- Email: [email protected]
Embryonic stem cell research in Spain
CORRESPONDENCE
to justify the use of HRT by “suitable” women with established coronary disease. Unfortunately he does not specify the hormone regimen he would recommend, nor the evidence on which this choice is based.
proposals with the national legislation. In establishing this line, the EC supported the opinion issued by the European Group on Ethics in Science and New Technologies on Nov 14 (number 15).
David C G Skegg
Achilleas Mitsos
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin, New Zealand
European Commission, B-1049 Brussels, Belgium 1
1
2
3
Mosca L, Collins P, Herrington DM, et al. Hormone replacement therapy and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation 2001; 104: 499–503. Skegg DCG. Evaluating the safety of medicines, with particular reference to contraception. Stat Med 2001; 20: 3557–69. Grady D, Wenger NK, Herrington D, et al. Postmenopausal hormone therapy increases risk for venous thromboembolic disease. Ann Intern Med 2000; 132: 689–96.
Embryonic stem cell research in Spain Sir—In your Oct 20 news item, Xavier Bosch1 finishes by stating “European supporters of [stem cell] research may come up against the European Commission (EC), which has made it clear that its programme for 2002–06 will fund adult and not embryonic stem cell work.” This statement does not reflect the present state of the debate correctly, nor does it represent the proposal of the European Commission. The ethical principles, which will guide European Union (EU) funded research under the next Framework Programme in 2002–06, are currently being discussed in the European Parliament and Council. The issue of EU funding is, therefore, still an open question awaiting the legislative decision of the Council and the Parliament. The EC, in its capacity to initiate proposals for legislative acts, submitted to Council on May 30, 2001, a proposal for a specific programme to implement the Framework Programme for the integration and strengthening of the European research area, explicitly excluding, among other provisions, research activities aiming at human cloning for reproductive purposes; intended to modify the genetic heritage of human beings, and render such modification hereditary; and intended to create human embryos for research or therapeutic purposes where national laws permit. The decision of EU funding for fetal and adult human stem cell research, as well as research on spare embryos is subject to the conformity of the
796
Bosch X. Spain closes the door to embryonic stem cell research. Lancet 2001; 358: 1351.
Chinese herbal nephropathy Sir—Graham Lord and colleagues (Nov 3, p 1515)1 propose a link between urothelial malignant disease and Chinese herbal nephropathy (CHN). The term CHN was used in medical reports after analysis of cases of renal failure arising from treatment at a Belgian slimming clinic in the early 1990s, where a mixture of conventional medicines and Chinese herbs was prescribed. The term again appeared in connection with two cases of renal failure in the UK after treatment with Chinese herbal remedies. The specific feature found in all cases of CHN is the presence of aristolochic acid-DNA adducts, after herbal treatment that contained a species of aristolochia. The nephropathy in question is an aristolochic acid nephropathy, and all aristolochias are now banned for use in unlicensed medicines in the UK. The term CHN is highly prejudicial. First, because, historically, the use of aristolochias is not confined to the Chinese tradition—several aristolochic species have been used in the herbal traditions of Europe, India, and South America. Second, the term is likely to raise unwarranted suspicions about Chinese herbal medicine in general. Several cases of renal failure have been linked to the use of non-steroidal anti-inflammatory drugs. If this phenomenon were to be called prescribed drug nephropathy, it would arouse legitimate indignation. We therefore urge that the term CHN be disregarded in favour of aristolochic acid nephropathy. This renaming is not a small matter; because, although some people might be clear about the detail, use of the term CHN in the general media causes great damage to Chinese medicine as a whole. *Nick Lampert, Yanzhong Xu *46 Clarence Road, Birmingham B13 9UH, UK; and Chinese Medicine Association of Suppliers, London (e-mail: [email protected])
1
Lord GM, Cook T, Arlt VM, Schmeiser HH, Williams G, Pusey CD. Urothelial malignant disease and Chinese herbal nephropathy. Lancet 2001; 358: 1515–16.
Authors’ reply Sir—Nick Lampert and Yanzhong Xu suggest that the term CHN has been used only in the initial description1 and in two subsequent cases of CHN in the UK.2 A review of medical reports shows that this is not the case, since the term has been used by many researchers around the world in describing this disorder. Use of the term does not mean that the term CHN is correct, but it does indicate that it is commonly recognised by the medical and scientific community. This point is not a trivial one, because international awareness of a serious adverse reaction to an unlicensed medicinal product is an important mechanism by which the risk of harm to further patients may be reduced. Since CHN may lead to renal failure and urothelial malignant disorders, its recognition and prevention are a high priority. Many cases of CHN have not been definitively linked with aristolochic acid. Whether this specific renal pathology was causally linked with the ingestion of Chinese herbs at all has been debated, given that patients from the Belgian CHN cohort were taking conventional medication at the same time.3 For this reason, our cases are of particular interest, since they did not occur within the original Belgian cohort and provide strong evidence about the cause of CHN, given that the only medication being taken was Chinese herbs. Although our case may well be better described as aristolochic acid nephropathy because of aristolochic acid in the herbal preparation and the presence of tissue aristolochic acid-DNA adducts, such evidence has not been reported for most cases of CHN. To suggest that all cases previously reported as CHN be reclassified as aristolochic acid nephropathy is currently unsustainable. Furthermore, although aristolochic acid may be used in herbal traditions from other cultures, to our knowledge aristolochic acid and renal failure have been linked only in the context of Chinese herbal remedies, raising the possibility that other, as yet unidentified, nephrotoxins act synergistically with aristolochic acid in the causation of this nephropathy. The term CHN is not used in a pejorative way, but merely as a label that is compatible with the salient facts of its cause and pathogenesis of
THE LANCET • Vol 359 • March 2, 2002 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet Publishing Group.
to justify the use of HRT by “suitable” women with established coronary disease. Unfortunately he does not specify the hormone regimen he would recommend, nor the evidence on which this choice is based.
proposals with the national legislation. In establishing this line, the EC supported the opinion issued by the European Group on Ethics in Science and New Technologies on Nov 14 (number 15).
