What’s the harm?

In my last post on Homeopathy, a commentator, 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. 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 solanaceous 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 ago. 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 the 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, as well as 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!

5 Comments

  1. Hear hear!

    One minor quibble, the Teething Tablets are, in one (broad) sense, homeopathic. In the sense that all other compounds or elements not found in the tablets make it just as homeopathic as any other supposed homeopathic remedy. I guess the packaging is just too small to contain a comprehensive list of all elements that have no molecules present. Funny how they usually only mention one that’s not there.

    Hmmmm, broad sense homeopathy. I wonder if it’ll catch on?

  2. Hi Kausik, great post!!  Yesterday in the UK a 48-year-old man was sentenced to six months’ imprisonment.  He is also suspended for two years and will need to carry out 200 hours of unpaid work for selling and supplying herbal medicines to the public without a marketing authorisation. 

    It is good to see that the UK is at least trying to clamp down on the unlawful selling of herbal medicines.  

     

  3. Thank you, Mike and Laura, for your comments.

    Good point, Mike, but I’d beg to differ with you on this. There can be any number of substances that are not there, for all I care, but FDA tests clearly revealed that there was belladonna in the Teething Tablets. The dangers of inconsistent amounts of an active principle aside, these tablets cannot be homeopathic for belladonna since it is there, can it? The circuitous logic is mindboggling, I know, but it is accurate! ✌

    Laura, your note reminded me that someone on Twitter the other day pointed out this old article on PubMed, where an Australian man taking Ayurvedic (Herbal) tonics during a visit to India came down with severe lead poisoning. Analysis of the herbal tablets revealed a very high lead content. And this, it appears, is not an uncommon occurrence.

  4. Kausik, I agree that the inconsistent concentrations are a serious flaw, but, apart from the more general point I was making, the presence of Belladona will depend on the homeopathic dilution.

    from the Hyland’s website:

    Each Teething Tablet (which weighs about 65 mg) is composed of 0.0003% Belladonna alkaloids as stated on the label. This means that each complete teething tablet contains only approximately 0.0002 mg of Belladonna alkaloids.

    So, low concentrations, for sure, but nothing below 10-23. In fact, my back of the envelope scribbles suggest that starting with (say) 1mg of nightshade in 1L of water, requires less than a 3C dilution. The precise starting quantities may differ, but it would be hard to imagine this ever coming close to Avogadro’s constant.

    So, the real question is: is this relatively low dilution* still homeopathic? 

    I suppose if you shake, rattle and roll everything in the right way, it is. But this just highlights more problems inherent in regulating the industry. ‘Homeopathy’ is used to describe more than just the process of serial dilution on large scales. There’s an awful lot of weird, unscientific practices involved in the methods that make something homeopathic. This clearly causes confusion for consumers and needs to be more carefully regulated.

     * with respect to homeopathic preparations.

  5. So, the real question is: is this relatively low dilution* still homeopathic?

    Exactly, Mike. I say, ‘not’. Having detectable presence of Belladonna goes against the very grain of homeopathic principle, particularly the law of infinitesimals.

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