Regulation Of Herbal Medicine

sassafras170In the UK there has been a drive to add medical herbalists to the growing list of health practitioners subject to statutory regulation (SR).  In fact this is government legislation we’re talking about, so the drive has been going on for over ten years. The stated motivation is, as usual, to ensure public safety.

However, many herbalists are fuming over the recent proposals. They claim that this regulation will take herbal medicine away from ordinary people whilst doing nothing to improve safety. They’ve even organised a rally in London and an online petition.

I’m in two minds about this. On the one hand, there is the rallying herbalists’ tendency to spell traditional with a capital T and employ the attendant fallacies of “traditional” or “natural” things being automatically better. On the other hand, some of their concerns may be valid.

Health risk mitigation

In particular, in their response to government consultation (PDF see questions 1 and 2), they question what risks there are to the public that SR would mitigate.

In fact, they are unwilling even to acknowledge any harm from traditional herbal medicine (they like to stress the traditional bit). And yes, some of the cases of harm have been outside of existing laws or regulatory advice, so presumably, by their definition, not traditional.

As far as we are aware, there is not any evidence of harm to the public. Replies received from the MHRA [Medicines and Healthcare products Regulatory Agency] and DH [Department of Health], our combined clinical experiences and research that we have undertaken cannot point to any evidence of harm. There has possibly been the odd one or two who have broken current laws.

However, a little more digging shows there is evidence of harm to the public as a result of herbal remedies. Here’s one example from the MCA report on the safety of herbal medicinal products (PDF).

In 1996, the UK the MCA extended its ‘Yellow Card Scheme’ to include reporting of suspected adverse reactions to unlicensed herbal products. This followed a report from Guy’s Hospital Toxicology Unit on potentially serious adverse reactions associated with herbal remedies. Twenty-one cases of liver toxicity, including two deaths, were associated with the use of TCM [Traditional Chinese Medicine].

Some of the more extreme and newsworthy examples of harm caused by herbal medicine from around the world are listed on the What’s The Harm website’s herbal medicine section which makes for grim reading.

So, there certainly are risks involved with herbal medicines, whether it’s the traditional use of heavy metals in traditional Chinese and Ayurvedic remedies, traditional plants with toxic constituents, allergic reactions or the interactions of herbal medicine with conventional medicine. That and the traditional risk of being ineffective (more on that later).

However, what is unclear is whether the proposed regulation would do any good.

SaveOurHerbs also state (PDF) that they are not aware of any research on whether SR lessens harm, so instead they list their perceived disadvantages with SR. Here’s a sample:

Loss of traditional philosophies and diversity of practice due to orthodox standards in education, science and CPD.

Diversity of practice? Isn’t that a bad thing? Surely if there’s a right way to do something, then everyone should be doing it that way. Are they suggesting that all methods of treatment are equally valid?

State regulation will be extremely and unnecessarily expensive to the tax payer, as are all these repetitive committees, reports and consultations.

OK, I’m sure legislation and regulation would cost the taxpayer, but even this has to be weighed against the possible benefits.

The state regulatory body will be based on a system whereby the majority of board members will be from professions who do not share the same philosophies or training and will be biased towards orthodox standards and philosophies that may be inappropriate, restrictive and damaging.

hbst200This seems to be a case of needing special rules for herbal medicine in order for it to be seen as safe and effective.  Without a recognised framework to sort the safe, effective treatments from the ineffective or dangerous, researchers are stumbling in the dark, not learning or discovering but guessing. Unfortunately guessing leads to bad decisions and lost lives.  Any treatment should be able to undergo testing for efficacy and it is irresponsible to try to circumvent this.

Statutory regulation

I can’t claim to have read all the consultation papers in detail, but I did gather that SR would mean practitioners will have to be suitably qualified and able to show certain competencies in order to maintain their regulated status. These competencies (PDF, page 44) include such good things as knowing their limits and referring patients appropriately when a case is beyond their expertise. While this all sounds nice, I’m far from convinced that it would be effective in practice.  It’s only slightly better than a code of practice that says practitioners must dress smartly and have a degree.

