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The much-delayed public consultation on the Pittilo report has just opened.

It is very important that as many people as possible respond to it.  It’s easy to say that the consultation is sham. It will be if it is left only to acupuncturists and Chinese medicine people to respond to it. Please write to them before the closing date, November 2nd 2009. The way to send your evidence is here.

There is a questionnaire that you can complete, with the usual leading questions.  Best do it anyway, but I’d suggest also sending written evidence as attachment too. I just got from DoH the email address where you can send it. They said

Here are three documents that I propose to submit in response to the consultation.I ‘d welcome criticisms that might make it more convincing. Use any parts of them you want in your own response.

• Submission to the Department of Health, for the consultation on the Pittilo report [download pdf].
• What is taught in degrees in herbal and traditional Chinese medicine? [download pdf]
• $2.5B Spent, No Alternative Med Cures [download pdf]

I’ve written quite a lot about the Pittilo report already, in particular A very bad report: gamma minus for the vice-chancellor, and in The Times (see also the blog version). Intriguingly, these posts are at number 2 in a Google search for “Michael Pittilo”.

Briefly, the back story is this.

It is now over a year since the Report to Ministers from “The Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK” [download the report].

The chair of the steering group was Professor R. Michael Pittilo, Principal and Vice-Chancellor of The Robert Gordon University, Aberdeen. The reason thet the report is so disastrously bad in its assessment of evidence is that it was written entirely by people with vested interests.

The committee consisted of five acupuncturists, five herbalists and five representatives of traditional Chinese medicine (plus eleven observers). There was not a single scientist or statistician to help in the assessment of evidence. And it shows: The assessment of the evidence in the report was execrable. Every one of the committee members would have found themselves out of work if they had come to any conclusion other than that their treatment works, Disgracefully, these interests were not declared in the report, though they are not hard to find. The university of which the chair is vice-chancellor runs a course in homeopathy, the most discredited of the popular forms of alternative medicine. That tells you all you need to know about the critical faculties of Michael Pittilo.

The two main recommendations of this Pittilo report are that

• Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine should be subject to statutory regulation by the Health Professions Council
• Entry to the register normally be through a Bachelor degree with Honours

Let’s consider the virtue of these two recommendations.

Regulation by the Health Professions Council (HPC) breaks their own rules

For a start, this should be ruled out by the HPC’s own rules, which require “Practise based on evidence of efficacy” as a condition for registration. Since there is practically no “evidence of efficacy”, it follows that the HPC can’t regulate acupuncture, herbal and Chinese medicine as Pittilo recommends. Or so you’d think. But the official mind seems to have an infinite capacity for doublespeak. The HPC published a report on 11 September 2008, Regulation of Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners.

The report says

1. Medical herbalists, acupuncturists and traditional Chinese medicine practitioners should be statutorily regulated in the public interest and for public safety reasons.

2. The Health Professions Council is appropriate as the regulator for these professions.

3. The accepted evidence of efficacy overall for these professions is limited, but regulation should proceed because it is in the public interest.

In other words, the HPC simply decided to ignore its own rules, Its excuse for doing so is that regulation would protect “public safety” . But it simply would not do that. It is ell known that some Chinese herbs are adulterated with dangerous substances, but laws against that already exist. Trading Standards are much more likely to take appropriate action than the HPC. The Medicines and Health Regulatory Authority (MHRA) already deals with the licensing of herbal medicines. and, despite the fact that it recently betrayed its trust by allowing them to be labelled in a misleading way, they are the people to do it, not the HPC.

The Pittilo report (page 11) says

In future, it is hoped that more Government funding can be allocated to research into traditional/herbal medicines and acupuncture and that grants will become available to encourage practitioners to undertake postgraduate research work.

So they are asking for more government money.

In March 2007, the Chinese Government pledged to spend over $130 million over the next five years on research into the effectiveness of traditional Chinese medicine. It is to be hoped that this money will be targeted effectively to evaluate TCM.

