The Binscombe Doctor Blog

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Metal on metal hips – a scare, but not a scandal

Posted on February 19, 2012 by Martin Brunet

Medical devices are hot news at the moment. The PIP breast implant scandal is likely to run and run, the way that devices are regulated is under scrutiny, and the merest whiff of a problem with any one of the thousands of devices on the market is likely to make headline news in the coming months. As long as we are able to keep a sense of proportion this will be no bad thing. If you are in possession of a suspect piece of medical technology then you have the right to know what might go wrong, and the news media is one of the most efficient ways of disseminating this information. And regulation has to be in place to protect patients and ensure that problems are picked up early – although we must resist the temptation to so entwine the industry with rules that we strangle innovation and fail to help the patients of the future.

The scare that has followed on from the PIP scandal (which I have already blogged on here) concerns metal on metal hip replacements. Both scenarios involve a surgical prosthesis, but this is where the similarities end. PIP implants are a true scandal – sub-standard implants were developed to save cost, using silicone that had not been cleared for medical use. Metal on metal hips are a scare, because they have caused problems that were not expected, but they were genuinely developed in an attempt to find a better device. The holy grail of hip surgery is to develop a joint that can last as long as the joint it is replacing – and that we are so far from reaching this goal is testament to the astonishing engineering inherent in the joints we are born with. Most hip replacements are a metal head in a plastic cup. Since the metal is the strongest part of this combination, it seemed logical to use this material for both parts of the artificial joint. Early experience was encouraging, and these hips were especially used in younger patients who had the most to gain from a long-lasting joint.

So what has been the problem? Well it is not that the joints are breaking – they seem to be as strong as promised. The difficulty is that, in a small number of people, tiny metallic shavings are coming away from the surface where the two components rub together. This is not weakening the joint, but the fragments are being absorbed into the surrounding tissues, where they make a considerable nuisance of themselves. Mostly this causes inflammation around the joint, and so pain starts to develop in a joint that had been performing well. This will not be sudden, but will come on gradually over weeks and months. In a small number of case reports the metal has been dispersed more widely, and led to high levels of cobalt or chromium in the blood, and associated toxicity. Symptoms have included neurological problems, such as tinnitus, vertigo, anxiety and depression, and memory problems, and also cardiac problems such as heart failure and high blood pressure, and so although this is rare, it is potentially quite worrying. In most cases these more general problems occur in people who have pain in the joint, but in at least one case reported in the British Medical Journal recently there was no pain in the joint – although the joint was inflamed when the patient underwent surgical revision.

The risk to patients is quite different to the situation with PIP breast implants. The implants are at an uncertain risk of a one-time sudden event, which is rupture of the implant. This means that a woman with a fully functioning implant might be well today, and have suffered from a rupture tomorrow. Although the consequences of rupture are not life-threatening, this uncertainty can be difficult to live with. The situation with hip replacements is more straight-forward, although potentially much more serious. A patient with a metal on metal hip who feels well, and has no pain in the hip, need not worry, and certainly won’t want to consider surgery to replace a joint that is working well. On the other hand, if it is causing problems, then revision surgery may well need to be considered – which is quite a significant thing to have to face.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance concerning these implants, as has the British Orthopaedic Association. The consensus view is that the majority of patients will not have a problem and do not need any special investigations. However, all patients should be followed up at least annually for the first five years, and have easy access to prompt follow-up should they develop symptoms. Where symptoms do occur there should be imaging of the joint (MRI scanning or ultrasound) and measurement of blood cobalt and chromium levels. Where revision surgery is needed it may be difficult due to the inflammation, and so should be performed by a surgeon experienced in revisions. For anyone who has had a hip replacement and is not sure of the type of joint they have, they should contact the orthopaedic surgeon who performed the surgery who will be able to advise on the type of joint used.

Posted in orthopaedics | Tagged , , | Leave a comment

On Shrinking or Growing

Posted on February 4, 2012 by Martin Brunet

We doctors like to think that each day brings another stream of contented patients, leaving our rooms with their health bolstered by the edifying power of our erudite and well-considered advice. And maybe each day a few do just that. We know, however, that lives are far more complex, that the doctor only plays a minor role in any individual healing journey – and that the patient may play no small part in the journey of the doctor also.

