• Threat to Herbal Medicine in the UK
• Write to your MP: sample letter
• Points you can make to your MP
• Details of who to contact and how - how to contact your MP
• Statutory Regulation of Practitioners: Summary of the current situation
• Details of the background to the situation
• Additional notes on ‘Evidence Based Medicine’

Save Herbal Medicine in UK

 

It seems the UK Government is considering a course of action that threatens the practice of traditional & herbal medicine in UK (summary of the situation). We need to let the current government know that our right to the herbal treatment of our choice is an important issue to us.

  

If you want access to safe and well regulated herbal medical practice and medicines for yourself and your family in future please let your political representatives know. There are some people working against this outcome so it is important that you express your opinion (see sample letter).

 

 

Sample letter to your MP, MSP, AM, MLA about the consultation

   

[Your Address: Insert as appropriate]

[MP’s Name: Insert as appropriate]

[Address: e.g. English, Scottish, Welsh, NI parliaments/assemblies – see section 2]

[Date: Insert as appropriate]

   

Dear [MP’s Name: Insert as appropriate]

  

I am writing to you to express my concern about the Department of Health joint consultation on Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine.

  

The right of access to a full range of herbal medical practice and herbal medicines from a professional herbalist who is statutorily registered is a matter of great importance to me.

  

[Add other points such as those listed below]

  

It is now a matter of urgency that the Government brings forward legislation leading to the statutory regulation of herbalists which is the only way to guarantee that a full range of herbal medicine and herbal medicines will be available after April 2011.

  

Would you please raise this matter on my behalf with the Department of Health.

  

Yours faithfully,

[Signature]

  

Points you can make to your MP

You could make one or more of the following points

• The government, in its consultation on the regulation of traditional and herbal practitioners and acupuncture, is considering a form of regulation that will threaten availability of herbal medicines to practitioners.
• I support statutory regulation of traditional and herbal practitioners as this is apparently the best method for ensuring safe practice and continued supply a safe medicines to practitioners.
• It is very important to me personally that I have access to practitioners of traditional and herbal medicine now and in the future. I consider this common sense and a widely acknowledged basic human right.
• The other means of regulation proposed by the government are much less effective ways of ensuring safety of practice and products.
• There have been several governmental committees that have recommended statutory regulation. The government has not indicated why it now wants to ignore all that advice.
• The Traditional and Herbal Medicines directive (THMD) applies to self-medication products and not those needed by herbal medicines practitioners.  The THMD is consequently of not much importance in the current circumstances except that its full implementation in April 2011 removes the current arrangements that allow supply of manufactured herbal medicines on the commission of a practitioner.
• Anyway the THMD has in various ways severely limited the self-medication products that can be registered and from April 2011 this situation will become serious. Continued access to medicines through practitioners, enabled by statutory regulation, will make this situation less severe.
• If the government is considering changing its mind because of lobbying by the exponents of ‘evidence based medicine’ they should take heed of the opinions of the medical conventional profession as a whole not just a small group.
• The importance of ‘evidence based medicine’ in its narrow sense has been distorted. [extract from an editorial in the British Medical Journal Aug 2008
  
  ‘Today, however, there is a common, rigid mindset that equates EBM solely with the conclusions of randomised controlled trials and systematic reviews of these studies, to the exclusion of other 'best evidence' and the needs of individual patients. This simplistic thinking is being increasingly challenged by new moves to enhance the status of older, under-researched treatments:’]
• Many conventional treatments are not ‘evidence based’ in this narrow sense and randomised controlled trials (RCTs) are often not a useful way of evaluating treatments.  ‘The stuff you can count is not always the stuff that counts’.
• The practice of medicine is both a science and an art and undue prominence cannot be safely given to either aspect. Many doctors use CAM therapies for themselves and their patients because they experience the benefits personally even if there is limited RCT evidence on the efficacy of the treatments.
• There is a growing RCT evidence base for herbal treatments and there will be a lot more when sufficient research is done.

