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Strengthening the regulation of herbal medicines in Europe
Editorial
Reuters
Strengthening the regulation of herbal medicines in Europe
See World Report page 1479
For more on the Traditional Herbal Medicinal Products Directive, 2004/24/EC see http://ec.europa.eu/health/ human-use/herbal-medicines/ index_en.htm For more on MHRA Traditional Herbal Medicines Registration Scheme see http://www.mhra. gov.uk/Howweregulate/ Medicines/Herbalmedicines/ Placingaherbalmedicineon theUKmarket/TraditionalHerbal MedicinesRegistration Scheme/index.htm#2
Although widely used, the efficacy of many herbal drugs is unproven. Moreover, many consumers misinterpret the natural origin of herbal medicines as a sign of safety, without appreciating that herbal ingredients can cause serious adverse effects. One of the worst cases of herbal misuse in Europe occurred in 1998, when over 100 Belgian women developed kidney failure after taking slimming pills containing the herb Aristolochic fangchi. 18 of them went on to develop urothelial carcinoma. Each year in the UK, the Medicines and Healthcare Products Regulatory Agency receives about 70 suspected adverse drug reaction reports relating to herbal medicines. To protect consumers, the European Parliament and Council adopted the Traditional Herbal Medicinal Products Directive, 2004/24/EC on March 31, 2004. The Directive requires all herbal medicinal products to meet standards of quality, safety, and efficacy before they can be registered and marketed in the European Union (EU). For those products marketed before the legislation, the Directive gave a 7-year transitional period to register them before April 30, 2011. Up to March 23, 2011, the MHRA had
received 211 applications, 101 of which have been granted a Traditional Herbal Medicinal Registration licence. The herbal medicines industry will be seriously affected by the Directive, especially in China, from where no manufacturer has successfully registered their herbal medicinal products in the EU. Hence, all herbal medicinal products from China will be banned in the EU from May 1, 2011. The Directive will also affect patients and herbal practitioners. Patients who use herbal remedies will not have access to treatments if the products have not been authorised, which might encourage them to purchase the products from alternative, less wellregulated sources. Herbal practitioners will find their legitimate pharmacopoeia limited. Nevertheless, the Directive is a vital step to safeguard public health in the EU. The public has a right to expect that licensed medicinal products, whether herbal or not, are safe and effective. Other countries, where herbal regimens are popular, have a similar obligation to implement standards of quality, consistency, and evidence for their own citizens. ■ The Lancet
William Daniels/Panos
Artesunate for severe malaria
For the WHO guidelines see http://www.who.int/malaria/ publications/atoz/mal_ treatchild_revised.pdf For the AQUAMAT study see Articles Lancet 2010; 376: 1647–57 For the Cochrane review see http://onlinelibrary.wiley.com/o/ cochrane/clsysrev/articles/ CD005967/frame.html Fo the MSF report see http://www.msf.org/msf/ articles/2011/04/malaria-makingthe-switch.cfm For the Amir Attaran article see Viewpoint Lancet 2004; 363: 237–40
1466
There are over 1 million deaths a year from severe malaria, mostly in children in sub-Saharan Africa. Quinine has been the mainstay treatment but it is painful, complex to administer, and has serious side-effects. Last week, in the run up to World Malaria Day (April 25), WHO revised its malaria treatment guidelines to recommend parenteral artesunate rather than quinine as the first-line treatment for severe malaria in children. The evidence supporting this switch is overwhelming. Last year, the AQUAMAT trial undertaken in nine African countries, showed a significant mortality reduction of 22% in the artesunate group compared with the quinine group. And, more recently, a Cochrane review further supported the superiority of parenteral artesunate over quinine in both adults and children worldwide. The challenge now is to translate this evidence into practice and without delay. In a new report, Making the Switch, Médicins Sans Frontières makes a strong case for switching to artesunate, citing that around 195 000 lives would be saved each year. Rightly, they call for a global
plan to be put in place led by the international community. WHO and Roll Back Malaria should assist with technical support and training. National governments need to lead by revising their guidelines. Given the higher cost of artesunate (US$3·3 to treat a child with severe malaria compared with $1·3 for quinine), donors need to put up the money to support the switch and give manufacturers confidence to produce quality artesunate. Traditionally, international donors have not supported treatment for severe malaria given the cheapness of quinine, but this must now change. As noted in the report, the additional yearly drug cost of $31 million for artesunate is a small price to pay, 10 years on from the recommendation to switch to artemisinin-based combinations for uncomplicated malaria, there are still countries using ineffective drugs. Amir Attaran and colleagues described this situation as tantamount to medical malpractice. It would be a travesty if treating severe malaria took the same course. ■ The Lancet www.thelancet.com Vol 377 April 30, 2011
