Editorial: The Latest Battleground - JAMA Fires at Herbals

By Len Monheit
[email protected]
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The latest issue of JAMA proves beyond the shadow of a doubt that this publication has both an agenda and the clout and widespread credibility to exercise it. For those of you not following the week’s news, three articles of industry significance appeared in the publication:

1. "Effect of St. John's Wort on Drug Metabolism"
Abstract at: http://jama.ama-assn.org/cgi/content/abstract/290/11/1500

2. "Internet Marketing of Herbal Products"
Abstract at: http://jama.ama-assn.org/cgi/content/abstract/290/11/1505

3. "Drugs Alias vs. Dietary Supplements" – editorial

The article receiving the most widespread coverage is the second, although the third ‘editorial’ has given rise to the usual barrage of outrage at perceived lack of herbal regulations. It’s impact is likely to be far less significant than the second piece, which has already resulted in hundreds of stories on various media around the world with titles including ‘Studies question herbal remedies' claims’ and ‘Rein in Herbal Remedies’.

The American Botanical Council has issued an advisory regarding the articles (http://www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=4940) and although the direct impact of the JAMA publication will likely be minimal, the effectiveness of the overall campaign to discredit herbs cannot be disputed.

So what’s the proper response? What is being and should be done to handle this situation?

With industry ultimately answerable to regulatory agencies (in the US, it’s FDA and FTC),obviously better and more frequent communication would be part of a strategy and is exactly what is being employed by industry trade associations and other groups. For instance the American Herbal Products Association (AHPA) had FTC make a presentation at their meeting at the recent Expo East trade show, and the comments indicated an excellent and supportive relationship between FTC and both the association in general and AHPA President Michael McGuffin in particular. Similarly, at this past week’s CRN (Council for Responsible Nutrition) annual conference, both FDA and FTC made presentations indicating a strong and regular dialogue with the association, and the evidence ofboth an agency and government outreach program was significant for both CRN as a whole (numerous meetings, an effective advertising program targeted directly at legislators) as well as for CRN President, Annette Dickinson specifically. And NNFA’s recent move to Washington is part of its larger commitment to proactively develop stronger relationships in Washington.

The JAMA article touches on an industry sore point, and that is the fact that outliers, operating on regulatory fringes or even outright illegally, are lumped together with companies providing efficacious and safe products. There has been talk of significant expansion of industry self-policing efforts. Recently,trade associations, both individually and collectively, have been vocal in criticism of coral calcium marketers, those seeking to take advantage ofSARS-related concern and companies persisting in operating on legal fringes and gray areas. While this is positive, and there are other initiatives planned, most are voluntary such as product monographs and third party certification. Participation in CRN’s proposed Product Stewardship program, although voluntary, has significant promise and is intended to be industry-wide.

The industry is gradually producing barriers to entry, ones that soon will be complemented by systems such as GMP, Food Security registration and notificationprocesses. ‘Are these barriers being erected fast and high enough in the right areas’ and ‘what to do about those already inside the walls’ are two issues industry must wrestle with because this challenge is one that industry has to face on its own.

And although there is evidence that as the saying goes ‘When the going gets tough, the tough get going’, with spokespeople in and out of the associations becoming more organized and vocal, I’ve been told on numerous occasions that industry lacks visible, charismatic, universal leaders. Part of this issue is directly the result of the diverse nature of the industry and its participants, and the other part may be inherent apathy or lack of interest. Sure, there are spokespeople and trusted sources, and a possible counter-argument is that a collective of trusted, visible, responsible people can be effective. Yet in the evolution of our responsible governmental systems, while we do have Congress, Senates and Parliaments, we also have Presidents and Prime Ministers.

Returning to the JAMA articles, especially the herbal claims on websites article, there is evidence that despite warnings on labels, despite media alerts and FDA advisories, despite industry and association efforts, consumers have a belief system that creates a lucrative market for unscrupulous marketers. Shutting down this market, and its financial incentives must be an industry priority. Although direct marketers and retailers have that final interaction with consumers and therefore could act as ultimate gatekeepers, significant power lies with manufacturers and contract manufacturers, and GMP’s alone will not suffice to ensure responsible practice. Besides, during the many-year implementation program for GMP’s, the damage will continue and will be devastating and discrediting.

Ultimately it must be made clear to both regulators and to consumers just who is legitimate and who is not, what products have legitimate potential and which do not and this must be done in such a way that innovation is not stifled and small companies can enter and participate in the market. Until that is done, the good and the bad, the legitimate and the false, the legal and the illegal, are treated far too often as one and the same.

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