Details of who to contact and how

MPs are careful to act on the concerns of only their own constituents, therefore remember to give your home address in letters and emails. It is most effective to write in your own words to.  However because in this case the regulatory issues are quite complicated MPs may accept it if you quote part of a briefing paper such as this.

Contact your representatives by writing or emailing them

Get email addresses from the sites listed

• House of Commons, Westminster, London, SW1A 0AA.
  Write to them
  Find your MP
• Scottish Parliament , Edinburgh, EH99 1SP
  Scottish Parliament Members
  Scottish Parliment Current Members
• Welsh Assembly
  National Assembly for Wales

Because a general election is likely to happen soon it will also be useful to inform any prospective candidates of your concerns. This will help to alert the individuals and parties that the right to the health care of choice is an important issue for you.

You can obtain contact information for political candidates from

• Conservatives
• The Green Party
• Labour Party
  ‘Labour In Your Area’, down the right margin and enter postcode.
  The Labour Party charge several hundred pounds for a comprehensive list of their candidates so either email their local office or ask the local office for the local candidates details.
• Liberal Democrats
• Plaid Cymru
• Scottish National Party (SNP)
• The UK Independance Party (UKIP)

For help and encouragement in writing to your political representative contact one of the following

• David Whitley
  dwhitley@uwclub.net
  Director, Maharishi Ayurveda Products
  tel: 01394 460782
• Lizzie Lines
  lizzielines@me.com
  tel:07957 865203
• Jai Brierley
  jbrierley@maharishi.co.uk
  General Manager, Maharishi Ayurveda Products
  tel: 01695 51015 ext 18

Summary of the current situation

Government policy and recent changes

For some years the UK government has had the sensible policy in regard to herbal medicine which aims to protect the public from dangerous products and practice while maintaining the publics’ access to the health care of its choice.

 

The Department of Health (DoH) had indicated that it favoured statutory regulation of practitioners of herbal/traditional medicine and acupuncture, but it has recently dramatically changed its stance and in a consultative document is proposing a weaker sort of regulation.

 

Statutory regulation involves laws which would ensure appropriate training, supervision of practice and investigation of bad practice similar to those governing other health professions.  The majority of traditional and herbal practitioners are in favour of statutory regulation because they want the standard of practice in their profession to be high and without statutory regulation it they will not be able to get the medicines they need for their patients.

 

In the recent consultation document a weaker regulation is now being proposed that would not ensure safety and good practice and would restrict practitioners so that they could only have legal access to very few herbal medicines and consequently it will be difficult for them to continue to practice.  If people are tempted to use illegal means to access herbal medicines there is greater risk of substandard medicines being used.

Relevant legislation of herbal medicines

The European Traditional Herbal Medicines directive (THMD) makes it easier to register a herbal medicine than it would have been to obtain a full medicines licence. However the THMD scheme applies only to products designed for self-medication and not to medicines a practitioner needs to treat more serious conditions.  (This is emphasised here because one government spokesperson tried to indicate that the existence of the THMD was a partial solution to the statutory regulation problem.)

 

Various aspects of the THMD and the way it has been implemented make it very difficult and costly to register the wide range of complex multiherbal products required by practitioners of Ayurveda, Traditional Chinese Medicine and other traditions.  Practitioners of the Western herbal tradition will also be affected but less severely.

 

The implementation of the THMD is now in a transitional phase which ends in April 2011. The MHRA, the medicines regulator, wants to implement a scheme that goes a long way to ensure the supply of safe herbal medicines to practitioners. This scheme will not be possible without statutory regulation.