Government regulation of complementary and alternative medicine (CAM) has not exactly got a glowing record of separating the safe, effective practices from the rest. The Complementary and Natural Healthcare Council CNHC (aka OffQuack) set up to “regulate” alternative therapies seem to be uncertain as to whether they are regulating or promoting CAM. As Matt Robbins of The Lay Scientist points out:

…this blatant conflict of interest is enshrined in their mission statement:

“CNHC’s mission is to support the use of complementary and natural healthcare as a uniquely positive, safe and effective experience”

Uniquely positive? Uniquely effective? How on Earth can they make such claims when they can provide nothing in the way of evidence to back it up? And why on Earth is a government sponsored regulator behaving like a bunch of lobbyists in making these claims in the first place? How can the body responsible for regulating therapists also be allowed to promote them? Again, if a pharamaceutical regulatory body behaved in this way, alternative medicine advocates would (rightly) be up in arms about it! It is utterly scandalous.

The government seems quite happy to gloss over this issue. In response to a petition demanding basic efficacy and safety requirements of all CNHC registered practitioners, they replied:

The Complementary and Natural Healthcare Council (CNHC) does not promote the efficacy of disciplines practised by its registrants.  The aim of the CNHC is protection of the public. Registration means that the practitioner has met certain entry standards (in terms of having an accredited qualification or relevant experience) and that they subscribe to a set of professional standards…

That’s not enough. I think all healthcare providers, whether registered and professional or not, have a responsibility to ensure their treatments are effective. Anecdotes and personal testimonies, for example, would not be sufficient to prove conventional medicines and they’re not sufficient for alternative therapies either.

Incidentally, many herbalists are already voluntarily regulated, the way many professions are, by an independent governing body for that purpose. In this case the National Institute of Medical Herbalists (NIMH). Disappointingly, the NIMH don’t appear to be regulating in the much-needed sense either.

“The Institute promotes the benefits, the efficacy and safe use of herbal medicine.”

Interesting that – “promotes”. Not “regulates”, not “ensures”, not even the legally arse-covering, “strives to ensure”. No, what they do is promotion.

Safety and efficacy

hbengl200Safety and efficacy are not unreasonable things to insist upon. They seems to me to be the most basic requirements of a medicine. Safety is enshrined in the Hippocratic Oath – “First,  do no harm”. Safety and efficacy are intrinsically linked; if a treatment is ineffective, that puts the patient at risk. A patient taking an ineffective alternative treatment is more likely to forego conventional evidence-based medicine. Even when the alternative therapy itself doesn’t directly injure the patient, avoiding an effective treatment can be fatal. I don’t think I’m exaggerating. Consider the distressing case of baby Gloria Thomas.

In the last months of her life, baby Gloria Thomas suffered such terrible eczema her skin would weep and peel, sticking to her clothing when she was changed.

Despite her bleeding, crying and malnutrition, her mother and homeopath father failed to get conventional medical help before she died a painful death, a Sydney jury has been told.

Note, I’m not trying to conflate the different practices of herbal medicine and homoeopathy, just to show that serious harm can occur indirectly even when harmless treatments such as water drop or sugar pills prescribed by homoeopaths are used. It seems any treatment which discourages the use of evidence-based medicines could have these kind of effects. Prayer is another example.

So, I think the herbalist campaigners are right to be suspicious of statutory regulation, but for the wrong reasons. I suspect deep down they are concerned that SR might one day be used to demand efficacy of their treatments. Conversely, I am unconvinced about SR because it doesn’t (yet) demand efficacy.

