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Erythropoietin in tumour anaemia
Newsdesk Australian company buys rights to Tonga gene pool Tonga and Autogen will establish a health database and a major research facility on the island.
© Autogen Ltd
An Australian genomic biotechnology company has signed a deal which gives it the right to access the entire gene pool of the small South Pacific Kingdom of Tonga, in its bid to uncover the genes which predispose people to diseases including cancer, diabetes and obesity. Autogen Ltd announced in November that it had struck the deal with Tonga’s Ministry of Health, giving it access to DNA samples volunteered by the island’s 108 000 population of mainly Polynesian descent. Tonga, a relatively isolated nation with distinctive family lineages, was a “major resource for geneticists”, the company said in a statement. A similar gene bank in Iceland has met with controversy, but Autogen chairman Joe Gutnick, a Melbourne-based millionaire and devout Jew, said the collection of DNA and medical information would be “in accordance with the highest ethical standards”. Gutnick told Australia’s ABC Radio: “I am sure that God would want people to be able to enhance their lifestyle and live longer”. The agreement states that any serum or DNA samples collected in Tonga will remain the property of
Joe Gutnick, the chairman of Autogen
In return for access to the samples and data, the company will provide annual research funding to Tonga’s Ministry of Health and will pay royalties on revenue generated from any discoveries that are commercialised. Autogen director of research and development Greg Collier, who described the deal as a “win–win situation” for Tonga and the company,
said there was no “exclusivity” clause in the deal, despite media reports to the contrary. He explained that Autogen’s research would focus on “diseases of affluence” such as obesity, diabetes, cardiovascular disease and certain cancers, yet to be identified. “The company is doing similar research in other areas of the Pacific, as well as on Australia’s island state of Tasmania, where the founder population of about 300 000 could be traced back to a small number of families”, he said. Former president of the Human Genome Organisation, Grant Sutherland explained that small island populations were of interest to geneticists because they often have less genetic variations than do large continental populations. Sutherland, Director of the Cytogenetics and Molecular Genetics at The Women’s and Children’s Hospital, Adelaide, said there did not appear to be any major ethical concerns about the Autogen project, because it would rely on Tongan citizens volunteering to provide DNA samples. “There is certainly nothing that I am aware of to compel anyone in Tonga to participate in this research”, he said. Megan Howe
Erythropoietin in tumour anaemia Early recognition of responders and non-responders is the key to appropriate and cost-effective treatment with erythropoietin (EPO), according to researchers Claudia Wild and Susanna Jonas of the Institute of Technology Assessment at the Austrian Academy of Sciences, Vienna, whose assessment methods were discussed and approved by haemato-oncologists at an expert hearing at the Austrian Academy of Sciences in May 2000. The assessment has now been published [in German] by the Institute of Technology Assessment, Vienna, and has been submitted for publication, in English, to Pharmacotherapie. Said Jonas: “Erythropoietin should be used selectively; using it on a broad scale is a waste of money. Our studies have shown that only half of the patients treated with this compound respond satisfactorily.” THE LANCET Oncology Vol 2 January 2001
A variety of parameters, including transfusion requirements, life expectancy, and tumour stability all combine to predict the chances of patients benefiting from treatment with EPO. Patients who achieve an increase in haemoglobin levels greater than 2 g/dl are considered to be responders. But a considerable number of patients do not show response, even at this level, and 20 – 30% still require blood transfusions. The success of EPO treatment is measured according to improved quality of life and reduction of transfusion requirements; there are few data on quality of life for those responders who still require transfusions, nor is there enough evidence for an association between response rates and tumour types.
“The excellent results achieved using recombinant human erythropoietin in cases of chronic anaemia due to renal insufficiency raised the hope that it might also be possible to correct the chronic anaemia caused by cancer”, said Wild. In Austria (and in the USA) EPO is used for a much broader spectrum of indications than it is registered for at the European Agency for the Evaluation of Medicinal Products. That is because EPO was already registered in Austria for a number of indications at the beginning of the 1990s, earlier than in other European countries. Although EPO is most effective in the treatment of anaemia caused by some haematological malignancies, its efficacy in anaemia caused by solid tumours is less conclusive. Günther Heinz
7
For personal use only. Not to be reproduced without permission of The Lancet.
