CONTINUING THE PHILOSOPHY OF REGINALD O. KAPP

9.44 WHERE IS THE EVIDENCE?
A LEVEL PLAYING FIELD FOR PUBLIC FUNDING OF CONVENTIONAL AND COMPLEMENTARY THERAPY


Paper for NHS commissioners and Councillors                               26.1.10

By John Kapp, 22, Saxon Rd Hove BN3 4LE 01273 417997 johnkapp@btinternet.com


Contents
1 Recommendations
2 Summary
3 The unravelling evidence base for drugs
4 The evidence base for complementary therapy (CAM)

a) Integration of CAM into the NHS
b) NICE-approved CAM
c) The NHS constitution becomes law
d) Health minister’s view of homeopathy
e) To whom may doctors refer patients?

5 The Boorman requirements to improve the health of NHS staff
6 What should a commissioning plan look like?
7 Conclusions – integrate CAM into the NHS
8 References


1 Recommendations

a) Public money should only be spent on treatments that have a sound evidence base that they are safe from harm, promote wellness, prevent illness and cure or alleviate illness.
b) Complementary therapy meets recommendation a) so should be included in strategic commissioning plans by integrating it into the NHS.
c) Drugs that alleviate illness by suppressing symptoms and have side effects should carry a government health warning: ‘This drug may suppress your symptoms and could seriously damage your health.’
d) Make Brighton and Hove the first integrated healthcare city as a pilot project for the nation.


2 Summary
There is a myth put out by drug company propaganda that drugs have a sounder evidence base than complementary and alternative medicine (CAM) because drugs have been through rigorous clinical trials and CAM has not. As time passes it is coming to light that drug company reporting of trial results cannot be trusted, so their evidence base is unravelling. As more and more CAM treatments are trialled the evidence base for them is strengthening.

For example, it was reported 2 years ago that ‘Prozac doesn’t work’ (1) and has side effects such as addiction. Taxpayers money should therefore not be spent on it, but 16 million prescriptions were written in UK every year for it then, and probably still are. However, CAM therapies that have the evidence of approval by the National Institute for Clinical Excellence (NICE), - the gold standard - such as the Mindfulness Based Cognitive Therapy (MBCT) course for depression, (NICE approved in 2004) are not yet commissioned, and should be.

This is not a level playing field, but is tipped in favour of drugs and against CAM. However, from last week (20.1.10) this tipping became illegal when the NHS constitution became law. It gives everybody the statutory right to all NICE approved treatments free, provided that their doctors says it is appropriate for them. It is therefore now statutorily mandatory for commissioners to commission the NICE –approved CAM therapies, or the commissioners risk being taken to judicial review without a leg to stand on.
These include physiotherapy, osteopathy, chiropractic, acupuncture and Alexander Technique for lower back pain, (LBP) the MBCT course for depression, and hypnotherapy for Irritable Bowel Syndrome (IBS)

The commissioning of CAM should not be limited to just the NICE-approved CAM treatments. Post Darzi the NHS have a new duty to prevent illness, as well as treat it. This duty applies not only to their patients, but (since last November) also their own staff, when the government accepted the Boorman recommendations. Preventing illness and promoting wellness is the business of CAM, so the NHS can discharge its new duty by integrating CAM fully into the NHS, for which Prince Charles’ Foundation for Integrated Health has been campaigning since 1993.

Our recommendation to: ‘Make Brighton and Hove the first integrated healthcare city as a pilot project for the nation’ is proposed in a report to Brighton and Hove City Council in paper ‘Proposal for Free Complementary Therapy on NHS – Report to Council’, published in section 9.43 of www.reginaldkapp.org. How that proposal would work is described in paper: ‘Business Plan for a Proposal for Free CAM in the NHS’ in section 9.39 of that website.

3 The unravelling evidence base for drugs
Most publicly funded prescription drugs have gone through rigorous clinical trials before being given a licence by the regulatory authorities. However, having been through that process does not prove that the drug is either safe or effective, because trial reporting by the drug companies has been shown repeatedly to be untrustworthy.

For example, the trial data showed that Seroxat made some children suicidal. However, this was not disclosed and the drug was given to children as well as adults for many years. It was only after many children committed suicide that this concealment came to light, and Seroxat was withdrawn for children.

