Browsing through the electronic Telegraph (Telegraph.co.uk) 22 April 2010 in an idle moment, I came across this intriguing, if slightly puzzling, alliterative headline: ‘Red Wine Bolsters Brain Against Strokes’.  Sounds like good news!  Not quite sure about the ‘Bolsters’ but maybe drinking red wine helps to prevent one getting a stroke.

But wait a minute – the sub-heading is a bit of a come down: ‘Red wine protects the brain from damage after a stroke, new research suggests.’  Oh dear, the main headline is misleading, then.  It seems red wine can protect the brain from damage only after you’ve already had a stoke, and this is not proven: the ‘new research’ only suggests this happens.  Better than nothing, I suppose.

Let’s read on:

‘Researchers discovered that a compound found in red grape skins and seeds lessens the effect of a blood clot on the brain and aids recovery.  It could be so effective that the substance, known as resveratrol, reduces the long-term brain damage by as much as 40 per cent.’

My hopes rise again.  But what does it mean ‘[R]educes the long-term brain damage by as much as 40 per cent.’?  Without knowing what is being compared with what, and whether this refers to relative or absolute damage reduction, such a statement is meaningless.

Never mind.  Drinkers of red wine, is seems, will or may suffer less brain damage if they are  unfortunate enough to have a stroke, compared with teetotallers.  Better than nothing.

Hopes slightly buoyed up.   Lets plough on.

Oh, oh, I knew it.  Here we go again:

‘Two hours after feeding mice a single modest dose of resveratrol the scientists induced a blood clot or ischemic stroke by essentially cutting off blood supply to the animals’ brains.’

My eyes glaze over.  Mice.

Can someone – anyone – please enlighten me about what inducing a stroke artificially in mice has got to do with naturally occurring strokes in humans.

There are enormous and obvious anatomical, physiological, and behavioural differences between mice and men (or women) so that such experiments – if the object is to discover something useful to the human race – are pointless and a waste of time.

To put it another way, I challenge – not for the first time – anyone who does these sorts of experiments to answer this simple question: what is the scientific basis for believing that the results of experiments on animals can be extrapolated to humans?  There is none.

It has been estimated that in no more that 50% of animals experiments are the results useful in predicting what will happen in humans.  In other words, you may just as well toss a coin.  Apparently, pre-feeding resveratrol results in less brain damage in induced strokes in mice.  Does this mean it will apply to strokes occurring in humans?  We don’t know.  Suppose pre-feeding resveratrol to mice resulted in the same amount or more brain damage in induced strokes in mice.  Would this mean the same would apply in humans?  We don’t know.

Significantly, Professor Sylvain Doré at the Johns Hopkins University School of Medicine in Baltimore who conducted these stupid experiments, has not tested resveratrol in clinical trials.  Clinical trials are the only way one can find out whether resveratrol is useful or not in limiting brain damage following strokes in humans.

Furthermore,  it should be noted that: ‘The scientists induced a…stroke by…cutting off [the] blood supply to the animals’ brains.’

Charming.  Mice are sentient beings.  What right does Professor Doré, or anyone else, have to cause pain and suffering in these creatures?

It is no wonder that such experiments have been called crude, cruel, and useless.

©Gabriel Symonds 2010

The former is not, as you might think, a chocolate bar.  As for the latter, I cannot help being reminded by the quirky spelling of the running ‘guru’ James Fixx, who unfortunately dropped dead at the age of 52 from a heart attack while running,  in 1984.

They are both prescription medicine trade names: an oral contraceptive and an anti-arthritis drug, respectively.

The disease that killed James Fixx has also been claimed to have caused the deaths of 40,000 to 60,000 Americans who died of heart attacks while taking Vioxx®.

Yasmin® was promoted to doctors in 2002 as an oral contraceptive which was “truly different”, with a claimed favourable effect on pre-menstrual tension, skin condition, and weight gain.  However, a year later an independent review found that Yasmin® had no advantages over existing, much cheaper, oral contraceptives. The Scottish Medicines Consortium advised in 2003 that Yasmin® is not recommended.  In spite of this it was, and still is, extensively prescribed.

In the case of Vioxx®, when the drug was withdrawn, the manufacturer, Merck, was hit with a deluge of lawsuits from patients and their survivors on the charge that they withheld information about adverse effects on the heart in order to get the drug quickly approved and on the market.  Quite right they should be sued, you might say.

But just a minute.  It is the manufacturer who is being sued?  What about the prescribing doctors?  Why aren’t they being sued as well, or instead?

When a new drug comes out it is often heavily promoted, and the drug company representatives (‘reps’, salesmen, detail men) visit doctors with information about their new drug.  And what do the doctors do?  They immediately prescribe it.  Like there is no tomorrow.  It is reported that nearly 107 million prescriptions for Vioxx® were dispensed in the US between 1999 and September 2004.