Reuters
Strengthening the regulation of herbal medicines in Europe
See World Report page 1479
For more on the Traditional Herbal Medicinal Products Directive, 2004/24/EC see http://ec.europa.eu/health/ human-use/herbal-medicines/ index_en.htm For more on MHRA Traditional Herbal Medicines Registration Scheme see http://www.mhra. gov.uk/Howweregulate/ Medicines/Herbalmedicines/ Placingaherbalmedicineon theUKmarket/TraditionalHerbal MedicinesRegistration Scheme/index.htm#2
Although widely used, the efficacy of many herbal drugs is unproven. Moreover, many consumers misinterpret the natural origin of herbal medicines as a sign of safety, without appreciating that herbal ingredients can cause serious adverse effects. One of the worst cases of herbal misuse in Europe occurred in 1998, when over 100 Belgian women developed kidney failure after taking slimming pills containing the herb Aristolochic fangchi. 18 of them went on to develop urothelial carcinoma. Each year in the UK, the Medicines and Healthcare Products Regulatory Agency receives about 70 suspected adverse drug reaction reports relating to herbal medicines. To protect consumers, the European Parliament and Council adopted the Traditional Herbal Medicinal Products Directive, 2004/24/EC on March 31, 2004. The Directive requires all herbal medicinal products to meet standards of quality, safety, and efficacy before they can be registered and marketed in the European Union (EU). For those products marketed before the legislation, the Directive gave a 7-year transitional period to register them before April 30, 2011. Up to March 23, 2011, the MHRA had
received 211 applications, 101 of which have been granted a Traditional Herbal Medicinal Registration licence. The herbal medicines industry will be seriously affected by the Directive, especially in China, from where no manufacturer has successfully registered their herbal medicinal products in the EU. Hence, all herbal medicinal products from China will be banned in the EU from May 1, 2011. The Directive will also affect patients and herbal practitioners. Patients who use herbal remedies will not have access to treatments if the products have not been authorised, which might encourage them to purchase the products from alternative, less wellregulated sources. Herbal practitioners will find their legitimate pharmacopoeia limited. Nevertheless, the Directive is a vital step to safeguard public health in the EU. The public has a right to expect that licensed medicinal products, whether herbal or not, are safe and effective. Other countries, where herbal regimens are popular, have a similar obligation to implement standards of quality, consistency, and evidence for their own citizens. ■ The Lancet
William Daniels/Panos
Artesunate for severe malaria
For the WHO guidelines see http://www.who.int/malaria/ publications/atoz/mal_ treatchild_revised.pdf For the AQUAMAT study see Articles Lancet 2010; 376: 1647–57 For the Cochrane review see http://onlinelibrary.wiley.com/o/ cochrane/clsysrev/articles/ CD005967/frame.html Fo the MSF report see http://www.msf.org/msf/ articles/2011/04/malaria-makingthe-switch.cfm For the Amir Attaran article see Viewpoint Lancet 2004; 363: 237–40
1466
There are over 1 million deaths a year from severe malaria, mostly in children in sub-Saharan Africa. Quinine has been the mainstay treatment but it is painful, complex to administer, and has serious side-effects. Last week, in the run up to World Malaria Day (April 25), WHO revised its malaria treatment guidelines to recommend parenteral artesunate rather than quinine as the first-line treatment for severe malaria in children. The evidence supporting this switch is overwhelming. Last year, the AQUAMAT trial undertaken in nine African countries, showed a significant mortality reduction of 22% in the artesunate group compared with the quinine group. And, more recently, a Cochrane review further supported the superiority of parenteral artesunate over quinine in both adults and children worldwide. The challenge now is to translate this evidence into practice and without delay. In a new report, Making the Switch, Médicins Sans Frontières makes a strong case for switching to artesunate, citing that around 195 000 lives would be saved each year. Rightly, they call for a global
plan to be put in place led by the international community. WHO and Roll Back Malaria should assist with technical support and training. National governments need to lead by revising their guidelines. Given the higher cost of artesunate (US$3·3 to treat a child with severe malaria compared with $1·3 for quinine), donors need to put up the money to support the switch and give manufacturers confidence to produce quality artesunate. Traditionally, international donors have not supported treatment for severe malaria given the cheapness of quinine, but this must now change. As noted in the report, the additional yearly drug cost of $31 million for artesunate is a small price to pay, 10 years on from the recommendation to switch to artemisinin-based combinations for uncomplicated malaria, there are still countries using ineffective drugs. Amir Attaran and colleagues described this situation as tantamount to medical malpractice. It would be a travesty if treating severe malaria took the same course. ■ The Lancet www.thelancet.com Vol 377 April 30, 2011