The industry’s predicament seems to mirror that of the auto industry that was laid out in a recent excellent article in The New Yorker magazine by Malcolm Gladwell titled The Engineer's Lament, which has what I might call the Exploding Ford Pinto Case as its center point. Gladwell's thesis is that engineers look at safety parameters and what constitutes a real problem much differently than do politicians trying to make a point or the general public does. It's interesting to note that what many people remember about that incident—that Ford was exposed as having knowingly sold cars that were grossly defective and easily exploded—is not accurate. Ford actually won the signature trial in the case that involved the horrific death of three teenage girls. The Pinto’s gas tank was similar in construction and placement to that of other small cars of the time, and the car itself was roughly equivalent in overall crash safety and in its propensity to burst into flames to its contemporary subcompact peers. The company successfully argued that only a battle tank could have withstood the 50 mph impact of the 4,000-lb van that hit the motionless car the girls were in.
It seems to me that Schneiderman and the people emboldened by him like the newly formed Organic & Natural Health Association on the one side and the safety and testing experts in the dietary supplement industry on the other are arguing past each other to some degree. An old joke (recounted in the article) is that an engineer looks at the situation of a 1000 ml capacity container with 500 ml of water in it not as a metaphor about optimism vs cynicism, but as a case of a glass that is too big.
How safe is too safe?
Looked at from an engineering point of view, dietary supplements are a very tolerant system. There can be wide variability in active constituents without affecting the overall safety of the system. (Efficacy is another question.) So the specification side of the coin can be somewhat lax without incurring excessive liability. It doesn't matter much to the safety of the system how big the glass is, in other words. To people who crunch the data this is obvious, and to them Schneiderman's (and to some degree, Dr Pieter Cohen's) rabble rousing on the subject of safety is just so much hot air. On the other side of the coin, Schneiderman et al seem to be striking a chord with the public in arguing that the industry has a cavalier attitude toward product specifications.
Schneiderman attacked the marketers of herbal dietary supplements on the basis that the products they sold were fraudulent. He made a case, based on a voluminously discredited DNA testing methodology, that there was little of the stated main active ingredients in the bottles, and went further to say that there were lots of other things in the bottles which weren’t on the labels. It raised the question in the public’s mind: Do they really know what’s in this stuff? Do they care?
In Ford’s case, the company steadfastly argued that the Pinto met all of the safety requirements then in existence. Even though the brand’s engineers felt they were in the right, the company eventually agreed to redesign the gas tank with a so-called ‘flak jacket’ around it that would make it less likely that sharp protuberances in the car’s structure would penetrate it in the case of a heavy rear end collision. From the engineers’ point of view this was mere window dressing, but arguing that this was a solution in search of a problem was no longer an option in a political climate in which the public was transfixed by stories of drivers immolated in a car that was obviously not a shining example of the Ford Motor Company’s expertise.
Are consumers entitled to their opinions?
A number of stakeholders in the dietary supplements industry continue to argue that Schneiderman has missed the mark, and has conducted his investigation in a scientifically invalid, remarkably clumsy and perhaps even cynical manner. After all, with GNC’s agreement with Schneiderman’s office, all of its supposedly fraudulent and potentially risky products are back on the shelf with no formulation changes. All of these things are, or could be, true. But lecturing public officials or consumers that they don’t know what they are talking about—that they are ignorant, essentially—when they raise Schneiderman’s talking points doesn’t defuse the political time bomb he has helped to create.
Rick Kingston, PharmD, is the president of scientific and regulatory affairs at SafetyCall International, a firm that manages adverse events for companies and helps them to decide when to issue recalls because of safety concerns. (Kingston is also a clinical professor at the University of Minnesota School of Pharmacy). Kingston is of the mind that it is time the industry steps up in a more transparent manner to address the issues that Schneiderman’s assault has raised.
“The bigger issue is the fact that fraud breeds fear. I’ve been dealing with this from the day I got involved in this. It’s one thing to have a product out of specification, but it’s another thing if it doesn’t have the right herb in it,” Kingston told NutraIngredients-USA.
“We keep shooting ourselves in the foot when we argue that there is never any risk. The reality is if there is zero risk, you are also going to have zero effects.
“That was the case with ephedra. By itself it was a pretty safe compound, but the folks who were manufacturing it were unwilling to admit that there could be a risk associated with it when used outside of the label recommendations or with other compounds, like caffeine. You have to be open to the possibility of an adverse event,” he said.
Swallowing the bitter pill
So it seems time for the industry to consider swallowing Schneiderman’s bitter pill and bolster identification programs for herbal ingredients. Indeed, this already seems to be happening; Nature’s Way, one of the companies targeted by Schneiderman in the second phase of his campaign, has instituted a new policy for identification of incoming botanical materials that will trace them back to the plants in the ground as they were harvested. There is no indication that the company was having problems with out-of-specification products before this, but this new program can only be seen as a good thing. And today’s story about the rapid over-subscription of a botanical identification seminar seems to indicate that the industry is moving past recrimination into a period of remediation. And it will come out stronger as a result. While these new programs will mean added expense, it has often been observed that if a company can’t say with absolute conviction that it knows what is in the bottles it sells, should it really be in business in the first place?