Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Harry Cayton
It makes a nice change to be able to compliment an official government report.
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Ever since the House of Lords report in 2000, the government has been vacillating about what should be done about herbalists. At the moment both western herbalists and traditional Chinese medicine (TCM) are essentially unregulated. Many (but not all) herbalists have been pushing for statutory regulation, which they see as government endorsement. It would give them a status like the General Medical Council. |
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A new report has ruled out this possibility, for very good reasons [download local copy].
Back story (abridged!)
My involvement began with the publication in 2008 of a report on the Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine . That led to my post, A very bad report: gamma minus for the vice-chancellor. The report was chaired by the late Professor Michael Pittilo BSc PhD CBiol FIBiol FIBMS FRSH FLS FRSA, Principal and Vice-Chancellor of The Robert Gordon University, Aberdeen. The membership of the group consisted entirely of quacks and the vice -chancellor’s university ran a course in homeopathy (now closed).
The Pittilo report recommended statutory regulation and "The threshold entry route to the register will normally be through a Bachelor degree with Honours". It ignored entirely the little problem that you can’t run a BSc degree in a subject that’s almost entirely devoid of evidence. It said, for example that acupuncturists must understand " yin/yang, 5 elements/phases, eight principles, cyclical rhythms, qi ,blood and body fluids". But of course there is nothing to "understand"! They are all pre-scientific myths. This “training dilemma” was pointed out in one of my earliest posts, You’d think it was obvious, but nonetheless the then Labour government seemed to take this absurd report seriously.
In 2009 a consultation was held on the Pittilo report. I and many of my friends spent a lot of time pointing out the obvious. Eventually the problem was again kicked into the long grass.
The THR scheme
Meanwhile European regulations caused the creation of the Traditional Herbal Registration (THR) scheme. It’s run by the Medicines and Healthcare products Regulatory Authority (MHRA). This makes it legal to put totally misleading claims on labels of herbal concoctions, as long as they are registered with THR, They also get an impressive-looking certification mark. All that’s needed to get THR registration is that the ‘medicines’ are not obviously toxic and they have been in use for 30 years. There is no need to supply any information whatsoever about whether they work or not. This appears to contradict directly the MHRA’s brief:
"”We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."
After much effort, I elicited an admission from the MHRA that there was no reason to think that any herbal concoctions were effective, and that there was nothing to prevent them from adding a statement to say so on the label. They just chose not to do so. That’s totally irresponsible in my opinion. See Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. Over 300 herbal products have been registered under the THR scheme (a small percentage of the number of products being used). So far only one product of Tibetan medicine and one traditional Chinese medicine have been registered under THR. These are the only ones that can be sold legally now, because no herbs whatsoever have achieved full marketing authorisation -that requires good evidence of efficacy and that doesn’t exist for any herb.
The current report
Eventually, in early 2014, the Tory-led government set up yet another body, "Herbal Medicines and Practitioners Working Group " (HMPWG). My heart sank when I saw its membership (Annex A.2). The vice-chair was none other that the notorious David Tredinnick MP (Con, Bosworth). It was stuffed with people who had vested interests. I wrote to the chair and to the few members with scientific credentials to put my views to them.
But my fears were unfounded, because the report of the HMPWG was not written by the group, but by its chair only. David Walker is deputy chief medical officer and he had clearly listened. Here are some quotations.
The good thing about the European laws is that
"This legislation effectively banned the importation and sale of large-scale manufactured herbal medicine products. This step severely limited the scope of some herbal practitioners to continue practising, particularly those from the Traditional Chinese Medicine (TCM) and Ayurvedic traditions."
The biggest loophole is that
"At present under UK law it is permitted for a herbal practitioner to see individual patients, offer diagnoses and prepare herbal treatments on their own premises, as long as these preparations do not contain banned or restricted substances. This is unchanged by the Traditional Herbal Medicinal Products Directive. "
Walker recognised frankly that there is essentially no good evidence that any herb, western or Chinese, works well enough to make an acceptable treatment. And importantly he, unlike Pittilo, realised that this precludes statutory regulation.
