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Drug companies and the threat to Evidence Based Medicine

November 27, 2007 by bobleckridge

Evidence Based Medicine has three principles – consider the evidence for an intervention; consider the relevance of this evidence for this particular patient based on clinical experience and; thirdly, in consultation with the patient respecting their values and perspectives – to draw up a therapeutic plan. That first part about the evidence base is weakened if the evidence itself is distorted. There are a number of ways to distort it.

One is to spin the findings, as was highlighted in this research –

Previous studies have shown that randomised controlled trials with financial ties to single drug companies are more likely to have results and conclusions that favour the sponsor’s products, and a recent study suggests that the same holds true for meta-analyses.

So researchers in the US set out to determine whether financial ties with single drug companies are associated with favourable results or conclusions in meta-analyses on blood pressure lowering (antihypertensive) therapies.

A total of 124 meta-analyses were included in the study, 49 (40%) of which had single drug company financial ties. Differences in study design and quality were measured.

Meta-analyses with single drug company financial ties were not associated with favourable results but were significantly more likely to have favourable conclusions, even when differences in study quality were taken into account.

In fact, the data show that studies funded by a single drug company have a 55% rate of favourable results that is transformed into a 92% rate for favourable conclusions, representing a 37% gap. The gap shrinks to 21% (57% to 79%) when two or more drug companies provide support. Yet the gap vanishes entirely for studies done by non-profit institutions alone or even in conjunction with drug companies.

These findings suggest a disconnect between the data that underlie the results and the interpretation or “spin” of these data that constitutes the conclusions, say the authors.

Another method is not to publish negative trial findings. Bayer, has just suspended one of its drugs because a trial showed it carried a higher risk of death.

The BART study was the latest in a series of worries about Trasylol’s safety in past years. In 2006 a study published in the New England Journal of Medicine showed increased risks of kidney failure, heart attack, and stroke (2006;354:353-65).

As a result, safety warnings for Trasylol were strengthened in 2006, and approval for use was limited to patients who were having heart bypass graft surgery and were at increased risk of blood loss and blood transfusion during the operation.

In October 2006 international drug regulators’ worries heightened when it became known that Bayer had failed to disclose to the agencies or their advisory panels the results of an unpublished study that had been sponsored by Bayer. Indeed, Bayer scientists had defended Trasylol at an FDA panel hearing but had not mentioned their own study.

Bayer announced that it regretted the mistake and that according to an internal investigation the findings of the trial had been withheld by two Bayer employees and not been passed on as necessary.

Evidence Based Medicine only works well for patients if it is applied in full, and the issue of pharmaceutical company influence on what becomes known and how it is presented required constant vigilance. The more we can have non-drug company funded experts involved in careful peer review the better.

Posted in from the consulting room, health | Leave a Comment »

Music and the geography of the spirit

November 25, 2007 by bobleckridge

I’m enjoying a series on BBC Scotland just now. It’s called Scotland’s Music with Phil Cunningham. Phil’s an amazing contemporary Scottish traditional musician and each part of this short series examines the relationship between some aspect of Scotland and Scottish music. This week’s episode (Part 4) was entitled ‘Heaven and Earth’ and explored what Phil called the soul of Scottish music. I loved this and understood with every fibre of my being. I liked the way he showed such diverse ‘spiritual’ inspirations for Scottish music, from superstitions and beliefs in magical creatures like selkies, to Christian traditions both Protestant and Catholic, to the ‘spiritual’ inspiration of the land itself. It’s this last that means most to Phil, and it’s this last that means most to me, but to range over such a diversity of sources for inspiration to produce music that connects the individual to something much greater, be it Life, or God, or the Natural World is quite unusual.

Take a look at the BBC site dedicated to this series. In particular take a look at episode 4, ‘Heaven and Earth’ and play the video entitled ‘Soraidh Leis An Ait’ which is played by all the musicians appearing in this part. If you’ve any Scottish blood in you, I swear this will touch your soul! And even if you’re not Scottish, Tommy Smith playing his sax in the Hamilton Mausoleum is enchantingly beautiful.