Why the change of government policy

The reasons the government changed its mind have not been stated. It may have been influenced by a small group of supporters of a narrow interpretation of ‘evidence based medicine’ who feel that no government resources should be spent on any treatment that is not supported by the evidence of randomised controlled trials (RCTs).  Also the government wants to introduce new legislation only where essential. (see: additional notes on ‘evidence based medicine’)

Reasons in favour of statutory regulation include

• Several governmental committees and working groups have recommended it
• Access to herbal medicine is a long held right in UK
• The right of citizens to healthcare of their choice is widely recognised throughout the world
• Herbal medicine is generally a lot less expensive than conventional medicine
• The government wants us to take more responsibility for our own health. Herbal medicine can promote health and prevent ill health.

Details of the background to the situation

The Regulatory Issues

Summary

1. Limitations to theses notes

All these notes refer to traditional and herbal medicine.  The DoH consultation applies also to regulation of acupuncture but none of these notes are presented as applying to acupuncture.  The term traditional and herbal medicines is used at times because some traditional medical practice such as Ayurveda and Traditional Chinese Medicine involve substantial herbal content but also other non-herbal practices.

2. Government policy

For many years the UK governments stated policy in regard to herbal products and healthcare that aims to protect the public from dangerous products and practice while maintaining the publics’ access to the health care of its choice. After years of discussions and consultations the Department of Health (DoH) had indicated that it favoured statutory regulation of practitioners of herbal/traditional medicine and acupuncture.

 

Instead the Government is considering imposing a lesser licensing system on practitioners which crucially will confer no special legal rights when it comes to medicines law and will relegate practitioners of herbal/traditional medicine and acupuncture (PTHMAs) to a  second-rate category, using a similar licensing scheme to that currently employed to regulate bouncers, bodyguards and wheel clampers. Another suggested possibility is that voluntary regulation continues in one form or another.

 

Recently however it has changed its stance dramatically and it seems intent on not proceed with statutory regulation.[1]

 

The reasons for the change in the government’s stance have not been specified but seems probably to involve:

• general difficulties and lack of confidence coupled with a wish to restrain the relentless growth of regulation in general
• a campaign by some conventional medical practitioners and arch sceptics in support of what they call evidence based medicine which takes the form of belittling all forms of medical treatments the efficacy of which is not supported by objective scientific evidence mainly in the form of randomised controlled trials.

Advantages of Statutory Regulation

Statutory regulation provides greater assurance to the public than any other option that practitioners are well trained and competent at their job. Should any practitioner be found seriously wanting he or she can be struck off the practitioners’ register. Voluntary regulation cannot deliver this and any other licensing system will do nothing to ensure that the public across the UK is able to identify those who have high quality training and professional development.

 

In addition statutory regulation raises the status of PTHMAs.  If they are not statutorily regulated, it will not be legal for doctors and other healthcare professional who are statutorily regulated to make referrals to them. This is certainly not in the interests of patients who wish that the health professionals they consult all work together in a complementary fashion on their behalf.

 

Statutory regulation of PTHMAs would also allow the government to classify practitioners as ‘authorised healthcare professionals’.  This classification would allow the government to set up a scheme, under European medicines legislation (Article 5.1), whereby PTHMAs could commission supply of manufactured herbal medicines from licensed suppliers. Current UK legislation is not fully in accord with EU requirements and all the other regulatory options for PTHMAs would not allow both access to manufactured herbal medicines and greater compliance with EU law.

Voluntary regulation – no security for patients or practitioners

Voluntary regulation [2] would mean that herbal practitioners will continue to be legally indistinguishable from ordinary members of the public. Failing practitioners cannot be prevented from practising and there would be no security of access to potent herbal ingredients whose use is already restricted.  There is also the danger that in the long-term, lack of legal professional identity would undermine the herbalist’s right to prescribe herbal medicines on a one-to-one basis. Indeed, for the first time the current Government Consultation Document actually contemplates the repeal of the vital piece of legislation that enables herbal/traditional medicine practitioners to prescribe individual herbal medicines for their patients. It is clear that access to a full range of herbal medicines can only be preserved if herbal/traditional medicine practitioners are statutorily regulated.