It seems to have escaped the notice of Pittilo that roughly 100 percent of trials of Chinese medicine done in China come out positive. Elsewhere, very few come out positive,(see Vickers et al., 1998, Controlled Clinical Trials, 19, 159-166: download reprint) The Department of Health would be unwise to rely on Chinese research. Remember that modern acupuncture was not so much a product of ancient wisdom, but rather it stems from nationalist propaganda by Mao Tse-Tung, who needed a cheap way to keep the peasants quiet, though he was too sensible to use it himself.

The HPC report (page 5) cites these with the words

” . . . a lack of evidence of efficacy should not prevent regulation but that the professions should be encouraged and funded to strengthen the evidence base.”

This sentence seems to assume that the outcomes of research will be to strengthen the evidence base. Thus far, precisely the opposite has been the case. The Pittilo group has apparently not noticed that the US National Institutes of Health has already spent a billion dollars on research in alternative medicine and failed to come up with a single effective treatment. There are better ways to spend money on health. See, for example $2.5B Spent, No Alternative Med Cures found. .An enornous amount of research has already been done and the outcomes have produced no good treatments,

The proposed regulation would endanger the public, not protect it.

The excuse given by the HPC for breaking its own rules is that it should do so to protect the public.

Likewise Ann Keen, Health Minister, said:

“Patient safety is paramount, whether people are accessing orthodox health service treatments or using alternative treatments”

So first we need to identify what dangers are posed by acupuncture, herbal medicine and traditional Chinese medicine.

• Acupuncture is fairly safe. Its biggest danger lies in the unjustified claims that are routinely made for what can be achieved by being impaled by needles. This poses a danger that people may use acupuncture in place of treatments that work
• Herbal medicines are unstandardised, so even the very few that may work are dangerous to patients because the dose of active principle is unknown and varies from one batch to another. Taking a herbal medicine is a bit like swallowing a random number of tablets, False health claims pose a danger to patients too, when they cause patients to avoid treatments that work.
• Traditional Chinese Medicine is probably the most dangerous. Like the other two, the medicines are unstandardised so the dose is never known. False health claims abound. And in addition to these dangers, many cases have been found of Chinese medicines being adulterated with poisonous substances or with conventional drugs.

The form of regulation proposed by Pittilo would do little or nothing to protect the public from any of these dangers.

The proposals accept the herbal and Chinese medicine as traditionally practised. Nothing would be done about one of the major dangers, the lack of standardisation. That is a problem that was solved by pharmacologists in the 1930s, when international standards were set for the biological activity of things like tincture of digitalis, and assays were devised so that different batches could be adjusted to the same potency. Now, 80 years later, it is being proposed by Pittilo that we should return to the standards of safety that existed at the beginning of the last century. That is a threat to public safety., but the proposed regulation would do nothing whatsoever to protect the public from this dangerous practice. On the contrary, it would give official government sanction to it.

The other major danger is that patients are deceived by false health claims. This is dangerous (as well as dishonest) because it can cause patients to avoid treatments that work better, The internet abounds with claims that herbs can cure anything from diabetes to cancer. Many are doubtless illegal, but regulators like the HPC have traditionally ignored such claims: they are left to Trading Standards, Advertising Standards and the Medicines and Health Regulatory Authority (MHRA) to deal with. The MHRA already also has responsibility for monitoring side effects. The HPC would not do this.

The analogy with chiropractic and the GCC

The foolishness of allowing statutory regulation for unproven treatments has recently been illustrated quite dramatically by the case of chiropractic. Chiropractors have had statutory regulation by the General Chiropractic Council, which was established by the Chiropractors Act of 1994. The British Chiropractic Association (BCA) recently decided to sue the science writer, Simon Singh, for defamation when he cast doubt on some of the claims made by chiropractors, in particular their claims to be able to cure colic and asthma in children. That led to close examination of the claims. In fact there is no reason to think that spinal manipulation works for asthma, or that it works for colic. In fact there is quite good evidence that the claims are false. The result was that about 600 well-justified complaints have been lodged with the GCC (enough to bankrupt the GCC if the complaints are dealt with properly).