Posted in from the living room, from the music room, life, music | 4 Comments »

The Water Experience

November 22, 2007 by bobleckridge

A big part of the debate about homeopathy centres on the issue of ultra-high dilutions of medicines. One of the explanations wheeled out is something called ‘the memory of water’ – it’s a catchy phrase but very problematic. Does water have a memory and if so, how does that work? The anti-homeopathy campaigners say it can’t be explained. In short, they say it’s implausible. More than that, they say that the difference between a starting substance and a highly diluted remedy is the difference between ‘something and nothing’. But still, I think it’s more reasonable to say it’s the difference between something and something else. One of the commenters here, Andy, asked ‘does the water retain a memory of everything else it has had in solution since the dawn of time? Or just the things that the homeopath wants it to remember?’ I rather liked that question. It got me thinking…..and I’m still thinking! But amongst the things it got me thinking about were how memory isn’t physical but water is, about how human beings are meaning-seeking/meaning-creating creatures and how we enrich our physical world with meaning, how we use language, symbolism, memory and imagination, to create an incredibly powerful presence in the world, and how experience is more than physical, more than can be measured.

So here’s the non-science bit – first off, some photos of my own. I love water and water imagery and it amazes me how diverse and complex it is. Have a browse through this slide show. I wonder how these images of water will feel to you? I wonder what they’ll mean to you?

Here’s the slide show

And then, here are some of my favourite water songs. Let’s start with Rain

I can show you that when it starts to rain, everything’s still the same

When it rains and shines it’s just a state of mind

Patty Griffin next…..

Sometimes a hurt is so deep deep deep
You think that you’re gonna drown
Sometimes all I can do is weep weep weep
With all this rain falling down

Strange how hard it rains now
Rows and rows of big dark clouds
When I’m holding on underneath this shroud
Rain

And, the fabulous Eurythmics –

Here comes the rain again
Falling on my head like a memory
Falling on my head like a new emotion
I want to walk in the open wind
I want to talk like lovers do
I want to dive into your ocean
Is it raining with you

It’s amazing how much the rain can change our emotions, our state of mind, and our mood, isn’t it?

Let’s spend a little time by the river! Rivers are so important to us. How many towns and cities grow up around rivers? Think how we use metaphors like “river of life”. Here’s Alison Krauss set to a lovely montage of BBC nature videos.

A complete change of musical genre, but keeping a religious theme, with Good Charlotte,

Baptized in the river,
I’ve seen a vision of my life,

My favourite river song about the importance of place – really, a song that gives us a real understanding of psychogeography! (the way place fashions a sense of self)

And, finally, with Christmas coming, here’s Sarah McLachlan’s version of Joni Mitchell’s The River

I wish I had a river
I could skate away on

Which paintings, photos, songs, films, poems or stories come to your mind on the theme of water, and what do they mean to you?

Posted in creativity, from the dark room, from the music room, from the viewing room, movies, music, video | 2 Comments »

Meditation and good outcomes in psychotherapy

November 21, 2007 by bobleckridge

Here’s an interesting study which looks at the influence of meditation on patient care. It wasn’t the patients who did the meditating however. It was the therapists. The researchers took a group of trainee psychotherapists and split them into two groups. One group practiced mindfulness meditation and the other didn’t. The patients they were treating showed improvements as follows –

the [patients treated by the meditation] group showed greater symptom reduction than the [no meditation] group on the Global Severity Index and 8 SCL-90-R scales, including Somatization, Insecurity in Social Contact, Obsessiveness, Anxiety, Anger/Hostility, Phobic Anxiety, Paranoid Thinking and Psychoticism.

So, who therapist is, and how they learn to focus their attention seems to matter. I’ve never learned meditation but I do think that care is a human activity and the current drive to homogenise medicine as if human individuality is not important is misguided. It is important who your therapist is and it is important that the therapist learns and practices focussed attention and active listening whatever the actual therapy being used.

Posted in from the consulting room, health, psychology | 1 Comment »

A Good Life

November 20, 2007 by bobleckridge

What makes a life a good life?

Philosophers have struggled over this question for centuries. It seems such a simple question but it’s not so easy to answer. One of the biggest problems with the question, of course, is that what constitutes a good life for each of us is probably a bit different.