David C G Skegg
Achilleas Mitsos
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin, New Zealand
European Commission, B-1049 Brussels, Belgium 1
1
2
3
Mosca L, Collins P, Herrington DM, et al. Hormone replacement therapy and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation 2001; 104: 499–503. Skegg DCG. Evaluating the safety of medicines, with particular reference to contraception. Stat Med 2001; 20: 3557–69. Grady D, Wenger NK, Herrington D, et al. Postmenopausal hormone therapy increases risk for venous thromboembolic disease. Ann Intern Med 2000; 132: 689–96.
Embryonic stem cell research in Spain Sir—In your Oct 20 news item, Xavier Bosch1 finishes by stating “European supporters of [stem cell] research may come up against the European Commission (EC), which has made it clear that its programme for 2002–06 will fund adult and not embryonic stem cell work.” This statement does not reflect the present state of the debate correctly, nor does it represent the proposal of the European Commission. The ethical principles, which will guide European Union (EU) funded research under the next Framework Programme in 2002–06, are currently being discussed in the European Parliament and Council. The issue of EU funding is, therefore, still an open question awaiting the legislative decision of the Council and the Parliament. The EC, in its capacity to initiate proposals for legislative acts, submitted to Council on May 30, 2001, a proposal for a specific programme to implement the Framework Programme for the integration and strengthening of the European research area, explicitly excluding, among other provisions, research activities aiming at human cloning for reproductive purposes; intended to modify the genetic heritage of human beings, and render such modification hereditary; and intended to create human embryos for research or therapeutic purposes where national laws permit. The decision of EU funding for fetal and adult human stem cell research, as well as research on spare embryos is subject to the conformity of the
796
Bosch X. Spain closes the door to embryonic stem cell research. Lancet 2001; 358: 1351.
Chinese herbal nephropathy Sir—Graham Lord and colleagues (Nov 3, p 1515)1 propose a link between urothelial malignant disease and Chinese herbal nephropathy (CHN). The term CHN was used in medical reports after analysis of cases of renal failure arising from treatment at a Belgian slimming clinic in the early 1990s, where a mixture of conventional medicines and Chinese herbs was prescribed. The term again appeared in connection with two cases of renal failure in the UK after treatment with Chinese herbal remedies. The specific feature found in all cases of CHN is the presence of aristolochic acid-DNA adducts, after herbal treatment that contained a species of aristolochia. The nephropathy in question is an aristolochic acid nephropathy, and all aristolochias are now banned for use in unlicensed medicines in the UK. The term CHN is highly prejudicial. First, because, historically, the use of aristolochias is not confined to the Chinese tradition—several aristolochic species have been used in the herbal traditions of Europe, India, and South America. Second, the term is likely to raise unwarranted suspicions about Chinese herbal medicine in general. Several cases of renal failure have been linked to the use of non-steroidal anti-inflammatory drugs. If this phenomenon were to be called prescribed drug nephropathy, it would arouse legitimate indignation. We therefore urge that the term CHN be disregarded in favour of aristolochic acid nephropathy. This renaming is not a small matter; because, although some people might be clear about the detail, use of the term CHN in the general media causes great damage to Chinese medicine as a whole. *Nick Lampert, Yanzhong Xu *46 Clarence Road, Birmingham B13 9UH, UK; and Chinese Medicine Association of Suppliers, London (e-mail: [email protected])
1
Lord GM, Cook T, Arlt VM, Schmeiser HH, Williams G, Pusey CD. Urothelial malignant disease and Chinese herbal nephropathy. Lancet 2001; 358: 1515–16.
Authors’ reply Sir—Nick Lampert and Yanzhong Xu suggest that the term CHN has been used only in the initial description1 and in two subsequent cases of CHN in the UK.2 A review of medical reports shows that this is not the case, since the term has been used by many researchers around the world in describing this disorder. Use of the term does not mean that the term CHN is correct, but it does indicate that it is commonly recognised by the medical and scientific community. This point is not a trivial one, because international awareness of a serious adverse reaction to an unlicensed medicinal product is an important mechanism by which the risk of harm to further patients may be reduced. Since CHN may lead to renal failure and urothelial malignant disorders, its recognition and prevention are a high priority. Many cases of CHN have not been definitively linked with aristolochic acid. Whether this specific renal pathology was causally linked with the ingestion of Chinese herbs at all has been debated, given that patients from the Belgian CHN cohort were taking conventional medication at the same time.3 For this reason, our cases are of particular interest, since they did not occur within the original Belgian cohort and provide strong evidence about the cause of CHN, given that the only medication being taken was Chinese herbs. Although our case may well be better described as aristolochic acid nephropathy because of aristolochic acid in the herbal preparation and the presence of tissue aristolochic acid-DNA adducts, such evidence has not been reported for most cases of CHN. To suggest that all cases previously reported as CHN be reclassified as aristolochic acid nephropathy is currently unsustainable. Furthermore, although aristolochic acid may be used in herbal traditions from other cultures, to our knowledge aristolochic acid and renal failure have been linked only in the context of Chinese herbal remedies, raising the possibility that other, as yet unidentified, nephrotoxins act synergistically with aristolochic acid in the causation of this nephropathy. The term CHN is not used in a pejorative way, but merely as a label that is compatible with the salient facts of its cause and pathogenesis of
THE LANCET • Vol 359 • March 2, 2002 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet Publishing Group.