Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Harry Cayton
The consistent failure of ‘regulators’ to do their job has been a constant theme on this blog. There is a synopsis of dozens of them at Regulation of alternative medicine: why it doesn’t work, and never can. And it isn’t only quackery where this happens. The ineptitude (and extravagance) of the Quality Assurance Agency (QAA) was revealed starkly when the University of Wales’ accreditation of external degrees was revealed (by me and by BBC TV Wales, not by the QAA) to be so bad that the University had to shut down.
Here is another example that you couldn’t make up.
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Yes, the Professional Standards Authority (PSA) has agreed to accredit that bad-joke pseudo-regulator, the Complementary & Natural Healthcare Council (CNHC, more commonly known as Ofquack)
Ofquack was created at the instigation of HRH the Prince of Wales, at public expense, as a means of protecting the delusional beliefs of quacks from criticism. I worked for them for a while, and know from the inside that their regulation is a bad joke.
When complaints were made about untrue claims made by ‘reflexologists’, the complaints were upheld but they didn’t even reach the Conduct and Competence committee, on the grounds that the reflexologists really believed the falsehoods that they’d been taught. Therefore, by the Humpty Dumpty logic of the CNHC, their fitness to practise was not affected by their untrue claims. You can read the account of this bizarre incident by the person who submitted the complaints, Simon Perry.
In fact in the whole history of the CNHC, it has received a large number of complaints, but only one has ever been considered by their Conduct and Competence Committee. The rest have been dismissed before they were considered properly. That alone makes their claim to be a regulator seem ridiculous.
The CNHC did tell its registrants to stop making unjustified claims, but it has been utterly ineffective in enforcing that ruling. In May 2013, another 100 complaints were submitted and no doubt they will be brushed aside too: see Endemic problems with CNHC registrants..
As I said at the time
It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.
If the CNHC implements properly its own code of conduct, few people will sign up and the CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.
In February of this year (2013), I visited the PSA with colleagues from the Nightingale Collaboration. We were received cordially enough, but they seemed to be bureaucrats with no real understanding of science. We tried to explain to them the fundamental dilemma of the regulation of quacks, namely that no amount of training will help when the training teaches things that aren’t true. They were made aware of all of the problems described above. But despite that, they ended up endorsing the CNHC.
How on earth did the PSA manage to approve an obviously ineffective ‘regulator’?
The job of the PSA is said to be “. . . protecting users of health and social care services and the public”. They (or at least their predecessor, the CHRE), certainly didn’t do that during the saga of the General Chiropractic Council.
The betrayal of reason is catalogued in a PSA document [get local copy]. Here is some nerdy detail.
It is too tedious to go through the whole document, so I’ll deal with only two of its many obvious flaws, the sections that deal with the evidence base, and with training.
The criteria for accreditation state
Standard 6: the organisation demonstrates that there is a defined knowledge base underpinning the health and social care occupations covered by its register or, alternatively, how it is actively developing one. The organisation makes the defined knowledge base or its development explicit to the public.
The Professional Standards Authority recognises that not all disciplines are underpinned by evidence of proven therapeutic value. Some disciplines are subject to controlled randomized trials, others are based on qualitative evidence. Some rely on anecdotes. Nevertheless, these disciplines are legal and the public choose to use them. The Authority requires organisations to make the knowledge base/its development clear to the public so that they may make informed decisions.
Since all 15 occupations that are “regulated” by the CNHC fall into the last category. they “rely on anecdotes”, you would imagine the fact that “The Authority requires organisations to make the knowledge base/its development clear to the public” would mean that the CNHC was required to make a clear statement that reiki, reflexology etc are based solely on anecdote. Of course the CNHC does no such thing. For example, the CNHC’s official definition of reflexology says
Reflexology is a complementary therapy based on the belief that there are reflex areas in the feet and hands which are believed to correspond to all organs and parts of the body
There is, of course, not the slightest reason to think such connections exist, but the CNHC gives no hint whatsoever of that inconvenient fact. The word “anecdote” is used by the PSA but occurs nowhere on the CNHC’s web site.
It is very clear that the CNHC fails standard 6.
But the PSA managed to summon up the following weasel words to get around this glaring failure:
“The professional associations (that verify eligibility for CNHC registration) were actively involved in defining the knowledge base for each of the 15 professions. The Panel further noted that Skills for Health has lead responsibility for writing and reviewing the National Occupational Standards (NOS) for the occupations CNHC registers and that all NOS have to meet the quality criteria set by the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors. The Panel considered evidence provided and noted that the applicant demonstrated that there is a defined knowledge base underpinning the occupations covered by its registers. The knowledge base was explicit to the public”.
The PSA, rather than engaging their own brains, simply defer to two other joke organisations, Skills for Health and National Occupational Standards. But it is quite obvious that for things like reiki, reflexology and craniosacral therapy, the “knowledge base” consists entirely of made-up nonsense. Any fool can see that (but not, it seems, the PSA).
Skills for Health lists made-up, HR style, “competencies” for everything under the sun. When I got them to admit that their efforts on distance-healing etc had been drafted by the Prince of Wales’ Foundation, the conversation with Skills for Health became surreal (recorded in January 2008)
DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps?
“You’d have to talk to LANTRA, the land-based organisation for that.”
DC. I’m sorry, I have to talk to whom?
“LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.”