Despite what the self-help books in the Body Mind Spirit section of the bookstores tell you, there’s no magic formula.

A C Grayling has recently published a book about this, ‘The Choice Of Hercules: Pleasure, Duty and the Good Life in the 21st Century’. He was talking about it on ‘Start The Week’ on BBC Radio 4 on Monday morning (podcast available here)

In a nutshell, he is considering the often opposing drives of duty and pleasure, or as Oliver Sacks, one of the other guests on the show said, between work and love. How we balance these determines how good we feel our lives are.  A C Grayling concluded that those rare individuals who love their work, are amongst those who have good lives. Well, I can sign up to that one. I have a good life and I certainly love my work.

I’ve just finished reading ‘The Weight of Things’ by Jean Kazez (ISBN 978-1-4051-6078-0). I bought this after reading an excellent article written by her, where she reviewed and compared three books on happiness.  I was impressed with her balance, style and insight and I’ve really enjoyed ‘The Weight of Things’. It’s about what constitutes a good life. She’s very clear in her book that she is not writing a manual or even giving a set of recommendations about living well. It’s a much more thoughtful and thought provoking book because of that. She refuses to be pinned down to a fixed set of specifics and I think that is so right, although at first, I thought, why is she being so difficult? Why doesn’t she just list the necessary features of a good life? I realised I was chasing the magic formula that doesn’t exist. Jean Kazez is much more realistic than that and completely acknowledges that we are all different and it would be wrong of her to proscribe the features which she thinks make life good. This is such a refreshing approach. I can’t stress often enough how much I value individual difference and diversity. I just can’t accept formulaic, one-size-fits-all approaches, and I don’t see the world through a two-value lens. (Ok, you’re probably thinking, ‘a what?’ ‘a two-value lens’? Well, I mean the categorisation of everything into one of two opposites – good/bad; black/white; proven/unproven. Sorry, life just doesn’t seem to fit that straightjacket for me).

What she does in this book is to consider some (but she expects, not all) features which are probably necessities if you want to have  good life, then goes on to consider other features, which she calls the B list, which make life better, but probably aren’t essential.

Here’s her very nice way of putting it –

The target we should aim for, if we want our lives to get better and better, is not like the familiar set of concentric circles. It’s like a grid of different coloured squares with different hues representing necessary and optional ingredients. The necessities are different shades of green (say) and we need to aim at each one. The various shades of purple are worth aiming for too, but they’re not so critical. If we start out with a life that’s not going well, we need to aim at the various greens: happiness, autonomy and the other basics. They remain central throughout our lives. But the purple squares – balance, accomplishment, and the like – are also life-enhancing.

I like that a lot. Maybe I wouldn’t pick green and purple but I like it all the same! The idea that a good life is not achieved through a recipe or formula but has ever changing variables which colour our lives in various hues and shades……that’s good. And it’s dynamic – she says –

a good life isn’t static, but involves some sort of growth over time.

I also like it because each of her characteristics, or squares is worthing focusing on and developing in its own right. She says that’s because making your aim a better life, as if ‘the good life’ has an independent quality you can aim at directly, is likely to fail.

Aiming for a better life is to be expected when life is going badly, but many of us take our focusoff our own lives when we feel like our lives are ‘good enough’. Many perfectly reasonable people with good lives will not aim for even better lives, let alone some conceivable ‘best life’. In some cases important things beyond ourselves start to take precedence.

How important is that last sentence? It’s a bit we often miss in our atomistic, disconnected lives. Remember the Hugh Grant character in About a Boy? That 80’s and 90’s idea of separateness, and, yes, selfishness, wasn’t enriching. Neither is the celebrity culture of our current times. Life really IS good when we get in touch with “important things beyond ourselves” – whether we see that in social, political, personal or spiritual terms.

Oh, I know, you still want her list, don’t you?

So did I.

(please remember – neither of lists should be considered definitive or complete!)