“Our patients are our greatest asset,” was what my former senior partner, Chris Jagger, said to me when he invited me to join the practice over ten years ago, and the longer I have been in General Practice the more I have understood what he meant – that the people I am meant to be helping will have an important role in teaching me and shaping me as a doctor.

One such lesson, which I come back to again and again, happened a year or so ago when a patient said to me: “When something bad happens to you, you can shrink or you can grow – and you do have a choice.” These wise words are well worth holding on to, storing somewhere safe and retrieving whenever the need arises.

They say that you can’t tell if a bridge is well made when a cat walks over it – but if a train crosses the same bridge then it has been well and truly tested. The woman who gave me this gem of wisdom has experienced the odd express train over the years, and so I know that this advice is born out of real life rather than the theoretical musings of someone who has never known adversity.

I have just come across a powerful example of someone choosing to grow despite impossible circumstances when I read The Diving-Bell and the Butterfly by Jean-Dominique Bauby – a book that I would recommend to everyone as a remarkable source of inspiration and hope. It is only 135 pages long and consists of short, disjointed chapters with no sense of a plot and so it makes an unusual read, but it is compelling nonetheless.

The book is the account of its author about life with “locked-in” syndrome. This aptly named, profoundly tragic condition occurs when the brainstem is devastatingly destroyed – usually by a stroke. The brainstem is the connection point between the thinking part of the brain and all the body’s functions. A person with locked-in syndrome can think, hear, and see, but cannot speak or move. Conscious yet totally paralysed – this is no ordinary express train to test the structure of your bridge. A stroke was the cruel force behind Jean-Dominique Bauby’s reduction from Editor-in-Chief of the French Elle magazine to locked-in patient at the frighteningly young age of 44. He had only the slightest residual movement – he could blink his left eyelid – and with this he communicated with the outside world, and ultimately dictated this book.

What is remarkable about the book is the author’s lack of bitterness and the strong sense of hope that permeates its pages. Bauby is honest - he does not hide the reader from the pain, frustration and humiliation inherent in his situation - but he has a determination to see the beauty of little things that we don’t normally notice, the ability to dwell in the moment and seize every opportunity to bring a richness to his existence – using his imagination to take him to places that were denied him when he was free to roam. For someone who could apparently do nothing, he was always busy – seeing, thinking, listening, and latterly composing, reworking and memorising the chapters of this beautiful book, ready to laboriously dictate them the next morning.

When someone shows as much courage in diversity as Bauby has shown there is a danger that the inspiration we might receive is tempered by a deep sense of inadequacy by comparison. Here, Bauby helps the reader to stay connected to him by making it clear that he is far from a perfect saint. He is open about his own inadequacies, particularly from before his illness, and you get the impression that he would have been hard to live with at times. He laughs at himself, cracks bad jokes and never gives up hoping for a cure. You feel that you can relate to him – here is a normal guy who has learnt, for the most part, to hold on to that most human of traits – hope – and choose to grow despite it all.

In our success-driven modern world we like to live our lives pretending that adversity won’t happen to us, but if you work in health-care you are reminded daily that it frequently does - and so I commend this book to you, and I will hold on to my patient’s advice. I only hope that, with God’s help and grace, I will always be able to choose to grow when I have the opportunity.

Posted in Neurological Medicine | Tagged , , | Leave a comment

To patch or not to patch? The latest on Nicotine Replacement Therapy

Posted on January 18, 2012 by Martin Brunet

It is an inevitable consequence of the headline-driven world we live in that the newsworthiness of any health story will always be measured by its ability to generate a good strap line on a popular subject with a high level of public interest, rather than its actual value to the health of the nation. I can’t say that I mind this – as someone who enjoys a catchy headline as much as anyone I suspect it would be terribly dull if it were not so.

Nevertheless, the inevitable consequence of this approach is to elevate some stories somewhat above their station, as was the case with last weekend’s headline: ‘Nicotine patches no better than will power to quit smoking‘. I can’t blame the Daily Telegraph for this somewhat misleading conclusion – after all, the Today Programme on Radio 4 said much the same thing, and it is rather more attention grabbing than ‘Ex-smokers relapse at the same rate regardless of how they quit’, or even ‘quite a lot of people who have recently quit smoking actually succeed’ – both of which are more true to the facts, but would never help me to get a job in journalism.

