HERB ALERT! [Summer 2004]

HERB ALERT!

I'm just back from the Acupuncture and Oriental Medicine Alliance (AOMA) conference in LA. The most pressing issue that came up is about herbs.

What Léonie Rosenstiel has been warning of for a few years now is happening—we are in danger of losing access to herbs within a year or two, and we're already losing several of them. If any of us doubt this, please read the May issue of Consumer Reports, and understand that this is the position being taken by all the major media outlets.

There are, however, some useful insights that were offered at the conference by Michael McGuffin of the American Herbal Products Association and by Loren Israelson, a lobbyist for the dietary supplements industry. As I write, I will sometimes note when something is the opinion or idea of Michael McGuffin with “(MM)”, and of Loren Israelson with “(LI)”.

First, some history. Right now, herbs are regulated and lumped together with “supplements.” Both are under the purview of the Food and Drug Administration (FDA), which has two main departments—simply, there is the food department, and there is the drug department. In 1994 the Dietary Supplement Health and Education Act (DSHEA) was passed. There are things about its passage that made bitter and long-lasting enemies to “alternative health” out of people like Ted Kennedy (LI), who was already unfriendly to the cause. In any case, DSHEA put herbs and supplements into the “food” class.

There were advantages; efficacy didn't need to be proved, harmlessness didn't need to be proved, licenses didn't need to be obtained, and there were no lengthy, expensive and/or strongly biased testing procedures to be undergone. All this applied to herbs, and to “supplements.” Thus the herbs we learned to use and to prescribe, basically as medicines, for specific conditions, were available to us for careful use.

There were also disadvantages; these same herbs were also available to anyone else to use in any way they wanted, responsibly or irresponsibly. There's a bigger problem, though. Quite some time ago a principle was established that if a food, or something sold as a food, was demonstrated to be carcinogenic or otherwise toxic, then it could, would and should be banned. This principle enabled the banning of several toxic flavorings and colorings, for instance. There are “food products” manufactured by large corporate entities (aspartame, for instance) that are questionable but are protected by the powerful financial, legal and political resources of their parent corporations. In the case of aristolochic acid, though, there were some postwar experiments to see if it could be used to treat cancer. High dosages of refined aristolochic acid were fed to rats, and the rats had kidney failure. These results surfaced last decade in the wake of some deaths in Europe. These deaths were from kidney failure related to highly irresponsible use of Chinese herbs. The herbs were given in huge dosages (100g of fang ji, for instance, and the wrong kind of fang ji at that), and they were given in combination with Western herbs (some difficult or impossible to identify), and with Western medicines (some since banned, although for cardiotoxicity rather than for nephrotoxicity). Westerners untrained in the use of Chinese herbs administered the herbs. But none of that matters, what matters is that these things labeled “foods” had ingredients that were once shown to be possibly dangerous. If we agree that toxic colorings, flavorings and other additives should be banned, then these herbs can, “should” and will be banned.

It has been objected that the herbs we use are relatively harmless, and that the damage attributed to them—never mind damage proven to have been caused by them—is negligible compared to what drugs, even fairly safe over-the-counter drugs like aspirin or acetaminophen, have done. As LI pointed out, the unfairness is due to the terms of DSHEA. When a drug is approved, it is understood that it may have some adverse effects. These are balanced against the medical benefits it provides. If the adverse effects are severe, then there's a risk vs. benefit analysis, and then it's decided whether the risks outweigh the benefits or not. Unfortunately, foods by definition have no medical benefits. We're all aware that herbs and supplements have disclaimers on their labels making it clear that no medical effects or benefits are claimed. This means that if any risk is shown, there is by law no benefit that might balance it.

In other words, for us in the Chinese Medical community DSHEA has probably reached the end of its usefulness. Major supplement manufacturers will remain relatively happy, but Traditional Chinese Medicine is now a target. We have few resources, no organization, and no real allies in Congress or in the Senate.

MM and others suggest a direction. What we may need to do is establish a third category, aside from “food” and “drug”. It's suggested that if we can establish a category of “Traditional Medicines”, then we can attribute the benefits that traditional medicine has been claiming for hundreds of years, and have something to balance “risk” against. If we limit “traditional medicines” to something like “plants and plant parts, animals and animal parts, and minerals and mineral salts”, then the supplement manufacturers can't take some extract from our pharmacopoeia, concentrate it, and sell it in irresponsible doses for non-traditional uses. It's further suggested that there be a “restricted list” for things like aconite, ephedra and such, that will only be available to practitioners, and only to those who can demonstrate proper training and/or qualification. (Much as I dislike the direction the NCCAOM has been forcing the profession into lately, they provide the only such nationally recognized criterion available right now.)

A proposal was made that the profession hold a congress of interested parties later this year (probably in the summer) so we can decide what we want to do. We need to decide if we agree with MM's suggestions, if we have modifications, if we want to stay allied with the “supplement” industry, or if we want to try to establish our own national voice. The two national associations—the AAOM (“Association”) and the AOMA (“Alliance”)—will be involved, and their roles need to be defined so neither undermines the common effort. We will need to raise a lot of money if we're going to afford the kind of lobbying to get us noticed in Washington, and we will need to establish an undeniable record of public service, so we can present ourselves as something other than another group out to grab all it can get.

We have a lot of work to do. If we don't do it, we can say good-bye to the herbal half of our practice within a few years.

The OMANM is setting up an account so that contributions earmarked for the effort to keep herbs in our practice will be set aside for that purpose only. Nothing much will happen until the congress is held to decide how to coordinate efforts nationally. If you are willing to help, and/or want to be informed of developments as we find out about them, you can contact the chair of the OMANM Herb Committee, Dr. Quinn Takei (505-306-3155), or me, Selah Chamberlain (505-751-3284).