Many similar stories are recounted in the literature, collectively showing that the evidence base for drugs is flawed and cannot be relied upon. This is documented in books such as ‘Food is Better Medicine than Drugs’ by Patrick Holford and Jerome Burne, 2007, and ‘The truth about the drug industry’ by Dr Maria Angell (2009). The following news reports list a few of the scandals over the safety and efficacy of drugs:

a) Pfitzer was fined $2.3 billion (£1.6 billion) in October 2009 for deception (2).
b) Thalidomide was withdrawn in 1961 after hundreds of babies were born without limbs. (3)
c) Vioxx was withdrawn in 2004, after 300,000 deaths from heart attack. (140,000 over 5 years)
d) Seroxat for children was withdrawn in 2006.
e) Drug TGN1412 was trialled it at Northwich hospital in 2006 and withdrawn after it was given to 6 men who were left fighting for their lives in intensive care. One (Ryan Wilson) was permanently maimed, losing his fingers and toes. (4)
f) Anti-psychotic drugs kill 1,800 dementia patients each year (5)
g) Prozac was shown in a meta study of 35 trials published in Feb 2008 to be no more effective than placebo. In May 2006 Patricia Hewitt, then Secretary of State for Health, made a speech to a mental health conference announcing ‘the end of the Prozac nation’, and the promotion of talking therapies.
h) Statins have been challenged in the book ‘The Great Cholesterol Con – The truth about what really causes hearth attacks and how to avoid it’. by Dr Malcolm Kendrick, 2007
i) Vaccination has been seriously challenged for a century (6) The additives and preservatives (such as thimersol) have recently been linked to the ‘explosion’ of autism, which is now said to affect 1% of recent births (7) The European parliament is holding a public inquiry into the swine flu vaccine (8) which it is claimed was neither licenced nor even tested. (7)
Despite being mandated to healthcare staff it had a low take up, leaving hundreds of millions of superfluous doses. Dr. James Shannon who served as director of NIH is quoted as saying "the only safe vaccine is one that is never used." (7)
j) Before 2000, 40,000 people were killed each year by doctors’ mistakes (9)
k) In the USA, 800,000 people are killed each year, mostly by adverse drug reactions, which makes iatrogenesis (doctor-induced disease) the biggest single killer after heart disease (700,000) and cancer (590,000) (10)
l) A Horizon programme on TV on 20.1.10 on drugs said that the average person in UK in their lifetime takes 14,000 prescription pills, and 28,000 non-prescription pain killers, including 60 courses of antibiotics. The average person over 70 takes 5 pills a day. 6 million people are on statins. There is no totally safe medicine. Patients were interviewed who said that they hate taking pills, and that they were being kept alive artificially. A clinician concluded: ‘In 20 years the drug companies have gone from treating people to treating risk factors…..We are all part of a continuous trial of drugs, the majority of which do more good than harm.’

4 The evidence base for complementary therapy (CAM)

a) Integration of CAM into the NHS
Public money for free CAM at the point of use has been trialled successfully in pilot schemes for 30 years under the banner of ‘integration of CAM into the NHS’. It was pioneered at the Marylebone clinic in London, (11) and some of the doctors working there (Dr David Petroni, and Dr David Peters) founded the British Holistic Medical Association in 1983, (12) which is still going strong. Under the name of ‘fundholding’ integration was funded under the Major government from about 1993-7, during which time many GP practices emulated Marylebone. The Blair government dropped the funding for integration, but many practices continued doing it, such as Glastonbury (13) because patients benefited.

The Prince of Wales set up the Foundation for Integrated Medicine in 1993, which changed its name a decade later to the Foundation for Integrated Health (14) They persuaded the House of Lords Select Committee under Lord Warner to write a report on CAM, published in 2000, which supported the integration of CAM provided that CAM therapists become state regulated and registered. Physiotherapy, osteopathy, and chiropractic are there already, and acupuncture and a dozen other CAM therapies are on the way to this (14).