The reports related to a study on the outcomes for people in the USA who had recently quit smoking which was published recently in the Journal Tobacco Control. I have no problems with the paper – it is well conducted study with honest intentions, and has added something to our understanding of smoking relapse. It does not, however, tell us about whether or not nicotine patches help smokers to quit – since it only looked at relapse rates of those who have already quit, either with the help of Nicotine Replacement Therapy (NRT) or without it.

The researchers conducted telephone interviews in 2001-2002 to make contact with 4991 people who were current smokers, recent quitters (those who had quit in the last 2 years) and young adults (who were thought more likely to take up smoking). They then phoned these people again at 2 and 4 years to review about their smoking habits. Of those who managed to quit, about 30% had started again at 2 years, and a further 30% of the remainder had started again at 4 years. Put it another way, 70% were not smoking at 2 years and 70% (so 49% of the original number) of these were still not smoking at 4 years – good for them! If 50% of people who manage to stop smoking are still ex-smokers at 4 years that is something to celebrate in my book.

The study then went on to look at any factors that might predict why a person would relapse – age, sex, ethnicity, educational attainment, level of smoking, duration of quitting at the time of the research and use of NRT were all studied. The problem with looking at so many variables is that the numbers start to get quite small when you break it down – so there were only just over 50 users of NRT in the entire study (compared with over 400 who had quit without using NRT). They found that the only factor that could predict whether or not someone might relapse was if they had already quit for longer then 6 months – when relapse fell from the baseline of 30% to around 17%, a figure that reached statistical significance.

So, if you quit using NRT then this (now quite small) study suggests that you are no less likely to relapse than someone who has not used NRT. Well that is not a finding that knocks me over! Why would we expect NRT to make a difference to relapse rates months later? There is no reason for it to have a prolonged effect – the key question is, does it make you more likely to quit in the first place? If I am twice as likely to quit by using NRT and I have the same relapse rate, then I am still twice as likely to become an ex-smoker in the long term. If NRT had double the relapse rate then we might have a problem, but that is not what this research has shown.

The considered opinion on the effectiveness of NRT from the meta-analyses of all the Randomised Controlled Trials (the major ones of which are actually quoted in this paper) is that the quit rate with NRT is somewhere between 1.5 and 3.1 times the rate with placebo. So NRT does work. It might not suit everyone, and is no substitute for a good dose of will power, but we should not throw it out of the smoker’s armoury just yet.

Posted in Health Promotion | Tagged , , | 2 Comments

The right not to be lectured to

Posted on January 11, 2012 by Martin Brunet

I recognise the signs now. They vary, of course. Sometimes it is the slight drop of the shoulders, the hangdog expression, the look of learned helplessness and defeat. Or it might be the just opposite – the set jaw and steely look in the eye that says: ‘Go on, then! Just you try, I’m ready for you!’

It usually happens in the second half of the consultation. We have talked about the problem, looked at the offending body part that has caused the symptoms and begun to skirt around the cause or hint at solutions, but we both know it is coming. There is no way around it – we are going to have to talk about weight. The best thing we can do is get it over with as quickly and as painlessly as possible.

I feel for my overweight patients. You can lie to me about how much you drink and admit to only half the cigarettes you smoke. You can even claim to actually get your money’s worth from your gym subscription and I will happily believe you, but you cannot leave your weight at home when you visit me or pretend it isn’t there. You know your heartburn/diabetes/foot pain/arthritis is largely down to your weight and all you can do is steel yourself for a lecture while you sit in the waiting room.

And now the Government tells me we have to have this conversation every time you come to see me.  You might come about a cough, a cold or a wart on your finger and I am to talk to you about your weight. Burst into tears with depression,    troubled with your periods, stressed at work or worried about your elderly demented mother – if it looks like you might tip my scales then I am to make every contact count and talk about your weight. And while we are at it, what about your smoking, drinking and that underused gym subscription…?

The Government has accepted in full the recommendations of the NHS Future Forum which includes the concept of making every contact count – that all health professionals, whether GPs, pharmacists, dentists, nurses or anyone else that has a professional contact with patients, should promote healthy lifestyle measures every time they see someone, whatever the reason for the contact. What is more, the recommendation is that: ‘To emphasise the importance of this responsibility, the Secretary of State should seek to include it in the NHS Constitution.’

