EU regulations on herbal medicines now in force

[leon_heller]

I just noticed this on the BBC News web site:

http://www.bbc.co.uk/news/health-13215010

Coincidentally, I saw the other day that a Chinese medicine shop in Hastings has closed. The sign in the window states that the closure is for "internal reasons". Perhaps the proprietor has poisoned herself with her own remedies.:)

[maccy]

They actually come into force tomorrow, this is the last day when the transitional arrangement, for products that were already on the market when the directive was passed in 2004, applies. So manufacturers have had seven years to get their licensing sorted out.

Weirdly enough, some people think now is the time to protest this, and there are petitions springing up. I've added some evidence to the comments on this page:

http://www.allvoices.com/contributed-news/8826364-european-union-directive-to-ban-natural-remedies-in-favor-of-pharmaceuticals

I suspect that the video that comes with it belongs in the conspiracy theory section.

[Ranga Nuts]

I have not frequented many sites like you have linked too maccy, do they all basically ignore what you have said like that. After reading the comments I laughed at how many people had their panties in a knot over things that were not going to happen. If only these rules were more stringent and applied here in Australia.

[maccy]

I only found out about it because I got an email from Avaaz, which was trying to get me to sign one of their petitions and linked me to that news article.

Because of that, all my comments are quite recent - I don't think I'm being ignored. One person thanked me for clarifying things and the person who wrote the article, who seems deep into the woo, accused me of having a vested interest.

[Ranga Nuts]

I've only looked into only a couple of the links and they seem to support your position. If Big Pharma only had to to jump through the same amount of hoops a lot of medicens (sp?) would be cheaper.

[maccy]

And a lot would get through that were either not effective or downright dangerous.

I'm sort of willing to accept that if you can show written evidence that herbal remedy has been in use for 30 years then it's probably reasonably safe. Or at least we can be more confident than with a brand new medicine.

But that doesn't rule out all possible risks and says nothing about the effectiveness, or lack of it, of the products.

So herbalists are still being given a comparatively easy ride.

[maccy]

Looks like the author of that article has the power to delete comments because they've all gone*. Luckily they still showed up in my profile for a while so here they are, in reverse order, for posterity:

maccy | 17 minutes ago
Please leave this comment up.

For whatever reason, most of my comments are now showing as deleted. It appears as if I have deleted them myself, which I haven't.

Whoever has deleted them may feel justified in doing so, but I'm hoping that this will be left to stand. Please don't take this article and video it links to at face value. Find the directive yourself and read it and make your own mind up about whether or not it amounts to a ban or whether what it is asking is unreasonable.

Also seek out some skeptical opinions about herbal medicine and how much regulation it may require. A quick Google should help you out.

Surely there's no harm in considering all the arguments before coming to a conclusion?
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Posted By maccy maccy | about 1 hour ago
Why are almost all my comments appearing as deleted?

I didn't delete them.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Posted By maccy maccy | about 3 hours ago
Right, I think there's enough counter-argument on this page now. Please read the links I've provided to get another view to the rather ill-informed one presented in the main article. And try and ignore the scaremongering and get down to the main facts: is it unfair to compel herbalists to licence their products by demonstrating (bibliographically, without need for clinical trials) that they are indeed traditional remedies? Is it unfair to compel them to include any safety information with the packaging? Is it unfair to make them reach a basic standard of production quality?

That's all that is being asked here, no-one is even forcing them to prove that their medicine works or that it is safe (written records to say that its been in use are sufficient). The cry is that these poor profit making companies can't afford it. But that doesn't void any other health and safety requirements in any other sectors. Are we really supposed to just trust anyone who puts the word herbal on their product with our health and the health of our children? Without even the attempt at some regulation?

I'll leave you with a few more links, that take a stronger line than I do:

http://www.guardian.co.uk/science/the-lay-scientist/2011/feb/21/1

http://www.dcscience.net/?p=4117

http://www.quackometer.net/blog/2011/02/how-to-spot-bad-regulation-of-alternative-medicine.html

http://www.dcscience.net/?p=4269

http://www.badscience.net/2010/02/how-do-you-regulate-wu/

http://www.badscience.net/2007/06/the-mighty-david-colquhoun/

and, finally, on the subject of choice:

http://www.guardian.co.uk/science/2010/jul/27/choice-fetish-homeopathy-policy

If your only way of dealing with the salient points in those articles is write them off as part of some "big pharma" conspiracy, you need to stop fantasising and start thinking.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 3 hours ago
So because sometimes pharmaceuticals that are harmful slip though the net, people who want to label their product "herbal" should receive no scrutiny whatsoever?

