Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Michael Rawlins
The first post was NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself.
That was followed by NICE fiasco, part 2. Rawlins should withdraw guidance and start again.
Since then, something of a maelstrom has engulfed NICE, so it’s time for an update.
It isn’t only those who are appalled that NHS should endorse voodoo medicine on the basis of very slim evidence who are asking NICE to rethink their guidance on low back pain. Pain specialists are up in arms too, and have even started a blog, ‘Not Nearly as NICE as you think …‘, to express their views. Equally adverse opinions are being expressed in the Britsh Medical Journal. A letter there is signed by over 50 specialists in pain medicine. It ends thus
“Because of these new guidelines patients will continue to experience unnecessary pain and suffering and their rights to appropriately individually tailored treatment have been removed on the basis of a flawed analysis of available evidence. We believe the guidelines do not reflect best practice, remove patient choice and are not in our patients’ best interests.”
In a contribution headed “NICE misguidance”. Dr Michel Vagg ends
It seems to me that this guideline has been used as a propaganda vehicle to allow cherry-picked evidence to be enshrined as doctrine. This is an abuse of the guideline development process . . . ”
I have to say, though, that it seems to me that some of these people are promoting their own interests as much as chiropractors and acupuncturists. The evidence that spinal injections produce worthwhile benefits seems to be as thin as the evidence that chiropractic and acupuncture produce worthwhile benefits. But no doubt the injections are good for the budgets of PCTs or private practice doctors.. Could it perhaps be the case that some of the clinicians’ anger is being generated by doctors who are rushing to defend their own favourite ineffective treatment?
Why, oh why, can’t either NICE or the pain consultants bring themselves to state the obvious, that nothing works very well. The only thing that can be said for most of the regular treatments is that although they may not be much more effective than acupuncture or chiropractic, at least they don’t come with the intellectually-offensive hokum that accompanies the latter. Very sensible attempts have been made to identify the cause of low back pain [reviewed here], Occasionally they succeed. Mostly they don’t.
One clinician’s letter deserves special attention because it goes into the evidence, and the costs, in some detail. Its conclusions are very different from those in the NICE guidance.
The letter, a Review of NICE guidance, is from Dr C.J.D. Wells [download the whole letter]. He is a pain relief consultant from Liverpool.
Let’s look at some highlights.
Wells points out the absurdity of the cost estimates
“In the pricing section, they estimate that this will require an increase of facilities so that 3,500 patients can be treated instead of 1,000 at present (again see comments on pricing). This is not many treatments for the 20 million sufferers, of whom we can estimate that at least 2 million will have significant long-term disability and psychological distress”
And that is without even costing all the secondary costs of miseducating a new generation of students in fables about “Qi”, meridians, energy flow, subluxations and innate intelligence.
“The abysmal ignorance of the committee is reflected in the poor overall advice. So if you have a committee with special interests in Exercise, Manipulation, PMP’s, and Surgery, and you call an expert on Acupuncture, you get advice to use Exercise, Manipulation, Acupuncture, PMP’s and Surgery. Amazing.”
Another pain consutant, Charles Guaci, says in a comment in the Daily Mail.
I am a Pain Consultant of 30 years experience, have published two books (one translated into different languages).
NICE never asked me for my opinion.
This is the most ridicuculous pseudo-scientific document I have ever seen.
The panel consisted of a surgeon, psychologist, osteopath, acupuncturist a physiotherapist and an academic; not one pain consultant! The conclusions are simply a means of increasing the employment of their friends!
All evidence submitted to NICE was ignored.
It is almost certain than unless NICE rethink their ideas that Pain Consultants will be seeking a judicial review as well as full disclosure of how the panel arrived at their bizarre findings under the Freedom of information act.
Patients should realise that they are being taken for a ride.
Despite the outcry from opponents of magic medicine and from pain specialists, the assessment by the normally excellent NHS Choices site was disappointing. It made no mention at all of the secondary consequences of recommending CAM and described the assertions of the guidance group quite uncritically.
The reputation of NICE
NICE has been criticised before, though usually unjustly. In the past I have often supported them. For example. when NICE said that treatment of dementia with anticholinesterase drugs like galantamine was ineffective, there was a great outcry, but NICE were quite right. There is little or no rationale for such treatments, and more importantly, very little evidence that they work. But patients, especially when they are desperate, have greater faith in drug treatments than most pharmacologists, They want to clutch at straws. A bit like the NICE guidance committee, faced with a bunch of treatments most of which are almost ineffective, clutched at the straws of acupuncture and chiropractic. But this time it isn’t only the patients who are cross. It is most of the medical and scientific world too.
One interpretation of these bizarre events is that they represent a case of medical/scientific arrogance. Ben Goldacre wrote of another aspect of the same problem thus week, in Dodgy academic PR [download the paper on which this is based].