© Autogen Ltd
An Australian genomic biotechnology company has signed a deal which gives it the right to access the entire gene pool of the small South Pacific Kingdom of Tonga, in its bid to uncover the genes which predispose people to diseases including cancer, diabetes and obesity. Autogen Ltd announced in November that it had struck the deal with Tonga’s Ministry of Health, giving it access to DNA samples volunteered by the island’s 108 000 population of mainly Polynesian descent. Tonga, a relatively isolated nation with distinctive family lineages, was a “major resource for geneticists”, the company said in a statement. A similar gene bank in Iceland has met with controversy, but Autogen chairman Joe Gutnick, a Melbourne-based millionaire and devout Jew, said the collection of DNA and medical information would be “in accordance with the highest ethical standards”. Gutnick told Australia’s ABC Radio: “I am sure that God would want people to be able to enhance their lifestyle and live longer”. The agreement states that any serum or DNA samples collected in Tonga will remain the property of
Joe Gutnick, the chairman of Autogen
In return for access to the samples and data, the company will provide annual research funding to Tonga’s Ministry of Health and will pay royalties on revenue generated from any discoveries that are commercialised. Autogen director of research and development Greg Collier, who described the deal as a “win–win situation” for Tonga and the company,
said there was no “exclusivity” clause in the deal, despite media reports to the contrary. He explained that Autogen’s research would focus on “diseases of affluence” such as obesity, diabetes, cardiovascular disease and certain cancers, yet to be identified. “The company is doing similar research in other areas of the Pacific, as well as on Australia’s island state of Tasmania, where the founder population of about 300 000 could be traced back to a small number of families”, he said. Former president of the Human Genome Organisation, Grant Sutherland explained that small island populations were of interest to geneticists because they often have less genetic variations than do large continental populations. Sutherland, Director of the Cytogenetics and Molecular Genetics at The Women’s and Children’s Hospital, Adelaide, said there did not appear to be any major ethical concerns about the Autogen project, because it would rely on Tongan citizens volunteering to provide DNA samples. “There is certainly nothing that I am aware of to compel anyone in Tonga to participate in this research”, he said. Megan Howe
Erythropoietin in tumour anaemia Early recognition of responders and non-responders is the key to appropriate and cost-effective treatment with erythropoietin (EPO), according to researchers Claudia Wild and Susanna Jonas of the Institute of Technology Assessment at the Austrian Academy of Sciences, Vienna, whose assessment methods were discussed and approved by haemato-oncologists at an expert hearing at the Austrian Academy of Sciences in May 2000. The assessment has now been published [in German] by the Institute of Technology Assessment, Vienna, and has been submitted for publication, in English, to Pharmacotherapie. Said Jonas: “Erythropoietin should be used selectively; using it on a broad scale is a waste of money. Our studies have shown that only half of the patients treated with this compound respond satisfactorily.” THE LANCET Oncology Vol 2 January 2001
A variety of parameters, including transfusion requirements, life expectancy, and tumour stability all combine to predict the chances of patients benefiting from treatment with EPO. Patients who achieve an increase in haemoglobin levels greater than 2 g/dl are considered to be responders. But a considerable number of patients do not show response, even at this level, and 20 – 30% still require blood transfusions. The success of EPO treatment is measured according to improved quality of life and reduction of transfusion requirements; there are few data on quality of life for those responders who still require transfusions, nor is there enough evidence for an association between response rates and tumour types.
“The excellent results achieved using recombinant human erythropoietin in cases of chronic anaemia due to renal insufficiency raised the hope that it might also be possible to correct the chronic anaemia caused by cancer”, said Wild. In Austria (and in the USA) EPO is used for a much broader spectrum of indications than it is registered for at the European Agency for the Evaluation of Medicinal Products. That is because EPO was already registered in Austria for a number of indications at the beginning of the 1990s, earlier than in other European countries. Although EPO is most effective in the treatment of anaemia caused by some haematological malignancies, its efficacy in anaemia caused by solid tumours is less conclusive. Günther Heinz
7
For personal use only. Not to be reproduced without permission of The Lancet.