Maintaining herbal supply via statutory regulation

1. Existing regulation is not enough

In April 2011 the transitional period for implementation of the Traditional Herbal Medicines Directive (THMD) comes to an end and then only herbal medicines that have received a registration can be sold anywhere in EU.  The THMD applies only to herbal medicines sold over-the-counter (OTC) for self-medication of non-serious conditions. It was aimed to ensure that only good quality and safe herbal medicines are sold. However the legislation has been implemented in such a way that it is very expensive to obtain a registration.

 

As a result the high costs the prices of all but the most simple and popular herbal products would have to be increased dramatically or taken off the market.  This is especially true for the great majority of Ayurvedic and TCM preparations which contain several or many ingredients[3]. There are greater technical difficulties and costs in registering multiherbal products than the simple one-ingredient herbal medicines popular in the western tradition such as St John’s Wort or Black Cohosh.

 

Furthermore THMD registered products may not be suitable for the more serious conditions that PTHMAs want to treat. Also use of the some potent herbs may not be allowed in THMD registered products.

2. New arrangements are needed

Without statutory regulation PTHMAs themselves would still be allowed to prepare medicines for their own clients. However, most PTHMAs prefer to concentrate on treating the clients rather than pharmacy work. Also it is more difficult for manufacture in a small pharmacy to maintain the standards of industrial manufacture. Consequently disallowing access to manufactured herbal medicines would tend to reduce the quality of medicines available to the public.

 

To solve these problems, the UK medicines regulator, The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed that third-party medicines supplied on request of ‘authorised health care professional’ practitioners for individual patients can continue under MHRA licence via Section 5.1 of the main European Medicines Act 2001/83/EC.[4] These would have to be made to assured medicinal quality. Without statutory regulation this would not be possible.

Herbal supply without statutory regulation

The loss of planned arrangements to enable continuing supply, under the supervision of the MHRA, will probably lead to an increase in the purchase of unregulated medicines via the internet. These remedies often lack any reliable quality assurance and some have been found to be illegally mixed with conventional drugs.

 

Policital Issues

What is going on?

The Government appears to be reluctant at the last minute to move ahead with regulation, in spite of the fact that a great deal of the groundwork has already been done and there will little cost to the public purse. Despite the fact that statutory regulation of this sector was recommended by the House of Lords’ Select Committee on Science and Technology and three subsequent Department of Health Working Groups[5], there is a serious risk that now, at the eleventh hour, it will be aborted.

 

‘It is a matter of considerable regret that the DoH has failed to meet its own targets on the statutory regulation of this sector. It would not be unjust to say the Government has singularly failed to live up to promises and public expectations’.[6]

The right to herbal medicine

Access to herbal medicine has been a right of the English and subsequently the British people since the reign of Henry VIII. In 1968 and 1996 public outcry caused the government of the day to reverse proposals that would have eliminated or severely restricted public access to herbal medicines. It now is necessary to reaffirm to the government that we are not ready to give up our traditional rights.

 

With ever increasing numbers seeking treatment from the herbal/traditional medicine and acupuncture sector, failure of Government to honour its long-term commitment to statutory regulation of these professionals seems inconsistent with the public interest.

 

Extract from EHTPA response to consulation: ‘Clearly, the public perceive that there is benefit a plenty [from acupuncture, herbal and traditional Chinese medicine (TCM)] otherwise the growth of this sector would not be the phenomenon that it is. Survey data demonstrates high demand for complementary and alternative medicine (CAM). 10.6% of the adult population of England had visited at least one therapist providing any one of the six more established therapies (acupuncture, chiropractic, homoeopathy, hypnotherapy, medical herbalism, osteopathy) during 1998 with an estimated 22 million visits.[7]

Costs

At present when virtually no herbal and acupuncture treatments are available on the NHS all successful herbal treatments help to reduce the state expenditures on healthcare. Promotion of health and prevention of disease is the better than cure and are the most obvious way to reduce the cost of healthcare.  Traditional systems such as Ayurveda have a lot to contribute in terms of promotion and prevention.