You're talking nonsense, again.

And enough with the whole "big pharma" paranoia. The supposedly virtuous "alternative medicine" sector is a mutli-billion worldwide market made up of profit making companies as well. Some of them are also owned by supposed "big pharma" companies:

http://www.boiron.com/en/Shareholders-and-investors-area/Group-information/Key-figures

http://nytol.co.uk/nytol/nytol-herbal-tablets.aspx

http://www.boots.com/en/Pharmacy-Health/Shop-by-product/Vitamins-Supplements/Herbal/

http://www.boots.com/en/Pharmacy-Health/Shop-by-product/Complementary-Therapies/Homeopathy/

http://www.seven-seas.com/products/new-era/comb-a-sciatica

http://www.seven-seas.com/seven-seas-and-merck

http://www.merck.com/

The way to deal with abuses in one sector is not to give another sector a free ride. If it's not commercially feasible to test the effectiveness of herbal remedies because they don't have patents attached to them, you should be pushing for more publicly funded testing, not encouraging people to muddle through with unproven remedies dispensed by people with no proven expertise in healing people.

To indulge in generalised conspiracy theories and to label whole realms of disparate chemicals as good or bad based entirely on the stories you want to believe about who makes them is idiotic.

I just hope you're not stupid enough to suggest herbal remedies for cancer or HIV - that kind of thing really does get people killed for no reason.

http://whatstheharm.net/
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 4 hours ago
That's OK. Make no mistake this does put a burden on people who want to market herbal remedies, but they've had since 2004 to plan their strategies. I don't know how its being handled in other countries, but it seems that best thing a UK citizen could do would be to help the European Herbal & Traditional Medicine Practitioners Association with their campaign to get statuatory regulation for herbalists in the UK:

http://ehtpa.eu/

Now I'd personally like to see all medicine treated the same - there's no such thing as alternative medicine, if it works it's just medicine, if it doesn't it's useless.

However, that's financially difficult to achieve so this seems to me to be a good starting point.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 4 hours ago
Replying to this again because the system won't let me reply to your most recent comment.

I have no vested interest, I got emailed by Avaaz about this, with a link to this story. I'm passionate about it only because you have got all the facts wrong.

Accusing people of having a vested interest is fallacious anyway in a couple of ways:

http://www.nizkor.org/features/fallacies/poisoning-the-well.html

http://www.nizkor.org/features/fallacies/ad-hominem.html

You don't seem to have an answer for any of my points so instead you seek to attack me and my motivation. "Discredit" also implies that the petition is in some way creditable and I'm telling lies about it. I'm not - the arguments you have posted here have no basis at all in fact.

There is an argument against the directive - that the requirements are too complex and expensive, but that's not the argument you are making. Nor is it an argument I agree with - especially not if the proposed alternative is a completely unregulated market.

So how do you propose herbal medicines should be handled? Should someone be able to claim that anything is herbal and not provide any evidence as its historical use, side effects, risk and probable effectiveness? How would you know what you're getting? Dangerous chemicals have been passed off as natural and safe in the past:

http://ehtpa.eu/about_us/latest_news/index.html

Note also that the European Herbal & Traditional Medicine Practitioners Association, who published that news report of a bogus herbalist causing massive damage are not campaigning against the directive - but they are campaigning for statuatory regulation of herbalists to be introduced quickly. I agree with them on this and think it should already have been done - that's a specifically UK failing, though, not an EU one. Once the UK has sorted it out, registered herbalists will be able to prescribe any herbal remedy, licenced or unlicenced. That hardly amounts to a ban.

Would you be happy if kava kava, was available over the counter in unknown doses with requirement for warnings about dosage levels and the risk of liver damage?

http://www.drweil.com/drw/u/QAA400800/Keen-on-Kava.html

Or are you happy with things like St Johns Wort being on sale without any advice and people assuming that they can take it with other medication (including other anti-depressants) without letting their doctor know? That's what has been happening in the UK, and this will go some way to stopping it.

So, if you want to engage on this, stop trying to cast aspersions on my motivations and address the points I've made.

Also, doing some research into evidence based medicine wouldn't do you any harm:

http://www.bmj.com/content/312/7023/71.long
http://www.patient.co.uk/showdoc/22/
http://www.evidencebasedmedicinematters.org/

Now the directive doesn't actually require any herbal medicine manufacturer to demonstrate effectiveness, but do you not agree that this is a worthwhile goal? If not, why should herbal remedies be exempt from demonstrating their effectiveness?

