by Karl Denninger, Market Ticker:
Let’s look at something that is being poo-pooed the last few days — and shouldn’t be.
CNN (among many others) reported that erythritol, an artificial sweetener used as a “cutting agent” for other artificial sweeteners (because it has the texture and bulk of sugar, but is less sweet — thus its use with Stevia and others) may be linked to heart attacks and strokes, particularly occlusive strokes.
This was instantly poo-pooed by a whole lot of people who went after the study and its methodology. In general I would agree with them in the broad sense, but not in this case and this is where our so-called “pundit class” fails miserably.
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The study was observational and retrospective; that is, it looked at various polyols (a class of chemicals that includes this) in the circulation and heart and stroke outcomes. Observational studies can only disprove a hypothesis; that is, if you look for something that should happen and don’t find it then you can, with a decent degree of certainty, say that the claimed thing is not caused by the potential agent.
You can’t make the converse statement, however, because if you find the correlation something else might be the cause which you have not identified. Since you can’t exclude the unknowns you can’t pin the tail on the donkey, and as a result your claim would fall flat. We did a lot of this with various interventions over the last three years and to buttress it we deliberately ignored those cases where the correlation was missing. By ignoring those fraud was committed because when you find the missing correlation you have disproved the hypothesis.
But here we have another factor which immediately raises my eyebrows: They identified a specific mechanism of action of the compound in question that causes the outcome and it occurs, in a test tube, at concentrations a person achieves by consuming the product in reasonably-expected amounts. Specifically at a blood level consistent with human consumption, which they were able to identify in actual persons as the substance was commonly used they found wildly-enhanced clotting activity in the blood.
That is a serious problem because we know that excessive clotting is directly implicated in occlusive strokes and heart attacks; indeed that’s the direct cause of these events.
Note that the WHO and FDA have both listed this substance as “approved” for more than 20 years. Let’s not forget that the FDA approved Vioxx as well. But is it approvable on the merits given this information? Is any substance, when taken in and found in the blood at levels that materially increase clotting activity “generally recognized as safe”? I’d say no, never, and if you didn’t know about this up front and then learn it later you are obligated to immediately revoke said authorization.
That doesn’t mean it might not be better than an alternative that has a worse safety profile.
But “GRAS” is a specific claim that there is no biological harm associated with it in the amounts that a human being could rationally consume.
That is absolutely, at this point, false as a specific mechanism of harm has been discovered and the concentrations required to cause it to occur in the blood of humans are commonly reached by ordinary and reasonable levels of consumption. Further, unlike many things there is no necessary level of consumption of this substance — that is, it does not impart any particular required nutrient, mineral or other contribution to your metabolism.