 

The potential contribution of CAM therapies to the cost of UK healthcare was reported by [1] Christopher Smallwood C in his report ‘The Role of Complementary and Alternative Medicine in the NHS’, Fresh Minds Ltd, Oct 2005 in which he writes:

 

 “Evidence ... indicates that many of the most effective CAM therapies correspond to recognised “effectiveness gaps” in NHS treatment. The main areas comprise chronic and complex conditions, anxiety, stress and depression and palliative care… Despite the fragmentary nature of the evidence, there is good reason to believe that a number of CAM treatments offer the possibility of significant savings in direct health costs.... the benefits to the economy ...  of a wider application of successful complementary therapies in the key areas could run to hundreds of millions of pounds...”

 

Smallwood also identifies statutory regulation for herbal medicine and acupuncture as: “important to remove a series of barriers that may stand in the way of GP referrals.”

 

Regarding herbal medicine, Smallwood said: “In many cases where the herbal remedy is sufficiently effective, cost savings would be generated by its wider use. For example, in 2004 the NHS spent £400 million on anti-depressant drugs at an average net ingredient cost of £13.82 per prescription. Compared with this a weekly course of St John’s wort costs just 82p”.

 

Since the Smallwood report the National Institute for Clinical Excellence (NICE) has published its guidelines on treating persistent, non-specific low back pain recommending (May 2009) a course of acupuncture, up to a maximum of 10 sessions over a period of up to 12 weeks.[8]

 

An evaluation of a pilot project conducted in Northern Ireland, which provided patients with access to a range of CAM treatments through their GP practice, documented the positive impact of CAM on patients who are economically active, particularly in the context of helping people back into work following illness.[9]

 

The Scientific Issue

Evidence based medicine  - summary

The argument against use of traditional and herbal medicine because it lacks an evidence base compared to conventional medical treatments is weak on several grounds:

 

1. There is still a lack of objective scientific evidence to support the majority of conventional medical treatments.
2. There is objective evidence for the efficacy and cost effectiveness of some herbal treatments. Traditional and herbal treatments tend to show value in just those areas in which conventional medicine is weak such as chronic diseases.
3. The methods that have been developed for evaluating conventional drug treatments are particularly useful for evaluating the specific effects of a simple drug treatment in a narrow target population over a short period of time.  Practitioners of traditional & herbal medicine tend to be much more interested in total effect (sum of specific and non-specific effects) of complex interventions on a large population over a long period of time.  In this regard the Randomised Controlled Trial, sometimes referred to as the ‘gold standard’, may be of little interest or utility.
4. It generally happens that the more ‘rigorous’ the methodology of objective medical research the more restricted the applicability of the results of the research.
5. Placebo: There is a growing realization of the clinical and financial importance of the non-specific effects of medical practice (sometimes called placebo effects) in the maintenance of public health and cure of disease.  Those who interact directly with the public may be a lot more aware of the importance of these effects than academic researchers.  Traditional and herbal medicine tend to have the ability to generate significant non-specific effects. It is to be hoped, for the benefit of the public health and the public purse, that the regulation and practice of conventional medicine will take more account of these factors in the future.
6. Conventional medicine has gradually adopted many ideas and therapies that originated as CAM and it is a frequent source of pleasure to see conventional medicines’ gradually recognition of truths that have been part of Ayurveda for a very long time.

What is ‘Evidence Based Medicine’?

Extract from EHTPA response to Question 11 of the consultation:

‘However, whatever public perception may be, this is certainly not the case as the following recent editorial from the BMJ Journal Evidence Based Medicine[10] makes clear. It draws attention to a clear double standard which sees CAM therapies under fire for lack of evidence and contrasts this to the way conventional medicine is incorrectly portrayed as being largely supported by a secure evidence base.