[BPSDB]

11 thoughts on “Regulation Of Herbal Medicine

  1. Surely the principle problem with alternative medicine is that very fact that it’s “alternative? As you and others have said before, Eshu, if it were properly tested and researched, it would just be “medicine”. The real danger of CAM, though is not so much the inherent risks involved in ingesting things you find in hedgerows, but the fact that patients are spending time (and money) on made-up and untested flim-flam when they could be getting propper medical treatment. For colds and sniffles, fair enough; load up on echinacea and good luck to you, but when you get cancer patients refusing chemotherapy because their herbalist/qigong teacher/reiki healer/ Tibetean voodoo master tells them it will interfer with their “treatment”, then you have a serious problem.

    (Spelling Nazi moment: should that not be “Hippocratic Oath” in the last section? Or is the “hypocratic oath” a special version for hypocr- I mean, CAM practitioners?)

  2. yunshui said,

    Surely the principle problem with alternative medicine is that very fact that it’s “alternative? As you and others have said before, Eshu, if it were properly tested and researched, it would just be “medicine”.

    Yep, I think we have to give the credit to Tim Minchin for that one. :-)

    That said, I wouldn’t want to write it all off without investigation. There’s likely some herbal medicine which has some benefit. Maybe even some that hasn’t been worked out and made into popular drugs like aspirin. I think Simon Singh and Edzard Ernst came to that conclusion, although the “signal to noise” ratio is rather poor.

    True, it’s mostly the “abandoning other treatments” bit that is most harmful and herbal medicine is arguably not the worst offender in that respect. It is often marketed as “complementary” rather than “alternative”. I understand homeopathy actually insists on the abandonment of other treatments, with an almost cult-like fervour in some cases.

    Sheesh, I wish Nazis were only obsessed with spelling! You’re right, of course and I’ve updated it. I was possibly thinking of the ironic team fortress two award.

  3. Great to see good, old daddy Yunshui around.

    I don’t know about regulating herbal medicine. They’re trying to do the same here in paradise (aka Canada).

    What confuses me is that we are trying to legalize marijuana and at the same time trying to regulate other herbs. Also, good luck regulating. A lot of herbs can be grown on one’s garden. Are they going to criminalize growing parsley?

    On this one I feel like a right-wing American: Let people be adults who take risks at their own discretion.

  4. Reference to point 1 relating to harm. If a member of the public consults a qualified medical herbalist then there is no harm to the public. The yellow card scheme covers the general public purchasing ‘herbal remedies’ over the counter. Traditional Western Medical Herbalists train for four years to ensure the correct, and therefore safest, herbs are chosen for their patient. The general public, nor the health food store sales assistant, has this indepth training. No one would purchase a betablocker or a steroid inhaler and take it without being prescribed by their GP. There has been problems with imported remedies from China, India etc. being contaminated with heavy metals and even being incorrectly labelled. This does need some sort of regulation to protect the public. After 2011 it will not be possible for the general public to buy any herbs over the counter. With regard to Traditional Western Medical Herbalists statutory regulation may not be necessary if the government can ensure a way of those qualified having access to the tools of their trade.

  5. Lorena said:

    “What confuses me is that we are trying to legalize marijuana and at the same time trying to regulate other herbs.”

    I would guess it’s not the same people campaigning for these two things.

    “Also, good luck regulating. A lot of herbs can be grown on one’s garden.”

    I’m not sure that should or could be covered. The issue is people prescribing things which either don’t work or can do harm. We can discourage people from being irresponsible idiots on their own time, but there are limits.

    “On this one I feel like a right-wing American: Let people be adults who take risks at their own discretion.”

    Well I’m a bit more on the side of “No, you really must wear a seatbelt in a car.”. But I agree that’s it’s impractical to stop individuals from picking something potentially poisonous and munching on it. In this case education is probably the most important thing. The thrust of my article was about regulating those who prescribe herbs to ensure the same standards are applied to them as to conventional medicine.

  6. Joy said,

    “If a member of the public consults a qualified medical herbalist then there is no harm to the public.”

    I’m not convinced that qualification is enough. Don’t conventional doctors have to go through a bit more than just qualification?

    “The yellow card scheme covers the general public purchasing ‘herbal remedies’ over the counter.”

