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]

Evidence Yes, But Evidence For What?

shoesDuring my catch-up reading I came across an observation made some time ago by Deacon Duncan at Evangelical Realism that got me thinking.

This is the old superstition vs. science dilemma, the fellow who says shoes are made by elves in a hollow tree, and then cites the existence of shoes as evidence that elves are real.

Phrased like that it is easy to see the error in the reasoning. Yes, shoes could be evidence of elves, but there are other, less fantastic, possibilities and we should consider these first. When the example is elves, most people will be willing to look critically at the claim and see through it. Those with a sense of irony and a knowledge of rhyming slang may even describe it as “Cobblers“!

Nevertheless, this kind of fallacy appears surprisingly regularly. For example, consider the patterns sometimes found in fields, known as crop circles. Often these can only be fully appreciated from the air and seem to describe the shape of some kind of complex craft. While some crop circles are created by people making no unusual claims about them, others are claimed as evidence of alien visitors. In my view it’s far more likely to be evidence of mischievous earthlings.

When a patient improves after having taken some previously untested treatment or medicine, is that evidence that the treatment is working or that their immune system is doing its job? In cases like these it can be hard to tell, so thorough clinical trials are needed, involving more than one patient, placebo controls, etc.

Similarly, the creationist website, allaboutcrreation.org makes this popular claim:

Where is the proof of God? If we’re willing to open our eyes, we’ll see the fingerprints of God all around us and all throughout us. Our very existence proves the existence of a Creator God.

270px-CropCircleWI’m sure most of us have seen religious people point to a beautiful flower and say, “There! That’s evidence that God exists!”. Again, this could be evidence of a great many things, including the symbiotic relationship between flowering plants and insects which are attracted by bright colours and floral scents. The fact that we as humans think that the flower is beautiful may be evidence that we are adapted to appreciate a fertile ecosystem and the fruits that it can bring.

Even the Bible has some of this kind of gargantuan jump, in reverse from what they are trying to establish – the existence of a god, to a piece of alleged evidence, as in Romans 1:20:

For since the creation of the world God’s invisible qualities–his eternal power and divine nature–have been clearly seen, being understood from what has been made, so that men are without excuse.

I think that verse could be rephrased to be clearer about the leap of logic it’s making. Anyone care to make a suggestion?

In all cases it seems we are in danger of leaping to a conclusion that is not necessarily the cause of the evidence we’re seeing. The solution is perhaps to imagine several possible causes and try to understand why we should prefer one over the others.

Hands Up – Anyone Believe In Palmistry?

I did.

Palmistry (also known as Chiromancy) is the reading of people’s hands to discover their fortune and personality type.  This is not limited the lines on the palm, but the shape of the hand and its proportions including length of fingers, natural lumps or “mounts” on the palm and the colour and condition of the nails and skin.

I got interested in this in my early teens after observing a fellow holidaymaker informally read people’s hands for entertainment at a social gathering. I got a few books on the subject and read the hands of my friends, most of whom were intrigued. Some Christian friends made sanctimonious remarks, but I responded that the Bible has a (admittedly vague) reference to people’s hands in Job 37:7

He sealeth up the hand of every man; that all men may know his work.  – KJV

Actually, now I look at it again, that is really vague and says nothing about the legitimacy or not of reading hands. There are more direct references in many other cultures and religions.

I don’t think I was an especially convincing palmist. Although I certainly believed in the validity of what I was saying I was naturally hesitant and guarded in my pronouncements on people’s hands. Perhaps with time I could’ve unintentionally learnt cold reading. However, as with most teenage fads, I slowly lost interest in palmistry as I grew up.

Some modern palmists play down the future prediction aspect of hand reading, perhaps because it sounds too stereotyped, easy to say and difficult to verify until years later, when any failed predictions will likely be forgotten. However, a quick survey of palmist’s websites shows almost all are involved in some other method of fortune or personality divination. Amelie Appleby is a palmist who also practices crystal ball and tarot card readings. Philena Bruce also offers a wide variety of psychic services including readings of photographs and healing through sound. Unfortunately, none offer any independent research showing the efficacy of their claims.