 

“Is the concept of evidence-based medicine flexible enough? In particular, can it embrace interventions for which there is a long history of use, but a lack of hard research data? It should do, according to a famous definition published 12 years ago in which evidence-based medicine (EBM) was portrayed as ‘the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients’. This definition made allowances for missing or inappropriate evidence, and, crucially, required the application of clinical judgment and recognition of patient values. Today, however, there is a common, rigid mindset that equates EBM solely with the conclusions of randomised controlled trials and systematic reviews of these studies, to the exclusion of other 'best evidence' and the needs of individual patients. This simplistic thinking is being increasingly challenged by new moves to enhance the status of older, under-researched treatments: for example, the registration of herbal medicinal products by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

 

When it comes to older treatments, there is often a gap between empirical evidence, clinical practice, and patient experience. Moreover, there are conspicuous double standards in attitudes to older treatments. For example, about half of all so-called conventional healthcare interventions continue to be used even though research on their efficacy is non-existent or equivocal. By contrast, traditional complementary and alternative therapies that have been widely used for many years and continue to be popular with patients are regularly dismissed out of hand on the grounds that there is little 'scientific' evidence to confirm whether they work.

 

There are also obvious problems associated with focusing entirely on published trial literature as the supposed basis for evidence-based practice. The efficacy studies that form the backbone of EBM represent only a small part of the total research literature, and may be of limited value in assessing safety. And, of course, most efficacy research is sponsored by the pharmaceutical industry and is drug orientated. Potentially valuable traditional medicines, non-drug interventions, or other aspects of health care receive much less attention. It is dangerous to assume that concentrating exclusively on published trials and systematic reviews at least identifies those interventions that have proven their worth to clinical practice. In reality, a good look through the Cochrane Library or other research databases reveals that the interventions and questions assessed by RCTs are often far removed from the real needs of patients and their healthcare professionals. This distortion reflects not just the selectivity of the research conducted, but also positive and negative publication biases. Examples include publication biases in trials of treatment for acute stroke, and also in trials of antidepressant drugs.

 

Less obviously, and more controversially, there are questions about whether the pharmacological randomised controlled trial model for research is sufficient to assess long-established interventions. One concern is that, because many of these interventions comprise several components, the individual effects of which may be hard to isolate and measure separately (e.g. palliative care, public health, or many complementary and alternative therapies), artificially standardising them to fit a drug-trial model may involve over-simplification. This will then raise questions about the real-world applicability of the study results. Accordingly, there is an argument for a different type of research strategy for long-established interventions, with a different order of priority...” 

 

This editorial is supported by recent data also published in the BMJ’s on-line Journal Clinical Evidence.[11] It shows that far from having a complete evidence base, only about 13% of 2,500 medical treatments surveyed are rated as beneficial with 46% “of unknown effectiveness”

 

“So what can Clinical Evidence tell us about the state of our current knowledge? What proportion of commonly used treatments are supported by good evidence, what proportion should not be used or used only with caution, and how big are the gaps in our knowledge? Of around 2500 treatments covered 13% are rated as beneficial, 23% likely to be beneficial, 8% as trade off between benefits and harms, 6% unlikely to be beneficial, 4% likely to be ineffective or harmful, and 46%, the largest proportion, as unknown effectiveness (see figure 1). Dividing treatments into categories is never easy hence our reliance on our large team of experienced information specialists, editors, peer reviewers and expert authors... However, the figures above suggest that the research community has a large task ahead and that most decisions about treatments still rest on the individual judgements of clinicians and patients.”[12]

 

Figure 1. (From BMJ Clinical Evidence)

 

 

Suitability of different kinds of evidence

Extract from EHTPA response to consultation

 ‘ …. there is growing concern, ….. about the appropriateness of research to provide EBM (evidence based medicine). This concern was explored by Professor Sir Michael Rawlins, Chairman of the National Institute for Health and Clinical Excellence (NICE) in his Harveian Oration to the Royal College of Physicians in October 2008.[13]

 

“The dispute about the evidential basis of modern therapeutics has become particularly apparent with the emergence, over the past 30 years, of what are known variously as ‘rules’, ‘levels’ or ‘hierarchies’ of evidence... Such hierarchies place randomised controlled trials (RCTs) at their summit with various forms of observational studies nestling in the foothills. They are used – as a form of shorthand – to provide some intimation of the ‘strength’ of the underlying evidence; and, particularly by guideline developers, to then ‘grade’ therapeutic recommendations on the basis of this perceived strength...