Why, Oh why, do the doctors do it?  Do they assume, because a drug has been approved for marketing and is available for prescription, it is safe?  Apparently, yes.  Are doctors so influenced by the blandishments of Big Pharma that their critical faculties fly out of the window?  Are they bereft of judgment, of caution?  Apparently, yes.  Are they over-awed by a free ball-pen, or even a free dinner, so that they go right ahead and widely prescribe the new drug?  Apparently, they do.

It has been demonstrated time and again that new drugs, approved after necessarily limited trials, are thought to be safe but later turn out not to be.

For me, the fact that a drug is new, is a reason not to prescribe it immediately, but to await independent confirmation of its possible benefits and freedom from harmful effects.  Of course, if someone came up with an effective and safe cure for cancer, I would use it straight away, but many new drugs are ‘me too-ers’ which are  similar to existing drugs; their claimed benefits or improvements are often questionable, or marginal.

How are new drugs to be tested, then?  There is no simple answer, but I intend to discuss this matter in a future article.

In the meantime, just as there are so-called NIMBY people (‘Not in My Back Yard’ – nuclear power stations and waste disposal plants, for example, are necessary but I don’t want them near where I live), I would not mind, in relation to using new drugs, being known as a NOMP doctor: ‘Not On My Patients’.

One of its functions is to ‘provide recommendations for the treatment and care of people by health professionals’.

So far so good.  But what does NICE have to say about a disorder that causes widespread suffering and a huge economic burden – low back pain?

They published a ‘guideline’ on this matter in May 2009 running to 240 pages, with the repetitious title: Low back pain: early management of persistent non-specific low back pain.

A summary of the guideline was published in the British Medical Journal (13 June 2009, p1441) which left me feeling rather bemused as to why they had bothered.

The very title contains a contradiction: ‘early’ management (i.e., treatment) of ‘persistent’ …pain.

If the pain is persistent, how can treatment for it be described as early?  Persistent pain is defined in the guideline as that which has lasted from between 6 weeks to 1 year.  So, if a patient has had pain for, say, five weeks, what then?  This doesn’t count as persistent?  Is the patient told to wait till the six weeks have elapsed and then one can apply the guideline?  And if the pain has lasted for, say, 11 months, one can still regard this stretch of time as sufficiently short so that if treatment is started at this point it is still considered early?

Let us stick just with the title of the paper a little longer.  What is ‘non-specific low back pain’ anyway?  Apart from the relatively rare serious disorders which can affect the lower back, such as cancer or tuberculosis, it seems to mean undiagnosed back pain.  Then it should be so called, and doctors’ ignorance should not be covered up this sort of pseudo-diagnosis.  Then at least our minds might be focussed on the need to try and make some sense of these ubiquitous disorders.

The title could more honestly, and concisely, be written: Treatment of persistent undiagnosed low back pain.

But this won’t do.  It violates the first rule of therapeutics: no treatment without diagnosis.

Now, let us get to the meat of the recommendations.  We should ‘Offer educational advice that includes information on the benign nature of non-specific low back pain…’

It includes such information?  So, what information besides should be offered?  Considering that the doctor (I’m sorry, I mean the health professional) – apart from realising (or hoping) that the patient’s ‘non-specific’ pain is not life-threatening – is abysmally ignorant of the cause and treatment of the patient’s condition, how can he or she presume to offer ‘educational advice’?  It is the blind leading the blind.

Then, we are supposed to ‘Encourage the person to be physically active and continue with normal activities (what’s the difference?) as far as possible’.  Oh, great.  Isn’t this what the patient is struggling to do anyway?

Now we get down to the nitty gritty:  ‘Take into account the person’s expectation and preferences…’  Don’t we do this as a matter of course?  Isn’t this passing the buck?  Let the patient (I’m sorry, the person) decide!   Suppose the person responds:  ‘I don’t know, doctor, what would you recommend?’  Or, ‘I leave it up to you, doctor.’  Or – no passing the buck here – ‘If you had my back pain, what would you do, doctor?’

The next paragraph is titled: ‘Therapies for low back pain’.  This looks more hopeful!

‘Offer one of the following treatment options, taking into account the patient’s preference (they’ve said that already): an exercise programme, a course of manual therapy, or a course of acupuncture.’

What a let down.  Here is the patient, suffering from low back pain for at least the last six weeks, coming to a ‘health professional’ for help, and all that should be done, according to this guideline, is to offer – not forgetting the person’s preference of course – one of these non-specific ways of passing the time.  Why should the patient bother at all?  What is the reasoning behind any of these treatments having any effect whatsoever on the back pain?  Will somebody please enlighten me.

Not to worry, there’s more:  ‘Combined physical and psychological treatment programme’.

Now we’re getting somewhere!  ‘[F]or people who have received at least one less intensive treatment and who also have high disability and/or substantial psychological distress’, a mere ‘100 hours over a maximum of eight weeks’ should sort it out.  I kid you not – this is actually what it says.

