LOB-vs
Download Lectures on Biostatistics (1971).
Corrected and searchable version of Google books edition

Download review of Lectures on Biostatistics (THES, 1973).

Latest Tweets
Categories
Archives

Jump to Open University course K221

Jump to follow-up

BBC2 TV showed a much-advertised series on alternative medicine, in February 2006. The programmes seem to be linked with a dubious Open University course.

The programmes are presented by Kathy Sykes, who is professor of the public understanding of science at Bristol University. She has done some excellent work in that area, for example, in the Rough Science TV series.

The first programme: acupuncture

The first programme, on acupuncture, was shown on 24th January, 2006. The programme did not start
in a very promising way. Just lots of testimonials from happy patients, the staple diet of all snake oil salesmen.
They are watchable, of course, but don’t do anything at all to promote public understanding of what constitutes evidence.

There is, of course, little doubt that sticking needles into your body can produce physiological responses. Two things remain uncertain.

  • Just how useful are these responses in helping particular conditions?
  • Is there anything at all in the mumbo jumbo of meridians and chi?.

With a big flourish we were shown “a 21-year-old Shanghai factory worker undergoing open-heart surgery with only the needles to control her pain”. It turns out that this was a sham. The patient was doped on opiates and local anaesthetics. The needles were merely cosmetic. Why were we not told?

The apparently contradictory trials suggested that, at least the alleged principles of acupuncture are nonsense. The programme concentrated on a trial by Berman (Ann Intern Med. 2004,
141, 901-10 ) which used ‘sham acupuncture’, with ‘stage dagger needles’, on osteoarthritis of the knees. In this sort of trial there is no actual penetration, and the sham needles are placed on the places dictated by the mumbo jumbo. This procedure was justly criticised by a subsequent letters in the same journal (Ann
Intern Med
2005, 142, 871
).

Another large study was ignored by the TV programme altogether. This was by Linde et al. (Journal of the American Medical Association. 2005 293(17):2118-25). This study concluded

“Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.”

As pointed out above, this study is, in many ways, much more interesting than Berman’s, because the control group did not have ‘sham acupuncture’. Needles were really inserted, but they were inserted in points that have nothing to do with the mumbo jumbo of meridians. The fact that the controls were much the same as the treated group suggests that, whatever effect the needles produce, it doesn’t matter much where they are inserted. The only obvious interpretation of this is that the ‘principles’ on which acupuncture is based are so much nonsense (and, therefore, it is not a subject that can possibly be taught in a university).

This crucial point was ignored by the TV programme. A big fuss was made of a functional magnetic resonance experiment, staged for TV, that showed that the effects on brain ‘activation’ are different for superficial needling and for real needling. There is nothing in the least surprising in the observation that have a needle pushed into you affects the brain, but it really does not help at all in answering the important questions. Incidentally that experiment had already been done anyway.

In summary, the first programme, failed to give a fair assessment of current knowledge about acupuncture, and failed to consider the important questions of what sort of controls are appropriate, and whether talk of meridians means anything whatsoever. Sadly, I can’t agree with the boast that “It’s the deepest investigation into the efficacy of alternative medicine ever attempted on TV”.  Let’s hope the second programme is a bit more critical.

The second programme: healing

The second programme (31st January, 2006). I liked this programme much better than the first, even if it left the crucial questions unresolved.

The programme started with a healing meeting by the notorious Benny Hinn.  The meeting had all the mass hysteria of a Nuremburg rally, though no mention was made of the fact that this (very rich) man’s financial malpractice had been revealed by a CBC TV programme.

On the right is his receipt for £3347 for two nights at the Lanesborough hotel in London (that did not include $1700 he gave in tips).

The lovely Ghanaian lady who cleans my office and lab every morning gives gives money to this mega-rich man because “he needs it to preach the gospel”.

The National Institutes of Health provided $1.8 m of US taxpayers’ money for this project which seems not to do real research at all. After seeing a demonstration of the “Gas Discharge Visualization”, GDV, or Kirlian camera, given by a very gullible Dr Melinda Connor, Sykes comments that this ‘research’ “is not so much trying to find the evidence for ‘healing energy’,  but is rather working on the basis that there is one”

Kathy Sykes did, though show a pretty healthy degree of scepticism about the people who pretend to photograph “auras” and other imaginary “force fields”. She visited the “Center for Frontier Medicine in Biofield Science” at the University of Arizona.

In other words, the ‘research’ is a con. Once again (see above) we see money given by well-intentioned governments diverted form the purpose for which it was given.  For more first class boloney on ‘imaging’, see for example, Biofield Sciences in Exeter (UK)  and ‘electro-crystal therapy’.  The list is endless.