Here’s her A list (the fundamental essentials)

  • Happiness
  • Autonomy
  • Sense of identity
  • Morality
  • Progress

And here’s her B list (features which enrich life but needn’t be seen in themselves as essential)

  • knowledge
  • friendship, love, affiliation
  • play
  • religion
  • making music
  • creating art
  • accomplishment
  • balance
  • talent
  • beauty

She makes it very clear that different people will need each of these to different degrees to have a good life and that there may be other features others would add, and people might find for them that some of her B list needs to be on their A list.

Posted in books, from the reading room, philosophy | 6 Comments »

What’s the role of a doctor?

November 18, 2007 by bobleckridge

The BMJ Editor’s column this week asks what readers think is the role of the doctor –

In his report into specialist training in the UK, John Tooke asks, “What is the role of the doctor?” The answer may be too various for a single coherent answer. So much depends on context—the clinical setting, the patient’s preferences, the doctor’s experience and seniority. But is there an irreducible core to the doctor’s role, regardless of the context? Tooke calls for a debate that will redefine the doctor’s role.

They point out that this is an important question for three reasons – first the role makes clear what attributes a doctor should have; second because it will set the standards against which their performance is judged; and third it affects the way we design health care.

I’m only just beginning to think this through, but I’d appreciate your own views – what do you see as the doctor’s role? what do expect the doctor to do? and what attributes do you think are important?

Posted in from the consulting room, health | 3 Comments »

Changing perspectives. Paradoxes

November 18, 2007 by bobleckridge

I think the only controversial principle of homeopathy is the degree of dilution of the medicines but one of the other principles that at first glance doesn’t make sense is that a smaller amount of something can have a greater effect. I think there are a number of reasons why that’s counterintuitive at first. One is that with poisons and drugs we’ve got used to the common phenomenon of bigger doses having more powerful, usually more toxic effects. You can be sure that if a small amount of a substance poisons you then a larger amount will poison you even more. In fact, it will probably kill you. That’s absolutely true. But if you reverse the direction, is it also true that a smaller amount of something will do the same as the larger amount did, but just more weakly? Strangely, the answer is……not always!

Here’s a couple of examples. Aspirin in large amounts increases body temperature. In fact, one of the signs of an aspirin overdose is hyperthermia. But a small dose of aspirin doesn’t put up the body’s temperature just a little bit. In fact it does the opposite. It lowers the body temperature, which is why we use it to treat a fever. Digoxin (from the Foxglove plant) in a high dose causes a highly irregular heart beat, but a small dose of digoxin doesn’t cause a small amount of irregularity, in fact it does the opposite. It produces a regulation of an irregular heart. An old term for this phenomenon is ‘hormesis’. It’s a term which fell into disuse but which has begun to reappear in two interesting areas.

First of all, in the area of toxicology. There’s an organisation called the International Dose-Response Society which seeks to promote research into hormesis. They distribute a newsletter from a scientific grouping which studies BELLE (Biological Effects of Low Level Exposures). You can find a radio item about this on CBC.

Secondly, Richard Bond, an Associate Professor of Pharmacology at the University of Houston, has proposed the term “paradoxical pharmacology” ( Bond, R.A.: Is Paradoxical Pharmacology a strategy worth pursuing? Trends Pharmacol. Sci 22: 273-276, 2001). This is a proposal for research to be done into the use of smaller amounts of drugs given intermittently in some situations to produce curative effects instead of the tolerances and toxicities which come from the use of large amounts constantly. His main area of interest is into the effects of beta blockers, which are drugs which are designed to block adrenaline and noradrenaline which increase the contractility of the heart. Logically, in a condition like heart failure where the body responds to the changed heart function by releasing more adrenaline and noradrenaline to increase the contractility of the heart, beta blockers should have made the situation worse. And in the short term they can do exactly that, but in the longer term they actually improve the situation. As he says –

Therefore, the paradox remains as to why impeding a contractile system results in an increase in contractility.

