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.

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Faith healing – What evidence would I need?

A Christian friend of mine (No, not that one, another one) recently mentioned in his Facebook status that he’d witnessed miraculous healings at a Christian gathering. Ever the sceptic, I responded by posting a video of James Randi’s investigation of faith healing. In this video, Randi exposes US televangelists Peter Popoff and WV Grant.

He responded to me by asking:

“… Ever wondered what evidence you would need…”

Which is a very sensible and reasonable question. If I couldn’t say what evidence would convince me that I’m wrong about faith healing, I could be accused of holding my sceptical position irrationally, dogmatically, “No matter what”. Adam Lee covered this idea in respect to religious belief in general and the result is his Theist’s Guide to Converting Atheists essay which I’d recommend to everyone.

For me it’s not enough to be able to say, “This could have been a miracle” – not getting rained on when you forgot your umbrella could have been a miracle, but it could just as easily be chance. I’m trying to find something which could only have been a miracle. Recovering from a particularly nasty cold might have involved divine intervention, but this also happens naturally, so we can’t be sure a miracle occurred in that particular case. So I’m not interested in evidence of improbable healings, but impossible healings. Impossible that is, without miraculous supernatural intervention.

The evidence has to be reliable and evaluated in a way that does not allow bias, whether intentional or not, to creep in. To start with, the patients should be carefully assessed to ensure that they genuinely suffer from the claimed illness in the first place. Then we need to be able to judge easily whether or not they have been cured.

Ailments such as back pain, migraines or depression are probably not worth investigating as it is too hard to independently assess them – you can only rely on what the patient tells you.

Ideally we should also be reasonably confident of what caused the healing. If the patient visited mystical healers of all stripes then a few weeks later finds themselves cured, we still have some unanswered questions.

So to summarise, the miraculous healing would need to be something which:

  • Could only occur due to a miraculous healing.
  • Can easily be judged a success or failure by all around.
  • Can be linked to a specific faith healing claim.

A good example of this would be an amputated limb regrowing. If a group of Christians gathered around a multiple amputee and prayed for him to regrow his limbs and it they did indeed regrow then you’d have a very convincing case. I’d like to witness this myself, but also have other independent witnesses there to check I wasn’t hallucinating or missing some sleight of hand (or leg). This idea is examined in detail by the website Why Won’t God Heal Amputees, which says on the subject of healing amputees:

Notice that there is zero ambiguity in this situation. There is only one way for a limb to regenerate through prayer: God must exist and God must answer prayers.

That may seem very stringent and a very narrow way to define faith healing, but I think it’s warranted. It’s the only kind of faith healing we could really be sure about. Furthermore, I’m just an ordinary person and I could easily be fooled. I’ve seen enough stage magicians do tricks I couldn’t explain, heard (and believed) enough tall tales and been swayed by enough anecdotal evidence to know that I’m as gullible as the next guy.

So I think it’s reasonable – prudent even – to ask that these standards of evidence are met. Incidentally, these ideas are by no means exclusive, I’m sure there are other tests which could potentially provide excellent evidence of faith healing. I’m keen to hear other people’s suggestions. If we could agree on a reasonable experiment that could discern real faith healing from false faith healing, I’d be happy to try it out and post the results here.

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When woo works

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I recently became aware of Tellington T Touch therapy which is an animal healing technique, partly influenced by the Feldenkrais Method. It is principally used on ailing horses, cats and dogs, although it can be applied to many species. I’ve even heard reports of it being used on snakes and tarantulas – apparently they “touched” the snake with sticks. According to the official spiel, instructors and practitioners can be found in 27 countries. The inventor was Linda Tellington-Jones; her website explains how it works:

The intent of the TTouch is to activate the function of the cells and awaken cellular intelligence – a little like “turning on the electric lights of the body.”

Predictably, no explanation of “cellular intelligence” is given, but I’m guessing it has nothing to do with the cellular neural network parallel computing paradigm. Further reading reveals that Ms Tellington Jones received an honorary doctorate degree from the dubiously accredited and pompously-named Wisdom University.

None of which means that Tellington T Touch therapy won’t work; it just sets off the woo-alarm.

So what is Tellington T Touch therapy?

Using a combination of specific touches, lifts, and movement exercises, TTouch helps to release tension and increase body awareness.

Which I sounds a lot like massage and exercise and I think it’s quite reasonable that massage and exercise should be good for animals. The physical and mental benefits of exercise for humans are well-known. Ordinary, non-magical massage – with no ineffable cellular intelligence – shows signs of being beneficial to elderly people suffering loneliness or depression amongst others. It makes sense that social creatures, be they humans or dogs, would benefit from physical contact and connection to those around them.

So I can really see Tellington T Touch working. I expect that a well-intentioned practitioner really could improve a pet’s behaviour and to some extent its general health. But I seriously doubt it could perform significantly better than a combination of loving attention and regular “walkies”.

Which rather clouds the issue. Practitioners vary in how much they market the pseudo-scientific side of their animal therapy; many of the UK ones steer clear of the vague explanations and simply use Tellington T Touch as an extra skill on their CV – no need to scare off the skeptics when the rest of what they do is fairly “normal”.

However, there are plenty who do claim that some holistic, cellular level awakening of energies or similar is behind the effects. Is such an animal therapist a con artist or not? If they can achieve the results they claim, then what does the reasoning behind it matter? After all, there are a number of medicines in common usage whose exact mechanisms are poorly-understood, but they are still rigorously tested before being administered to the general public.

Which is exactly the point – all alternative therapies should be tested, like any other medical treatment. That means randomised, double-blind, placebo-controlled trials.

