Why herbal medicines need regulation

Foxglove by Mike Kuriata

‘The great thing about herbal medicines,’ someone once told me, ‘is that they have no side effects.’ Apart from death, unwanted pregnancy, haemorrhage, heart palpitations, skin reactions, vomiting and diarrhoea, depending on the herb and dosage, I replied. You can see why I’m popular at parties.

Herbal medicines, like pharmaceutical medicines, have lots of effects. Some are positive, some negative. There may be a medicine out there that has only the effects we want, which never causes any unwanted effects, but I’ve yet to hear of it. There’s nothing particularly safe about plant-based medicines; many of of our pharmaceutical medicines are derived from plants. Antibiotics are derived from fungus, aspirin from willow bark, digoxin from foxgloves and tamoxifen from daffodils. (See here for a hair-raising list of plants with deadly effects.)

Yet weirdly, until this week, herbal medicines were virtually unregulated. You can’t produce aspirin without a license, but pretty much anyone can sell extract of willow bark. There was no legislation insisting that herbal medicine manufacturers prove that their products were effective, or that they’d been manufactured safely to an industry standard, or to provide standardised information for consumers so they could avoid overdoses or interactions with other drugs. Some manufacturers do this, but others don’t.

The result is a minefield for consumers. Did you know that the popular herb St John’s wort, taken for depression and anxiety, interacts with many drugs, often blocking their effects? For example, it may reduce the action of the contraceptive pill, putting you at risk of unwanted pregnancy. It also interacts with some antidepressants, meaning you could get dangerous side effects such as serotonin syndrome. Yet there was no legislative onus on manufacturers to warn about this.

You’d think that everyone would be pleased that, finally, this dangerous situation is being remedied. The Medicines and Healthcare Products Regulatory Agency (MHRA) has been charged with ensuring that all herbal products on sale are regulated. The regulation scheme came into effect last week. It isn’t very onerous – manufacturers don’t actually have to prove that their product works, as they would if they produced a pharmaceutical drug. They can rely on saying that it has traditionally been used in this way. But they do need to show the product actually contains the right herb, in the stated doses, and provide safety information for consumers. Herbal products meeting these criteria are given the Traditional Herbal Registration mark. The MHRA has a section on its website with good advice for consumers thinking of using herbal medicines.

Yet, crazily enough, some people don’t agree. On the radio last week, a comedian (no, she really was) ranted that herbs like echinacea and St John’s Wort would no longer be available because of a campaign by the pharmaceutical industry. Wrong on two counts – products containing both these herbs have been licensed by the MHRA already, and some of the big herbal drug companies are actually owned by pharmaceutical companies. (For example, Potters’ Herbal Supplies is owned by pharmaceutical wholesaler Galenica). Herbal drug companies are not little old ladies crushing roots in a pestle and mortar; this is a multi-million pound business.

Others take the opposite tack, criticising the MHRA for agreeing to provide a ‘watered down’ form of licensing for herbal medicines, which they say should be subject to the same stringent regulations as pharmaceuticals. The scheme might give false legitimacy to herbal medicines, giving people the impression they have been proven to work.

I have some sympathy with that, but on balance I believe this scheme means people determined to buy herbal medicines can at least choose products that have been through basic safety checks. The rules of the scheme are clear and available for anyone to read. The only people with anything to fear are those who don’t manufacture their medicines to safe standards, or would prefer to mislead customers about the side effects.

Image: Thanks to Salt Spring Community on Flickr, with CCL.

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