The NHS Constitution is a list of the rights and responsibilities of patients and professionals with respect to the NHS. It is an important and helpful document that shapes health policy rather like the Human Rights Acts shapes legal judgements. I don’t deny that there is a responsibility of health professionals to promote health and well-being, as well as to diagnose and treat ill-health and disease. However, where, alongside this responsibility and the patient’s right to receive lifestyle advice, is the patient’s equally important right not to be lectured to?

Like all GPs, I regularly talk to patients about their lifestyle – where it is appropriate. The idea that GPs should promote good health has been enshrined in the very fabric of the GP consultation since at least the 1970′s. I am not afraid to confront quite forcefully when it is needed, and I know it can make a huge difference to a patient who is ready to change. I will always remember seeing a man in a hospital clinic many years ago who had recently had a stay in hospital with his first episode of angina. ‘Can you thank that young doctor who admitted me?’ he said. ‘She so frightened me about my smoking that I handed her my packet of cigarettes and haven’t touched one since!’  I was only too pleased with the result, and to pass on his thanks. What I decided not to tell him, however, was that rather than waste his cigarettes she had smoked every one!

However, there is a major difference between challenging a patient when they are ready to consider change, and lecturing, nagging and bullying patients when they are not. The latter is not only irritating and stressful for the patient, but also counter productive in terms of psychological theory – one of the basic premises of which is that if someone is not receptive to change then you should stop pushing (you can find out more about this by reading about Motivational Interviewing if you are interested). If I have not seen someone for a while then it may well be worth raising the issue of smoking even if they have come in for a quick chat about something else – maybe they are ready and I can strike while the iron is hot – but many of my patients I know better than that. We will have talked about smoking, or weight, or whatever, many times before and sometimes they just need to know they can have a break – permission to see me without being told off, without feeling guilty.

I don’t think this paper will change anything at the moment, but I worry about where the Government will go with it. Once they start to enshrine it in the NHS Constitution it is only a step away from red tape and performance targets – nurses spending yet more time away from the patient while they tick the box marked ‘Making Every Contact Count’, GPs being paid according to how often they raise lifestyle issues regardless whether the patient wants it, pharmacists being incentivised to talk about lifestyle rather than actually answering the patient’s queries – and patients being afraid to come near us all for fear of yet another lecture.

Posted in Health Promotion | Tagged , , , , , , | 1 Comment

PIP Breast Implants – Where is the meaning behind the statistics?

Posted on January 7, 2012 by Martin Brunet

The controversy over the PIP Breast Implant Scare all seems to come down to the  rate of rupture of these suspect devices – believe the French figure of 5% and you may agree with the French Government that all the implants should be removed. However, if you side with the statistics of the English Government and the Medicines and Healthcare products Regulatory Authority (the MHRA, the UK body that approves or otherwise the licence for medicines and surgical devices), and you may find the 1% rupture rate they quote rather more reassuring, and agree that there is no cause for alarm. If it offends your European sensibilities to decide which side of the channel should win your allegiance, then you can always opt for the 7% figure quoted by the Transform cosmetic surgery group – although as this was only 7 out of 108 patients this is hardly the most robust of statistics.

For my own part, I have a major problem with all these numbers, which is this: What do they mean by a rupture rate? Is the quoted rupture rate the rate of rupture in the lifetime of the implant or the rate per year? There is a very great difference between the two! 5% over the lifetime of an implant might be very acceptable to some women, but I suspect few would be unconcerned about a 5% risk year-on-year.

In the last 2 weeks I have made several attempts to scour the internet and try to find clarification on this matter. I have reviewed the guidance on the MHRA website, and trawled through numerous news reports from the BBC, Reuters and other respected news agencies; I have searched Google Scholar and done my best to review the literature (distinctly lacking as much of the important data is held by the companies themselves or the surgeons performing the operations and has not been published in journals). I have read the letters to Health Care Professionals from the Chief Executive of the NHS and the Chief Medical Officer. In all, I have probably spent 2 or 3 hours in the cause, and – until today when the first glimmer of clarity has come my way – I have found nothing: No clarity on what is meant by the rupture rate, and no reference for the original figure that these data are based upon. If it is this hard for a GP to find answers, how must it be for a worried patient, who may have no medical training, to make the important decision as to whether or not to subject herself to an operation on the basis of an uncertain and undefined risk?