I realise that the lack of patents makes funding research harder - but research into herbal remedies has gone on in the public sphere. Surely it would be better to encourage more public research than to simply give a free pass to anyone who wants to put the word herbal on a label?
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Posted By maccy maccy | about 8 hours ago
One last thing, from the BBC News site:

http://www.bbc.co.uk/news/health-13215010

Michael McIntyre, chairman of the European Herbal and Traditional Medicines Practitioners Association, says there will be a significant impact on herbal medicine practitioners and their suppliers, but admits the rules do need bringing up to date.

"Products that go on the market now will definitely do what it says on the bottle, while we didn't know how good they were in the past.

"But registration is expensive so perhaps there may be fewer products on the market and a smaller range.

"It's difficult to argue that the market should stay as it is, without any regulation, but how many businesses will pack up and walk away? I can't say."

---------------------

I'd hardly count that as unqualified opposition, would you?

Also, he doesn't mention banning or some wild "big pharma" conspiracy.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
There are no mass protests because if you bother to research this properly its no where near as bad as Cathy has made out.

Nothing is being banned, as long as the manufacturers obtain a licence. That's pretty basic consumer protection when it comes to medicine.

Or would you rather people just bought things and found out for themselves if they were dangerous? Or simply that they weren't very well made? The directive applies quality standards as well - so that people can sure that say, if they use valerian, that what they're taking was well made and contains a reasonable amount of the active ingredient. As things stand, unscrupulous manufacturers could pad out their fills with filler and have hardly any herbal ingredient. That's about to change.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
As a US citizen your right is entirely unaffected by this.

Still even for EU citizens the choice is still there - they'll just be able to make a more informed choice thanks to better labelling and have some degree of protection from charalatans. Not the extent of avoiding products that have yet to demonstrate any effectiveness, but hopefully to avoid actively dangerous one like this:

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON108628
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
Herbs are not being banned. Read the directive.

All that is being required is a licence to demonstrate that commercial products marketed as medicines have traditionally and safely been used as medicines. They don't even have to give evidence that they work.

Anything marketed as food or cosmetics is not subject to the directive (although it falls under consumer law covering those areas). Anything not for sale is also no affected by the directive.

Finally, any unlicensed product can still be supplied by a registered herbalist.

The article and the majority of the comments are equally ill-informed.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
The directive has nothing to do with people growing anything in their gardens. You should do some basic research before making such ignorant comments.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
Utter nonsense.

And herbal medicines are not being banned - they're requiring a licence, which many have already obtained. The licence is significantly less stringent than that required for other medicines and is all about protecting consumers.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 8 hours ago
No none of the things you mention will come to pass.

It's specifically about the claims that commercial manufacturers make for their herbal products, nothing more.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Posted By maccy maccy | about 8 hours ago
For those that seem convinced that any product labelled natural or herbal must be safe, here's just one example of when it's not:

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON108628

Concerning the impact of this, the MHRA in the UK is looking at 211 applications and has so far granted 105. St Johns Wort, echinacea and valerian have already been registered.

Here's an estimate of the effect from a retailer:

"Josine Atsma, who recently became the owner of Stirling Health Food Store, said she would have to stop selling products which currently account for around 10% of her business. However, she believes it will just be a hiatus as her main supplier is likely to have more products licensed over the coming months. "

http://www.heraldscotland.com/news/health/health-shops-fear-over-eu-ban-on-herbal-medicines-1.1098810?localLinksEnabled=false

On top of that, unlicensed herbs will still be able to be prescribed by registered herbalists. Now the UK won't have its registration scheme in place until 2012, but that's hardly the fault of the EU.

And for all the whining that manufacturers are engaging in over the requirements that this places on them, there still much less stringent than those placed on pharmaceuticals. If you want to produce paracetamol, for example, you still need a licence, even though the effectiveness, side effects and safe dose levels have been established for years now.

And paracetamol, like many over the counter medications, has an expired patent, so anyone can make it, subject to licencesing. In that respect, it's exactly the same as herbal remedies - so to suggest that companies wanting to market it have an advantage over herbal manufacturers because of the patent is a nonsense.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
Plenty of toxic things are wild natural plants. Plenty of pharmaceutical drugs with side effects are derived from natural ingredients. Natural does not equal safe. And everything is made up of chemicals, so the only way to avoid chemicals is to not put anything into you baby, including food. Seriously, you need to get a clue.

Still your herb garden will be unaffected by this directive. Unless you want to start selling herbal remedies - then you'll need licence to demonstrate that what you're selling is a traditional remedy, is safe and has any side effects or risks included with the packaging and is also made to a standard.

Why should the consumer expect anything less?
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
You don't have a few more hours. This law was passed in 2004 - that was the time to try and do something about it.