However, I discovered with excitement that one hand reading website does include a discussion of the Forer Effect. Ken Lagerstrom of HumanHand.com writes:

The Forer Effect (also called the Barnum Effect or Subjective Validation Effect) refers to the tendency to accept vague or general statements as being very personal and accurate. The Forer Effect is a serious consideration in hand analysis, for both the professional and client. Psychologist Bertram R. Forer ran a series of tests in which he gave people a personality profile and asked them to rate its accuracy. Forer actually gave each person the exact same profile…

The test subjects rated these supposedly individual profiles as 85% accurate! With a vague enough profile that is mostly positive, most people will believe at least part of it truly relates to them.

Positivity is clearly important for the clients of psychic readers. Amelie Appleby, perhaps unwittingly, acknowledges this need:

…Amelie’s intuitive palm, tarot and crystal ball readings are positive and upbeat, full of enthusiasm and integrity, good humour and great fun.

Certainly people paying money are more likely to be pleased with a reading that predicts meeting a tall dark handsome stranger (although they’re probably smart enough not to use those exact words) than one divining a life of miserable solitude. Crucially, I think people are also more likely to believe things they find comforting.

Sadly, despite a promising looking article, Ken Lagerstrom ends up resorting to ad-hominem attacks:

In my experience, the real hard-core skeptics are just as fanatical (and biased, judgemental, self-certain, etc.) as the more extreme religious zealots. It’s just a different “faith”.

To call skepticism a faith is to broaden the definition of faith to become meaningless. A hard-core skeptic (or at least a serious one) is willing to assess the evidence and reach a tentative conclusion. Some skeptics get sick of hearing anecdotal evidence presented as if it were absolute proof. That might make them cynical about vague pseudo-science claims after a while. That’s not the same as being a zealot.

Then he presents a flawed analogy:

If you go to your doctor and hear him say “You need to examine your habits with diet and exercise, because you are damaging your health with your present body weight.”, does that physician’s diagnosis get dismissed along with the entire field of orthodox medicine?

No, you’d test his claim. Excessive weight may affect many people, but you can measure the person’s BMI and compare it to the healthy band. All conventional medical advice is in a constant state of being formally tested and reviewed. This is a good thing; it leads to better understanding and treatments.

It might not be as simple to test a hand reading, but some fair experiments could be devised and carried out on a statistically significant number of people. Specific predictions could be recorded and compared in later years to reality and their chance of occurring. Importantly the subjects should be blind to the predictions made. For example, telling someone they’ll make a journey to the Far East could influence their decision and is statistically fairly likely for certain demographics. Recording as part of the experiment that they’ll find a new job in early 2009 with a French company would be more significant if it occurred. Similarly personality predictions could be carefully controlled (perhaps so only the hands are seen) and compared to psychological assessments and surveys made beforehand.

The problem was, I began really searching for statistical proof that all palmistry was nothing more than superstitious garbage for the weak-minded.

That certainly was the problem. Ken Lagerstrom was trying to prove a negative. No matter how many charlatans employing the Forer Effect, cold reading or other psychological techniques (whether deliberately or not) he uncovered, he would always be wondering if the next one might be genuine. It’s like trying to prove the non-existence of a celestial teapot orbiting the sun. Proving its existence is theoretically possible (simply by finding one), but proving it’s non-existence can never be done. At what point would you stop searching?

That doesn’t mean we have to believe all extraordinary claims by default. Rather, the skeptic should tentatively disbelieve something out of the ordinary until appropriate evidence is presented. The burden of proof is most definitely on the psychics making the claims, all the more so if they are charging money for their services.

In the UK at least, new regulations have made this clear and on one website I noticed that, below her many testimonials, at the bottom of the page in small print, Philena Bruce has included this message.

This service is intended for entertainment purposes.
This is a scientific experiment, the results of which cannot be guaranteed.

I wonder if such regulations will make a difference to the wishful-thinking punters considering paying for a psychic reading, but it is a step in the right direction. Just to be clear I’d have no problem with these businesses if they could provide evidence that their psychic claims are true – to a standard similar to that required of other products. If they can’t, then every consumer should ask themselves why that is.

[BPSDB]