And the glimmer of clarity? Well the Department of Health published its interim report yesterday. It is a typically meaty Government document and so not for the faint hearted, but it does contain the following point (page 8, paragraph 18):

“Much attention so far has been given to the issue of rupture in breast implants. The cumulative risk of rupture of a breast implant increases progressively over time. An analysis published by the FDA showed that the rupture rate for the Allergan implant is 0.5% after 2 years, rising to 10.1% (cumulative) after 10 years. For Mentor implants, the post implantation failure rate at 8 years was 13.6% (cumulative). It follows that quoting a “rate of rupture” for an implant, without specifying the time since the original implant, is unhelpful and  potentially misleading (my italics). ”

Thank you Department of Health! So the 1% rate (relating to a different implant that has no safety concerns) rises to 10% over 10 years – in other words it is 1% per year. Interestingly the 7% rate quoted by the Transform cosmetic group was 7 patients out of 108 who had had implants since 2005, so presumably this is 7% over 6 years, which sounds suspiciously close to 1% per year to me, even though it was reported by the media as being higher even than the 5% French rate – which still remains totally unclarified.

The baseline rate, therefore, that any woman should have had explained to her prior to surgery and against which the PIP data needs to be compared, is a 1% year-on-year rupture rate. Unfortunately, when the group analysing the data for the DOH report came to the PIP implants (included in a very confusing Annex D in their report) they found that the data was woefully incomplete and that no conclusions can be drawn. For the moment there is not enough evidence to recommend routine removal on the basis of the risk of rupture, but they do conclude that it could be warranted on the grounds of the anxiety that the implant scare has caused, and that private clinics should be prepared to pay for this.

A significant concern about the way this controversy has been handled is the assumption that has often been made that the only thing the patient needs is guidance from the authorities – that all that is required is for the Government, be it English or French, to issue a recommendation that all the affected women should follow. It is certainly helpful for Governments to issue advice where they can, and many women will indeed want to follow it, but many will want to decide for themselves. Whether or not to have the implants removed will be a very personal decision, and women will need to be able to come to this individually. For this they need a clear presentation of the risk, with numbers that actually mean something and in a form that can be easily understood.

Posted in Women's Health | Tagged , , , | 1 Comment

A Small Contribution to the Year of Protest

Posted on December 16, 2011 by Martin Brunet

Time Magazine recently announced their Person of the Year 2011. Following on from previous notables such as Mark Zuckerberg and Barack Obama, this year the award has been given to The Protester – the nameless man or woman who has taken to the streets in their tens of thousands in 2011 and brought about major change in so many parts of the world – the Arab Spring being the most notable example, but austerity marches in Greece, the protesters bedding in for winter outside St Paul’s, and those taking to the streets in Moscow (ironically, protesting against the 2007 winner of this award, Vladimir Putin – how times change!) have added their noteworthy voices to the rise of the people in this turbulent year.

Well, I would like to add my own small voice to the crowd, and have decided to draw the battle lines for my own miniature protest. There is a joke that when an Englishman is really angry about something he nearly writes a letter to complain about it – well, I have actually gone so far as to write a letter – in fact four letters – so there!

Not that I am that angry, but I did feel challenged recently that if I am going to complain about something on this blog, then I should also try to do something about it. And the object of my frustration? The rightful target of my wrath? Not, I am afraid, rampant government corruption, nor am I remotely newsworthy enough for someone to consider hacking into my telephone, nor is it anger at the actions of bankers, nor the foolish words of Jeremy Clarkson. No, what has motivated me to put pen to paper is nothing more or less than breakfast cereals.

I love breakfast cereals. I encourage young parents to make their baby into “a Weetabix baby” (sorry to display the typical frankness of a doctor, but there really is no better way to ensure a lifetime without constipation!), I am heartened by the idea of young people heading off to school equipped with the energy-giving properties of a good breakfast, and live in hope that families might sit down together and make this important event a social occasion that transcends the usual grunts and groans of an early morning. What I hate, however, is the concept of ‘children’s breakfast cereals’. I know that companies market cereals for children, and I am not naive enough to think that they should be banned from doing so, but for supermarkets to label them as ‘children’s cereals’ implies that children are incapable of eating anything that is not sugar-coated or covered in transfats.