Kathy Sykes went on to show several interesting experiments on placebo effects. For example sham healers (played by actors) do at least as well as ‘real’ healers.  And sham knee surgery may be as effective as real surgery, though the programme failed to mention the obvious possibility that this could mean nothing more than that real knee surgery is itself pretty ineffective.  As so often in this series, the producers failed to talk to the right people.

She concludes “healing does not work beyond placebo”.

So I’m right with her, though it would have been better if there had been a more critical mention of the fact that not all placebo effects are real.  Many probably depend on the natural fluctuations in the intensity of the patient’s condition.  Anything can ‘cure a cold’, because you recover from a cold in a few days anyway,

Sykes concludes, speaking of the placebo effect, “I want to see that power properly harnessed -we’d be mad not to”.  But that, disappointingly, was the end of the programme.  That point is where the problems begin.  How do you harness the placebo effect?  How do you justify lying to the patient in order to maximize the effect?  How do you train the ‘healers’? Are they themselves to believe the same lies, or are they to be trained in the art of deception?  As pointed out in a recent review of the neurobiology of placebos (Colloca and Benedetti, 2005)

“For example, the assertion that placebos, fake therapies, fresh water and sugar pills could  positively affect the brain biochemistry in the appropriate psychosocial context might lead to a dangerous justification for deception, lying and quackery”.

These are the central dilemmas of sCAM, as listed at the top of this page. The programme did nothing to solve them, or even to draw attention to them.

The link with Open University Course K221

The blurb on this programme on the Open University/BBC site concludes

“So, could the power of the mind explain the benefits people experience from healers? And have healers tapped into this power somehow? The conclusion throws new light on all healing processes, and has a surprising and inspirational message for every practitioner and patient.”

But what is to be done about this “inspiration”? Nothing is said about that.  The TV programme was immediately followed by voice-over that advertised an Open University pamphlet, which is publicity for their course K221. That course, judging from what is posted on the web, is run by true believers who are a lot less sceptical than Sykes. She says that she did the voice-over but has not yet been shown the contents of the course.

The third programme: herbalism

Oooh dear. The third programme was, in my view, by far the worst.  Hardly a single critical voice was heard. Despite the odd word of reservation,  the programme left the impression of being an advertisement for the herbal medicine industry. Did the BBC not think of asking a pharmacologist?  In my view, this programme was a disservice to human knowledge.  Let’s look at some of the details.

The programme once again starts with dramatic testimonials from satisfied customers. No hint is given to the viewer of the total unreliability of such testimonials. References, in awed voice, are mad to “a vast body of ancient knowledge that herbalists draw on”.  No mention of the superb track record that ‘ancient knowledge’ has for turning out to being dead wrong.  It was 11 minutes into the programme before the question of evidence was even mentioned and then we had a herbalist wandering through a field. At 13 minutes, the herbalist, Simon Mills, was interviewed -he rattled on about dampness. marshy conditions. “There
are herbs for heating and drying”. Sheer gobbledygook. And still no discussion of evidence.

Sutherlandia At 18 minutes “To get another view I’m going to a country where herbs are claimed to have dramatic effects”. Off to Africa to spend a good 10 minutes on Sutherlandia, a totally unverified treatment for AIDS.  Why spend all this time (and licence-payers money) to end up with the conclusion that clinical trials have
not been done yet, and we have no real idea whether it works or not?  A search of Pubmed for Sutherlandia and AIDS produces a mere five papers.  Mills et al. Nutrition Journal 2005, 4:19 write as follows.

“Despite the popularity of their use and the support of Ministries of Health and NGOs in some  African countries, no clinical trials of efficacy exist, and low-level evidence of harm identifies the potential for drug interactions with antiretroviral drugs.”

(and one of the authors on that paper is from the Canadian College of Naturopathic Medicine: hardly likely to have a bias against herbs). The comments made in the programme about AIDS were irresponsible and potentially dangerous:  they could kill people..

It took until almost half way through the programme, before we got round to the question of whether any of these claims are true. Very impressive to learn that the Nazis pushed herbal medicine, but totally uninformative (or does it mean that herbalism appeals to nutters?). We are shown the German herbal bible, but again it is pointed out that it contains no evidence about their efficacy. So no further forward yet.  Then we are introduced to chromatography: very pretty, but still no evidence about whether herbs help people.

At 9.34 pm we are last get round to some evidence. Or do we? Not yet, just another personal testimonial about the the wonders of St John’s Wort. St John’s Wort (Hypericum) is an interesting case, because there is at least some evidence that it works, though certainly not enough for it to be described as a “superherb”, as Sykes did.  Of course depression (like knee surgery -above) makes a pretty good case for herbalists, because conventional antidepressants are so very unsatisfactory themselves.  It doesn’t take much to do better than Seroxat (Paxil, paroxetine).  At 9.38 pm we get the first actual numbers. And very selective numbers they are
too. The view presented in the programme was desperately over-optimistic about the wondrous effects of St John’s wort.  Consider the recent review by Linde et al. (2005 Brit J. Psychiatry, 186, 99-107) (read
it yourself –download pdf file).  The conclusion was as follows.