What about drug treatments?  Surely, here must be some nuggetts of wisdom.  Let’s see:  ‘Advise regular paracetamol (acetoaminophen, Tyelenol®, Panadol®) as the first medication option.’  Well, I could have thought of that.  However, ‘When paracetamol alone provides insufficient pain relief, offer non-steroidal anti-inflammatory drugs (commonly used for painful conditions of the moving parts of the body, referred to as NSAIDs for short) or weak opioids (related to morphine), or both.’  Wow, real rocket science!  And, for those with poor memories, don’t forget to ‘Take into account…the patient’s preference’!

All right, let’s not be cynical.  After all, these are experts who are offering guidance to us lesser forms of medical life, so they presumably know what they are talking about.  Don’t they?

After exhorting us to ‘Give due consideration to the risk of side-effects from NSAIDs’, (thank you, that would never have occurred to me) next on the list is the advice that ‘Either an oral NSAID…or a cyclo-oxygenase-2 (COX2) inhibitor (such as celecoxib) may be offered when an anti-inflammatory painkiller is recommended.’

Now hang on a minute.  Isn’t there something about cyclo-oxygenase-2 inhibitors of which one should be careful?  Oh yes, it’s in my September 2009 edition of the British National Formulary, page 561, in the box:

Cyclo-oxygenase-2 inhibitors are associated with an increased risk of thrombotic events (e.g. myocardial infarction and stroke) and should not be used in preference to non-selective NSAIDs except when specifically indicated…

The anti-arthritis drug celecoxib belongs to the same chemical group as rofecoxib, one trade name of which is Vioxx®, which was withdrawn in 2004 because it was suspected of causing heart attacks in thousands of users.

If all this hasn’t cured you, and if you haven’t had a heart attack or a stroke from the COX-2 drug, there is still hope:  spinal fusion (an operation using bone grafts or metal rods and screws to fix together two or more vertebrae).  Now, I ask you.  In patients with undiagnosed back pain what is the logic of recommending spinal fusion?  It is most curious, because in the list of ‘Treatments not recommended’ is the item ‘Lumbar supports (devices to reduce spinal movement) such as corsets.’  It would be hard to think of a more effective way of reducing spinal movement than an operation for spinal fusion.

Another treatment helpfully listed among the not-recommended sort, is ‘Injection of therapeutic substances into the back’.  Should one inject them into the front, then, or perhaps the side?  This patronising prohibition appears to have been thought up by people who have had no experience in actually treating patients with back pain.

It seems to me the writers of this guideline should go back to the drawing board.

Incidentally, healthcare as one word does not appear in the 2007 edition of the Shorter Oxford English Dictionary.  (Well, at least they don’t (yet) say HealthCare so let’s let this neologism pass.) 

The relationship in which a doctor advised the patient, say, to take a pill three times a day after meals, used be regarded as one where the patient complied, or not, with the doctor’s instructions.  But this was thought to be patronising and so instead there is meant to be a ‘partnership’ with the patient who is fully involved in all aspects of decision making, having had all possible side-effects of the proposed treatment explained to him or her, among much else. 

And now in Britain there is talk of allowing Nurse Practitioners to accelerate the process of attrition of the functions of doctors by being allowed, after suitable training of course, to examine patients from the beginning, make diagnoses, and prescribe drugs.

In a discussion about whether nurses should take over more of the functions of general practitioners (British Medical Journal, 20 September 2008), one article is illustrated with a photograph titled ‘A nurse removes a mole from a patient’s back’.  Great.  Wonderful.  Nurses can do difficult medical procedures like removing moles.  And, by the way, aren’t moles those things which can sometimes turn into cancer?  Presumably that is why it is being removed.  She must be highly trained to that.  And I should jolly well hope so.  But let’s look at the photo a little more closely.

For a start, the patient is sitting in a chair while the nurse operates upon her back in the region of the right shoulder blade.  Not a good idea.  Patients sometimes faint when having injections or their skin cut and fall to the floor.  She should be lying down on an operating table.  Secondly, it is remarkable that the nurse is wearing only one (bloodstained) glove, on her right hand.  This is not safe for the patient or the nurse.  Thirdly, in spite of modern sensible advice that practitioners should be ‘bare below the elbows’, the nurse in the picture is wearing a wedding ring and a wristwatch.  Nasty germs could be lurking around the ring or the watch, including the dreaded MRSA ‘superbugs’.  Fourthly,  the nurse is literally operating in the dark – there is no proper illumination of the operation site with a lamp.  Fifthly…all right, I think you get the point.     

I don’t know about you, but if I had something wrong with me or was just worried about my health, I would want to consult someone who was medically qualified.  And as for this new-fangled notion of having a relationship with patients of ‘concordance’, which the SOED defines as Agreement or harmonious relations between persons, surely this is what any self-respecting doctor has always been aiming to achieve anyway. 

©Gabriel Symonds 2010