Northern Doctor’s Antidote and the new blog

I used to have another blog, Northern Doctor’s Antidote, that I started in 2008. When it kicked off I can recall reading in one blogging guide that it was inexcusable to let a blog slowly languish, to let it atrophy and die a slow lingering web-death. I felt that was indeed happening so I pulled the plug. No valedictory message and no fuss. After all, let’s not over-egg it, no one really cares. Or very few anyway.

I had a lot of fun with the blog. The ‘antidote’ bit of the name came from Adam Smith’s quote:

Science is the great antidote to the poison of enthusiasm and superstition.

I still believe that but my views since 2008 have, perhaps, become more nuanced. The way the science is presented to the world is a serious problem and medical journals are, in many ways, deeply flawed. In addition to that there is a lot of nonsense out there; it would be a lifetime’s work to debunk all the myths, half-truths, woo, Big Pharma and media guff in the world. I certainly plan to continue blogging in that vein and doing my wee bit but I needed a new home. I have posted a handful of the old Northern Doctor posts here just to kick things off.

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The GP business model – a delicate balance

The GP business model – a delicate balance

Posted on Thursday, May 26, 2011 at northerndoctor.com

I can remember Andrew Lansley making the case at the last RCGP conference that one of the reasons that GPs are ideally placed to be intimately linked to commissioning was because of their independent status within the NHS.

The GP business model is frequently misunderstood. Most GPs are independent contractors who work in their own self-contained partnerships, employing staff and often owning their own premises. GPs have a great deal of independence in how they run their business but many wouldn’t be viable if they weren’t shackled to the NHS. They are not true free-marketeers by any stretch of the imagination. Most GPs have never really been involved in competition and they have enjoyed the privileged position of being in a business that is, collectively, too big to fail. A recent opinion article in Pulse written by Dr Paul Charlson (a Tory) pushes the case for opening up competition and claims that GPs ‘conveniently ignore they are private practices’. He, like many others advocating competition, conveniently ignores the current limitations on the GP business model.

Another article in Pulse suggesting ways GPs might seek to increase their practice list size also highlights the problem. One of the biggest factors in a practice’s income is the size of its list of patients. Therefore, getting more patients may seem like a great idea. Of course, it takes about two seconds to work out that this a zero-sum game. There are no extra people to register and no spares just sitting around waiting to be swept up by a diligent GP. The bottom line is that if one practice takes more patients then it does so entirely at the expense of a neighbouring practice that will lose the income.

The RCGP has been opposed to a relaxation of the rules on practice boundaries. A lot of patients find this irksome – particular commuting types who are rarely in their home areas within working hours. Many GPs will oppose practice boundary abolition out of naked self-interest as maintaining the practice boundary system retains their position of provider privilege. However, the restrictions around practice boundaries have provided a financial safety net for general practice and is one of the factors that helps to ensure a universal service.

The private practice status of the typical GP business is an awkward tension held together by the need to provide that universal service while allowing local flexibility. It isn’t a true blue, devil-take-the-hindmost competitive world and there are good reasons for that. Practices do make a profit but in most cases it is a modest one that pays GPs and their staff a reasonable salary. Most practices can’t make a significant profit above this but the quid pro quo is that they are unlikely to go bust. Don’t be persuaded by the straw man argument that GPs are already private providers and the NHS reforms are a natural development.

We only need to pull a few small threads to unravel the whole fabric of our primary care.

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Tobacco harm reduction – no smoke without fire

Tobacco harm reduction – no smoke without fire

Posted on Wednesday, November 18, 2009 at northerndoctor.com

Smoking kills millions of people every year and yet the medical community seems pathologically opposed to any measure to tackle the issue other than through the promotion of total abstinence.

Carl Phillips suggests in his paper in the Harm Reduction Journal this month that smoking for just one month is more dangerous than switching to a smokeless nicotine product for a lifetime. Take a moment to take a deep drag on a few breathtaking statistics. Across the world approximately 1.3 billion people use tobacco products and by 2030 it is estimated that 10 million people will die annually from smoking-related diseases and 70% of these deaths will be in developing countries. We’ve known about the harmful effects of smoking for over 50 years and yet over that same period 6 million Britons have died of tobacco-related disease.

It’s no secret that it’s hard to stop smoking. Bandolier published an interesting little analysis of trials which included smokers and heroin addicts. They asked: which is the most addictive? In a rather elegant twist they looked at the cessation rates in the placebo arms of all the relevant trials. Cessation rates for smokers were around 8-9% yet for opiates users were around 43%. No surprises there – smoking is extraordinarily difficult to stop. Even in those that are highly motivated 12 month cessation rates are often no better than 10%. Opposing a harm reduction approach might be doing a grave disservice to those that just find it too tough to stop.

