Week in Review - When Interests Collide

Ironically, even as reputable (peer reviewed) journals and key associations were supporting supplementation and nutrition research, the article in question made sweeping accusations and raised questions about the science of supplements and how research was typically supported and conducted.

The trigger for the article was the recent false-advertising judgment handed down in California against Cytodyne Technologies, maker of Xenadrine RFA-1. In the judgment, according to the article, the company was accused of exaggerating clinical trials findings as well as cajoling researchers into fudging results in scientific articles. (Cytodyne has since filed a federal lawsuit accusing the article “omitted facts and evidence in a manner designed to defame Cytodyne” and the Times of “engaging in a pattern and practice of failing to supervise its reporters and failing to check the accuracy and completeness of the stories”.)

There’s no doubt the damage has been done, whatever the suit outcome, and the industry placed on the defensive yet again, without an opportunity to tell a complete story or to even build a communications bridge.

The article went on to cite increases in litigation against manufacturers, and recent false-advertising judgments (despite the fact that mainstream industry and certainly the trade associations had proactively distanced themselves, from the actions of the ‘few’). The article also drew attention to ephedra replacements, questioning the science and safety data supporting these products, using the apparent lack of such information as an introduction to the deficiencies of the present regulatory environment, in ‘contrast’ to that in the more regulated pharmaceutical environment, describing both the qualitative and quantitative differences in research required and typically performed.

This article does state that while not obligated to do research, “at a time of concern about the safety and effectiveness of its products, the $18 billion-a-year supplement industry
has embraced research because, when carefully aimed, it can be worth money.” It goes on to say “because the industry is not regulated, though, its research is sometimes less than strictly scientific.”

In all cases, the industry comes out on the losing end of this analysis despite the fact that there are economic, intellectual property, historic and regulatory issues which should ideally be part of this story. Even when industry insiders such as Anthony Almada are quoted (“The rigor applied in these studies on the average is somewhat notably less than that of a drug study"), a true statement that few can deny, another face of the reality is not presented – that is, prohibitive cost, lack of IP protection, history of safe use etc. In fact, a recent trade article, Industry Innovators: A Research Perspective (Nutraceuticals World, June 2003) discusses the (recognized) need for a new nutraceutical research and study model that makes sense given product nature, regulatory environment and market reality.

Despite its presentation and omissions the Times article points out certain truths. This sector is identifiable, as are its players and participants. With its success, it has developed a consumer following and powerful group of enemies. It has also provided most of the ammunition its detractors need to see it repeatedly raked through adverse coverage and publicity.

It’s very easy for communicators to point to one organization, whether it’s SeaSilver or Cytodyne, and make gross generalizations that get widespread coverage. The Times story was picked up by numerous other papers but you can bet the lawsuit, or even its ultimate result, will not get similar play.

It’s also apparent that issues and fires such as this will continue to happen so long as there is EVEN ONE organization about which a story can be told. And that, and not the story we want them to tell is what they will tell – no matter what other information should be presented to offer an unbiased story. An entire sector can be tarnished for the (apparent) deeds of a few.

How many times have we heard the comparison between supplements or nutritional products and drugs? Whether it’s the regulatory process, the clinical evidence, product safety - whatever, the reality is, aspects of the comparison which depict supplements negatively will continuously be made.

Much of the recent press and challenges point again to the need for an industry high ground. This might take the form of a resolution around a research model ‘sanctioned’ by industry. Perhaps this involves an accredited industry scientific board, sub-committees in each of several sub-sectors, that rate ‘clinical evidence’ according to a set of industry standards or criteria. Without necessary ratings, association memberships would be in jeopardy, ads would not run and tradeshow admission would be prohibited. (finding and managing a solution not politically compromised, would be difficult, I admit).

As the Nutraceuticals World article notes, input and collaboration in NIH and other non-company specific research programs help. Steven Dentali, vice president for science and technical affairs at the American Herbal Products Association is quoted in the NY Times article, "whenever there's a desired outcome, you've got the potential for bias," Given our industry’s multiple black eyes and present credibility crisis, we’ve got to be super-clean and an abuse reporting system, even to be maintained exclusively within the industry, may not be a bad thing.

Conflict of interest guidelines, anyone?

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