"There are a small number of studies indicating benefit from herbal medicine in a limited range of conditions but the majority of herbal medicine practice is not supported by good quality evidence. A great deal of international, primary research is of poor quality. "
"ts. Herbal medicine practice is therefore currently based upon traditional practice rather than science. It is difficult to differentiate good practice from poor practice on the basis of this evidence in a way that could establish standards for statutory regulation"
The second problem was the harms done by herbs. Herbalists, western and Chinese, have no satisfactory way of reporting side effects
" . . . there is very limited understanding of the risks to patient safety from herbal medicines and herbal practice. A review of safety data was commissioned from HMAC as part of this review. This review identified many anecdotal reports and case studies but little systematically collected data. Most herbal medicine products have not been through the rigorous licensing process that is required of conventional pharmaceutical products to establish their safety and efficacy. Indeed, only a small proportion have even been subject to the less rigorous Traditional Herbal Registration (THR) process. "
"The anecdotal evidence of risk to patients from herbal products in the safety review highlighted the prominence of manufactured herbal medicines in the high profile serious incidents which have been reported in recent years. Many of these reports relate to harm thought to be caused by industrially manufactured herbal products which contained either dangerous herbs, the wrong constituents, toxic contaminants or adulterants. All such industrially manufactured products are now only available under European regulations if their safety is assured through MHRA licensing or THR
accreditation; and specific dangerous herbs have been banned under UK law. This has weakened the case for introduction of statutory regulation as a further safety measure. "
Then Walker identified correctly the training dilemma. Although it seems obvious, this is a big advance for a government document. Degrees that teach nonsense are not good training: they are miseducation.
"The third issue is the identification of educational standards for training practitioners and the benchmarking of standards for accrediting practitioners. With no good data on efficacy or safety, it is difficult for practitioners and patients to understand or quantify the potential benefits and risks of a proposed therapeutic intervention. Training programmes could accredit knowledge and skills in some areas including pharmacology and physiology, professional ethics and infection control but without a credible evidence base relating to the safety and effectiveness of herbal medicine it is hard to see how they could form the basis of accreditation in this field of practice.
There are a number of educational university programmes offering courses in herbal medicine although the number has declined in recent years. Some of these courses are accredited by practitioner organisations which is a potential governance risk as the accreditation may be based on benchmarks established by tradition and custom rather than science.
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"The herbal medicine sector is in a dilemma" is Walker’s conclusion.
"Some practitioners would like to continue to practise as
they do now, with no further regulation, and accept that their practice is based on tradition and personal experience rather than empirical science. The logical consequence of adopting this form of practice is that we should take a precautionary approach in order to ensure public safety. The public should be protected through consumer legislation to prevent false claims, restricting the use of herbal products which are known to be hazardous to health"
The problem with this is, if course, is that although there is plenty of law, it’s rarely enforced : see Most alternative medicine is illegal Trading Standards very rarely enforce the Consumer Protection Regulations (2008) but Walker is too diplomatic to mention that fact.
"The herbals sector must recognise that its overall approach (including the rationale for use of products and methods of treatment, education and training, and interaction with the NHS) needs to be more science and evidence based if in order to be established as a profession on the same basis as other groups that are statutorily regulated."
So what happens next?
In the short term nothing will happen.
The main mistake has been avoided: there wil be no statutory regulation.
The other options are (a) do nothing, or (b) go for accreditation of a voluntary register (AR) by the Professional Standards Authority for Health and Social Care (PSA). Walker ends up recommending the latter, but only after a lot more work (see pages 28-29 of report). Of particular interest is recommendation 5.
"As a first step it would be helpful for the sector organisations to develop an umbrella voluntary register that could support the development of standards and begin to collaborate on the collection of safety data and the establishment of an academic infrastructure to develop training and research. This voluntary register could in due course seek accreditation from the Professional Standards Authority for Health and Social Care (PSA)."
So it looks as though nothing will happen for a long time, and herbalists and TCM may end up with the utterly ineffectual PSA. After all, the PSA have accredited voluntary registers of homeopaths, so clearly nothing is too delusional for them. It’s very obvious that, unlike Walker, the PSA are quite happy to ignore the training dilemma.
Omissions from the report
Good though this report is, by Department of Health standards, it omits some important points.
Endangered species and animal cruelty aren’t mentioned in the report. Traditional Chinese medicine, and its variants, are responsible for the near-extinction of rhinoceros, tiger and other species because of the superstitious belief that they have medicinal value. It’s not uncommon to find animal parts in Chinese medicines sold in the UK despite it being illegal
And the unspeakably cruel practice of farming bears to collect bile is a direct consequence of TCM.
A bile bear in a “crush cage” on Huizhou Farm, China (Wikipedia)
Statutory regulation of Chiropractors
The same arguments used in Walker’s report to deny statutory regulation of herbalism, would undoubtedly lead to denial of statutory regulation of chiropractors. The General Chiropractic Council was established in 1994, and has a status that’s the same as the General Medical Council. That was a bad mistake. The GCC has not protected the public, in fact it has acted as an advertising agency for chiropractic quackery.
Perhaps Prof. Walker should be asked to review the matter.