He cites the use of stimulants such as amphetamines to treat hyperactivity in children and skin irritants such as retinoic acid and benzoyl peroxide are used to treat acne, which is an inflammatory skin condition as other such paradoxical examples. (it’s also known than giving sedative antihistamines, like ‘phenergan’ to children who don’t sleep makes them more awake!) His potential explanation for these effects is interesting –

acute and chronic effects of drugs often produce opposite effects. This is particularly true for receptor-mediated events. For example, acute agonist exposure can produce activation of receptors and increased signaling, whereas chronic exposure can produce desensitization and decreased signaling

We tend to think of the chronic effects of something as just being a linear extension of the acute situation but that’s actually not true. Here’s his rather startling conclusion –

if acute versus chronic responses are often opposite in nature, and if the contraindications [of drugs] have been made based on the acute effects, there is a suggested list of where basic research can begin to look for clues to investigate paradoxical pharmacology. It is the list under ‘Contraindications’ because the opposite of contraindicated is indicated. This is the list where one would have found β-blockers in CHF just a short time ago. I suggest we test the first precept of medicine, ‘do no harm’, and determine its validity by performing basic research with paradoxical pharmacology. If medicine and pharmacology behave as other areas where short-term discomfort produces longer-term benefit, it might well be that we have paid a high price for accepting a presumption.

This is really another example of the non-linear nature of reality. You can’t take a simplistic notion like more of something will do more of the same so less of something will just do less of what more is, and declare it as a Truth. Life, it turns out, is more complex, and way more interesting! It’s Good Science.

Posted in from the consulting room, from the reading room, health, science | 19 Comments »

Heads up

November 17, 2007 by bobleckridge

Heads up, originally uploaded by bobsee.

I took three of my grandchildren to the Kelvingrove Gallery last week.
I’d seen photos of these heads but I’d never actually been to see them in situ so to speak.
It’s a great experience. You can stand and look at them for ages and you keep seeing something new, something different. Some of the expressions make you laugh. In fact, I think the whole installation makes you laugh and that is SO Glasgow! Glasgow people have quite a reputation for their sense of humour. I think it’s one of their greatest qualities.
I like art that makes you think and/or makes you feel. It’s that old Deleuzean thing again – the three ways to think – science, art and philosophy. It’s not a competition between those perspectives – they work together to reveal more than any one approach can do by itself.
If you ever take a trip to Glasgow I’d recommend taking in the Kelvingrove while you’re there.

Posted in art, from the dark room, life, philosophy, photography | 1 Comment »

Different perspectives – what do symptoms mean?

November 17, 2007 by bobleckridge

Most people don’t go to see a doctor unless they feel that something’s not right – in other words, they have a symptom. However, you might go and see a doctor just for a check up or for some screening, even if you’re feeling well. Maybe the following graphs will provoke some thoughts about this.

basic.jpg

If you’re healthy, let’s assume you can place yourself in the bottom left hand quadrant. However, if you’re feeling OK but you go to your doctor and he or she finds something not right, say raised blood pressure, or raised cholesterol level or something then you’re in the bottom right quadrant (where the red star is)

obj.jpg

If you’re not feeling well, say you’ve got some pain, or maybe nausea, or you’re feeling unusually exhausted or something, and either there’s something you can see wrong – a lump, or swelling, or a rash, for example – or your doctor examines you or does a few tests and finds some abnormalities, then you’re up there with the
blue star in the top right corner.

objsubj.jpg

But if the doctor examines you and does tests and finds NO abnormalities then you’re in the top left with the green star

subj.jpg

Doctors are most comfortable dealing with patients who fall into the right hand side of this chart. When we can make objective findings we can diagnose a particular disease.

dis.jpg

This is the main goal of undergraduate medical training – to be able to make diagnoses (in the sense of being able to identify or exclude the presence of a particular disease).
Two things follow this clinically. First of all, treatments are specifically targeted towards the disease. Secondly, symptoms are assumed to be in direct, linear relationship with the disease, so if the disease is reduced, there is an expectation that the symptoms will be reduced accordingly, and, on the other hand, if symptoms are reduced then that can be taken as a sign that the disease is on the wane.
But, actually, human beings are more complex than that. Symptoms and disease are not in direct linear relationships. In fact, in all complex systems, we find that non-linearity is a key characteristic.
Let me give you an example. A woman may complain of severe recurrent or chronic pelvic pain. Tests show that she has some of the tissue which normally lines the uterus lying outside the uterus – a condition known as endometriosis. The surgeon removes the offending wayward tissue but after recovery she finds she still has the pain. I’ve seen patients who have had large portions of their bowel removed for bowel pain who continue to have bowel pain and patients whose spinal abnormalities are treated surgically but whose back pain remains as severe as ever. That’s the downside. On the upside, if a patient has, say diabetes, then getting the dose of insulin right is highly likely to improve ALL of their symptoms. Or if a patient has a broken leg then repairing the fracture is highly likely to remove the disability and the pain. There are relationships between symptoms and diseases, they’re just not simple, linear ones!

