By Len Monheit

A few weeks ago, industry received another series of blows with fallout from the NIH State-of-the-Science Conference on Multivitamin/Mineral Supplements, which concluded, among other things, that there is inadequate information available about the role of vitamins and minerals in disease prevention or cure and that the safety of these products requires further investigation. Media pickup of the conference outcomes was certainly, in general not favorable, and some of the communications even made the usual observations regarding inadequate supplement regulation. A number of groups issued responses to the published outcomes, but the effects in stalling or altering either headlines or public takeaway were minimal at best.

There is a battle being fought – and we are losing.

Some have suggested that the conference outcomes were a done deal before it was even convened, and that bias, including study and personnel selection, had essentially distorted beyond recognition any objectivity the panel could possible have. Others have suggested that more well-designed studies would have helped, while observing that the challenges and costs inherent in long-term benefit analysis, make it difficult, if not impossible to counter some of the conference’s conclusions. The issue of safety, it was felt by the industry majority, was totally distorted, and played right into the current confusion that exists over product safety in many categories, including foods, supplements, drugs, household products and much more. The absence of an Adverse Event Reporting system for supplements also played its role in contributing to the risk fears.

Clearly, this type of outcome is bad for the industry. Clearly, whether by intent or simply by outcome analysis, more such communications are imminent. Less clear though is what industry can do, and almost certainly our ability to challenge negative outcomes falls well short of the ability of the media and ‘experts’ to generate and communicate these negative stories.

While I’m concerned with the efficacy debate, I think the safety issues might in fact be more far-reaching. This issue plays on the emotion of fear, creating a significant, in many cases, illogical reaction that quickly becomes so distorted that it loses all connection to its original context. It is this fear which certainly prevents new consumers from using our products and begins to cause a wavering of those who take supplements because, “I’m not getting a good diet - and it can’t hurt.” (Caught up in this issue too are several international level discussions deciding RDAs and maximum allowed values, so this issue of supplement safety (particularly vitamins and nutrients) will certainly play a key role in defining our future.

What can we do?

If one analyzes typical study outcomes, one always sees comments regarding efficacy, and only on some occasions are comments made regarding safety and tolerability. In fact, it is frequently considered to be of such little importance or to be a foregone conclusion so as to not even be worth the space in communication; if it is mentioned at all, it is an afterthought in the concluding remarks. Whether we’re speaking about supplements or foods, there are in fact mechanisms in place to ensure only ingredients with no safety concerns appear in the marketplace (ie. NDI or GRAS). While it is true that both of these are dose related (and dose is exactly where the issue gets tricky), in many cases the safety evaluation, where performed, covers a broad range of doses far in excess of what a typical consumer might be expected to ingest on a day be day basis.

It appears as though companies are forced further into a conundrum. Now, when they are trying to prove product efficacy in a study (and with a commodity type product it is frequently not possible to justify the study investment), the background work in product safety might need to be stepped up. (Being background work, it translates to no market value directly for products already on the market, so the only way companies can justify this investment is in terms of opportunity cost, a very tough stretch.)

Only by reaffirming product safety in both study design as well as messaging will this argument have any decent weight for media, consumers, as well as those subsequently performing meta-analyses to determine why so few studies with safety as a measured endpoint were performed.

A good part of the argument appears to center around risk, in either an absolute or relative sense. It seems that industry ought to be able to demonstrate in both absolute and relative terms, that its products are safe, both from an ingredient and finished product standpoint. A serious adverse event reporting system will assist this effort, and to ensure that industry’s message is heard above the din of those focusing on a few selected AERs which no doubt will be reported, a communications strategy must be devised for any contingency, and consistent, repeated messages directed to media, consumers and healthcare providers of all types.

I can’t help but wonder whether solid, evidence backed risk analysis shouldn’t be factored into a proactive campaign as well. And if more companies are measuring safety and tolerability as primary study endpoints, surely this provides more data points for the risk analysis exercise.

Seems like a risk analysis project might be in order