“Current evidence regarding Hypericum extracts inconsistent and confusing. In patients who meet criteria for major depression, several recent placebo-controlled trials suggest that Hypericum has minimal beneficial effects while other trials suggest that Hypericum and standard antidepressants have similar beneficial effects. ”

And another trial, again not mentioned in the programme, was published in Journal of the American Medical Association, 2002, 287, 1807 – 1814) [download the pdf file]. This paper was interesting because it compared placebo, St John’s Wort and sertraline (Zoloft), a drug of the same class as Seroxat).  All three were indistinguishable (on the two primary outcome measures).  So St John’s Wort was as good as Zoloft, but only because Zoloft was no better than placebo either.  The paper concluded thus.

“This study fails to support the efficacy the efficacy of H. perforatum [St John’s Wort] in moderately severe major depression. The result may be due to low assay sensitivity of the trial, but the  complete absence of trends suggestive of efficacy for H. perforatum is noteworthy.”

Why were we not told about trials like these?

At 9.43 pm, almost three quarters of the way through the programme, we are eventually told that ginseng, echinacea and evening primrose oil do not work. What took so long?

9.46 pm. Off to South Africa to look at research in Johannesburg on Sutherlandia by Carl Albrecht (more of him below).  Some impressive stuff about flavonoids but no results.   Flavonoids can’t be absorbed, but, aha, it contains saponins too. Perhaps they allow the flavonoids into cells. Well perhaps.
But this is not information, it is idle speculation.

At 9.51, we get back to brain imaging, this time at Imperial College. Professor Sykes seems to be excessively impressed by brain imaging. We are then treated to more idle speculation about how ginko might help in Alzheimer’s disease. Dr Warner is running a clinical trial to find out whether ginko really helps. But there were no results yet. In that case why not wait until there is a result, before telling us all about it?

We are told that herbs now “have to go through rigorous quality standards”.  It was NOT made clear that the standards don’t include anything about the herb actually doing anything useful.  The standards may give some protection against your being poisoned.  They do nothing at all to guarantee you’ll be helped.

The conclusions

“What’s really impressed me is the way that different ingredients from particular herb can combine together and have really powerful effects on us humans. So I believe that herbs are going to play a key role in medicines of the future”

“What started as an ancient wisdom may just might provide new medicines that will help us all live longer, fuller lives”

These statements are quite outrageous!   The first statement has no basis whatsoever.  It is sheer idle speculation.  It could be true, but there is no reason to believe it is.

The second statement is content-free.  Yes, it “may just” do that. On the other hand it may not.

The web site for the third programme. (7th February, 2006, 2100-2200) concludes thus.

“So, what’s their secret? Working with fellow scientists, Kathy discovers that plants contain much  more than a single – or even two or three – active ingredients. They are enormously complex

Chemical cocktails that have medicinal properties modern pharmaceuticals simply can’t reproduce.”

Just one snag (apart from the misleading implication the Sykes was doing pharmacological experiments), There is not the slightest reason, thus far, to think there is any advantage in using an “enormously complex chemical cocktail”.


Stop press: on Saw palmetto (one of the “superherbs” of the TV series)

The New England Journal of Medicine, for February 9th 2006 (354, 557 – 566), reports a clinical trial of “Saw Palmetto for Benign Prostatic Hyperplasia”. This is what they say.

“Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration.”

“In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo.”

“Conclusions. In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia.”

I hope that the BBC, the Open University and Prof Sykes now appreciate the folly of judging treatments before the results are in.

Postscript. Some reviews of the TV programmes

  • There has been some lively discussion of the BBC2 series on a forum of the James Randi Educational Foundation, on the BBC2/Open University site, on Ben Goldacres’s Badscience site, and at ebm-first.com.

  • The Times TV critic was unenthusiastic.

    “So having started out as a sceptic, Sykes ended the programme chirruping, like a born-again Christian, about how herbs contain complex combinations of chemicals that scientists cannot yet reproduce&”;

  • Simon Singh writes in the Daily Telegraph (14 Feb., 2006): "Did we really witness the ‘amazing power’ of acupuncture?

    “A BBC series on unorthodox therapies was devoid of scepticism and rigour, says Simon Singh.”

    “Although the second programme was indeed a rational look at the placebo effect, the other two episodes were little more than rose-tinted adverts for the alternative medicine industry.”

