Editorial: GAIT And Beyond

By Len Monheit

The release of results from the NIH Glucosamine / Chondroitin Arthritis Intervention Trial (GAIT) is being looked upon as validation of industry’s joint support category and long-held contention that the combination of glucosamine and chondroitin sulfate is effective in treating pain associated with osteoarthritis.

NCCAM has issued a statement indicating that it won’t comment on the results until they are further validated by publication in a peer-reviewed journal, and the attention to accepted scientific practice and review is noteworthy. The fact that the glucosamine and chondroitin sulfate were required to meet pharmaceutical standards as GAIT was conducted under an Investigational New Drug application has been lost in some of the hype and translation, as we see widespread coverage of the study results.

Even before the abstract was posted (ie. presumably still under embargo) companies began their marketing positioning, including messaging indicating that conventional dietary supplements, procured off any store shelf, would produce similar successful treatment. (One release I read even commented on the fact that ‘low’ cost supplements would do so.)

Well, we’re already on dangerous ground here. First of all, all products on the marketplace are not equal, and the very reason for the clamor for highest qualified materials for research of this type is that it provides the best chance of a successful study and ensures that the study can be reproduced, hopefully in a wide population suffering from the pain of osteoarthritis. In this case, the materials are described as drug quality.

The whole scenario has me asking questions such as “What percentage of products in the marketplace truly offer this quality?” and “Tested using what methodology and validation criteria?”

Yes, this news is significant and legitimizes to a certain extent what those in the industry have been saying for years. A top quality glucosamine-chondroitin supplement can be effective. And this legitimization, in the hands of marketers, leads to another problem – treatment claims. Will industry falter at the start and undermine the study itself by quickly attempting to capitalize on hype and frenzy with the issuance of claims that are illegal, unsubstantiated and invalid especially for lesser quality products on which no research will or should ever be conducted? Past history would suggest so.

In theory, this study should lead to an upsurge in sales for the highest quality raw materials. In reality, that’s not so certain – and that’s a shame. It should also lead to a focus on alternative strategies to health management – ones that remove a portion of the health care cost burden, in this case by providing some alternative (presumably at a reduced overall health cost) to some of the millions afflicted with the condition. This is really a great opportunity for industry to be part of the solution.

On another positive note, by all accounts interest in analytical method development and in properly conducted clinical trials was at an all-time high at the recently concluded SupplySide West in Las Vegas last week. Let’s hope interest turns to action as those companies that can’t support their C of A’s or test methods begin to lose business as clients ask better questions and become more demanding. And it shouldn’t be only because there are new GMP’s to comply with – it should be because the marketplace, and success in it, demands it.

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