The petition will make absolutely no difference. Some companies are apparently taking legal action - so that may have an effect, but probably won't.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
http://news.google.co.uk/news/more?q=eu+traditional+herbal+medicines+directive

It's being widely reported and has been since the lead up to the directive being passed in 2004.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
It was passed in 2004, we've had a seven year transitional period for companies to get their acts together regarding their existing products. To complain with a few days to go is ridiculous.

Come May 1st, any half-decent supplier will have still have their products on the shelves. No-one should be mourning the loss of the rest.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
Nobody is trying to ban herbal medicine either. It's simply a requirement to demonstrate that the medicine has been used traditionally for at least 30 years; is produced to a high quality and is safe, with a further requirement that any risks or side effects are stated on the packaging. It's about consumer protection and informed choice. Manufacturers of herbal medicine products can get a licence simply by providing biographical information that meets the criteria, they don't need to do any clinical trials. This is a significantly easier requirement than that placed on new pharmaceutical products.

As it stood previous to this directive (which has been in force since 2004, so companies have had seven years of transition to prepare for this) anyone could sell anything as a traditional herbal remedy without having to show any evidence that it was effective or even safe. Do you think that's OK? As it stands, the only requirement for effectiveness is to show that the remedy is traditional and has been in use for a while - ie that it hasn't just been invented. No clinical trials needed, just biographical evidence.

Oh and no medication, herbal or otherwise, is free from risk or side effects. The directive forces herbal medicine suppliers to be specific in their packaging about the risks and side effects. It also enforces a basic standard of production, which is simple consumer protection.

The intention of the directive is to apply some standards and make an informed choice easier. It is not going to lead to wholesale banning of herbal products.

It's obvious you haven't read the directive, perhaps you should.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals
Reply By maccy maccy | about 9 hours ago
They don't even have to prove effectiveness under the directive all they have to do is provide biographical evidence that the remedy has been used traditionally for 30 years and biographical evidence of safety and of any side effects and safe administration requirements (ie safe dosage levels, what not to take alongside the medication etc). Also to comply to a basic quality standard of production and include all relevant information on the packaging (which doesn't happen at present - you can, for example, buy St Johns Wort without any indication of side effects or of possibly dangerous interactions with other drugs). There is no requirement for clinical trials to demonstrate either effectiveness or safety.
Posted on European Union directive to ban natural remedies in favor of pharmaceuticals

You have to guess what I was replying to, in some cases.


*that's just been confirmed by support.

[Emet]

@ maccy:

To my readers:

The 20 + comments by maccy have been deleted at the advice of our moderators for violation of community rules, not for a differing opinion.

Maccy's conduct slipped into harassment and stalking as well as personal character assaults. Even so, some of his 20 comments had been left for the sake of professionalism; but when personal attacks began through private message we had to draw the line.

I apologize to my readers and friends at Allvoices for this inconvenience -

Best,

Cathy

[maccy]

Yes. just saw that. You can judge for yourselves how abusive I was as I think all my comments are reproduced above.

My final comment, which I think will also be deleted:

Cathy I apologise for losing my temper with you after you'd deleted all my comments. My intention was not to be abusive or personal, just to be robust. I think our perceptions of what has happened are very different but I'm prepared to leave things as they are with just one more, polite, attempt at outlining the facts and issues. After that, I'm done here, regardless

So, as briefly as I can.

The directive was passed in 2004, and we're at the end of a 7 year transitional period, which allowed existing herbal medicines to continue to be sold. There's no evidence of a "big pharma" plot here and certainly not in relation to any recent events.

There are plenty of good reasons to be sceptical of products offered by "big pharma" companies and of their ability to manipulate testing and regulation. However, bad things that one group of profit making companies do (and they are separate companies, not a single entity) doesn't automatically make another group of profit making companies good.

The directive does not criminalise the growing or owning of herbs, or their use in food or cosmetics. It merely places a licensing requirement on the manufacturers of products that they want to claim as medicinal. In effect it is attempting to properly define what is a traditional herbal product and impose some standards of dosage and production quality.

Now you may think this is the wrong way to go about it - but it is replacing a system of no regulation at all, so anyone could claim something was traditional, herbal, safe and effective when it could be nothing of the sort. The intention is consumer protection - as exists in many fields.

The requirement is simply to provide bibliographical evidence (ie written accounts) of the use of the ingredients in traditional medicine for at least 30 years (ie back to 1980). I'd argue that if that evidence can't be provided then it isn't traditional and should be treated with caution. Herbal doesn't necessarily mean a long history of safe use. Natural doesn't automatically mean safe.

