What's the harm?

In my last post on Homeopathy, a commentor, Mike Fowler, mentioned an interesting fact:

Here in Spain, "Homeopathy" basically means something different. Many "Homeopathico" preparations sold in pharmacies here contain trace and greater concentrations of the active ingredient, so they are probably more like "herbal" remedies.

Spain notwithstanding (I agreed with Mike when he further said that it might be a cultural or linguistic issue here), there is an important distinction to be made - not just by the proponents of science- and evidence-based medicine, but also, it would appear, by regulatory agencies. Because it transpires that ignoring this distinction can be... detrimental, quite detrimental. Read on for details.

A bit of a background first. You may or may not have heard of Belladonna, but I am sure you're familiar with Deadly Nightshade; I have long known about it as one of the plant poisons favorite of Agatha Christie - the famous British writer of tales of mystery and detection (she used it to great effects in many of her books, including Postern of Fate and The Caribbean Mystery). But I digress.

Deadly Nightshade (Atropa belladonna Linn.) is a perennial solanceous herb native to Europe, North Africa, and Western Asia; its foliage and berries contain extremely toxic alkaloids, including scopolamine and hyoscyamine. This herb is also the source for the anticholinergic agent, Atropine.

As the linked Wikipedia article mentions, belladonna has long been used in traditional herbal medicine for various conditions including headache, menstrual symptoms, peptic ulcer disease, histaminic reaction, inflammation, and motion sickness (an old but relevant review can be found for free at PubMed Central: Farnsworth et al. Medicinal plants in therapy. Bull World Health Organ. 1985; 63(6): 965–981). In homeopathy, on the other hand, belladonna preparations are commonly used at dilutions from 6C (10^-12) to 30C (10^-60!!) - which, by the way, has been shown to have 'no observable clinical effects' in a randomized, double-blind, placebo-controlled trial (Free at PubMed Central: Brien et al. Br J Clin Pharmacol. 2003 November; 56(5): 562–568).

I hope you, dear folks, appreciate this distinction; I cannot over-emphasize its gravity. The herbal preparations (presumably made from extracts of the belladonna plant) - which are available in the traditional medicine systems of various countries and cultures - actually contain measurable quantities of the plant's active principles. The major problem with these preparations is that these products are not regulated, and in the US, FDA doesn't evaluate their safety and efficacy; therefore, there is no guarantee of consistency of the active substances in them. In contrast, the homeopathic belladonna preparations contain only the name of belladonna and no active product, none.

Why is this important?

Because the homeopathic preparation is harmless, by virtue of being devoid of any trace of the original toxic substance. But the herbal preparations aren't like that; they do contain the substance(s) in quantities that can be measured by analytical means.

Therefore, mis-labeling of this herbal product as 'homeopathic' raises serious public health issues, the danger of unregulated belladonna being plausible and real. And FDA, too, appears to have discovered this a few months back. A consumer safety alert released by FDA in October last year elaborates the alarming nature of their findings.

Indicates the FDA notice:

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity... FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.

Note the problem inherent in the wordings of this notice: (emphasis mine, in bold)

Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.

It is indicative of how FDA sees belladonna. Sorry, FDA, but it is NOT homeopathic. I hope - I sincerely hope - that, at least now, in view of these serious conditions in children reminiscent of acute belladonna toxicity, and FDA's own lab tests confirming their suspicions, FDA wakes up to the existing problem of mis-leading, incorrect labeling of such herbal products, and decides to impose stricter control and regulation on them - for the good of the patients. Think of the children!