Proving our products are safe is excessive regulation, claim herbalists

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The alternative medicine industry has been complaining that regulations demanding they prove their products are safe before being granted a licence resemble "a sledgehammer to crack a walnut".

Global Regulatory Services reports from a keynote debate at the Natural & Organic Products Europe Show held in London earlier this month. A panel of speakers from across the herbal remedies industry stated that while they supported the MHRA's Herbal Directive in principle, some felt it was too stringent and expensive in requiring companies to prove their products were safe, effective and consistent before granting a full licence. Lynn Lord of Natures Aid bemoaned the fact that registering a herbal medicine to the new licence could cost up to £50,000! Wow, who thought making medicine could be so expensive?

The Herbal Directive is an attempt by the Medicines and Healthcare products Regulatory Agency to bring the burgeoning market of herbal remedies under its control. There are two different standards to which a herbal remedy can aspire. Licensed herbal medicines are held to similar standards as other medicines, and are required to show evidence of safety, effectiveness and quality. Sellers of registered traditional herbal medicines, by contrast, aren't required to prove that their medicine actually works - they just need to show that the remedy is safe and has been in use for 30 years, 15 of which must be in Europe. However, even this proved too onerous for some:

[Greer Deal asked if the] panel thought it would make a difference if this rule was amended or even removed altogether. The panel were united in their response: yes, this one amendment would make a significant difference to the herbal industry.

Well they would say that - clearly these people are salivating over the near limitless supply of new, ineffective medications that could be sold if the 15/30 rule was abandoned, or extended to include other hubs of quackery such as India and China.

The MHRA has come under a lot of criticism for the Herbal Directive, which many feel established a two-tier system where some medicines are held to higher standards than others, and gives a Governmental seal of approval on what is essentially quackery. I would like to think that the MHRA will slowly tighten the noose on herbal medicines, eventually requiring all to be full licensed, but given their stated commitment to the Blairite mantra of 'patient choice', I won't hold my breath.

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Step one: Advertise your wholesome natural herbal remedy as an alternative to "Big PHar$ma's" lethal yet ineffective conspiracy against health.

Step two: Demand not to be held to even basic standards of safety demonstration.

Step three: Profit!

hubs of quackery such as India

I'll have you know, in india people don't revel in quackery. While we have an embarassing history of it as much as any other culture, people who can afford "western" medicine, use western medicine.

There isn't the american and european phenomenon of huge chunks of, lets say, california, skipping out on effective treatments like vaccines in favor of ayurvedic treatments.

@Whitecoat Tales
I didn't mean to paint Indian or Chinese medicine as wholly unsound - rather the GRS article specifically mentioned importing herbal remedies from those two places. A better phrasing on my part would have been "Indian and Chinese catalogues of herbal medicine".

or perhaps hubs of quackery in india, rather than like

No offense meant either way, I just felt the need to clarify the point.

Every time a patient wants to push some new agey crap on me they always say something like "your people are so in touch with the universe, do you give ayurvedic medicines and teach me to do yoga?"

Then I need to explain that just because I'm indian doesn't mean I think they can treat their heart disease with voodoo.

It gets frustrating, so perhaps I was slightly oversnarky in that post, my apologies

But surely any herbal remedy which is "natural" is by definition safe? I mean, there's no possibility of anything which doesn't include "chemicals" being in any way dangerous or debilitating? Right?

[snort]

By Brain Hertz (not verified) on 25 Apr 2009 #permalink

omg Brain Hertz I almost had a massive rant at you.

Then I saw the sarcasm font :)

Twisting this post the otherway around, can you imagine the fuss there would be if they thought about passing a law that allowed Pharmaceutical companies to only fulfil these measures?

So is this regulation on saying that certain herbs have "x" and "y" benefits, rather that selling the herbs themselves.

What I mean is, for example, there's a "natural health food" store in my town that sells bulk echinecia, ginseng, etc. Would the selling of these herbs be regulated, or would it be regulaing things like ginseng 'pills' that claim to, I don't know, increase your memory?

LOL.

One thing to consider here: what would stop the pharmaceutical industry from using these regulations for its own products? Whilst there are many new pharmaceuticals which are syntheised for the purpose, what's stopping anybody from mixing up a concoction of older ingredients (like, say, aspirin) and marketing the result as an effective medicine?

By Brain Hertz (not verified) on 25 Apr 2009 #permalink

Hey, try my all-natural hemlock pills! If you take enough of them I guarantee that you'll never die of cancer.

By Matthew Cline (not verified) on 26 Apr 2009 #permalink

A Traditional Chinese Medicine doctor told me that she couldn't take any "medicines," not even a calcium supplement, or it would make her very sick. But she could take Chinese herbs, because they are "gentle."

Of course! If it's all natural, it can't hurt you! Medicines aren't derived from plants or anything like that, no, plants are diiiiiffferrreeeeent and don't have any scary "chemical" things in them at all. Nobody should ever HAVE to show that ALL NATURAL stuff won't hurt you, it's self-evident. Of course.

(sigh)

It's understandable from the quacks' point of view: they want to have nothing to do with the MRHA because they are the ones who approve BigPharma's nasty toxic - yet strangely ineffective - chemical poisons. ;-)

To any morons who might be thinking of actually trying hemlock to cure/avoid cancer: I was joking. Hemlock is poison. Don't try this at home, etc

By Matthew Cline (not verified) on 11 May 2009 #permalink