If something has been in use for 30 years then I agree that it's probably safe. However, herbal remedies are not necessarily without side effects (Kava Kava and St John's Wort being two examples) so compulsory inclusion of any known side effects and risks is also a good idea. Still, the directive doesn't require any safety testing and I'm OK with that - as long as it can be established that particular combinations of ingredients have been in traditional use.

Again, there are specific examples of unusual combinations and doses of ingredients being marketed as a brand new product, with no idea if that particular combination is safe. Just calling such products "herbal" and assuming that means safety is not sufficient in these cases - hence the 30 year rule.

Regardless of all this, registered herbalist will still be able to prescribe unlicenced herbs. The directive only applies to retail sales, where the consumer is far more likely to be self-medicating and may well require some basic protection.

There are no requirements to prove the effectiveness of any of these remedies, so the bar is being set much lower than it is for pharmaceutical drugs.

As for the effect of the directive - the full version is now in force, so we'll see how it pans out. A health food shop interviewed by a Scottish newspaper estimated that 10% of their products would be affected, but that it would soon be sorted out as their supplier resolved the licences for those products.

So, to be clear, this directive does put a logistical and financial requirement on companies that want to market herbal medicines, which you may wish to object to, but it doesn't amount to a ban.

Even though the effectiveness or otherwise of herbal medicines is not an issue here (there's no requirement to demonstrate it under the directive) I'll just comment briefly. There's quite a lot of positive evidence for herbal remedies out there and I'd like to see more. I'm all in favour of freely available non-patented medicine. The issue is that the various herbs and their combinations are all unique. Herbal isn't a single medication - if one thing works and is safe then it doesn't follow that all things work and are safe. Nor does it follow that there aren't risks or side effects worthy of study (most active chemicals, naturally derived or otherwise, will have side effects for at least part of the population). That's why I'd support a great deal more by the way of publicly funded testing, since it's impractical to ask companies to test herbal remedies that they can't patent.

This obviously isn't the place for further discussion, but if anyone is interested then please feel free to get involved over here:

http://forums.randi.org/showthread.php?p=7135320#post7135320

[maccy]

I've queried support about my supposed breach of the community rules (again judge for yourselves, it's all up there).

Here's me apparently crossing the line when she deleted the bulk of my comments:

maccy (http://www.allvoices.com/users/maccy) on Apr 30, 11:04 AM PDT
Have you deleted my comments or asked for them to be deleted?
If so why?
That was so heinous, apparently, that she also got rid of the few that were left.


Here's me descending into stalking and abuse as a result:


You're an intellectual coward

Forward (http://www.allvoices.com/messages/compose?fid=557974)


http://img3.allvoices.com/thumbs/users/50/50/467691-maccy.jpg?1304226504 maccy (http://www.allvoices.com/users/maccy) on Apr 30, 12:52 PM PDT
You couldn't answer the counterpoints to your ridiculous article so you just deleted them. Truly pathetic.
Well you are your own punishment when it comes to this sort of thing. I just hope that you or someone close to you never has a serious condition that acual medicine could help you with. And if such a terrible thing comes to pass you actually do somereal thinking.

Even though I'm now done with that entire site and will stop paying attention to them, I'm sure this must be accurate:

Cathy, Every writer/journalist I know receives nut mail from misfits who take a major story and try to take it over to bring attention to themselves. Then, these stalkers become obsessed with the writer.
The sheer number of "responses" 'maccy' posted shows that he or she is a classic example of the obsessed fan. This is why celebrities including movie stars become so distant and eventually slide into harmful behaviors due to the stress. And that stress can be severe and hurtful.
This is why the State of California will now accept a P.O. number instead of a home address for their driver's license after an obsessed fan of Rebecca Shaeffer (a young acress on a TV series) went to DMV, obtained a copy of her driver's license that listed her home address, went to her apartment in Southern California, and when she answered the door, the stalker shot her dead.
Unfortunately, these sick stalkers, or even worse, those who have an agenda of stopping certain information from being published which might cut out their profits, are very common. This is obviously the case of the individual attacking you for publishing the story. This has become a normal occurrence for those in the public eye.
Don't take such responses personally. They have nothing, absolutely nothing to do with your competence as a writer. In fact, you are a great writer/journalist. Keep writing, stand strong and be security conscious.
Rev. Austin Miles Which apparently doesn't break any community standards...

People can be very strange.

This has reminded me why I don't bother trying to talk sense to them that often (you'd thought I'd have learned my lesson from arguing with conspiracy theorists). Still I had an entirely reasonable discussion with someone on Twitter about it.