I am intrigued by the concept of tobacco harm reduction – not least because it requires a considerable effort of will to put aside a pathological distrust of Big Tobacco. Some of this post is taken from one I posted over at doc2doc a few months ago. The very first comment on the blogpost at doc2doc sums up the gut reaction of many doctors:

I think we should dismiss this out of hand! This argument is like low tar cigarettes are healthier..so you can smoke more of them. There is no such things as a safe(r) cigarette. The safer cigarette makes no sense given my understanding of how nicotine receptors work, not to say addiction. Do not trust Big Tobacco who have a vested interest in not losing their customers.

End of. Decision made. One suspects that the notion of smokeless nicotine products is simply not endorsable by the scientific orthodoxy in any shape or form. Phillips addresses all the arguments and using a back of a fag packet (though he prefers an envelope) calculation suggests that:

Whatever the explanation for it, the present analysis shows that anti-THR [tobacco harm reduction] activism is deadly. Hiding THR from smokers, waiting for them to decide to quite entirely or waiting for a new anti-smoking magic bullet, causes the deaths of more smokers every month than a lifetime using low-risk nicotine products ever could.

If you are inclined to read the paper then flick to the back first and read the competing interests statement. Not for our Carl a bland ‘nothing to declare’ and instead it reads like a heartfelt plea that we pause, ignore the gut reaction and consider the evidence. It also speaks volumes for the ignominious role of mavericks in the scientific world; they may occasionally be lauded as heroes but more often they will be squeezed out of funding, shunned at the peer-review review stage and ostracised by their own community.

Within the wider medical community tobacco harm reduction remains an exercise in thinking the unthinkable. Doctors recommending it may be vilified and it opens up a researcher to accusations of acting as an industry patsy; labelled as a dull-eyed lackey in the pay of malignant giants. Yet it could save millions of lives and it certainly merits wider debate.

Phillips, C. (2009). Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments Harm Reduction Journal, 6 (1) DOI: 10.1186/1477-7517-6-29

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IV heroin – I predict a RIOTT

IV heroin – I predict a RIOTT

Posted on Tuesday, September 15, 2009 at northerndoctor.com

There is almost a sad inevitability about the discussion in the media around the issue of giving heroin to heroin users. When it come to heroin-assisted treatment (HAT) it is inevitable that any reasonable discussion will be drowned out by the clamouring commentariat.

The UK has been using heroin as part of the treatment of users in one form or another since 1926. More recently, there have been studies of HAT in Switzerland, Germany, the Netherlands and Canada which have shown benefits in health, psycho-social adjustment and illicit drug use to socially excluded heroin dependent patients resistant to other treatments.

However, it’s inevitable that ill-informed parallels will be drawn with alcohol, smoking and the funding of almost anything else in the NHS deemed more worthy. It’s even possible to drag in ‘our boys’ fighting the drugs (spot of mission creep here) war in Afghanistan if one wants to work up a proper lather. The RIOTT study (I am assuming the obligatory acronym is an ironic nod to the impact this study will have on Daily Mail readers) isn’t even published yet and already the hysteria begins…

Is it even worth discussing the science amongst this hubbub? It might be better to crawl back under the duvet, let the dust settle and have a more rational discussion when we actually have the results of the UK study.

But there is some science to look at and consider. It is only last month that the New England Journal of Medicine published the results of NAOMI, the North American Opiate Medication Initiative (another tortured acronym) which looked at exactly this issue and it’s probable that RIOTT will have similar results. NAOMI compared oral methadone versus injectable diamorphine. It was open-label and there was no attempt to blind users to their treatment. They had better retention in the diamorphine arm at 88% versus the methadone arm at 54%. The reduction in rates of illicit drugs were 67% in the heroin group and 48% in the methadone group. Overall, the diamorphine arm tended to do better.

There were clear benefits but it wasn’t without issues and there were serious adverse events. There were 18 events in the methadone group (n=111) but none of them were felt to be related to the treatment. In the diamorphine arm (n=115) there were a total of 51 serious adverse events. However, it was reckoned that 27 of these were directly related to the diamorphine and included overdoses and seizures. This has to be put in context: a total of 89,924 doses of diamorphine were self-administered during the course of the study so that’s 0.03% of injections causing an event.

There are some issues around the methodology. Users know what kind of trial they are entering and many will drop-out when they get randomised to methadone rather than injectable. Indeed, this was the case in this study and it raises some issues around bias. The methodology of RIOTT was published in the Harm Reduction Journal in 2006 and is available for free.