 

The notion that evidence can be reliably placed in hierarchies is illusory. Hierarchies place RCTs on an undeserved pedestal for, as I discuss later, although the technique has advantages it also has significant disadvantages. Observational studies too have defects but they also have merit. Decision makers need to assess and appraise all the available evidence irrespective as to whether it has been derived from RCTs or observational studies, and the strengths and weaknesses of each need to be understood if reasonable and reliable conclusions are to be drawn. Nor, in reaching these conclusions, is there any shame in accepting that judgements are required about the ‘fitness for purpose’ of the components of the evidence base. On the contrary, judgements are an essential ingredient of most aspects of the decision-making process....

 

Hierarchies attempt to replace judgement with an oversimplistic, pseudoquantitative, assessment of the quality of the available evidence. Decision makers have to incorporate judgements, as part of their appraisal of the evidence, in reaching their conclusions. Such judgements relate to the extent to which each of the components of the evidence base is ‘fit for purpose’. Is it reliable? Does it appear to be generalisable? Do the intervention’s benefits outweigh its harms? And so on. Decision makers have to be teleoanalysts. Although techniques such as Bayesian statistics will undoubtedly assist they will not be a substitute for judgement. As William Blake (1757–1827) observed: ‘God forbid that truth should be confined to mathematical demonstration’.”

 

A recent editorial on Integrative Medicine in the BMJ reflects on the conundrum facing those who wish to integrate herbal/traditional medicine, TCM and acupuncture into healthcare alongside mainstream medicine: [14]

 

“We do not currently have enough evidence to close the door on research into integrative medicine and pronounce it ineffective. However, we will not be serving the best interests of evidence informed choice simply by undertaking more, and expensive, placebo controlled trials with non-typical patients and artificially standardised interventions, and ever more systematic reviews of existing heterogeneous, underpowered, and low quality studies. Rather, we should work towards closing the evidence gap by broadening the range of evidence we use to evaluate the complex interventions that are characteristic of, although not exclusive to, integrative medicine.“.’

 

The Dept of Health Consultation on Statutory Regulation

The Consultation was initially due to close on 2nd Nov. but was extended until 18th November.

• The document is available here
• You can respond via the ‘automated response system’ template provided by the DH here

Additional notes on ‘Evidence Based Medicine’

It has long been recognised that the practice of medicine is both an art and a science. In the last hundred years much more attention has been given to the scientific aspect of medicine that the artistic. It is very important that the artistic element be not forgotten and that balance be created by putting more attention on it.

 

What is needed is a science (systematic reliable knowledge verifiable by repeated experiment) that can integrate both objective science and the arts. Maharishi’s Vedic Science does provide the theoretical structure and the practical programmes that are capable of such an integration and as such are a valuable tool for medical practice.

 

Knowledge is the basis for success in all fields of life and more knowledge is certainly urgently needed in the all fields of healthcare. But -

 

1. It is estimated that less than half of conventional medical practice is supported by RCTs, but this is not a problem in itself because -
2. There is a lot of valuable evidence that is not based on randomised controlled trials but even that is not so important because -
3. The crucial requirement is an ability to evaluate medical treatments in a more holistic way that fully includes the ‘artistic’ aspects.
4. Therefore the idea that conventional medicine and traditional & herbal medicine need to be regulated differently because of the relative amounts of RCT evidence for each is very far from the mark.

