Terra Sigillata

For several years, various media outlets have asked my opinion about herbal medicine and dietary supplement issues. I’ve generally written several pages of responses only to find a few key quotes mined from my paragraphs of wisdom (in my mind). No problem at all; I just have trouble with churning out sound bites. So, I’d like to share with you stuff that never makes it to the so-called mainstream media. This is a repost of classic Terra Sigillata that first appeared on the old site on 8 May 2006.

Recently, I was asked by a US television network to comment on the value of the release of Consumer Reports’ Natural Medicines Ratings Database (follow link then click on “Browse Index”). In filing my response, I composed the following diatribe that concluded with my ‘best of’ final recommendations for sources in which I have no financial or scholarly interest (except for Terra Sig, of course) but find to be quite valuable to the general public.

What do consumers/patients want to know about “natural medicines?”
My interactions with patients are mostly through giving public education programs and talking with BS/PharmD-level pharmacists and my MD colleagues at academic medical centers. The first question patients have is, Will taking this supplement interfere with my prescription drug(s)?” This question is undoubtedly the most common and the most serious challenge since 95% of patients who use alternative therapies do so together with conventional medicine (conversely, only 5% of patients who use alternative medicines do so exclusively of conventional medicine).

The second question is usually, Is this herb/supplement really good for disease/disorder X?” This is a difficult question to answer since supplements in the US are not required to undergo efficacy testing although they can be advertised for thinly-veiled indications like “supports a healthy cholesterol level” rather than “reduces cholesterol” as the latter would be a drug claim requiring clinical trials. Support claims or “structure-function” claims are acceptable for foods and supplements under the 1994 US Dietary Supplement Health and Education Act (DSHEA; pronounced duh-SHAY).

Hence, most of what we know clinically about herbs/supplements comes from companies, usually European, who support clinical trials of their product to gain a market advantage. In such cases, like the 1997 JAMA paper showing that Ginkgo extract slows the progression of Alzheimer’s disease, that conclusion can only be made for that Ginkgo product and not the 20 others that are on the health food store shelves. Other companies rushed to advertise that their Ginkgo products were standardized to the same composition of active compounds, but a consumer could not be certain this was the case. In fact, the sponsor of the JAMA study, Dr Willmar Schwabe (pronounced VIL-mar SCHVAB-uh) Pharmaceuticals (Karlsruhe, Germany) had a US process patent for this product, rare in the herbal industry, and threatened to bring suit against any company who was trying to sell their products under this patent.

This brings me to the third related question, “Where can I buy an herbal product that has shown efficacy in a placebo-controlled, randomized trial that has been published in a major peer-reviewed journal?” Let’s take the Ginkgo example above. If you go to the JAMA paper, you’ll find that the product used was called EGb 761 and is sold as Tebonin. Well, great, but Tebonin is not available in the US. You would have to know that Utah’s Nature’s Way imports EGb 761 and sells it here under the brand name Ginkgold. However, you will pay a premium of about 4-fold to buy Ginkgold over Nature’s Way’s regular brand of Ginkgo extract.

Where does the consumer find this information? First, the American Botanical Council (also abbreviated ABC) of Austin, TX is a non-profit educational organization that publishes a journal called HerbalGram, kind of like the Scientific American of the herbal field. Periodically, they will publish a table of clinically-proven herbs and the name of the formulation as sold in the US. For example, an extract of saw palmetto has been shown to reduce prostate swelling in men with BPH (benign prostatic hypertrophy) but the product, Permixon, does not yet appear to be for sale in the US. ABC founder and director Mark Blumenthal also included this table in the latest English translation of the German Commission E monographs, the equivalent of an FDA sanctioned guidebook if the FDA had any power to make prospective pronouncements on herbs.

Based on what we know about Consumer Reports, how might the new CR database be useful?
Related to the third question above, most patients now understand that all herbs of the same name are not created equal. Several scientists, and Consumer Reports itself, demonstrated as early as the late 80s and early 90s that composition of active constituents in a given herb can vary by 20-fold or more across manufacturers. In fact, I have a copy of my original 1995 lecture I gave on the topic to my pharmacy students and the handout contains a table from an issue of Consumer Reports on active components from ginseng products – I still use this table in my professional and public lectures.