----------------------

By the way, I'm wary of getting into the slagging off of other forums habit, which the CT forum used to be full of. I don't think there's much more to be said about the Allvoices site. I'm happy to discuss the herbal medicine issues here with anyone who might wander over from there, but there's no pointing in dwelling on my being silenced and smeared over there - that type of thing is par for the course when a content system lets authors moderate their own comments.

Edit: sorry, can't resist one last bit of nasty stalking, here's an article by the Rev who supposedly knows so much about me:

http://www.allvoices.com/contributed-news/8878110-the-crucifixion-of-easterwar-declared

[fls]

maccy,

I think your post #9 was excellent. I especially like the line "...so anyone could claim something was traditional, herbal, safe and effective when it could be nothing of the sort."

I have one quibble, though. There is a perception that a long period of traditional use is sufficient to rule out harm. It isn't. It may be sufficient to discover unique or unusual effects which happen within a fairly short period of time. But it won't rule out effects which take longer to manifest (like kidney or liver failure) or effects which exacerbate common conditions (like heart disease). Plus, without a system in place to mandate record-keeping and review, even suspicions cannot be acted upon. So even known effects discovered through traditional use may not lead to identifying a drug as 'not safe'. For example, had Vioxx (a drug withdrawn from the market a few years ago for suspicion that it caused heart attacks and death) been a traditional herbal product, it would still be on the market with no hint of suspicion attached to it. Herbals with centuries of traditional use have been found to cause liver and kidney failure (e.g. comfrey and aristolochic acid). And it wasn't traditional use which discovered these effects, but rather the process of medicine.

Linda

[maccy]

I'll stand by "probably safe" which is what I said. Now I definitely agree that probably isn't sufficient, but at that point I was wording pretty carefully in the hope that the comment wouldn't get deleted (so far, it hasn't been). It's a moot point in the discussion of the directive, anyway, since the directive doesn't require any testing.

You can get into a distracting argument about the merits of evidence based medicine. The person I was talking to on twitter seemed to have muddled ideas about the value of testing*. She seems to believe that because pharmaceuticals that have been tested have sometimes still turned out to be dangerous (or only sightly better than placebo) testing is not very useful so herbal medicines shouldn't be tested at all. Now disentangling the poor thinking in that would take a lot of time and effort and you still might not convince the believer. In terms of their opposition to the directive though, you don't need to - the directive doesn't require testing.

It's still a step forward, though. If you can find written evidence of something being in use for the past thirty years the chances of it being safe are much higher than for something using herbal ingredients that has just been devised. Also where there known side effects and risks these will now be included in the packaging - whereas previously they weren't. I'm hoping that "if you are taking any other medicine, please consult your doctor of pharmacist" is also included, but I don't know if it will be.

From the Daily Mail, well known for their love of woo:

"At least 50 herbs, including horny goat weed (so-called natural Viagra), hawthorn berry, used for angina pain, and wild yam will no longer be stocked in health food shops, says the British Herbal Medicine Association."
http://www.dailymail.co.uk/health/article-1382135/Herbal-medicines-banned-EU-directive-comes-force.html

At least the first of those is almost certainly not a traditional remedy that has been is use for some time. "Herbal Viagra" reminds me of "Herbal Ecstasy". Funny how many long standing traditional remedies only come into existence in response to a development in pharmaceutical medicine.

*Edit - Twitter discussion, spoiler tagged for length:

Think for yourself, don't let big Pharma think for you. Stop the EU ban on #herbalmeds (https://twitter.com/#%21/search?q=%23herbalmeds) http://bit.ly/jTa0xq
https://twitter.com/#!/lucyglynn/status/64397840683769857 (https://twitter.com/#%21/lucyglynn/status/64397840683769857)

@lucyglynn (http://twitter.com/lucyglynn) think for yourself, don't let paranoid theories of "big pharma" think for you. By the way it's not a ban, it's a licence.
https://twitter.com/#!/radiophonicpop/status/64403641993404416 (https://twitter.com/#%21/radiophonicpop/status/64403641993404416)

@lucyglynn (http://twitter.com/lucyglynn) or are you happy with the idea that anyone could stick anything is a bottle call it herbal and sell it as medicine?
https://twitter.com/#!/radiophonicpop/status/64403937775718400 (https://twitter.com/#%21/radiophonicpop/status/64403937775718400)

@lucyglynn (http://twitter.com/lucyglynn) other views to consider: http://bit.ly/dSYSnT http://bit.ly/hF0IPG http://bit.ly/gehEfy http://bit.ly/aREsu9 #herbalmeds (https://twitter.com/#%21/search?q=%23herbalmeds)
https://twitter.com/#!/radiophonicpop/status/64405803523768320 (https://twitter.com/#%21/radiophonicpop/status/64405803523768320)

