of ABC News, who has been following the story since 2003, James Hardie has spent about $25 million so far fighting the ASIC’s case, while asbestos victims and their families have been simultaneously negotiating for new funding for the foundation. Payments to the new asbestos compensation foundation are currently suspended.
Walsh also noted that Australia has one of the highest rates of asbestos disease in the world, including asbestos-caused lung cancer, mesothelioma. In 2003, when the sale of all asbestos products was finally banned in Australia, the National Occupational Health and Safety Commission went on record as saying there is no known safe level of asbestos exposure.
The only known cause of mesothelioma is asbestos exposure, and there is currently no known cure. Mesothelioma most often affects the lining of the chest cavity and lungs, but also may affect the lining of the abdomen or, more rarely, the heart. Asbestos exposure also causes a variety of other diseases, including asbestos, a severe scarring of the lungs.
It is estimated that the levels of asbestos disease will not peak in Australia until 2020, when it is expected that there will be 13,000 cases of mesothelioma and up to 40,000 cases of other asbestos-related lung cancer and disease.
The New South Wales Supreme Court imposed financial penalties totaling $750,000, and said the company directors and executives named in the case will be barred from serving other boards of directors for between 5 and 15 years.
According to the ASIC, the James Hardie decision underlines the responsibility of companies to assess and check the veracity of statements make to the market. ASIC Chairman Tony D’Aloisio said, “The decision is another important step in improving corporate governance in Australia and that improvement will add confidence to the integrity of our markets.”
The matter will return to the Court on August 27, at which time the Court will make orders reflecting the penalties. The defendants will then have 28 days to appeal the findings.
The Australian Securities and Investment Commission (ASIC) reported this week that the New South Wales Supreme Court on Thursday ruled that it will impose penalties against seven former directors and three executives of James Hardie Industries Limited. James Hardie is a manufacturer of Fiber Cement Siding and Backerboard. The court said the former Australian listed entity (JHIL) breached the Corporations Act in 2001 when making statements about the adequacy of asbestos compensation funding. The court also ruled James Hardie Industries NV (JHINV, based in the Netherlands) breached its continuous disclosure obligation in 2003.
James Hardie was one of Australia’s largest manufacturers of asbestos building products, and was alleged to have known the dangers of asbestos for decades.
The current proceedings came about as a result of ASIC’s investigation of matters identified by the Special Commission of Inquiry into the Medical Research and Compensation Foundation. James Hardie established the foundation, which was intended to compensate families who lost loved ones to asbestos disease, in 2001. The inquiry into the MRCF was established in 2004, and the commission found that James Hardie industries deliberately underfunded the victims’ compensation fund
According to a report by Nonee Walsh of ABC News, who has been following the story since 2003, James Hardie has spent about $25 million so far fighting the ASIC’s case, while asbestos victims and their families have been simultaneously negotiating for new funding for the foundation. Payments to the new asbestos compensation foundation are currently suspended.
Walsh also noted that Australia has one of the highest rates of asbestos disease in the world, including asbestos-caused lung cancer, mesothelioma. In 2003, when the sale of all asbestos products was finally banned in Australia, the National Occupational Health and Safety Commission went on record as saying there is no known safe level of asbestos exposure.
The only known cause of mesothelioma is asbestos exposure, and there is currently no known cure. Mesothelioma most often affects the lining of the chest cavity and lungs, but also may affect the lining of the abdomen or, more rarely, the heart. Asbestos exposure also causes a variety of other diseases, including asbestos, a severe scarring of the lungs.
It is estimated that the levels of asbestos disease will not peak in Australia until 2020, when it is expected that there will be 13,000 cases of mesothelioma and up to 40,000 cases of other asbestos-related lung cancer and disease.
The New South Wales Supreme Court imposed financial penalties totaling $750,000, and said the company directors and executives named in the case will be barred from serving other boards of directors for between 5 and 15 years.
According to the ASIC, the James Hardie decision underlines the responsibility of companies to assess and check the veracity of statements make to the market. ASIC Chairman Tony D’Aloisio said, “The decision is another important step in improving corporate governance in Australia and that improvement will add confidence to the integrity of our markets.”
The matter will return to the Court on August 27, at which time the Court will make orders reflecting the penalties. The defendants will then have 28 days to appeal the findings.
Tuesday 18 August 2009
Government Response To Mesothelioma Petition
We the undersigned petition the Prime Minister to to ensure that all Mesothelioma patients get treatment they need in the UK and should not have to travel abroad. We would like to see Chemoembolization trialled in the UK and become a treatment that would be offered to Mesothelioma sufferers.
Details of Petition:
“Chemoembolization is a procedure that is most commonly used in the UK for liver cancer. Professor Thomas Vogl, Frankfurt, Germany, has been studying its uses with Mesothelioma with some sucess One successes is Debbie Brewer who, aged 47 was told she had 6-9 months to live, in Nov 2006. She started to take Mistletoe in April 08 & after meetin the prof started treatment May 08 & in June 08 for a 2nd treatment & was told the tumour had shrunk 10%. After 5 treatments it has, so far shrunk 53% & she has been given a partial remission diagnosis & has been told the tumour MAY NOT return. This treatment should be available in the UK as the treatments for Mesothelioma are limited to chemo, radiotherapy or major operation to remove the damaged lung. We are currently campaigning to get trials started in the UK *Chemoembolization involves passing a catheter through the femoral artery into the lung & targeting the tumour directly. *Mistletoe, A therapy used to boost the immune system & educate it to fight the tumour. It is administered via injection in the abdomen.”