Follow-up
You can also read minutes of the HMPWG meetings (and here). But, as usual, all the interesting controversies have been sanitised.
Edzard Ernst has also commented on this topic: Once again: the regulation of nonsense will generate nonsense – the case of UK herbalists.
The King’s Fund recently published Assessing complementary practice Building consensus on appropriate research methods [or download pdf].
It is described as being the “Report of an independent advisory group”. I guess everyone knows by now that an “expert report” can be produced to back any view whatsoever simply by choosing the right “experts”, so the first things one does is to see who wrote it. Here they are.
- Chair: Professor Dame Carol Black
- Harry Cayton, Chief Executive, Council for Healthcare Regulatory Excellence
- Professor Adrian Eddleston, then Vice-Chairman, The King’s Fund
- Professor George Lewith, Professor of Health Research, Complementary and Integrated Medicine Research Unit, University of Southampton
- Professor Stephen Holgate, MRC Clinical Professor of Immunopharmacology, University of Southampton
- Professor Richard Lilford, Head of School of Health and Population Sciences, University of Birmingham
We see at once two of the best known apologists for alternative medicine, George Lewith (who has appeared here more than once) and Stephen Holgate.
Harry Cayton is CEO of Council for Healthcare Regulatory Excellence (CHRE) which must be one of the most useless box-ticking quangos in existence. It was the CHRE that praised the General Chiropractic Council (GCC) for the quality of its work. That is the same GCC that is at present trying to cope with 600 or so complaints about the people it is supposed to regulate (not to mention a vast number of complaints to Trading Standards Offices). The GCC must be the prime example of the folly of giving government endorsement to things that don’t work. But the CHRE were not smart enough to spot that little problem. No doubt Mr Cayton did good work for the Alzheimer’s Society. His advocacy of patient’s choice may have helped me personally. But it isn’t obvious to me that he is the least qualified to express an opinion on research methods in anything whatsoever. According to the Guardian he is “BA in English and linguistics from the University of Ulster; diploma in anthropology from the University of Durham; B Phil in philosophy of education from the University of Newcastle.”
Adrian Eddlestone is a retired Professor of Medicine. He has been in academic administration since 1983. His sympathy for alternative medicine is demonstrated by the fact that he is also Chair of the General Osteopathic Council, yet another “regulator” that has done nothing to protect the public
from false health claims (and which may, soon, find itself in the same sort of trouble as the GCC).
Richard Lilford is the only member of the group who has no bias towards alternative medicine and also the only member with expertise in clinical research methods His credentials look impressive, and his publications show how he is the ideal person for this job. I rather liked also his article Stop meddling and let us get on.. He has written about the harm done by postmodernism and relativism, the fellow-travellers of alternative medicine.
Most damning of all, Lewith, Eddlestone and Holgate (along with Cyril Chantler, chair of the King’s Fund, and homeopaths, spiritual healers and Karol Sikora) are Foundation Fellows of the Prince of Wales Foundation for Magic Medicine, an organisation that is at the forefront of spreading medical misinformation.
I shall refer here to ‘alternative medicine’ rather than ‘complementary medicine’ which is used in the report. It is not right to refer to a treatment as ‘complementary’ until such time as it has been shown to work. The term ‘complementary’ is a euphemism that, like ‘integrative’, is standard among alternative medicine advocates whose greatest wish is to gain respectability.
The Report
The recommendations
On page 10 we find a summary of the conclusions.
The report identifies five areas of consensus, which together set a framework for moving forward. These are:
- the primary importance of controlled trials to assess clinical and cost effectiveness.
- the importance of understanding how an intervention works
- the value of placebo or non-specific effects
- the need for investment and collaboration in creating a sound evidence base
- the potential for whole-system evaluation to guide decision-making and subsequent research.
The first recommendation is just great. The rest sound to me like the usual excuses for incorporating ineffective treatments into medical practice. Notice the implicit assumption in the fourth point
that spending money on research will establish “a sound evidence base". There is a precedent, but it is ignored. A huge omission from the report is that it fails to mention anywhere that a lot of research has already been done.
Much research has already been done (and failed)
The report fails to mention at all the single most important fact in this area. The US National Institutes of Health has spent over a billion dollars on research on alternative medicines, over a period
of more than 10 years. It has failed to come up with any effective treatments whatsoever. See, for example Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded; Should there be more alternative research?; Integrative baloney @ Yale, and most recently, $2.5B Spent, No Alternative Med Cures found. .
Why did the committee think this irrelevant? I can’t imagine. You guess.
The report says
“This report outlines areas of potential consensus to guide research funders, researchers, commissioners and complementary practitioners in developing and applying a robust evidence base for complementary practice.”
