NICE fiasco, part 2. Rawlins should withdraw guidance and start again

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Two days ago I wrote NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself

Now the official ‘guidance’ is out, and it is indeed quite as bad as the draft.

The relevant bits now read thus.

• Offer one of the following treatment options, taking into account patient preference: an exercise programme, a course of manual therapy or a course of acupuncture. Consider offering another of these options if the chosen treatment does not result in satisfactory improvement.
• Consider offering a structured exercise programme tailored to the person:
• This should comprise of up to a maximum of 8 sessions over a period of up to 12 weeks.
• Offer a group supervised exercise programme, in a group of up to 10 people.
• A one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person.
• Consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks
• Consider offering a course of acupuncture needling comprising up to a maximum of 10 sessions over a period of up to 12 weeks.

The summary guidance still doesn’t mention chiropractic explicitly, just a coy reference to “spinal manipulation”. At a time when the British Chiropractic Association is busy trying to suppress free speech via the law courts, I guess it isn’t surprising that they don’t like to use the word.

The bias in the recommendations is perhaps not surprising because the guidance development group had a heavy representation from alternative medicine advocates, and of people with a record of what, is, in my view, excessive tolerance of mumbo-jumbo.

Royal College of General Practitioners (RCGP) played a large part in writing the guidance. That is an organisation thar has steadfastly refused to make any sort of sensible statement of policy about magic medicine.   It isn’t long since I was told by a senior person at the RCGP that there was nothing odd about neuro-linguistic programming. That does not bode well.

Professor Martin Underwood, Professor of Primary Care Research Warwick Medical School, University of Warwick. Underwood chaired the guidance development group. Martin Underwood is also a GP in Coventry See also the British Osteopathic Association. Underwood was lead author of the BEAM trial (download reprint). It is well worth reading the comments on this trial too. It was a randomised trial (though not, of course, blind).

In other words, none of them worked very well. The paper failed to distinguish between manipulation by physiotherapists, chiropractors and osteopaths and so missed a valuable chance to find out whether there is an advantage to employing people from alternative medicine (the very problem that this NICE guidance should have dealt with)

Steve Vogel, another member of the guidance development group, is an osteopath. Osteopathy has cast off its shady origins better than chiropractic, but it remains a largely evidence-free zone, and is still usually classified as alternative medicine.

Peter Dixon DC FCC FBCA is chairman of the General Chiropractic Council and founder of Peter Dixon Associates. They run six chiropractic clinics. The claims made by these clinics on their web site are mostly related to musculo-skeletal conditions (not, all spine-related however). But they also include

“Chiropractic is also suitable for relieving the symptoms of stress, and optimizing the way the body works is one of the best ways of enhancing health and wellbeing.”

I wonder how they could justify that claim? Then we get

A chiropractor is always willing to discuss individual conditions or answer questions in order to assess whether chiropractic may be of benefit.

Thanks for the invitation. I accepted it. After the first two phone calls, I had learned all I needed.

The first of Peter Dixon’s clinics that I called, was asked about my son who was suffeiing from perpetual colic.  I asked for advice. I was put through to the chiropractor. Here are some extracts from the conversation.

“I think now it’s termed irritable baby syndrome. . . . . We’ve found chiropractic is very effective for colic . . . . £50 up to 3/4 hour which would involve taking a case history, examining the baby, with regard to seeing how the joints in the spine work because often colic is down to, er um, faulty movement patterns in the spine. We deal with an awful lot of things to do with the frame -how the spine moves -and it’s often problems with the way that the bones of the spine move in infants and babies that is the underlying cause in colicky symptoms. . . usually on the whole, I’ve shot myself in the foot by saying this in the past, if there are -um when I say back problems they’re usually temporary issues -when they are there the response for most babies is quite quick . . . it depends on how it’s related to what’s gone on in the birth process -there is usually some traumatic cause and it usually sets up a problem in the upper neck or the mid-back and that will drive those colic symptoms. . . . Yes it’s quite a straightforward thing we just check the baby’s spine and see if it’s problem we can deal with or not.”