This is small beer compared with the global crises we have been faced with in 2011 – but the more I think about it, the more fundamental it seems to be. It is at the heart of how we treat our children. If we believe that they are fussy, untrainable creatures that will only respond to the instant gratification that sugar, chocolate, television and video games can provide, then we can only expect one thing – they will become fussy, untrainable creatures that will only respond to the instant gratification that sugar, chocolate, television and video games can provide. We will find ourselves avoiding the cereal aisle altogether because we can’t imagine how we could walk past some chocolate-covered offering without either putting it in the trolley or having an intolerable tantrum. I have ranted on this subject before in a post on Fussy Eating, which also received some comments that are well worth reading.

Children are not demanding monsters who must be appeased, but intelligent, empathic individuals who look to adults for supportive guidance as to what is right and what is wrong, and thrive in an environment that is liberated, but with clearly defined, appropriate boundaries. Teaching them how to distinguish what should be the staple of a healthy life-long diet, and what is an enjoyable occasional treat, is an important part of their development that will equip them well for the rest of their lives. Most parents believe this, and do an excellent job in bringing it about – but we could do with all the help we can get, as it is not always easy!

To walk down a cereal aisle in your local supermarket, and find a section clearly marked as ‘Children’s Cereals’ and another ‘Adult Cereals’ (as is the case in the Guildford branch of Sainsbury’s. although not, I am glad to say, their Godalming branch) is really not helpful. Apart from the advice that nuts are best avoided in children under three years of age, there is no cereal that is not suitable for children. For as long as products are labelled in this way, new parents will assume it is the norm and be susceptible to this marketing lie, and children will absorb the message that there is something wrong with cereal if it is not coated with sugar or chocolate.

And so to the campaign! I have written letters to the Guildford branch of Tesco’s (who are just as culpable as their rivals) and Sainsbury’s (both attached below), as well as the central office of both stores. I will keep an eye on other stores as I visit them, and will send more letters accordingly. If anyone would like to join me in this small venture I would be delighted to have your support, and I will post any response to my letters in this blog. Wish me luck in this year of protest! Onwards into 2012!

Tesco’s Letter

Sainsbury’s Letter

Tesco’s Central Office Letter

Sainsbury’s Central Office Letter

Posted in Child Health, Nutrition | Tagged , , , , , | 2 Comments

Multiple Sclerosis – the developing link with Vitamin D

Posted on December 12, 2011 by Martin Brunet

The 19th Century was the real heyday of discovery when it came to the enigmatic role that vital amines (or vitamins as they came to be known) play in human physiology. That our bodies could be so dependent on minute quantities of these mysterious substances was demonstrated profoundly in the cure of the dreaded disease of scurvy, by the simple provision of limes to sailors. The prevention of beriberi, rickets and other diseases of deficiency soon followed, and in the early 20th century all the scientists had left to do was to identify and purify the dietary compounds responsible.

We are never likely to cure a vitamin-related disease in one fell swoop in quite the same way again, but there is still much to be learnt about the role they play, and the possibility that a relative deficiency in a single vitamin might influence our risk of developing a particular disease. High on that list is multiple sclerosis (MS), a debilitating disease of the nervous system, and its relationship with Vitamin D. Although we do not know the cause of MS, we can be sure that it is not simply a matter of deficiency – many people have low Vitamin D levels and do not develop MS, while many of those who do develop it will have normal levels of the vitamin. Genetic factors and other environmental triggers will certainly play their part. The question is – does a low level of Vitamin D make you more susceptible?

Well, there is some compelling circumstantial evidence. One of the most striking reasons to think about Vitamin D in particular is the unusual geographical incidence of the disease. This is beautifully demonstrated on this map, based on WHO data. Whatever explanation we come up with for MS, it has to account for the remarkable predilection that the condition has for increasing latitude away from the equator – something that also makes it a pressing issue in the northern climes of the United Kingdom. That sunshine is our most potent source of Vitamin D is something I have already commented on in this blog, and this is clearly a commodity the equator has in abundance compared with the poles. There is also evidence of an association between low blood levels of Vitamin D and the development of MS, and only last week, new research was published from Oxford which suggested that at least some of the genetic link could be related to problems with Vitamin D.