As happens so often, there is implicit in this sentence the assumption that if you spend enough money evidence will emerge. That is precisely contrary to the experence in the USA where spending a billion dollars produced nothing beyond showing that a lot of things we already thought didn’t work were indeed ineffective.
And inevitably, and tragically, NICE’s biggest mistake is invoked.
“It is noteworthy that the evidence is now sufficiently robust for NICE to include acupuncture as a treatment for low back pain.” [p ]
Did the advisory group not read the evidence used (and misinterpeted) by NICE? It seems not. Did the advisory group not read the outcome of NIH-funded studies on acupuncture as summarised by Barker Bausell in his book, Snake Oil Science? Apparently not. It’s hard to know because the report has no references.
George Lewith is quoted [p. 15] as saying “to starve the system of more knowledge means we will continue to make bad decisions”. No doubt he’d like more money for research, but if a billion dollars
in the USA gets no useful result, is Lewith really likely to do better?
The usual weasel words of the alternative medicine industry are there in abundance
“First, complementary practice often encompasses an intervention (physical treatment or manipulation) as well as the context for that intervention. Context in this setting means both the physical setting for the delivery of care and the therapeutic relationship between practitioner and patient.” [p. 12]
Yes, but ALL medicine involves the context of the treatment. This is no different whether the medicine is alternative or real. The context (or placebo) effect comes as an extra bonus with any sort of treatment.
“We need to acknowledge that much of complementary practice seeks to integrate the positive aspects of placebo and that it needs to be viewed as an integral part of the treatment rather than an aspect that should be isolated and discounted.” [p. 13]
This is interesting. It comes very close (here and elsewhere) to admitting that all you get is a placebo effect, and that this doesn’t matter. This contradicts directly the first recommendation of the House of Lords report (2000).. Both the House of Lords report on Complementary and Alternative Medicine, and the Government’s response to it, state clearly
“. . . we recommend that three important questions should be addressed in the following order”. (1) does the treatment offer therapeutic benefits greater than placebo? (2) is the treatment safe? (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?.
The crunch comes when the report gets to what we should pay for.
“Should we be prepared to pay for the so-called placebo effect?
The view of the advisory group is that it is appropriate to pay for true placebo (rather than regression to the mean or temporal effects).” [p 24]
Perhaps so, but there is very little discussion of the emormous ethical questions:that this opinion raises:
- How much is one allowed to lie to patients in order to elicit a placebo effect?
- Is is OK if the practitioner believes it is a placebo but gives it anyway?
- Is it OK if the pratitioner believes that it is not a placebo when actually it is?
- Is it OK for practitioners to go degrees taught by people who believe that it is not a placebo when actually it is?
The report fails to face frankly these dilemmas. The present rather absurd position in which it is considered unethical for a medical practitioner to give a patient a bottle of pink water, but
perfectly acceptable to refer them to a homeopath. There is no sign either of taking into account the cultural poison that is spread by telling people about yin, yang and meridians and such like preposterous made-up mumbo jumbo. That is part of the cost of endorsing placebos. And just when one thought that believing things because you wished they were true was going out of fashion
Once again we hear a lot about the alleged difficulties posed by research on alternative medicine. These alleged difficulties are, in my view, mostly no more than excuses. There isn’t the slightest
difficulty in testing things like herbal medicine or homeopathy, in a way that preserves all the ‘context’ and the ways of working of homeopaths and herbalists. Anyone who reads the Guardian knows
how to do that.
In the case of acupuncture, great ingenuity has gone into divising controls. The sham and the ‘real’ acupuncture always come out the same. In a non-blind comparison between acupuncture and no acupuncture the latter usually does a bit worse, but the effects are small and transient and entirely compatible with the view that it is a theatrical placebo.
Despite these shortcomings, some of the conclusions [p. 22] are reasonable.
“The public needs more robust evidence to make informed decisions about the use of complementary practice.
Commissioners of public health care need more robust evidence on which to base decisions about expenditure of public money on complementary practice.”
What the report fails to do is to follow this with the obvious conclusion that such evidence is largely missing and that until such time as it is forthcoming there should be no question of the NHS paying for alternative treatments.
Neither should there be any question of giving them official government recognition in the form of ‘statutory regulation’. The folly of doing that is illustrated graphically by the case of chiropractic which is now in deep crisis after inspection of its claims in the wake of the Simon Singh defamation case. Osteopathy will, I expect, suffer the same fate soon.
In the summary on p.12 we see a classical case of the tension
Controlled trials of effectiveness and cost-effectiveness are of primary importance
We recognise that it is the assessment of effectiveness that is of primary importance in reaching a judgement of different practices. Producing robust evidence that something works in practice – that it is effective – should not be held up by the inevitably partial findings and challenged interpretations arising from inquiries into how the intervention works.