A big trial of integration was done in Northern Ireland under the name GETWELL UK, (15) led by Boo Armstrong, in which more that 700 patients experience of integrated healthcare in many practices was thoroughly researched. It reported favourably in 2008.

b) NICE-approved CAM
A number of CAM therapies have received the gold standard of NICE approval (16) as follows:

i) Chiropractic, osteopathy and manipulative physiotherapy for lower back pain (LBP) which is said to be suffered by 40 % of the adult population.
ii) Mindfulness Based Cognitive Therapy for depression (2004) which is said to comprise one third of GP consultations.
iii) Hypnotherapy for Irritable Bowel Syndrome (IBS)
iv) Acupuncture and Alexander Technique (2009) for LBP

c) The NHS constitution becomes law
The NHS constitution was proposed by Lord Darzi in July 2008, and has been consulted on for a year. It became law on 20.1.10. The following is from the government press release (17) (my emphasis added):
‘All NHS organisations in England are legally obliged to take account of the rights and pledges set out in the NHS Constitution as from this week. The NHS Constitution, published in January 2009, resulted from Lord Darzi's review of the NHS, High Quality Care for All. It sets out patients' rights to NHS services and safeguards the NHS for the future.
Among other things, it gives patients the legal rights to: access NHS services; drugs and treatments approved by NICE; choice about where they receive their care; be treated with dignity and respect. There are also some specific pledges relating to health information:

• "You have the right to be given information about your proposed treatment in advance, including any significant risks and any alternative treatments which may be available, and the risks involved in doing nothing."
• "The NHS commits to offer you easily accessible, reliable and relevant information to enable you to participate fully in your own healthcare decisions and to support you in making choices. This will include information on the quality of clinical services where there is robust and accurate information available."

Health Secretary Andy Burnham said: "One year ago, the NHS Constitution came into being. This landmark document gives patients and staff real power to know what they can expect and what they can demand "“ demands that cannot go unchecked by the NHS from today.’

d) Health minister’s view of homeopathy
Homeopathy is one of the most controvertial CAM treatments because the active ingredient in some remedies is so diluted that there is not a single molecule of it left in the pill. Critics call it fraudulaent, but homeopaths claim that the succucion imprints the energetic memory of the ingredient into the water, so that they get the active ingredient without its side effects, which may be very toxic.

The House of Commons Science and Technology Committee heard evidence against homeopathy from Prof Edzard Ernst, Ben Goldacre and Tracey Brown. The health minister, Mike O'Brien MP made the following response: 'We take the view that it is not our job to stop clinicians prescribing these medications if they feel they are appropriate. NHS homeopathy is practised by trained doctors who have to take responsibility for what they do. Cutting the (NHS) funding would be illiberal, and a denial of personal choice. ’ He also said there were a range of opinions about homeopathy amongst clinicians and scientists which could not be ignored.

e) To whom may doctors refer patients?
Doctors are only allowed to refer patients to regulated therapists. (18) Most CAM therapists are regulated. For example, nutritional therapists are voluntarily regulated at present. Some would like more regulation via the Health Professions Council (HPC) but there is not a consensus on this. Until recently many nutritional therapists were registered voluntarily by the Nutritional Therapy Council. This has now been transferred to the CNHC (19)

5 The Boorman requirements to improve the health of NHS staff
These were accepted by the government in Nov 2009, and are now additional targets that the NHS have to meet. The following is an abbreviated list of them, which are aimed at saving 3.5 million days lost pa through staff sickness, by reducing the rate by 1% from about 5% at present (which is 50% worse than the national average of 3.3%)

1 Provide staff with health and wellbeing services centred on prevention.
2 Develop and implement strategies for improving the health and wellbeing of their workforce.
3 Implement the guidance from NICE on the promotion of mental health.
4 Put staff health at the heart of their work.
5 Training in health and wellbeing should be managed training and built into annual performance and personal development planning.
6 Managers have skills and tools to support staff with mental health problems.
7 Draw up a staff health and wellbeing strategy.
8 Provide access to early and effective interventions for common muscular-skeletal and mental health problems as these are the major cause of ill health among NHS staff.

As I have said in earlier papers, asking the NHS to prevent illness is like asking car mechanics who have been fixing crashed cars to prevent accidents. Neither car mechanics not NHS clinicians know how to do this, because they have not been trained in the science and art of doing it. Prevention of accidents (and illnesses) requires a totally different set of skills to fixing crashed cars (and crashed people) The Darzi / Boorman requirements of preventing patients and staff from falling ill can only be delivered by the NHS if it outsources prevention services to the experts in prevention who have been trained professionally and qualified to deliver them, namely CAM therapists.