The point of this story is that the statutory regulator had nothing whatsoever to prevent these false health claims being made. Two of the complaints concern practices run by the chair of the GCC. Worse, the GCC actually endorsed such claims. The statutory regulator saw its duty to defend chiropractic (apart from a handful of cases of sexual misdemeanours), not to protect the patient from false health claims. The respectability conferred by statutory regulation made false health claims easier and endangered the public. It would be a disaster if the same mistake were made again.

On 11th December 2008 I got a letter form the HPC which said

in our opinion a lack of evidence of efficacy would not impede our ability to set standards or deal with complaints we receive. The vast majority of cases we consider are related to conduct.

But perhaps that is because they haven’t tried “regulating” quacks before. Now that the public is far more conscious about health fraud than it used to be, one can predict confidently that the HPC would be similarly overwhelmed by a deluge of complaints about the unjustified health claims made by acupuncturists, herbal medicine and traditional Chinese medicine practitioners. There is no shortage of them to complain about.

The education problem

The Pittilo report recommends that the entry level for registration should be a bachelors degree with honours. At first sight it seems reasonable to ask that practitioners should be ‘properly qualified’, but when one looks at what is actually taught on these degrees it becomes clear that they endanger, rather than protect, the public,

There are two very big problems with this recommendation.

Firstly, you can’t have a bachelors degree with honours until after you have decided whether or not there is anything useful to teach. If and when any of the subjects under consideration and shown to work to a useful extent, then it would be quite reasonable to establish degrees in them. Even the report does not pretend seriously that that stage has been reached. The proposal to set up degrees in subjects, at least some of which are quite likely to have no more than placebo value, is self-evidently nonsense,

The time for degrees, and the time for government endorsement by statutory regulation, is after the therapies have been shown to work, not before.

The absurdity of thinking that the public will be protected because a practitioner has a degree in, say, acupuncture, is shown with startling clarity by a recently revealed examination paper in acupuncture’

You can download the entire exam paper. Here are a few highlights from it.

So students, in 2009, are being taught the crudest form of vitalism.

Teaching of traditional Chinese medicine is just as bad. Here are two slides from a course run by the University of Westminster.

The first ‘explains’ the mysterious and entirly mythical “Qi”.

So “Qi” means breath, air, vapour, gas, energy, vitalism. This is meaningless nonsense.

The second slide shows the real dangers posed by the way Chinese medicine is taught, The symptoms listed at the top could easily be a clue to serious illness, yat students are taught to treat them with ginger. Degrees like this endanger the public.

There are more mind-boggling slides from lectures on Chinese medicine and cancer: they show that what students are being taught is terrifyingly dangerous to patients.

It is entirely unacceptable that students are being taught these ancient myths as though they were true, and being encouraged to treat sick people on their basis.  The effect of the Pittilo recommendations would be to force new generations of students to have this sort of thing forced on them.  In fact the course for which this exam was set has already closed its doors.  That is the right thing to do.

Here’s another example. The course leader for “BSc (Hons) Herbal Medicine” at the Univsrsity of Central Lancashire is Graeme Tobyn BA. But Tobyn is not only a herbalist but also an astrologer. In an interview he said

“At the end I asked her if I could cast her horoscope. She threw up her hands and said, ‘I knew this would happen if I came to an alternative practitioner.”

“I think the ruler of the ascendant was applying to Uranus in the ninth house, which was very pertinent.”

This would be preposterous even in the life style section of a downmarket women’s magazine,  The Pittilo report wants to make degrees run my people like this compulsory. Luckily the Univerity of Central Lancashire is much more sensible and the course is being closed.

The matter is, in any case, being taken out of the hands of the government by the fact that universities are closing degrees in complementary medicine, including courses in some of those under discussion here, The University of Salford and the University of Central Lancashire have recently announced the closure of all the degree programmes in complementary and alternative medicine. The largest provider of such degrees, the University of Westminster has already shut down two of them, and the rest are being assessed at the moment. It is likely that the rest will be closed in the future.