The headline sounds impeccable, but directly below it we see a clear statement that we should use treatments before we know whether they work. “Effectiveness”, in the jargon of the alternative medicine business, simply means that uncontrolled trials are good enough. The bit about “how it works” is another very common red herring raised by alternative medicine people. Anyone who knows anything about pharmacology that knowledge about how any drug works is incomplete and often turns out to be wrong. That doesn’t matter a damn if it performs well in good double-blind randomised controlled trials.
One gets the impression that the whole thing would have been a lot worse without the dose of reality injected by Richard Lilford. He is quoted as a saying
“All the problems that you find in complementary medicine you will encounter in some other kind of treatment … when we stop and think about it… how different is it to any branch of health care – the answer to emerge from our debates is that it may only be a matter of degree.” [p. 17]
I take that to mean that alternative medicine poses problems that are no different from other sorts of treatment. They should be subjected to exactly the same criteria. If they fail (as is usually the case) they should be rejected. That is exactly right. The report was intended to produce consensus, but throughout the report, there is a scarcely hidden tension between believers on one side, and Richard Lilford’s impeccable logic on the other.
Who are the King’s Fund?
The King’s Fund is an organisation that states its aims thus.
“The King’s Fund creates and develops ideas that help shape policy, transform services and bring about behaviour change which improve health care.”
It bills this report on its home page as “New research methods needed to build evidence for the effectiveness of popular complementary therapies”. But in fact the report doesn’t really recommend ‘new research methods’ at all, just that the treatments pass the same tests as any other treatment. And note the term ‘build evidence’. It carries the suggestion that the evidence will be positive. Experience in the USA (and to a smaller extent in the UK) suggests that every time some good research is done, the effect is not to ‘build evidence’ but for the evidence to crumble further
If the advice is followed, and the results are largely negative, as has already happened in the USA, the Department of Health would look pretty silly if it had insisted on degrees and on statutory regulation.
The King’s Fund chairman is Sir Cyril Chantler and its Chief Executive is Niall Dickson. It produces reports, some of which are better than this one. I know it’s hard to take seriously an organisation that wants to “share its vision” withyou, but they are trying.
“The King’s Fund was formed in 1897 as an initiative of the then Prince of Wales to allow for the collection and distribution of funds in support of the hospitals of London. Its initial purpose was to raise money for London’s voluntary hospitals,”
It seems to me that the King’s Fund is far too much too influenced by the present Prince of Wales. He is, no doubt, well-meaning but he has become a major source of medical misinformation and his influence in the Department of Health is deeply unconstitutional. I was really surprised to see thet Cyril Chantler spoke at the 2009 conference of the Prince of Wales Foundation for Integrated Health, despite having a preview of the sort of make-believe being propagated by other speakers. His talk there struck me as evading all the essential points. Warm, woolly but in the end, a danger to patients. Not only did he uncritically fall for the spin on the word “integrated”, but he also fell for the idea that “statutory regulation” will safeguard patients.
Revelation of what is actually taught on degrees in these subjects shows very clearly that they endanger the public.
But the official mind doesn’t seem ever to look that far. It is happy ticking boxes and writing vacuous managerialese. It lacks curiosity.
Follow-up
The British Medical Journal published today an editorial which also recommends rebranding of ‘pragmatic’ trials. No surprise there, because the editorial is written by Hugh MacPherson, senior research fellow, David Peters, professor of integrated healthcare and Catherine Zollman, general practitioner. I find it a liitle odd that the BMJ says “Competing Interests: none. David Peters interest is obvious from his job description. It is less obvious that Hugh MacPherson is an acupuncture enthusiast who publishes mostly in alternative medicine journals. He has written a book with the extraordinary title “Acupuncture Research, Strategies for Establishing an Evidence Base”. The title seems to assume that the evidence base will materialise eventually despite a great deal of work that suggests it won’t. Catherine Zollman is a GP who is into homeopathy as well as acupuncture. All three authors were speakers at the Prince of Wales conference, described at Prince of Wales Foundation for magic medicine: spin on the meaning of ‘integrated’.
The comments that follow the editorial start with an excellent contribution from James Matthew May. His distinction between ‘caring’ and ‘curing’ clarifies beautifully the muddled thinking of the editorial.
Then a comment from DC, If your treatments can’t pass the test, the test must be wrong. It concludes
“At some point a stop has to be put to this continual special pleading. The financial crisis (caused by a quite different group of people who were equally prone to wishful thinking) seems quite a good time to start.”