Yes, I think you just shot yourself in the foot again. I have no idea in what fraction of cases a chiropractor would fail to claim that it was a case that they could deal with. At least that possibility was envisaged. But when I asked where he’d refer me to in such case I was told it might be a result of bottle feeding -“what they consume”. So I expect it would have been sent to some sort of “nutritional therapist” who would have used one of their usual battery of unreliable tests for food allergies.

I tried a second clinic in Peter Dixon’s empire and asked if chiropractic could help with asthma.”It can do, depending on what type of asthma you have".    After some questions I was asked

“Do you have any general aches and pains otherwise, any tension .problems round the rib cage or thoracic spine . . . There are two things we’d look as chiropractors as to whether we could help or not and that would include the tension round the rib cage -in any type of asthma you’ll become tight round the rib cage and merely by keeping that area loose you’d help to stop the asthma from becoming quite as bad. And the second part is we’d look at the neck area with you to see if there is any restriction there -which houses the nerve supply to the lungs which can be indicated in some asthma cases also.”

I was invited to come for a free screen, so I asked if it usually worked quickly, “It depends what the problem is but you’d need a course I suspect”.  £45 for the first appointment then £28 per session. “In most cases you’d need to look at a six to eight session course”.

Would anyone with experience of crying babies or of asthma like to comment on these proposed treatments? They are not my idea of evidence-based treatments and I find it quite surprising that someone who sponsors them is thought appropriate to write guidance for NICE.

This sort of ‘sting’ always makes me feel a bit uneasy, but it seems to be the only way to find out what actually goes on. And what goes on has all the appearance of classic bait and switch. You go in for your backache, and before you know where you are you are being sold a course of treatment to stop your baby crying.

Media follow-up after the NICE announcement

Sadly, I heard that the Today programme (my favourite news programme) was pretty wet. if only their science reporting was as good as their politics reporting.

The 27th May was certainly pretty busy for me, Apart from a couple of local paper interviews, this is what happened,

Sky News TV. Richard Suchet and two cameraman came to UCL and filmed a lot of stuff out of which a 20 second clip was used. And then they grumble that they don’t make money.

BBC TV 6 o’clock News. Similar, but at least only two people this time. Both TV stations spent ages showing pictures of people having needles pushed into them and very little time discussing the problems. A pathetically bad attempt at science reporting. Radio, on the whole, did much better

BBC Three Counties Radio (09.20) Host Ronnie Barbour, The daytime talk shows may be appalling to some of us, but the hosts did a far better job of airing the problems than TV [download the mp3].

Radio 5 Live Victoria Derbyshire [download the mp3]

BBC Radio Sheffield (12.05) was the best talk show by far.  First speaker was Steve Vogel, the osteopath from the guidance development group. Although invited by the rather sensible host, Rony, to respond to the idea that a secondary consequence of the guidance would be to introduce hocus-pocus, he steadfastly refused to answer the question. At the end a rather sensible GP summed up the view from the coalface. [play the mp3]

Radio 4 PM programme This excellent early evening news programme is run by Eddie Mair. It was the best interview yet. The other side was put by Martin Underwood, chair of the guidance development group [play the mp3]

Underwood said “the evidence shows that it [acupuncture] works”. I disagree. The evidence shows that acupuncture, in a non-blind comparison with no acupuncture shows a small, variable additional effect that doesn’t last and is of marginal clinical significance, That is not what I call “works”. Underwood then indulges in the subgroup analysis fallacy by asserting that a few people get a large benefit from acupuncture. Or perhaps a few people just happen to get better that day. I was not convinced.

More 4 News TV 20.20 was an interview, with the other side being put by my old friend, George Lewith.

During the introduction, an acupuncturist. Lisa Sherman, ‘explained’ acupuncture in the usual sort of utterly meaningless words that illustrate perfectly the problem.

George Lewith said that “we don’t have a good pretend form of acupuncture”. “We don’t have a good placebo and we can demonstrate that acupuncture is literally twice as effective as conventional care”. The first is simply nonsense: huge efforts have gone into developing good controls in acupuncture studies (see, for example, Barker Bausell’s book, Snake Oil Science). And I hope that George will send the references for his “twice as effective” claim. It seems to me to be nothing short of preposterous.