    I’ve never seen this operating. Maybe I’m unobservant, but I think this needs to be more widely publicised.

    “With regard to Traditional Western Medical Herbalists statutory regulation may not be necessary if the government can ensure a way of those qualified having access to the tools of their trade.”

    Is that really the only issue? How can you be sure that anyone with a degree in Herbal Medicine is necessarily able to prescribe safely?

    What are your opinions on the important issue of efficacy?

  7. I don’t understand why there has to be any special regulation of herbal medicines at all. If they’re medicines, regulate them like medicines. Proper reviews, trials, evidence, etc.

    If they’re not medicines, then admit they’re not medicines and move on. Asking for special treatment is an admission that they will not pass the standard test – it’s like me asking for a special “alternative driving test” because my style of driving is not adequately assessed by the standard driving test (i.e. I fail too often).

  8. Investigating other people’s beliefs are we?
    Or making vastly condescending statements about people’s right to choose their own form of healthcare, are people to stupid to work out what they want to do with their own bodies, do they need your permission? you said you hadn’t bothered to read all the legislation and consultation documents, so why are you qualified to make strong opinions either way?
    As for herbalists who sit four year degrees in herbal medicine (bachelor of science) who study pharmacology, biochemistry, anatomy and physiology, pharmacognosy, pharmacodynamics, clinical medicine, differential diagnosis, physical examinations, sit in on 500 hours of real clinics with real patients and observe first hand the side effects of conventional medicine. Who are taught contraindications i.e which herbs don’t interact well with which mainstream drugs or medical conditions and when to refer a patient, yes they are qualified to talk about herbs and prescribe them safely–to what was it you said of our patients ‘ idiots’ . Why is mainstream conventional medicine the grail of all safety? seek you the comfort of science, while you read the list of side effects of any pharmaceutical drug on the market. You are naive and ill informed. Get off the internet and go read something please, you might want to start with the yellow card system, You haven’t heard of it therefor it doesn’t exsist? you contradict the science you hold so dear. My dear

  9. Herbalista wrote,

    you said you hadn’t bothered to read all the legislation and consultation documents, so why are you qualified to make strong opinions either way?

    You obviously have strong opinions on this matter, so I presume that you have read all the legislation and consultation. Would you care to enlighten us?

    sit in on 500 hours of real clinics with real patients

    I think you exaggerate. I know qualified medical herbalists and they have not spent anything like the 500hrs (or about 3.5 months full-time) that you suggest. Can you direct us to the standards that existing voluntary regulatory bodies (like the NIMH) require of all their members and accredited courses? This would be a good start.

    Why is mainstream conventional medicine the grail of all safety?

    It’s not.

    All medicine should be tested to ensure it is safe and effective. We should not trust any medicine simply on the say-so of any individual or organisation, whoever they are. This goes for big pharma and little herbalist. Both can be deceived by wishful thinking and both can be dishonest. Clinical trials are the best way we have to prevent this. No system of medicine should be exempt from having to prove itself safe and effective. Surely that is common sense and not controversial.

    What exactly are you so afraid of?

  10. The question you have to ask is whether State Regulation ensures safety? There are plenty of cases whereby a SR practitioner is found guilty of malpractise. The evidence for the lack of safety of herbal medicines cannot be based on a handful of cases, some of which are not conclusive, a number of which use non-traditional herbal medicines ie standardised extracts. If pharmaceutical drugs were judged the same they would have been illegal a long time ago.
    Herbal medicines cannot be judged by the same rule as pharmaceutical drugs, many are also foods and we all know that foods can also contain ‘dangerous’ chemicals.

  11. chris,

    Something doesn’t have to be perfect to be worth doing. It has to be better than the alternatives.

    I’m suggesting that state regulation is better than no regulation.

    What an alleged medicine contains or whether it is also a “food” is not relevant to how its safety and effectiveness is judged. I am curious why some people think certain medicine should have special exemption from certain kinds of testing.