dinoiii
October 28th, 2006, 10:30 AM
Short Topic Series III: Comission E Defined
Introduction
The Eastern Bloc (namely, the European subset) approaches evaluation of the dietary supplement industry in a very different way when compared to the United States. The United States often finds ridicule of an industry that is quoted unregulated an easier scapegoat, namely when things go awry in terms of medical pathophysiologic states. Now, despite the fact that this "unregulated" term is more readily defined as not being supported by the Food and Drug Administration (FDA) due to the monetary offerings of a much larger industry - the pharmaceutical industry, media and the like play off such suggestion virtually bastardizing anyone who supports such an "unregulated" subsector of industry, namely dietary supplements.
AMG 76
One thing often forgotten by the Western subset (namely, the US) is that the industry does in fact have a prudent watchdog. Regulation within the European community, especially Germany, falls under a German legislative piece, known as AMG 76 enacted in 1976. Under this particular law, the German government required a review of all medicine, NOT JUST HERBAL, for sale within the country. Expert committees were appointed to review different groups and types of drugs. These committees worked within the Federal Health Agency, the German equivalent of the United States' Department of Health & Human Services.
A total of 16 different commissions stemmed from this legislation, and each was subsequently designated by an initial. Commission B1, for instance, was responsible for review of drugs used in cardiology and nephrology; Commission B2 was responsible for the review of drugs used in rheumatology. Commission E - for which 24 members sat on - was the subsector of "phytotherapy" (which could be considered that which includes herbal remedies, etc...). Evidence of safety and effectiveness for 360 different herbs were reviewed and published as official government documents called, "monographs." These monographs were subsequently translated into English and published as The Complete German Commission E Monographs, Therapeutic Guide to Herbal Medicines, edited by Mark Blumenthal, and published by the American Botanical Council.
American Physician Response = YAWN
Long-since brainwashed by the more powerful pharmaceutical influence on the FDA and of course the fringe benefit of who supplies free physician lunches, doctors responded in virtual unison in a rather unenthused manner. For one thing, the references used by the experts to form their opinions are not included in the monographs, and much of the wording is more vague than anything written about prescription drugs. Plus, well - there is the fact that the pharmacuetical industry begins their propaganda while we are in medical school. We have a minimum of one full course on pharmaceutical therapy while investing no time in an industry that perplexes many physicians (dietary supplements). This is interesting considering the fact that physicians are suggested as whom you should seek advice from when embarking on a dietary and supplement regimen, yet truly are likely nine out of ten times the most clueless on the subject matter (even quoted "experts" in the industry are pretty clueless though).
Conclusion
So, in summary - though there are some expert panels, minimally as effective, if not moreso, that exist for the dietary supplement industry (herbal at least, not necessarily the complete sports supplement sector) as a whole - yet there is still simple bastardization of such review. It is important to understand that this is, in effect "regulation," albeit from a different bloc.
In light of the propaganda forums setup by both the pharmaceutical subsector as well as the FDA set, in place to influence practicing physicians with a trickle-down effect on the media, the dietary supplement industry oftentimes takes unnecessary and more importantly unwarranted hits. It is therefore, up to the consumer to understand the various govening bodies and what they stand for - if at all we are to have impact on our own health and fitness status.
Introduction
The Eastern Bloc (namely, the European subset) approaches evaluation of the dietary supplement industry in a very different way when compared to the United States. The United States often finds ridicule of an industry that is quoted unregulated an easier scapegoat, namely when things go awry in terms of medical pathophysiologic states. Now, despite the fact that this "unregulated" term is more readily defined as not being supported by the Food and Drug Administration (FDA) due to the monetary offerings of a much larger industry - the pharmaceutical industry, media and the like play off such suggestion virtually bastardizing anyone who supports such an "unregulated" subsector of industry, namely dietary supplements.
AMG 76
One thing often forgotten by the Western subset (namely, the US) is that the industry does in fact have a prudent watchdog. Regulation within the European community, especially Germany, falls under a German legislative piece, known as AMG 76 enacted in 1976. Under this particular law, the German government required a review of all medicine, NOT JUST HERBAL, for sale within the country. Expert committees were appointed to review different groups and types of drugs. These committees worked within the Federal Health Agency, the German equivalent of the United States' Department of Health & Human Services.
A total of 16 different commissions stemmed from this legislation, and each was subsequently designated by an initial. Commission B1, for instance, was responsible for review of drugs used in cardiology and nephrology; Commission B2 was responsible for the review of drugs used in rheumatology. Commission E - for which 24 members sat on - was the subsector of "phytotherapy" (which could be considered that which includes herbal remedies, etc...). Evidence of safety and effectiveness for 360 different herbs were reviewed and published as official government documents called, "monographs." These monographs were subsequently translated into English and published as The Complete German Commission E Monographs, Therapeutic Guide to Herbal Medicines, edited by Mark Blumenthal, and published by the American Botanical Council.
American Physician Response = YAWN
Long-since brainwashed by the more powerful pharmaceutical influence on the FDA and of course the fringe benefit of who supplies free physician lunches, doctors responded in virtual unison in a rather unenthused manner. For one thing, the references used by the experts to form their opinions are not included in the monographs, and much of the wording is more vague than anything written about prescription drugs. Plus, well - there is the fact that the pharmacuetical industry begins their propaganda while we are in medical school. We have a minimum of one full course on pharmaceutical therapy while investing no time in an industry that perplexes many physicians (dietary supplements). This is interesting considering the fact that physicians are suggested as whom you should seek advice from when embarking on a dietary and supplement regimen, yet truly are likely nine out of ten times the most clueless on the subject matter (even quoted "experts" in the industry are pretty clueless though).
Conclusion
So, in summary - though there are some expert panels, minimally as effective, if not moreso, that exist for the dietary supplement industry (herbal at least, not necessarily the complete sports supplement sector) as a whole - yet there is still simple bastardization of such review. It is important to understand that this is, in effect "regulation," albeit from a different bloc.
In light of the propaganda forums setup by both the pharmaceutical subsector as well as the FDA set, in place to influence practicing physicians with a trickle-down effect on the media, the dietary supplement industry oftentimes takes unnecessary and more importantly unwarranted hits. It is therefore, up to the consumer to understand the various govening bodies and what they stand for - if at all we are to have impact on our own health and fitness status.