The final conclusion of the NEJM paper is a reasonable one:

In this trial, both diacetylmorphine treatment and optimized methadone maintenance treatment resulted in high retention and response rates. Methadone, provided according to best-practice guidelines, should remain the treatment of choice for the majority of patients. However, there will continue to be a subgroup of patients who will not benefit even from optimized methadone maintenance. Prescribed, supervised use of diacetylmor-phine appears to be a safe and effective adjunctive treatment for this severely affected population of patients who would otherwise remain outside the health care system.

It will certainly need to be given in a specialised environment so it is likely to remain a very limited intervention. The headlines have tended to highlight that crime rates fall. How can this be surprising? UK studies have shown reductions in criminal activity across all treatment modalities for years. Part of the reason for this emphasis is presumably to make it as palatable to the public as possible. It’s not enough for it to be a useful option to improve health in a limited group of treatment resistant users. There has to be a fringe benefit to society as well.

There is an excellent paper by the authors of NAOMI commenting on some of the controversies around HAT. Again, it is freely available at the Harm Reduction Journal and will give you as good a background knowledge of the issues around HAT as anything. The authors commented on the media:

Treating heroin addiction with heroin tends to evoke a knee-jerk reaction. Lack of understanding, restrictions on time and resources, and the need for a catchy headline often lead to sensationalism by the media. As previously mentioned, opposition both within Canada and the US also contributed to misleading reports from local, national, and international media. The resulting focus has been on a seeming shift in Canadian drug policy in direct contradiction to the US war on drugs, rather than on the scientific or medical merits of the NAOMI study.

Much hand-wringing will be provoked by these studies for the simple reason that some will perceive that the logical development of this whole debate is that the next step will be de-criminalisation of drugs. It is entirely possible that we are waging a phoney ‘war on drugs’ but that’s really not what these studies are all about.

Oviedo-Joekes E, Brissette S, Marsh DC, Lauzon P, Guh D, Anis A, & Schechter MT (2009). Diacetylmorphine versus methadone for the treatment of opioid addiction. The New England journal of medicine, 361 (8), 777-86 PMID: 19692689

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Homeopathic clairvoyant dogs. Er, barking.

Homeopathic clairvoyant dogs. Er, barking.

First posted on Friday, April 10, 2009 at northerndoctor.com

 

Hill PB, Hoare J, Lau-Gillard P, Rybnicek J, Mathie RT. Pilot study of the effect of individualised

homeopathy on the pruritus associated with atopic dermatitis in dogs. Vet Rec. 2009. 164(12):364-70

 

I am not a vet but I enjoy sniffing around The Veterinary Record on a weekly basis. After reading this article I was found wandering around the house guffawing loudly in pleasure at the insanity of the world. This is probably not the professional approach to critical appraisal so I turned to Trish for help.

Trisha Greenhalgh on ‘the science of “trashing” papers’ suggests that :

‘Strictly speaking if you are going to trash a paper, you should do so before you even look at the

results.’

This seems to be one of the most singularly useful and regularly ignored pieces of advice in the whole of critical appraisal. Ultimately, if the methodology of the trial is rubbish then stop reading. Stick your fingers in your ears and go nahnahnah. So given Trisha G’s comments let us consider the methodology for a moment. They took a load of itchy scratchy dogs and gave ‘em homeopathy. There were two phases:

Phase 1

Open phase. Owners with itchy pooches were invited to take part. There were 20 dogs in this phase and they were given individualised homeopathic remedies by a veterinary homeopath. They had their pruritus scores measured on a validated scale. If the owners felt there had been a substantial response to homeopathy they were invited to take part in Phase 2. Only 5 dogs showed any response but dog 15 was euthanased for an unrelated illness and dog 6 got better.

Phase 2

Blinded, randomised, placebo-controlled phase. There were 3 dogs left in this phase. This was actually a cross-over study where dogs received both a placebo and a homeopathic remedy in random order. They had their pruritus scores measured again during placebo and homeopathy phases. Why could they not just put dogs straight into Phase 2 and what purpose does the open phase possibly have? The main issue that screams at me from this is bias. BIAS! Volunteers are never an ideal sample for any trial but they have ratcheted it up another notch by further sub-selecting those that think there is an effect. There is also an issue with a cross-over design in a condition that is not stable. My understanding of atopic canine dermatitis is that is a disease that will wax and wane.