6 What should a commissioning plan look like?
Commissioning means setting something or somebody working. When a power station is commissioned it is set delivering power into the grid. When an officer is commissioned into the armed services he is set to work to serve Her Majesty as commanded by his superior officers. In the same way a strategic commissioning plan should set out a costed shopping list of treatments that the commissioners commit to purchase from providers with public money for the next 5 years.

The purpose of that list is to inform the public what they can expect to get (and not get) in the way of treatment, and also to give providers enough notice to set themselves up to deliver those treatments.

The problem with the strategic commissioning plans that I have seen on the NHS website is that they are not that sort of list. They are a set of good intentions from which such a list could be drawn up, but they are not that list. Until such a list is published, providers cannot plan to deliver those treatments, so there is no way that the treatments could happen.

For example, I have called for the NICE-approved MBCT course to be provided en masse, by which I mean 1,500 courses pa in the city to meet the expected demand from 30,000 people pa at 20 people per course. If that treatment were officially listed in the plan, and priced at say £300 per person per course, potential providers of the MBCT could set themselves up with premises and course facilitators to deliver that service.

7 Conclusions – integrate CAM into the NHS
Patients pay for the NHS in their taxes, so should determine the treatments that are commissioned. They want treatments which are safe from harming them, and effective in preventing illnesses and curing them if they are ill. This means that the NHS commissioners now have no option but to integrate CAM into the NHS, since patients and NHS staff have been given legal rights to have preventative treatments, particularly NICE-approved ones, under the NHS constitution and the Darzi/Boorman requirements.

The evidence base for drugs cannot be trusted, as the drug companies who conducted the trials have been shown to have fudged the results. No drug is fully safe from harming patients, as all drugs have side effects which are potentially harmful. The new government requirement in the constitution (that clinicians have to inform patients about these harmful effects) will result in a better informed public who want safer and more effective alternatives to drugs. This requirement should be strengthened by a government health warning on the packaging of all drugs, (prescription and over the counter): ‘This drug may alleviate your symptoms but could seriously damage your health.’

Increasing numbers of staff and patients would choose the CAM vouchers rather than the drugs, so the strategic commissioning plans should include a rising demand for CAM vouchers and a falling demand for drugs. CAM is cheaper and more cost-effective than drugs, so the total cost of the NHS to the taxpayers will fall, as the government have said that it must.

Integration of CAM into the NHS can be implemented by adopting our proposal to make Brighton and Hove the first integrated healthcare city in the country. We have applied for a government grant of £150,000 to create a Social Enterprise Complementary Treatment (SECT) Company. This would print £50 CAM vouchers, and give them to NHS managers to give to healthcare staff, and GPs to give to patients. These vouchers would be tradable for CAM treatment of the holder’s choice at any of the 100 CAM centres in the city. The details of this scheme are given in the papers referred to in paragraph 2 Summary, above.

8 References
1 ’Prozac doesn’t work’ News bulletin Feb 2008
2 ‘Pfitzer fined $2.3 bn’ news bulletin Oct 2009.
3 ‘Thalidomide victims compensated £20 m by government’ News bulletin 14.1.10
4 TV programme ‘Dispatches’ 29.9.06, re Ryan Wilson losing fingers and toes.
5 ‘1,800 dementia patients killed each year by anti-psychotic drugs’ news bulletin 1.12.09
5 Book ‘Horrors of Vaccination’, by Charles M Higgins, 1920 republished by Google as a pdf file under ‘horros of vaccination exposed’.
6 Autism and vaccination . Why you should avoid taking vaccines
7 ‘Swine flu inquiry announced’ new bulletin 10.1.10
8 TV programme Nov 2000 ‘Why Doctors Make Mistakes’.
9 Report ‘Death by Medicine’ by Dr Gary Null et al, Death by Medicine
10 Marylebone Integrated Healthcare Clinic
11 British Holistic Medical Association British Holistic Medical Association
12 Glastonbury GP practice Glastonbury GP practice
13 Foundation for Integrated Health FIH
14 Foundation for Integrated Health Health Guidelines - Shining Lights
15 GETWELL UK study of integration Getwell Study
16 NICE guidelines NICE guidelines CG88
17 Government press release on NHS constitution becoming law Government release
18 British Medical Journal on referral to CAM therapists BMJ on CAM therapists
19 New regulatory bodies Regulatory bodies

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