The revelation that Westminster had been teaching its first year students that “amethysts emit high yin energy” and that students had been taught to diagnose disease and choose treatments by means of a dowsing pendulum, showed very clearly the sort of utter nonsense that undergraduates were being forced to learn to get a ‘bachelors degree with honours’. It stretches credulity to its limits to imagine that the public is protected by degrees like this. Precisely the opposite is true. The universities have recognised this, and shut the degrees. One exception is Professor Pittilo’s own university which continues to run a course in homeopathy, the most discredited of all the popular types alternative medicine.

A simpler, more effective and cheaper way to protect the public

I must certainly agree with the minister that protection of the public is an important matter. Having established that the Pittllo recommendations are more likely to endanger the public than protect them, it is essential to suggest alternative proposals that would work better.

Luckily, that is easy, because mechanisms already exist for dealing with the dangers that were listed above. The matter of adulteration, which is serious in traditional Chinese medicine, is a matter that is already the responsibility of the Office of Trading Standards. The major problem of false claims being made for treatment is also the responsibility of the Office of Trading Standards, which has a statutory duty to enforce the Unfair Trading Consumer Protection Regulations of May 2008. These laws state, for example, that

“One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction or malformations”

The monitoring of false claims, and of side effects of treatments, is also the responsibility of the Medicines and Health Regulatory Authority (MHRA).

Rather than setting up complicated, expensive and ineffective ‘regulation’ by the HPC, all that need to be done is to ensure that the MHRA and/or Trading Standards have the funds to enforce existing laws. At the moment, they are not being implemented effectively, so I’d recommend that responsibility for enforcing the law against false health claims be transferred entirely to the MHRA, which has much more expertise in such matters than Trading Standards This would be both cheaper and more effective than the present system in which the responsibility is divided between the two organisations in an unclear way.

This proposal would protect the public against unsafe and adulterated treatments, and it would protect the public against false and fraudulent claims. That is what matters. It would do so more effectively,
more cheaply and more honestly than the Pittilo recommendations. There would be no reduction in patient choice either, There is no proposal to ban acupuncture, herbal medicine or traditional Chinese medicine. All that is necessary is to ensure that they don’t endanger the public.

Since the root of the problem lies in the fact that the evidence for the effectiveness is very weak. the question of efficacy, and cost-benefit ratio, should be referred to NICE. This was recommended by the House of Lords Report (2000). It is recommended again by the Smallwood report (sponsored by the Prince of Wales Foundation). It is baffling that this has not been done already. It does not seem wise to spend large amounts of money on new research at the moment, in the light of the fact that the US National Institutes of Health has already spent over $1 billion on such research without finding a single useful treatment.

The results of all this research has been to show that hardly any alternative treatment are effective. That cannot be ignored.

Conclusion

Recent events show that the halcyon days for alternative medicine are over. When the Pittilo report first appeared, it was greeted with derision in the media. For example, in The Times Alice Miles wrote

“This week came the publication of the Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK. Otherwise known as twaddle.”

In the Independent, Dominic Lawson wrote

So now we will have degrees in quackery.

What, really, is the difference between acupuncture and psychic surgery?

People will no doubt continue to use it and that is their right and their responsibility. But if the government were to accept the recommendations of the Pittilo report it would be seen, quite rightly, as being anti-scientific and of posing a danger to the public.

Fortunately there is a better, and cheaper, way to protect the public.

Follow-up

Margaret McCartney’s blog in the Financial Times puts rhw view of a GP with her usual sense, humour and incisiveness.

“This report would, if implemented, create lots more nonsense exam papers funded by a lot more public money – and would produce practitioners without the absolutely crucial skill of how to assess evidence and reject or use it appropriately”

The Times has covered the story (with some interesting comments) Consultation on how to regulate complementary and alternative therapies

Times Higher Education UK-wide consultation on CAM regulation is launched Excellent response from Andy Lewis.

The Sun has by far the best coverage up to now, Jane Symons writes “Regulating quacks helps them prey on gullible patients“