DC. We are talking about medicine aren’t we? Not horticulture.
“You just gave me an example of talking to trees, that’s outside our remit ”
You couldn’t make it up, but it’s true. And the Professional Standards Authority rely on what these jokers say.
The current Skills for Health entry for reflexology says
“Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.”
This is crass, made-up nonsense. Of course there are no connections between “areas in the feet and hands that relate to corresponding parts of the body” and no reason to think that reflexology is anything more than foot massage. That a very expensive body, paid for by you and me, can propagate such preposterous nonsense is worrying. That the PSA should rely on them is even more worrying.
National Occupational Standards is yet another organisation that is utterly dimwitted about medical matters, but if you look up reflexology you are simply referred to Skills for Health, as above.
UK Commission for Employment and Skills
(UKCES) is a new one on me. The PSA says that “the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors” It is only too obvious that the UKCES leadership team have failed utterly to do their job when it comes to made-up medicine. None of them know much about medicine. It’s true that their chairman did once work for SmithKline Beecham, but as a marketer of Lucozade, a job which anyone with much knowledge of science would not find comfortable..
You don’t need to know much medicine to spot junk. I see no excuse for their failure.
The training problem.
The PSA’s criteria for accreditation say
Standard 9: education and training
The organisation:
9a) Sets appropriate educational standards that enable its registrants to practise competently the occupation(s) covered by its register. In setting its standards the organisation takes account of the following factors:
- The nature and extent of risk to service users and the public
- The nature and extent of knowledge, skill and experience required to provide
service users and the public with good quality careand later
9b) Ensures that registrants who assess the health needs of service users and provide any form of care and treatment are equipped to:
- Recognise and interpret clinical signs of impairment
- Recognise where a presenting problem may mask underlying pathologies
- Have sufficient knowledge of human disease and social determinants of health to identify where service users may require referral to another health or social care professional.
Anyone who imagines for a moment that a reflexologist or a craniosacral therapist is competent to diagnose a subarachnoid haemorrhage or malaria must need their head examining. In any case, the CNHC has already admitted that their registrants are taught things that aren’t true, so more training presumably means more inculcation of myths.
So how does the PSA wriggle out of this? Their response started
“The Panel noted that practitioners must meet, as a minimum, the National Occupational Standards for safe and competent practice. This is verified by the professional associations, who have in turn provided written undertakings to CNHC affirming that there are processes in place to verify the training and skills outcomes of their members to the NOS”
Just two problems there. The NOS standards themselves are utterly delusional. And checking them is left to the quacks themselves. To be fair, the PSA weren’t quite happy with this, but after an exchange of letters, minor changes enabled the boxes to be ticked and the PSA said “The Panel was now satisfied from the evidence provided, that this Standard had been
met”.
What’s wrong with regulators?
This saga is typical of many other cases of regulators doing more harm than good. Regulators are sometimes quacks themselves, in which case one isn’t surprised at their failure to regulate.
But organisations like the Professional Standards Authority and Skills for Health are not (mostly) quacks themselves. So how do they end up giving credence to nonsense? I find that very hard to comprehend, but here are a few ideas.
(1) They have little scientific education and are not really capable of critical thought
(2) Perhaps even more important, they lack all curiosity. It isn’t very hard to dig under the carapace of quack organisations, but rather than finding out for themselves, the bureaucrats of the PSA are satisfied by reassuring letters that allow them to tick their boxes and get home.
(3) A third intriguing possibility is that people like the PSA yield to political pressure. The Department of Health is deeply unscientific and clearly has no idea what to do about alternative medicine. They have still done nothing at all about herbal medicine, traditional Chinese medicine or homeopathy, after many years of wavering. My guess is that they see the CNHC as an organisation that gives the appearance that they’ve done something about reiki etc. I wonder whether they applied pressure to the PSA to accredit CNHC, despite it clearly breaking their own rules. I have sent a request under the Freedom of Information Act in an attempt to discover if the Department of Health has misbehaved in the way it did when it attempted to override NHS Choices.
The responsibility for this cock-up has to rest squarely on the shoulders of the PSA’s director, Harry Cayton. He was director of the CHRE from which PSA evolved and is the person who so signally failed to do anything about the General Chiropractic Council fiasco,
What can be done?
This is just the latest of many examples of regulators who not only fail to help but actually do harm by giving their stamp of approval to mickey mouse organisations like the CNHC. Most of the worst quangos survived the “bonfire of the quangos”.. The bonfire should have started with the PSA, CNHC and Skills for Health. They cost a lot and do harm.
There is a much simpler answer. There is a good legal case that much of alternative medicine is illegal. All one has to do is to enforce the existing law. Nobody would object to quacks if they stopped making false claims (though whether they could stay in business if they stopped exaggerating is debatable). There is only one organisation that has done a good job when it comes to truthfulness. That is the Advertising Standards Authority. But the ASA can do nothing apart from telling people to change the wording of their advertisements, and even that is often ignored.
The responsibility for enforcing the Consumer Protection Law is Trading Standards. They have consistently failed to do their job (see Medico-Legal Journal, Rose et al., 2012. “Spurious Claims for Health-care Products“.
If they did their job of prosecuting people who defraud the public with false claims, the problem would be solved.
But they don’t, and it isn’t.
Follow-up
The indefatigable Quackometer has wriiten an excellent account of the PSA fiasco
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.”