The first job of a scientist is to say openly when the answer to a question is not known. But scientists are under constant pressure to exaggerate the importance of their results. Last year we published an article which I feel may, if verified, turn out to be the second most important that I have ever been an author on. Because it happened to be published in Nature (not because of its quality), a press release was written (by an arts graduate!). It took some argument to prevent the distorted and exaggerated account being imposed on the public. This is typical of the sort of thing reported in Goldacre’s column. I reported a similar case a while ago, Why honey isn’t a wonder cough cure: more academic spin.
If NICE does not reconsider this guidance, it is hard to see how it can be taken seriously in the future. I hope that when NICE’s director, Professor Sir Michael Rawlins, returns from his trips abroad, he will find time to look at the case himself.
Indirectly, then, it can be argued that NICE’s bizarre guidance is just another manifestation of the management of science being passed from the hands of scientists into the hands of administrators and spin experts. It is yet another example of DC’s rule
Never trust anyone who uses the word ‘stakeholder’
Some bone-headed bureaucrat decides that any charlatan or quack is a ‘stakeholder’ in the provision of NHS care and gives them a quite disproportionate say in how taxpayers’ money is spent. The bureaucrats are so busy following processes and procedures, ticking boxes, and so deficient in scientific education, that they failed to notice that they’ve been caught out by the old trick of used car salesmen, bait and switch.
The consequences
The expected consequences have already started to materialise. The Prince of Wales’ Foundation for Magic Medicine is jubilant about having been endorsed by NICE. And I’m told that “The chiropractors have now just written letters to all health boards in Scotland asking for contracts for their services to deal with back pain”.
There could hardly have been a worse time for NICE to endorse chiropractic. We are in the middle of a storm about free speech because of the disgraceful action of the British Chiropractic Associaton in suing one of our best science writers, Simon Singh, for defamation because he had the temerity to express an opinion, Of course, even if the BCA wins in court, it will be the overall loser, because chiropractic claims are now being scrutinised as never before (just look at what they told me).
Follow-up
A much-cited paper. The paper that is most often cited by chiropractors who claim to be able to cure colic by spinal manipulation is Klougart N, Nilsson N and Jacobsen J (1989) Infantile Colic Treated by Chiropractors: A Prospective Study of 316 Cases, J Manip Physiol Ther,12:281-288. This is not easy to get hold of but Steve Vogel has sent me s scanned copy which you can download here. As evidence it is about as useless as the infamous Spence study so beloved of homeopaths. There was no control group at all. It simply follows 316 babies and found that most of them eventually got better. Well, they do, don’t they? It is a sign of the pathetic standard of reaearch in chiropractic that anyone should think this paper worth mentioning at all.
June 6 2009. More flak for NICE from the Royal College of Anaesthetists, and more adverse comment in the BMJ. And of course the blogs. for example, “If this is “evidence based medicine” I want my old job back“.
“Acupuncture on the NHS: a dangerous precedent”: a good analysis at counterknowledge.com.
June 6 2009, Comment sent to the BMJ. The comment was submitted, as below, early on Friday 5th June. The BMJ said it was a “sensitive issue” and for the next five days lawyers pondered over it.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors find it so hard to find evidence for their practices that, when one of our finest science writers, Simon Singh, asked to see the evidence they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against this iniquitous persecution.
Of course I’m sure this bizarre decision has nothing to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. Nevertheless, I am curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that they could probably treat infantile colic and asthma. Such claims have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments work very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, when asked to produce evidence, resort to legal intimidation.
Eventually, on Wednesday 10 June the comment appeared in the BMJ, and it wasn’t greatly changed. Nevertheless if is yet another example of legal chill. This is the final version.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors are so sensitive about criticisms of their practices that, when one of our finest science writers, Simon Singh, queried the evidence-base for their therapeutic claims they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against an illiberal court ruling in this iniquitous persecution.
One wonders whether this bizarre decision by NICE has anything to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. I am also curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that chiropractic could be effective in the treatment of infantile colic and asthma. Similar claims about treating colic have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments works very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, instead of engaging in scientific debate, resort to legal intimidation.
Bait and switch. Oh dear, oh dear. Just look at this. British Chiropractic Association tell their members to hide their sins from prying eyes.
Excellent round-up of the recent outburst of writing about “chiroquacktic” (Tut, tut, is there no respect?).
Dr Crippen writes “NICE recommends a cure for all known disease” [Ed some exaggeration, surely]
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).
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Our main aim was to estimate, for patients consulting their general practitioner with back pain, the effectiveness of adding the following to best care in general practice: a class based exercise programme (“back to fitness”), a package of treatment by a spinal manipulator (chiropractor, osteopath, or physiotherapist), or manipulation followed by exercise Conclusions |
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).