However, one of the few advantages of only having 20 subjects is that it is possible to give details of the doggie themselves. Whatever the concerns with the methodology this paper might be worth reading for these vital scientific details alone. Some highlights: dog 4 had an aversion to onions, dog 11 was very sensitive but did not console his owner, dog 15 has loud flatus when excited (who doesn’t) and dog 16 fears thunderstorms, desires chicken and is clairvoyant (I’m not making this up).Oh, one other thing. This study received funding from the British Homeopathic Society. Poor sampling, massive bias introduced systematically into the methodology, inadequate numbers and conflict of interest issues. Amusing doggie vignettes aside; my fingers are now in my ears.

The Veterinary Record has been publishing weekly for vets since 1888. The British Veterinary Association and the Vet Record are the vet equivalent of the BMA and the BMJ. One has to wonder what on earth happened to the peer-review process here.

Interestingly, the provision of homeopathy to animals is very well-regulated – it can only be provided by gen-u-ine vets. This is both reassuring and alarming in equal measure. It might ensure that animals do not receive ineffective therapies for serious illnesses but it does professionalise one of the most scientifically ludicrous alternative treatments in history. Homeopaths for humans could claim (although inexplicably they tend not to) that they are providing some kind of psychosocial intervention for the benefit of patients. After all, as Bob Hoskins once said: it’s good to talk. Of course, this potential benefit is somewhat diluted for vets who are not actually Dr Dolittle himself. What is left is a sugar pill coated with an active ingredient diluted to 200C. My advice is to cut out the middle dog and give the psychological intervention directly to the owner.

The British Homeopathic Association couldn’t resist trumpeting this trial and released a press release.

…a small, rigorously designed, research study at the University of Bristol’s Department of Clinical Veterinary Science.

The other four dogs that responded well in this first phase were then put forward into a blinded randomised trial in which they received their homeopathic prescription at some times and placebo atother times. The three dogs that completed this phase of the study improved more with the active remedy than with placebo, and owners were able to distinguish correctly which pill was which. As mentioned in the methodology there was just three dogs in Phase 2. If there was a 50/50 chance of the owners guessing correctly then there would be a one in eight chance (12.5%) of getting the results by chance alone. Statistical significance it ain’t. It is not too difficult to imagine tossing a coin three times and getting three heads in a row.

Dr Peter Hill, who was lead clinician on the study, said “These preliminary data indicate the need for a large randomised controlled trial of homeopathy in canine atopic dermatitis.”

In no way does this study constitute any evidence that there is some effect of homeopathy on pruritus in dogs. It certainly does not justify the “need for a large randomised controlled trial of homeopathy in canine atopic dermatitis.”

The discussion is a masterpiece of obfuscation. The authors trot out some miserable canards as they grasp for explanations as to why the homeopathy didn’t reach the success rate of ’60-70 per cent predicted’. The dogs remained on the immunosuppressants corticosteroids and ciclosporin and this interferes with the action of the homeopathic remedy. Because the cases were volunteers these were cases which were more difficult to treat. These cases were from a referral population so were more severe than usual.

They finally suggest:

“If the beneficial responses were due to spontaneous recoveries and chance occurrence, the failure rate would merely reflect the fact that homeopathy is not an effective treatment for canine atopic dermatitis.”

Bingo. The authors also seem to be confused about their motivations for the study. On one hand: The authors’ interpretation of the results is that they provide data to justify a larger study to determine whether the findings are repeatable.

Two paragraphs later and they are suggesting:

…the authors consider that the overall success or failure rate in this study is somewhat irrelevant. The

objective of this study was to determine whether homeopathic remedies appeared to be beneficial in

enough cases of canine atopic dermatitis to justify a larger trial. Even with a cautious interpretation,

the preliminary data appear to support that view…

This is all a touch circular. Surely the way to establish benefit is to conduct a proper randomised trial in the first instance. We are right back where we started. Labelling this study as a ‘pilot’ is a ruse to throw the scent off the appraisal hounds. If I may paraphrase Blackadder, this study has about as much power as an asthmatic ant with some heavy shopping. It is methodologically flawed with no reasonable conclusions.

The British Veterinary Voodoo Society have the measure of those that would pervert the evidence process.

Clinical trials are still in their early stages, however we are confident that by performing a sufficient

number of small, poorly-controlled investigations we will easily generate enough p<0.05 outcomes

to be able to claim with absolute assurance that the method is well proven by properly conducted

double-blind research.

So why publish it? You could drive a coach and horses through the holes in the methodology. I usually treat with deep suspicion any published ‘pilot’ trials. Pilots might be essential pieces of work to facilitate research projects but rarely justify independent publication. Imagine for one minute if this was a Big Pharma sponsored ‘pilot’ study. It wouldn’t get past the editor’s shredder. Yet alternative medicine seems to have a special dispensation to exert influence over journals of which Big Pharma can but dream.

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