The Oxford study was clever in its approach. They took about 1500 children with MS and looked at the genetics of their parents, to see if they were carriers for a genetic defect known to be linked to Vitamin D deficiency. If a child inherits two copies of the gene (one from each parent) then they develop a congenital form of rickets due to severe Vitamin D deficiency, but being a carrier for the genetic defect is not thought to be a problem. They discovered that of the 3000 parents, 35 of them were carriers for the gene. In itself that is not too remarkable. That means 2965 parents did not have the gene and yet had a child who developed MS – hardly evidence of a strong genetic cause. What was interesting, though, is that in all 35 cases the affected child inherited the genetic defect. Left to chance you would expect only 50% of the children to have inherited the gene – as the researchers say, it is like tossing a coin 35 times and getting heads every single time. Interesting indeed!

The problem is that all this evidence, good as it is, is circumstantial – there is no proof of cause and effect. It is rather like finding the candlestick that killed Colonel Mustard in the library with Miss Scarlett’s fingerprints on it – good, but not quite good enough to make a conviction – maybe she just liked polishing candlesticks? What we want to know is this: Would taking Vitamin D supplements help to prevent MS, or help avoid relapses in people who already have MS? To answer those questions we need a large, randomised study where thousands of people are given either the vitamin or placebo, and a second, similar study in people who already have MS.

The problems are these: The first study has to be large, and large means expensive. Vitamin D is cheap and generically available which means drug companies will not be interested in making an investment, leaving the cost to fall on research charities and governments in these austere times. The second study can be smaller, since episodes of relapse in people who have MS will be much more frequent than new episodes of MS in the general population, but how do you stop people with MS from taking Vitamin D on their own initiative? The placebo arm of the study will not be much of a placebo if everyone is also obtaining the vitamin from their local pharmacist. If I had MS would I take it? Well, yes. On the grounds that Vitamin D supplements (at normal levels) are safe and probably a good thing anyway, I think I could be convinced on even circumstantial evidence.

Posted in Neurological Medicine, Nutrition | Tagged , , , , | 2 Comments

Cervical Cancer Vaccine – warts and all

Posted on December 5, 2011 by Martin Brunet

Warts don’t make headline news. They never have, and they never will. And so when the Government announced a change in the cervical cancer vaccine available on the NHS, to a vaccine that also protects against genital warts, it was never going to make the front page – or if it did, I certainly missed it.

I caught up with the change via the medical press, and an announcement sent to all GPs from the Department of Health, but was comforted to see that the ever-reliable Fergus Walsh managed to find space for it on the BBC News website. In case you missed it, I thought I would air it here.

The issue relates to a previous article I have written in this blog where the issues are discussed in more detail. In brief, there are two vaccines that are equally effective in their protection against cervical cancer Cervarix and Gardasil. The only real differences between them are that Gardasil is more expensive (hence not an initial favourite with our limited NHS resources) and also gives protection against the two strains of Human Papilloma Virus (HPV) that do not have any link with cancer, but cause the majority of genital warts. The Government has redone its calculations, and been advised by the Health Protection Agency that the cost saving in terms of the reduced cost of treating genital warts makes the more expensive vaccine better value for money after all. The change will happen in September 2012.

If you have read my previous article, you will know that I am quite ambivalent with regard any merit of one vaccine over the other,  and the purpose of this article is to try to allay the natural fears that may arise in any young woman, or her parents, who are being told that the vaccine they received is to be replaced by a ‘better’ one. I am glad to say that if you want to protect against cervical cancer then you don’t need to worry one jot: The current vaccine is as good as anything at preventing the HPV strains that are associated with cancer. Sure, you might have liked to be protected against warts – it has a sort of Buy-One-Get-One-Free appeal to it after all – but at best this is a useful by-product of a vaccine designed for an altogether different purpose, and at worst a clever bit of marketing by Sanofi Pasteur MSD who, like any good salesperson, have managed to convince us to buy an upgrade that we didn’t know we needed.

At the end of the day, if you are concerned about genital warts your best protection is always going to be a responsible attitude towards sex, and a condom – with the real BOGOF bonus of protecting against something really important – like HIV…Hepatitis B…Herpes…unwanted pregnancy…Chlamydia…

Posted in Cancer, Infectious Disease, Women's Health | Tagged , , , , | Leave a comment

New NICE Guidance on Caesarian Section – no major change in practice, but welcome nevertheless

Posted on November 24, 2011 by Martin Brunet

The updated NICE guidance on the use of Caesarian Sections in obstetric care proved sufficiently newsworthy yesterday to receive widespread coverage, including on the BBC, and with good reason. The decision to opt for a planned Caesarian Section in an uncomplicated pregnancy has always been a controversial one, and the previous guidance stated that maternal preference alone was not sufficient to proceed with this option. This has now been overturned, and maternal choice has prevailed.