Hence, I view the Consumer Reports Natural Medicine Ratings Database with great enthusiasm. The organization has really only been off-base once in the past with their “12 Supplements to Avoid” in May 2004. At least two of their “dangerous” recommendations were based on hearsay (i.e., unpublished reports) that had been medically discounted well before 1994 (such as skullcap-mediated liver damage which is now well-known to be due to one report of one wholesale batch of herb that was contaminated with germander, a herb that really is hepatotoxic).

Other than that, Consumer Reports has a excellent brand recognition, a history of impartiality that extends back at least 60 or 70 years, with its only agenda being to protect the consumer. The fact that they are often remembered in the estates of subscribers yet frequently attacked by industries they criticize speaks to their impartiality and the high level of confidence that they generate among the public.

The database is outstanding and the few entries on herbs I know about are comprehensive and up-to-date. I attribute this to their partnership with the Pharmacist’s Letter and Natural Medicines Comprehensive Database director/founder, Jeff Jellin, PharmD. Jeff is held in the highest regard by a great many of us in herbal medicine research and pharmacy education (and, no, I do not get any free subscriptions from his organization. However, many hospitals and academic medical centers subscribe to one or more these databases).

Another great feature is the drug-herb interaction search engine that errs on the side of caution. However, I fear that patients may use this feature rather than tell their physician about their herbal use. An additional concern for the health care provider is that the original literature citations for the interactions are not provided on this site and one must subscribe to the professional version of Jellin’s Natural Medicines Comprehensive Database (a clever marketing tactic).

Technically, I don’t really like the drop-down menus that only show one section at a time – I’d like a choice to “expand all.”

What are other credible sources, outside of physicians, currently on the internet or elsewhere that can help guide patients on natural medicine choices?
First, the internet is largely a horrible place for information on natural medicine choices. Misinformation outweighs objective truth 99 times out of 100 (no exaggeration). Most internet sites are written to sell you a product and make you think you are getting “scientific” information.

The one thing missing from the CR site is a rating of products based upon labeled content matching actual, independently-analyzed content of active components, something CR has done previously for select herbal products. ConsumerLab.com does fill this void and it would be great if CR could work out a deal to partner with ConsumerLab.com. ConsumerLab.com was founded by an MD and a former FDA natural products chemist to serve as a sort of Consumer Reports for herb and dietary supplement content and issues of contamination and safety. For example, they were the first to bring to widespread knowledge that some herbal products can contain toxic levels of cadmium, mercury, and even uranium depending on where the plant is grown. (Full disclosure, they gave me a free $24.95 annual subscription two years ago (now $27.00) – however, I had paid for my own subscription previously and now continue to do so since the freebie expired).

I am also partial to HerbalGram and the American Botanical Council because they have a long history of working hand-in-hand with researchers in the field and in pharmacy education. (I get nothing free from them and, in fact, donate at least $250/year to them to support their mission.).

I also think very highly of Joe and Terry Graedon of The People’s Pharmacy enterprise and their very recently updated and well-constructed website. As mentioned above, they have a syndicated weekly NPR radio show on drug, natural medicine, and health issues, maintain herb and home remedy information on their website, have published over a half-dozen books, and have a syndicated weekly column in over 500 papers across the US. They are pioneers in self-care, with Joe’s first book, The People’s Pharmacy, released in 1976 when it reached #1 on the NY Times bestseller list. I have recommended them for over 15 years but have come to know them personally over the last 5 years or so. Joe holds a master’s in pharmacology but has done enough work in this field for several PhDs; his wife Terry holds a PhD in medical anthropology and has been a professor in the nursing school at Duke University. They sell CDs of each radio show for $16 and almost 400 well-researched in-depth guides on drugs and natural medicines for $3 or $4 each. (Disclosure: I have been a guest on their radio show but have not received any compensation from them in either money or services).

(I also disclosed the truth about the following to the media outlet who consulted me). There is also a blogger that I know personally who writes at Terra Sigillata and covers issues of natural medicines and even solicits and answers questions from readers. He has very similar training to me (PhD in pharmacology with experience in herbal medicine research and pharmacy/medical education) but his current employment situation requires that he writes under a pseudonym.