@lucyglynn (http://twitter.com/lucyglynn) and read some of the media coverage to see its not a ban: http://bbc.in/lJTp1m http://bit.ly/kBpQKl #herbalmeds (https://twitter.com/#%21/search?q=%23herbalmeds) need regulating
https://twitter.com/#!/radiophonicpop/status/64406464399278080 (https://twitter.com/#%21/radiophonicpop/status/64406464399278080)

@radiophonicpop (http://twitter.com/radiophonicpop) @lucyglynn (http://twitter.com/lucyglynn) and if you think I'm being silly, have a look here: http://bit.ly/d0ETtH #herbalmeds (https://twitter.com/#%21/search?q=%23herbalmeds) can kill people.
https://twitter.com/#!/radiophonicpop/status/64408392449523712 (https://twitter.com/#%21/radiophonicpop/status/64408392449523712)

For all the people thinking about protesting the EU directive on #herbalmeds (https://twitter.com/#%21/search?q=%23herbalmeds) all it requires is a licence and it's been around since 2004...
https://twitter.com/#!/radiophonicpop/status/64409207507648512 (https://twitter.com/#%21/radiophonicpop/status/64409207507648512)

...this is the end of a seven year transitional period. So don't try all that big pharma crap on me. Plenty of links in my previous tweets.
https://twitter.com/#!/radiophonicpop/status/64409510357381120 (https://twitter.com/#%21/radiophonicpop/status/64409510357381120)

When something works it's medicine when it doesn't it's a scam. You find out the difference by testing. Alternative medicine is a nonsense.
https://twitter.com/#!/radiophonicpop/status/64409762233724929 (https://twitter.com/#%21/radiophonicpop/status/64409762233724929)

Specific exchange #1:

@radiophonicpop (http://twitter.com/radiophonicpop) I think people should be allowed to make their own decisions and for that they need to have choice
https://twitter.com/#!/lucyglynn/status/64409561569837056 (https://twitter.com/#%21/lucyglynn/status/64409561569837056)

@lucyglynn (http://twitter.com/lucyglynn) so you're opposed to all consumer protection laws or just for herbal products that people claim to be medicine?
https://twitter.com/#!/radiophonicpop/status/64410109916360704 (https://twitter.com/#%21/radiophonicpop/status/64410109916360704)

@radiophonicpop (http://twitter.com/radiophonicpop) You say say 'claim' to be medicine but how do you know they aren't? And who makes the decisions about regulation?
https://twitter.com/#!/lucyglynn/status/64410648615976961 (https://twitter.com/#%21/lucyglynn/status/64410648615976961)

@lucyglynn (http://twitter.com/lucyglynn) The burden of proof is on the person making the claim. Make no mistake, herbal products have killed and injured people.
https://twitter.com/#!/radiophonicpop/status/64413050882625536 (https://twitter.com/#%21/radiophonicpop/status/64413050882625536)

@lucyglynn (http://twitter.com/lucyglynn) in the UK the MHRA issues the licences: http://bit.ly/dUFzX2 previously they've only be able to do this: http://bit.ly/dFfYkX
https://twitter.com/#!/radiophonicpop/status/64414060615176193 (https://twitter.com/#%21/radiophonicpop/status/64414060615176193)

@radiophonicpop (http://twitter.com/radiophonicpop) As with everything it's about the benefits outweighing the risks. Nothing is perfect but what will do the greater good?
https://twitter.com/#!/lucyglynn/status/64413886257954817 (https://twitter.com/#%21/lucyglynn/status/64413886257954817)

@lucyglynn (http://twitter.com/lucyglynn) how do you know that herbal medicines do good? Or what the risks are? Without clinical studies? Not that that's the issue...
https://twitter.com/#!/radiophonicpop/status/64414459170525185 (https://twitter.com/#%21/radiophonicpop/status/64414459170525185)

@lucyglynn (http://twitter.com/lucyglynn) ...herbal med manufacturers aren't been asked to prove anything beyond a record that their product uses traditional ingredients..
https://twitter.com/#!/radiophonicpop/status/64414672098557952 (https://twitter.com/#%21/radiophonicpop/status/64414672098557952)

@lucyglynn (http://twitter.com/lucyglynn) ...with no known major safety issues and proper documentation of any minor issues. Plus standardised production standards...
https://twitter.com/#!/radiophonicpop/status/64415022079684608 (https://twitter.com/#%21/radiophonicpop/status/64415022079684608)