My conclusions

So what went wrong?

One problem could be regarded as medical arrogance. The fact is that the problem of low back pain has not been solved, either by drugs or anything else. It is a failure of medicine (and of pharmacology). That should be the premise of all discussions, and it smacks of arrogance not to tell people straight out. Of course there are some cases when causes can be identified, and perhaps remedied, usually by surgery, but these are the exceptions not the rule.

One consequence of the inability of medicine to help much is that patients get desperate, and willing to try anything. And of course if they happen to have a remission, that is attributed to the treatment, however preposterous that treatment may have been. Conditions like back pain that come and go unpredictable are a gift for quacks.

Another consequence, for researchers rather than patients, is to clutch at straws. Even small and inconsistent effects are seized on as ‘successes’. This phenomenon seems to be part of the reason for the NICE guidance. Another reason is, almost certainly, the grinding of axes by some of the people who wrote it.

What should be done now?

Professor Sir Michael Rawlins is a sensible chap. He cares about evidence, But it does seem that in this case, he might have taken his eye off the ball, for once. In my opinion, he should restore the reputation of NICE by withdrawing this guidance and starting again.

Follow-up

An interesting document has come my way. It shows the responses of the guidance group to the consultation on the draft guidance. Many people made comments not unlike mone, but they were all brushed aside in a way that looks to me rather partisan. The document appears to have vanished from NICE’s web site, but you can download it here.

Friday 29th May. The Times prints a letter from two consultants in pain medicine, Joan Hestor and Stephen Ward. It says, inter alia

“As experienced pain specialists we feel that NICE has lost its way in publishing these guidelines.”

“We are saddened that NICE has chosen to ignore our important role and promote seemingly unworkable and for the most part clinically ineffective treatments”

Friday 29th May. NICE has had a good reputation in the USA for its important, and usually high-quality, attempts to assess what works and what doesn’t. That makes it all the sadder to see it condemned already from the USA for its latest effort. The excellent Yale neurologist, Steven Novella, has written about it on his Neurologica blog.

Friday 29th May. A correspondent points out that the costings of the guidance can be found on the NICE web site. Table 1 has a strong air of make-believe.

The Daily Mail (29 May 2009). Their article quotes serious criticisms of NICE.

Dr Ron Cooper, past chairman of the group and a consultant pain specialist in Northern Ireland, said: ‘I have never known so many pain medicine specialists to be so furious. More patients will end up having more expensive surgery, which is unnecessary, risky and has worse results.

‘NICE made it difficult for us to submit evidence to a committee on which there was not one experienced pain physician.

‘The guidelines will make us the laughing stock of Europe, Australia and the U.S. where pain specialists will continue to have full access to a wide range of treatments.’

Chirowatch suspended.  30 May 2009.  The invaluable chiro-watch site, http://www.chirowatch.com, run by Dr Canadian physician, Dr Tom Polevoy, has been “suspended”. In fact the whole of his domain, healthwatcher.net, has been disabled. It seems that this was the result of a legal threat to his ISP, not by chiropractors this time, but by William O’Neill of the Canadian Cancer Research Group, which is far from being what the respectable-sounding title suggests, according to Dr Stephen Barrett. The site will be back soon, I’m told. Meanwhile you can read the suspended page here, and the only result of their hamfisted bullying will be to vastly increase the number of people who read it. You can read lots more at Quackwatch’s chirobase and at ebm-first.

A new blog, Not as NICE as you think appeared on May 30th. It is written by a pain physician, Stephen Ward. and is devoted to pointing out the serious problems raised by NICE’s guidance. It starts with the (very critical) World Institute of Pain Press Release.

British Medical Journal has more flak for the NICE guidelines

And the BMJ has published a letter signed by 50 consultants in pain medicine, NICE guidelines on low back pain are flawed.(this will probably appear as a letter in the print edition of the BMJ).