Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Professional Standards Authority
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 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