It’s also worth noting that it doesn’t matter what the claimed reasoning behind the treatment might be. Whether it’s “cellular intelligence” or “a certain energy” or just “a mystery” – whether it works or not can still be tested. As long as you can compare it against a “fake” version without the patients or those measuring the results knowing, you have a double-blind trial. I think it’s safe to say that the animals won’t be able to read the Tellington T Touch practitioner’s certificates on the wall, so will be unaware of which is a real treatment and which is the control. As for the measurers, there’s no need for them to see the therapy or control being carried out and they could assess the results over the next few days or weeks. As long as it’s done on a statistically signficant number of animals the study can be fair and informative.

I think testing is important and I see no reason that alternative therapies should be able to shirk this responsibility. Few people would be willing to take a pharmaceutical company’s products if for example, they said “Yes it works, although it can’t be tested, but they’ve been using it in the far East for generations and my grandmother swears by it” (that’s probably more akin to Reiki than T Touch, but the implications are similar). I’d like all “medical” treatments to be held to the same high standards. If “Fairy dust” or “cellular intelligence” is an unreasonable explanation for GlaxoSmithKline, then it’s unreasonable for everyone.

Granted, a bit of ineffective massage is unlikely to make your eyes drop out or to cause sterility (unless it’s very clumsy). However, even if you were to give the therapy for free, I still don’t think it’s entirely harmless. An ailing person (or animal) only has a certain amount of time and energy to spend trying out alternatives. Confusing the issue with ill-defined treatments of dubious efficacy is at best an irresponsible waste of people’s time and at worst cruel and deceitful.

As regards Tellington T Touch, I think it sits on a borderline. Most of the claims it makes sound reasonable for simple massage and exercise (except perhaps the treatment of snakes and spiders), so why add all the magical nonsense? Perhaps it means they can charge more or take on cases where traditional therapy has failed. In any case, I think they should undergo independent clinical trials – preferably by an institution which doesn’t have “Truth” or “Wisdom” in the title. If their techniques show significantly better results than plain massage and exercise, then they’ve earned the right to be respected medical practitioners. If not, then they should call a spade a spade and admit it’s just massge and exercise.

An offer of prayer

I have a colleague who is a big fan of prayer. He’s an Evangelical Christian and regularly makes friendly offers to pray for people’s family and friends who might be sick. He seems completely sincere and I believe the gesture is well-intentioned.

However, many who receive his offers find them… not exactly offensive, but certainly irritating. Perhaps they’ve heard this kind of thing before and are anticipating the little sermon that so often forms part of the package of such offers. One person told me they felt like they were being “sold to”. I don’t know if anyone has actually taken him up on these offers, but I’m sure some were more receptive than those I spoke with.

My first thoughts were along these lines. The recipients of this kind of offer could be crudely divided into two categories:

  1. The ones who believe that intercessory prayer will work.
  2. Those who don’t believe it will work.

Now surely those in the first group would already be praying if they had a sick relative? It seemed strange to me that any god would be unable to hear a single prayer, but a chorus of prayer – well, that’s different, is it? Surely God doesn’t need a critical number of prayers before he’s willing to take action? As for those in the second group, well they’re not likely to take up the offer if they don’t think it will have any effect.

All of which lead me to wonder whether my Evangelical colleague’s motivation was rather more evangelical (small ‘e’). Perhaps he had that sermon up his sleeve ready to spring on a polite and unsuspecting enquirer. On the other hand it could have been an attempt to show (either to us or to his god) what an amazingly altruistic Christian he is.

Perhaps more likely is that he anticipated a third group, somewhere in between the other two. People who were perhaps desperate for the health of their loved-ones and willing to try anything.

So I questioned him about it and we ended up going for a drink and having a long discussion on this and related topics. Well, if I’m honest I mostly listened. Before that discussion I did some reading and thinking and managed to crystallize my thoughts on prayer. The main issue I had is outlined below.

(Disclaimers: IANAL (I am not a logician) and this might be full of holes, but I think my meaning is clear enough. Secondly, it borrows the idea from Ebonmuse’s thorough discussion of the Problem of Evil):

Assumption (1). The patient currently has a medical problem.
Assumption (2). Praying for the patient to be healed can cause miraculous healing of that patient.
Assumption (3). The god to whom the prayer to heal the patient is directed :-

a) Exists;
b) Is all-powerful (omnipotent);
c) Is all-knowing (omniscient);
d) Has perfect judgement;
e) Will only do what is right;

Conclusion (4). An omnipotent being would be able to heal the patient (from 3a, 3b);
Conclusion (5). An omniscient being would already know about the patient’s problem. (from 1, 3a, 3c);
Conclusion (6). Any patient whom the god deems it right to heal will already be healed. (from 3d, 3e, 4, 5)
Conclusion (7). It is not right to heal the patient (from 1, 6).
Conclusion (8). Praying for the patient to heal will not cause miraculous healing of that patient (from 6, 7)

Contradiction : ( 2 & 8 )

So I ask: What makes you think you (in your less-than-infinite wisdom) can change God’s mind about healing this patient?

That’s not the only problem with the idea of praying to a god to ask for things. As Greta Christina points out if a prayer doesn’t work the answer always seems to be:

“You did something wrong. You didn’t pray hard enough. You didn’t pray right, with the right kind of feeling or faith. You didn’t get enough people to pray for you. There’s something wrong with you. It’s your fault.”

Even more perniciously, any unreliable offer of healing can cause those most in need to abandon genuine treatments which might actually help them.

I’m going to continue asking awkward questions and challenging my colleague’s ideas about prayer. He tells me he’s keen to question and test his beliefs, so I’m hopeful I may be able to encourage him to try some kind of formal test or experiment. Maybe I’m too optimistic…