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Edited on Sat Aug-13-11 10:58 AM by HysteryDiagnosis
http://www.google.com/#sclient=psy&hl=en&source=hp&q=german%20commission%20e%20monographs&pbx=1&oq=german%20commis&aq=1&aqi=g5&aql=&gs_sm=sc&gs_upl=740l4604l0l6568l13l12l0l3l3l0l391l1610l2.4.2.1l9l0&bav=on.2,or.r_gc.r_pw.&fp=43b3d7638083a689&biw=1280&bih=657&pf=p&pdl=300
The therapeutic use of herbs and phytomedicines has always been very popular in Germany. About 600-700 different plant drugs are currently sold there, singly and in combination, in Apotheken (pharmacies), Drogerien (drugstores), Reformhauser (health food stores), and Markte (markets). In addition to the self-selection of herbal products by consumers, about 70 percent of the physicians in general practice prescribe the thousands of registered herbal remedies, and a significant portion of the $1.7 billion annual sales (a conservative estimate) is paid for by government health insurance. In 1988, 5.4 million prescriptions were written for a single phytomedicine, ginko biloba extract, a figure that does not include the substantial over-the-counter sales of the product.
In view of the significant role which phytomedicines play in Germany, it is only natural that the government there would develop a mechanism to assure users of their safety and efficacy.
The process is unique. For various reasons, other advanced nations have not yet chosen to emulate it. But it is worthy of imitation, and it is probably only a matter of time before consumers in other countries are able to benefit from the German experience.
This experience began in 1976 when the Federal Republic of Germany defined herbal remedies in the same manner as other drugs-specifically as plants, parts of plants, or preparations of plants, either in the processed or crude state-intended to cure, alleviate, or prevent disease, suffering, physical injury, or symptoms of illness, or to influence the nature, state, or function of the body or mental health conditions. Interestingly, herbal remedies are considered as a single active constituent, even though they may contain many different chemical constituents. Isolated constituents of plant origin-morphine, quinine, digitoxin, etc. – are not legally considered to be herbal remedies. Then in 1978, the Bundesgesundheitsamt (Federal Health Agency), now called the Federal Institute for Drugs and Medical Devices, established an expert committee on herbal remedies, composed principally of members proposed by associations of the health professions, to evaluate the safety and efficacy of phytomedicines. This so-called “Commissioin E” included physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry, and lay persons. Its assessment is independent of the Federal Health Agency, which handles only the organizational details.
Unlike the United States Food and Drug Administration which evaluates drugs only in a passive manner based on data supplied by the manufacturer, Commission E actively checks so-called bibliographic data independently. Such data include information obtained from clinical trials, field studies, collections of single cases, scientific literature including facts published in the standard reference works, and expertise of medical associations. If controlled clinical data are lacking, safety and efficacy can still be determined on the basis of information in the literature, the presence of supplemental data supporting clinical results, and significant experimental studies supporting traditional use. |
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