@lucyglynn (http://twitter.com/lucyglynn) ...research St John's Wort or Kava Kava to see a couple of instances where this is a good idea.
https://twitter.com/#!/radiophonicpop/status/64415208587796480 (https://twitter.com/#%21/radiophonicpop/status/64415208587796480)

@radiophonicpop (http://twitter.com/radiophonicpop) I 'd say clinical studies aren't perfect & results are often little better than placebos & trad meds survived cos they work
https://twitter.com/#!/lucyglynn/status/64416256316551168 (https://twitter.com/#%21/lucyglynn/status/64416256316551168)

@lucyglynn (http://twitter.com/lucyglynn) herbal and traditional are not the same thing - that's the distinction the directive makes. Also things survive because people...
https://twitter.com/#!/radiophonicpop/status/64417608946024448 (https://twitter.com/#%21/radiophonicpop/status/64417608946024448)

@lucyglynn (http://twitter.com/lucyglynn) ...think they work, which isn't the same as working. Directive agrees with you, though - all that's being established is a long..
https://twitter.com/#!/radiophonicpop/status/64417936290492418 (https://twitter.com/#%21/radiophonicpop/status/64417936290492418)

@lucyglynn (http://twitter.com/lucyglynn) ...record of use as a medicine, not safety or effectiveness. I still say that some testing is always better than no testing.
https://twitter.com/#!/radiophonicpop/status/64418234828455936 (https://twitter.com/#%21/radiophonicpop/status/64418234828455936)Specific exchange #2:

@radiophonicpop (http://twitter.com/radiophonicpop) I think people should be allowed to make their own decisions and for that they need to have choice
https://twitter.com/#!/lucyglynn/status/64409561569837056 (https://twitter.com/#%21/lucyglynn/status/64409561569837056)

@lucyglynn (http://twitter.com/lucyglynn) to get a licence a manufacturer only has to provide literature to show that their ingredients have been used in tarditional...
https://twitter.com/#!/radiophonicpop/status/64411001713471488 (https://twitter.com/#%21/radiophonicpop/status/64411001713471488)

@lucyglynn (http://twitter.com/lucyglynn) ...medicine for thirty years. They also have to include any safety literature and reach manufacturing standards. That's it...
https://twitter.com/#!/radiophonicpop/status/64411299722956800 (https://twitter.com/#%21/radiophonicpop/status/64411299722956800)

@lucyglynn (http://twitter.com/lucyglynn) ...no requirements to test for efficacy or safety. If a manufacturer can't meet those requirements then they don't deserve...
https://twitter.com/#!/radiophonicpop/status/64411548604563456 (https://twitter.com/#%21/radiophonicpop/status/64411548604563456)

@lucyglynn (http://twitter.com/lucyglynn) ...to have their products on the shelves. Pharmaceutical drugs have to undergo much more stringent testing. In one of the news...
https://twitter.com/#!/radiophonicpop/status/64411777915564032 (https://twitter.com/#%21/radiophonicpop/status/64411777915564032)

@lucyglynn (http://twitter.com/lucyglynn) ...articles I sent you a shop owner estimated it would affect 10% of their business temporarily until their supplier sorted out..
https://twitter.com/#!/radiophonicpop/status/64412041187835904 (https://twitter.com/#%21/radiophonicpop/status/64412041187835904)

@lucyglynn (http://twitter.com/lucyglynn) ...their remaining licences. That isn't a ban. Also registered herbalist will still be able to prescribe unlicensed herbs.
https://twitter.com/#!/radiophonicpop/status/64412613781618688 (https://twitter.com/#%21/radiophonicpop/status/64412613781618688)

(in reply to "Pharmaceutical drugs have to undergo much more stringent testing"):

@radiophonicpop (http://twitter.com/radiophonicpop) I would say pharmaceutical testing isn't as conclusive as it seems,which isn't, of course, suffice for general low standards
https://twitter.com/#!/lucyglynn/status/64413128036855808 (https://twitter.com/#%21/lucyglynn/status/64413128036855808)Specific exchange #3:

@radiophonicpop (http://twitter.com/radiophonicpop) I will read your articles and let you know what I think but pharmaceuticals can do a lot of harm too
https://twitter.com/#!/lucyglynn/status/64410047811289088 (https://twitter.com/#%21/lucyglynn/status/64410047811289088)

@lucyglynn (http://twitter.com/lucyglynn) that's not a reason not to regulate other types of medicine. In fact it's an argument for better regulation of all medicine.
https://twitter.com/#!/radiophonicpop/status/64410402360000513 (https://twitter.com/#%21/radiophonicpop/status/64410402360000513)