Read the Government’s response
One of the recommendations of the LCAMAG was the development of a mesothelioma framework to provide the NHS with advice on how to deliver services for mesothelioma patients in order to improve standards of care to a uniformly high level across the country.
The Government's Reponse
The National Mesothelioma Framework was launched on 27 February 2008. The framework takes on board comments from a public consultation and includes advice on the configuration of services, raising awareness of mesothelioma and the clinical management of the condition. The Government hopes that the adoption of the framework’s recommendations by the NHS will make a substantial difference to mesothelioma patients and their families. Details of the framework can be viewed on the Department of Health website at www.dh.gov.uk.
Chemoembolisation is currently available for the treatment of liver cancer. However, the risks and benefits of using chemoembolisation to treat patients with mesothelioma are not yet known. The Department of Health is not aware of any trials of chemoembolisation for patients with mesothelioma that are currently underway in the UK.
The main agency through which the Government supports medical and clinical research is the Medical Research Council (MRC), an independent body funded by the Department for Innovation, Universities and Skills via the Office of Science and Innovation. The MRC is dedicated to improving human health through the best scientific research. While funds are not generally earmarked for particular topics, the MRC always welcomes high quality applications for funding to support research into any aspect of human health. Awards are made according to scientific quality and importance to human health and are judged in open competition with other demands on funding. Further details are available on the MRC’s website at: www.mrc.ac.uk.
The Department of Health’s National Institute for Health Research (NIHR) programme also supports high quality research of relevance and in areas of high priority to patients and the NHS.
Neither the NIHR nor the MRC ring fence funds for expenditure on particular topics: research proposals in all areas compete for the funding available. Both organisations welcome applications for support into any aspect of human health and these are subject to peer review and judged in open competition, with awards being made on the basis of the scientific quality of the proposals made.
It is for clinicians, using their expert judgement, to decide on the most effective treatment for patients based on their individual circumstances. As Primary Care Trusts are responsible for commissioning services to meet the healthcare needs of their local populations, it is for them to decide whether to fund any proposed treatment taking into account any available evidence of the effectiveness of that treatment.
Details of Petition:
“Chemoembolization is a procedure that is most commonly used in the UK for liver cancer. Professor Thomas Vogl, Frankfurt, Germany, has been studying its uses with Mesothelioma with some sucess One successes is Debbie Brewer who, aged 47 was told she had 6-9 months to live, in Nov 2006. She started to take Mistletoe in April 08 & after meetin the prof started treatment May 08 & in June 08 for a 2nd treatment & was told the tumour had shrunk 10%. After 5 treatments it has, so far shrunk 53% & she has been given a partial remission diagnosis & has been told the tumour MAY NOT return. This treatment should be available in the UK as the treatments for Mesothelioma are limited to chemo, radiotherapy or major operation to remove the damaged lung. We are currently campaigning to get trials started in the UK *Chemoembolization involves passing a catheter through the femoral artery into the lung & targeting the tumour directly. *Mistletoe, A therapy used to boost the immune system & educate it to fight the tumour. It is administered via injection in the abdomen.”
Read the Government’s response
One of the recommendations of the LCAMAG was the development of a mesothelioma framework to provide the NHS with advice on how to deliver services for mesothelioma patients in order to improve standards of care to a uniformly high level across the country.
The Government's Reponse
The National Mesothelioma Framework was launched on 27 February 2008. The framework takes on board comments from a public consultation and includes advice on the configuration of services, raising awareness of mesothelioma and the clinical management of the condition. The Government hopes that the adoption of the framework’s recommendations by the NHS will make a substantial difference to mesothelioma patients and their families. Details of the framework can be viewed on the Department of Health website at www.dh.gov.uk.
Chemoembolisation is currently available for the treatment of liver cancer. However, the risks and benefits of using chemoembolisation to treat patients with mesothelioma are not yet known. The Department of Health is not aware of any trials of chemoembolisation for patients with mesothelioma that are currently underway in the UK.
The main agency through which the Government supports medical and clinical research is the Medical Research Council (MRC), an independent body funded by the Department for Innovation, Universities and Skills via the Office of Science and Innovation. The MRC is dedicated to improving human health through the best scientific research. While funds are not generally earmarked for particular topics, the MRC always welcomes high quality applications for funding to support research into any aspect of human health. Awards are made according to scientific quality and importance to human health and are judged in open competition with other demands on funding. Further details are available on the MRC’s website at: www.mrc.ac.uk.
The Department of Health’s National Institute for Health Research (NIHR) programme also supports high quality research of relevance and in areas of high priority to patients and the NHS.
Neither the NIHR nor the MRC ring fence funds for expenditure on particular topics: research proposals in all areas compete for the funding available. Both organisations welcome applications for support into any aspect of human health and these are subject to peer review and judged in open competition, with awards being made on the basis of the scientific quality of the proposals made.
It is for clinicians, using their expert judgement, to decide on the most effective treatment for patients based on their individual circumstances. As Primary Care Trusts are responsible for commissioning services to meet the healthcare needs of their local populations, it is for them to decide whether to fund any proposed treatment taking into account any available evidence of the effectiveness of that treatment.
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