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]