But what about the patients who present with symptoms but where the doctors can’t find any objective abnormalities? Well, they are part of a group of patients who can be understood from a different perspective from the disease one – illness.

ill.jpg

Eric Cassell puts it very nicely in his “Healer’s Art” where he says that illness is what a man has, and disease is what an organ has; illness is what you go to the doctor with, and disease is what you come home with! In other words, illness is the whole picture of the patient’s symptoms and their disease.

Sure, if their illness does at least include an indentifiable disease process, the treatments can still be targeted against that disease (in the hope that such an approach will solve the whole problem), but what about the patients who have symptoms but no identifiable disease?

subj.jpg

In Glaswegian there’s an expression for this “It’s in yer heid!” But this is more than a little unfair! It implies that if you’ve got a symptom which remains “medically unexplained” then it’s either imaginary, or due to a psychological problem. This is overly simplistic. First of all because there may indeed be a physical disease process going on that’s just not been uncovered yet. Secondly, because as complex organisms, disturbances of the inner healthy functions are often vague and hard to pin down, but become clearer as they become more severe. And thirdly, because we are all embedded creatures, you can’t consider us in isolation. If you want to understand someone’s symptoms, you need to understand something about their life, especially their changes, challenges and stresses. Changes, challenges and stresses can impact on the mind and the body in diverse ways.

How often does this latter case appear in the working life of a doctor? Well, an American physician by the name of Kroenke, has done a lot of research into this and here’s a slide which summarises one of his key findings –

kroenke.001.jpg

Kroenke has found that of the top ten commonest symptoms presented to doctors by their patients, almost 9 out of 10 of them will fall into this category. As I heard him say once – medical school teaches you how to treat the 1 in 10 with a medical diagnosis, but how are you going to treat the other 9 in 10?

This illness perspective presents a completely different set of challenges from the disease one. I’ll say more about them in another post cos this one’s gone on long enough I think.

But, tell me, what do you think about this?

Oh, and just in case you were wondering, the bottom left segment does represent health, but that feels strangely unsatisfying. Health is just the absence of the bad stuff? It was this diagram which led me to explore what health actually is.

Posted in from the consulting room, health | 6 Comments »

Homeopathy

November 16, 2007 by bobleckridge

Some of you who have been around this blog for a while will be aware that I’m a medical doctor and that I work in the National Health Service in Scotland at the Glasgow Homeopathic Hospital. I blog with a hope that my photos and my writings might add a little to the lives of people who browse here. I want to make a contribution. I want my contribution to the intricate net of connections between us to be one of positivity, something which you might find life-enhancing, or inspiring, or thought-provoking, or interesting, or moving.

You know what I hate? Negativity and cynicism. There are people who like to pour their energies into tearing things down. I’m not one of them. I don’t know what you’d think constitutes a good life, but for me, it’s something to do with being the hero of your own story, not a zombie in somebody else’s. What do I mean by that? Well, you can read more about these ideas on the permanent pages (see the tabs, Hero or zombie?, and AdaptCreateEngage, above the banner photo at the top of the blog).

There is a concerted campaign to drive homeopathy out of the National Health Service. This is a campaign to tear something down. I had a brush with it today and the experience has provoked me to write down my views about this therapy which I practice – to explain it a bit.

I wrote a post about homeopathy once before, but what I’ve done now is copy that text into a new permanent page entitled “Homeopathy“. You’ll find that first post under the heading “Part One”. Then I’ve added my thoughts on some of the points which are raised in this debate. You’ll find them under the heading “Part Two”.

These two parts make for an article that’s way too long for a post and I hope there are some points in there which will make a positive contribution.

Posted in from the consulting room, health | 14 Comments »

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