Reply to the Letter of Dr. Lang
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CORRESPONDENCE
Reply to the Letter of Dr. Lang
Willen K. Sckolten, MSc, Pharm, MPA
That Good Agricultural Practice (GAP) and Practice (GMP) should w i ' ~ ' ~ ~ ~ ~ ~ Good ; - ~ Manufacturing ~ ~ ; [email protected]). aim only for safety is only the view of Dr. Lang. In my view, GAP and GMP should both aim not only for safety, but also for the total reproducibility and reliability of a medicine, including equal efficacy from batch to batch. The consumer has the right to buy safe medicines, as well as the right to buy effective medicines if they are advertised as such. Unfortunately, herbal medicines that are advertised as effective often are not. Although l cannot prove it, I am convinced that the use of "average qualities" of starting material is one reason why so many commercially-available preparations do not work. Especially for herbal medicinal products, it is shown that the starting material can vary tremendously. Consequently,this variation is responsible for variations in the end product. The only way to prevent this variation is to standardize cultivation, which becomes more important as the complexity of the plant composition increases and there is less analytical knowledge of the extract. Standardization should go far enough so that the end product has a constant composition, but further standardization does not make sense. If it is shown that including a certain aspect of the standardization is not necessary, it Correspondence Address
should be left out. This could be the intra-day standardization of the harvest. However, in the case of ginkgo it has been shown that there is a major difference between leaves harvested at sunset and at sunrise. Intra-day standardization of the harvest should not necessarily mean that the leaves are harvested only for 10 minutes at sunrise, but this can be made practicable by ensuring that the relative amounts are spread equally throughout the day. Blending material from many unstandardized sources only mitigates a larger variance, however. By including many different types of such material one hopes to include the effective chemotype. This is a gamble. In the case of Egb 761, the manufacturer managed to register the product as effective, which was a real achievement, but one must admit that it was marginal. Nobody knows how effective this product could have been if the optimal starting material was first identified, before continuing further development. On the other hand, blending would not be irrelevant for standardized material and it would contribute to greater batch-to-batch consistency. This could mean that we do need climatic chambers for cultivation. Our Dutch medicinal cannabis program (which works with standardized cultivation, but not with blending) shows that this is possible. Not only do we set lower
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Drug Information Journal. Vd.38,pp. 101- 102.2004 0092-86l5/2004 Printed in the USA. All rights mewed. Copyright 0 2004 Drug Information Asson'ation, lnc.
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