Several well-known scientists and clinicians, including some from the US National Institutes of Health, have authored an ever-expanding book called, The Encyclopedia of Dietary Supplements, from Dekker. It is written at a higher level than for the average consumer but is approachable by the internet-savvy consumer. Its original price was quite high but I know they are addressing this as their website no longer lists an official price and directs the consumer to call for pricing. I know many of the chapter authors and editors and find this to be a top-notch reference for upper-level consumers through PhDs and MDs.

Finally, there is a two-volume book series that addresses clinical trials issues and the mystery of US marketed names of supplements tested in clinical trials called The Handbook of Clinically Tested Herbal Remedies. It is written by an independent pharmacognosy consultant named Marilyn Barrett, PhD. It is superb but not regularly updated (no web mirror) and goes for about $160 for both volumes.

I’m afraid that the consumer won’t have much luck turning to their conventional medical provider. I think there is a slightly higher probability that a pharmacist will know more about herbal products and drug interactions than the average physician. Frankly though, the overall percentage isn’t that high in either profession and can be quite spotty geographically. A survey in 1998 of US pharmacy schools on alternative medicine course offerings revealed that the problem is due in part to the fact that some schools devote entire semesters to the topic while others have 2 or 4 lectures in the entire curriculum. Also, I have found that some unscrupulous physicians and pharmacists sometimes sell supplements regardless of the scientific basis for their use.

I would encourage consumers to BEWARE of herb counseling advice they might receive in a health food store or supplement store. There are several reports in the scientific literature of incorrect or dangerous advice given to patients by health food or vitamin store clerks when asked about products for diseases as serious as cancer or HIV/AIDs.

Final recommendations
My advice, for what it’s worth, is to get a subscription to this new Consumer Reports Natural Medicine Ratings ($19), ConsumerLab.com ($27), and HerbalGram of the American Botanical Council (starts at $50/year for a superb print journal and web access to it and other added info). For less than $100 per year, you’d be set up pretty well and be able to stay current.

For free on the web, the two objective sources I recommend are The People’s Pharmacy and, of course, the Terra Sigillata blog. Take a look at The People’s Pharmacy once a week, especially if your newspaper or NPR station doesn’t get them and check out their store. As a supplement, dial-up Terra Sigillata twice a week as [he] often links to other content that he has reviewed for accuracy and objectivity.

Hope this helps – I’m happy to add useful links that readers might find.

Comments

  1. #1 Dan R.
    July 11, 2006

    Adding to your excellent list of resources:

    When looking for supplaments, look for a USP Verified mark, which means that the supplament has been independently tested for amount (matching that on label), bioavailability, abscense of harmful chemicals (mercury, etc).

    For more information, including manufactorers who participate — including many generics, see http://www.usp.org/USPVerified/.

    USP Verified
    Overview

    In response to increasing consumer concerns about dietary supplements, USP established a rigorous third-party testing program to verify the integrity of dietary supplements submitted by manufacturers voluntarily participating in the program. USP then extended its verification capabilities by developing a program to verify the quality of ingredients used in the manufacture of dietary supplements. USP’s verification programs draw upon its experience of more than 185 years in setting federally recognized public standards for medicines and dietary supplements. USP’s independent nonprofit status and its volunteer-based scientific expertise lend authority and credibility to its verification programs.
    USP-Verified Dietary Supplements

    The USP-Verified mark on a dietary supplement label helps to assure consumers that the supplements they buy provide the expected value. See which companies are participating in the USP-Verified program. Get a list of verified supplements and find out where they’re available. Learn how USP verifies supplements. Find out how supplement manufacturers can join the program.
    USP-Verified Ingredients

    USP verifies active and inactive ingredients used in the manufacture of dietary supplement products. The USP-Verified Ingredient mark helps manufacturers recognize that they are buying ingredients of consistent quality for use in the supplements they manufacture. Learn which companies are participating in the ingredient verification program. Get a list of verified ingredients. Learn how USP verifies ingredients. Find out how ingredient manufacturers can join the program.

  2. #2 define_me
    July 13, 2006

    How I miss your herbal medicine diatribes…I’m definitely glad to be back…how’s the new abode btw??? The banner is looking fantastic!

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