The change in the guidance has obviously stirred strong opinions – the BBC site had elicited 622 comments within 12 hours, and is now closed to further postings. Views range from the strong feeling that a woman’s right to choose has to take priority, to others who say we can’t afford it, and still more who question why on earth a woman would want to subject herself to an unnatural major operation in place of the wonderful experience of childbirth (usually posted by women who have been blessed by a very positive and rewarding experience of the latter). As a man, I couldn’t possibly comment!

I do think, however, that it is very difficult for a woman to be able to choose what is best for her as an individual when she feels that a perfectly valid option is being denied her. The previous guidance made the situation very difficult for her, and Trusts are undoubtedly under pressure to keep their Caesarian Section rate low. For women who wanted to consider this option, there was the very real danger that a discussion with their obstetrician would become a challenge to prove to him or her that your case was worthy to upset their statistics, rather than an unbiased discussion on the potential harms and benefits of Caesarian Section verses a trial of natural labour. If there is even a hint of conspiracy and denial of rights then this can seriously undermine the doctor-patient relationship and so lead to bad decision-making. Patients need to be able to believe that their doctor really does have their best interest at heart with the information and advice that they give, and to be at the centre of decisions made about their care.

In reality, few women want to choose a Caesarian for an uncomplicated pregnancy, and most are able to face the uncertainty and huge physical challenge of natural labour with great courage and strength – and the majority are delighted afterwards (if not usually during!) that they have done so. However, the fact that the majority are best served by this outcome does not mean that we should underestimate the fact that some women have very difficult labours that are far from rewarding, and for some the security of a planned operation is indeed the right choice. This is something the NHS should value sufficiently to find the necessary additional expense it may entail, and NICE has done well to make this advance for patient-centred care.

Posted in Women's Health | Tagged , , , , | 1 Comment

Where is the Evidence?

Posted on November 18, 2011 by Martin Brunet

I had one of my increasingly rare encounters with a representative from the pharmaceutical industry this afternoon. As usual, it left me wondering when our society will have the courage to stand up to the giants of the industry, and insist that they show some real evidence before they are allowed to market their products.

The drug in question is a new form of pain-killer called Tapentadol. I was quite interested to hear about this product since I had only come across it for the first time three days earlier, and it seemed worthwhile finding out a bit more. The drug is a morphine-like pain-killer, and the major selling point is that it has a novel, dual mode of action. Pain can be classed as nociceptive (standard, hit your thumb with a hammer type pain) and neuropathic (pain caused by over sensitive pain nerves, as occurs for instance after a bout of shingles). We already have drugs that can work on each type of pain, and these include Oxycodone (which is similar to morphine and good for your broken thumb), and Duloxetine, which works on neuropathic pain. ‘All the power of Oxycodone and Duloxetine wrapped up in one molecule!’ the Rep proudly informed me.

Well, if it has the combined strength of two drugs, is it not reasonable to expect it to be more effective than one of those drugs on its own? Apparently not. The best data she could show me was that Tapentadol was no less effective than Oxycodone.

‘I thought you said it was more effective?’ I asked her.

‘Oh it is, it has a dual mode of action.’ she replied.

‘But this just shows it’s no worse.’

‘But we know it is more effective.’

‘And how do we know this?’

‘The consultants at St George’s are using it.’

Well, much as I am sure I respect the consultants at St George’s, this is not what I would call evidence-based medicine.

When a Drug Rep shows you data you can be sure of one thing – it is the best data they have in favour of their drug. What you have to worry about is the data out there that they are not showing you. If this was the best she had in terms of efficacy, then this drug is not yet ready to convince me about its novel new dual mode of action.

It’s at times like this that I am glad of organisations like NICE which will look at whether these new agents really are what they claim to be – and even the PCT which gives increasingly tight guidance on what should usually be prescribed on the grounds of cost-effectiveness. Whilst we might not like being told what we can and cannot do, these organisations stop doctors jumping on the latest bandwagon and are some of our best defences against being hoodwinked by the pharmaceutical industry.

Hmmm, I seem to have strayed into politics. Well, sometimes you just have to do these things. Rant over.

Posted in Medicines | Tagged , , , , , | 4 Comments