What evidence do we really need

The strident supporters of ‘evidence based medicine’ use the phrase in a narrow sense to refer only to the evidence of randomised controlled trials (RCTs) and systematic reviews based on RCTs. RCTs are very useful for investigating pharmaceutical drugs but not so useful for many other treatments – both conventional and herbal.  Less than half of NHS treatments have sufficient RCT evidence to meet the narrow standards of ‘evidence based medicine’.  There is a lot of other evidence available including that gained through long experience by many practitioners.

 

IfIf modern medicine were very successful the cost of it would be decreasing. That this is not happening indicates some knowledge is missing.  Health is ‘wholeness’- the integrated functioning of all the parts of mind and body. It is clear that reductive medical science has difficulty delivering health to the nation especially because it largely excludes itself from the realms of mind and culture which have such an important role in healthcare.  Alternative healthcare can make important contributions to national health.

There is evidence for herbal treatments

There is a growing body of RCT evidence for herbal treatments in spite of the fact that the amount of money spent on herbal research is miniscule compared with that spent on pharmaceutical drugs.  In spite of the paucity of RCT evidence many conventional practitioners do make use of alternative therapies because their patients want them and because they experience for themselves that they work.

 

It is said that the key element in the interaction between practitioner and patient is that the patient feels that they are liked by their practitioner. It seems therefore that the much derided placebo effect may be the most important ‘treatment’ of all.

 

 

Footnotes

[1] Statutory regulation of practitioners of herbal/traditional medicine and acupuncture (PHTMAs) would means passing a law that prescribes the system of regulation to be applied to them. This would be the same as for other medical practitioners and would involve agreed standards of training and ability to understand and be understood by the public, other medical practitioners and regulators; systems for continuing professional education; and systems for investigating and preventing bad practice.

 

[2]  Voluntary regulation means regulation through membership of a professional association with its own set of rules.  These might in theory be the similar to those applied by statutory regulation but their application would probably be less rigorous and not subject to official and systematic checks.

 

[3] This does not apply to products sold as food supplements but these also facing various regulatory pressures whose impact is hard to predict at present but can be reliably assumed to increase cost and decrease choice.

 

[4] ] This proposal can be read in detail on the MHRA website here

 

[5] The following is taken from the DH Website at the time of the launch of the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK (2006).“Statutory regulation of herbal medicine, acupuncture and traditional Chinese medicine practitioners. Summary: The Government is committed to the statutory regulation of herbal medicine, acupuncture and traditional Chinese medicine practitioners. We are in the process of setting up a Joint Working Group. We hope to have the Working Group set up and the first meeting arranged around June 2006 and to move gradually towards statutory regulation, probably in 2008/9.”

 

[6] Extract from The Prince’s Foundation for Integrated Health’s informative and authoritative response to the DoH consultation on statutory regulation of herbal practitioners at www.fih.org.uk.

 

[7] Thomas K S, Nicoll J P, Coleman P C 2001. Use and expenditure on complementary medicine in England: a population based survey. Complementary Therapies in Medicine 9:2-11

 

[8] http://www.nice.org.uk/nicemedia/pdf/CG88NICEGuideline.pdf.  May 2009

 

[9] DHSSPS. Evaluation of a CAM Pilot Project in Northern Ireland (2008),

 http://www.dhsspsni.gov.uk/final_report_from_smr_on_the_cam_pilot_project_-_may_2008.pdf.

 

[10] Barnett H, Iheanacho I. Editorial in BMJ Evidence Based Medicine –August 28th, 2008.

 

[11] BMJ Clinical Evidence, http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp. Accessed 3 September 09.

 

[12] Ibid

 

[13] Rawlins M, De Testimonio – ‘On the evidence for decisions about the use of therapeutic interventions’, The Harveian Oration, Royal College of Physicians, Oct 2008, ISBN 978-1-86016-347-0.

 

[14] MacPherson H, Peters D,  Zollman C. ‘ Closing the evidence gap in integrative medicine’, British Medical Journal  2009;339:b3335, doi: 10.1136/bmj.b3335 , 1 September 2009.