    “For example, the scene showing a patient punctured with needles and undergoing open heart surgery left viewers with the strong impression that acupuncture was providing immense pain relief. In fact, in addition to acupuncture, the patient had a combination of three very powerful sedatives (midazolam, droperidol, fentanyl) and large volumes of local anaesthetic injected into the tissues on the front of the chest.
    With such a cocktail of chemicals, the acupuncture needles were apparently cosmetic. In short, this memorable bit of telly was emotionally powerful, but scientifically meaningless in building a case for acupuncture. ”

    “This TV series pretended to be scientific and had the chance to set the record straight, but instead it chickened out of confronting the widespread failure of alternative medicine. ”

  • Advertisers cash in. Sadly, but predictably, the programme on herbalism has
    already been exploited by vendors of unproven treatments. While it is true that the programme did not actually assert that this herb cured AIDS, it certainly left the impression that it was good stuff.  Here is an example: “As seen on BBC2”

    “In South Africa, BBC 2 TV presenter, Professor Kathy Sykes learnt of the herb Sutherlandia, which is being touted as a new weapon in the fight against HIV and ”

    “It is with thanks to programmes such as Alternative Medicine shown on BBC 2 on Tuesday 7th February, and the work carried out by Professor Kathy Sykes that medicinal herbs can receive the acknowledgement they truly deserve, and this knowledge be passed on to the general public.”

    “Bioharmony Sutherlandia is available from Revital Ltd in 60 x 300mg tablets for £19.99rrp. ”

  • A groundbreaking experiment … or a sensationalised TV stunt?

    Simon Singh, in The Guardian (25 March 2006) followed through with some more details on the BBC2 series. It’s not only pharmacologists who were unhappy about it. So were several of the people who advised the BBC and/or appeared on the programme.

    “But this week scientists involved in the series have complained that elements of the programmes were misleading, the production team was uninformed, and scientists were used as “marionettes” ”

    At the end of the first programme a “hugely ambitious” imaging experiment was shown with an enormous flourish. The outcome was, roughly speaking, that pushing needles into yourself produces a signal in the brain. Good heavens! Who’d have thought it? Even George Lewith, normally an apologist for CAM, was critical.

    “The interpretation of the science in this particular programme was not good and was inappropriately sensationalised by the production team. I think all of us on the experiment felt like that.”

    “The experiment was not groundbreaking, its results were sensationalised and there was insufficient time to analyse the data properly and so draw any sound conclusions. It was oversold and over-interpreted. We were encouraged to over-interpret, and proper scientific qualifications that might suggest alternative interpretations of the data appear to have been edited out of the programme.”

    Edzard Ernst, professor of complementary medicine at Exeter University, and the main consultant for the series says:

    “The BBC decided to do disturbingly simple storylines with disturbingly happy endings. But none of these stories is as simple as they presented, nor do they have such happy endings. Even when the evidence was outright negative, they somehow bent over backwards to create another happy ending.
    “I feel that they abused me in a way. It was as if they had instructions from higher up that this had to be a happy story about complementary medicine without any complexity, and they used me to give a veneer of respectability.”

    The BBC, thus far, remain unapologetic

    “We take these allegations very seriously and we strongly refute them.We used two scientific consultants for the series, Prof Ernst and Dr Jack Tinker, dean emeritus of the Royal Society of Medicine, both of whom signed off the programme scripts.”

    This is the same Jack Tinker who, as Chairman of the Ethics Committee of the Dr Foster organisation, also approved their “COMPLEMENTARY therapists Guide 2004”, and the utterly uncritical complementary practioner directory. The ‘Dr Foster’ organisation is a commercial business that supplies "management information", "market research services", "marketing services" and "information for the public". Let’s hope their services in conventional health care are a bit more critical than their evaluation of CAM. Their “Guide to [CAM] therapies” repeats all the usual pseudo-scientific gobbledygook in a totally uncritical way.

    Singh’s article ended with some quotations from this site, concerning Sutherlandia and AIDS, with the remark made above, highlighted: "Comments about Aids were irresponsible and potentially dangerous".

  • Science accuses BBC of medical quackery

    Lois Rogers, in the Sunday Times for 26th March, reports on the same topic.

    “Ernst yesterday released the contents of a letter that he has written to Martin Wilson, the series producer, criticising him for promoting “US-style anti-science”.

    He said he felt “abused” by the programme makers: “It was as if they had instructions from higher up that this had to be a happy story about complementary medicine without any complexity, and they used me to give a veneer of respectability.”  “

    “This is no longer a fringe game played by new age people,” said Colquhoun. “It is beginning to erode intellectual standards at real universities.”

Later a letter appeared in defence of the programmes. Investigation showed that this letter had actually been written by the BBC and not all of the ‘signatories’ had seen it.This is dealt with in a separate post, Alternative Medicine series: dirty tricks at the BBC?

Print Friendly, PDF & Email

3 Responses to BBC2 and the Open University on Alternative Medicine

Leave a Reply

Your email address will not be published. Required fields are marked *

 

This site uses Akismet to reduce spam. Learn how your comment data is processed.